S-1: General form of registration statement for all companies including face-amount certificate companies
Published on March 11, 2008
As
filed with the Securities and Exchange Commission on __________
Registration
Number 333-____
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
S-1
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
ACCESS
PHARMACEUTICALS,
INC.
(Exact
Name of Registrant as Specified in its Charter)
|
Delaware
(State
or other jurisdiction of
incorporation
or organization)
|
3841
(Primary
Standard Industrial
Classification
Code Number)
|
83-0221517
(I.R.S.
Employer
Identification
No.)
|
||
|
2600
Stemmons Freeway, Suite 176
Dallas,
Texas 75207
(214)
905-5100
(Address,
Including Zip Code, and Telephone Number, Including Area Code, of
Registrant’s Principal Executive Offices)
|
||||
|
Stephen
B. Thompson
Chief
Financial Officer
Access
Pharmaceuticals, Inc.
2600
Stemmons Freeway, Suite 176
Dallas,
Texas 75207
(214)
905-5100
(Name,
Address, Including Zip Code, and Telephone Number, Including Area
Code, of
Agent for Service)
|
||||
|
with
a copy to:
|
|
John
J. Concannon III, Esq.
Bingham
McCutchen LLP
150
Federal Street
Boston,
MA 02110
(617)
951-8000
|
Approximate
date of commencement of proposed sale to public:
As
soon as practicable after the effective date hereof.
If
any of
the securities being registered on this Form are to be offered on a delayed
or
continuous basis pursuant to Rule 415 under the Securities Act, check the
following box. þ
If
this
Form is filed to register additional securities for an offering pursuant to
Rule 462(b) under the Securities Act, check the following box and list the
Securities Act registration statement number of the earlier effective
registration statement for the same offering.
If
this
Form is a post-effective amendment filed pursuant to Rule 462(c) under the
Securities Act, check the following box and list the Securities Act registration
number of the earlier effective registration statement for the same offering.
If
this
Form is a post-effective amendment filed pursuant to Rule 462(d) under the
Securities Act, check the following box and list the Securities Act registration
number of the earlier effective registration statement for the same offering.
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company.
(Check one):
Larger
accelerated
filer ¨ Accelerated
filer ¨
Non-accelerated
filer ¨ Smaller
reporting company x
CALCULATION
OF REGISTRATION FEE
|
|
||||||||
|
Title
of Each Class of
Securities
to be Registered
|
Amount
to
be
Registered
|
Proposed
Maximum
Offering
Price
Per
Security
|
Proposed
Maximum
Aggregate
Offering
Price
|
Amount
of
Registration
Fee
|
||||
|
|
||||||||
|
Common
stock, $0.01 par value per share
|
11,666,195
(1)
|
$
2.01(5)
|
$23,449,052
|
$922
(5)
|
||||
|
Common
stock, $0.01 par value per share
|
4,149,464
(2)
|
$
2.01(5)
|
$8,340,423
|
$328
(5)
|
||||
|
Common
stock, $0.01 par value per share
|
772,728(
3)
|
$
2.01(5)
|
$1,553,183
|
$61
(5)
|
||||
|
Common
stock, $0.01 par value per share
|
1,582,360
(4)
|
$
2.01(5)
|
$3,180,544
|
$125
(5)
|
||||
|
Total
common stock, $0.01 par value per share
|
18,170,747
|
$36,523,202
|
$1,436
|
|||||
|
|
||||||||
(1) 11,666,195
shares are issuable
to selling stockholders upon
conversion of Series A Preferred Stock.
(2) 4,149,464
shares are issuable to
selling stockholders upon exercise of warrants
for
the purchase of shares of the Registrant's Common Stock at $3.50.
(3) 772,728
shares are issuable to selling stockholders upon the exercise of warrants for
the purchase of shares of the Registrant’s Common Stock at $1.35 per
share.
(4) 1,582,360
shares of Common Stock that may be issued as dividends on the Series A Preferred
Stock.
(5) Estimated
solely for the purpose of
calculating the registration fee pursuant to Rule 457(c) under the Securities
Act of 1933. For the purposes of this table, we have used the average of the
high and low prices as reported on the OTC Bulletin Board on March 6,
2008.
Pursuant
to Rule 416, there are also being registered such additional securities as
may
be issued to prevent dilution resulting from stock splits, stock dividends
or
similar transactions as a result of the anti-dilution provisions contained
in
the warrants and certificate of the Series A Preferred Stock.
THE
REGISTRANT HEREBY AMENDS THIS
REGISTRATION STATEMENT ON SUCH DATE OR DATES AS MAY BE NECESSARY TO DELAY ITS
EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE A FURTHER AMENDMENT WHICH
SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME
EFFECTIVE IN ACCORDANCE WITH SECTION 8(A) OF THE SECURITIES ACT OF 1933 OR
UNTIL
THE REGISTRATION STATEMENT SHALL BECOME EFFECTIVE ON SUCH DATE AS THE
COMMISSION, ACTING PURSUANT TO SECTION 8(A), MAY
DETERMINE.
INFORMATION
CONTAINED HEREIN IS SUBJECT TO COMPLETION OR AMENDMENT. A REGISTRATION STATEMENT
RELATING TO THESE SECURITIES HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION. THESE SECURITIES MAY NOT BE SOLD UNTIL THE REGISTRATION STATEMENT
BECOMES EFFECTIVE. THIS PROSPECTUS IS NOT AN OFFER TO SELL AND IS NOT A
SOLICITATION OF AN OFFER TO BUY IN ANY STATE IN WHICH AN OFFER, SOLICITATION,
OR
SALE IS NOT PERMITTED.
SUBJECT
TO COMPLETION, DATED ________, 2008
PROSPECTUS
ACCESS
PHARMACEUTICALS, INC.
18,170,747
Shares of Common Stock
This
Prospectus relates to the offer and sale of up to 18,170,747 shares of common
stock, $0.01 par value per share, of Access Pharmaceuticals, Inc. (“Access”) by
certain stockholders of Access, namely SCO Capital Partners LLC, (“SCO”) and
affiliates (SCO Capital Partners LP and Beach Capital LLC), Credit Suisse
Securities (USA) LLC, Enable Growth Partners LP, Edward and Patricia Kelly,
Dennis Lavalle, Lake End Capital LLC, David Luci, Midsummer Investment, Ltd.,
Oracle Partners LP and affiliates (Oracle Institutional Partners LP, Oracle
Offshore Ltd., SAM Oracle Investments, Inc.) Perceptive Life Sciences Master
Fund Ltd., Rockmore Investment Master Fund Ltd., Brio Capital LP, Catalytix
LDC
Life Science Hedge AC, Cobblestone Asset Management LLC, Cranshire Capital
LP,
Schroder & Co. Bank AG and Rodman and Renshaw LLC.
Access
is
not selling any shares of common stock in this offering and therefore will
not
receive any of the proceeds from this offering. However, if the
warrants are exercised, Access will receive the proceeds from such exercise
if
payment is made in cash. All costs associated with this registration
will be borne by Access.
The
shares of common stock are being offered for sale by the selling stockholders
at
prices established on the OTC Bulletin Board during the term of this offering.
On March 7, 2008, the last reported sale price of our common stock was $1.90
per
share. Our common stock is presently listed on the OTC Bulletin Board under
the
symbol “ACCP”. These prices will fluctuate based on the demand for the shares of
common stock.
Brokers
or dealers effecting transactions in these shares should confirm that the shares
are registered under the applicable state law or that an exemption from
registration is available.
No
underwriter or person has been engaged to facilitate the sale of shares of
common stock in this offering. None of the proceeds from the sale of stock
by
the selling stockholders will be placed in escrow, trust or any similar
account.
These
securities are speculative and involve a high degree of risk.
You
should purchase securities only if you can afford a complete loss of your
investment.
See
“Risk factors” beginning on page 10.
These
securities have not been approved or disapproved by the Securities and Exchange
Commission or any state securities commission nor has the Securities and
Exchange Commission or any state securities commission passed upon the accuracy
or adequacy of this Prospectus. Any representation to the contrary is a criminal
offense.
THE
DATE
OF THIS PROSPECTUS IS ________________, 2008.
| Page |
|
||
| PROSPECTUS SUMMARY | 1 |
|
|
|
EXPLANATORY
NOTE
|
1 | ||
|
ABOUT
ACCESS
|
1 | ||
|
SUMMARY
OF THE
OFFERING
|
5 | ||
|
SUMMARY
CONDENSED CONSOLIDATED FINANCIAL INFORMATION
|
6 | ||
| RISK FACTORS | 10 | ||
| FORWARD-LOOKING STATEMENTS | 19 | ||
| SELLING STOCKHOLDERS | 20 | ||
| USE OF PROCEEDS | 25 | ||
| PLAN OF DISTRIBUTION | 25 | ||
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
|
27 | ||
| DESCRIPTION OF BUSINESS | 39 | ||
| DESCRIPTION OF PROPERTY | 56 | ||
| CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING | |||
|
AND
FINANCIAL
DISCLOSURES
|
56 | ||
| DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS | 57 | ||
| LEGAL PROCEEDINGS | 68 | ||
|
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND
MANAGEMENT
|
68 | ||
|
TRANSACTIONS
WITH RELATED PERSONS, PROMOTERS AND CERTAIN
CONTROL PERSONS
|
73 | ||
| MARKET FOR OUR COMMON STOCK | 74 | ||
| DESCRIPTION OF SECURITIES | 77 | ||
| EXPERTS | 79 | ||
| LEGAL MATTERS | 79 | ||
| WHERE YOU CAN FIND MORE INFORMATION | 79 | ||
| FINANCIAL STATEMENTS | F-1 | ||
WE
HAVE NOT AUTHORIZED ANY DEALER, SALESPERSON OR OTHER PERSON TO GIVE ANY
INFORMATION OR TO MAKE ANY REPRESENTATIONS NOT CONTAINED IN THIS PROSPECTUS
OR
ANY PROSPECTUS SUPPLEMENT. YOU MUST NOT RELY ON ANY UNAUTHORIZED INFORMATION.
NEITHER THIS PROSPECTUS NOR ANY PROSPECTUS SUPPLEMENT IS AN OFFER TO SELL OR
A
SOLICITATION OF AN OFFER TO BUY ANY OF THESE SECURITIES IN ANY JURISDICTION
WHERE AN OFFER OR SOLICITATION IS NOT PERMITTED. NO SALE MADE PURSUANT TO THIS
PROSPECTUS SHALL, UNDER ANY CIRCUMSTANCES, CREATE ANY IMPLICATION THAT THERE
HAS
NOT BEEN ANY CHANGE IN OUR AFFAIRS SINCE THE DATE OF THIS
PROSPECTUS.
i
PROSPECTUS
SUMMARY
This
summary highlights selected information contained elsewhere in this Prospectus.
This summary does not contain all the information you should consider before
investing in shares of our common stock. You should read this entire Prospectus
carefully, including “Risk Factors” beginning on page 10 and our financial
statements and the notes to those financial statements beginning on F-1 before
making an investment decision.
EXPLANATORY
NOTE
Of
the
18,170,747 shares being registered for sale in this offering:
|
(1)
|
2,186,549
of such shares relate to shares of common stock underlying Series
A
Preferred Stock and common stock warrants which were issued to Oracle
and
affiliates on November 13, 2007 in exchange for the cancellation
of
$4,015,000 of principal amount of convertible promissory notes plus
interest, as amended, originally issued to Oracle on September 13,
2000.
The Company had previously registered the common stock underlying
such
convertible notes on a registration statement on Form S-1 Registration
Statement No. 333-135734 which was declared effective on August 7,
2006.
|
|
(2)
|
7,242,200
of such shares relate to shares of common stock underlying Series
A
Preferred Stock and common stock warrants which were issued to Lake
End
Capital LLC and SCO and affiliates on November 13, 2007 in exchange
for
the cancellation of $6,000,000 of principal amount of convertible
promissory notes plus interest originally issued to Lake End Capital
LLC
and SCO and affiliates on February 16, 2006 ($5,000,000), October
24, 2006
($500,000) and December 6, 2006, ($500,000). The Company had previously
registered the common stock underlying $5,000,000 of the convertible
notes
issued on a registration statement on Form S-1 Registration Statement
No.
333-135734, which was declared effective on August 7,
2006.
|
|
(4)
|
6,132,493
of such shares relate to shares of common stock underlying Series
A
Preferred Stock and common stock warrants acquired by new and certain
previously existing investors. Such shares include 2,499,998 shares
underlying Series A Preferred Stock and common stock warrants purchased
by
SCO and affiliates and 3,632,495 shares underlying Series A Preferred
Stock and common stock warrants purchased by new investors.
The issuance of such shares occurred in November 7, 2007 with regard
to 4,769,995 shares and February 4, 2008 with regard to 1,362,498
shares.
|
|
(4)
|
1,582,360
of such shares relate to common stock dividends which may be paid
on the
Series A Preferred Stock. The Series A Preferred Stock accrues
dividends at the rate of 6% per annum. Subject to certain
conditions being met, Access in its sole discretion may choose to
pay
these dividends in shares of common stock rather than in cash. The
common
stock dividend shares being registered represents anticipated dividends
on
the Series A Preferred Stock over 2 years assuming a fixed market
price of
$2.00 per share for Access’ common
stock.
|
|
(5)
|
772,728
of such shares relate to shares of common stock underlying common
stock
warrants acquired by Lake End Capital LLC and SCO and affiliates
in
October and December of 2005 for the aggregate issuance of $1,000,000
of
convertible promissory notes.
|
|
(6)
|
254,417
of
such shares
relate to shares of common stock underlying common stock warrants
paid to
Rodman & Renshaw, LLC, SCO Capital Partners LLC, and Lake End Capital
LLC as placement agent fees pursuant to the sale of the Series
A Preferred
Stock.
|
ABOUT
ACCESS
Company
Overview
Access
Pharmaceuticals, Inc. (“Access” or the “Company”) is a Delaware corporation. We
are an emerging biopharmaceutical company focused on developing products based
upon our nanopolymer chemistry technologies. We currently have one approved
product, two products in Phase 2 clinical trials and five products in
pre-clinical development.
|
·
|
MuGard™
is our approved product for the management of oral mucositis, a frequent
side-effect of cancer therapy for which there is no established treatment.
The market for mucositis treatment is estimated to be in excess of
US$1
billion world-wide. MuGard, a proprietary nanopolymer formulation,
has
received marketing allowance in the U.S. from the Food & Drug
Administration (“FDA”).
|
|
·
|
Our
lead development candidate for the treatment of cancer is ProLindac™, a
nanopolymer DACH-platinum prodrug. ProLindac is currently in a Phase
2
clinical trial being conducted in the EU in patients with ovarian
cancer.
The DACH-platinum incorporated in ProLindac is the same active moiety
as
that in oxaliplatin (Eloxatin; Sanofi-Aventis), which has sales in
excess
of $2.0 billion.
|
1
|
·
|
Pre-clinical
development of Cobalamin™, our proprietary nanopolymer oral drug delivery
technology based on the natural vitamin B12 uptake mechanism. We
are
currently developing a product for the oral delivery of
insulin.
|
|
·
|
Pre-clinical
development of Angiolix®, a humanized monoclonal antibody which acts as an
anti-angiogenesis factor and is targeted to cancer cells, notably
breast,
ovarian and colorectal cancers.
|
|
·
|
Pre-clinical
development of Prodrax®, a non-toxic prodrug which is activated in the
hypoxic zones of solid tumors to kill cancer
cells.
|
|
·
|
Pre-clinical
development of Alchemix®, a chemotherapeutic agent that combines multiple
modes of action to overcome drug
resistance.
|
|
·
|
Pre-clinical
development of Cobalamin-mediated targeted
delivery.
|
|
·
|
Phenylbutyrate
(“PB”), an HDAC inhibitor and a differentiating agent, is a Phase 2
clinical candidate being developed in collaboration with Virium
Pharmaceuticals.
|
Products
Access
used its drug delivery technologies to develop the following products and
product candidates:
Access
Drug Portfolio
|
Compound
|
Originator
|
Technology
|
Indication
|
Clinical
Stage
(1)
|
||||
|
MuGard™
|
Access
|
Mucoadhesive
liquid
|
Mucositis
|
Marketing
clearance received
|
||||
|
ProLindacTM
(Polymer
Platinate,
AP5346) (2)
|
Access
– U London
|
Synthetic
polymer
|
Cancer
|
Phase
2
|
||||
|
Phenylbutyrate
(PB)
|
National
Institute
of
Health
|
Small
molecule
|
Cancer
|
Phase
2
|
||||
|
Oral
Insulin
|
Access
|
Cobalamin
|
Diabetes
|
Pre-clinical
|
||||
|
Oral
Delivery System
|
Access
|
Cobalamin
|
Various
|
Pre-clinical
|
||||
|
Angiolix®
|
Immunodex,
Inc.
|
Humanized
monoclonal
antibody
|
Cancer
|
Pre-clinical
|
||||
|
Prodrax®
|
Univ
London
|
Small
molecule
|
Cancer
|
Pre-clinical
|
||||
|
Alchemix®
|
DeMontford
Univ
|
Small
molecule
|
Cancer
|
Pre-clinical
|
||||
|
Cobalamin-Targeted
Therapeutics
|
Access
|
Cobalamin
|
Anti-tumor
|
Pre-clinical
|
||||
|
(1)
|
For
more information, see “Government Regulation” for description of clinical
stages.
|
|
(2)
|
Licensed
from the School of Pharmacy, The University of London. Subject to
a 1%
royalty and milestone payments on
sales.
|
Other
Key Developments
On
February 12, 2008, the Board of Directors of the Company elected Steven H.
Rouhandeh as director and Chairman of the Board effective as of March 4,
2008.
On
February 4, 2008, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 272.5 shares of
our preferred stock, designated “Series A Cumulative Convertible Preferred
Stock”, par value $0.01 per share, for an issue price of $10,000 per share, (the
“Series A Preferred Stock”) and agreed to issue warrants to purchase 545,000
shares of our common stock, which includes placement agent warrants to purchase
90,883 shares of our common stock, at an exercise price of $3.50 per share,
for
an aggregate purchase price for the Series A Preferred Stock and Warrants of
$2,700,000. The shares of Series A Preferred Stock are convertible into common
stock at the initial conversion price of $3.00 per share.
2
On
January 14, 2008, we announced the signing of a definitive licensing agreement
under which RHEI Pharmaceuticals, Inc. will market and manufacture MuGard in
the
Peoples Republic of China and certain Southeast Asian countries. RHEI will
also
obtain the necessary regulatory approvals for MuGard in the
territory.
On
January 4, 2008 we closed the acquisition of Somanta Pharmaceuticals, Inc.
(“Somanta”). In connection with the merger, Access issued an aggregate of
approximately 1.5 million shares of Access Pharmaceuticals, Inc. common stock
to
the common and preferred shareholders of Somanta as consideration. In addition,
Access exchanged all outstanding warrants of Somanta for warrants to
purchase 191,991 shares of Access common stock at exercise prices ranging
between $18.55 and $69.57 per share.
On
December 26, 2007, Jeffrey B. Davis, Chairman of the Board of Directors was
named Chief Executive Officer. Stephen R. Seiler resigned as President and
Chief
Executive Officer and concurrently resigned from the Board of Directors
effective December 19, 2007.
On
November 7, 2007, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 954.0001 shares
of a newly created series of our preferred stock, designated “Series A
Cumulative Convertible Preferred Stock”, par value $0.01 per share, for an issue
price of $10,000 per share, (the “Series A Preferred Stock”) and agreed to issue
warrants to purchase 1,589,999 shares of our common stock at an exercise price
of $3.50 per share, for an aggregate purchase price for the Series A Preferred
Stock and Warrants of $9,540,001. The shares of Series A Preferred Stock are
convertible into common stock at the initial conversion price of $3.00 per
share.
As
a
condition to closing, SCO Capital Partners LLC and affiliates, along with the
other holders of an aggregate of $6,000,000 Secured Convertible Notes, also
exchanged their notes and accrued interest for an additional 1,836.0512 shares
of Series A Preferred Stock and were issued warrants to purchase 1,122,031
shares of our common stock at an exercise price of $3.50 per share, and Oracle
Partners LP and affiliates, along with the other holders of an aggregate of
$4,015,000 Convertible Notes also exchanged their notes and accrued interest
for
437.3104 shares of the Series A Preferred Stock and were issued warrants to
purchase 728,850 shares of our common stock at an exercise price of $3.50 per
share. SCO Capital Partners LLC currently has two designees serving on our
Board
of Directors. In connection with the exchange of the notes, all security
interests and liens relating thereto were terminated.
As
a
condition to closing, we entered into an Investor Rights Agreement with each
of
the investors purchasing shares of Series A Preferred Stock, and our Board
of
Directors approved with respect to the shareholder rights plan any action
necessary under our shareholder rights plan to accommodate the issuance of
the
Series A Preferred Stock and warrants without triggering the applicability
of
the shareholder rights plan. The Investor Rights Agreement grants certain
registration and other rights to each of the investors.
In
connection with the sale and issuance of Series A Preferred Stock and warrants,
we entered into a Director Designation Agreement whereby we agreed to continue
SCO’s right to designate two individuals to serve on the Board of Directors of
Access.
On
August
27, 2007, we signed a definitive licensing agreement with SpePharm Holding,
B.V.
under which SpePharm will market Access’ product MuGard in Europe.
On
August
1, 2007, we announced that Esteban Cvitkovic, a member of our board of directors
as Vice Chairman Europe, agreed to an expanded role as Senior Director, Oncology
Clinical R&D.
On
April
26, 2007, we entered into a Note Purchase Agreement with Somanta
Pharmaceuticals, Inc. in order for Access to loan Somanta amounts to keep
certain of their licenses and vendors current. As of September 30, 2007 we
have
loaned Somanta $859,000.
All
shares and per share information reflect a one for five reverse stock split
effected June 5, 2006.
On
December 8, 2006 Access amended its 2005 Asset Sale Agreement with Uluru, Inc.
Access received from Uluru an upfront payment of $4.9 million, received an
additional $350,000 on April 9, 2007 and in the future could receive potential
milestones of up to $4.8 million based on Uluru sales. The amendment agreement
included the anniversary payment due October 12, 2006, the early payment of
the
two year anniversary payment, and a payment in satisfaction of certain future
milestones. Access also transferred to Uluru certain patent applications that
Access had previously licensed to Uluru under the 2005 License Agreement. Under
a new agreement, Access has acquired a license from Uluru to utilize the
nanoparticle aggregate technology contained in the transferred patent
applications for subcutaneous, intramuscular, intra-peritoneal and intra-tumoral
drug delivery. Additionally, one future milestone was increased by
$125,000.
3
On
October 12, 2005, Access sold its oral/topical care business unit to Uluru,
Inc,
a private Delaware corporation, for up to $18.8 million to focus on Access’
technologies in oncology and oral drug delivery. The products and technologies
sold to Uluru included amlexanox 5% paste (marketed under the trade names
Aphthasol® and Aptheal®), OraDiscTM,
Zindaclin® and Residerm® and all of Access’ assets related to these products. In
addition, Access sold to Uluru its nanoparticle hydrogel aggregate technology
which could be used for applications such as local drug delivery and tissue
filler in dental and soft tissue applications. Access received a license from
Uluru for certain applications of the technology. The CEO of Uluru is Kerry
P.
Gray, the former CEO of Access. In conjunction with the sale transaction, Access
received a fairness opinion from a nationally recognized investment banking
firm.
At
the
closing of the sale to Uluru, Access received $8.7 million. In addition, in
connection with the Amended Asset Sale Agreement in December 2006, Access
received $4.9 million and received an additional $350,000 on April 9, 2007
for
the first and second anniversary payments and settlement of certain milestones.
Access recorded $550,000 less $173,000 tax expense as revenue from the
discontinued operations in 2006.
Access
was incorporated in Wyoming in 1974 as Chemex Corporation, and in 1983 Access
changed its name to Chemex Pharmaceuticals, Inc. Access changed its state of
incorporation from Wyoming to Delaware on June 30, 1989. In 1996 Access merged
with Access Pharmaceuticals, Inc., a private Texas corporation, and changed
its
name to Access Pharmaceuticals, Inc. Access’ principal executive office is
located at 2600 Stemmons Freeway, Suite 176, Dallas, Texas 75207; Access’
telephone number is (214) 905-5100.
|
|
4
SUMMARY
OF THE OFFERING
This
offering relates to the sale of common stock by certain persons who are the
selling stockholders who intend to sell up to 18,170,747 shares of common stock,
consisting of (1) 11,666,195 shares are issuable to selling stockholders upon
conversion of Series A Preferred Stock, (2) 4,149,464 shares are issuable to
selling stockholders upon exercise of warrants for the purchase of shares of
the
Registrant's Common Stock at $3.50, including shares issuable to selling
stockholders upon the exercise of warrants for the purchase of shares of the
Registrant's Common Stock at $3.50 received as placement agent fees pursuant
to
the sale of Series A Preferred Stock, (3) 772,728 shares are issuable to selling
stockholders upon the exercise of warrants for the purchase of shares of the
Registrant’s Common Stock at $1.35 per share and (4) 1,582,360 shares of Common
Stock that may be issued as dividends on the Series A Preferred
Stock.
In
connection with the Closing, our Board of Directors approved with respect to
the
shareholder rights plan any action necessary under our shareholder rights plan
to accommodate the issuance of the Series A Preferred Stock and warrants without
triggering the applicability of the shareholder rights plan.
Unless
a
holder of Series A Preferred Stock either elected otherwise prior to the
purchase of such preferred stock or elects otherwise upon not less than 61
days
prior written notice, its ability to convert its Series A Preferred Stock into
common stock or to vote on an as-if-converted to common stock basis is
restricted pursuant to a beneficial ownership cap to the extent that such
conversion would result in the holder owning more than 4.99% of our issued
and
outstanding common stock or voting together with the common stock on an
as-if-converted to common stock basis in respect of more than 4.99% of our
issued and outstanding common stock. The warrants issued in connection with
the
Series A Preferred Stock are subject to a similar beneficial ownership cap
restriction on their exercise. SCO Capital Partners LLC, SCO Capital Partners,
L.P. and Beach Capital LLC have elected not to be governed by these
restrictions.
Our
registration of these shares does not necessarily mean that the selling
shareholders will convert or exercise the any of these shares or warrants or
sell any or all of the shares of our common stock that we are
registering.
|
Common
stock offered by Access:
|
None.
|
|
Common
stock offered by selling shareholders:
|
18,170,747
shares, which includes 11,666,195 shares issuable upon conversion
of
Series A Preferred Stock, 4,149,464 issuable upon exercise of warrants,
1,582,360 shares to be issued as dividends and 772,728 issuable upon
exercise of warrants as described
above.
|
|
Common
stock outstanding:
|
As
of March 6, 2008, 5,623,781 shares of our common stock were issued
and
outstanding.
|
|
Offering
Price:
|
To
be determined by the prevailing market price for the shares at the
time of
the sale or in negotiated
transactions.
|
|
Proceeds
to Access:
|
We
will not receive proceeds from the resale of shares by the selling
shareholders. If the warrants described herein are fully exercised
without
using any applicable cashless exercise provisions, we will receive
approximately $15,566,307 in cash from the warrant
holders.
|
|
Use
of proceeds:
|
We
will not receive any of the proceeds from the sale by any selling
shareholder of our common stock offered hereby, although in the event
that
the warrants are fully exercised without using any applicable cashless
exercise provisions, we will receive approximately $15,566,307 in
cash. We
intend to use these proceeds, if any, for general corporate
purposes.
|
|
OTC
Bulletin Board Symbol:
|
ACCP:OB
|
|
|
5
SUMMARY
CONDENSED CONSOLIDATED FINANCIAL INFORMATION
The
following summary condensed consolidated financial information as of and for
the
years ended December 31, 2006, 2005, 2004, 2003, and 2002 have been derived
from our audited financial statements. The financial information as of and
for
the nine months ended September 30, 2007 and 2006 is derived from our unaudited
condensed financial statements. The summary condensed consolidated financial
information set forth below should be read in conjunction with “Management's
Discussion and Analysis of Financial Condition and Results of Operations” and
the financial statements and notes thereto included elsewhere in this
Prospectus.
|
For
the Nine
Months
Ended
September
30
|
For
the Year Ended
December 31,
|
|||||||
|
2007
|
2006
|
2006
|
2005
|
2004
|
2003
|
2002
|
||
|
(in
thousands, except amounts per
share)
|
||||||||
|
Consolidated
Statement of Operations and Comprehensive Loss Data:
|
||||||||
|
Total
revenues
|
$ | 6 | $ | - | $ | - | $ | - | $ | - | $ | - | $ | 89 | ||||||||||||||
|
Operating
loss
|
(4,988 | ) | (4,129 | ) | (5,175 | ) | (9,622 | ) | (6,003 | ) | (5,426 | ) | (5,925 | ) | ||||||||||||||
|
Interest
and miscellaneous income
|
72 | 278 | 294 | 100 | 226 | 279 | 594 | |||||||||||||||||||||
|
Interest
and other expense
|
(3,277 | ) | (5,244 | ) | (7,436 | ) | (2,100 | ) | (1,385 | ) | (1,281 | ) | (1,278 | ) | ||||||||||||||
|
Unrealized
loss on fair value of warrants
|
- | (1,107 | ) | (1,107 | ) | - | - | - | - | |||||||||||||||||||
|
Income
tax benefit
|
- | - | 173 | 4,067 | - | - | - | |||||||||||||||||||||
|
Loss
from continuing operations
|
(8,193 | ) | (10,202 | ) | (13,251 | ) | (7,555 | ) | (7,162 | ) | (6,428 | ) | (6,520 | ) | ||||||||||||||
|
Discontinued
operations net of taxes
|
||||||||||||||||||||||||||||
|
($173
in 2006 and $4,067 in 2005)
|
- | - | 377 | 5,855 | (3,076 | ) | (507 | ) | (2,864 | ) | ||||||||||||||||||
|
Net
loss
|
(8,193 | ) | (10,202 | ) | (12,874 | ) | (1,700 | ) | (10,238 | ) | (6,935 | ) | (9,384 | ) | ||||||||||||||
|
Common
Stock Data:
|
||||||||||||||||||||||||||||
|
Net
loss per basic and
diluted
common share
|
$ | (2.31 | ) | $ | (2.89 | ) | $ | (3.65 | ) | $ | (0.53 | ) | $ | (3.38 | ) | $ | (2.61 | ) | $ | (3.58 | ) | |||||||
|
Weighted
average basic and
diluted
common shares
outstanding
|
3,544 | 3,531 | 3,532 | 3,237 | 3,032 | 2,653 | 2,621 | |||||||||||||||||||||
|
September
30,
|
December
31,
|
||||||
|
2007
|
2006
|
2006
|
2005
|
2004
|
2003
|
2002
|
|
|
(in
thousands)
|
|||||||
|
Consolidated
Balance Sheet Data:
|
|||||||||||||||||||||||||||||
|
Cash,
cash equivalents and
short
term investments
|
$ | 1,176 | $ | 705 | $ | 4,389 | $ | 474 | $ | 2,261 | $ | 2,587 | $ | 9,776 | ||||||||||||||
|
Restricted
cash
|
- | - | - | 103 | 1,284 | 649 | 468 | |||||||||||||||||||||
|
Total
assets
|
3,500 | 7,073 | 6,426 | 7,213 | 11,090 | 11,811 | 19,487 | |||||||||||||||||||||
|
Deferred
revenue
|
1,167 | 173 | 173 | 173 | 1,199 | 1,184 | 1,199 | |||||||||||||||||||||
|
Convertible
notes, net of discount
|
16,906 | 17,608 | 8,833 | 7,636 | 13,530 | 13,530 | 13,530 | |||||||||||||||||||||
|
Total
liabilities
|
20,691 | 21,272 | 16,313 | 11,450 | 17,751 | 17,636 | 18,998 | |||||||||||||||||||||
|
Total
stockholders' equity (deficit)
|
(17,191 | ) | (14,199 | ) | (9,887 | ) | (4,237 | ) | (6,661 | ) | (5,825 | ) | 489 |
Somanta
We
have
derived the following historical information from Somanta’s audited consolidated
financial statements from inception through the fiscal year ended April 30,
2006
contained in Somanta’s annual reports on Form 10-KSB. The information is
only a summary and should be read in conjunction with Somanta’s consolidated
financial statements and accompanying notes, as well as management’s discussion
and analysis of results of operations and financial condition, all of which
can
be found in publicly available documents, including those incorporated by
reference into this Registration Statement.
6
|
For
the Years Ended April 30,
|
||||||||||
|
2007
|
2006
|
2005
|
||||||||
|
(In
thousands, except per share data)
|
||||||||||
|
Consolidated
Statement of Operations and Comprehensive Loss Data
|
||||||||||
|
Total
revenues
|
$
|
1
|
$
|
1
|
$
|
-
|
||||
|
Operating
loss
|
(4,550
|
)
|
(4,108
|
)
|
(1,129
|
)
|
||||
|
Interest
and miscellaneous income
|
28
|
17
|
-
|
|||||||
|
Interest
and other expense
|
(2,969
|
)
|
(908
|
)
|
-
|
|||||
|
Income
tax
|
4
|
2
|
-
|
|||||||
|
Net
loss
|
(7,496
|
)
|
(5,002
|
)
|
(1,129
|
)
|
||||
|
Deemed
dividends on convertible preferred stock
|
-
|
(1,522
|
)
|
-
|
||||||
|
Net
loss applicable to common shareholders
|
(7,496
|
)
|
(6,524
|
)
|
(1,129
|
)
|
||||
|
Comprehensive
loss-foreign currency translation adjustment
|
-
|
-
|
(6
|
)
|
||||||
|
Comprehensive
loss
|
(7,496
|
)
|
(6,524
|
)
|
(1,135
|
)
|
||||
|
Common
Stock Data:
|
||||||||||
|
Net
loss per basic and diluted
common
share
|
$
|
(0.56
|
)
|
$
|
(0.47
|
)
|
$
|
(0.20
|
)
|
|
|
Weighted
average basic and
diluted
common shares
outstanding
|
14,278,247
|
14,274,365
|
5,576,845
|
|||||||
|
As
of April 30,
|
|||||||
|
2007
|
2006
|
||||||
|
(In
thousands)
|
|||||||
|
Consolidated Balance
Sheet Data
|
|||||||
|
Cash,
cash equivalents and short term investments
|
$
|
5
|
$
|
1,588
|
|||
|
Restricted
cash
|
2
|
152
|
|||||
|
Total
assets
|
67
|
1,859
|
|||||
|
Current
liabilities
|
8,245
|
3,443
|
|||||
|
Total
liabilities
|
8,245
|
3,443
|
|||||
|
Total
stockholders' equity (deficit)
|
(8,178
|
)
|
(1,585
|
)
|
|||
|
|
7
Selected
Unaudited Pro Forma Condensed Combined Financial Data
The
following unaudited pro forma condensed combined financial statements are based
upon the historical condensed consolidated financial statements and notes
thereto (as applicable) of Access and Somanta, which are included elsewhere
in
this Registration Statement. The financial data gives pro forma effect to the
merger as if the merger had been completed on September 30, 2007 for the
unaudited pro forma condensed combined balance sheet and January 1, 2006 for
the
unaudited pro forma condensed combined statement of operations.
Somanta
preferred and common stockholders received approximately 1,500,000 shares of
Access common stock for Somanta capital stock they owned immediately prior
to the completion of the merger.
The
pro
forma adjustments are based upon available information and certain assumptions
that Access believes are reasonable under the circumstances. A final
determination of fair values relating to the merger, which could not be made
prior to the completion of the merger, may differ materially from the
preliminary estimates and will include management’s final valuation of the fair
value of assets acquired and liabilities assumed. This final valuation will
be
based on the actual net tangible assets of Somanta that existed as of the date
of the completion of the merger. The final valuation may change the allocations
of the purchase price, which could affect the fair value assigned to the assets
and liabilities and could result in a change to the unaudited pro forma
condensed combined financial statements data. These adjustments are more fully
described in the notes to the unaudited pro forma condensed combined financial
statements under the heading “Unaudited Pro Forma Condensed Combined Financial
Statements.” beginning on page F-80.
The
selected unaudited pro forma condensed combined financial data (i) have been
derived from and should be read in conjunction with the unaudited pro forma
condensed combined financial statements and accompanying notes included in
this
Registration Statement as described under “Unaudited Pro Forma Condensed
Combined Financial Statements” beginning on page F-80, and (ii) should be read
in conjunction with the consolidated financial statements of Access and Somanta
and other information filed by Access and Somanta with the SEC and incorporated
by reference into this Registration Statement.
|
Unaudited
Pro Forma Condensed Combined
Consolidated
Statement of Operations Data:
|
For
the Twelve
Months
Ended
December
31, 2006
|
For
the Nine
Months
Ended
September
30, 2007
|
|||||
|
(in
thousands)
|
(in
thousands)
|
||||||
|
Total
revenues
|
$
|
1
|
$
|
7
|
|||
|
Total
expenses
|
9,727
|
7,531
|
|||||
|
Loss
from operations
|
(9,726
|
)
|
(7,524
|
)
|
|||
|
Interest
and miscellaneous income
|
322
|
84
|
|||||
|
Interest
and other expenses
|
(7,436
|
)
|
(3,304
|
)
|
|||
|
Change
in fair value of warrant liabilities
|
(4,038
|
)
|
5,807
|
|
|||
|
Net
loss before discontinued
operations
and before tax benefit
|
(20,916
|
)
|
(4,939
|
)
|
|||
|
Income
tax benefit
|
169
|
-
|
|||||
|
Loss
from continuing operations
|
(20,747
|
)
|
(4,939
|
)
|
|||
|
Discontinued
operations, net of
taxes
of $173,000
|
377
|
-
|
|||||
|
Net
loss
|
$
|
(20,370
|
)
|
$
|
(4,943
|
)
|
|
Note
1:
The above statement gives effect to the merger of Access and Somanta, as
if the
merger had occurred on January 1, 2006. Somanta statements used were for
the
twelve months ended April 30, 2007 and the nine month period ended October
31,
2007.
|
|
8
|
Unaudited
Pro Forma Condensed Combined
Consolidated
Balance Sheet:
|
As
of September 30, 2007
|
||||
|
(in
thousands)
|
|||||
|
Cash
and cash equivalents
|
$
|
663
|
|||
|
Short
term investments, at cost
|
515
|
||||
|
Total
current assets
|
1,361
|
||||
|
Property
and equipment, net
|
170
|
||||
|
Patents
net
|
752
|
||||
|
Total
assets
|
2,308
|
||||
|
Accounts
payables and accrued expenses
|
3,538
|
||||
|
Current
portion of long-term debt net of discount
|
11,406
|
||||
|
Long-term
debt
|
5,500
|
||||
|
Total
liabilities
|
22,921
|
||||
|
Additional
paid-in capital
|
77,172
|
||||
|
Notes
receivable from stockholders
|
(1,045
|
)
|
|||
|
Accumulated
deficit
|
(96,787
|
)
|
|||
|
Total
stockholders’ deficit
|
(20,613
|
)
|
|||
Note
1:
The above statement gives effect to the merger of Access and Somanta, as
if the
merger had occurred on January 1, 2006. Somanta statements used were for
the
period ended October 31, 2007.
|
|
9
RISK
FACTORS
Any
investment in our securities involves a high degree of risk. You should
carefully consider the risks described below, which we believe represent certain
of the material risks to our business, together with the information contained
elsewhere in this Prospectus, before you make a decision to invest in our
company.
Without
obtaining adequate capital funding, Access may not be able to continue as a
going concern.
The
report of Access’ independent registered public accounting firm for the fiscal
year ended December 31, 2006 contained a fourth explanatory paragraph to reflect
its significant doubt about Access’ ability to continue as a going concern as a
result of Access’ history of losses and Access’ liquidity position. If Access is
unable to obtain adequate capital funding in the future, Access may not be
able
to continue as a going concern, which would have an adverse effect on Access’
business and operations, and investors’ investment in Access may
decline.
Access
has experienced a history of losses, Access expects to incur future losses
and
Access may be unable to obtain necessary additional capital to fund operations
in the future.
Access
has recorded minimal revenue to date and Access has incurred a cumulative
operating loss of approximately $8.2 million for the nine months ended September
30, 2007. Net losses for the years ended 2006, 2005 and 2004 were $12,874,000,
$1,700,000 and $10,238,000, respectively. Access’ losses have resulted
principally from costs incurred in research and development activities related
to Access’ efforts to develop clinical drug candidates and from the associated
administrative costs. Access expects to incur additional operating losses over
the next several years. Access also expects cumulative losses to increase if
Access expands research and development efforts and preclinical and clinical
trials. Access’ net cash burn rate for the nine months ended September 30, 2007
was approximately $430,000 per month. Access projects its net cash burn rate
from operations for the next 15 months to be approximately $450,000 per month.
Capital expenditures are forecasted to be minor for the next 15
months.
Access
requires substantial capital for its development programs and operating
expenses, to pursue regulatory clearances and to prosecute and defend its
intellectual property rights. Access believes that its existing capital
resources, interest income, product sales, royalties and revenue from possible
licensing agreements and collaborative agreements will be sufficient to fund
its
currently expected operating expenses and capital requirements into the
second quarter of 2009. Access will need to raise substantial additional capital
to support its ongoing operations.
If
Access
does raise additional funds by issuing equity securities, further dilution
to
existing stockholders would result and future investors may be granted rights
superior to those of existing stockholders. If adequate funds are not available
to Access through additional equity offerings, Access may be required to delay,
reduce the scope of or eliminate one or more of its research and development
programs or to obtain funds by entering into arrangements with collaborative
partners or others that require Access to issue additional equity securities
or
to relinquish rights to certain technologies or drug candidates that Access
would not otherwise issue or relinquish in order to continue independent
operations.
Access
has issued and outstanding shares of Series A Preferred Stock with rights and
preferences superior to those of its common stock.
The
issued and outstanding shares of Series A Preferred Stock grants the holders
of
such preferred stock anti-dilution, dividend and liquidations rights that are
superior to those held by the holders of our common stock. Should
Access issue additional shares of common stock for a price below $3.00 per
share, the conversion price of the Series A Preferred Stock shall be lowered
to
the lowest issue price below $3.00 per share which will have the effect of
diluting the holders of our common stock.
10
Access
does not have operating revenue and it may never attain
profitability.
To
date,
Access has funded its operations primarily through private sales of common
stock, preferred stock and convertible notes. Contract research payments and
licensing fees from corporate alliances and mergers have also provided funding
for its operations. Its ability to achieve significant revenue or profitability
depends upon its ability to successfully complete the development of drug
candidates, to develop and obtain patent protection and regulatory approvals
for
Access’ drug candidates and to manufacture and commercialize the resulting
drugs. Access sold its only revenue producing assets to Uluru, Inc. in October
2005. Access is not expecting any revenues in the short-term from its other
assets. Furthermore, Access may not be able to ever successfully identify,
develop, commercialize, patent, manufacture, obtain required regulatory
approvals and market any additional products. Moreover, even if Access does
identify, develop, commercialize, patent, manufacture, and obtain required
regulatory approvals to market additional products, Access may not generate
revenues or royalties from commercial sales of these products for a significant
number of years, if at all. Therefore, its proposed operations are subject
to
all the risks inherent in the establishment of a new business
enterprise. In the next few years, its revenues may be limited to
minimal product sales and royalties, any amounts that Access receives under
strategic partnerships and research or drug development collaborations that
Access may establish and, as a result, Access may be unable to achieve or
maintain profitability in the future or to achieve significant revenues in
order
to fund its operations.
Although
Access and Somanta expect that the merger will result in benefits to the
combined company the combined company may not realize those benefits because
of
integration and other challenges.
Access’
ability to realize the anticipated benefits of the merger will depend, in part,
on the ability of Access to integrate the business of Somanta with the business
of Access. The combination of two independent companies is a complex, costly
and
time-consuming process. This process may disrupt the business of either or
both
of the companies, and may not result in the full benefits expected by Access
and
Somanta. The difficulties of combining the operations of the companies include,
among others:
|
•
|
unanticipated
issues in integrating information, communications and other
systems;
|
|
•
|
retaining
key employees;
|
|
•
|
consolidating
corporate and administrative
infrastructures;
|
|
•
|
the
diversion of management’s attention from ongoing business concerns;
and
|
|
•
|
coordinating
geographically separate
organizations.
|
Access
may not successfully commercialize its drug candidates.
Access’
drug candidates are subject to the risks of failure inherent in the development
of pharmaceutical products based on new technologies, and its failure to develop
safe commercially viable drugs would severely limit its ability to become
profitable or to achieve significant revenues. Access may be unable to
successfully commercialize Access’ drug candidates because:
|
·
|
some
or all of its drug candidates may be found to be unsafe or ineffective
or
otherwise fail to meet applicable regulatory standards or receive
necessary regulatory clearances;
|
|
·
|
its
drug candidates, if safe and effective, may be too difficult to develop
into commercially viable drugs;
|
|
·
|
it
may be difficult to manufacture or market its drug candidates on
a large
scale;
|
|
·
|
proprietary
rights of third parties may preclude it from marketing its drug
candidates; and
|
|
·
|
third
parties may market superior or equivalent
drugs.
|
11
The
success of Access’ research and development activities, upon which Access
primarily focuses, is uncertain.
Access’
primary focus is on its research and development activities and the
commercialization of compounds covered by proprietary biopharmaceutical patents
and patent applications. Research and development activities, by their nature,
preclude definitive statements as to the time required and costs involved in
reaching certain objectives. Actual research and development costs, therefore,
could exceed budgeted amounts and estimated time frames may require extension.
Cost overruns, unanticipated regulatory delays or demands, unexpected adverse
side effects or insufficient therapeutic efficacy will prevent or substantially
slow Access’ research and development effort and Access’ business could
ultimately suffer. Access anticipates that it will remain principally engaged
in
research and development activities for an indeterminate, but substantial,
period of time.
Access
may be unable to successfully develop, market, or commercialize its products
or
its product candidates without establishing new relationships and maintaining
current relationships.
Access’
strategy for the research, development and commercialization of its potential
pharmaceutical products may require it to enter into various arrangements with
corporate and academic collaborators, licensors, licensees and others, in
addition to its existing relationships with other parties. Specifically, Access
may seek to joint venture, sublicense or enter other marketing arrangements
with
parties that have an established marketing capability or Access may choose
to
pursue the commercialization of such products on its own. Access may, however,
be unable to establish such additional collaborative arrangements, license
agreements, or marketing agreements as Access may deem necessary to develop,
commercialize and market Access’ potential pharmaceutical products on acceptable
terms. Furthermore, if Access maintains and establishes arrangements or
relationships with third parties, its business may depend upon the successful
performance by these third parties of their responsibilities under those
arrangements and relationships.
Access’
ability to successfully commercialize, and market Access’ product candidates
could be limited if a number of these existing relationships were
terminated.
Furthermore,
its strategy with respect to its polymer platinate program is to enter into
a
licensing agreement with a pharmaceutical company pursuant to which the further
costs of developing a product would be shared with its licensing partner.
Although Access has had discussions with potential licensing partners with
respect to its polymer platinate program, to date Access has not entered into
any licensing arrangement. Access may be unable to execute its licensing
strategy for polymer platinate.
Access
may be unable to successfully manufacture its products and its product
candidates in clinical quantities or for commercial purposes without the
assistance of contract manufacturers, which may be difficult for it to obtain
and maintain.
Access
has limited experience in the manufacture of pharmaceutical products in clinical
quantities or for commercial purposes and Access may not be able to manufacture
any new pharmaceutical products that Access may develop. As a result, Access
has
established, and in the future intends to establish arrangements with contract
manufacturers to supply sufficient quantities of products to conduct clinical
trials and for the manufacture, packaging, labeling and distribution of finished
pharmaceutical products if any of its potential products are approved for
commercialization. If Access is unable to contract for a sufficient supply
of
its potential pharmaceutical products on acceptable terms, its preclinical
and
human clinical testing schedule may be delayed, resulting in the delay of its
clinical programs and submission of product candidates for regulatory approval,
which could cause its business to suffer. Its business could suffer if there
are
delays or difficulties in establishing relationships with manufacturers to
produce, package, label and distribute its finished pharmaceutical or other
medical products, if any, market introduction and subsequent sales of such
products. Moreover, contract manufacturers that Access may use must adhere
to
current Good Manufacturing Practices, as required by the FDA. In this regard,
the FDA will not issue a pre-market approval or product and establishment
licenses, where applicable, to a manufacturing facility for the products until
the manufacturing facility passes a pre-approval plant inspection. If Access
is
unable to obtain or retain third party manufacturing on commercially acceptable
terms, Access may not be able to commercialize its products as planned. Its
potential dependence upon third parties for the manufacture of its products
may
adversely affect its ability to generate profits or acceptable profit margins
and its ability to develop and deliver such products on a timely and competitive
basis. ProLindac™
is manufactured by third parties for Access’ Phase 2 clinical trials.
Manufacturing is ongoing for the current clinical trials. Certain manufacturing
steps are conducted by the Company to enable significant cost savings to be
realized.
12
Access
is subject to extensive governmental regulation which increases its cost of
doing business and may affect its ability to commercialize any new products
that
Access may develop.
The
FDA
and comparable agencies in foreign countries impose substantial requirements
upon the introduction of pharmaceutical products through lengthy and detailed
laboratory, preclinical and clinical testing procedures and other costly and
time-consuming procedures to establish its safety and efficacy. All of its
drugs
and drug candidates require receipt and maintenance of governmental approvals
for commercialization. Preclinical and clinical trials and manufacturing of
its
drug candidates will be subject to the rigorous testing and approval processes
of the FDA and corresponding foreign regulatory authorities. Satisfaction of
these requirements typically takes a significant number of years and can vary
substantially based upon the type, complexity and novelty of the product. The
status of Access’ principal products is as follows:
|
●
|
A
mucoadhesive liquid technology product, MuGard™, has received marketing
approval by the FDA.
|
|
●
|
ProLindac™
is currently in a Phase 2 trial in
Europe.
|
|
●
|
ProLindac™
has been approved for an additional Phase 1 trial in the US by
the
FDA.
|
|
●
|
Phenylbutrate
is in planning stage for a Phase 2 trial in the United
States.
|
|
●
|
Cobalamin™
mediated delivery technology is currently in the pre-clinical
phase.
|
|
●
|
Angiolix®
is currently in the pre-clinical
phase.
|
|
●
|
Prodrax®
is currently in the pre-clinical
phase.
|
|
●
|
Alchemix®
is currently in the pre-clinical
phase.
|
|
●
|
Access
also has other products in the preclinical
phase.
|
Due
to
the time consuming and uncertain nature of the drug candidate development
process and the governmental approval process described above, Access cannot
assure you when Access, independently or with its collaborative partners, might
submit a NDA, for FDA or other regulatory review.
Government
regulation also affects the manufacturing and marketing of pharmaceutical
products. Government regulations may delay marketing of Access’ potential drugs
for a considerable or indefinite period of time, impose costly procedural
requirements upon its activities and furnish a competitive advantage to larger
companies or companies more experienced in regulatory affairs. Delays in
obtaining governmental regulatory approval could adversely affect Access’
marketing as well as its ability to generate significant revenues from
commercial sales. Access’ drug candidates may not receive FDA or other
regulatory approvals on a timely basis or at all. Moreover, if regulatory
approval of a drug candidate is granted, such approval may impose limitations
on
the indicated use for which such drug may be marketed. Even if Access obtains
initial regulatory approvals for its drug candidates, Access’ drugs and its
manufacturing facilities would be subject to continual review and periodic
inspection, and later discovery of previously unknown problems with a drug,
manufacturer or facility may result in restrictions on the marketing or
manufacture of such drug, including withdrawal of the drug from the market.
The
FDA and other regulatory authorities stringently apply regulatory standards
and
failure to comply with regulatory standards can, among other things, result
in
fines, denial or withdrawal of regulatory approvals, product recalls or
seizures, operating restrictions and criminal prosecution.
The
uncertainty associated with preclinical and clinical testing may affect Access’
ability to successfully commercialize new products.
Before
Access can obtain regulatory approvals for the commercial sale of any of its
potential drugs, the drug candidates will be subject to extensive preclinical
and clinical trials to demonstrate their safety and efficacy in
humans. Preclinical or clinical trials of any of its future drug
candidates may not demonstrate the safety and efficacy of such drug candidates
at all or to the extent necessary to obtain regulatory approvals. In this
regard, for example, adverse side effects can occur during the clinical testing
of a new drug on humans which may delay ultimate FDA approval or even lead
it to
terminate its efforts to develop the drug for commercial use. Companies in
the
biotechnology industry have suffered significant setbacks in advanced clinical
trials, even after demonstrating promising results in earlier trials. In
particular, polymer platinate has taken longer to progress through clinical
trials than originally planned. This extra time has not been related to concerns
of the formulations but rather due to the lengthy regulatory process. The
failure to adequately demonstrate the safety and efficacy of a drug candidate
under development could delay or prevent regulatory approval of the drug
candidate. A delay or failure to receive regulatory approval for any of Access’
drug candidates could prevent Access from successfully commercializing such
candidates and Access could incur substantial additional expenses in its
attempts to further develop such candidates and obtain future regulatory
approval.
13
Access
may incur substantial product liability expenses due to the use or misuse of
its
products for which Access may be unable to obtain insurance
coverage.
Access’
business exposes it to potential liability risks that are inherent in the
testing, manufacturing and marketing of pharmaceutical products. These risks
will expand with respect to its drug candidates, if any, that receive regulatory
approval for commercial sale and Access may face substantial liability for
damages in the event of adverse side effects or product defects identified
with
any of its products that are used in clinical tests or marketed to the public.
Access generally procures product liability insurance for drug candidates that
are undergoing human clinical trials. Product liability insurance for the
biotechnology industry is generally expensive, if available at all, and as
a
result, Access may be unable to obtain insurance coverage at acceptable costs
or
in a sufficient amount in the future, if at all. Access may be unable to satisfy
any claims for which Access may be held liable as a result of the use or misuse
of products which Access has developed, manufactured or sold and any such
product liability claim could adversely affect its business, operating results
or financial condition.
Access
may incur significant liabilities if it fails to comply with stringent
environmental regulations or if Access did not comply with these regulations
in
the past.
Access’
research and development processes involve the controlled use of hazardous
materials. Access is subject to a variety of federal, state and local
governmental laws and regulations related to the use, manufacture, storage,
handling and disposal of such material and certain waste products. Although
Access believes that its activities and its safety procedures for storing,
using, handling and disposing of such materials comply with the standards
prescribed by such laws and regulations, the risk of accidental contamination
or
injury from these materials cannot be completely eliminated. In the event of
such accident, Access could be held liable for any damages that result and
any
such liability could exceed its resources.
Intense
competition may limit Access’ ability to successfully develop and market
commercial products.
The
biotechnology and pharmaceutical industries are intensely competitive and
subject to rapid and significant technological change. Access’ competitors in
the United States and elsewhere are numerous and include, among others, major
multinational pharmaceutical and chemical companies, specialized biotechnology
firms and universities and other research institutions.
The
following products may compete with polymer platinate:
•
Cisplatin, marketed by Bristol-Myers Squibb, the originator of the drug,
and
several generic manufacturers;
•
Carboplatin, marketed by Bristol-Myers Squibb in the US; and
•
Oxaliplatin, marketed exclusively by Sanofi-Aventis.
The
following companies are working on therapies and formulations that may be
competitive with Access’ polymer platinate:
|
•
|
Antigenics
and Regulon are developing liposomal platinum
formulations;
|
|
•
|
Spectrum
Pharmaceuticals and GPC Biotech are developing oral
platinum formulations;
|
|
•
|
Poniard
Pharmaceuticals is developing both i.v. and oral platinum
formulations;
|
|
•
|
Nanocarrier
and Debio are developing micellar nanoparticle platinum formulations;
and
|
|
|
•
|
American Pharmaceutical Partners, Cell Therapeutics, Daiichi, and Enzon are developing alternate drugs in | |
| combination with polymers and other drug delivery systems. |
Companies
working on therapies and formulations that may be competitive with Access’
vitamin mediated drug delivery system are Bristol-Myers Squibb, Centocor
(acquired by Johnson & Johnson), Endocyte, GlaxoSmithKline, Imclone and Xoma
which are developing targeted monoclonal antibody therapy.
Amgen,
Carrington Laboratories, CuraGen Corporation, Cytogen Corporation, Endo
Pharmaceuticals, MGI Pharma, Nuvelo, Inc. and OSI Pharmaceuticals are developing
products to treat mucositis that may compete with Access’ mucoadhesive liquid
technology.
BioDelivery
Sciences International, Biovail Corporation, Cellgate, CIMA Labs, Inc., Cytogen
Corporation, Depomed Inc., Emisphere Technologies, Inc., Eurand, Flamel
Technologies, Nobex and Xenoport are developing products which compete with
Access’ oral drug delivery system.
Companies
working on therapies and formulations that may be competitive with Access’
Sodium Phenylbutyrate are Medicis Pharmaceuticals currently sells Sodium
Phenylbutyrate (Buphenyl ®)
for the
treatment of a urea cycle disorder, hyperuremia. We are aware of numerous
products in development for brain cancers. We are aware of several products
being developed by academic and commercial organizations targeting
glioblastoma.
We
are
targeting a propriety gene product which is expressed by cancerous
tumors. We are not aware of any other organization developing similar
products targeting this type of protein.
Companies
working on therapies and formulations that may be competitive with Access’
Prodrax are Novocea, Inc., which has exclusively licensed from KuDOS
Pharmaceuticals, a subsidiary of Astra Zeneca, a small molecule prodrug that
is
selectively activated by low oxygen tumors that is similar to our Prodrax,
and
Novocea is developing this small molecule prodrug in a similar fashion to
Prodrax.
We are
not aware of any other organization developing a drug similar to Alchemix.
Several groups are developing agents against p-glycoprotein, which is only
one
of the identified mechanisms of drug resistance within cells, and other groups
are developing agents that have the potential to become chemosensitisers, which
means they will make cancer cells more sensitive to the effects of
chemotherapy.
Many
of
these competitors have and employ greater financial and other resources,
including larger research and development, marketing and manufacturing
organizations. As a result, Access’ competitors may successfully develop
technologies and drugs that are more effective or less costly than any that
Access is developing or which would render Access’ technology and future
products obsolete and noncompetitive.
In
addition, some of Access’ competitors have greater experience than Access does
in conducting preclinical and clinical trials and obtaining FDA and other
regulatory approvals. Accordingly, Access’ competitors may succeed in obtaining
FDA or other regulatory approvals for drug candidates more rapidly than Access
does. Companies that complete clinical trials, obtain required regulatory agency
approvals and commence commercial sale of their drugs before their competitors
may achieve a significant competitive advantage. Drugs resulting from Access’
research and development efforts or from its joint efforts with collaborative
partners therefore may not be commercially competitive with its competitors'
existing products or products under development.
14
Access depends
on licenses from third parties and the maintenance of its licenses are
necessary for its success.
Access
has obtained rights to some product candidates through license
agreements with various third party licensors as follows:
|
•
|
Exclusive
Patent and Know-how Sub-license Agreement between Somanta and
Immunodex, Inc. dated August 18, 2005, as amended;
|
|
|
•
|
Patent
and Know-how Assignment and License Agreement between Somanta and De
Montfort University dated March 20, 2003;
|
|
|
•
|
Patent
and Know-how Assignment and License Option Agreement between Somanta
and The School of Pharmacy, University of London dated March 16,
2004, as amended on September 21, 2005; and
|
|
|
|
||
|
•
|
The
Phenylbutyrate Co-Development and Sublicense Agreement
between Somanta and Virium Pharmaceuticals, Inc. dated
February 16, 2005, as amended.
|
Access
is dependent upon these licenses for its rights to develop and
commercialize its product candidates. While Access believes it is
in compliance with its obligations under the licenses, certain licenses may
be
terminated or converted to non-exclusive licenses by the licensor if Access
breaches the terms of the license. Access cannot guarantee you that the
licenses will not be terminated or converted in the future.
While Access
expects that it will be able to continue to identify licensable product
candidates or research suitable for licensing and commercialization by it,
there
can be no assurance that this will occur. For example, Access is in
discussions with the National Institutes of Health to obtain licenses to certain
patents held by them that will be necessary for the manufacture of its
product candidate Angiolix. Unless Access obtains licenses on terms that
are acceptable to it, Access may not be able to manufacture and obtain
product registrations on Angiolix. On December 5, 2006, NIH provided
Access with proposed terms for a non-exclusive license. Access is in
discussion with NIH on those proposed terms and conditions. On May 15, 2007,
NIH
terminated Access’ non-exclusive license application since it had not
accepted the terms and had not executed the proposed license
agreement.
Access’
ability to successfully develop and commercialize its drug candidates will
substantially depend upon the availability of reimbursement funds for the costs
of the resulting drugs and related treatments.
The
successful commercialization of, and the interest of potential collaborative
partners to invest in the development of its drug candidates, may depend
substantially upon reimbursement of the costs of the resulting drugs and related
treatments at acceptable levels from government authorities, private health
insurers and other organizations, including health maintenance organizations,
or
HMOs. Limited reimbursement for the cost of any drugs that Access develops
may
reduce the demand for, or price of such drugs, which would hamper its ability
to
obtain collaborative partners to commercialize its drugs, or to obtain a
sufficient financial return on its own manufacture and commercialization of
any
future drugs.
The
market may not accept any pharmaceutical products that Access successfully
develops.
The
drugs
that Access is attempting to develop may compete with a number of
well-established drugs manufactured and marketed by major pharmaceutical
companies. The degree of market acceptance of any drugs developed by it will
depend on a number of factors, including the establishment and demonstration
of
the clinical efficacy and safety of its drug candidates, the potential advantage
of its drug candidates over existing therapies and the reimbursement policies
of
government and third-party payers. Physicians, patients or the medical community
in general may not accept or use any drugs that Access may develop independently
or with its collaborative partners and if they do not, its business could
suffer.
Trends
toward managed health care and downward price pressures on medical products
and
services may limit its ability to profitably sell any drugs that Access may
develop.
Lower
prices for pharmaceutical products may result from:
|
·
|
third-party
payers' increasing challenges to the prices charged for medical products
and services;
|
|
·
|
the
trend toward managed health care in the United States and the concurrent
growth of HMOs and similar organizations that can control or significantly
influence the purchase of healthcare services and products;
and
|
|
·
|
legislative
proposals to reform healthcare or reduce government insurance
programs.
|
The
cost
containment measures that healthcare providers are instituting, including
practice protocols and guidelines and clinical pathways, and the effect of
any
healthcare reform, could limit Access’ ability to profitably sell any drugs that
Access may successfully develop. Moreover, any future legislation or regulation,
if any, relating to the healthcare industry or third-party coverage and
reimbursement, may cause its business to suffer.
15
Access
may not be successful in protecting its intellectual property and proprietary
rights.
Access’
success depends, in part, on its ability to obtain U.S. and foreign patent
protection for its drug candidates and processes, preserve its trade secrets
and
operate its business without infringing the proprietary rights of third parties.
Legal standards relating to the validity of patents covering pharmaceutical
and
biotechnological inventions and the scope of claims made under such patents
are
still developing and there is no consistent policy regarding the breadth of
claims allowed in biotechnology patents. The patent position of a biotechnology
firm is highly uncertain and involves complex legal and factual questions.
Access cannot assure you that any existing or future patents issued to, or
licensed by, it will not subsequently be challenged, infringed upon, invalidated
or circumvented by others. As a result, although Access, together with its
subsidiaries, are either the owner or licensee to 17 U.S. patents and to 9
U.S.
patent applications now pending, and 5 European patents and 13 European patent
applications, Access cannot assure you that any additional patents will issue
from any of the patent applications owned by, or licensed to, it. Furthermore,
any rights that Access may have under issued patents may not provide it with
significant protection against competitive products or otherwise be commercially
viable.
Access’
patents for the following technologies expire in the years and during the date
ranges indicated below:
|
·
|
Mucoadhesive
technology in 2021,
|
|
·
|
ProLindac™
in 2021,
|
|
·
|
Phenylbutyrate
between 2011 and 2016,
|
|
·
|
Angiolix®
in 2015,
|
|
·
|
Alchemix®
in 2015,
|
|
·
|
Cobalamin
mediated technology between 2008 and
2019
|
In
addition to issued patents, Access has a number of pending patent applications.
If issued, the patents underlying theses applications could extend the patent
life of its technologies beyond the dates listed above.
Patents
may have been granted to third parties or may be granted covering products
or
processes that are necessary or useful to the development of Access’ drug
candidates. If Access’ drug candidates or processes are found to infringe upon
the patents or otherwise impermissibly utilize the intellectual property of
others, Access’ development, manufacture and sale of such drug candidates could
be severely restricted or prohibited. In such event, Access may be required
to
obtain licenses from third parties to utilize the patents or proprietary rights
of others. Access cannot assure you that it will be able to obtain such licenses
on acceptable terms, if at all. If Access becomes involved in litigation
regarding its intellectual property rights or the intellectual property rights
of others, the potential cost of such litigation, regardless of the strength
of
its legal position, and the potential damages that Access could be required
to
pay could be substantial.
Access’
business could suffer if Access loses the services of, or fail to attract,
key
personnel.
Access
is
highly dependent upon the efforts of its senior management and scientific team,
including its President and Chief Executive Officer, Jeffrey B. Davis. The
loss
of the services of one or more of these individuals could delay or prevent
the
achievement of its research, development, marketing, or product
commercialization objectives. While Access has employment agreements with
Jeffrey B. Davis, David P. Nowotnik, PhD its Senior Vice President Research
and
Development, and Stephen B. Thompson, its Vice President and Chief Financial
Officer, their employment may be terminated by them or Access at any time.
Mr.
Davis’, Dr. Nowotnik's and Mr. Thompson’s agreements expire within one year and
are extendable each year on the anniversary date. Access does not have
employment contracts with its other key personnel. Access does not maintain
any
"key-man" insurance policies on any of its key employees and Access does not
intend to obtain such insurance. In addition, due to the specialized scientific
nature of its business, Access is highly dependent upon its ability to attract
and retain qualified scientific and technical personnel. In view of the stage
of
its development and its research and development programs, Access has restricted
its hiring to research scientists and a small administrative staff and Access
has made only limited investments in manufacturing, production, sales or
regulatory compliance resources. There is intense competition among major
pharmaceutical and chemical companies, specialized biotechnology firms and
universities and other research institutions for qualified personnel in the
areas of Access’ activities, however, and Access may be unsuccessful in
attracting and retaining these personnel.
16
An
investment in Access’ common stock may be less attractive because it is not
traded on a recognized public market.
Access’
common stock has traded on the OTC Bulletin Board, or OTCBB since June 5, 2006.
From February 1, 2006 until June 5, 2006 Access traded on the “Pink Sheets”
after its common stock was de-listed from trading on AMEX. The OTCBB and Pink
Sheets are viewed by most investors as a less desirable, and less liquid,
marketplace. As a result, an investor may find it more difficult to purchase,
dispose of or obtain accurate quotations as to the value of its common
stock.
Access’
common stock is subject to Rules 15g-1 through 15g-9 under the Exchange Act,
which imposes certain sales practice requirements on broker-dealers who sell
its
common stock to persons other than established customers and "accredited
investors" (as defined in Rule 501(c) of the Securities Act). For transactions
covered by this rule, a broker-dealer must make a special suitability
determination for the purchaser and have received the purchaser's written
consent to the transaction prior to the sale. This rule adversely affects the
ability of broker-dealers to sell Access’ common stock and purchasers of its
common stock to sell their shares of Access’ common stock.
Additionally,
Access’ common stock is subject to SEC regulations applicable to "penny stock."
Penny stock includes any non-NASDAQ equity security that has a market price
of
less than $5.00 per share, subject to certain exceptions. The
regulations require that prior to any non-exempt buy/sell transaction in a
penny
stock, a disclosure schedule proscribed by the SEC relating to the penny stock
market must be delivered by a broker-dealer to the purchaser of such penny
stock. This disclosure must include the amount of commissions payable
to both the broker-dealer and the registered representative and current price
quotations for Access’ common stock. The regulations also require
that monthly statements be sent to holders of penny stock that disclose recent
price information for the penny stock and information of the limited market
for
penny stocks. These requirements adversely affect the market
liquidity of Access’ common stock.
Ownership
of Access’ shares is concentrated in the hands of a few investors which could
limit the ability of Access’ other stockholders to influence the direction of
the company.
As
calculated by the SEC rules of beneficial ownership, SCO Capital Partners LLC
and affiliates, Larry N. Feinberg (Oracle Partners LP, Oracle Institutional
Partners LP and Oracle Investment Management Inc.), Lake End Capital LLC,
Perceptive Life Sciences Master Fund Ltd and Midsummer Investment, Ltd. each
beneficially owned approximately 69.8%, 31.7%, 21.7%, 15.1% and 11.8%,
respectively, of Access’ common stock as of March 6, 2008. Accordingly, they
collectively may have the ability to significantly influence or determine the
election of all of Access’ directors or the outcome of most corporate actions
requiring stockholder approval. They may exercise this ability in a manner
that
advances their best interests and not necessarily those of Access’ other
stockholders.
Access
may be required to pay liquidated damages to certain investors if it does not
maintain an effective registration statement relating to common stock issuable
upon conversion of Series A Preferred stock or upon exercise of certain
warrants.
Pursuant
to issuing Series A Preferred Stock and warrants, Access entered into an
Investor Rights Agreement with the purchasers of Series A Preferred
Stock. The Investor Rights Agreement requires, among other things,
that Access maintain an effective registration statement for common stock
issuable upon conversion of Series A Preferred Stock or upon exercise of certain
warrants. If Access fails to maintain such an effective registration
statement it may be required to pay liquidated damages to the holders of such
Series A Preferred Stock and warrants for the period of time in which an
effective registration statement was not in place.
17
Provisions
of Access’ charter documents could discourage an acquisition of our company that
would benefit its stockholders and may have the
effect of entrenching, and making it difficult to remove,
management.
Provisions
of Access’ Certificate of Incorporation, By-laws and Stockholders Rights Plan
may make it more difficult for a third party to acquire control of the Company,
even if a change in control would benefit Access stockholders. In particular,
shares of Access preferred stock may be issued in the future without further
stockholder approval and upon such terms and conditions, and having such rights,
privileges and preferences, as Access’ Board of Directors may determine,
including, for example, rights to convert into Access common stock. The rights
of the holders of Access common stock will be subject to, and may be adversely
affected by, the rights of the holders of any of Access’ preferred stock that
may be issued in the future. The issuance of Access preferred stock, while
providing desirable flexibility in connection with possible acquisitions and
other corporate purposes, could have the effect of making it more difficult
for
a third party to acquire control of Access. This could limit the price that
certain investors might be willing to pay in the future for shares of Access
common stock and discourage these investors from acquiring a majority of Access
common stock. Further, the existence of these corporate governance provisions
could have the effect of entrenching management and making it more difficult
to
change Access’ management.
Substantial
sales of Access common stock could lower its stock price.
The
market price for Access common stock could drop as a result of sales of a large
number of its presently outstanding shares or shares
that Access may issue or be obligated to issue in
the future. All of the 5,623,781 shares of Access common stock that are
outstanding as of March 6, 2008, are unrestricted and freely tradable or
tradable pursuant to a resale registration statement or under Rule 144 of the
Securities Act or are covered by a registration rights agreement.
Failure
to achieve and maintain effective internal controls could have a material
adverse effect on Access’ business.
Effective
internal controls are necessary for Access to provide reliable financial
reports. If Access cannot provide reliable financial reports, Access’ operating
results could be harmed. All internal control systems, no matter how well
designed, have inherent limitations. Therefore, even those systems determined
to
be effective can provide only reasonable assurance with respect to financial
statement preparation and presentation.
While
Access continues to evaluate and improve its internal controls, Access cannot
be
certain that these measures will ensure that Access implements and maintains
adequate controls over its financial processes and reporting in the future.
Any
failure to implement required new or improved controls, or difficulties
encountered in their implementation, could harm its operating results or cause
Access to fail to meet its reporting obligations.
Failure
to achieve and maintain an effective internal control environment could cause
investors to lose confidence in Access’ reported financial information, which
could have a material adverse effect on its stock price.
Future
sales by our stockholders may adversely affect our stock price and our ability
to raise funds in new stock offerings.
Sales
of
our common stock in the public market following this offering could lower the
market price of our common stock. Sales may also make it more difficult for
us
to sell equity securities or equity-related securities in the future at a time
and price that our management deems acceptable or at all. Of the 5,623,781
shares of common stock outstanding as of March 6, 2008, 5,623,781 shares are,
or
will be, freely tradable without restriction, unless held by our “affiliates.”
Some of these shares may be resold under Rule 144. The sale of the 11,666,195
shares issuable upon conversion of our preferred stock and 9,269,734 shares
issuable upon exercise of outstanding warrants could also lower the market
price
of our common stock.
The
selling stockholders intend to sell their shares of common stock in the market,
which sales may cause our stock price to decline.
The
selling stockholders intend to sell in the public market 16,588,387 shares
of
our common stock being registered in this offering. That means that up to
16,588,387 shares may be sold pursuant to this registration statement. Such
sales may cause our stock price to decline. Our officers and directors and
our
shareholders who are significant shareholders, as defined by the SEC, will
continue to be subject to the provisions of various insider trading and rule
144
regulations.
18
The
price you pay in this offering will fluctuate and may be higher or lower than
the prices paid by other people participating in this offering.
The
price
in this offering will fluctuate based on the prevailing market price of our
common stock on the OTC Bulletin Board. Accordingly, the price you pay in this
offering may be higher or lower than the prices paid by other people
participating in this offering.
FORWARD-LOOKING
STATEMENTS
This
Prospectus contains “forward-looking statements” within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of
the Securities Exchange Act of 1934, as amended, and that involve risks and
uncertainties. These statements include, without limitation, statements relating
to uncertainties associated with research and development activities, clinical
trials, our ability to raise capital, the timing of and our ability to achieve
regulatory approvals, dependence on others to market our licensed products,
collaborations, future cash flow, the timing and receipt of licensing and
milestone revenues, the future success of our marketed products and products
in
development, our sales projections, and the sales projections of our licensing
partners, our ability to achieve licensing milestones, our ability to continue
as a going concern, anticipated payments to be received from Uluru, anticipated
product approvals and timing thereof, product opportunities, clinical trials
and
U.S. Food and Drug Administration (“FDA”) applications, as well as our drug
development strategy, our clinical development organization expectations
regarding our rate of technological developments and competition, our plan
not
to establish an internal marketing organization, our expectations regarding
minimizing development risk and developing and introducing technology, the
terms
of future licensing arrangements, our ability to secure additional financing
for
our operations and our expected cash burn rate. These statements relate to
future events or our future financial performance. In some cases, you can
identify forward-looking statements by terminology such as “may,” “will,”
“should,” “expects,” “plans,” “could,” “anticipates,” “believes,” “estimates,”
“predicts,” “potential” or “continue” or the negative of such terms or other
comparable terminology. We intend the forward-looking statements to
be covered by the safe harbor for forward-looking statements in these sections.
The forward-looking information is based on various factors and was derived
using numerous assumptions.
Forward-looking
statements necessarily involve risks and uncertainties, and our actual results
could differ materially from those anticipated in the forward-looking statements
due to a number of factors, including those set forth above under “Risk Factors”
and elsewhere in this Prospectus. The factors set forth above under “Risk
Factors” and other cautionary statements made in this Prospectus should be read
and understood as being applicable to all related forward-looking statements
wherever they appear in this Prospectus. The forward-looking statements
contained in this Prospectus represent our judgment as of the date of this
Prospectus. We caution readers not to place undue reliance on such statements.
Except as required by law, we undertake no obligation to update publicly any
forward-looking statements for any reason, even if new information becomes
available or other events occur in the future.
19
SELLING
STOCKHOLDERS
The
following table presents information regarding the selling stockholders. The
selling shareholders are the entities who have assisted in or provided financing
to us. A description of each selling shareholder's relationship to us and how
each selling shareholder acquired the shares to be sold in this offering is
detailed in the information immediately following this table. The shares listed
in the table do not include the shares of common stock that may be paid as
a
dividend on outstanding shares of Series A Preferred Stock.
|
Selling
Stockholder
|
Shares
Beneficially
Owned
Before
Offering
(1)
|
Percentage
of
Outstanding
Shares
Beneficially
Owned
Before
Offering
|
Shares
to
be Sold in the
Offering
|
Percentage
of
Outstanding
Shares
Beneficially
Owned
After
Offering
|
|
Mark
J. Alvino (2)
|
80,525
|
1.4%
|
9,091
|
1.3%
|
|
Beach
Capital LLC (3)
|
949,496
|
14.4%
|
608,587
|
5.7%
|
|
Brio
Capital LP (4)
|
75,000
|
1.3%
|
75,000
|
-
|
|
Catalytix
LDC Life Science
Hedge
AC (5)
|
24,999
|
*
|
24,999
|
-
|
|
Cobblestone
Asset Mangement LLC (6)
|
155,450
|
2.7%
|
125,000
|
*
|
|
Cranshire
Capital, LP (7)
|
250,000
|
4.3%
|
250,000
|
-
|
|
Credit
Suisse Securities (USA) LLC (8)
|
500,000
|
8.2%
|
500,000
|
-
|
|
Enable
Growth Partners LP (9)
|
249,999
|
4.3%
|
249,999
|
-
|
|
Howard
Fischer (10)
|
54,545
|
*
|
9,091
|
*
|
|
Edward
and Patricia Kelly (11)
|
99,999
|
1.8%
|
99,999
|
-
|
|
Lake
End Capital LLC (12)
|
1,988,784
|
26.1%
|
1,556,166
|
7.1%
|
|
Dennis
Lavalle (13)
|
45,000
|
*
|
45,000
|
-
|
|
David
P. Luci (14)
|
37,500
|
*
|
12,500
|
*
|
|
Midsummer
Investment, Ltd (15)
|
750,000
|
11.8%
|
750,000
|
-
|
|
Oracle
Institutional Partners LP (16)
|
390,828
|
6.5%
|
380,399
|
*
|
|
Oracle
Offshore Ltd. (17)
|
76,893
|
1.4%
|
71,886
|
*
|
|
Oracle
Partners, LP (18)
|
1,622,482
|
23.2%
|
1,374,831
|
4.4%
|
|
Perceptive
Life Sciences
Master
Fund Ltd (19)
|
999,999
|
15.1%
|
999,999
|
-
|
|
Rockmore
Investment
Master
Fund Ltd (20)
|
249,999
|
4.3%
|
249,999
|
-
|
|
Rodman
& Renshaw LLC (21)
|
109,000
|
1.9%
|
109,000
|
-
|
|
SAM
Oracle Investments, Inc (22)
|
389,169
|
6.5%
|
359,433
|
*
|
|
Schroder
& Co. Bank AG, Zurich (23)
|
125,000
|
2.2%
|
125,000
|
-
|
|
SCO
Capital Partners LLC (24)
|
11,033,426
|
66.2%
|
8,033,427
|
34.8%
|
|
SCO
Capital Partners LP (25)
|
999,999
|
15.1%
|
999,999
|
-
|
|
Total:
|
21,258,092
|
17,020,705
|
20
--------------------
*
- less
than 1%
|
(1)
|
Applicable
percentage of ownership is based on 5,623,781 shares of common stock
outstanding as of March 6, 2008, together with securities exercisable
or
convertible into shares of common stock within 60 days of March 6,
2008,
for each stockholder. Beneficial ownership is determined in accordance
with Rule 13d-3(d) promulgated by the Commission under the Securities
and Exchange Act of 1934, as amended. Shares of common stock issuable
pursuant to options, warrants and convertible securities are treated
as
outstanding for computing the percentage of the person holding such
securities but are not treated as outstanding for computing the percentage
of any other person. Unless otherwise noted, each person or group
identified possesses sole voting and investment power with respect
to
shares, subject to community property laws where applicable. Shares
not
outstanding but deemed beneficially owned by virtue of the right
of a
person or group to acquire them within 60 days are treated as
outstanding only for purposes of determining the number of and percent
owned by such person or group. Unless a holder of Series A Cumulative
Convertible Preferred Stock either elected otherwise prior to the
purchase
of such preferred stock or elects otherwise upon not less than 61
days
prior written notice, its ability to convert its Series A Cumulative
Convertible Preferred Stock into common stock or to vote on an
as-if-converted to common stock basis is restricted pursuant to
a beneficial ownership cap to the extent that such conversion would
result
in the holder owning more than 4.99% of our issued and outstanding
common
stock or voting together with the common stock on an as-if-converted
to
common stock basis in respect of more than 4.99% of our issued and
outstanding common stock. The warrants issued in connection with
the
Series A Cumulative Convertible Preferred Stock are subject to a
similar
beneficial ownership cap restriction on their exercise. SCO Capital
Partners LLC, SCO Capital Partners, L.P. and Beach Capital LLC, have
elected not to be governed by these restrictions. For purposes of
the
table, beneficial ownership has been calculated as if there were
no such
beneficial ownership cap.
|
|
(2)
|
Mark
J. Alvino is Managing Director of Griffin Securities LLC. Mr. Alvino
is a
director of Access designated by SCO Capital Partners LLC pursuant
to an
agreement between SCO Capital Partners LLC and Access. Mr. Alvino
is known
to beneficially own warrants to purchase an aggregate of 55,525 shares
of
Access’ Common Stock and options to purchase 25,000 shares of Access’
Common Stock pursuant to the 2005 Equity Incentive
Plan.
|
|
(3)
|
Beach
Capital LLC is known to directly beneficially own warrants to purchase
an
aggregate of 435,197 shares of Access’ Common Stock and Series A Preferred
Stock which may be converted into an aggregate of 514,299 shares
of
Access’ Common Stock. Beach Capital LLC and affiliates (SCO Capital
Partners LP and SCO Capital Partners LLC) are known to beneficially
own
warrants to purchase an aggregate of 5,924,770 shares of Access’ Common
Stock and 7,077,100 shares of Common Stock issuable to them upon
conversion of Series A Preferred Stock. Steven H. Rouhandeh, in his
capacity as managing member of Beach Capital LLC has the power to
direct
the vote and disposition of the shares owned by Beach Capital
LLC. Beach Capital LLC has opted out of the beneficial
ownership cap described above. Each of Mr. Davis and Mr. Alvino,
Access’
directors and Mr. Davis an executive with SCO Capital Partners LLC,
disclaim beneficial ownership of such shares except to the extent
of his
pecuniary interest therein.
|
|
(4)
|
Brio
Capital LP is known to beneficially own an aggregate of warrants
to
purchase and aggregate of 25,000 shares of Access’ Common Stock and Series
A Preferred Stock which may be converted into an aggregate of 50,000
shares of Access’ Common Stock.
|
|
(5)
|
Catalytix
LDC Life Science Hedge AC is known to beneficially own warrants to
purchase an aggregate of 8,333 shares of Access’ Common Stock and Series A
Preferred Stock which may be converted into an aggregate of 16,666
shares
of Access’ Common Stock.
|
|
(6)
|
Cobblestone
Asset Management LLC is known to beneficially own an aggregate of
30,450
shares of Access’ Common Stock, warrants to purchase an aggregate of
41,667 shares of Access’ Common Stock and Series A Preferred Stock which
may be converted into an aggregate of 83,333 shares of Access’ Common
Stock.
|
|
(7)
|
Cranshire
Capital, LP is known to beneficially own warrants to purchase an
aggregate
of 83,333 shares of Access’ Common Stock and Series A Preferred Stock
which may be converted into an aggregate of 166,667 shares of Access’
Common Stock. Michael P. Koplin, the president of Downsview Capital,
Inc.,
the general partner of Cranshire Capital, L.P., has sole voting control
and investment discretion over securities held by Cranshire Capital,
L.P.
Each of Michael P. Koplin and Downsview Capital, Inc. disclaims beneficial
ownership of shares held by Cranshire Capital,
L.P.
|
|
(8)
|
Credit
Suisse Securities (USA) LLC is known to beneficially own warrants
to
purchase an aggregate of 166,667 shares of Access’ Common Stock and Series
A Preferred Stock which may be converted into an aggregate of 333,333
shares of Access’ Common Stock.
|
|
(9)
|
Enable
Growth Partners LP is known to beneficially own warrants to purchase
an
aggregate of 83,333 shares of Access’ Common Stock and Series A Preferred
Stock which may be converted into an aggregate of 166,666 shares
of
Access’ Common Stock.
|
|
(10)
|
Howard
Fischer is known to beneficially own warrants to purchase an aggregate
of
54,545 shares of Access’ Common
Stock.
|
|
(11)
|
Edward
and Patricia Kelly are known to beneficially own warrants to purchase
an
aggregate of 33,333 shares of Access’ Common Stock and Series A Preferred
Stock which may be converted into an aggregate of 66,666 shares of
Access’
Common Stock.
|
21
|
(12)
|
Lake
End Capital LLC is known to beneficially own warrants to purchase
an
aggregate of 1,195,717 shares of Access’ Common Stock and Series A
Preferred Stock which may be converted into an aggregate of 793,067
shares
of Access’ Common Stock. Lake End Capital LLC and Mr. Davis are known to
beneficially own warrants and options to purchase an aggregate of
1,832,357 shares of Access’ Common Stock and 793,067 shares of Common
Stock issuable upon conversion of Series A Preferred Stock. Jeffrey
B.
Davis, in his capacity as managing member of Lake End Capital LLC,
has the
power to direct the vote and disposition of the shares owned by Lake
End
Capital LLC. Mr. Davis is President of SCO Securities LLC, a wholly-owned
subsidiary of SCO Financial Group LLC. Mr. Davis is a director of
Access
designated by SCO Capital Partners LLC pursuant to an agreement between
SCO Capital Partners LLC and
Access.
|
|
(13)
|
Dennis
Lavalle is known to beneficially own warrants to purchase an aggregate
of
15,000 shares of Access’ Common Stock and Series A Preferred Stock which
may be converted into an aggregate of 30,000 shares of Access’ Common
Stock.
|
|
(14)
|
David
P. Luci is known to beneficially own warrants and options to purchase
an
aggregate of 29,167 shares of Access’ Common Stock and 8,333 shares of
Common Stock issuable upon conversion of Series A Preferred
Stock.
|
|
(15)
|
Midsummer
Investment, Ltd. is known to beneficially own warrants to purchase
an
aggregate of 250,000 shares of Access’ Common Stock and Series A Preferred
Stock which may be converted into an aggregate of 500,000 shares
of
Access’ Common Stock.
|
|
(16)
|
Oracle
Institutional Partners LP is known to beneficially own an aggregate
of
10,429 shares of Access’ Common Stock, warrants to purchase an aggregate
of 126,800 shares of Access’ Common Stock and Series A Preferred Stock
which may be converted into an aggregate of 253,599 shares of Access’
Common Stock. Larry N. Feinberg is a partner in Oracle Partners,
L.P.
Oracle Partners, L.P. and affiliates (Oracle Institutional Partners,
L.P.,
Oracle Investment Management, Inc., SAM Oracle Fund, Inc. and Mr.
Feinberg) are known to beneficially own an aggregate of 292,823 shares
of
Access’ Common Stock, warrants to purchase an aggregate of 728,850 shares
of Access’ Common Stock and Series A Preferred Stock which may be
converted into an aggregate of 1,457,699 shares of Access’ Common
Stock.
|
|
(17)
|
Oracle
Offshore Ltd is known to beneficially own an aggregate of 5,007 shares
of
Access’ Common Stock, warrants to purchase an aggregate of 23,962 shares
of Access’ Common Stock and Series A Preferred Stock which may be
converted into an aggregate of 47,924 shares of Access’ Common Stock.
Larry N. Feinberg is a partner in Oracle Partners, L.P. Oracle Partners,
L.P. and affiliates (Oracle Institutional Partners, L.P., Oracle
Investment Management, Inc., SAM Oracle Fund, Inc. and Mr. Feinberg)
are
known to beneficially own an aggregate of 292,823 shares of Access’ Common
Stock, warrants to purchase an aggregate of 728,850 shares of Access’
Common Stock and Series A Preferred Stock which may be converted
into an
aggregate of 1,457,699 shares of Access’ Common
Stock.
|
|
(18)
|
Oracle
Partners, LP is known to beneficially own an aggregate of 247,651
shares
of Access’ Common Stock, warrants to purchase an aggregate of 458,277
shares of Access’ Common Stock and Series A Preferred Stock which may be
converted into an aggregate of 916,554 shares of Access’ Common Stock.
Larry N. Feinberg is a partner in Oracle Partners, L.P. Oracle Partners,
L.P. and affiliates (Oracle Institutional Partners, L.P., Oracle
Investment Management, Inc., SAM Oracle Fund, Inc. and Mr. Feinberg)
are
known to beneficially own an aggregate of 292,823 shares of Access’ Common
Stock, warrants to purchase an aggregate of 728,850 shares of Access’
Common Stock and Series A Preferred Stock which may be converted
into an
aggregate of 1,457,699 shares of Access’ Common
Stock.
|
|
(19)
|
Perceptive
Life Sciences Master Fund Ltd is known to beneficially own warrants
to
purchase an aggregate of 333,333 shares of Access’ Common Stock and Series
A Preferred Stock which may be converted into an aggregate of 666,666
shares of Access’ Common Stock.
|
|
(20)
|
Rockmore
Investment Master Fund Ltd is known to beneficially own warrants
to
purchase an aggregate of 83,333 shares of Access’ Common Stock and Series
A Preferred Stock which may be converted into an aggregate of 166,666
shares of Access’ Common Stock. Rockmore Capital, LLC (“Rockmore Capital”)
and Rockmore Partners, LLC (“Rockmore Partners”), each a limited liability
company formed under the laws of the State of Delaware, serve as
the
investment manager and general partner, respectively, to Rockmore
(US) LP,
a Delaware limited partnership, which invests all of its assets through
Rockmore Investment Master Fund Ltd., an exempted company formed
under the
laws of Bermuda (“Rockmore Master Fund”). By reason of such relationships,
Rockmore Capital and Rockmore Partners may be deemed to share dispositive
power over shares of our common stock owned by Rockmore Master Fund.
Rockmore Capital and Rockmore Partners disclaim beneficial ownership
of
such shares of our common stock. Rockmore Partners has delegated
authority
to Rockmore Capital regarding portfolio management decisions with
respect
to the shares of common stock owned by Rockmore Master Fund and,
as of
December 10, 2007, Mr. Bruce T. Bernstein and Mr. Brian Daly, as
officers
of Rockmore Capital, are responsible for the portfolio management
decisions of the shares of common stock owned by Rockmore Master
Fund. By
reason of such authority, Messsrs. Bernstein and Daly may be deemed
to
share dispositive power over the shares of our common stock owned
by
Rockmore Master Fund. Messrs. Bernstein and Daly disclaim beneficial
ownership of such shares of our common stock and neither of such
persons
has any legal right to maintain such authority. No other person has
sole
or shared voting or dispositive power with respect to the shares
of our
common stock as those terms are used for purposes under Regulation
13D-G
of the Securities Exchange Act of 1934, as amended. No person or
“group”
(as that term is used in Section 13(d) of the Securities Act of 1934,
as
amended, or the SEC’s Regulation 13D-G) controls Rockmore Master
Fund.
|
|
(21)
|
Rodman
& Renshaw LLC is known to beneficially own warrants to purchase an
aggregate of 109,000 shares of Access’ Common
Stock.
|
22
|
(22)
|
SAM
Oracle Investments, Inc. is known to beneficially own an aggregate
of
29,736 shares of Access’ Common Stock, warrants to purchase an aggregate
of 119,811 shares of Access’ Common Stock and Series A Preferred Stock
which may be converted into an aggregate of 239,622 shares of Access’
Common Stock. Larry N. Feinberg is a partner in Oracle Partners,
L.P.
Oracle Partners, L.P. and affiliates (Oracle Institutional Partners,
L.P.,
Oracle Investment Management, Inc., Sam Oracle Fund, Inc. and Mr.
Feinberg) are known to beneficially own an aggregate of 292,823 shares
of
Access’ Common Stock, warrants to purchase an aggregate of 728,850 shares
of Access’ Common Stock and Series A Preferred Stock which may be
converted into an aggregate of 1,457,699 shares of Access’ Common
Stock.
|
|
(23)
|
Schroder
& Co. Bank AG, Zurich is known to beneficially own warrants to
purchase an aggregate of 41,667 shares of Access’ Common Stock and Series
A Preferred Stock which may be converted into an aggregate of 83,333
shares of Access’ Common Stock.
|
|
(24)
|
SCO
Capital Partners LLC is known to directly beneficially own warrants
to
purchase an aggregate of 5,156,240 shares of Access’ Common Stock and
Series A Preferred Stock which may be converted into an aggregate
of
5,896,135 shares of Access’ Common Stock. SCO Capital Partners LLC and
affiliates (SCO Capital Partners, L.P. and Beach Capital LLC) are
known to
beneficially own warrants to purchase an aggregate of 5,924,770 shares
of
Access’ Common Stock and 7,077,100 shares of Common Stock issuable to them
upon conversion of Series A Preferred Stock. Steven H. Rouhandeh,
in his
capacity as chairman and managing member of SCO Capital Partners
LLC, has
the power to direct the vote and disposition of the shares owned
by SCO
Capital Partners LLC. SCO Capital Partners LLC has opted out of
the beneficial ownership cap described
above.
|
|
(25)
|
SCO
Capital Partners, L.P. is known to directly beneficially own warrants
to
purchase an aggregate of 333,333 shares of Access’ Common Stock and Series
A Preferred Stock which may be converted into an aggregate of 666,666
shares of Access’ Common Stock. SCO Capital Partners, L.P. and affiliates
(SCO Capital Partners LLC and Beach Capital LLC) are known to beneficially
own warrants to purchase an aggregate of 5,924,770 shares of Access’
Common Stock and 7,077,100 shares of Common Stock issuable to them
upon
conversion of Series A Preferred Stock. Steven H. Rouhandeh, in his
capacity as managing member of the entity that serves as general
partner
of SCO Capital Partners, L.P. has the power to direct the vote and
disposition of the shares owned by SCO Capital Partners, L.P. SCO
Capital
Partners, L.P. has opted out of the beneficial ownership cap described
above.
|
The
following information contains a description of each selling shareholder's
relationship to us and how each selling shareholder acquired the shares to
be
sold in this offering is detailed below. None of the selling stockholders have
held a position or office, or had any other material relationship, with us,
except as follows:
SCO
Capital Partners LLC and
affiliates
On
November 7, 2007, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 954.0001 shares
of a newly created series of our preferred stock, designated “Series A
Cumulative Convertible Preferred Stock”, par value $0.01 per share, for an issue
price of $10,000 per share, (the “Series A Preferred Stock”) and agreed to issue
warrants to purchase 1,589,999 shares of our common stock at an exercise price
of $3.50 per share, for an aggregate purchase price for the Series A Preferred
Stock and Warrants of $9,540,001. Subsequently on February 4, 2008 we entered
into an Amended and Restated Purchase Agreement whereby we issued an additional
200 shares of Series A Preferred Stock and warrants to purchase 333,333 shares
of our common stock on substantially the same terms contained in the Purchase
Agreement and related transaction documents.
The
Series A Preferred Stock has a liquidation preference of $10,000 per share,
is
entitled to a dividend of 6% per annum, payable in shares of our common stock
at
our option. The number of shares of common stock into which each
share of Series A Preferred Stock is convertible is determined by dividing
the
liquidation preference per share plus all accrued and unpaid dividends thereon
by $3.00. Unless a holder of Series A Preferred Stock either elected
otherwise prior to the purchase of such preferred stock or elects otherwise
upon
not less than 61 days prior written notice, its ability to convert its Series
A
Preferred Stock into common stock or to vote on an as-if-converted to common
stock basis is restricted pursuant to a beneficial ownership cap to the extent
that such conversion would result in the holder owning more than 4.99% of our
issued and outstanding common stock or voting together with the common stock
on
an as-if-converted to common stock basis in respect of more than 4.99% of our
issued and outstanding common stock. The warrants issued in
connection with the Series A Preferred Stock are subject to a similar beneficial
ownership cap restriction on their exercise. SCO Capital Partners
LLC, SCO Capital Partners, L.P. and Beach Capital LLC have elected not to be
governed by these restrictions.
As
a
condition to closing, SCO Capital Partners LLC and affiliates, along with the
other holders of an aggregate of $6,000,000 Secured Convertible Notes, also
exchanged their notes and accrued interest for an additional 1,836.0512 shares
of Series A Preferred Stock and were issued warrants to purchase 1,122,031
shares of our common stock at an exercise price of $3.50 per share. In
connection with the exchange of the notes, all security interests and liens
relating thereto were terminated.
23
In
connection with its sale and issuance of Series A Preferred Stock and warrants,
Access entered into an investor rights agreement whereby it granted registration
rights with respect to the shares of common stock of Access underlying the
Series A Preferred Stock and warrants. In addition, in connection
with the sale and issuance of Series A Preferred Stock and warrants, we entered
into a Director Designation Agreement whereby we agreed to continue SCO’s right
to designate two individuals to serve on the Board of Directors of
Access.
On
December 6, 2006, we entered into a note and warrant purchase agreement pursuant
to which we sold and issued an aggregate of $500,000 of 7.5% convertible notes
due November 15, 2007 and warrants to purchase 386,364 shares of common stock
of
Access. Net proceeds to Access were $450,000. The notes and warrants were sold
in a private placement to a group of accredited investors led by SCO Capital
Partners LLC and affiliates. All of the principal and interest under these
notes
were exchanged for shares of our Series A Preferred Stock and warrants as
described above. The warrants associated with the notes are currently
outstanding.
On
October 24, 2006, we entered into a note and warrant purchase agreement pursuant
to which we sold and issued an aggregate of $500,000 of 7.5% convertible notes
due November 15, 2007 and warrants to purchase 386,364 shares of common stock
of
Access. Net proceeds to Access were $450,000. The notes and warrants were sold
in a private placement to a group of accredited investors led by SCO and
affiliates. All of the principal and interest under these notes were exchanged
for shares of our Series A Preferred Stock and warrants as described above.
The
warrants associated with the notes are currently outstanding.
On
February 16, 2006, we entered into a note and warrant purchase agreement
pursuant to which we sold and issued an aggregate of $5,000,000 of 7.5%
convertible notes due November 15, 2007 and warrants to purchase an aggregate
of
3,863,634 shares of common stock of Access. Net proceeds to Access were $4.5
million. The notes and warrants were sold in a private placement to a group
of
accredited investors led by SCO and affiliates. All of the principal and
interest under these notes were exchanged for shares of our Series A Preferred
Stock and warrants as described above. The warrants associated with the notes
are currently outstanding.
Each
noteholder received a warrant to purchase a number of shares of common stock
of
Access equal to 75% of the total number shares of Access common stock into
which
such holder's note is convertible. Each warrant has an exercise price of $1.32
per share and is exercisable at any time prior to February 16, 2012, October
24,
2012 and December 6, 2012.
In
connection with its sale and issuance of notes and warrants, Access entered
into
an investors rights agreement whereby it granted SCO the right to designate
two
individuals to serve on the Board of Directors of Access while the notes are
outstanding, and also granted registration rights with respect to the shares
of
common stock of Access underlying the notes and warrants. In connection with
its
sale and issuance of notes and warrants, Access entered into an investor rights
agreement whereby it granted registration rights with respect to the shares
of
common stock of Access underlying the notes and warrants. In
addition, pursuant to the purchase agreements in connection with each of the
note and warrant financings, Access granted SCO the right to designate two
individuals to serve on the Board of Directors of Access while the notes are
outstanding, and also granted. This right has now terminated in
accordance with its terms and as been replaced by a similar right pursuant
to
the Director Designation Agreement described above.
On
February 12, 2008, the Board of Directors of the Company elected Steven H.
Rouhandeh as director and Chairman of the Board effective as of March 4,
2008.
Mr. Steven H. Rouhandeh is a Chief Investment Officer of
SCO Capital Partners, L.P., a New York based life sciences
fund.
In
the
event SCO Capital Partners LLC (“SCO”) and its affiliates were to convert all of
their shares of Series A Preferred Stock and exercise all of their warrants,
they would own approximately 69.8% of the voting securities of Access. SCO
Capital Partners, LLC and affiliates (SCO Capital Partners LP and Beach Capital
LLC) are known to beneficially own warrants to purchase an aggregate of
5,924,770 shares of Access’ Common Stock and 7,077,100 shares of Common Stock
issuable to them upon conversion of Series A Preferred Stock. Steven H.
Rouhandeh, in his capacity as managing member of the entity that serves as
general partner of SCO Capital Partners, L.P. has the power to direct the
vote
and disposition of the shares owned by SCO Capital Partners, L.P. Steven
H.
Rouhandeh, in his capacity as Chairman of SCO Capital Partners, LLC. has
the
power to direct the vote and disposition of the shares owned by SCO Capital
Partners, LLC.
24
During
2007 SCO and affiliates were paid $240,000 in placement agent fees relating
to
the issuance of preferred stock and 100,000 warrants to purchase our common
stock. SCO and affiliates also were paid $150,000 in investor relations
fees in
2007. During 2006 SCO and affiliates were paid $415,000 in fees relating
to the
issuance of convertible notes and were paid $131,000 in investor relations
fees.
Oracle Partners LP and affiliates
As
a
condition to the closing of the sale of the Series A Preferred Stock and
warrants, Oracle Partners LP and affiliates, along with the other holders of
an
aggregate of $4,015,000 Convertible Notes also exchanged their notes and accrued
interest for 437.3104 shares of the Series A Preferred Stock and were issued
warrants to purchase 728,850 shares of our common stock at an exercise price
of
$3.50 per share.
USE
OF PROCEEDS
We
will
not receive any proceeds from the sale of shares by the selling stockholders.
We
will receive proceeds from the exercise of warrants if payment of the exercise
price is made in cash. All such proceeds will be used for general corporate
purposes.
PLAN
OF DISTRIBUTION
We
are
registering the shares of common stock on behalf of the selling security
holders. Sales of shares may be made by selling security holders, including
their respective donees, transferees, pledgees or other successors-in-interest
directly to purchasers or to or through underwriters, broker-dealers or through
agents. Sales may be made from time to time on the OTC Bulletin Board, any
other
exchange or market upon which our shares may trade in the future, in the
over-the-counter market or otherwise, at market prices prevailing at the time
of
sale, at prices related to market prices, or at negotiated or fixed prices.
The
shares may be sold by one or more of, or a combination of, the
following:
|
-
|
a
block trade in which the broker-dealer so engaged will attempt to
sell the
shares as agent but may position and resell a portion of the block
as
principal to facilitate the transaction (including crosses in which
the
same broker acts as agent for both sides of the
transaction);
|
|
-
|
purchases
by a broker-dealer as principal and resale by such broker-dealer,
including resales for its account, pursuant to this
prospectus;
|
|
-
|
ordinary
brokerage transactions and transactions in which the broker solicits
purchases;
|
|
-
|
through
options, swaps or derivatives;
|
|
-
|
in
privately negotiated transactions;
|
|
-
|
in
making short sales or in transactions to cover short sales;
and
|
|
-
|
put
or call option transactions relating to the
shares.
|
|
-
|
through
the writing or settlement of options or other hedging transactions,
whether through an options exchange
|
or
otherwise;
|
-
|
a
combination of any such methods of sale;
or
|
|
-
|
any
other method permitted pursuant to applicable
law.
|
The
selling security holders may effect these transactions by selling shares
directly to purchasers or to or through broker-dealers, which may act as agents
or principals. These broker-dealers may receive compensation in the form of
discounts, concessions or commissions from the selling security holders and/or
the purchasers of shares for whom such broker-dealers may act as agents or
to
whom they sell as principals, or both (which compensation as to a particular
broker-dealer might be in excess of customary commissions). The selling security
holders have advised us that they have not entered into any agreements,
understandings or arrangements with any underwriters or broker-dealers regarding
the sale of their securities.
The
selling security holders may enter into hedging transactions with broker-dealers
or other financial institutions. In connection with those transactions, the
broker-dealers or other financial institutions may engage in short sales of
the
shares or of securities convertible into or exchangeable for the shares in
the
course of hedging positions they assume with the selling security holders.
The
selling security holders may also enter into options or other transactions
with
broker-dealers or other financial institutions which require the delivery of
shares offered by this prospectus to those broker-dealers or other financial
institutions. The broker-dealer or other financial institution may then resell
the shares pursuant to this prospectus (as amended or supplemented, if required
by applicable law, to reflect those transactions).
25
The
selling security holders and any broker-dealers that act in connection with
the
sale of shares may be deemed to be “underwriters” within the meaning of Section
2(11) of the Securities Act of 1933, and any commissions received by
broker-dealers or any profit on the resale of the shares sold by them while
acting as principals may be deemed to be underwriting discounts or commissions
under the Securities Act. The selling security holders may agree to indemnify
any agent, dealer or broker-dealer that participates in transactions involving
sales of the shares against liabilities, including liabilities arising under
the
Securities Act. We have agreed to indemnify each of the selling security holders
and each selling security holder has agreed, severally and not jointly, to
indemnify us against some liabilities in connection with the offering of the
shares, including liabilities arising under the Securities Act.
The
selling security holders will be subject to the prospectus delivery requirements
of the Securities Act. We have informed the selling security holders that the
anti-manipulative provisions of Regulation M promulgated under the Securities
Exchange Act of 1934 may apply to their sales in the market.
Selling
security holders also may resell all or a portion of the shares in open market
transactions in reliance upon Rule 144 under the Securities Act, provided they
meet the criteria and conform to the requirements of Rule 144.
Upon
being notified by a selling security holder that a material arrangement has
been
entered into with a broker-dealer for the sale of shares through a block trade,
special offering, exchange distribution or secondary distribution or a purchase
by a broker or dealer, we will file a supplement to this prospectus, if required
pursuant to Rule 424(b) under the Securities Act, disclosing:
|
-
|
the
name of each such selling security holder and of the participating
broker-dealer(s);
|
|
-
|
the
number of shares involved;
|
|
-
|
the
initial price at which the shares were
sold;
|
|
-
|
the
commissions paid or discounts or concessions allowed to the
broker-dealer(s), where applicable;
|
|
-
|
that
such broker-dealer(s) did not conduct any investigation to verify
the
information set out or incorporated by reference in this prospectus;
and
|
|
-
|
other
facts material to the transactions.
|
In
addition, if required under applicable law or the rules or regulations of the
Commission, we will file a supplement to this prospectus when a selling security
holder notifies us that a donee or pledgee intends to sell more than 500 shares
of common stock.
We
are
paying all expenses and fees customarily paid by the issuer in connection with
the registration of the shares. The selling security holders will bear all
brokerage or underwriting discounts or commissions paid to broker-dealers in
connection with the sale of the shares.
26
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
The
following discussion should be read in conjunction with our consolidated
financial statements and related notes included in this Prospectus.
Overview
Access
Pharmaceuticals, Inc. (“Access” or the “Company”) is a Delaware corporation. We
are an emerging biopharmaceutical company focused on developing products based
upon its nanopolymer chemistry technologies. We currently have one approved
product, two products in Phase 2 clinical trials and five products in
pre-clinical development.
|
·
|
MuGard™
is our approved product for the management of oral mucositis, a frequent
side-effect of cancer therapy for which there is no established treatment.
The market for mucositis treatment is estimated to be in excess of
US$1
billion world-wide. MuGard, a proprietary nanopolymer formulation,
has
received marketing allowance in the U.S. from the Food & Drug
Administration (“FDA”).
|
|
·
|
Our
lead development candidate for the treatment of cancer is ProLindac™, a
nanopolymer DACH-platinum prodrug. ProLindac is currently in a Phase
2
clinical trial being conducted in the EU in patients with ovarian
cancer.
The DACH-platinum incorporated in ProLindac is the same active moiety
as
that in oxaliplatin (Eloxatin; Sanofi-Aventis), which has sales in
excess
of $2.0 billion.
|
|
·
|
Pre-clinical
development of Cobalamin™, our proprietary nanopolymer oral drug delivery
technology based on the natural vitamin B12 uptake mechanism. We
are
currently developing a product for the oral delivery of
insulin.
|
|
·
|
Pre-clinical
development of Angiolix®, a humanized monoclonal antibody which acts as an
anti-angiogenesis factor and is targeted to cancer cells, notably
breast,
ovarian and colorectal cancers.
|
|
·
|
Pre-clinical
development of Prodrax®, a non-toxic prodrug which is activated in the
hypoxic zones of solid tumors to kill cancer
cells.
|
|
·
|
Pre-clinical
development of Alchemix®, a chemotherapeutic agent that combines multiple
modes of action to overcome drug
resistance.
|
|
·
|
Pre-clinical
development of Cobalamin-mediated targeted
delivery.
|
|
·
|
Phenylbutyrate
(“PB”), an HDAC inhibitor and a differentiating agent, is a Phase 2
clinical candidate being developed in collaboration with Virium
Pharmaceuticals.
|
Products
Access
used its drug delivery technologies to develop the following products and
product candidates:
Access
Drug Portfolio
|
Compound
|
Originator
|
Technology
|
Indication
|
Clinical
Stage
(1)
|
||||
|
MuGard™
|
Access
|
Mucoadhesive
liquid
|
Mucositis
|
Marketing
clearance received
|
||||
|
ProLindacTM
(Polymer
Platinate,
AP5346) (2)
|
Access
– U London
|
Synthetic
polymer
|
Cancer
|
Phase
2
|
||||
|
Phenylbutyrate
(PB)
|
National
Institute
of
Health
|
Small
molecule
|
Cancer
|
Phase
2
|
||||
|
Oral
Insulin
|
Access
|
Cobalamin
|
Diabetes
|
Pre-clinical
|
27
|
Oral
Delivery System
|
Access
|
Cobalamin
|
Various
|
Pre-clinical
|
||||
|
Angiolix®
|
Immunodex,
Inc.
|
Humanized
monoclonal
antibody
|
Cancer
|
Pre-clinical
|
||||
|
Prodrax®
|
Univ
London
|
Small
molecule
|
Cancer
|
Pre-clinical
|
||||
|
Alchemix®
|
DeMontford
Univ
|
Small
molecule
|
Cancer
|
Pre-clinical
|
||||
|
Cobalamin-Targeted
Therapeutics
|
Access
|
Cobalamin
|
Anti-tumor
|
Pre-clinical
|
||||
|
(1)
|
For
more information, see “Government Regulation” for description of clinical
stages.
|
|
(2)
|
Licensed
from the School of Pharmacy, The University of London. Subject to
a 1%
royalty and milestone payments on
sales.
|
Approved
Products
MuGard™
- -
Mucoadhesive
Liquid Technology (MLT)
Access’
MuGard is a viscous polymer solution which provides a coating for the oral
cavity. MuGard is dispensed in a ready to use form. A multi-site, randomized
clinical study was performed in the United States testing MuGard and MuGard
containing an anti-inflammatory drug to determine the effect of these products
on the prevention and treatment of mucositis. The data from this trial indicated
that the patients using MuGard displayed a lower incidence of mucositis than
is
typically seen in the studied population with no additional benefit from the
drug.
Access
is
currently seeking marketing partners to market MuGard™ in the United States and
in other territories worldwide.
In
August
2007, we signed a definitive licensing agreement with SpePharm Holding, B.V.
under which SpePharm will market Access’ product MuGard in Europe.
Products
in Development Status
ProLindac™
(Polymer
Platinate, AP5346) DACH Platinum
We
have
commenced a European Phase 2 ProLindac trial in ovarian cancer patients who
have
relapsed after first line platinum therapy. The primary aim of the study is
to
determine the response rate of ProLindac monotherapy in this patient population.
The response rates for other platinum compounds in this indication are well
known, and will be used for comparison.
We
have
submitted an IND application to the US Food and Drug Administration, and have
received clearance from the agency to proceed with a Phase 2 clinical study
of
ProLindac in combination with fluorouracil and leucovorin. The study is designed
to evaluate the safety of ProLindac in combination with two standard drugs
used
to treat colorectal cancer and to establish a safe dose for further clinical
studies of this combination in colorectal cancer. We are currently evaluating
whether clinical development of ProLindac in this indication might proceed
more
rapidly by utilizing an alternative clinical strategy and/or conducting studies
in the US and/or elsewhere in the world.
28
Recent
Events
On
February 12, 2008, the Board of Directors of the Company elected Steven H.
Rouhandeh as director and Chairman of the Board effective as of March 4,
2008.
On February 4, 2008, we entered into securities purchase agreements (the “Purchase Agreements”) with accredited investors whereby we agreed to sell 272.5 shares of our preferred stock, designated “Series A Cumulative Convertible Preferred Stock”, par value $0.01 per share, for an issue price of $10,000 per share, (the “Series A Preferred Stock”) and agreed to issue warrants to purchase 545,000 shares of our common stock, which includes placement agent warrants to purchase 90,883 shares of our common stock, at an exercise price of $3.50 per share, for an aggregate purchase price for the Series A Preferred Stock and Warrants of $2,700,000. The shares of Series A Preferred Stock are convertible into common stock at the initial conversion price of $3.00 per share.
On
January 14, 2008, we announced the signing of a definitive licensing agreement
under which RHEI Pharmaceuticals, Inc. will market and manufacture MuGard in
the
Peoples Republic of China and certain Southeast Asian countries. RHEI will
also
obtain the necessary regulatory approvals for MuGard in the
territory.
On
January 4, 2008 we closed the acquisition of Somanta Pharmaceuticals, Inc.
In
connection with the merger, Access issued an aggregate of approximately 1.5
million shares of Access Pharmaceuticals, Inc. common stock to the common and
preferred shareholders of Somanta as consideration. In addition,
Access exchanged all outstanding warrants of Somanta for warrants to
purchase 191,991 shares of Access common stock at exercise prices ranging
between $18.55 and $69.57 per share.
On
December 26, 2007, Jeffrey B. Davis, Chairman of the Board of Directors was
named Chief Executive Officer. Stephen R. Seiler resigned as President and
Chief
Executive Officer and concurrently resigned from the Board of Directors
effective December 19, 2007.
On
November 7, 2007, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 954.0001 shares
of a newly created series of our preferred stock, designated “Series A
Cumulative Convertible Preferred Stock”, par value $0.01 per share, for an issue
price of $10,000 per share, (the “Series A Preferred Stock”) and agreed to issue
warrants to purchase 1,589,999 shares of our common stock at an exercise price
of $3.50 per share, for an aggregate purchase price for the Series A Preferred
Stock and Warrants of $9,540,001. The shares of Series A Preferred Stock are
convertible into common stock at the initial conversion price of $3.00 per
share.
As
a
condition to closing, SCO Capital Partners LLC and affiliates, along with the
other holders of an aggregate of $6,000,000 Secured Convertible Notes, also
exchanged their notes and accrued interest for an additional 1,836.0512 shares
of Series A Preferred Stock and were issued warrants to purchase 1,122,031
shares of our common stock at an exercise price of $3.50 per share, and Oracle
Partners LP and affiliates, along with the other holders of an aggregate of
$4,015,000 Convertible Notes also exchanged their notes and accrued interest
for
437.3104 shares of the Series A Preferred Stock and were issued warrants to
purchase 728,850 shares of our common stock at an exercise price of $3.50 per
share. SCO Capital Partners LLC currently has two designees serving
on our Board of Directors. In connection with the exchange of the
notes, all security interests and liens relating thereto were
terminated.
On
August
27, 2007, we signed a definitive licensing agreement with SpePharm Holding,
B.V.
under which SpePharm will market Access’ product MuGard in Europe.
On
August
1, 2007, we announced that Esteban Cvitkovic, a member of our board of directors
as Vice Chairman Europe, agreed to an expanded role as Senior Director, Oncology
Clinical R&D.
On
April
26, 2007, we entered into a Note Purchase Agreement with Somanta
Pharmaceuticals, Inc. in order for Access to loan Somanta amounts to keep
certain of their licenses and vendors current. As of September 30, 2007 we
have
loaned Somanta $859,000.
29
Results
of Operations
Comparison
of Third Quarter 2007 Compared To Third Quarter 2006
Our
licensing revenue in the third quarter of 2007 was $6,000. We recognize
licensing revenue over the period of the performance obligation under our
licensing agreement. We received a $1.0 million upfront licensing payment in
August 2007 from SpePharm Holding, B.V. for marketing MuGard in Europe. We
will
recognize the upfront licensing fee over 14 ¾ years, the license
term.
Total
research spending for the third quarter of 2007 was $596,000, as compared to
$379,000 for the same period in 2006, an increase of $217,000. The increase
in
expenses was primarily due to:
|
·
|
costs
for product manufacturing for a new ProLindac clinical trial expected
to
start in 2008 ($214,000);
|
|
·
|
higher
salary and related cost due to the hiring of additional scientific
staff
($30,000); and
|
|
·
|
other
net increases ($25,000).
|
The
increase in research spending is partially offset by lower clinical development
costs ($52,000). We incurred start-up costs for the clinical trial in early
2006.
Total
general and administrative expenses were $1,000,000 for the third quarter of
2007, an increase of $200,000 as compared to the same period in 2006. The
increase in spending was due primarily to the following:
|
·
|
higher
investor relations expenses ($149,000) due to our increased investor
relations efforts;
|
|
·
|
higher
salary related expenses due to stock option expenses ($156,000);
and
|
|
·
|
higher
salary expenses ($65,000).
|
The
increase in general and administrative spending is partially offset
by:
|
·
|
lower
patent expenses ($90,000);
|
|
·
|
lower
professional fees ($59,000); and
|
|
·
|
other
net decreases ($21,000).
|
Depreciation
and amortization was $61,000 for the third quarter of 2007 as compared to
$77,000 for the same period in 2006 reflecting a decrease of $16,000. The
decrease in depreciation and amortization was due to assets becoming fully
depreciated.
Total
operating expenses in the third quarter of 2007 were $1,657,000 as compared
to
total operating expenses of $1,256,000 for the same period in 2006, an increase
of $401,000.
Interest
and miscellaneous income was $12,000 for the third quarter of 2007 as compared
to $86,000 for the same period in 2006, a decrease of $74,000. The decrease
in
interest income was due to accretion of the receivable due from Uluru that
was
recorded in 2006.
Interest
and other expense was $318,000 for the third quarter of 2007 as compared to
$1,976,000 the same period in 2006, a decrease of $1,658,000. The decrease
in
interest and other expense was due to amortization of the discount on the Oracle
convertible notes and the amortization of the SCO notes recognized in
2006.
In
2006,
there was an unrealized loss on fair value of warrants of $1,131,000 due to
the
warrants issued to SCO and affiliates. We changed our accounting for the
warrants in the fourth quarter of 2006 and there are no unrealized losses or
gains in 2007.
Net
loss
in the third quarter of 2007 was $1,957,000, or a $0.55 basic and diluted loss
per common share, compared with a loss of $2,015,000, or a $0.57 basic and
diluted loss per common share for the same period in 2006, a decreased loss
of
$58,000.
30
Comparison
of Nine Months Ended September 30, 2007 Compared To Nine Months Ended September
30, 2006
Our
licensing revenue in the first nine months of 2007 was $6,000. We recognize
licensing revenue over the period of the performance obligation under our
licensing agreement. We received a $1.0 million upfront licensing payment in
August 2007 from SpePharm Holding, B.V. for marketing MuGard in Europe. We
will
recognize the upfront licensing fee over 14 ¾ years, the license
term.
Total
research spending for the first nine months of 2007, was $1,532,000, as compared
to $1,769,000 for the same period in 2006, a decrease of $237,000. The decrease
in expenses was primarily due to
|
·
|
lower
costs for product manufacturing for ProLindac ($198,000). Product
manufacturing was completed early in 2006 which we believe is adequate
to
supply drug product for our current ovarian cancer
trial;
|
|
·
|
lower
costs of clinical trials for ProLindac ($170,000). We incurred start-up
costs for the clinical trial in early 2006;
and
|
|
·
|
other
net decreases ($53,000).
|
The
decrease in research spending is partially offset by
|
·
|
higher
salary and related cost due to the hiring of additional scientific
staff
($121,000); and
|
|
·
|
higher
scientific consulting costs
($63,000).
|
Total
general and administrative expenses were $3,252,000 for the first nine months
of
2007, an increase of $1,123,000 as compared to the same period in 2006. The
increase in general and administrative expenses was due primarily to the
following:
|
·
|
higher
salary related expenses due mainly to stock option expenses
($580,000);
|
|
·
|
higher
investor relations expenses ($368,000) due to our increased investor
relations efforts;
|
|
·
|
higher
salary and related costs ($178,000);
and
|
|
·
|
higher
travel costs ($58,000).
|
The
increase in general and administrative expenses is partially offset
by:
|
·
|
lower
patent expenses ($45,000); and
|
|
·
|
other
net decreases ($16,000).
|
Depreciation
and amortization was $210,000 for the first nine months of 2007 as compared
to
$231,000 for the same period in 2006 reflecting a decrease of $21,000. The
decrease in depreciation and amortization was due to assets becoming fully
depreciated.
Interest
and miscellaneous income was $72,000 for the first nine months of 2007 as
compared to $278,000 for the same period in 2006, a decrease of $206,000. The
decrease in interest income was due to accretion of the receivable due from
Uluru that was recorded in 2006.
Interest
and other expense was $3,277,000 for the first nine months of 2007 as compared
to $5,244,000 for the same period in 2006, a decrease of $1,967,000. The
decrease in interest and other expense was due to amortization of the discount
on the Oracle convertible notes and the amortization of the SCO notes recognized
in 2006.
In
2006
there was an unrealized loss on fair value of warrants of $1,107,000 due to
the
warrants issued to SCO and affiliates. We changed our accounting for the
warrants in the fourth quarter of 2006 and there is no unrealized losses or
gains in 2007.
Net
loss
in the first nine months of 2007 was $8,193,000, or a $2.31 basic and diluted
loss per common share, compared with a loss of $10,202,000, or a $2.89 basic
and
diluted loss per common share for the same period in 2006, a decreased loss
of
$2,009,000.
31
Comparison
of Years Ended December 31, 2006 and 2005
Our
total
research spending for continuing operations for the year ended December 31,
2006
was $2,053,000, as compared to $2,783,000 in 2005, a decrease of $730,000.
The
decrease in expenses was the result of Phase 2 clinical trial start-up costs,
including manufacturing costs for ProLindac™ in 2005 whereas 2006 costs were
primarily clinical trial costs.
Our
total
general and administrative expenses were $2,813,000 for 2006, a decrease of
$1,825,000 over 2005 expenses of $4,638,000, due to lower:
|
·
|
Salary
expenses due to the separation agreement in 2005 with our former
CEO
($909,000);
|
|
·
|
Professional
fees for investment strategies and fairness opinions in 2005
($397,000);
|
|
·
|
Legal
fees ($313,000);
|
|
·
|
Patent
and license fees ($194,000);
|
|
·
|
Rent
($113,000);
|
|
·
|
Compensation
paid to Chairman in 2005 ($140,000)
and
|
|
·
|
Other
net decreases ($41,000).
|
The
decrease in general and administrative expenses is offset partially by
higher:
|
·
|
Salary
related costs due to the expensing of stock options ($180,000);
and
|
|
·
|
Investor/public
relations fees ($102,000).
|
Depreciation
and amortization was $309,000 in 2006 as compared to $333,000 in 2005, a
decrease of $24,000 due to the lower depreciation expense.
In
2005
we wrote off our goodwill of $1,868,000 following an impairment
analysis.
Our
loss
from operations in 2006 was $5,175,000 as compared to a loss of $9,622,000
in
2005.
Interest
and miscellaneous income was $294,000 for 2006 as compared to $100,000 for
2005,
an increase of $194,000, relating to interest recognized on the Uluru receivable
and higher cash balances in 2006 as compared with 2005.
Interest
and other expense was $7,436,000 for 2006 as compared to $2,100,000 for the
same
period in 2005, an increase of $5,336,000. The increase was due to amortization
of the discount of the Secured Convertible Notes and to amortization of the
discount on the extension of a convertible note.
We
had
$550,000 less $173,000 tax expense in 2006 in milestone revenues from our oral
care assets that we sold to Uluru, Inc. due to the amended 2005 Asset Sale
Agreement. We had no milestone revenues in 2005.
The
Secured Convertible Notes include warrants and a conversion feature. Until
September 30, 2006 we accounted for the warrants and conversion feature as
liabilities and recorded at fair value. From the date of issuance to September
30, 2006, the fair value of these instruments increased resulting in a net
unrealized loss of $1.1 million. On October 1, 2006, we adopted the
provisions of Financial Accounting Standards Board Staff Position EITF No.
00-19-2, “Accounting for
Registration Payment Arrangements” (EITF 00-19-2), which requires that
contingent obligations to make future payments under a registration payment
arrangement be recognized and measured separately in accordance with SFAS
No. 5, “Accounting for
Contingencies.” Under previous guidance, the fair value of the
warrant was recorded as a current liability in our balance sheet, due
to a potential cash payment feature in the warrant. The current liability
was
marked-to-market at each quarter end, using the Black-Scholes option-pricing
model, with the change being recorded to general and administrative expenses.
Under the new guidance in EITF 00-19-2, as we believe the likelihood of such
a
cash payment to not be probable, have not recognized a liability for such
obligations. Accordingly, a cumulative-effect adjustment of $1.4 million
was
made as of October 1, 2006 to accumulated deficit, representing the
difference between the initial value of this warrant and its fair value as
of
this date and recorded to equity.
32
Net
loss
for 2006 was $12,874,000, or $3.65 basic and diluted loss per common share
compared with a loss of $1,700,000, or a $0.53 basic and diluted loss per common
share, for 2005.
Comparison
of Years Ended December 31, 2005 and 2004
Our
total
research spending for continuing operations for the year ended December 31,
2005
was $2,783,000, as compared to $2,335,000 in 2004, an increase of $448,000.
The
increase in expenses was the result of Phase 2 start-up costs including
manufacturing and clinical costs for ProLindac™ clinical trials ($674,000) and
other net costs ($20,000) offset by lower salary costs due to cutbacks in
scientific staff ($246,000).
Our
total
general and administrative expenses were $4,638,000 for 2005, an increase of
$1,439,000 over 2004 expenses of $3,199,000, due to:
|
·
|
Expenses
due to the separation agreement with our former CEO
($909,000);
|
|
·
|
Professional
fees for investment banking and financing decisions
($397,000);
|
|
·
|
Higher
legal fees due to changes in our convertible debt and legal fees
associated with merger candidates
($161,000); and
|
|
·
|
Royalty
license fee ($150,000).
|
The
increases in general and administrative expenses is offset by:
|
·
|
Lower
investor relations costs ($90,000);
|
|
·
|
Lower
patent expenses ($61,000); and
|
|
·
|
Lower
net other increases ($27,000).
|
Depreciation
and amortization was $333,000 in 2005 as compared to $469,000 in 2004, a
decrease of $136,000 due to the impairment of a license which is no longer
effective ($109,000) plus lower depreciation.
In
addition we wrote off our goodwill in 2005 of $1,868,000 following an impairment
analysis.
Our
loss
from continuing operations in 2005 was $9,622,000 as compared to a loss of
$6,003,000 in 2004.
Interest
and miscellaneous income was $100,000 for 2005 as compared to $226,000 for
2004,
a decrease of $126,000, relating to interest income due to lower cash balances
in 2005 as compared with 2004.
Interest
and miscellaneous expense was $2,100,000 for 2005 as compared to $1,385,000
for
the same period in 2004, an increase of $715,000. The increase was due to
repayment of the secured convertible notes and contractually accelerated
interest and penalty and due to amortization of the discount on the extension
on
of the convertible note.
Net
loss
for 2005 was $1,700,000, or a $0.53 basic and diluted loss per common share
compared with a loss of $10,238,000, or a $3.38 basic and diluted loss per
common share, for 2004.
33
Discontinued
Operations
In
October 2005 we sold our oral/topical care business to Uluru, Inc. for a gain
of
$12,891,000 less $4,067,000 tax expense and we closed down our Australian
operations. The loss from our discontinued operations of our oral/topical care
business and our Australian operation was $2,969,000.
Liquidity
and Capital Resources
We
have
funded our operations primarily through private sales of common stock and
convertible notes and our principal source of liquidity is cash and cash
equivalents. Licensing fees provided minimal funding for operations during
the
quarter ended September 30, 2007. As of February 29, 2008, our cash and cash
equivalents and short-term investments were $6,772,000 and our net cash burn
rate for the nine months ending September 30, 2007 was approximately $430,000
per month. As of September 30, 2007 our working capital deficit was $12,624,000.
Our working capital at September 30, 2007 represented a decrease of $6,842,000
as compared to our working capital deficit as of December 31, 2006 of
$5,782,000. Our working capital as of September 30, 2007 was negative reflecting
approximately $11.4 million of debt that was a current liability at September
30, 2007 and $1.0 million of accrued interest payments accrued at September
30,
2007. As of February 29, 2008 we have convertible notes outstanding
due of $5.6 million, in the principle amount of $5.5 million which are due
September 13, 2011.
As
of
February 29, 2008, the Company did not have enough capital to achieve its
long-term goals. If we raise additional funds by selling equity securities,
the
relative equity ownership of our existing investors would be diluted and the
new
investors could obtain terms more favorable than previous investors. A failure
to obtain necessary additional capital in the future could jeopardize our
operations.
We
have
generally incurred negative cash flows from operations since inception, and
have
expended, and expect to continue to expend in the future, substantial funds
to
complete our planned product development efforts. Since inception, our expenses
have significantly exceeded revenues, resulting in an accumulated deficit as
of
September 30, 2007 of $85,865,000. We expect that our capital resources will
be
adequate to fund our current level of operations into the second quarter of
2009. However, our ability to fund operations over this time could change
significantly depending upon changes to future operational funding obligations
or capital expenditures. As a result we may be required to seek additional
financing sources within the next twelve months. We cannot assure you that
we
will ever be able to generate significant product revenue or achieve or sustain
profitability.
All
shares and per share information reflect a one for five reverse stock split
effected June 5, 2006.
Currently,
one noteholder holding $5.5 million worth of 7.7% convertible notes has amended
their note to a new maturity date, September 13, 2011.
Since
our
inception, we have devoted our resources primarily to fund our research and
development programs. We have been unprofitable since inception and to date
have
received limited revenues from the sale of products. We cannot assure you that
we will be able to generate sufficient product revenues to attain profitability
on a sustained basis or at all. We expect to incur losses for the next several
years as we continue to invest in product research and development, preclinical
studies, clinical trials and regulatory compliance.
We
plan
to expend substantial funds to conduct research and development programs,
preclinical studies and clinical trials of potential products, including
research and development with respect to our acquired and developed technology.
Our future capital requirements and adequacy of available funds will depend
on
many factors, including:
|
·
|
the
successful development and commercialization of ProLindac™, MuGard™ and
our other product candidates;
|
|
·
|
the
ability to convert, repay or restructure our outstanding convertible
notes
and debentures;
|
34
|
·
|
the
ability to integrate Somanta Pharmaceuticals, Inc. assets and programs
with ours;
|
|
·
|
the
ability to establish and maintain collaborative arrangements with
corporate partners for the research, development and commercialization
of
products;
|
|
·
|
continued
scientific progress in our research and development
programs;
|
|
·
|
the
magnitude, scope and results of preclinical testing and clinical
trials;
|
|
·
|
the
costs involved in filing, prosecuting and enforcing patent
claims;
|
|
·
|
the
costs involved in conducting clinical
trials;
|
|
·
|
competing
technological developments;
|
|
·
|
the
cost of manufacturing and scale-up;
|
|
·
|
the
ability to establish and maintain effective commercialization arrangements
and activities; and
|
|
·
|
successful
regulatory filings.
|
We
have
devoted substantially all of our efforts and resources to research and
development conducted on our own behalf. The following table summarizes research
and development spending by project category (in thousands), which spending
includes, but is not limited to, payroll and personnel expense, lab supplies,
preclinical expense, development cost, clinical trial expense, outside
manufacturing expense and consulting expense:
|
(in
thousands)
|
Twelve
Months ended
December
31,
|
Nine
Months ended
September
30,
|
Inception
To
Date
(1)
|
|
Project
|
2006
|
2005
|
2007
|
|
Polymer
Platinate
(ProLindac™)
|
$ | 2,043 | $ | 2,653 | $ | 1,433 | $ | 21,087 | ||||||||
|
Mucoadhesive
Liquid
Technology
(MLT)
|
10 | - | 21 | 1,511 | ||||||||||||
|
Others
(2)
|
- | 130 | 78 | 5,122 | ||||||||||||
|
Total
|
$ | 2,053 | $ | 2,783 | $ | 1,532 | $ | 27,720 | ||||||||
|
(1)
|
Cumulative
spending from inception of the Company or project through September
30,
2007.
|
|
(2)
|
Includes: Vitamin
Mediated Targeted Delivery, carbohydrate targeting, amlexanox cream
and
gel and other related projects.
|
Due
to
uncertainties and certain of the risk factors described above, including those
relating to our ability to successfully commercialize our drug candidates,
our
ability to obtain necessary additional capital to fund operations in the future,
our ability to successfully manufacture our products and our product candidates
in clinical quantities or for commercial purposes, government regulation to
which we are subject, the uncertainty associated with preclinical and clinical
testing, intense competition that we face, market acceptance of our products
and
protection of our intellectual property, it is not possible to reliably predict
future spending or time to completion by project or product category or the
period in which material net cash inflows from significant projects are expected
to commence. If we are unable to timely complete a particular
project, our research and development efforts could be delayed or reduced,
our
business could suffer depending on the significance of the project and we might
need to raise additional capital to fund operations, as discussed in the risk
factors above, including without limitation those relating to the uncertainty
of
the success of our research and development activities and our ability to obtain
necessary additional capital to fund operations in the future. As
discussed in such risk factors, delays in our research and development efforts
and any inability to raise additional funds could cause us to eliminate one
or
more of our research and development programs.
We
plan
to continue our policy of investing any available funds in certificates of
deposit, money market funds, government securities and investment-grade
interest-bearing securities. We do not invest in derivative financial
instruments.
35
Critical
Accounting Policies and Estimates
The
preparation of our consolidated financial statements in conformity with
accounting principles generally accepted in the United State of America requires
us to make estimates and assumptions that affect the reported amounts of assets
and liabilities, disclosure of contingent assets and liabilities at the date
of
the financial statements and the reported amount of revenues and expenses during
the reported period. In applying our accounting principles, we must often make
individual estimates and assumptions regarding expected outcomes or
uncertainties. As you might expect, the actual results or outcomes are often
different than the estimated or assumed amounts. These differences are usually
minor and are included in our consolidated financial statements as soon as
they
are known. Our estimates, judgments and assumptions are continually
evaluated based on available information and experience. Because of the use
of
estimates inherent in the financial reporting process, actual results could
differ from those estimates.
Asset
Impairment
On
January 1, 2002, we adopted SFAS 142, “Goodwill and Other Intangible
Assets.” Upon adoption, we performed a transitional impairment test on
our recorded intangible assets that consisted primarily of acquisition related
goodwill and license intangibles. We also performed an annual impairment test
in
the fourth quarter of 2005. The analysis compared the Company’s market
capitalization with net asset value resulting in an impairment charge in 2005
of
$1,868,000.
Our
intangible assets at December 31, 2006 consist primarily of patents
acquired in acquisitions and licenses which were recorded at fair value on
the
acquisition date. We perform an impairment test on at least an annual basis
or
when indications of impairment exist. At December 31, 2006, Management believes
no impairment of our intangible assets exists.
Based
on
an assessment of our accounting policies and underlying judgments and
uncertainties affecting the application of those policies, we believe that
our
consolidated financial statements provide a meaningful and fair
perspective of us. We do not suggest that other general factors, such as those
discussed elsewhere in this report, could not adversely impact our consolidated
financial position, results of operations or cash flows. The impairment test
involves judgment on the part of management as to the value of goodwill,
licenses and intangibles.
Stock
Based Compensation Expense
On
January 1, 2006, we adopted SFAS No. 123 (revised 2004), “Share-Based Payment,” (“SFAS
123(R)”), which requires the measurement and recognition of all share-based
payment awards made to employees and directors including stock options based
on
estimated fair values. SFAS 123(R) supersedes the Company’s previous accounting
under Accounting Principles Board (“APB”) Opinion No. 25, “Accounting for Stock Issued
to
Employees” (“APB 25”), for periods beginning in fiscal year 2006. In
March 2005, the Securities and Exchange Commission issued Staff Accounting
Bulletin No. 107 (“SAB 107”) relating to SFAS 123(R). We applied the
provisions of SAB 107 in its adoption of SFAS 123(R).
We
adopted SFAS 123(R) using the modified prospective transition method, which
requires the application of the accounting standard as of January 1, 2006,
the first day of the Company’s 2006 fiscal year. Our consolidated financial
statements for the year ended December 31, 2006, reflect the impact of SFAS
123(R). In accordance with the modified prospective transition method, our
consolidated financial statements for prior periods have not been restated
to
include the impact of SFAS 123(R). Stock-based compensation expense recognized
under SFAS 123(R) for the year ended December 31, 2006 was approximately
$248,000. Stock-based compensation expense which would have been recognized
under the fair value based method would have been approximately $750,000 during
the year ended December 31, 2005.
36
SFAS
123(R) requires companies to estimate the fair value of share-based payment
awards on the date of grant using an option-pricing model. The value of the
portion of the award that is ultimately expected to vest is recognized as
expense over the requisite service period in the company’s Statement of
Operations. Prior to the adoption of SFAS 123(R), we accounted for stock-based
awards to employees and directors using the intrinsic value method in accordance
with APB No. 25 as allowed under SFAS No. 123, “Accounting for Stock-Based
Compensation” (“SFAS 123”). Under the intrinsic value method, no
stock-based compensation expense for stock option grants was recognized because
the exercise price of our stock options granted to employees and directors
equaled the fair market value of the underlying stock at the date of grant.
In
2005, we did recognize stock compensation expense for restricted stock awards
based on the fair value of the underlying stock on date of grant and this
expense was amortized over the requisite service period. There were no
restricted stock awards granted in 2006 and therefore no stock compensation
expense is recognized in 2006 for these awards.
Stock-based
compensation expense recognized in our Statement of Operations for the first
year ended December 31, 2006 includes compensation expense for share-based
payment awards granted prior to, but not yet vested as of December 31,
2005, based on the grant date fair value estimated in accordance with the pro
forma provisions of SFAS 123 and compensation expense for the share-based
payment awards granted subsequent to December 31, 2005, based on the grant
date
fair value estimated in accordance with the provisions of SFAS 123(R).
Stock-based compensation expense recognized in the Company’s Statement of
Operations for the year ended December 31, 2006 is based on awards ultimately
expected to vest and has been reduced for estimated forfeitures, which currently
is nil. SFAS 123(R) requires forfeitures to be estimated at the time of grant
and revised, if necessary, in subsequent periods if actual forfeitures differ
from those estimates. In the Company’s pro forma information required under SFAS
123 for periods prior to fiscal year 2006, forfeitures have been accounted
for
as they occurred.
We
use
the Black-Scholes option-pricing model (“Black-Scholes”) as its method of
valuation under SFAS 123(R) in fiscal year 2006 and a single option award
approach. This fair value is then amortized on a straight-line basis over the
requisite service periods of the awards, which is generally the vesting period.
Black-Scholes was also previously used for our pro forma information required
under SFAS 123 for periods prior to fiscal year 2006. The fair value of
share-based payment awards on the date of grant as determined by the
Black-Scholes model is affected by our stock price as well as other assumptions.
These assumptions include, but are not limited to the expected stock price
volatility over the term of the awards, and actual and projected employee stock
option exercise behaviors.
Recent
Accounting Pronouncements
In
September 2006, the FASB issued Statement of Financial Accounting Standards
No. 157, “Fair Value
Measurements” (SFAS 157). SFAS 157 defines fair value,
establishes a framework for measuring fair value in accordance with generally
accepted accounting principles, and expands disclosures about fair value
measurements. SFAS 157 is effective for fiscal years beginning after
November 15, 2007. We are evaluating the potential impact of the
implementation of SFAS 157 on our financial position and results of
operations.
In
2006,
the Financial Accounting Standards Board issued FASB Interpretation No. 48
(FIN 48), which
clarifies the accounting for uncertainty in tax positions. FIN 48 requires
that
we recognize in our financial statements the impact of a tax position, if that
position is more likely than not of being sustained on audit, based on the
technical merits of the position. We adopted the provisions of FIN 48 as of
the
beginning of our 2007 fiscal year. There was no effect as a result of our
adoption of FIN 48.
As
of the
beginning of our 2007 fiscal year, due to our cumulative net losses we do not
have any reserves for income taxes because no taxes are due.
37
We
file
income tax returns in the U.S. federal jurisdiction and various state
jurisdictions. A number of years may elapse before an uncertain tax position
is
audited and finally resolved. While it is often difficult to predict the final
outcome or the timing of resolution of any particular uncertain tax position,
we
believe that our reserves for income taxes reflect the most probable outcome.
We
adjust these reserves, as well as the related interest, in light of changing
facts and circumstances. Settlement of any particular position would usually
require the use of cash. The resolution of a matter would be recognized as
an
adjustment to our provision for income taxes and our effective tax rate in
the
period of resolution.
Off-Balance
Sheet Transactions
None
38
DESCRIPTION
OF BUSINESS
Business
Access
Pharmaceuticals, Inc. (“Access” or the “Company”) is a Delaware corporation. We
are an emerging biopharmaceutical company focused on developing products based
upon our nanopolymer chemistry technologies. We currently have one approved
product, two products in Phase 2 clinical trials and five products in
pre-clinical development.
|
·
|
MuGard™
is our approved product for the management of oral mucositis, a frequent
side-effect of cancer therapy for which there is no established treatment.
The market for mucositis treatment is estimated to be in excess of
US$1
billion world-wide. MuGard, a proprietary nanopolymer formulation,
has
received marketing allowance in the U.S. from the Food & Drug
Administration (“FDA”).
|
|
·
|
Our
lead development candidate for the treatment of cancer is ProLindac™, a
nanopolymer DACH-platinum prodrug. ProLindac is currently in a Phase
2
clinical trial being conducted in the EU in patients with ovarian
cancer.
The DACH-platinum incorporated in ProLindac is the same active moiety
as
that in oxaliplatin (Eloxatin; Sanofi-Aventis), which has sales in
excess
of $2.0 billion.
|
|
·
|
Pre-clinical
development of Cobalamin™, our proprietary nanopolymer oral drug delivery
technology based on the natural vitamin B12 uptake mechanism. We
are
currently developing a product for the oral delivery of
insulin.
|
|
·
|
Pre-clinical
development of Angiolix®, a humanized monoclonal antibody which acts as an
anti-angiogenesis factor and is targeted to cancer cells, notably
breast,
ovarian and colorectal cancers.
|
|
·
|
Pre-clinical
development of Prodrax®, a non-toxic prodrug which is activated in the
hypoxic zones of solid tumors to kill cancer
cells.
|
|
·
|
Pre-clinical
development of Alchemix®, a chemotherapeutic agent that combines multiple
modes of action to overcome drug
resistance.
|
|
·
|
Pre-clinical
development of Cobalamin-mediated targeted
delivery.
|
|
·
|
Phenylbutyrate
(“PB”), an HDAC inhibitor and a differentiating agent, is a Phase 2
clinical candidate being developed in collaboration with Virium
Pharmaceuticals.
|
Products
Access
used its drug delivery technologies to develop the following products and
product candidates:
Access
Drug Portfolio
|
Compound
|
Originator
|
Technology
|
Indication
|
Clinical
Stage
(1)
|
||||
|
MuGard™
|
Access
|
Mucoadhesive
liquid
|
Mucositis
|
Marketing
clearance received
|
||||
|
ProLindacTM
(Polymer
Platinate,
AP5346) (2)
|
Access
– U London
|
Synthetic
polymer
|
Cancer
|
Phase
2
|
||||
|
Phenylbutyrate
(PB)
|
National
Institute
of
Health
|
Small
molecule
|
Cancer
|
Phase
2
|
||||
|
Oral
Insulin
|
Access
|
Cobalamin
|
Diabetes
|
Pre-clinical
|
||||
|
Oral
Delivery System
|
Access
|
Cobalamin
|
Various
|
Pre-clinical
|
||||
|
Angiolix®
|
Immunodex,
Inc.
|
Humanized
monoclonal
antibody
|
Cancer
|
Pre-clinical
|
39
|
Prodrax®
|
Univ
London
|
Small
molecule
|
Cancer
|
Pre-clinical
|
||||
|
Alchemix®
|
DeMontford
Univ
|
Small
molecule
|
Cancer
|
Pre-clinical
|
||||
|
Cobalamin-Targeted
Therapeutics
|
Access
|
Cobalamin
|
Anti-tumor
|
Pre-clinical
|
||||
|
(1)
|
For
more information, see “Government Regulation” for description of clinical
stages.
|
|
(2)
|
Licensed
from the School of Pharmacy, The University of London. Subject to
a 1%
royalty and milestone payments on
sales.
|
|
|
|
Approved
Products
MuGard™
- -
Mucoadhesive
Liquid Technology (MLT)
Mucositis
is a debilitating condition involving extensive inflammation of mouth tissue
that affects annually an estimated 400,000 cancer patients in the United States
undergoing chemotherapy and radiation treatment. Any treatment that would
accelerate healing and/or diminish the rate of appearance of mucositis would
have a significant beneficial impact on the quality of life of these patients
and may allow for more aggressive chemotherapy. We believe the potential
addressable market for a mucositis product could be over $1 billion
world-wide.
Access’
MuGard is a viscous polymer solution which provides a coating for the oral
cavity. MuGard is dispensed in a ready to use form. A multi-site, randomized
clinical study was performed in the United States testing MuGard and MuGard
containing an anti-inflammatory drug to determine the effect of these products
on the prevention and treatment of mucositis. The data from this trial indicated
that the patients using MuGard displayed a lower incidence of mucositis than
is
typically seen in the studied population with no additional benefit from the
drug.
The
data
were retrospectively compared with two historical patient databases to evaluate
the potential advantages MuGard may represent in the prevention, treatment
and
management of mucositis. The patient evaluation was conducted using the oral
mucositis assessment scale, which qualifies the disease severity on a scale
of
0-5. Key highlights of the comparison with the historical patient databases
are
as follows:
•
the average severity of the disease was reduced by approximately
40%;
•
the maximum intensity of the mucositis was approximately 35% lower;
and
•
the median peak intensity was approximately 50% lower.
These
data confirmed the fact that MuGard could represent an important advancement
in
the management and prevention of mucositis. On September 20, 2006, we announced
that we had submitted a Premarket Notification 510(k) application to the United
States Food and Drug Administration (FDA) announcing the Company’s intent to
market MuGard. On December 13, 2006, we announced that we had received marketing
clearance for MuGard from FDA for the indication of the management of oral
wounds including mucositis, aphthous ulcers and traumatic ulcers.
Access
is
currently seeking marketing partners to market MuGard in the United States
and
in other territories worldwide. In August 2007, we signed a definitive licensing
agreement with SpePharm Holding, B.V. under which SpePharm will market Access’
product MuGard in Europe. In January 2008 we also signed a definitive licensing
agreement with RHEI Pharmaceuticals, Inc. under which RHEI will market Access’
product MuGard in China and other Southeast Asian countries.
40
Products
in Development Status
ProLindac™
(Polymer
Platinate, AP5346) DACH Platinum
Chemotherapy,
surgery and radiation are the major components in the clinical management of
cancer patients. Chemotherapy serves as the primary therapy for some solid
tumors and metastases and is increasingly used as an adjunct to radiation and
surgery to improve their effectiveness. For chemotherapeutic agents to be
effective in treating cancer patients, however, the agent must reach the target
cells in effective quantities with minimal toxicity in normal
tissues.
The
current optimal strategy for chemotherapy involves exposing patients to the
most
intensive cytotoxic regimens they can tolerate and clinicians attempt to design
a combination of chemotherapeutic drugs, a dosing schedule and a method of
administration to increase the probability that cancerous cells will be
destroyed while minimizing the harm to healthy cells. Notwithstanding
clinicians’ efforts, most current chemotherapeutic drugs have significant
shortcomings that limit the efficacy of chemotherapy. For example, certain
cancers are inherently unresponsive to chemotherapeutic agents. Alternatively,
other cancers may initially respond, but subgroups of cancer cells acquire
resistance to the drug during the course of therapy and the resistant cells
may
survive and cause a relapse. Serious toxicity, including bone marrow
suppression, renal toxicity, neuropathy, or irreversible cardiotoxicity, are
some of the limitations of current anti-cancer drugs that can prevent their
administration in curative doses.
Oxaliplatin,
a formulation of DACH platinum, is a chemotherapeutic which was initially
approved in France and in Europe in 1999 for the treatment of colorectal cancer.
It is now also being marketed in the United States and generated worldwide
sales
in excess of $2 billion in 2006. Carboplatin and Cisplatin, two other approved
platinum chemotherapy drugs, are not indicated for the treatment of metastatic
colorectal cancer. Oxaliplatin, in combination with 5-flurouracil and folinic
acid (known as the FOLFOX regime) is indicated for the first-line treatment
of
metastatic colorectal cancer in Europe and the U.S. The colorectal cancer market
is a significant opportunity as there are over 940,000 reported new cases
annually worldwide, increasing at a rate of approximately three percent per
year, and 500,000 deaths.
Currently,
platinum compounds are one of the largest selling categories of chemotherapeutic
agents, with annual sales in excess of $3.0 billion in 2006. As is the case
with
all chemotherapeutic drugs, the use of such compounds is associated with serious
systemic side effects. The drug development goal therefore is to enhance
delivery of the active drug to the tumor and minimize the amount of active
drug
affecting normal organs in the body.
Utilizing
a biocompatible water-soluble polymer (HPMA) as a drug carrier, Access’ drug
candidate ProLindac, links DACH platinum to a polymer in a manner which permits
the selective release of active drug to the tumor by several mechanisms,
including taking advantage of the differential pH in tumor tissue compared
to
healthy tissue. The polymer also capitalizes on the biological differences
in
the permeability of blood vessels at tumor sites versus normal tissue. In this
way, tumor selective delivery and platinum release is achieved. The ability
of
ProLindac to inhibit tumor growth has been evaluated in more than ten
preclinical models. Compared with the marketed product oxaliplatin, ProLindac
showed either marked superiority or superiority in most of these models.
Preclinical studies of the delivery of platinum to tumors in an animal model
have shown that, compared with oxaliplatin at equitoxic doses, ProLindac
delivers in excess of 16 times more platinum to the tumor. An analysis of tumor
DNA, which is the main target for anti-cancer platinum agents, has shown that
ProLindac delivers
approximately 14 times more platinum to tumor DNA than oxaliplatin. Results
from
preclinical efficacy studies conducted in the B16 and other tumor models have
also shown that ProLindac is superior to oxaliplatin in inhibiting the growth
of
tumors. An extensive preclinical package has been developed supporting the
development of ProLindac.
In
2005
we completed a Phase 1 multi-center clinical study conducted in Europe, which
enrolled 26 patients. The study was reported at the AACR-NCI-EORTC conference
in
Philadelphia in November 2005. The European trial was designed to identify
the maximum tolerated dose, dose limiting toxicities, the pharmacokinetics
of
the platinum in plasma and the possible anti-tumor activity of ProLindac. The
open-label, non-randomized, dose-escalation Phase 1 study was performed at
two
European centers. ProLindac was administered as an intravenous infusion over
one
hour, once a week on days 1, 8 and 15 of each 28-day cycle to patients with
solid progressive tumors. We obtained results in 26 patients with a broad
cross-section of tumor types, with doses ranging from 80-1,280 mg Pt/m2.
41
Of
the 26
patients, 10 were not evaluable for tumor response, principally due to
withdrawal from the study prior to completing the required cycle. Of the 16
evaluable patients, 2 demonstrated a partial response, 1 experienced a partial
response based on a biomarker and 4 experienced stable disease. One of the
patients who attained a partial response had a melanoma with lung metastasis;
a
CT scan revealed a tumor decrease of greater than 50%. The other patient who
responded had ovarian cancer; she had a reduction in lymph node metastasis
and
remission of a liver metastasis. The patient who experienced a partial response
based on a biomarker was an ovarian cancer patient for whom CA-125 levels
returned to normal. Also of note, a patient with cisplatin resistant cervical
cancer showed a short lasting significant reduction in lung metastasis after
3
doses. However, due to toxicity, the patient could not be retreated to determine
whether the partial response could be maintained.
A
Phase 2
clinical trial of ProLindac is underway in ovarian cancer patients who have
relapsed after first line platinum therapy. The primary aim of the study is
to
the determine the response rate of ProLindac monotherapy in this patient
population. The response rates for other platinum compounds in this indication
are well known, and will be used for comparison. Patients are dosed either
once
every 2 weeks or once every three weeks. As the Phase 1 study involved weekly
dosing, the initial phase of the ovarian cancer monotherapy study involves
some
dose escalation to determine recommended doses using these dosing regimens.
Preliminary results from the dose ranging part of the study were presented
at
AACR-NCI-EORTC conference in San Francisco in October 2007. Significantly,
there
was a reduction of the Ca125 biomarker in five of the six patients in a cohort
receiving of ProLindac on a once every three week dosing schedule. The Ca125
biomarker has been demonstrated to be a reliable indicator of the clinical
progression of ovarian cancer
The
company has submitted an IND application to the US Food and Drug Administration,
and has received clearance from the agency to proceed with a Phase 1 clinical
study of ProLindac in combination with fluorouracil and leucovorin. The study
is
designed to evaluate the safety of the ProLindac in combination with two
standard drugs used to treat colorectal cancer and to establish a safe dose
for
Phase 2 clinical studies of this combination in colorectal cancer. The company
is currently evaluating whether clinical development of ProLindac in this
indication might proceed more rapidly by utilizing an alternative clinical
strategy and/or conducting studies in the US and/or elsewhere in the
world.
Sodium
Phenylbutyrate
Sodium
Penylbutyrate, or PB, is a small molecule that was previously approved by the
FDA for sale as a treatment for a rare genetic disorder in infants known as
hyperuremia. PB has a number of additional mechanisms of action, including
the inhibition of histone deacetylase. Histone deacetylase is a class of
enzymes that remove acetyl groups from the amino acids in DNA. The
inhibition of histone deacetylase allows the body’s cancer suppressing genes to
work as intended. In addition, PB is not toxic to cells. These
characteristics make PB a good candidate to become a chemopotentiator; that
is,
a substance that enhances the activity of a chemotherapeutic agent. As a
result, PB will ideally be administered in conjunction with radiation and/or
chemotherapy.
In
February 2005, we entered into a Phenylbutyrate Co-development and Sublicense
Agreement with Virium Pharmaceuticals, Inc., pursuant to which Virium granted
us
an exclusive, worldwide sublicense to PB, excluding the U.S. and Canada, for
the
treatment of cancer, autoimmune diseases and other clinical indications. We
paid
Virium a license fee of $50,000. Virium has retained all rights with respect
to
PB inside the U.S. and Canada. Access’ single largest stockholder, SCO
Capital Partners, LLC, is also the single largest stockholder of Virium
Pharmaceuticals, Inc.
42
Virium
is
also a party to a sublicense agreement with VectraMed, Inc. for the rights
to
develop and commercialize PB worldwide for the treatment of cancer, autoimmune
diseases and other clinical indications. VectraMed obtained its rights to the
product under an Exclusive Patent License Agreement dated May 25, 1995 with
the
U.S. Public Health Service, representing the National Institutes of Health.
VectraMed subsequently assigned all its rights to PB to Virium pursuant to
a
novation agreement dated May 10, 2005.
Pursuant
to our agreement with Virium, we are responsible for the conduct of clinical
trials and patent prosecution related to PB outside of the U.S. and Canada.
The
Virium agreement also requires us to pay Virium a royalty on the sales of PB
products until such time as the patents covering such products
expire. These patents expire at various times between 2011 and 2016. Our
agreement with Virium expires upon the expiration of the last to expire of
these
patents in 2016.
Our
agreement with Virium does not fully comply with the sublicensing requirements
set forth in Virium’s agreement with the National Institutes of Health because
it does not expressly incorporate by reference all of the relevant sections
of
Virium’s license with NIH. We are currently seeking to amend its agreement
with Virium to bring it into full compliance with such sublicensing requirements
and to permit us to become a direct licensee of the NIH, should Virium default
on its license with the NIH.
On
October 20, 2006, NIH conditionally consented to the sublicense to us.
However, the NIH conditions include an amendment to the Virium license to
reflect an updated Virium development plan and milestones, the payment of
$216,971 in past due patent expenses and the payment of a $5,000 sublicense
royalty. Based on the information provided by NIH, it appears that about
$200,000 relates to foreign patent expenses for calendar 2005 which would be
our
responsibility under its license agreement with Virium. Of that amount,
approximately $12,000 relates to foreign patent maintenance fees and $197,000
largely relates to foreign patent legal expenses. Somanta accrued $248,300
as
patent annuity and legal expense for the year ended April 30, 2007. Virium
advised us that they satisfied two of the three conditions to obtaining final
NIH approval for our sublicense. Virium is in the process of negotiating an
installment payment plan with respect to the past due patent
expenses.
On
December 6, 2006, we signed a letter of intent (LOI) pertaining to a license
and
collaboration agreement with Virium covering all formulations or drug
combinations where Phenylbutyrate is an active ingredient. Pursuant to the
LOI,
in addition to current worldwide rights, excluding North America, involving
the
current formulation of Phenylbutyrate, we would obtain a participation in any
revenue or royalties derived from sales in the U.S. and Canada. In return,
we
would grant Virium a reciprocal participation in Europe. In the rest of the
world, Access and Virium would share revenues and royalties equally. The LOI’s
terms provide that both companies will, among other things, share data and
jointly undertake the necessary pre-clinical and clinical studies, seek
regulatory approvals and file for patent protection in all territories. It
also
provides for the formation of a joint development committee to oversee all
aspects of the development and commercialization of Phenylbutyrate. Completion
of the transaction contemplated by the LOI remains subject to the negotiation
and execution of a definitive agreement.
Phenylbutyrate
has been the subject of numerous Phase 1 and Phase 2 clinical studies sponsored
by the National Cancer Institute and others demonstrating the safety and
efficacy of PB in cancer, both as a monotherapy and in combination with other
anticancer compounds. To date, we have not been involved in any capacity in
the
conduct of any clinical trial related to PB.
We
believe that PB may be a candidate to become a biological-response modifier
that
acts as a dose-dependent inhibitor of cancer cell proliferation, migration,
and
invasiveness, possibly by inhibition of urokinase and c-myc pathways, which
means that it inhibits the protease activity that irreversibly induces
programmed cell death. In addition, we believe that PB shows potential for
the
treatment of malignant gliomas, which are cancers of the brain. We are aware
of
numerous products in development for brain cancers. We are aware of several
products being developed by academic and commercial organizations targeting
glioblastoma. Medicis Pharmaceuticals currently sells Sodium Phenylbutyrate
(Buphenyl ®
) for
the treatment of a urea cycle disorder, hyperuremia.
43
There
are
thirteen key use patents related to PB which have been issued as
follows:
|
•
|
A
patent covering a method of inhibiting rapid tumor growth issued
in the
U.S. that expires on March 14, 2014 with foreign counterparts in
Austria, Australia, Canada, Germany, European Union, Spain, Israel,
New
Zealand and South Africa;
|
|
•
|
A
patent covering a method of treating brain cancer, leukemia, prostate
cancer, breast cancer, skin cancer and non-small cell lung cancer
issued
in the U.S. that expires on June 3, 2014 with foreign counterparts
in
Austria, Australia, Canada, Germany, European Union, Spain, Israel,
Japan,
New Zealand, Portugal and South
Africa;
|
|
•
|
A
patent covering a method of treating brain cancer, skin cancer, benign
enlarged prostate and a cervical infection issued in the U.S. that
expires
on February 25, 2014 with foreign counterparts in Austria, Australia,
Canada, Germany, European Union, Spain, Israel, Japan, New Zealand,
Portugal and South Africa;
|
|
•
|
A
patent covering a method of inducing the production of TGF alpha
(which
slows the growth of cancer cells) issued in the U.S. that expires
on
January 13, 2015 with foreign counterparts in Austria, Australia,
Canada,
Germany, European Union, Spain, Israel, Japan, New Zealand, Portugal
and
South Africa;
|
|
•
|
A
patent covering a pharmaceutical composition for treating or preventing
a
cancerous condition issued in the U.S. that expires on January 20,
2015
with foreign counterparts in Austria, Australia, Canada, Germany,
European
Union, Spain, Israel, Japan, New Zealand, Portugal and South
Africa;
|
|
•
|
A
patent covering a method of inducing the differentiation of a cell
issued
in the U.S. that expires on June 3, 2014 with foreign counterparts
in
Austria, Australia, Canada, Germany, European Union, Spain, Israel,
Japan,
New Zealand, Portugal and South
Africa;
|
|
•
|
A
patent covering a method of treating brain cancer, non-small cell
lung
cancer, prostate cancer, skin cancer, brain tumors, cancers of the
blood,
lung cancer and breast cancer issued in the U.S. that expires on
August
26, 2014 with foreign counterparts in Austria, Australia, Canada,
Germany,
European Union, Spain, Israel, Japan, New Zealand, Portugal and South
Africa;
|
|
•
|
A
patent covering a method of inhibiting the growth of rapidly growing
nonmalignant or malignant tumor cells issued in the U.S. that expires
on
March 2, 2016 with foreign counterparts in Austria, Australia, Canada,
Germany, European Union, Spain, Israel, Japan, New Zealand, Portugal
and
South Africa;
|
|
•
|
A
patent covering a method of sensitizing a subject to radiation therapy
or
chemotherapy and a method of treating brain cancer, leukemia, non-small
cell lung cancer, skin cancer, cancers of the blood, lung cancer,
or renal
cancer issued in the U.S. that expires on December 1, 2015 with foreign
counterparts in Austria, Australia, Canada, Germany, European Union,
Spain, Israel, Japan, New Zealand, Portugal and South
Africa;
|
|
•
|
A
patent covering a method of treating brain cancer, non-small cell
lung
cancer, prostate cancer, skin cancer, cancers of the blood, breast
cancer,
benign prostate enlargement, cervical infection, bladder cancer,
kidney
cancer, colon cancer, or nose cancer issued in the U.S. that expires
on
March 16, 2016 with foreign counterparts in Austria, Australia, Canada,
Germany, European Union, Spain, Israel, Japan, New Zealand, Portugal
and
South Africa;
|
|
•
|
A
patent covering a method of inducing the production of hemoglobin
(blood)
and a method of treating a pathology associated with abnormal hemoglobin
(blood) activity issued in the U.S. that expires on January 27, 2015
with
foreign counterparts in Austria, Australia, Canada, Germany, European
Union, Spain, Israel, Japan, New Zealand, Portugal and South
Africa;
|
44
|
•
|
A
patent covering a method of preventing prostate cancer, brain cancer,
skin
cancer, cancers of the blood, breast cancer, non-small cell lung
cancer,
or renal cancer issued in the U.S. that expires on August 5, 2014
with
foreign counterparts in Austria, Australia, Canada, Germany, European
Union, Spain, Israel, Japan, New Zealand, Portugal and South Africa;
and
|
|
•
|
A
patent covering a method of inhibiting the production of cancer in
a cell
issued in the U.S. that expires on March 14, 2011, June 3, 2013 or
March
7, 2014, depending on the subject matter disclosed in the priority
applications with foreign counterparts in Austria, Australia, Canada,
Germany, European Union, Spain, Israel, Japan, New Zealand, Portugal
and
South Africa.
|
Our
co-development partner, Virium advised us that it intends to initiate a Phase
1/2 clinical trial using PB to treat glioblastoma in the near future. We intend
to wait for the results of this Phase 1/2 clinical trial and the re-formulation
of the PB compound to a sustained release version before initiating our own
clinical trial related to PB in Europe. At this time, we do not know when
Virium will initiate such clinical trial or when it will be completed, nor
do we
know when Virium will have completed the re-formulation of the PB compound
to a
sustained release version.
We
also
believe that further studies should be considered to identify a subset of
patients that have tumors sensitive to PB, either as a single agent or in
combination with radiation therapy or other chemotherapeutic agents, and that
we
should focus on this subset of patients in our future clinical trials related
to
PB.
Research
Projects, Products
and Products in Development
Drug
Development Strategy
A
part of
our integrated drug development strategy is to form alliances with centers
of
excellence in order to obtain alternative lead compounds while minimizing the
overall cost of research. The Company does not spend significant resources
on
fundamental biological research but rather focuses on its chemistry expertise
and clinical development. For example, certain of our polymer platinate
technology has resulted in part from a research collaboration with The School
of
Pharmacy, University of London.
Our
strategy is to focus on our polymer therapeutic program for the treatment of
cancer while continuing to develop technologies such as MuGard and
Cobalamin-mediated oral drug delivery which could provide us with a revenue
stream in the short term through commercialization or outlicensing to fund
our
longer-term polymer and oncology drug development programs. To reduce financial
risk and equity financing requirements, we are directing our resources to the
preclinical and early clinical phases of development. Where the size of the
necessary clinical studies and cost associated with the later clinical
development phases are significant, we plan to co-develop with or to outlicense
to marketing partners our therapeutic product candidates. By forming strategic
alliances with pharmaceutical and/or biotech companies, we believe that our
technology can be more rapidly developed and successfully introduced into the
marketplace.
We
will
continue to evaluate the most cost-effective methods to advance our programs.
We
will contract certain research and development, manufacturing and manufacturing
scaleup, certain preclinical testing and product production to research
organizations, contract manufacturers and strategic partners. As appropriate
to
achieve cost savings and accelerate our development programs, we will expand
our
internal core capabilities and infrastructure in the areas of chemistry,
formulation, analytical methods development, clinical development, biology
and
project management to maximize product opportunities in a timely manner.
Process
We
begin
the product development effort by screening and formulating potential product
candidates, selecting an optimal active component, developing a formulation,
and
developing the processes and analytical methods. Pilot stability, toxicity
and
efficacy testing are conducted prior to advancing the product candidate into
formal preclinical development. Specialized skills are required to produce
these product candidates utilizing our technology. We have a limited core
internal development capability with significant experience in developing these
formulations, but also depend upon the skills and expertise of our
contractors.
45
Once
the
product candidate has been successfully screened in pilot testing, our
scientists, together with external consultants, assist in designing and
performing the necessary preclinical efficacy, pharmacokinetic and toxicology
studies required for IND submission. External investigators and scaleup
manufacturing facilities are selected in conjunction with our consultants.
The
initial Phase 1 and Phase 2 studies are conducted by institutions and
investigators supervised and monitored by our employees and contract research
organizations. We do not plan to have an extensive clinical development
organization as we plan to have the advance phases of this process conducted
by
a development partner. Should we conduct Phase 3 clinical studies we expect
to
engage a contract research organization to perform this work.
We
contract with third party contract research organizations to complete our large
clinical trials and for data management of all of our clinical trials.
Generally, we manage the smaller Phase 1 and 2 trials ourselves. Currently,
we
have one Phase 2 trial in process continuing into 2008 and a new Phase 2 trial
planned for next year subject to preliminary findings in other trials and our
ability to fund such trials.
With
all
of our product development candidates, we cannot assure you that the results
of
the in vitro or animal studies are or will be indicative of the results that
will be obtained if and when these product candidates are tested in humans.
We
cannot assure you that any of these projects will be successfully completed
or
that regulatory approval of any product will be obtained.
We
expended approximately $2,053,000, $2,783,000 and $2,335,000 on research and
development during the years 2006, 2005 and 2004, respectively.
Scientific
Background
Access
posseses a broad range of technologies and intellectual property in the areas
of
drug delivery and oncology. Our core technologies rely on the use of
nonopolymers for use in the management of oral conditions such as mucositis,
and
in drug delivery. We also have small molecule and monoclonal antibody programs
which also embody the principals of drug delivery and drug
targeting.
The
ultimate criteria for effective drug delivery is to control and optimize the
localized release of the drug at the target site and rapidly clear the
non-targeted fraction. Conventional drug delivery systems such as controlled
release, sustained release, transdermal systems and others are designed for
delivering active product into the systemic circulation over time with the
objective of improving patient compliance. These systems do not address the
biologically relevant issues such as site targeting, localized release and
clearance of drug. The major factors that impact the achievement of this
ultimate drug delivery goal are the physical characteristics of the drug and
the
biological characteristics of the disease target sites. The physical
characteristics of the drug affect solubility in biological systems, its
biodistribution throughout the body, and its interactions with the intended
pharmacological target sites and undesired areas of toxicity. The biological
characteristics of the diseased area impact the ability of the drug to
selectively interact with the intended target site to allow the drug to express
the desired pharmacological activity.
We
believe our drug delivery technologies are differentiated from conventional
drug
delivery systems in that they seek to apply a disease-specific approach to
improve the drug delivery process with formulations to significantly enhance
the
therapeutic efficacy and reduce toxicity of a broad spectrum of
products.
Core
Drug Delivery Technology Platforms
Our
current drug delivery technology platforms for use in cancer chemotherapy
are:
|
·
|
Synthetic
Polymer Targeted Drug Delivery
Technology;
|
|
·
|
Cobalamin™-Mediated
Oral Delivery Technology;
|
|
·
|
Cobalamin™-Mediated
Targeted Delivery Technology;
|
46
|
·
|
Angiolix®;
|
|
·
|
Prodrax®;
and
|
|
·
|
Alchemix®.
|
Each
of these platforms is discussed below:
Synthetic
Polymer Targeted Drug Delivery Technology
In
collaboration with The School of Pharmacy, University of London, we have
developed a synthetic polymer technology, which utilizes
hydroxypropylmethacrylamide with platinum, designed to exploit enhanced
permeability and retention, or EPR, at tumor sites to selectively accumulate
drug and control drug release. This technology is employed in our lead clinical
program, ProLindac. Many solid tumors possess vasculature that is
hyperpermeable, or leaky, to macromolecules. In addition to this enhanced
permeability, tumors usually lack effective lymphatic and/or capillary drainage.
Consequently, tumors selectively accumulate circulating macromolecules,
including, for example, up to 10% of an intravenous dose in mice. This effect
has been termed EPR, and is thought to constitute the mechanism of action of
styrene-maleic/anhydride-neocarzinostatin, or SMANCS, which is in regular
clinical use in Japan for the treatment of hepatoma. These polymers take
advantage of endothelial permeability as the drug carrying polymers are trapped
in tumors and then taken up by tumor cells. Linkages between the polymer and
drug can be designed to be cleaved extracellularly or intracellularly. Utilizing
the principles of prodrugs, the drug is essentially inert while attached to
the
polymer, but is released inside the tumor mass while polymer/drug not delivered
to tumors is cleared from the body via the kidneys. For example, ProLindac
is
attached to a pH-sensitive linker which releases the platinum cytotoxic agent
much faster in the low pH environments found typically outside of hypoxic tumor
cells and within specific compartments inside of tumor cells. Data generated
in
animal studies have shown that the polymer/drug complexes are far less toxic
than free drug alone and that greater efficacy can be achieved. Thus, these
polymer complexes have demonstrated significant improvement in the therapeutic
index of anti-cancer drugs, including, for example, platinum.
Cobalamin™-Mediated
Oral Delivery Technology
Oral
delivery is the preferred method of administration of drugs where either
long-term or daily use (or both) is required. However many therapeutics,
including peptide and protein drugs, are poorly absorbed when given orally.
With
more and more peptide and protein based biopharmaceuticals entering the market,
there is an increasing need to develop an effective oral delivery system for
them, as well as for long-standing injected drugs such as insulin.
The
difficulty in administering proteins orally is their susceptibility to
degradation by digestive enzymes, their inability to cross the intestinal wall
and their rapid excretion by the body. Over the years, many different
methodologies for making protein drugs available orally have been attempted.
Most of the oral protein delivery technologies involve protecting the protein
degradation in the intestine. More recently, strategies have been developed
that
involve coadministering the protein or peptide with permeation enhancers, which
assist in passive transit through the gut wall or by attaching the protein
or
peptide to a molecule that transports the protein across the gut wall. However,
the field of oral drug delivery of proteins and peptides has yet to achieve
successful commercialization of a product (although positive results have been
achieved in early clinical trials for some products under
development).
Many
pharmaceutically active compounds such as proteins, peptides and cytotoxic
agents cannot be administered orally due to their instability in the
gastrointestinal tract or their inability to be absorbed and transferred to
the
bloodstream. A technology that would allow many of these actives to be taken
orally would greatly enhance their acceptance and value. Several technologies
for the protection of sensitive actives in the gastro-intestinal tract and/or
enhancement of gastro-intestinal absorption have been explored and many have
failed.
47
Our
proprietary technology for oral drug delivery utilizes the body’s natural
vitamin B12 (VB12) transport system in the gut. The absorption of VB12 in the
intestine occurs by way of a receptor-mediated endocytosis. Initially, VB12
binds to intrinsic factor (IF) in the small intestine, and the VB12-IF complex
then binds to the IF receptor on the surface of the intestine. Receptor-mediated
endocytosis then allows the transport of VB12 across the gut wall. After binding
to another VB12-binding protein, transcobalamin II (TcII), VB12 is transferred
to the bloodstream.
Our
scientists discovered that Cobalamin (analogs of VB12) will still be transported
by this process even when drugs, macromolecules, or nanoparticles are coupled
to
the Cobalamin. Thus Cobalamin serves as a carrier to transfer these
materials from the intestinal lumen to the bloodstream. For drugs and
macromolecules that are stable in the gastro-intestinal tract, the drug or
macromolecule can be coupled directly (or via a linker) to Cobalamin. If the
capacity of the Cobalamin transport system is inadequate to provide an effective
blood concentration of the active, transport can be amplified by attaching
many
molecules of the drug to a polymer, to which Cobalamin is also attached. A
further option, especially for drugs and macromolecules that are unstable in
the
intestine, is to formulate the drug in a nanoparticle which is then coated
with
Cobalamin. Once in the bloodstream, the active is released by diffusion and/or
erosion of the nanoparticle. Utilization of nanoparticles also serves to
‘amplify’ delivery by transporting many molecules at one time due to the
inherently large nanoparticle volume compared with the size of the
drug.
Our
proprietary position in this technology involves the conjugation of Cobalamin
and/or folic acid and/or biotin (or their analogs) to a polymer to which is
also
attached the drug to be delivered, or attached to a nanoparticle in which the
drug is incorporated. Since many molecules of the drug are attached to a single
polymer strand, or are incorporated in a single nanoparticle, disease targeting
is amplified compared to simpler conjugates involving one molecule of the
vitamin with one drug molecule. However, in situations when such a simple
conjugate might be preferred, our patents also encompass these vitamin-drug
conjugates.
Cobalamin™-Mediated
Targeted Delivery Technology
Most
drugs are effective only when they reach a certain minimum concentration in
the
region of disease, yet are well distributed throughout the body contributing
to
undesirable side effects. It is therefore advantageous to alter the natural
biodistribution of a drug to have it more localized where it is needed. Our
Cobalamin-mediated targeted delivery technology utilizes the fact that in many
diseases where there is rapid growth and/or cell division, the demand for
certain vitamins increases. By coupling the drug to a vitamin analog, the analog
serves as a carrier to increase the amount of drug at the disease site relative
to its normal distribution.
One
application of this technology is in tumor targeting. The use of cytotoxic
drugs
is one of the most common methods for treating a variety of malignancies
including solid and non-solid tumors. The drawbacks of chemotherapeutic
treatments, which include tumor resistance, cancer relapse and toxicity from
severe damage to healthy tissues, has fuelled a scientific quest for novel
treatments that are specifically targeted to malignant cells thus reducing
damage to collateral tissues.
The
design of targeted therapies involves exploitation of the difference between
the
structure and function of normal cells compared with malignant cells.
Differences include the increased levels of surface receptors on cancer cells,
which makes them more sensitive to treatment regimes that target these cell
surface receptors and differences in blood supply within and around
tumor cells compared with normal cells.
Two
basic
types of targeting approaches are utilized, passive tumor targeting and active
tumor targeting.
|
●
|
passive
tumor targeting involves transporting anti-cancer agents through
the
bloodstream to tumor cells using a “carrier” molecule. Many
different carrier molecules, which can take a variety of forms
(micelles,
nanoparticles, liposomes and polymers), are being investigated as
each provides advantages such as specificity and protection of
the
anti-cancer drug from degradation due to their structure, size
(molecular
weights) and particular interactions with tumor cells. Our polymer
platinate program is a passive tumor targeting
technology.
|
48
|
●
|
active
tumor targeting involves attaching an additional fragment to the
anticancer drug and the carrier molecule to create a new “targeted” agent
that will actively seek a complementary surface receptor to which
it binds
(preferentially located on the exterior of the tumor cells). The
theory is
that the targeting of the anti-cancer agent through active means
to the
affected cells should allow more of the anti-cancer drug to enter
the
tumor cell, thus amplifying the response to the treatment and reducing
the
toxic effect on bystander, normal
tissue.
|
Examples
of active targeting fragments include antibodies, growth factors and vitamins.
Our scientists have specifically focused on using Cobalamin compounds (analogs
of vitamin B12), but we have also used and have certain intellectual property
protection for the use of folate and biotin which may more
effectively target anti-cancer drugs to certain solid tumors.
It
has
been known for some time that vitamin B12 and folic acid are essential for
tumor
growth and as a result, receptors for these vitamins are up-regulated in certain
tumors. Vitamin B12 receptor over-expression occurs in breast, lung, leukemic
cells, lymphoma cells, bone, thyroid, colon, prostate and brain cancers and
some
other tumor lines, while folate receptor over-expression occurs in breast,
lung,
ovarian, endometrial, renal, colon, brain and cancers of myeloid hemotopoietic
cells and methotrexate-sensitive tumors.
Angiolix®
Angiolix
(huMc-3 mAB) is a humanized monoclonal antibody targeting a protein known as
Lactadherin. Lactadherin promotes the growth of new blood vessels (angiogenesis)
to support tumor growth. Angiolix, by blocking Lactadherin, has the potential
to
induce programmed cell death, or apoptosis, in blood vessels supporting tumors.
Angiolix was sublicensed from Immunodex, Inc., who licensed the product from
Cancer Research Institute of Contra Costa Under that agreement, we
are required to meet certain development targets, and make certain payments
including an annual license maintenance fee and milestone payments.
We
believe that Angiolix has a large market potential in the treatment of cancer.
Avastin®
is a
marketed anti-angiogenesis monoclonal antibody that is effective by using a
similar mechanism to that of Angiolix, and is used in the treatment of
colorectal and other cancer types. Angiolix is unique in that it targets a propriety
gene product which is expressed by cancerous tumors. We are not aware of
any other organization developing similar products targeting this
protein. The key patent relating to Angiolix has been issued in the U.S.
and Australia. In general, it covers the composition of matter and various
aspects of the binding to applicable antigens as well as the manufacture of
Angiolix. We also have foreign counterparts to this patent pending in the
European Union and Canada.
Angiolix
is a humanized monoclonal antibody. Humanization is a process by which genetic
material from a mouse cell is made tolerable to humans, using a patented
technology developed by the National Institutes of Health. The NIH
previously granted to the Cancer Research Institute of Contra Costa a license
to
the applicable humanization technology. Pursuant to the Immunodex agreement,
Immunodex and the Cancer Research Institute of Contra Costa are seeking to
obtain for us the NIH’s consent to a sublicense to us of the Cancer Research
Institute of Contra Costa right to use the NIH humanization
technology.
We
have
an agreement with an academic investigator for the development of Angiolix.
We
intend to complete preclinical development of Angiolix through the contributions
of this investigator and through a contract manufacturer and contract testing
laboratories, such that we are able to begin a Phase 1 clinical study of
Angiolix in 2009.
Prodrax®
Prodrax
is a small molecule anticancer prodrug that is non-toxic in normally oxygenated
healthy tissue but becomes highly toxic in low oxygen tumors where it becomes
irreversibly converted to its toxic form which binds to the DNA in tumor cells,
resulting in tumor cell death. The chemical structure of Prodrax is a
di-N-oxides of chloroethylaminoanthraquinone. We have an license to this
technology from the University of London School of Pharmacy.
49
Prodrax
is inert in normally oxygenated cells and becomes toxic in low oxygen areas,
enabling it to kill tumor cells. Many solid tumors have a low oxygen area that
is resistant to radiation and conventional chemotherapy. These cells repopulate
the tumor with additional radiation- and conventional chemotherapy-resistant
cells. These cells are often referred to as quiescent.
Prodrax
becomes irreversibly converted to its toxic form in low oxygen tumor cells
where
it remains localized. When the surrounding oxygenated cells are killed by
radiotherapy or chemotherapy, these Prodrax-containing quiescent cells move
closer to the oxygen source and attempt to resume more active
replication. It is in this state that they are killed by Prodrax, through
potent DNA damage.
When
given in conjunction with radiotherapy or chemotherapy we expect Prodrax to
result in significant improvement of tumor clearance and to reduce the
likelihood of tumor repopulation, improving disease free survival. It is
estimated that over 50% of all solid tumors exhibit clinically significant
hypoxia, or low oxygenation, and that over two million people in the U.S. and
Europe suffer from solid tumor cancers. If successful, Prodrax could improve
the
prognosis for a significant number of cancer sufferers in a wide range of tumor
types.
In
March
2006, we entered into a two year agreement with the University of Bradford
to
perform pre-clinical studies. The Prodrax technology allows for the modification
of various drugs to make them inert until they are activated by a low oxygen
environment. Varieties of analogues have been developed and are being tested
by
researchers at the University of Bradford for the purpose of enabling us to
select the lead compound to take forward into clinical development. We expect
to
select a lead compound in 2008.
Alchemix®
Alchemix,
is a small molecule that is toxic to cancer cells. Alchemix attacks cancers
cells through at least two modes of action and is intended to interrupt all
phases of the cancer cell growth cycle o overcome drug resistant tumors. We
believe that Alchemix is toxic to cancer cells due to its selective inhibition
of many DNA processing enzymes and that it is as well tolerated in animals
as a
number of classes of approved chemotherapeutic drugs such as epirubicin and
cisplatin, .
The
Alchemix platform technology is licensed from De Montfort University in the
UK.
Although we are not obligated to make any royalty payments to De Montfort based
on the sale of any product that is based on Alchemix, we are obligated to pay
De
Montfort certain milestone payments based on the achievement of agreed upon
clinical milestones. Our agreement with De Montfort expires in 2015, upon the
expiration of the last to expire of the Alchemix patents in 2015. The key patent
relating to Alchemix has been issued in the U.S, the European Union and in
Australia. In general, it covers composition of matter. We have entered into
a
research and development collaboration with the University of Bradford. The
initial goal for this collaboration is to select one molecule for preclinical
development. We have prepared a detailed pre-clinical and clinical development
plan related to Alchemix. We intend to manufacture, undertake pre-clinical
studies and, based on the results of these studies, to initiate a Phase1/2
clinical trial with respect to Alchemix within the next 12-24
months.
In
August
2004, we entered into a Research Collaboration and License Agreement with
Advanced Cardiovascular Devices, LLC. Under this agreement, we granted Advanced
Cardiovascular Devices an exclusive, worldwide license to Alchemix solely for
use in the treatment of vascular disorders or proliferations using stents and
other medical devices. The term of this agreement expires when the underlying
patent expires in 2015. Pursuant to this agreement, Advanced Cardiovascular
Devices paid Somanta an upfront fee of $10,000. In addition, Advanced
Cardiovascular Devices is obligated to develop a product based on Alchemix
pursuant to an agreed upon timetable. If Advanced Cardiovascular Devices fails
to achieve any of the agreed upon milestones, we would then have the right
to
terminate the agreement; provided, however, that Advanced Cardiovascular Devices
could prevent us from so terminating the agreement with respect to the
applicable failure by paying us a fee not to exceed $500,000 to reinstate its
rights under the agreement. In addition, Advanced Cardiovascular Devices is
also
obligated to pay us a royalty based on net sales, if any, of products based
on
Alchemix. Either party may terminate this agreement on thirty (30) days advance
notice for breach by the other party if the breach is not cured within such
thirty (30) day period. In addition, Advance Cardiovascular Devices may
terminate the agreement upon written notice to us and without any further
obligation to us if the licensed technology does not perform to the reasonable
satisfaction of Advanced Cardiovascular Devices or cannot be commercialized
because of safety or efficacy reasons or because Advanced Cardiovascular Devices
is unable to raise the funds necessary to develop a product based on the
licensed technology.
50
Other
Key Developments
On
February 12, 2008, the Board of Directors of the Company elected Steven H.
Rouhandeh as director and Chairman of the Board effective as of March 4,
2008.
On February 4, 2008, we entered into securities purchase agreements (the “Purchase Agreements”) with accredited investors whereby we agreed to sell 272.5 shares of our preferred stock, designated “Series A Cumulative Convertible Preferred Stock”, par value $0.01 per share, for an issue price of $10,000 per share, (the “Series A Preferred Stock”) and agreed to issue warrants to purchase 545,000 shares of our common stock, which includes placement agent warrants to purchase 90,883 shares of our common stock, at an exercise price of $3.50 per share, for an aggregate purchase price for the Series A Preferred Stock and Warrants of $2,700,000. The shares of Series A Preferred Stock are convertible into common stock at the initial conversion price of $3.00 per share.
On
January 14, 2008, we announced the signing of a definitive licensing agreement
under which RHEI Pharmaceuticals, Inc. will market and manufacture MuGard in
the
Peoples Republic of China and certain Southeast Asian countries. RHEI will
also
obtain the necessary regulatory approvals for MuGard in the
territory.
On
January 4, 2008 we closed the acquisition of Somanta Pharmaceuticals, Inc.
In
connection with the merger, Access issued an aggregate of approximately 1.5
million shares of Access Pharmaceuticals, Inc. common stock to the common and
preferred shareholders of Somanta as consideration. In addition, Access
exchanged all outstanding warrants of Somanta for warrants to purchase 191,991
shares of Access common stock at exercise prices ranging between $18.55 and
$69.57 per share.
On
December 26, 2007, Jeffrey B. Davis, Chairman of the Board of Directors was
named Chief Executive Officer. Stephen R. Seiler resigned as President and
Chief
Executive Officer and concurrently resigned from the Board of Directors
effective December 19, 2007.
On
November 7, 2007, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 954.0001 shares
of a newly created series of our preferred stock, designated “Series A
Cumulative Convertible Preferred Stock”, par value $0.01 per share, for an issue
price of $10,000 per share, (the “Series A Preferred Stock”) and agreed to issue
warrants to purchase 1,589,999 shares of our common stock at an exercise price
of $3.50 per share, for an aggregate purchase price for the Series A Preferred
Stock and Warrants of $9,540,001. The shares of Series A Preferred Stock are
convertible into common stock at the initial conversion price of $3.00 per
share.
As
a
condition to closing, SCO Capital Partners LLC and affiliates, along with the
other holders of an aggregate of $6,000,000 Secured Convertible Notes, also
exchanged their notes and accrued interest for an additional 1,836.0512 shares
of Series A Preferred Stock and were issued warrants to purchase 1,122,031
shares of our common stock at an exercise price of $3.50 per share, and Oracle
Partners LP and affiliates, along with the other holders of an aggregate of
$4,015,000 Convertible Notes also exchanged their notes and accrued interest
for
437.3104 shares of the Series A Preferred Stock and were issued warrants to
purchase 728,850 shares of our common stock at an exercise price of $3.50 per
share. SCO Capital Partners LLC currently has two designees serving
on our Board of Directors. In connection with the exchange of the
notes, all security interests and liens relating thereto were
terminated.
As
a
condition to closing, we entered into an Investor Rights Agreement with each
of
the investors purchasing shares of Series A Preferred Stock, and our Board
of
Directors approved with respect to the shareholder rights plan any action
necessary under our shareholder rights plan to accommodate the issuance of
the
Series A Preferred Stock and warrants without triggering the applicability
of
the shareholder rights plan.
51
In
connection with the sale and issuance of Series A Preferred Stock and warrants,
we entered into a Director Designation Agreement whereby we agreed to continue
SCO’s right to designate two individuals to serve on the Board of Directors of
Access.
On
August
27, 2007, we signed a definitive licensing agreement with SpePharm Holding,
B.V.
under which SpePharm will market Access’ product MuGard in Europe.
On
August
1, 2007, we announced that Esteban Cvitkovic, a member of our board of directors
as Vice Chairman Europe, agreed to an expanded role as Senior Director, Oncology
Clinical R&D.
On
April
26, 2007, we entered into a Note Purchase Agreement with Somanta
Pharmaceuticals, Inc. in order for Access to loan Somanta amounts to keep
certain of their licenses and vendors current. As of September 30, 2007 we
have
loaned Somanta $859,000.
All
shares and per share information reflect a one for five reverse stock split
effected June 5, 2006.
On
December 8, 2006 Access amended its 2005 Asset Sale Agreement with Uluru, Inc.
Access received from Uluru an upfront payment of $4.9 million, received an
additional $350,000 on April 9, 2007 and in the future could receive potential
milestones of up to $4.8 million based on Uluru sales. The amendment agreement
included the anniversary payment due October 12, 2006, the early payment of
the
two year anniversary payment, and a payment in satisfaction of certain future
milestones. Access also transferred to Uluru certain patent applications that
Access had previously licensed to Uluru under the 2005 License Agreement. Under
a new agreement, Access has acquired a license from Uluru to utilize the
nanoparticle aggregate technology contained in the transferred patent
applications for subcutaneous, intramuscular, intra-peritoneal and intra-tumoral
drug delivery. Additionally, one future milestone was increased by
$125,000.
On
October 12, 2005, Access sold its oral/topical care business unit to Uluru,
Inc,
a private Delaware corporation, for up to $18.8 million to focus on Access’
technologies in oncology and oral drug delivery. The products and technologies
sold to Uluru included amlexanox 5% paste (marketed under the trade names
Aphthasol® and Aptheal®), OraDiscTM,
Zindaclin® and Residerm® and all of Access’ assets related to these products. In
addition, Access sold to Uluru its nanoparticle hydrogel aggregate technology
which could be used for applications such as local drug delivery and tissue
filler in dental and soft tissue applications. Access received a license from
Uluru for certain applications of the technology. The CEO of Uluru is Kerry
P.
Gray, the former CEO of Access. In conjunction with the sale transaction, Access
received a fairness opinion from a nationally recognized investment banking
firm.
At
the
closing of the sale to Uluru, Access received $8.7 million. In addition, in
connection with the Amended Asset Sale Agreement in December 2006, Access
received $4.9 million and received an additional $350,000 on April 9, 2007
for
the first and second anniversary payments and settlement of certain milestones.
Access recorded $550,000 less $173,000 tax expense as revenue from the
discontinued operations in 2006.
Access
was incorporated in Wyoming in 1974 as Chemex Corporation, and in 1983 Access
changed its name to Chemex Pharmaceuticals, Inc. Access changed its state of
incorporation from Wyoming to Delaware on June 30, 1989. In 1996 Access merged
with Access Pharmaceuticals, Inc., a private Texas corporation, and changed
its
name to Access Pharmaceuticals, Inc. Access’ principal executive office is
located at 2600 Stemmons Freeway, Suite 176, Dallas, Texas 75207; Access’
telephone number is (214) 905-5100.
52
Patents
We
believe that the value of technology both to us and to our potential corporate
partners is established and enhanced by our broad intellectual property
positions. Consequently, we have already been issued and seek to obtain
additional U.S. and foreign patent protection for products under development
and
for new discoveries. Patent applications are filed with the U.S. Patent and
Trademark Office and, when appropriate, with the Paris Convention's Patent
Cooperation Treaty (PCT) Countries (most major countries in Western Europe
and
the Far East) for our inventions and prospective products.
One
U.S.
patent has issued and one U.S. patent application and two European patent
applications are under review for our mucoadhesive liquid technology. Our patent
applications cover a range of products utilizing our mucoadhesive liquid
technology for the management of the various phases of mucositis.
Three
U.S. patents and two European patents have issued and one U.S. patent and two
European patent applications are pending for polymer platinum compounds. The
two
patents and patent applications are the result in part of our collaboration
with
The School of Pharmacy, University of London, from which the technology has
been
licensed and include a synthetic polymer, hydroxypropylmethacrylamide
incorporating platinates, that can be used to exploit enhanced permeability
and
retention in tumors and control drug release. The patents and patent
applications include a pharmaceutical composition for use in tumor treatment
comprising a polymer-platinum compound through linkages that are designed to
be
cleaved under selected conditions to yield a platinum which is selectively
released at a tumor site. The patents and patent applications also include
methods for improving the pharmaceutical properties of platinum
compounds.
We
have
three patented Cobalamin-mediated targeted therapeutic
technologies:
|
–
|
folate
conjugates of polymer therapeutics, to enhance tumor delivery by
targeting
folate receptors, which are upregulated in certain
tumor types with two U.S. and two European patent
applications;
|
|
–
|
the
use of vitamin B12 to target the transcobalamin II receptor which
is
upregulated in numerous diseases including cancer, rheumatoid
arthritis, certain neurological and autoimmune disorders with two
U.S.
patents and three U.S. and four European patent applications;
and
|
|
–
|
oral
delivery of a wide variety of molecules which cannot otherwise
be orally
administered, utilizing the active transport
mechanism
which transports vitamin B12 into the
systemic circulation with six U.S. patents and two European patents
and
one U.S. and one European patent
application
|
mechanism
which transports vitamin B12 into the systemic circulation with six U.S.
patents
and two European patents and one U.S. and one European patent
application.
Our
patents for the following technologies expire in the years and during the date
ranges indicated below:
|
·
|
Mucoadhesive
technology in 2021,
|
|
·
|
ProLindac™
in 2021,
|
|
·
|
Cobalamin
mediated technology between 2008 and
2019
|
In
addition to issued patents, we have a number of pending patent applications.
If
issued, the patents underlying theses applications could extend the patent
life
of our technologies beyond the dates listed above.
We
have a
strategy of maintaining an ongoing line of patent continuation applications
for
each major category of patentable carrier and delivery technology. By this
approach, we are extending the intellectual property protection of our basic
targeting technology and initial agents to cover additional specific carriers
and agents, some of which are anticipated to carry the priority dates of the
original applications.
53
Government
Regulation
We
are
subject to extensive regulation by the federal government, principally by the
FDA, and, to a lesser extent, by other federal and state agencies as well as
comparable agencies in foreign countries where registration of products will
be
pursued. Although a number of our formulations incorporate extensively tested
drug substances, because the resulting formulations make claims of enhanced
efficacy and/or improved side effect profiles, they are expected to be
classified as new drugs by the FDA.
The
Federal Food, Drug and Cosmetic Act and other federal, state and foreign
statutes and regulations govern the testing, manufacturing, safety, labeling,
storage, shipping and record keeping of our products. The FDA has the authority
to approve or not approve new drug applications and inspect research, clinical
and manufacturing records and facilities.
Among
the
requirements for drug approval and testing is that the prospective
manufacturer's facilities and methods conform to the FDA's Code of Good
Manufacturing Practices regulations, which establish the minimum requirements
for methods to be used in, and the facilities or controls to be used during,
the
production process. Such facilities are subject to ongoing FDA inspection to
insure compliance.
The
steps
required before a pharmaceutical product may be produced and marketed in the
U.S. include preclinical tests, the filing of an IND with the FDA, which must
become effective pursuant to FDA regulations before human clinical trials may
commence, numerous phases of clinical testing and the FDA approval of a New
Drug
Application (“NDA”) prior to commercial sale.
Preclinical
tests are conducted in the laboratory, usually involving animals, to evaluate
the safety and efficacy of the potential product. The results of preclinical
tests are submitted as part of the IND application and are fully reviewed by
the
FDA prior to granting the sponsor permission to commence clinical trials in
humans. All trials are conducted under International Conference on
Harmonization, or ICH, good clinical practice guidelines. All investigator
sites
and sponsor facilities are subject to FDA inspection to insure compliance.
Clinical trials typically involve a three-phase process. Phase 1 the initial
clinical evaluations, consists of administering the drug and testing for safety
and tolerated dosages and in some indications such as cancer and HIV, as
preliminary evidence of efficacy in humans. Phase 2 involves a study to evaluate
the effectiveness of the drug for a particular indication and to determine
optimal dosage and dose interval and to identify possible adverse side effects
and risks in a larger patient group. When a product is found safe, an initial
efficacy is established in Phase 2, it is then evaluated in Phase 3 clinical
trials. Phase 3 trials consist of expanded multi-location testing for efficacy
and safety to evaluate the overall benefit to risk index of the investigational
drug in relationship to the disease treated. The results of preclinical and
human clinical testing are submitted to the FDA in the form of an NDA for
approval to commence commercial sales.
The
process of forming the requisite testing, data collection, analysis and
compilation of an IND and an NDA is labor intensive and costly and may take
a
protracted time period. In some cases, tests may have to be redone or new tests
instituted to comply with FDA requests. Review by the FDA may also take
considerable time and there is no guarantee that an NDA will be approved.
Therefore, we cannot estimate with any certainty the length of the approval
cycle.
We
are
also governed by other federal, state and local laws of general applicability,
such as laws regulating working conditions, employment practices, as well as
environmental protection.
Competition
The
pharmaceutical and biotechnology industry is characterized by intense
competition, rapid product development and technological change. Competition
is
intense among manufacturers of prescription pharmaceuticals and other product
areas where we may develop and market products in the future. Most of our
potential competitors are large, well established pharmaceutical, chemical
or
healthcare companies with considerably greater financial, marketing, sales
and
technical resources than are available to us. Additionally, many of our
potential competitors have research and development capabilities that may allow
such competitors to develop new or improved products that may compete with
our
product lines. Our potential products could be rendered obsolete or made
uneconomical by the development of new products to treat the conditions to
be
addressed by our developments, technological advances affecting the cost of
production, or marketing or pricing actions by one or more of our potential
competitors. Our business, financial condition and results of operation could
be
materially adversely affected by any one or more of such developments. We cannot
assure you that we will be able to compete successfully against current or
future competitors or that competition will not have a material adverse effect
on our business, financial condition and results of operations. Academic
institutions, governmental agencies and other public and private research
organizations are also conducting research activities and seeking patent
protection and may commercialize products on their own or with the assistance
of
major health care companies in areas where we are developing product candidates.
We are aware of certain development projects for products to treat or prevent
certain diseases targeted by us, the existence of these potential products
or
other products or treatments of which we are not aware, or products or
treatments that may be developed in the future, may adversely affect the
marketability of products developed by us.
54
Our
principal competitors in the polymer area are Cell Therapeutics, Daiichi, Enzon,
Polytherics Ltd, and Inhale which are developing alternate drugs in
combination with polymers. We believe we are the only company conducting
clinical studies in the polymer drug delivery of platinum compounds. We believe
that the principal current competitors to our polymer targeting technology
fall
into two categories: monoclonal antibodies and liposomes. We believe that our
technology potentially represents a significant advance over these older
technologies because our technology provides a system with a favorable
pharmacokinetic profile.
A
number
of companies are developing or may in the future engage in the development
of
products competitive with the Access polymer delivery system. Several companies
are working on targeted monoclonal antibody therapy including Bristol-Myers
Squibb, Centocor (acquired by Johnson & Johnson), GlaxoSmithKline, Imclone
and Xoma. Currently, liposomal formulations being developed by Gilead Sciences
and Alza Corporation (acquired by Johnson & Johnson), are the major
competing intravenous drug delivery formulations that deliver similar drug
substances.
In
the
area of advanced drug delivery, which is the focus of our early stage research
and development activities, a number of companies are developing or evaluating
enhanced drug delivery systems. We expect that technological developments will
occur at a rapid rate and that competition is likely to intensify as various
alternative delivery system technologies achieve similar if not identical
advantages.
Even
if
our products are fully developed and receive required regulatory approval,
of
which there can be no assurance, we believe that our products can only compete
successfully if marketed by a company having expertise and a strong presence
in
the therapeutic area. Consequently, we do not currently plan to establish an
internal marketing organization. By forming strategic alliances with major
and
regional pharmaceutical companies, management believes that our development
risks should be minimized and that the technology potentially could be more
rapidly developed and successfully introduced into the marketplace.
Employees
As
of
March 6, 2008, we had nine full time employees, four of whom have advanced
scientific degrees. We have never experienced employment-related work stoppages
and consider that we maintain good relations with our personnel. In addition,
to
complement our internal expertise, we have contracts with scientific
consultants, contract research organizations and university research
laboratories that specialize in various aspects of drug development including
clinical development, regulatory affairs, toxicology, process scale-up and
preclinical testing.
Web
Availability
We
make
available free of charge through our web site, www.accesspharma.com, our annual
reports on Form 10-KSB and other reports required under the Securities and
Exchange Act of 1934, as amended, as soon as reasonably practicable after such
reports are filed with, or furnished to, the Securities and Exchange Commission
(the “SEC”). These documents are also available through the SEC’s
website at www.sec.gov certain
of our corporate governance policies, including the charters for the Board
of
Directors’ audit, compensation and nominating and corporate governance
committees and our code of ethics, corporate governance guidelines and
whistleblower policy. We will provide to any person without charge, upon
request, a copy of any of the foregoing materials. Any such request must be
made
in writing to Access Pharmaceuticals, Inc., 2600 Stemmons Freeway, Suite 176,
Dallas, TX 75207 attn: Investor Relations.
55
Access
maintains one facility of approximately 9,000 square feet for administrative
offices and laboratories in Dallas, Texas. Access has a lease agreement for
the
facility, which terminates in December 2008. Adjacent space may be available
for
expansion which Access believes would accommodate growth for the foreseeable
future.
Access
believes that its existing properties are suitable for the conduct of its
business and adequate to meet its present needs.
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS
ON
ACCOUNTING AND FINANCIAL DISCLOSURE
Grant
Thornton LLP ("Grant Thornton") was previously the principal accountants for
Access. On September 15, 2006, Grant Thornton resigned as our independent
registered public accounting firm.
In
connection with the audits of fiscal years ended December 31, 2005 and 2004
and
the subsequent interim period through September 15, 2006, (i) there have been
no
disagreements with Grant Thornton on any matter of accounting principles or
practices, financial statement disclosure or auditing scope or procedure, which
disagreement(s), if not resolved to Grant Thornton's satisfaction, would have
caused Grant Thornton to make reference to the subject matter of
the disagreement(s) in connection with its reports for such year, and
(ii) there were no "reportable events" as such term is defined in Item
304(a)(1)(v) of Regulation S-K. However, as reported in Access’ Form 10-K for
the year ended December 31, 2005, Grant Thornton has communicated to Access’
audit committee the existence of material weaknesses in its system of internal
control over financial reporting related to the inadequacy of staffing and
a
lack of segregation of duties.
Grant
Thornton's reports did not contain an adverse opinion or disclaimer of opinion,
but the 2005 report was modified to include an explanatory paragraph related
to
uncertainties about Access’ ability to continue as a going concern.
Effective
September 20, 2006, the Audit Committee of the Board of Directors of Access
approved the engagement of Whitley Penn LLP (“Whitley Penn”) as our independent
registered public accounting firm to audit the Access’ financial statements for
the year ended December 31, 2006. On October 2, 2006, Whitley Penn formally
advised Access that it was accepting the position as Access’ independent
registered public accounting firm for the year ending December 31,
2006.
During
the years ended December 31, 2005 and 2004, and the interim period through
October 2, 2006, Whitley Penn was not engaged as an independent registered
public accounting firm to audit either the financial statements of Access or
any
of its subsidiaries, nor has Access or anyone acting on its behalf consulted
with Whitley Penn regarding: (i) the application of accounting principles to
a
specified transaction, either completed or proposed, or the type of audit
opinion that might be rendered on Access’ financial statements; or (ii) any
matter that was the subject of a disagreement or reportable event as set forth
in Item 304(a)(2)(ii) of Regulation S-K.
56
DIRECTORS,
EXECUTIVE OFFICERS, PROMOTERS ABD CONTROL PERSONS
The
following table sets forth the Directors, Executive Officers, and Key Employees
of Access along with their respective ages and positions and is as
follows:
Name Age Title
| Steven H. Rouhandeh | 50 | Chairman of the Board |
| Jeffrey B. Davis | 44 | Chief Executive Officer, Director |
|
Rosemary
Mazanet, M.D., Ph.D.
|
52
|
Vice
Chairman
|
| Esteban Cvitkovic, M.D. | 58 | Vice Chairman – Europe |
| Mark J. Ahn, Ph.D. | 45 | Director |
| Mark J. Alvino | 40 | Director |
| Stephen B. Howell, M.D. | 63 | Director |
| David P. Luci | 41 | Director |
| John J. Meakem, Jr. | 71 | Director |
| David P. Nowotnik, Ph.D | 58 | Senior Vice President Research & Development |
| Phillip S. Wise | 49 | Vice President, Business Development & Strategy |
| Stephen B. Thompson | 54 | Vice President, Chief Financial Officer, Treasurer, |
| Secretary |
No
director, officer, affiliate or promoter of Access has, within the past five
years, filed any bankruptcy petition, been convicted in or been the subject
of
any pending criminal proceedings, or is any such person the subject or any
order, judgment or decree involving the violation of any state or federal
securities laws.
The
following is a brief account of the business experience during the past five
years of each director and executive officer of Access, including principal
occupations and employment during that period and the name and principal
business of any corporation or other organization in which such occupation
and
employment were carried on.
Mr.
Steven H. Rouhandeh
became a director and Chairman of the Board on March 4, 2008. He is a Chief Investment Officer
of SCO Capital Partners, L.P., a New York based life sciences fund. Mr.
Rouhandeh also is a founder of SCO Financial Group LLC, a highly successful
value-oriented healthcare group with an 11-year track record in this sector
(advisory, research, banking and investing). He possesses a diverse
background in financial services that includes experience in asset management,
corporate finance, investment banking and law. He has been active
throughout recent years as an executive in venture capital and as a founder
of
several companies in the biotech field. His experience also includes
positions as Managing Director of a private equity group at Metzler Bank, a
private European investment firm and Vice President, Investment Banking at
Deutsche Morgan Grenfell. Mr. Rouhandeh was also a Corporate
Attorney at New York City-based Cravath, Swaine & Moore. Mr. Rouhandeh holds
a J.D., from Harvard Law School, Harvard University and B.A. Government,
Economics, from Southern Illinois University.
Mr.
Jeffrey B. Davis became a
director in March 2006. Mr. Davis became Chief Executive Officer of the Company
on December 26, 2007. Previously, Mr. Davis was Chairman of the Board, member
of
the Executive Committee and a Chairman of the Compensation Committee of the
Board. Mr. Davis currently serves as President of SCO Financial Group LLC.
Previously, Mr. Davis served in senior management at a publicly traded
healthcare technology company. Prior to that, Mr. Davis was an investment banker
with various Deutsche Bank banking organizations, both in the U.S. and Europe.
Mr. Davis also served in senior marketing and product management positions
at
AT&T Bell Laboratories, where he was also a member of the technical staff,
and at Philips Medical Systems North America. Mr. Davis is currently on
the board of MacroChem Corporation, Uluru, Inc. and Virium Pharmaceuticals,
Inc., a private biotechnology company. Mr. Davis holds a B.S. in
biomedical engineering from Boston University and an M.B.A. degree from the
Wharton School, University of Pennsylvania.
Rosemary
Mazanet, M.D. became
a director of the Company in May 2006. Dr. Mazanet currently serves as Chief
Executive Officer of Breakthrough Therapeutics, LLC, a privately held
development stage biotechnology company. From May 2005 to January 2007 she
served as Access’ Acting Chief Executive Officer. From June 1998 to February
2004, Dr. Mazanet served as Chief Scientific Officer and a General Partner
of
Oracle Partners, L.P., a healthcare investment firm. Dr. Mazanet also serves
as
an independent director at GTx, Inc (Nasdaq: GTXI), Aksys, Ltd. and is a trustee
at the University of Pennsylvania, School of Medicine. Prior to joining Oracle,
Dr. Mazanet was the Director of Clinical Research at Amgen, Inc. She has over
20
years experience in the pharmaceutical industry, and was trained as a Medical
Oncologist/Hematologist in the Harvard Medical System, and holds an M.D. and
Ph.D. from University of Pennsylvania.
57
Dr.
Esteban Cvitkovic became
a director in February 2007 as Vice Chairman (Europe) and is also a consultant
to the Company as Senior Director, Oncology Clinical Research & Development.
Recently, the oncology-focused CRO, Cvitkovic & Associés Consultants (CAC),
founded by Dr. Cvitkovic 11 years ago and which he developed from a small
oncology consultancy to a full-service CRO, was sold to AAIPharma to become
AAIOncology. Dr. Cvitkovic is currently a Senior Medical Consultant to
AAIOncology. In addition, he maintains a part-time academic practice including
teaching at the hospitals Beaujon and St Louis in Paris. Dr. Cvitkovic is
Scientific President of the FNAB, a foundation devoted to the furthering of
personalised cancer treatments. Together with a small number of collaborators
he
has recently co-founded Oncoethix, a biotech company focused on licensing and
co-development of anti-cancer molecules. Dr. Cvitkovic has authored more than
200 peer-reviewed articles and 600 abstracts focused on therapeutic oncology
development. His international career includes staff and academic appointments
at Memorial Sloan Kettering Cancer Center (New York), Columbia Presbyterian
(New
York), Instituto Mario Negri (Milan), Institut Gustave Roussy (Villejuif),
Hôpital Paul Brousse (Villejuif) and Hôpital St. Louis (Paris).
Dr.
Mark J. Ahn became a
director in September 2006 and is a member of the Executive Committee and the
Nominating & Corporate Governance Committee. Dr. Ahn is Professor and Chair,
Science & Technology Faculties of Commerce & Administration Science at
Victoria University of Welling, New Zealand since September 2007. Dr. Ahn was
President and Chief Executive Officer and a member of the board of directors
of
Hana Biosciences, Inc. from November 2003 to September 2007. Prior to joining
Hana, from December 2001 to November 2003, he served as Vice President,
Hematology and corporate officer at Genentech, Inc. where he was responsible
for
commercial and clinical development of the Hematology franchise. >From February
1991 to February 1997 and from February 1997 to December 2001, Dr. Ahn was
employed by Amgen and Bristol-Myers Squibb Company, respectively, holding a
series of positions of increasing responsibility in strategy, general
management, sales & marketing, business development, and finance. He has
also served as an officer in the U.S. Army. Dr. Ahn is a Henry Crown Fellow
at
the Aspen Institute, founder of the Center for Non-Profit Leadership, a director
of TransMolecular, Inc., a privately held biotechnology company focused on
neuroncology, and a member of the Board of Trustees for the MEDUNSA (Medical
University of South Africa) Trust. Dr. Ahn received a B.A. in History and an
M.B.A. in Finance from Chaminade University. He was a graduate fellow in
Economics at Essex University, and has a Ph.D. in Business Administration from
the University of South Australia.
Mr.
Mark J. Alvino became a
director in March 2006 as a designee of SCO Capital Partners LLC and is a member
of the Nominating and Corporate Governance Committee. Mr. Alvino is currently
Managing Director for Griffin Securities since May 2007. Mr. Alvino was Managing
Director for SCO Financial Group LLC from July 2002 to May 2007. He is currently
on the board of directors of MacroChem Corporation. He previously worked at
Feinstein Kean Healthcare, an Ogilvy Public Relations Worldwide Company. There
he was Senior Vice President, responsible for managing both investor and
corporate communications programs for many private and public companies and
acted as senior counsel throughout the agency's network of offices. Prior to
working at FKH, Mr. Alvino served as Vice President of Investor Relations and
managed the New York Office of Allen & Caron, Inc., an investor relations
agency. His base of clients included medical devices, biotechnology, and
e-healthcare companies. Mr. Alvino also spent several years working with Wall
Street brokerages including Ladenburg, Thallman & Co. and Martin Simpson
& Co.
58
Stephen
B. Howell, M.D. has
served as one of Access’ directors since 1996. Dr. Howell is a member of the
Compensation Committee of the Board and a scientific consultant to the Company.
Dr. Howell is a Professor of Medicine at the University of California, San
Diego, and director of the Cancer Pharmacology Program of the UCSD Cancer
Center. Dr. Howell is a recipient of the Milken Foundation prize for his
contributions to the field of cancer chemotherapy. He has served on the National
Research Council of the American Cancer Society and is on the editorial boards
of multiple medical journals. Dr. Howell founded DepoTech, Inc. and served
as a
member of its board of directors from 1989 to 1999. Dr. Howell served on the
board of directors of Matrix Pharmaceuticals from 2000 to 2002. Dr. Howell
received his A.B. at the University of Chicago and his M.D. from Harvard Medical
School.
Mr.
David P. Luci has served
as one of Access’ directors since January 2007 and is also chairman of the Audit
and Finance Committee and a member of the Compensation Committee. Mr. Luci
is
currently General Counsel and Vice President of Corporate Development of
MacroChem Corporation. Mr. Luci was Executive Vice President of Bioenvision,
Inc. until August 2007. He has also served as Bioenvision’s chief financial
officer, general counsel and corporate secretary since July 2004, after serving
as director of finance, general counsel and corporate secretary since July
2002.
From September 1994 to July 2002, Mr. Luci served as a corporate associate
at
Paul, Hastings, Janofsky & Walker LLP (New York office). Prior to that, Mr.
Luci served as a senior auditor at Ernst & Young LLP (New York office). Mr.
Luci is a certified public accountant. He holds a Bachelor of Science in
Business Administration with a concentration in accounting from Bucknell
University and a J.D. (cum laude) from Albany Law School of Union
University.
Mr.
John J. Meakem, Jr. has
been one of Access’ directors since 2001. Mr. Meakem is also the chairman of the
Nominating and Corporate Governance Committee of the Board and a member of
the
Audit and Finance Committee of the Board. Mr. Meakem is a private investor
with
portfolio holdings in innovative companies with a particular focus on
healthcare. Most recently Mr. Meakem served as Chairman of the Board, President
and Chief Executive Officer of Advanced Polymer Systems, Inc. from 1991 to
2000.
Prior to 1991, he was Corporate Executive Vice President of Combe, Inc. and
President of Combe North America. Prior to 1970, Mr. Meakem was with Vick
Chemical Company, a division of Richardson Merrell Drug Corporation, for ten
years as Vice President of Marketing, New Products &
Acquisitions.
David
P. Nowotnik, Ph.D. has
been Senior Vice President Research and Development since January 2003 and
was
Vice President Research and Development from 1998. From 1994 until 1998, Dr.
Nowotnik had been with Guilford Pharmaceuticals, Inc. in the position of Senior
Director, Product Development and was responsible for a team of scientists
developing polymeric controlled-release drug delivery systems. >From 1988 to
1994
he was with Bristol-Myers Squibb researching and developing technetium
radiopharmaceuticals and MRI contrast agents. From 1977 to 1988 he was with
Amersham International leading the project which resulted in the discovery
and
development of Ceretec.
Mr.
Phillip S. Wise has been
Access’ Vice President Business Development since June 2006. Mr. Wise was Vice
President of Commercial and Business Development for Enhance Pharmaceuticals,
Inc. and Ardent Pharmaceuticals, Inc. from 2000 until 2006. Prior to that time
he was with Glaxo Wellcome, from 1990 to 2000 in various
capacities.
Mr.
Stephen B. Thompson has
been Vice President since 2000 and Access’ Chief Financial Officer since 1996.
From 1990 to 1996, he was Controller and Administration Manager of Access
Pharmaceuticals, Inc., a private Texas corporation. Previously, from 1989 to
1990, Mr. Thompson was Controller of Robert E. Woolley, Inc., a hotel real
estate company where he was responsible for accounting, finances and investor
relations. From 1985 to 1989, he was Controller of OKC Limited Partnership,
an
oil and gas company, where he was responsible for accounting, finances and
SEC
reporting. Between 1975 and 1985 he held various accounting and finance
positions with Santa Fe International Corporation.
59
Code
of Business Conduct and Ethics
In
October 2004, Access adopted a written Code of Business Conduct and Ethics
for
Employees, Executive Officers and Directors, applicable to all employees,
management, and directors, designed to deter wrongdoing and promote honest
and
ethical conduct, full, fair and accurate disclosure, compliance with laws,
prompt internal reporting and accountability to adherence to the Code of
Business Conduct and Ethics.
The
following executive compensation disclosure reflects compensation awarded to,
earned by or paid to Access’ Chief Executive Officer and each of Access’ other
executive officers listed below whose total compensation exceeded $100,000
for
the fiscal year ended December 31, 2006. Access refers to Access’ Chief
Executive Officer and these other executive officers as Access’ "named executive
officers" elsewhere in this prospectus.
Summary
Compensation Table
|
Name
and Principal Position
(7)
|
Year
|
Salary
($) (1)
|
Bonus
($)
|
Stock
Awards
($)
(2)
|
Option
Awards ($)
(3)
|
All
Other Compensation
(4)
|
Total
($)
|
|
Rosemary
Mazanet(5)(8)
Acting
CEO
|
2006
2005
|
$
|
357,385217,500
|
$
|
100,00030,000
|
$
|
-
-
|
|
$
|
81,464168,468
|
$
|
2,5941,297
|
$
|
541,443248,797
|
||||||||||||||
|
Kerry
P. Gray(6)
Former
President and CEO
|
2005
|
|
$
|
133,332
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
3,505
|
$
|
136,837
|
||||||||||||||
|
David
P. Nowotnik, Ph.D.
Senior
Vice President Research
and
Development
|
20062005
|
$
|
253,620250,710
|
$
|
20,00025,408
|
$
|
-24,154
|
$
|
40,73267,619
|
$
|
7,1527,094
|
$
|
321,504374,985
|
|||||||||||||||
|
Phillip
S. Wise(7)
Vice
President, Business
Development
|
2006
|
$
|
116,667
|
$
|
25,000
|
$
|
-
|
$
|
40,732
|
$
|
358
|
$
|
182,757
|
|||||||||||||||
|
Stephen
B. Thompson
Vice
President, Chief Financial Officer
|
20062005
|
$
|
154,080152,310
|
$
|
20,00015,435
|
$
|
-
14,704
|
$
|
40,73242,262
|
$
|
4,5084,455
|
$
|
219,320229,166
|
|||||||||||||||
____________________
|
(1)
|
Includes
amounts deferred under Access’ 401(k)
Plan.
|
|
(2)
|
There
were no stock awards granted in 2006 and no restricted stock outstanding
at December 31, 2006.
|
|
(3)
|
The
value listed in the above table represents the fair value of the
options
granted in prior years that were recognized in 2006 under FAS 123R.
Fair
value is calculated as of the grant date using a Black-Sholes
option-pricing model. The determination of the fair value of share-based
payment awards made on the date of grant is affected by Access’ stock
price as well as assumptions regarding a number of complex and subjective
variables. Access’ assumptions in determining fair value are described in
note 10 to Access’ audited financial statements for the year ended
December 31, 2006, included in Access’ Annual Report on Form
10-KSB.
|
|
(4)
|
Amounts
reported for fiscal years 2006 and 2005 consist of: (i) amounts Access
contributed to its 401(k) Plan with respect to each named individual,
(ii)
amounts Access paid for group term life insurance for each named
individual, and (iii) for Mr. Gray, premiums paid by Access each
year for
life insurance for Mr. Gray.
|
|
(5)
|
Amounts
listed in 2006 and 2005 for Dr. Mazanet indicate compensation paid
to her
in connection with her services as Access’ Acting CEO commencing on May
11, 2005.
|
60
|
(6)
|
Amounts
listed in 2005 for Mr. Gray indicate compensation paid to him in
connection with his services as Access’ President and CEO through May 10,
2005. In addition to such amounts listed in the table above,
Mr. Gray also received a total of $333,333 and $488,335 per the terms
of
his Separation Agreement in 2006 and 2005,
respectively.
|
|
(7)
|
Phillip
S. Wise became Access’ Vice President Business Development June 1,
2006.
|
|
(8)
|
Jeffrey
B. Davis became Access’ Chief Executive Officer on December 26, 2007 and
is not included in this table. Stephen R. Seiler was Access’ President and
Chief Executive Officer effective January 4, 2007 through December
19,
2007 and is not included in this
table.
|
Employment
Agreements
President
and Chief
Executive Officer
Access
is
a party to an employment arrangement with Jeffrey B. Davis, who was named by
the
Board as Access’ Chief Executive Officer, effective as of December 26, 2007. Mr.
Davis agreement was effective January 4, 2007 (the “Effective Date”) and is paid
an annual salary of $335,000 and was granted stock options to purchase 600,000
shares of Common Stock with an exercise price equal to the closing price of
Common Stock on the day preceding the Effective Date. Mr. Davis' options vest
25% on January 4, 2008 and monthly thereafter over a period of 24 months. The
stock options are granted under Access’ 2005 Equity Incentive Plan. Mr. Davis is
entitled to similar employee benefits as Access’ other executive
officers.
Access
was a party to an employment arrangement with Stephen R. Seiler, who was named
by the Board as Access’ President and Chief Executive Officer and director,
effective as of January 4, 2007 (the "Effective Date") and resigned December
16,
2007. Mr. Seiler was paid an annual salary of $350,000 and was granted stock
options to purchase 125,000 shares of Common Stock with an exercise price equal
to the closing price of Common Stock on the day preceding the Effective Date.
Mr. Seiler's options vested 25% on December 16, 2007. The stock options are
granted under Access’ 2005 Equity Incentive Plan and the 2007 Special Stock
Option Plan. Mr. Seiler was entitled to similar employee benefits as Access’
other executive officers.
Access
was a party to an employment arrangement with Rosemary Mazanet, Access’ former
Acting Chief Executive Officer. Dr. Mazanet reported directly to, and was
subject to the direction of, the Board. Dr. Mazanet salary was set at $25,000
monthly. Dr. Mazanet was granted a non-qualified stock option of 6,000 shares
of
Common Stock, vesting over a six month period. In November 2005, Dr.
Mazanet was also granted 50,000 options under Access’ 2005 Equity Incentive
Plan. Of the options granted, 14,000 options vested on grant, the rest vest
upon
attainment of preset milestones. Dr. Mazanet also received similar employee
benefits as Access’ other executive officers, D&O insurance coverage and
received a signing bonus of $30,000. The Board granted Dr. Mazanet an additional
200,000 options in 2006. Additionally, Dr. Mazanet was awarded a bonus of
$100,000 in April 2007.
Senior
Vice
President
Access
is
a party to an employment agreement with David P. Nowotnik, Ph.D., Access’ Senior
Vice President, Research and Development, which renews automatically for
successive one-year periods, with the current term extending until November
16,
2007. Under this agreement, Dr. Nowotnik is currently entitled to receive an
annual base salary of $253,620, subject to adjustment by the Board. Dr. Nowotnik
is eligible to participate in all of Access’ employee benefit programs available
to executives. Dr. Nowotnik is also eligible to receive:
|
·
|
a
bonus payable in cash and Common Stock related to the attainment
of
reasonable performance goals specified by the
Board;
|
|
·
|
stock
options at the discretion of the
Board;
|
|
·
|
long-term
disability insurance to provide compensation equal to at least $60,000
annually; and
|
|
·
|
term
life insurance coverage of
$254,000.
|
61
Dr.
Nowotnik is entitled to certain severance benefits in the event that Access
terminates his employment without cause or if Dr. Nowotnik terminates his
employment following a change of control. In the event that Access terminates
the employment agreement for any reason, other than for cause, Dr. Nowotnik
will
receive his salary for six months. Access will also continue benefits for such
period. In the event that Dr. Nowotnik's employment is terminated within six
months following a change in control or by Dr. Nowotnik upon the occurrence
of
certain events following a change in control, Dr. Nowotnik will receive twelve
months salary and his stock options will become immediately exercisable. Access
will also continue payment of benefits for such period.
Vice
President – Chief
Financial Officer
Access
is
party to an employment agreement with Stephen B. Thompson, Access’ Vice
President and Chief Financial Officer, which renews automatically for successive
one-year periods. Mr. Thompson is entitled to an annual base salary of $154,080,
subject to adjustment by the Board. The employment agreement also grants Mr.
Thompson similar employee benefits as Access’ other executive officers. Mr.
Thompson is also eligible to receive:
|
·
|
a
bonus payable in cash and Common Stock related to the attainment
of
reasonable performance goals specified by the
Board;
|
|
·
|
stock
options at the discretion of the
Board;
|
|
·
|
long-term
disability insurance to provide compensation equal to at least $90,000
annually; and
|
|
·
|
term
life insurance coverage of
$155,000.
|
Mr.
Thompson is entitled to certain severance benefits in the event that Access
terminates his employment without cause or if Mr. Thompson terminates his
employment following a change of control. In the event that Access terminates
the employment agreement for any reason, other than cause, Mr. Thompson will
receive salary for six months. Access will also continue benefits for such
period. In the event that Mr. Thompson's employment is terminated within six
months following a change of control or by Mr. Thompson upon the occurrence
of
certain events following a change in control, Mr. Thompson will receive twelve
months salary and his stock options will become immediately exercisable. Access
will also continue payment of benefits for such period.
2005
Equity Incentive Plan
Access’
board of directors adopted and Access’ stockholders approved Access’ 2005 Equity
Incentive Plan in May 2005. As of December 31, 2006, options to purchase 802,672
shares of common stock were outstanding at a weighted average exercise price
of
$1.04 per share and 197,328 shares remained available for future
grant.
Purpose. The
purpose of the Plan is to attract and retain the best available personnel for
positions of substantial responsibility and to provide additional incentive
to
employees and directors of and advisers and consultants to the Company. The
purpose of the proposed amendment is to provide the Company with additional
capacity to award stock options to existing personnel and to attract qualified
new employees, directors, advisers and consultants through grants of stock
options.
Administration. The
Plan is administered by the Compensation Committee. During 2006, the
Compensation Committee was composed of four directors, Jeffrey B. Davis, Herbert
H. McDade, Jr., J. Michael Flinn and Max Link. The Compensation Committee
presently is composed of Jeffrey B. Davis, David P. Luci and Stephen B. Howell,
MD. Subject to the provisions of the Plan, the Compensation Committee has
discretion to determine when awards are made, which employees are granted
awards, the number of shares subject to each award and all other relevant terms
of the awards. The Compensation Committee also has broad discretion to construe
and interpret the Plan and adopt rules and regulations thereunder. The
Compensation Committee approved the 2007 Special Stock Option Plan and the
grant
of 450,000 options to Access’ new President and Chief Executive Officer in
January 2007.
Eligibility. Awards
may be granted to persons who are employees of Access whether or not officers
or
members of the Board and directors of or advisers or consultants to Access
or of
any of Access’ subsidiaries. No election by any such person is
required to participate in the Plan.
62
Shares
Subject to the
Plan. The shares issued or to be issued under the Plan
are shares of Common Stock, which may be newly issued shares or shares held
in
the treasury or acquired in the open market. Previously, no more than 1,000,000
shares could be issued under the Plan. The foregoing limit is subject to
adjustment for stock dividends, stock splits or other changes in the Company’s
capitalization.
Stock
Options. The Compensation Committee in its discretion
may issue stock options which qualify as incentive stock options under the
Internal Revenue Code or non-qualified stock options. The Compensation Committee
will determine the time or times when each stock option becomes exercisable,
the
period within which it remains exercisable and the price per share at which
it
is exercisable, provided that no incentive stock option shall be exercised
more
than 10 years after it is granted and no other options shall be exercised more
than 10 years and one day after it is granted, and further provided that the
exercise price of any incentive stock option shall not be less than the fair
market value of the Common Stock on the date of grant. The closing price of
the
Common Stock on the OTC Bulletin Board on December 7, 2007 was $2.57 per
share.
|
Payment
for shares purchased upon exercise of an option must be made in full
in
cash or check, by payment through a broker in accordance with Regulation
T
of the Federal Reserve Board or by such other mode of payment as
the
Committee may approve, including payment in whole or in part in shares
of
the Common Stock, when the option is exercised. No option is transferable
except by will or the laws of descent and distribution or pursuant
to a
qualified domestic relations order, as defined by the Code or in
Title I
of the Employee Retirement Income Security Act of 1974, as
amended.
|
Notwithstanding
any other provision of the Plan, each non-employee director is also entitled
to
receive options to purchase 2,500 shares of Common Stock on the date of each
annual meeting of stockholders and options to purchase 25,000 shares of Common
Stock when he or she is first appointed as a director.
Tax
Considerations. The following is a brief and general
discussion of the federal income tax rules applicable to awards under the Plan.
With respect to an incentive stock option, an employee will generally not be
taxed at the time of grant or exercise, although exercise of an incentive option
will give rise to an item of tax preference that may result in an alternative
minimum tax. If the employee holds the shares acquired upon exercise of an
incentive stock option until at least one year after issuance and two years
after the option grant, he or she will have long-term capital gain (or loss)
based on the difference between the amount realized on the sale or disposition
and his or her option price. If these holding periods are not satisfied, then
upon disposition of the shares the employee will recognize ordinary income
equal, in general, to the excess of the fair market value of the shares at
time
of exercise over the option price, plus capital gain in respect of any
additional appreciation. With respect to a non-qualified option, an employee
will not be taxed at the time of grant; upon exercise, he or she will generally
realize compensation income to the extent the then fair market value of the
stock exceeds the option price. Access will generally have a tax deduction
to
the extent that, and at the time that, an employee realizes compensation income
with respect to an award.
Any
tax
deductions Access may be entitled to in connection with awards under the Plan
may be limited by the $1 million limitation under Section 162(m) of the Code
on
compensation paid to any of Access’ chief executive officer or other named
officers. This limitation is further discussed in the Compensation Committee
Discussion on Executive Compensation.
For
purposes of this summary, Access has assumed that no award will be considered
“deferred
compensation”
as that term is defined for purposes of the federal tax rules governing
nonqualified deferred compensation arrangements, Section 409A of the Code,
or,
if any award were considered to any extent to constitute deferred compensation,
its terms would comply with the requirements of that legislation (in general,
by
limiting any flexibility in the time of payment). For example, the award of
a
non-qualified stock option with an exercise price which is less than the market
value of the stock covered by the option would constitute deferred compensation.
If an award includes deferred compensation, and its terms do not comply with
the
requirements of these tax rules, then any deferred compensation component of
the
award will be taxable when it is earned and vested (even if not then payable)
and the recipient will be subject to a 20% additional tax.
63
In
all
cases, recipients of awards should consult their tax advisors regarding the
tax
treatment of any awards received by them.
401(k)
Plan
Access
maintains a defined contribution employee retirement plan, or 401(k) plan,
for
Access’ employees. Access’ executive officers are also eligible to participate
in the 401(k) plan on the same basis as Access’ other employees. The plan is
intended to qualify as a tax-qualified plan under Section 401(k) of the Internal
Revenue Code. The plan provides that each participant may contribute up to
the
statutory limit, which is $15,500 for calendar year 2007. Participants who
are
50 years or older can also make "catch-up" contributions, which in calendar
year
2007 may be up to an additional $5,000 above the statutory limit. Under the
plan, each participant is fully vested in his or her deferred salary
contributions, including any matching contributions by us, when contributed.
Participant contributions are held and invested by the participants in the
plan's investment options. The plan also permits Access to make discretionary
contributions and matching contributions, subject to established limits and
a
vesting schedule. In 2006, Access matched 100% of participant contributions
up
to the first two percent of eligible compensation. Access matched participant
contributions at the first four percent of eligible compensation in
2007.
Outstanding
Equity Awards at December 31, 2006
The
following table sets forth certain information regarding outstanding equity
awards held by Access’ named executive officers at December 31,
2006.
|
Option
Awards
|
|||||
|
Name
|
Number
of Securities Underlying Unexercised Options (#)
Exercisable
|
Number
of Securities Underlying Unexercised Options (#)
Unexercisable
|
Equity
Incentive Plan Awards: Number of Securities Underlying Unexercised
Unearned Options (#)
|
Option
Exercise Price ($)
|
Option
Grant
Date
(5)
|
|
Rosemary
Mazanet(2)
(4)
|
50,000
39,796
6,000
|
150,000
10,204
|
-
|
0.63
5.45
12.50
|
08/17/06
11/02/05
05/11/05
|
|
Kerry
P. Gray(3)
|
20,000
28,000
32,000
32,000
20,000
100,000
32,000
32,000
|
-
|
29.25
11.50
18.65
34.38
27.50
12.50
10.00
15.00
|
01/23/04
05/19/03
03/22/02
11/20/00
10/12/00
03/01/00
07/20/99
06/18/98
|
|
|
David
P. Nowotnik, Ph.D.
|
25,000
3,167
3,646
6,854
10,000
10,000
10,000
10,000
|
75,000
4,833
1,354
146
|
-
|
0.63
11.60
29.25
10.10
18.65
12.50
10.00
15.00
|
08/17/06
05/23/05
01/23/04
01/30/03
03/22/02
03/01/00
07/20/99
11/16/98
|
|
Phillip
S. Wise
|
25,000
|
75,000
|
-
|
0.63
|
08/17/06
|
|
Stephen
B. Thompson
|
25,000
1,979
2,187
3,917
6,000
9,000
4,000
4,000
|
75,000
3,021
813
83
|
-
|
0.63
11.60
29.25
10.10
18.65
12.50
10.00
15.00
|
08/17/06
05/23/05
01/23/04
01/30/03
03/22/02
03/01/00
07/20/99
06/18/98
|
____________________
64
|
(1)
|
On
December 31, 2006, the closing price of Access’ Common Stock as quoted on
the OTC Bulletin Board was $2.80.
|
|
(2)
|
Options
listed for Dr. Mazanet include options paid to her in connection
with her
services as Access’ Acting CEO commencing on May 11,
2005.
|
|
(3)
|
Options
listed for Mr. Gray include options paid to him in connection with
his
services as Access’ President and CEO through May 10, 2005. Mr.
Gray resigned as CEO on May 10,
2005.
|
|
(4)
|
Jeffrey
B. Davis became Access’ Chief Executive Officer on December 26, 2007 and
is not included in this table. Stephen R. Seiler was Access’ President and
Chief Executive Officer effective January 4, 2007 through December
19,
2007 and is not included in this
table.
|
|
(5)
|
All
options expire 10 years after the grant
date.
|
Board
Committees
The
Board
established an Audit and Finance Committee, a Compensation Committee and a
Nominating and Corporate Governance Committee. Each of the committees of the
Board acts pursuant to a separate written charter adopted by the Board. On
February 8, 2007, the Board also established an Executive Committee consisting
of Mr. Davis, Mr. Seiler and Dr. Ahn. The committee was dissolved on February
12, 2008.
The
Audit
and Finance Committee is currently comprised of David P. Luci (chairman) and
John J. Meakem, Jr. All of the current members of the Audit and Finance
Committee are independent under applicable SEC and AMEX rules and
regulations. The Board has determined that Mr. Luci, the chairman of the
Audit and Finance Committee, is an “audit committee financial expert,” under
applicable SEC rules and regulations. The Audit and Finance Committee’s
responsibilities and duties are among other things
to
engage the independent auditors, review the audit fees, supervise matters
relating to audit functions and review and set internal policies and procedure
regarding audits, accounting and other financial controls.
The
Compensation Committee is currently comprised of Jeffrey B. Davis (chairman),
Mr. David P. Luci and Dr. Stephen B. Howell. Mr. Luci is
independent under
applicable AMEX rules and regulations and is a non-employee director
under applicable SEC rules and “outside” under Internal Revenue Code Section
162(m). Mr. Davis and Mr. Howell are not independent under applicable AMEX
rules
and regulations.
The
Nominating and
Corporate Governance Committee is currently comprised of John J. Meakem, Jr.
(chairman), Mark Ahn, PhD and Mark J. Alvino. Mr. Meakem and Mr. Ahn are
independent under applicable AMEX rules and regulations. Mr. Alvino
is not
independent under applicable AMEX rules and regulations. The Nominating
and Corporate Governance Committee is responsible for, among other things,
considering potential Board members, making recommendations to the full Board
as
to nominees for election to the Board, assessing the effectiveness of the Board
and implementing Access’ corporate governance guidelines.
65
Compensation
of Directors
Each
director who is not also an Access employee receives a quarterly fee of $3,000
and $1,000 per quarter per committee (aggregate for all committees) in which
he/she is a member. The Chairman of the Board is paid an additional $1,000
per
quarter and the Chairman of each of the Audit and Finance and Compensation
Committee is paid an additional $500 per quarter. Mr. Flinn was paid $183,000
in
2006 for serving as Chairman of the Board for 2005 and 2006. Each director
will
have $2,000 deducted from his or her fee if the director misses more than one
Board meeting, and $1,000 deducted per committee meeting not attended. In
addition, Access reimbursed each director, whether an employee or not, the
expenses of attending Board and committee meetings. Each non-employee director
is also entitled to receive options to purchase 2,500 shares of Common Stock
on
the date of each annual meeting of stockholders and options to purchase 25,000
shares of Common Stock when he/she is first appointed as a
director.
Director
Compensation Table - 2006
The
table
below represents the compensation paid to Access’ outside directors during the
year ended December 31, 2006:
|
Name
|
Fees
earned or Paid in Cash ($)
|
Option
Awards ($)(1)
|
All
Other Compensation ($)
|
Total
($)
|
|
Mark
J. Ahn, PhD (2)
|
4,000
|
7,592
|
-
|
11,592
|
|
Mark
J. Alvino (3)
|
13,000
|
5,581
|
-
|
18,581
|
|
Esteban
Cvitkovic, MD (8)
|
-
|
-
|
-
|
-
|
|
Jeffrey
B. Davis (3)
|
16,650
|
5,581
|
-
|
22,231
|
|
Stuart
M. Duty (4)
|
16,000
|
8,379
|
-
|
24,379
|
|
J.
Michael Flinn (5)
|
17,525
|
15,411
|
183,333
|
216,269
|
|
Stephen
B. Howell, MD (6)
|
12,000
|
6,137
|
-
|
18,137
|
|
David
P. Luci (8)
|
-
|
-
|
-
|
-
|
|
Rosemary
Mazanet, MD, PhD (9)
|
-
|
-
|
-
|
-
|
|
Max
Link, PhD (9)
|
12,000
|
556
|
-
|
12,557
|
|
Herbert
H. McDade, Jr. (6)
|
17,200
|
6,137
|
-
|
23,338
|
|
John
J. Meakem, Jr. (4)
|
16,000
|
8,379
|
-
|
24,380
|
|
|
(1)
|
|
The
value listed in the above table represents the fair value of the
options
recognized as expense under FAS 123R during 2006, including unvested
options granted before 2006 and those granted in 2006. Fair value
is
calculated as of the grant date using a Black-Scholes (“Black-Scholes”)
option-pricing model. The determination of the fair value of share-based
payment awards made on the date of grant is affected by Access’ stock
price as well as assumptions regarding a number of complex and subjective
variables. Access’ assumptions in determining fair value are described in
note 10 to Access’ audited financial statements for the year ended
December 31, 2006, included in Access’ Annual Report on Form
10-KSB.
|
|
(2)
|
Represents
expense recognized in 2006 in respect of option to purchase 25,000
shares
based on a grant date fair value of $7,592.
|
||
|
(3)
|
Represents
expense recognized in 2006 in respect of option to purchase 25,000
shares
based on grant date fair value of $5,581.
|
||
|
(4)
|
Represents
expense recognized in 2006 in respect of option to purchase 25,000
shares
based on a grant date fair value of $5,581; option to purchase 1,200
shares based on a grant date fair value of $556; and option to
purchase 4,836 shares based on a grant date fair value of
$2,242.
|
||
|
(5)
|
Represents
expense recognized in 2006 in respect of option to purchase 25,000
shares
based on a grant date fair value of $5,581; option to purchase 1,200
shares based on a grant date fair value of $556; and option to
purchase 20,000 shares based on a grant date fair value of
$9,274.
|
||
|
(6)
|
Represents
expense recognized in 2006 in respect of option to purchase 25,000
shares
based on a grant date fair value of $5,581 and option to purchase
1,200
shares based on a grant date fair value of $556.
|
||
|
(7)
|
Represents
expense recognized in 2006 in respect of option to purchase 1,200
shares
based on grant date fair value of $556.
|
||
|
(8)
|
Dr.
Cvitkovic and Mr. Luci became directors in 2007.
|
||
|
(9)
|
Dr.
Mazanet was an inside director during 2006 and was not paid directors
fees. She became an outside director in January
2007.
|
The
following table summarizes the aggregate number of option awards held by each
director at December 31, 2006. There were no outstanding stock awards held
by
any director at December 31, 2006:
66
|
Name
|
Number
of Securities Underlying Unexercised Options (#)
Exercisable
|
Number
of Securities Underlying Unexercised Options (#)
Unexercisable
|
Equity
Incentive Plan Awards: Number of Securities Underlying Unexercised
Unearned Options (#)
|
Option
Exercise Price ($)
|
Option
Expiration Date
|
|
Mark
J. Ahn, PhD
|
-
|
25,000
|
-
|
0.85
|
09/01/16
|
|
Mark
J. Alvino
|
-
|
25,000
|
-
|
0.63
|
08/17/16
|
|
Jeffrey
B. Davis
|
-
|
25,000
|
-
|
0.63
|
08/17/16
|
|
Esteban
Cvitkovic, MD (1)
|
-
|
-
|
-
|
-
|
-
|
|
Stuart
M. Duty
|
2,500
4,836
1,200
|
25,000
|
-
|
0.63
12.40
3.15
3.15
|
08/17/16
5/12/15
2/05/16
2/05/16
|
|
J.
Michael Flinn
|
2,000
2,000
1,000
2,000
2,000
2,500
2,500
2,500
1,200
20,000
|
25,000
|
-
|
0.63
15.00
10.00
17.81
23.05
14.05
11.50
28.50
12.40
3.15
3.15
|
08/17/16
06/18/08
07/20/09
06/26/10
05/21/11
05/20/12
05/19/13
05/19/14
05/12/15
02/05/16
02/05/16
|
|
Stephen
B. Howell, MD (3)
|
417
1,000
2,000
2,000
2,500
2,500
2,500
1,200
|
25,000
|
-
|
0.63
15.00
17.81
23.05
14.05
11.50
28.50
12.40
3.15
|
08/17/16
06/18/08
06/26/10
05/21/11
05/20/12
05/19/13
05/19/14
05/12/15
02/05/16
|
|
David
P. Luci (1)
|
-
|
-
|
-
|
-
|
-
|
|
Rosemary
Mazanet, MD, PhD (2)
|
-
|
||||
|
Max
Link, PhD
|
1,200
|
-
|
0.63
|
08/17/16
|
|
|
Herbert
H. McDade, Jr.
|
2,500
1,000
2,000
2,000
2,500
2,500
1,200
|
25,000
|
-
|
0.63
15.00
17.81
23.05
14.05
28.50
12.40
3.15
|
08/17/16
06/18/08
06/26/10
05/21/11
05/20/12
05/19/14
05/12/15
02/05/16
|
|
John
J. Meakem, Jr.
|
4,000
2,000
2,500
2,500
2,500
4,836
1,200
|
25,000
|
-
|
0.63
20.25
14.05
11.50
28.50
12.40
3.15
3.15
|
08/17/16
02/16/11
05/20/12
05/19/13
05/19/14
05/12/15
02/05/16
02/05/16
|
____________________
|
(1)
|
Dr.
Cvitkovic and Mr. Luci became directors in 2007.
|
|
(2)
|
Since
Dr. Mazanet became an outside director in January 2007, her options
are
reported in the executive compensation tables.
|
|
(3)
|
Dr.
Howell also has a warrant to purchase 3,000 shares of Access Common
Stock
at an exercise price of $15.00 per share, and a warrant to purchase
2,000
shares of Access Common Stock at an exercise price of $24.80 per
share.
|
67
LEGAL
PROCEEDINGS
The
Company is not currently subject to any material pending legal
proceedings.
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
Based
solely upon information made available to Access, the following table sets
forth
certain information with respect to the beneficial ownership of Access’ Common
Stock as of March 6, 2008 by (i) each person who is known by Access to
beneficially own more than five percent of Access’ Common Stock; (ii) each of
Access’ directors; (iii) each of Access’ named executive officers; and (iv) all
Access’ executive officers and directors as a group. Beneficial ownership as
reported in the following table has been determined in accordance with Rule
13d-3 under the Securities Exchange Act of 1934, as amended. The address of
each
holder listed below, except as otherwise indicated, is c/o Access
Pharmaceuticals, Inc., 2600 Stemmons Freeway, Suite 176, Dallas, Texas
75207.
|
Common
Stock Beneficially Owned
|
||
|
Name
of Beneficial Owner
|
Number
of Shares(1)
|
%
of Class
|
|
Steven
H. Rouhandeh(2)
|
-
|
*
|
|
Jeffery
B. Davis (3)
|
30,820
|
*
|
|
Mark
J. Ahn, Ph. D. (4)
|
25,000
|
*
|
|
Mark
J. Alvino (5)
|
80,525
|
1.4%
|
|
Esteban
Cvitkovic, M.D. (6)
|
50,000
|
*
|
|
Stephen
B. Howell, M.D. (7)
|
53,839
|
*
|
|
David
P. Luci (8)
|
37,500
|
*
|
|
Rosemary
Mazanet, M.D., Ph.D.(9)
|
279,251
|
4.7%
|
|
John
J. Meakem, Jr.
(10)
|
53,536
|
*
|
|
David
P. Nowotnik, Ph.D. (11)
|
175,349
|
3.0%
|
|
Phillip
S. Wise (12)
|
100,000
|
1.8%
|
|
Stephen
B. Thompson (13)
|
143,167
|
2.5%
|
|
SCO
Capital Partners LLC, SCO Capital Partners LP, and Beach Capital
LLC (14)
|
13,001,870
|
69.8%
|
|
Larry
N. Feinberg (15)
|
2,479,372
|
31.7%
|
|
Lake
End Capital LLC (16)
|
1,556,966
|
21.7%
|
|
Perceptive
Life Sciences
Master
Fund, Ltd. (17)
|
999,999
|
15.1%
|
|
Midsummer
Investment, Ltd. (18)
|
750,000
|
11.8%
|
|
All
Directors and Executive
Officers
as a group
(consisting
of 12 persons) (19)
|
1,028,987
|
15.6%
|
*
- Less
than 1%
|
(1)
|
Includes
Access’ outstanding shares of Common Stock held plus all shares of Common
Stock issuable upon conversion of Series A Preferred Stock, exercise
of
options, warrants and other rights exercisable within 60 days of
March 6,
2008.
|
68
|
(2)
|
Steven
H. Rouhandeh is Chairman of SCO Securities LLC. a wholly-owned subsidiary
of SCO Financial Group LLC. His address is c/o SCO Capital Partners
LLC,
1285 Avenue of the Americas, 35th Floor, New York, NY 10019. SCO
Securities LLC and affiliates (SCO Capital Partners LP and Beach
Capital
LLC) are known to beneficially own warrants to purchase an aggregate
of
5,924,770 shares of Access’ Common Stock and 7,077,100 shares of Common
Stock are issuable to them upon conversion of Series A Preferred
Stock.
Mr. Rouhandeh disclaims beneficial ownership of all such shares except
to
the extent of his pecuniary interest
therein.
|
|
(3)
|
Includes
5,820 shares underlying warrants held directly by Mr. Davis and presently
exercisable options for the purchase of 25,000 shares of Access’ Common
Stock pursuant to the 2005 Equity Incentive Plan. Mr. Davis is President
of SCO Securities LLC, a wholly-owned subsidiary of SCO Financial
Group
LLC. His address is c/o SCO Capital Partners LLC, 1285 Avenue of
the
Americas, 35th Floor, New York, NY 10019. SCO Securities LLC and
affiliates (SCO Capital Partners LP and Beach Capital LLC) are known
to
beneficially own warrants to purchase an aggregate of 5,924,770 shares
of
Access’ Common Stock and 7,077,100 shares of Common Stock are issuable to
them upon conversion of Series A Preferred Stock. Mr. Davis disclaims
beneficial ownership of all such shares except to the extent of his
pecuniary interest therein.
|
|
(4)
|
Includes
presently exercisable options for the purchase of 25,000 shares of
Access’
Common Stock pursuant to the 2005 Equity Incentive
Plan.
|
|
(5)
|
Includes
55,525 shares of Common Stock underlying warrants held by Mr. Alvino
and
presently exercisable options for the purchase of 25,000 shares of
Access’
Common Stock pursuant to the 2005 Equity Incentive Plan. Mr. Alvino
is
Managing Director of Griffin Securities LLC. His address is c/o Griffin
Securities LLC, 17 State St., 3rd
Floor, New York, NY 10004. Mr. Alvino is a designated director of
SCO
Securities LLC. SCO Securities LLC and affiliates (SCO Capital Partners
LP
and Beach Capital LLC) are known to beneficially own warrants to
purchase
an aggregate of 5,924,770 shares of Access’ Common Stock and 7,077,100
shares of Common Stock are issuable to them upon conversion of Series
A
Preferred Stock. Mr. Alvino disclaims beneficial ownership of all
such
shares except to the extent of his pecuniary interest therein. Mr.
Alvino
disclaims beneficial ownership of all such shares except to the extent
of
his pecuniary interest therein.
|
|
(6)
|
Includes
presently exercisable options for the purchase of 50,000 shares of
Access’
Common Stock pursuant to the 2005 Equity Incentive
Plan.
|
|
(7)
|
Includes
presently exercisable options for the purchase of 26,200 shares of
Access’
Common Stock pursuant to the 2005 Equity Incentive Plan, 12,917 shares
of
Access’ Common Stock pursuant to the 1995 Stock Option Plan, a warrant to
purchase 3,000 shares of Access’ Common Stock at an exercise price of
$15.00 per share, and a warrant to purchase 2,000 shares of Access’ Common
Stock at an exercise price of $24.80 per
share.
|
|
(8)
|
Includes
warrants to purchase an aggregate of 4,167 shares of Access’ Common Stock,
8,333 shares of Common Stock are issuable to him upon conversion
of Series
A Preferred Stock and presently exercisable options for the purchase
of
25,000 shares of Access’ Common Stock pursuant to the 2005 Equity
Incentive Plan.
|
|
(9)
|
Includes
presently exercisable options for the purchase of 273,251 shares
of
Access’ Common Stock pursuant to the 2005 Equity Incentive Plan and 6,000
shares of Access’ Common Stock pursuant to the 1995 Stock Option
Plan.
|
|
(10)
|
Includes
presently exercisable options for the purchase of 31,036 shares of
Access’
Common Stock pursuant to the 2005 Equity Incentive Plan and 13,500
shares
of Access’ Common Stock pursuant to the 1995 Stock Option
Plan.
|
|
(11)
|
Includes
presently exercisable options for the purchase of 100,000 shares
of
Access’ Common Stock pursuant to the 2005 Equity Incentive Plan and 57,833
shares of Access’ Common Stock pursuant to the 1995 Stock Option
Plan.
|
|
(12)
|
Includes
presently exercisable options for the purchase of 100,000 shares
of
Access’ Common Stock pursuant to the 2005 Equity Incentive
Plan.
|
|
(13)
|
Includes
presently exercisable options for the purchase of 100,000 shares
of
Access’ Common Stock pursuant to the 2005 Equity Incentive Plan and 33,646
shares of Access’ Common Stock pursuant to the 1995 Stock Option
Plan.
|
69
|
(14)
|
SCO
Capital Partners LLC, SCO Capital Partner LP and Beach Capital LLC's
address is 1285 Avenue of the Americas, 35th
Floor, New York, NY 10019. SCO Capital Partners LLC and affiliates
(SCO
Capital Partners LP and Beach Capital LLC) are known to beneficially
own
warrants to purchase an aggregate of 5,924,770 shares of Access’ Common
Stock and 7,077,100 shares of Common Stock issuable to them upon
conversion of Series A Preferred Stock. Each of Mr. Rouhandeh. Mr.
Davis
and Mr. Alvino, Access’ directors and Mr. Rouhandeh and Mr. Davis a
executives with SCO Capital Partners LLC, disclaim beneficial ownership
of
such shares except to the extent of their pecuniary interest
therein.
|
|
(15)
|
Larry
N. Feinberg is a partner in Oracle Partners, L.P. His address is
c/o
Oracle Partners, L.P., 200 Greenwich Avenue, 3rd
Floor, Greenwich, CT 06830. Oracle Partners, L.P. and affiliates
(Oracle
Institutional Partners, L.P., Oracle Investment Management, Inc.,
Sam
Oracle Fund, Inc. and Mr. Feinberg) are known to beneficially own
an
aggregate of 339,964 shares of Access’ Common Stock, warrants to purchase
an aggregate of 728,850 shares of Access’ Common Stock and Series A
Preferred Stock which may be converted into an aggregate of 1,457,699
shares of Access’ Common Stock.
|
|
(16)
|
Lake
End Capital LLC’s address is 1285 Avenue of the Americas, 35th
Floor, New York, NY 10019. Lake End Capital LLC is known to beneficially
own warrants to purchase an aggregate of 1,195,717 shares of Access’
Common Stock and 793,067 shares of Common Stock issuable to them
upon
conversion of Series A Preferred
Stock.
|
|
(17)
|
Perceptive
Life Sciences Master Fund, Ltd.’s address is 499 Park Ave., 25th
Fl., New York, NY 10022. Perceptive Life Sciences Master Fund is
known to
beneficially own warrants to purchase an aggregate of 333,333 shares
of
Access’ Common Stock and Series A Preferred Stock which may be converted
into an aggregate of 666,666 shares of Access’ Common
Stock.
|
|
(18)
|
Midsummer
Investment, Ltd.’s address is 295 Madison Ave., 38th
Fl., New York, NY 10017. Midsummer Investment is known to beneficially
own
warrants to purchase an aggregate of 250,000 shares of Access’ Common
Stock and Series A Preferred Stock which may be converted into an
aggregate of 500,000 shares of Access’ Common
Stock.
|
|
(19)
|
Does
not include shares held by SCO Securities LLC and
affiliates.
|
SECURITIES
AUTHORIZED FOR ISSUANCE UNDER EQUITY COMPENSATION PLANS
Access
adopted its 2005 Equity Incentive Plan in May 2005, as amended, authorizing
1,675,000 shares under the plan. Access issued 1,539,136 options or rights
under
this plan as of March 6, 2008. The balance of the options outstanding as of
March 6, 2008 is 135,864. Access adopted its 2001 Restricted Stock Plan in
May
2001, authorizing 80,000 shares of its authorized but unissued common stock
were
reserved for issuance to certain employees, directors, consultants and advisors.
Access issued 27,182 shares and 52,818 shares are available for
grant.
The
following table sets forth information as of December 31, 2006 about shares
of
Common Stock outstanding and available for issuance under Access’ equity
compensation plans existing as of such date.
|
Plan
Categorty
|
Number
of securities to be issued upon exercise of outstanding options,
warrants and rights
|
Weighted-average
exercise price of outstanding options, warrants and rights
|
Number
of securities remaining available for future issuance under equity
compensation plans (excluding securities reflected in column (a))
|
|
(a)
|
(b)
|
(c)
|
|
|
Equity
compensation plans approved by security holders
|
|||
|
2005
Equity Incentive Plan
1995
Stock Awards Plan
2001
Restricted Stock Plan
|
802,672
360,917
-
|
$ 1.04
$18.03
-
|
197,328
-
52,818
|
|
Equity
compensation plans not approved by security holders
|
|||
|
2000
Special Stock
Option
Plan *
|
100,000
|
$12.50
|
-
|
|
Total
|
1,263,589
|
$
6.80
|
250,146
|
*
expired
unexercised June 30, 2007
70
The
2007 Special Stock Option Plan
The
2007
Special Stock Option Plan (the "Plan") was adopted by the Board in January
2007.
The Plan is not intended to be an incentive stock option plan within the meaning
of Section 422 of the Internal Revenue Code of 1986, as amended (the “Code”).
The Plan allows for the issuance of up to 450,000 options to acquire Access’
stock of which 112,500 have been issued. The purpose of the Plan is to encourage
ownership of Common Stock by employees, consultants, advisors and directors
of
Access and its affiliates and to provide additional incentive for them to
promote the success of Access’ business. The Plan provides for the grant of
non-qualified stock options to employees (including officers, directors,
advisors and consultants). The Plan will expire in January 2017, unless earlier
terminated by the Board. The granted options in the Plan expire in January
2009.
Annual
Incentive
Each
year, the Compensation Committee evaluates the performance of the Company as
a
whole, as well as the performance of each individual executive. Factors
considered include Company development, performance against objectives,
advancement of our research and development programs, commercial operations,
product acquisition, and in-licensing and out-licensing agreements. The
Compensation Committee does not utilize formalized mathematical formulas, nor
does it assign weightings to these factors. The Compensation Committee, in
its
sole discretion, determines the amount, if any, of incentive payments to be
awarded to each executive based on an individual’s targeted incentive payment.
The Compensation Committee believes that analysis of our corporate growth
requires subjectivity on the part of the Compensation Committee when determining
incentive payments. The Compensation Committee believes that specific formulas
restrict flexibility. Based on this criteria, for the 2006 fiscal year Dr.
Mazanet was granted options to purchase 200,000 shares of Common Stock under
the
2005 Equity Incentive Plan.
Stock
Option Plans
The
Board
has adopted and our stockholders have approved our 2005 Equity Incentive Plan
and 1995 Stock Awards Plan. The 2005 Equity Incentive Plan currently provides
for the issuance of up to a maximum of 1,000,000 shares of our Common Stock
to
our employees, directors and consultants or any of our subsidiaries. The 1995
Stock Awards Plan provided for the issuance of up to a maximum of 500,000 shares
of our Common Stock to our employees, directors and consultants or any of our
subsidiaries. A total of 474,044 options were granted under the 1995 Stock
Awards Plan before it terminated. Options granted under both plans may be either
incentive stock options or options which do not qualify as incentive stock
options. In 2000, the Board adopted the 2000 Special Stock Option Plan and
Agreement (the “2000 Plan”).
The 2000 Plan
provides for the award of options to purchase a maximum of 100,000 shares of
our
Common Stock. In 2007, the Board adopted the 2007 Special Stock Option Plan
and
Agreement (the “2007 Plan”). The 2007 Plan provides for the award of options to
purchase a maximum of 450,000 shares of our Common Stock.
The
stock
option plans are administered by a committee of non-employee members of the
Board, chosen by the Board, and is currently administered by the Compensation
Committee. During 2006, the Compensation Committee was composed of four
directors, Herbert H. McDade, Jr., Jeffrey B. Davis, J. Michael Flinn and
Stephen B. Howell, MD. The Compensation Committee presently is composed of
Jeffrey B. Davis and Stephen B. Howell, MD. The Compensation Committee has
the
authority to determine those individuals to whom stock options are granted,
the
number of shares to be covered by each option, the option price, the type of
option, the option period, the vesting restrictions, if any, with respect to
exercise of each option, the terms for payment of the option price and other
terms and conditions of each option.
71
Our
non-employee directors, who include members of the Compensation Committee,
are
eligible to receive options under the 2005 Equity Incentive Plan. Each
non-employee director is entitled to receive options to purchase 2,500 shares
of
our Common Stock on the date of each annual meeting of stockholders and options
to purchase 25,000 shares of Common Stock when he/she is first appointed as
a
director.
Dr.
Mazanet received options to purchase 6,000 shares of Common Stock in the 2005
fiscal year under the 1995 Stock Awards Plan and options to purchase 50,000
shares of Common Stock in the 2005 fiscal year under the 2005 Equity Incentive
Plan. Dr. Mazanet also received options to purchase 200,000 shares of Common
Stock in the 2006 fiscal year under the 2005 Equity Incentive Plan. As of
December 31, 2005, we had granted to Mr. Gray options under the 1995 Stock
Awards Plan and the 2000 Plan to purchase an aggregate of 1,480,000 shares
of
Common Stock at a weighted average exercise price per share of $17.60. All
1,480,000 of such options expired on June 30, 2007.
We
also
have a restricted stock plan, the 2001 Restricted Stock Plan under which 80,000
shares of our Common Stock have been reserved for issuance to certain employees,
directors, consultants and advisors. The restricted stock granted under the
plan
generally vests over five years, 25% two years after the grant date with an
additional 25% vesting on the next three anniversary dates. All stock is vested
after five years. At December 31, 2006 there were 27,182 shares granted and
52,818 shares available for grant under the 2001 Restricted Stock
Plan.
Section
162(m)
Section
162(m) of the Internal Revenue Code of 1986, as amended, currently imposes
a $1
million limitation on the deductibility of certain compensation paid to each
of
our five highest paid executives. Excluded from this limitation is compensation
that is “performance
based.” For
compensation to be performance based it must meet certain criteria, including
being based on predetermined objective standards approved by stockholders.
In
general, we believe that compensation relating to options granted under the
1995
Stock Awards Plan and 2000 Plan should be excluded from the $1 million
limitation calculation. Compensation relating to our incentive compensation
awards do not currently qualify for exclusion from the limitation, given the
discretion that is provided to the Compensation Committee in establishing the
performance goals for such awards. The Compensation Committee believes that
maintaining the discretion to evaluate the performance of our management is
an
important part of its responsibilities and inures to the benefit of our
stockholders. The Compensation Committee, however, intends to take into account
the potential application of Section 162(m) with respect to incentive
compensation awards and other compensation decisions made by it in the
future.
Section
16(a) Beneficial Ownership Reporting Compliance
Section
16(a) (“Section
16(a)”) of the
Securities Exchange Act of 1934, as amended, requires our directors, executive
officers and holders of more than ten percent of our Common Stock to file with
the SEC initial reports of ownership and reports of changes in ownership of
such
securities. Directors, officers and 10% holders are required by SEC rules to
furnish us with copies of all of the Section 16(a) reports they
file.
Based
solely on a review of reports furnished to us during the 2006 fiscal year or
written representations from our directors and executive officers, none of
our
directors, executive officers and 10% holders failed to file on a timely basis
reports required by Section 16(a) during the 2006 fiscal year or in prior years,
except for Dr. Mazanet who filed one late Form 4, reporting one
transaction.
72
TRANSACTIONS
WITH RELATED PERSONS, PROMOTERS AND CERTAIN CONTROL PERSONS
On
February 12, 2008, the Board of Directors of the Company elected Steven H.
Rouhandeh as director and Chairman of the Board effective as of March 4,
2008.
David
P.
Luci, one of our directors, participated in the February 2008 sale of our
preferred stock. Mr. Luci purchased 2.5 preferred shares for $25,000 and
warrants to purchase 4,167 shares of our common stock.
Dr.
Esteban Cvitkovic, one of our directors, also serves as a consultant as Senior
Director, Oncology Clinical Research & Development to the Company since
August 2007. Dr. Cvitkovic currently receives $20,000 per month plus $2,500
for
office expenses. During 2007 Dr. Cvitkovic received $75,000. Dr. Cvitkovic
received warrants to purchase 25,000 shares of our Common Stock at $4.35 per
share with 12,500 options immediately in August 2007 and 12,500 options will
vest in March 2008 based on the completion of certain defined
tasks.
In
the
event SCO Capital Partners LLC (“SCO”) and its affiliates were to convert all of
their shares of Series A Preferred Stock and exercise all of their warrants,
they would own approximately 69.8% of the voting securities of Access. During
2007 SCO and affiliates were paid $240,000 in placement agent fees relating
to
the issuance of preferred stock and 100,000 warrants to purchase our common
stock. SCO and affiliates also were paid $150,000 in investor relations fees
in
2007. During 2006 SCO and affiliates were paid $415,000 in fees relating to
the
issuance of convertible notes and were paid $131,000 in investor relations
fees.
On
November 7, 2007, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 954.0001 shares
of a newly created series of our preferred stock, designated “Series A
Cumulative Convertible Preferred Stock”, par value $0.01 per share, for an issue
price of $10,000 per share, (the “Series A Preferred Stock”) and agreed to issue
warrants to purchase 1,589,999 shares of our common stock at an exercise price
of $3.50 per share, for an aggregate purchase price for the Series A Preferred
Stock and Warrants of $9,540,001. The shares of Series A Preferred Stock are
convertible into common stock at the initial conversion price of $3.00 per
share.
As
a
condition to closing, SCO Capital Partners LLC and affiliates, along with the
other holders of an aggregate of $6,000,000 Secured Convertible Notes, also
exchanged their notes and accrued interest for an additional 1,836.0512 shares
of Series A Preferred Stock and were issued warrants to purchase 1,122,031
shares of our common stock at an exercise price of $3.50 per share, and Oracle
Partners LP and affiliates, along with the other holders of an aggregate of
$4,015,000 Convertible Notes also exchanged their notes and accrued interest
for
437.3104 shares of the Series A Preferred Stock and were issued warrants to
purchase 728,850 shares of our common stock at an exercise price of $3.50 per
share. SCO Capital Partners LLC currently has two designees serving
on our Board of Directors. In connection with the exchange of the
notes, all security interests and liens relating thereto were
terminated.
As
a
condition to closing, we entered into an Investor Rights Agreement with each
of
the investors purchasing shares of Series A Preferred Stock and our Board of
Directors approved with respect to the shareholder rights plan any action
necessary under our shareholder rights plan to accommodate the issuance of
the
Series A Preferred Stock and warrants without triggering the applicability
of
the shareholder rights plan.
The
Investor Rights Agreement grants certain registration and other rights to each
of the investors.
In
connection with the sale and issuance of Series A Preferred Stock and warrants,
we entered into a Director Designation Agreement whereby we agreed to continue
SCO’s right to designate two individuals to serve on the Board of Directors of
Access.
Lake
End
Capital LLC is known to beneficially own warrants to purchase an aggregate
of
1,195,717 shares of Access’ Common Stock and Series A Preferred Stock which may
be converted into an aggregate of 793,067 shares of Access’ Common Stock. Lake
End Capital LLC and Mr. Davis are known to beneficially own warrants and options
to purchase an aggregate of 1,832,357 shares of Access’ Common Stock and 793,067
shares of Common Stock issuable upon conversion of Series A Preferred Stock.
Jeffrey B. Davis, in his capacity as managing member of Lake End Capital LLC,
has the power to direct the vote and disposition of the shares owned by Lake
End
Capital LLC. Mr. Davis is President of SCO Securities LLC, a wholly-owned
subsidiary of SCO Financial Group LLC.
73
Dr.
Howell, one of our directors, also serves as a scientific consultant to the
Company pursuant to a consulting agreement that provides for a minimum of two
days consulting during 2007 at a rate of $5,880 per month plus expenses. Dr.
Howell received warrants to purchase 2,000 shares of our Common Stock at $24.80
per share that can be exercised until January 1, 2009; and warrants to purchase
3,000 shares of our Common Stock at $15.00 per share that can be exercised
until
January 1, 2008. During 2006, Dr. Howell was paid $69,000 in consulting fees;
during 2005, Dr. Howell was paid $79,000 in consulting fees; and during 2004
Dr.
Howell was paid $58,000 in consulting fees. Dr. Howell’s agreement with us
expires March 1, 2008.
On
January 20, 2006, Board approved the payment of a fee of $140,000 to J. Michael
Flinn, our former Chairman of the Board, for services as Chairman of the Board
for fiscal 2005. The $140,000 fee was paid on the completion of a financing.
The
Board also approved the grant of options to purchase 20,000 shares of Common
Stock at an exercise price of $3.15 per share to J. Michael Flinn for services
as Chairman of the Board. In May 2006, the Board also approved the payment
of a
fee of $43,333 to Mr. Flinn for services as Chairman of the Board for 2006.
The
Board also approved the grant of options to purchase 4,836 shares of Common
Stock at an exercise price of $3.15 per share to Messrs. Duty and Meakem,
members of the then existing Merger and Acquisitions Committee of the Board,
for
services in connection therewith. The Board also approved the grant of options
to purchase 1,200 shares of Common Stock at an exercise price of $3.15 per
share
to each member of the Board, for services as members of the Board.
In
August
2006, the Board approved the grant of options to purchase 25,000 shares of
Common Stock at an exercise price of $0.63 per share to each member of the
Board.
On
October 12, 2000, the Board authorized a restricted stock purchase program.
Under the program, our executive officers were given the opportunity to purchase
shares of Common Stock in an individually designated amount per participant
determined by our Compensation Committee. A total of 36,000 shares were
purchased by such officers at $27.50 per share, the fair market value of the
Common Stock on October 12, 2000, for an aggregate consideration of $990,000.
The purchase price was paid through the participant’s delivery of a 50%-recourse
promissory note payable to us. Each note bears interest at 5.87% compounded
semi-annually and has a maximum term of ten years. The notes are secured by
a
pledge to us of the purchased shares. We recorded the notes receivable of
$990,000 from participants in this program as a reduction of equity in the
Consolidated Balance Sheet. As of December 31, 2006, principal and interest
on
the notes was: Mr. Gray - $809,000; Dr. Nowotnik - $404,000; and Mr. Thompson
-
$243,000. In accordance with the Sarbanes-Oxley Act of 2002, we no longer make
loans to our executive officers.
MARKET
FOR COMMON STOCK
Price
Range of Common Stock and Dividend Policies
Access’
common stock has traded on the OTC Bulletin Board, or OTCBB, under the trading
symbol ACCP since June 5, 2006. From February 1, 2006 until June 5, 2006 Access
traded on the “Pink Sheets” under the trading symbol AKCA. From March 30, 2000
until January 31, 2006 Access traded on the American Stock Exchange, or AMEX,
under the trading symbol AKC.
The
following table sets forth, for the periods indicated, the high and low closing
prices as reported by OTCBB, the Pink Sheets and AMEX for Access’ common stock
for fiscal years 2007 and 2006 and as the most recent date of the first quarter
2008. The OTCBB and Pink Sheet quotations reflect inter-dealer prices, without
retail mark-up, mark-down or commission and may not represent actual
transactions.
All
per
share information reflect a one for five reverse stock split effected June
5,
2006.
74
|
Common
Stock
|
|
||||||||
|
High
|
Low
|
||||||||
|
Period
Ended
|
|||||||||
|
First
quarter March 7, 2008
|
$ | 3.60 | $ | 1.90 | |||||
|
Fiscal
Year Ended December 31,
2007
|
|||||||||
|
First
quarter
|
$ | 10.66 | $ | 2.50 | |||||
|
Second
quarter
|
6.75 | 4.30 | |||||||
|
Third
quarter
|
5.16 | 2.10 | |||||||
|
Fourth
quarter
|
4.48 | 2.10 | |||||||
|
Fiscal
Year Ended December 31,
2006
|
|||||||||
|
First
quarter
|
$ | 2.65 | $ | 0.80 | |||||
|
Second
quarter
|
1.50 | 0.10 | |||||||
|
Third
quarter
|
1.30 | 0.45 | |||||||
|
Fourth
quarter
|
3.00 | 1.05 | |||||||
Holders
The
number of record holders of Access common stock at March 7, 2008 was
approximately 3,000. On March 7, 2008, the closing price for the common stock
as
quoted on the OTCBB was $1.90. There were 5,623,781 shares of common stock
outstanding at March 7, 2008.
Options
and Warrants
There
are
9,269,734 outstanding warrants and 1,814,053 outstanding options to purchase
Access’ common equity as of March 7, 2008.
Shares
Eligible for Future Sales
Access
has issued 5,623,781 shares of its common stock as of March 7, 2008. Of these
shares, all shares are unrestricted and held by non-affiliates, and are freely
tradable without restriction under the Securities Act. These shares will be
eligible for sale in the public market, subject to certain volume limitations
and the expiration of applicable holding periods under Rule 144 under the
Securities Act. In general, under Rule 144 as currently in effect, a person
(or
persons whose shares are aggregated) who has beneficially owned restricted
shares for at least one year (including the holding period of any prior owner
or
affiliate) would be entitled to sell within any three-month period a number
of
shares that does not exceed the greater of one percent (1%) of the number of
shares of common stock then outstanding or (2) the average weekly trading volume
of the common stock during the four calendar weeks preceding the filing of
a
Form 144 with respect to such sale. Sales under Rule 144 are also subject to
certain manner of sale provisions and notice requirements and to the
availability of current public information about us. Under Rule 144(k), a person
who is not deemed to have been an affiliate of Access at any time during the
three months preceding a sale, and who has beneficially owned the shares
proposed to be sold for at least two years (including the holding period of
any
prior owner except an affiliate), is entitled to sell such shares without
complying with the manner of sale, public information, volume limitation or
notice provisions of Rule 144.
75
Dividends
Access
never declared or paid any cash dividends on its preferred stock or common
stock
and Access does not anticipate paying any cash dividends in the foreseeable
future on its common stock. The payment of dividends on common stock, if any,
in
the future is within the discretion of Access’ Board of Directors and will
depend on its earnings, capital requirements and financial condition and other
relevant facts. Access currently intends to retain all future earnings, if
any,
to finance the development and growth of its business.
The
holders of Series A Preferred Stock are entitled to receive dividends of 6%
per
annum on their shares Series A Preferred Stock. The dividends are payable by
Access semi-annually and may be paid by Access either in cash, or if certain
conditions are met, at Access’ option, in shares of Access’ common stock. To be
eligible to pay dividends in shares of common stock, among other things, there
must be in place a registration statement pursuant to which the holders of
the
Series A Preferred Stock are permitted to utilize the prospectus thereunder
to
resell all of the shares of common stock issuable in relation to the Series
A
Preferred Stock.
76
Access’
certificate of incorporation authorizes the issuance of 100,000,000 shares
of
its common stock, $.01 par value per share, and 2,000,000 shares of preferred
stock, $.01 par value per share, which may be issued in one or more series.
Currently, 4,000 shares of preferred stock are designated as Series A Preferred
Stock. As of March 6, 2008 there were 5,623,781 shares of Access’
common stock outstanding and held of record by approximately 3,000 stockholders,
and there were 3,449.8617 shares of its preferred stock outstanding convertible
into 11,666,195 shares of common stock.
Common
Stock
Holders
of Access’ common stock are entitled to one vote for each share held on all
matters submitted to a vote of stockholders and have the right to vote
cumulatively for the election of directors. This means that in the voting at
Access’ annual meeting, each stockholder or his proxy, may multiply the number
of his shares by the number of directors to be elected then cast the resulting
total number of votes for a single nominee, or distribute such votes on the
ballot among the nominees as desired. Holders of Access’ common stock are
entitled to receive ratably such dividends, if any, as may be declared by
Access’ Board of Directors out of funds legally available therefor, subject to
any preferential dividend rights for Access’ outstanding preferred stock. Upon
Access’ liquidation, dissolution or winding up, the holders of Access’ common
stock are entitled to receive ratably Access’ net assets available after the
payment of all debts and other liabilities and subject to the prior rights
of
any of Access’ outstanding preferred stock. Holders of Access’ common stock have
no preemptive, subscription, redemption or conversion rights. The outstanding
shares of Access’ common stock are, and the shares offered by the selling
stockholders in this offering will be, fully paid and nonassessable. The rights,
preferences and privileges of holders of Access’ common stock are subject to,
and may be adversely affected by, the rights of the holders of shares of any
series of Access’ preferred stock which Access may designate and issue in the
future.
Preferred
Stock
Access’
Board of Directors is authorized, subject to certain limitations prescribed
by
law, without further stockholder approval, to issue from time to time up to
an
aggregate of 2,000,000 shares of preferred stock in one or more series and
to
fix or alter the designations, preferences, rights and any qualifications,
limitations or restrictions of the shares of each such series thereof, including
the dividend rights, dividend rates, conversion rights, voting rights and terms
of redemption of shares constituting any series or designations of such series.
The issuance of preferred stock may have the effect of delaying, deferring
or
preventing a change of control. The fact that Access’ board of
directors has the right to issue preferred stock without stockholder approval
could be used to institute a “poison pill” that would work to dilute the stock
ownership of a potential hostile acquirer, effectively preventing acquisitions
that have not been approved by Access’ board of directors.
Access’
Board of Directors has designated 4,000 shares of preferred stock as Series
A
Preferred Stock. The shares of Series A Preferred are convertible at
the option of the holder into shares of our common stock at a conversion price
of $3.00 per share of common stock.
The
Series A Preferred Stock is entitled to a liquidation preference equal to
$10,000 per share and is entitled to a dividend of 6% per annum, payable
semi-annually in cash or if certain conditions are met, in common stock, at
the
option of the Company at time of payment. Our ability to pay
dividends in shares of common stock is limited by among other things a
requirement that (i) there is an effective registration statement on the shares
of common stock, issuable to the holders of Series A Preferred Stock, in the
20
day period immediately prior to such dividend or (ii) that such shares of common
stock referred to in (i) may be sold without restriction pursuant to Rule 144(k)
during the 20 day period immediately prior to such dividend.
77
The
Company has the right, but not the obligation, to force conversion of all,
and
not less than all, of the outstanding Series A Preferred Stock into common
stock
(i) as long as the closing price of our common stock exceeds $7.00 for at least
20 of the 30 consecutive trading days immediately prior to the conversion and
the average daily trading volume is greater than 100,000 shares per day for
at
least 20 of the 30 consecutive trading days immediately prior to such
conversion, in each case, immediately prior to the date on which we gives notice
of such conversion or (ii) if we close a sale of common stock in which the
aggregate proceeds are equal to or greater than $10,000,000. Our
ability to cause a mandatory conversion is subject to certain other conditions,
including that a registration statement covering the common stock issuable
upon
such mandatory conversion is in effect and able to be used.
The
conversion price of the Series A Preferred Stock is subject to a price
adjustment upon the issuance of additional shares of common stock for a price
below $3.00 per share and equitable adjustment for stock splits, dividends,
combinations, reorganizations and the like.
The
Series A Preferred Stock will vote together with the common stock on an
as-if-converted basis.
Holders
of Series A Preferred Stock are entitled to purchase their pro rata share of
additional stock issuances in certain future financings.
Transfer
Agent and Registrar
The
transfer agent and registrar of our common stock is American Stock Transfer
& Trust Company, New York, New York.
Delaware
Law and Certain Charter and By-Law Provisions
Certain
anti-takeover provisions.
We
are
subject to the provisions of Section 203 of the General Corporation Law of
Delaware. Section 203 prohibits certain publicly held Delaware corporations
from
engaging in a "business combination" with an "interested stockholder," for
a
period of three years after the date of the transaction in which the person
became an "interested stockholder", unless the business combination is approved
in a prescribed manner. A "business combination" includes mergers, asset sales
and other transactions resulting in a financial benefit to the interested
stockholder. Subject to certain exceptions, an "interested stockholder" is
a
person or entity who, together with affiliates and associates, owns (or within
the preceding three years, did own) 15% or more of the corporation's voting
stock. The statute contains provisions enabling a corporation to avoid the
statute's restrictions if the stockholders holding a majority of the
corporation's voting stock approve our Certificate of Incorporation provides
that our directors shall be divided into three classes, with the terms of each
class to expire on different years.
In
addition, our Certificate of Incorporation, in order to combat "greenmail,"
provides in general that any direct or indirect purchase by us of any of our
voting stock or rights to acquire voting stock known to be beneficially owned
by
any person or group which holds more than five percent of a class of our voting
stock and which has owned the securities being purchased for less than two
years
must be approved by the affirmative vote of at least two-thirds of the votes
entitled to be cast by the holders of voting stock, subject to certain
exceptions. The prohibition of "greenmail" may tend to discourage or foreclose
certain acquisitions of our securities which might temporarily increase the
price of our securities. Discouraging the acquisition of a large block of our
securities by an outside party may also have a potential negative effect on
takeovers. Parties seeking control of us through large acquisitions of its
securities will not be able to resort to "greenmail" should their bid fail,
thus
making such a bid less attractive to persons seeking to initiate a takeover
effort.
We
are a
party to a Rights Agreement pursuant to which we agree to provide holders of
our
common stock with the right to buy shares of preferred stock should a party
acquire or beneficially own more than 15% of our common stock without first
being exempted by us. Such shares of preferred stock will entitle to
the holder to certain voting, dividend and liquidation preferences and is
designed to discourage take-over attempts not previously approved by our Board
of Directors.
78
Elimination
of Monetary Liability for Officers and Directors
Our
Certificate of Incorporation incorporates certain provisions permitted under
the
General Corporation Law of Delaware relating to the liability of directors.
The
provisions eliminate a director's liability for monetary damages for a breach
of
fiduciary duty, including gross negligence, except in circumstances involving
certain wrongful acts, such as the breach of director's duty of loyalty or
acts
or omissions, which involve intentional misconduct or a knowing violation of
law. These provisions do not eliminate a director's duty of care. Moreover,
these provisions do not apply to claims against a Director for certain
violations of law, including knowing violations of federal securities law.
Our
Certificate of Incorporation also contains provisions to indemnify the
directors, officers, employees or other agents to the fullest extent permitted
by the General Corporation Law of Delaware. We believe that these provisions
will assist us in attracting and retaining qualified individual to serve as
directors.
Indemnification
of Officers and Directors
Our
Certificate of Incorporation also contains provisions to indemnify the
directors, officers, employees or other agents to the fullest extent permitted
by the General Corporation Law of Delaware. These provisions may have the
practical effect in certain cases of eliminating the ability of shareholders
to
collect monetary damages from directors. We believe that these provisions will
assist us in attracting or retaining qualified individuals to serve as our
directors.
Disclosure
of Commission Position on Indemnification For Securities Act
Liabilities
Insofar
as indemnification for liabilities arising under the Securities Act of 1933
may
be permitted to directors, officers and controlling persons of the Registrant
pursuant to the foregoing provisions, or otherwise, the Registrant has been
advised that in the opinion of the Securities and Exchange Commission such
indemnification is against public policy as expressed in the Securities Act
and
is, therefore, unenforceable.
EXPERTS
The
consolidated financial statements for the year ended December 31, 2006 included
in this prospectus, and included by reference in the Registration Statement,
were audited by Whitley Penn LLP, an independent registered public
accounting firm, as stated in their report appearing with the consolidated
financial statements herein and incorporated in this Registration Statement,
and
are included in reliance upon the report of such firms given upon their
authority as experts in accounting and auditing.
The
consolidated financial statements for the years ended April 30, 2006 and
April
30, 2007 included in this prospectus, and included by reference in the
Registration Statement, were audited by Stonefiled Josephson, Inc., an
independent registered public accounting firm, as stated in their report
appearing with the consolidated financial statements herein and incorporated
in
this Registration Statement, and are included in reliance upon the report
of
such firms given upon their authority as experts in accounting and auditing.
None
of
the independent public registered accounting firms named above have any interest
in the prospectus.
LEGAL
MATTERS
Bingham
McCutchen LLP will pass upon the validity of the shares of common stock offered
hereby. Several partners and attorneys of Bingham McCutchen LLP are
also shareholders of Access.
WHERE
YOU CAN FIND MORE INFORMATION
We
have
filed with the Securities and Exchange Commission, Washington, D.C. 20549,
under
the Securities Act of 1933, a registration statement on Form S-1 relating to
the
shares of common stock offered hereby. This Prospectus does not contain all
of
the information set forth in the registration statement and the exhibits and
schedules thereto. For further information with respect to our company and
the
shares we are offering by this Prospectus you should refer to the registration
statement, including the exhibits and schedules thereto. You may inspect a
copy
of the registration statement without charge at the Public Reference Section
of
the Securities and Exchange Commission at Room 1024, 450 Fifth Street, N.W.,
Washington, D.C. 20549. The public may obtain information on the operation
of
the Public Reference Room by calling the Securities and Exchange Commission.
The
Securities and Exchange Commission also maintains an Internet site that contains
reports, proxy and information statements and other information regarding
registrants that file electronically with the Securities and Exchange
Commission. The Securities and Exchange Commission's World Wide Web address
is
http://www.sec.gov.
79
We
file
periodic reports, proxy statements and other information with the Securities
and
Exchange Commission in accordance with requirements of the Exchange Act. These
periodic reports, proxy statements and other information are available for
inspection and copying at the regional offices, public reference facilities
and
Internet site of the Securities and Exchange Commission referred to above.
In
addition, you may request a copy of any of our periodic reports filed with
the
Securities and Exchange Commission at no cost, by writing or telephoning us
at
the following address:
Investor
Relations
Access
Pharmaceuticals, Inc.
2600
Stemmons Freeway, Suite 176
Dallas,
Texas 75207
(214)
905-5100
Information
contained on our website is not a prospectus and does not constitute a part
of
this Prospectus.
You
should rely only on the information contained in or incorporated by reference
or
provided in this Prospectus. We have not authorized anyone else to provide
you
with different information. We are not making an offer of these securities
in
any state where the offer is not permitted. You should not assume the
information in this Prospectus is accurate as of any date other than the date
on
the front of this Prospectus.
80
FINANCIAL
STATEMENTS
ACCESS
PHARMACEUTICALS, INC.
|
PAGE
|
|
|
Report
of Independent Registered Public Accounting
Firm
|
F-2
|
|
Consolidated
Balance Sheets at December 31, 2006 and 2005
|
F-3
|
|
Consolidated
Statements of Operations and Comprehensive Loss for 2006, 2005 and
2004
|
F-4
|
|
Consolidated
Statement of Stockholders' Equity (Deficit) for 2006, 2005 and
2004
|
F-5
|
|
Consolidated
Statements of Cash Flows for 2006, 2005 and
2004
|
F-6
|
|
Notes
to Consolidated Financial Statements (Three years ended December
31,
2006)
|
F-7
|
|
Condensed
Consolidated Balance Sheets at September 30, 2007
(unaudited)
|
F-24
|
|
Condensed
Consolidated Statements of Operations for September 30, 2007 and
2006
(unaudited)
|
F-25
|
|
Condensed
Consolidated Statements of Cash Flows for September 30, 2007 and
2006
(unaudited)
|
F-26
|
|
Notes
to Condensed Consolidated Financial Statements (Nine Months Ended
September 30, 2007 and 2006) (unaudited)
|
F-27
|
Note
Regarding Financial Statements
The
financial statements included in this Registration Statement do not include
the
audit opinion and consent of the auditors for the Company’s 2005 financial
statements. The Company does not plan to request that the
Registration Statement be declared effective until after it has filed its
Form
10-K for the year ended December 31, 2007, which will include the audit opinion
and consent of Whitely Penn LLP for the years ended 2006 and
2007. The Company plans to file a pre-effective amendment to this
Registrations Statement to include audited financial statements for the year
ended December 31, 2007 and other financial and business information for
the
year then ended.
F-1
Report
of Independent Registered
Public Accounting Firm
To
the
Board of Directors and Stockholders of Access Pharmaceuticals, Inc. and
Subsidiaries
We
have
audited the accompanying consolidated balance sheet of Access Pharmaceuticals,
Inc. and Subsidiaries, as of December 31, 2006, and the related consolidated
statements of operations, changes in stockholders’ deficit, and cash flows for
the year then ended. These financial statements are the responsibility of
the
Company’s management. Our responsibility is to express an opinion on these
financial statements based on our audit.
We
conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that
we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. The Company is not required
to
have, nor were we engaged to perform, an audit of its internal control over
financial reporting. An audit includes consideration of internal control
over
financial reporting as a basis for designing audit procedures that are
appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Company's internal control over financial
reporting. Accordingly, we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and disclosures
in
the financial statements, assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audit provides a
reasonable basis for our opinion.
In
our
opinion, the consolidated financial statements referred to above present
fairly,
in all material respects, the consolidated financial position of Access
Pharmaceuticals, Inc. and Subsidiaries as of December 31, 2006, and the
consolidated results of their operations and their cash flows for the year
then
ended in conformity with accounting principles generally accepted in the
United
States of America.
The
accompanying consolidated financial statements have been prepared assuming
that
the Company will continue as a going concern. As discussed in Note 2 to the
consolidated financial statements, the Company has had recurring losses from
operations and a net working capital deficiency and accumulated deficit that
raises substantial doubt about its ability to continue as a going concern.
Management’s plans in regard to these matters are also described in Note 2.
These conditions raise substantial doubt about the Company’s ability to continue
as a going concern. These consolidated financial statements do not include
any
adjustments to reflect the possible future effects on the recoverability
and
classification of assets or the amounts and classification of liabilities
that
may result from the outcome of this uncertainty.
As
discussed in Note 1 to the consolidated financial statements, the Company
adopted Statement of Financial Accounting Standards No. 123(R),
“Share-Based Payment”, effective January 1, 2006. As discussed in Note 7 to
the consolidated financial statements the Company adopted Financial Accounting
Standards Board Staff Position No. EITF 00-19-2, “Accounting for
Registration Payment Arrangements”, effective October 1, 2006.
/s/
WHITLEY PENN LLP
Dallas,
Texas
March
30,
2007
F-2
Access
Pharmaceuticals, Inc. and
Subsidiaries
CONSOLIDATED
BALANCE SHEETS
|
ASSETS
|
December
31, 2006
|
December
31, 2005
|
|||||
|
Current
assets
|
|||||||
|
Cash
and cash equivalents
|
$
|
1,194,000
|
$
|
349,000
|
|||
|
Short
term investments, at cost
|
3,195,000
|
125,000
|
|||||
|
Receivables
|
359,000
|
4,488,000
|
|||||
|
Prepaid
expenses and other current assets
|
283,000
|
197,000
|
|||||
|
Total
current assets
|
5,031,000
|
5,159,000
|
|||||
|
Property
and equipment, net
|
212,000
|
300,000
|
|||||
|
Debt
issuance costs, net
|
158,000
|
-
|
|||||
|
Patents,
net
|
878,000
|
1,046,000
|
|||||
|
Licenses,
ne
|
25,000
|
75,000
|
|||||
|
Restricted
cash and other assets
|
122,000
|
633,000
|
|||||
|
Total
assets
|
$
|
6,426,000
|
$
|
7,213,000
|
|||
|
LIABILITIES
AND STOCKHOLDERS' DEFICIT
|
|||||||
|
Current
liabilities
|
|||||||
|
Accounts
payable and accrued expenses
|
$
|
1,226,000
|
$
|
2,883,000
|
|||
|
Accrued
interest payable
|
581,000
|
652,000
|
|||||
|
Deferred
revenues
|
173,000
|
173,000
|
|||||
|
Current
portion long-term debt, net
of discount $2,062,000 in 2006
|
8,833,000
|
106,000
|
|||||
|
Total
current liabilities
|
10,813,000
|
3,814,000
|
|||||
|
Long-term
debt, net of discount $1,879,000 in 2005
|
5,500,000
|
7,636,000
|
|||||
|
Total
liabilities
|
16,313,000
|
11,450,000
|
|||||
|
Commitments
and contingencies
|
|||||||
|
Stockholders'
deficit
|
|||||||
|
Preferred
stock - $.01 par value; authorized 2,000,000 shares;
none
issued or outstanding
|
-
|
-
|
|||||
|
Common
stock - $.01 par value; authorized 100,000,000 shares;
issued,
3,535,108 at December 31, 2006 and authorized
50,000,000
shares; issued 3,528,108 at December 31, 2005
|
35,000
|
35,000
|
|||||
|
Additional
paid-in capital
|
68,799,000
|
62,942,000
|
|||||
|
Notes
receivable from stockholders
|
(1,045,000
|
)
|
(1,045,000
|
)
|
|||
|
Treasury
stock, at cost - 163 shares
|
(4,000
|
)
|
(4,000
|
)
|
|||
|
Accumulated
deficit
|
(77,672,000
|
)
|
(66,165,000
|
)
|
|||
|
Total
stockholders' deficit
|
(9,887,000
|
)
|
(4,237,000
|
)
|
|||
|
Total
liabilities and stockholders' deficit
|
$
|
6,426,000
|
$
|
7,213,000
|
|||
The
accompanying notes are an integral part of these consolidated
statements.
See
note
regarding financial statements on page F-1.
F-3
Access
Pharmaceuticals, Inc. and
Subsidiaries
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
Year
ended December 31,
|
||||||||||
|
2006
|
2005
|
2004
|
||||||||
|
Expenses
|
||||||||||
|
Research
and development
|
$
|
2,053,000
|
$
|
2,783,000
|
$
|
2,335,000
|
||||
|
General
and administrative
|
2,813,000
|
4,638,000
|
3,199,000
|
|||||||
|
Depreciation
and amortization
|
309,000
|
333,000
|
469,000
|
|||||||
|
Write
off of goodwill
|
-
|
1,868,000
|
-
|
|||||||
|
Total
expenses
|
5,175,000
|
9,622,000
|
6,003,000
|
|||||||
|
Loss
from operations
|
(5,175,000
|
)
|
(9,622,000
|
)
|
(6,003,000
|
)
|
||||
|
Interest
and miscellaneous income
|
294,000
|
100,000
|
226,000
|
|||||||
|
Interest
and other expense
|
(7,436,000
|
)
|
(2,100,000
|
)
|
(1,385,000
|
)
|
||||
|
Unrealized
loss on fair value of warrants and beneficial
conversion
feature
|
(1,107,000
|
)
|
-
|
-
|
||||||
|
(8,249,000
|
)
|
(2,000,000
|
)
|
(1,159,000
|
||||||
|
Loss
before discontinued operations and before tax benefit
|
(13,424,000
|
)
|
(11,622,000
|
)
|
(7,162,000
|
)
|
||||
|
Income
tax benefit
|
173,000 |
4,067,000
|
-
|
|||||||
|
Loss
from continuing operations
|
(13,251,000
|
)
|
(7,555,000
|
)
|
(7,162,000
|
)
|
||||
|
Discontinued
operations, net of taxes of $173,000 in 2006 and $4,067,000
in
2005
|
377,000
|
5,855,000
|
(3,076,000
|
)
|
||||||
|
Net
loss
|
$
|
(12,874,000
|
)
|
$
|
(1,700,000
|
)
|
$
|
(10,238,000
|
)
|
|
|
Basic
and diluted loss per common share
|
||||||||||
|
Loss
from continuing operations allocable to common
stockholders
|
$
|
(3.75
|
)
|
$
|
(2.34
|
)
|
$
|
(2.36
|
)
|
|
|
Discontinued
operations
|
0.11
|
1.81
|
(1.02
|
)
|
||||||
|
Net
loss allocable to common stockholders
|
$
|
(3.65
|
)
|
$
|
(0.53
|
)
|
$
|
(3.38
|
)
|
|
|
Weighted
average basic and diluted common shares
outstanding
|
3,531,934
|
3,237,488
|
3,032,451
|
|||||||
|
Net
loss
|
$
|
(12,874,000
|
)
|
$
|
(
1,700,000
|
)
|
$
|
(10,238,000
|
)
|
|
|
Other
comprehensive loss
Foreign
currency translation adjustment
|
-
|
3,000
|
(17,000
|
)
|
||||||
|
Comprehensive
loss
|
$
|
(12,874,000
|
)
|
$
|
(1,697,000
|
)
|
$
|
(10,255,000
|
)
|
The
accompanying notes are an integral part of these consolidated
statements.
See
note
regarding financial statements on page F-1.
F-4
Access
Pharmaceuticals, Inc. and
Subsidiaries
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT)
|
Common
Stock
|
|||||||||||||||||||||||
|
Shares
|
Amount
|
Additional
paid in capital
|
Notes
receivable from stockholders
|
Unamortized
value
of restricted stock grants
|
Treasury
stock
|
Accumulated
other
comprehensive
income
(loss)
|
Accumulated
deficit
|
||||||||||||||||
|
Balance,
December 31, 2003
|
2,679,000
|
$
27,000
|
$49,704,000
|
(1,045,000)
|
$(294,000)
|
$(4,000)
|
$14,000
|
$(54,227,000)
|
|||||||||||||||
|
Common
stock issued
for
cash, net of offering
costs
|
359,000
|
4,000
|
9,012,000
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
|
Common
stock issued for
cash
exercise of
warrants
and options
|
23,000
|
-
|
283,000
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
|
Common
stock issued for cashless
exercise
of warrants
|
42,000
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
|
Issuance
of restricted
stock
grants
|
2,000
|
-
|
135,000
|
-
|
(135,000)
|
-
|
-
|
-
|
|||||||||||||||
|
Other
comprehensive
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
(17,000)
|
-
|
|||||||||||||||
|
Amortization
of restricted stock grants
|
-
|
-
|
-
|
-
|
120,000
|
-
|
-
|
-
|
|||||||||||||||
|
Net
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(10,238,000)
|
|||||||||||||||
|
Balance,
December 31, 2004
|
3,105,000
|
31,000
|
59,134
000
|
(1,045,000)
|
(309,000)
|
(4,000)
|
(3,000)
|
(64,465,000)
|
|||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
|
Common
stock issued,
net
of offering costs
|
237,000
|
2,000
|
1,119,000
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
|
Common
stock issued
for
payment of interest
|
190,000
|
2,000
|
616,000
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
|
Other
comprehensive
income
|
-
|
-
|
-
|
-
|
-
|
-
|
3,000
|
-
|
|||||||||||||||
|
Discount
on convertible
note
extension
|
-
|
-
|
2,109,000
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
|
Amortization
and
forfeiture
of restricted
stock
grants
|
(4,000)
|
-
|
(36,000)
|
-
|
309,000
|
-
|
-
|
-
|
|||||||||||||||
|
Net
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(1,700,000)
|
|||||||||||||||
|
Balance,
December 31, 2005
|
3,528,000
|
35,000
|
62,942,000
|
(1,045,000)
|
-
|
(4,000)
|
-
|
(66,165,000)
|
|||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
|
Common
stock issued for
compensation
|
7,000
|
-
|
77,000
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
|
Warrants
issued
|
-
|
-
|
100,000
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
|
Stock
option
compensation
expense
|
-
|
-
|
248,000
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
|
Issuance
of convertible
debt
with warrants
|
-
|
-
|
5,432,000
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
|
Cumulative
effect of
change
in accounting
principle
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
1,367,000
|
|||||||||||||||
|
Net
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(12,874,000)
|
|||||||||||||||
|
Balance,
December 31, 2006
|
3,535,000
|
$
35,000
|
$
68,799,000
|
(1,045,000)
|
$
-
|
$
(4,000)
|
$
-
|
$(77,672,000)
|
|||||||||||||||
The accompanying notes are an integral part of these consolidated statements.
See
note
regarding financial statements on page F-1.
F-5
Access
Pharmaceuticals, Inc. and
Subsidiaries
CONSOLIDATED
STATEMENTS OF CASH FLOWS
|
Year
ended December 31,
|
||||||||||
|
2006
|
2005
|
2004
|
||||||||
|
Cash
flows from operating activities
|
||||||||||
|
Net
loss
|
$
|
(12,874,000
|
)
|
$
|
(1,700,000
|
)
|
$
|
(10,238,000
|
)
|
|
|
Adjustments
to reconcile net loss to net cash used
|
||||||||||
|
in
operating activities:
|
||||||||||
|
Unrealized
Loss
|
1,107,000
|
-
|
-
|
|||||||
|
Loss
on sale Australia assets
|
-
|
208,000
|
-
|
|||||||
|
Impairment
of investment
|
-
|
-
|
112,000
|
|||||||
|
Write
off of goodwill
|
-
|
1,868,000
|
-
|
|||||||
|
Amortization
of restricted stock grants
|
-
|
309,000
|
120,000
|
|||||||
|
Stock
option expense
|
248,000
|
-
|
-
|
|||||||
|
Stock
issued for compensation
|
77,000
|
42,000
|
-
|
|||||||
|
Stock
issued for interest
|
-
|
618,000
|
-
|
|||||||
|
Depreciation
and amortization
|
309,000
|
570,000
|
773,000
|
|||||||
|
Amortization
of debt costs and discounts
|
6,749,
000
|
695,000
|
183,000
|
|||||||
|
Gain
on sale of assets
|
(550,000)
|
(12,891,000
|
)
|
-
|
||||||
|
Change
in operating assets and liabilities:
|
||||||||||
|
Receivables
|
4,129,000
|
622,000
|
358,000
|
|||||||
|
Inventory
|
-
|
104,000
|
60,000
|
|||||||
|
Prepaid
expenses and other current assets
|
14,000
|
|
817,000
|
(195,000
|
)
|
|||||
|
Restricted
cash and other assets
|
127,000
|
-
|
-
|
|||||||
|
Accounts
payable and accrued expenses
|
(1,657,000
|
)
|
490,000
|
401,000
|
||||||
|
Accrued
interest payable
|
363,000
|
341,000
|
-
|
|||||||
|
Deferred
revenues
|
-
|
606,000
|
15,000
|
|||||||
|
Net
cash used in operating activities
|
(1,958,000
|
)
|
(7,301,000
|
)
|
(8,411,000
|
)
|
||||
|
Cash
flows from investing activities:
|
||||||||||
|
Capital
expenditures
|
(3,000
|
)
|
(28,000
|
)
|
(221,000
|
)
|
||||
|
Proceeds
from sale of equipment
|
-
|
355,000
|
-
|
|||||||
|
Proceeds
from sale of patents
|
-
|
974,000
|
-
|
|||||||
|
Proceeds
from sale of oral/topical care assets
|
550,000
|
7,391,000
|
-
|
|||||||
|
Restricted
cash and other assets
|
|
684,000
|
(666,000
|
)
|
||||||
|
Redemptions
of short-term investments
|
||||||||||
|
and
certificates of deposit, net
|
(3,070,000
|
)
|
361,000
|
1,374,000
|
||||||
|
Net
cash provided by (used in) investing activities
|
(2,523,000
|
)
|
9,717,000
|
487,000
|
||||||
|
Cash
flows from financing activities:
|
||||||||||
|
Payments
of notes payable
|
(106,000
|
)
|
(407,000
|
)
|
(310,000
|
)
|
||||
|
Payment
of secured notes payable and convertible notes
|
-
|
(6,648,000
|
)
|
-
|
||||||
|
Proceeds
from secured notes payable
|
5,432,000
|
2,633,000
|
-
|
|||||||
|
Proceeds
from stock issuances, net of costs
|
-
|
577,000
|
9,299,000
|
|||||||
|
Net
cash provided by (used in) financing activities
|
5,326,000
|
(3,845,000
|
)
|
8,989,000
|
||||||
|
Net
increase (decrease) in cash and cash equivalents
|
845,000
|
(1,429,000
|
)
|
1,065,000
|
||||||
|
Effect
of exchange rate changes on cash and cash equivalents
|
-
|
3,000
|
(17,000
|
)
|
||||||
|
Cash
and cash equivalents at beginning of year
|
349,000
|
1,775,000
|
727,000
|
|||||||
|
Cash
and cash equivalents at end of year
|
$
|
1,194,000
|
$
|
349,000
|
$
|
1,775,000
|
||||
|
Cash
paid for
interest
|
$
|
315,000
|
$
|
445,000
|
$
|
1,073,000
|
||||
|
Supplemental
disclosure of
noncash transactions
|
||||||||||
|
Value
of restricted stock
grants
|
-
|
-
|
135,000
|
|||||||
|
Assets
acquired under capital
leases
|
-
|
-
|
59,000
|
|||||||
|
Common
stock issued for SEDA
and
|
||||||||||
|
Secured
Convertible
Notes
|
-
|
502,000
|
-
|
|||||||
|
Discount
on convertible note
extension
|
-
|
2,109,000
|
-
|
|||||||
|
Debt
issuance
costs
|
568,000
|
|||||||||
|
Accrued
interest
capitalized
|
433,000
|
|||||||||
|
Warrants
issued per
professional agreement of consulting services
|
100,000
|
|||||||||
|
Cumulative
change of
accounting principle
|
1,367,000
|
|||||||||
|
Issuance
of convertible debt
with warrants
|
5,432,000
|
|||||||||
The
accompanying notes are an integral part of these consolidated
statements.
See
note
regarding financial statements on page F-1.
F-6
Access
Pharmaceuticals, Inc. and
Subsidiaries
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
Three
years ended December 31, 2006
NOTE
1 - NATURE OF OPERATIONS AND
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Nature
of
Operations
Access
Pharmaceuticals, Inc. is an emerging pharmaceutical company engaged in the
development of novel therapeutics for the treatment of cancer and supportive
care of cancer patients. This development work is based primarily on the
adaptation of existing therapeutic agents using the Company’s proprietary drug
delivery technology. Our efforts have been principally devoted to research
and
development, resulting in significant losses since inception on February
24,
1988.
A
summary
of the significant accounting policies applied in the preparation of the
accompanying consolidated financial statements follows.
Principles
of
Consolidation
The
consolidated financial statements include the financial statements of Access
Pharmaceuticals, Inc. and our wholly-owned subsidiaries. All intercompany
balances and transactions have been eliminated in consolidation.
Use
of
Estimates
In
preparing consolidated financial statements in conformity with accounting
principles generally accepted in the United States of America, management
is
required to make estimates and assumptions that affect the reported amounts
of
assets and liabilities, the disclosure of contingent assets and liabilities
at
the date of the financial statements, and the reported amounts of revenues
and
expenses during the reporting period. Actual results could differ from those
estimates.
We
tested
intangible assets for impairment based on estimates of fair value. It is
at
least reasonably possible that the estimates used by us will be materially
different from actual amounts. These differences could result in the impairment
of all or a portion of our intangible assets, which could have a materially
adverse effect on our results of operations.
Cash
and Cash Equivalents
We
consider all highly liquid instruments purchased with a maturity of three
months
or less to be cash equivalents for purposes of the statements of cash flows.
Cash and cash equivalents consist primarily of cash in banks, money market
funds
and short-term corporate securities. We invest any excess cash in government
and
corporate securities. All other investments are reported as short-term
investments.
Short-term
Investments
Short-term
investments consist of certificates of deposit. All short term investments
are
classified as held to maturity. The cost of debt securities is adjusted for
amortization of premiums and accretion of discounts to maturity. Such
amortization is included in interest income. The cost of securities sold
is
based on the specific identification method.
Property
and Equipment
Property
and equipment are recorded at cost. Depreciation is provided using the
straight-line method over estimated useful lives ranging from three to seven
years. Expenditures for major renewals and betterments that extend the useful
lives are capitalized. Expenditures for normal maintenance and repairs are
expensed as incurred. The cost of assets sold or abandoned and the related
accumulated depreciation are eliminated from the accounts and any gains or
losses are recognized in the accompanying consolidated statements of operations
of the respective period.
F-7
Access
Pharmaceuticals, Inc. and
Subsidiaries
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Three
years ended December 31, 2006
NOTE
1 - NATURE OF OPERATIONS AND
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Continued
Research
and Development
Expenses
Pursuant
to SFAS No. 2, “Accounting
for Research and
Development Costs,”
our
research and development costs are expensed as incurred. Research and
development expenses include, but are not limited to, payroll and personnel
expense, lab supplies, preclinical, development cost, clinical trial expense,
outside manufacturing and consulting. The cost of materials and equipment
or
facilities that are acquired for research and development activities and
that
have alternative future uses are capitalized when acquired.
Fair
Value of Financial
Instruments
The
carrying value of cash, cash equivalents, short-term investments and accounts
payable approximates fair value due to the short maturity of these items.
It is
not practical to estimate the fair value of the Company’s long-term debt because
quoted market prices do not exist and there were no available securities
with
similar terms to use as a basis to value our debt.
Income
Taxes
Income
taxes are accounted for under the asset and liability method. Deferred tax
assets and liabilities are recognized for the future tax consequences
attributable to differences between the financial statement carrying amounts
of
existing assets and liabilities and their respective tax bases and operating
loss and tax credit carryforwards. Deferred tax assets and liabilities are
measured using enacted tax rates expected to apply to taxable income in the
years in which those temporary differences are expected to be recovered or
settled. The effect on deferred tax assets and liabilities of a change in
tax
rates is recognized in income in the period that includes the enactment date.
A
valuation allowance is provided for deferred tax assets to the extent their
realization is in doubt.
Loss
Per
Share
We
have
presented basic loss per share, computed on the basis of the weighted average
number of common shares outstanding during the year, and diluted loss per
share,
computed on the basis of the weighted average number of common shares and
all
dilutive potential common shares outstanding during the year. Potential common
shares result from stock options, vesting of restricted stock grants,
convertible notes and warrants. However, for all years presented, all
outstanding stock options, restricted stock grants, convertible notes and
warrants are anti-dilutive due to the losses for the periods. Anti-dilutive
common stock equivalents of 12,548,342; 1,730,135; and 1,114,122 were excluded
from the loss per share computation for 2006, 2005 and 2004,
respectively.
Restricted
Cash
Restricted
cash is cash that is or may be committed for a particular purpose. We had
restricted cash in 2005 as collateral for a note payable of $103,000. The
note
was paid in full in 2006 and there is no restricted cash in 2006.
Intangible
Assets
We
expense internal patent and application costs as incurred because, even though
we believe the patents and underlying processes have continuing value, the
amount of future benefits to be derived therefrom are uncertain. Purchased
patents are capitalized and amortized over the life of the patent. We recognize
the purchase cost of licenses and amortize them over their estimated useful
lives.
The
Company operates in a single segment. In 2005, the Company wrote off its
goodwill as determined by comparing the Company’s market capitalization with its
net asset value resulting in an impairment charge of $1,868,000. In 2005,
the
Company sold one of its patents for $974,000 and the Company believes the
fair
value of the remaining patents based on discounted cash flow analysis exceeds
the carry value.
F-8
Access
Pharmaceuticals, Inc. and
Subsidiaries
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Three
years ended December 31, 2006
NOTE
1 - NATURE OF OPERATIONS AND
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Continued
Intangible
assets consist of the following (in thousands):
|
December
31, 2006
|
December
31, 2005
|
December
31, 2004
|
|||||||||||||||||
|
Gross
carrying
value
|
Accumulated
amortization
|
Gross
carrying
value
|
Accumulated
amortization
|
Gross
carrying
value
|
Accumulated
amortization
|
||||||||||||||
|
Amortizable
intangible assets
|
|||||||||||||||||||
|
Patents
|
$
|
1,680
|
$
|
802
|
$
|
1,680
|
$
|
634
|
$
|
3,179
|
$
|
864
|
|||||||
|
Licenses
|
500
|
475
|
500
|
425
|
500
|
375
|
|||||||||||||
|
Total
|
$
|
2,180
|
$
|
1,277
|
$
|
2,180
|
$
|
1,059
|
$
|
3,679
|
$
|
1,239
|
|||||||
Amortization
expense related to intangible assets totaled $218,000, $345,000 and $421,000
for
the years ended December 31, 2006, 2005 and 2004, respectively. The aggregate
estimated amortization expense for intangible assets remaining as of December
31, 2006 is as follows (in thousands):
|
2007
|
$
|
193
|
||
|
2008
|
168
|
|||
|
2009
|
168
|
|||
|
2010
|
168
|
|||
|
2011
|
168
|
|||
|
Thereafter
|
38
|
|||
|
Total
|
$
|
903
|
Stock-Based
Compensation
On
January 1, 2006, we adopted SFAS No. 123 (revised 2004), “Share-Based
Payment,”
(“SFAS
123(R)”), which requires the measurement and recognition of all share-based
payment awards made to employees and directors including stock options based
on
estimated fair values. SFAS 123(R) supersedes the Company’s previous accounting
under Accounting Principles Board (“APB”) Opinion No. 25, “Accounting
for Stock Issued to
Employees”
(“APB
25”), for periods beginning in fiscal year 2006. In March 2005, the Securities
and Exchange Commission issued Staff Accounting Bulletin No. 107 (“SAB
107”) relating to SFAS 123(R). We applied the provisions of SAB 107 in its
adoption of SFAS 123(R).
We
adopted SFAS 123(R) using the modified prospective transition method, which
requires the application of the accounting standard as of January 1, 2006,
the first day of the Company’s 2006 fiscal year. Our consolidated financial
statements for the year ended December 31, 2006, reflect the impact of SFAS
123(R). In accordance with the modified prospective transition method, our
consolidated financial statements for prior periods have not been restated
to
include the impact of SFAS 123(R). Stock-based compensation expense recognized
under SFAS 123(R) for the year ended December 31, 2006 was approximately
$248,000. Stock-based compensation expense which would have been recognized
under the fair value based method would have been approximately $750,000
during
the year ended December 31, 2005.
F-9
Access
Pharmaceuticals, Inc. and
Subsidiaries
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Three
years ended December 31, 2006
NOTE
1 - NATURE OF OPERATIONS AND
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Continued
SFAS
123(R) requires companies to estimate the fair value of share-based payment
awards on the date of grant using an option-pricing model. The value of the
portion of the award that is ultimately expected to vest is recognized as
expense over the requisite service period in the company’s Statement of
Operations. Prior to the adoption of SFAS 123(R), we accounted for stock-based
awards to employees and directors using the intrinsic value method in accordance
with APB No. 25 as allowed under SFAS No. 123, “Accounting
for Stock-Based
Compensation”
(“SFAS
123”). Under the intrinsic value method, no stock-based compensation expense
for
stock option grants was recognized because the exercise price of our stock
options granted to employees and directors equaled the fair market value
of the
underlying stock at the date of grant. In 2005, we did recognize stock
compensation expense for restricted stock awards based on the fair value
of the
underlying stock on date of grant and this expense was amortized over the
requisite service period. There were no restricted stock awards granted in
2006
and therefore no stock compensation expense is recognized in 2006.
Stock-based
compensation expense recognized in our Statement of Operations for the first
year ended December 31, 2006 includes compensation expense for share-based
payment awards granted prior to, but not yet vested as of December 31,
2005, based on the grant date fair value estimated in accordance with the
pro
forma provisions of SFAS 123 and compensation expense for the share-based
payment awards granted subsequent to December 31, 2005, based on the grant
date
fair value estimated in accordance with the provisions of SFAS 123(R).
Stock-based compensation expense recognized in the Company’s Statement of
Operations for the year ended December 31, 2006 is based on awards ultimately
expected to vest and has been reduced for estimated forfeitures, which currently
is nil. SFAS 123(R) requires forfeitures to be estimated at the time of grant
and revised, if necessary, in subsequent periods if actual forfeitures differ
from those estimates. In the Company’s pro forma information required under SFAS
123 for periods prior to fiscal year 2006, forfeitures have been accounted
for
as they occurred.
We
use
the Black-Scholes option-pricing model (“Black-Scholes”) as its method of
valuation under SFAS 123(R) in fiscal year 2006 and a single option award
approach. This fair value is then amortized on a straight-line basis over
the
requisite service periods of the awards, which is generally the vesting period.
Black-Scholes was also previously used for our pro forma information required
under SFAS 123 for periods prior to fiscal year 2006. The fair value of
share-based payment awards on the date of grant as determined by the
Black-Scholes model is affected by our stock price as well as other assumptions.
These assumptions include, but are not limited to the expected stock price
volatility over the term of the awards, and actual and projected employee
stock
option exercise behaviors.
During
2006, 753,872 stock options were granted and 50,000 stock options were granted
during 2005 under the 2005 Equity Incentive Plan. In addition, 49,700 stock
options were granted during 2005 under the 1995 Stock Award Program. Assumptions
for 2006 are:
| · |
127%
- the expected volatility assumption was based upon a combination
of
historical stock price volatility measured on a twice a month basis
and is
a reasonable indicator of expected volatility.
|
| · |
4.85%
(average) - the risk-free interest rate assumption is based upon
U.S.
Treasury bond interest rates appropriate for the term of the Company’s
employee stock options.
|
| · |
None
- the dividend yield assumption is based on our history and expectation
of
dividend payments.
|
| · |
1.6
years - the estimated expected term (average of 1.6 years) is based
on
employee exercise behavior.
|
At
December 31, 2006, the balance of unearned stock-based compensation to be
expensed in future periods related to unvested share-based awards, as adjusted
for expected forfeitures, is approximately $360,000. The period over which
the
unearned stock-based compensation is expected to be recognized is approximately
three years. We anticipate that we will grant additional share-based awards
to
employees in the future, which will increase our stock-based compensation
expense by the additional unearned compensation resulting from these grants.
The
fair value of these grants is not included in the amount above, because the
impact of these grants cannot be predicted at this time due to the dependence
on
the number of share-based payments granted. In addition, if factors change
and
different assumptions are used in the
F-10
Access
Pharmaceuticals, Inc. and
Subsidiaries
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Three
years ended December 31, 2006
NOTE
1 - NATURE OF OPERATIONS AND
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Continued
application
of SFAS 123(R) in future periods, stock-based compensation expense recorded
under SFAS 123(R) may differ significantly from what has been recorded in
the current period.
Our
Employee Stock Option
Plans
have been deemed compensatory in accordance with SFAS 123(R). Stock-based
compensation relating to this plan was computed using the Black-Scholes model
option-pricing formula with interest rates, volatility and dividend assumptions
as of the respective grant dates of the purchase rights provided to employees
under the plan. The weighted-average fair value of options existing under
all
plans during 2006 was $5.00.
The
following table summarizes stock-based compensation in accordance with SFAS
123(R) for the year ended December 31, 2006, which was allocated as follows
(in thousands):
|
|
|
Year ended
December 31,
2006
|
|
|
Research
and development
|
|
$
|
68
|
|
General
and administrative
|
|
|
180
|
|
|
|
|
|
|
Stock-based
compensation expense included in operating expenses
|
|
|
248
|
|
|
|
|
|
|
Total
stock-based compensation expense
|
|
|
248
|
|
Tax
benefit
|
|
|
—
|
|
|
|
|
|
|
Stock-based
compensation expense, net of tax
|
|
$
|
248
|
|
|
|
|
|
The
following table reflects net income and diluted earnings per share for the
year
ended December 31, 2006, compared with proforma information for the year
ended December 31, 2005, had compensation cost been determined in
accordance with the fair value-based method prescribed by SFAS 123(R).
F-11
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Three
years ended December 31, 2006
NOTE
1 - NATURE OF
OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES -
Continued
|
(in
thousands)
|
Year
ended
December
31,
|
||||||
|
2006
|
|
|
2005
|
|
|||
|
Net
loss, as reported under APB 25 for the prior period (1)
|
$
|
N/A
|
$
|
(1,700
|
)
|
||
|
Add
back stock based employee compensation expense in
reported
net loss, net of related tax effects
|
-
|
-
|
|||||
|
Subtract
total stock-based compensation expense determined
under
fair value-based method for all awards, net of related tax
effects(2)
|
(248
|
)
|
(750
|
)
|
|||
|
Net
loss including the effect of stock-based compensation expense(3)
|
$
|
(12,874
|
)
|
$
|
(2,450
|
)
|
|
|
Loss
per share:
|
|||||||
|
Basic
and diluted, as reported for the prior period(1)
|
$
|
(3.65
|
)
|
$
|
(0.53
|
)
|
|
|
Basic
and diluted, including the effect of stock-based
compensation
expense(3)
|
$
|
(3.65
|
)
|
$
|
(0.76
|
)
|
|
|
(1)
|
Net
loss and loss per share for periods prior to year 2006 does not
include
stock-based compensation expense under SFAS 123 because the Company
did
not adopt the recognition provisions of SFAS 123.
|
|
(2)
|
Stock-based
compensation expense for periods prior to year 2006 was calculated
based
on the pro forma application of SFAS 123.
|
|
(3)
|
Net
loss and loss per share for periods prior to year 2006 represent
pro forma
information based on SFAS 123.
|
Stock
compensation expense for options granted to nonemployees has been determined
in
accordance with SFAS 123 and EITF 96-18, “Accounting
for Equity Instruments
That Are Issued to Other Than Employees for Acquiring, or in Conjunction
with
Selling, Goods or Services,” as
the
fair value of the consideration received or the fair value of the equity
instruments issued, whichever is more reliably measured.
Recent
Accounting
Pronouncement
In
September 2006, the FASB issued Statement of Financial Accounting Standards
No. 157, “Fair
Value
Measurements”
(SFAS 157). SFAS 157 defines fair value, establishes a framework for
measuring fair value in accordance with generally accepted accounting
principles, and expands disclosures about fair value measurements. SFAS 157
is effective for fiscal years beginning after November 15, 2007. We are
evaluating the potential impact of the implementation of SFAS 157 on our
financial position and results of operations.
In
June
2006, the FASB issued FASB Interpretation No. 48, “Accounting
for Income Tax
Uncertainties”
(FIN 48). FIN 48 defines the threshold for recognizing the benefits of
tax return positions in the financial statements as “more-likely-than-not” to be
sustained by the taxing authority. The recently issued literature also provides
guidance on the derecognition, measurement and classification of income tax
uncertainties, along with any related interest and penalties. FIN 48 also
includes guidance concerning accounting for income tax uncertainties in interim
periods and increases the level of disclosures associated with any recorded
income tax uncertainties. FIN 48 is effective for Access as of
January 1, 2007. Any differences between the amounts recognized in the
balance sheets prior to the adoption of FIN 48 and the amounts reported
after adoption will be accounted for as a cumulative-effect adjustment recorded
to the beginning balance of retained earnings. We are evaluating the potential
impact of the implementation of FIN 48 on our financial position and
results of operations.
F-12
Access
Pharmaceuticals, Inc. and
Subsidiaries
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Three
years ended December 31, 2006
NOTE
2 -
LIQUIDITY
The
Company incurred significant losses from continuing operations of $13.4 million
for the year ended December 31, 2006 and $7.6 million for the year ended
December 31, 2005. Additionally, at December 31, 2006, we had negative working
capital of $5.8 million. As of December 31, 2006, we did
not have
sufficient funds to repay our convertible notes at their maturity and support
our working capital and operating requirements.
We
do not
have funds to pay our debt obligations which are due in March, April and
September 2007 and will have to raise more funds or attempt to restructure
the
convertible notes.
SCO
Capital Partners LLC
Note and Warrant Purchase Agreement
On
December 6, 2006, we entered into a note and warrant purchase agreement pursuant
to which we sold and issued an aggregate of $500,000 of 7.5% convertible
notes
due March 31, 2007 and warrants to purchase 386,364 shares of common stock
of
Access. Net proceeds to Access were $450,000. The notes and warrants were
sold
in a private placement to a group of accredited investors led by SCO Capital
Partners LLC (“SCO”) and affiliates.
On
October 24, 2006, we entered into a note and warrant purchase agreement pursuant
to which we sold and issued an aggregate of $500,000 of 7.5% convertible
notes
due March 31, 2007 and warrants to purchase 386,364 shares of common stock
of
Access. Net proceeds to Access were $450,000. The notes and warrants were
sold
in a private placement to a group of accredited investors led by SCO and
affiliates.
On
February 16, 2006, we entered into a note and warrant purchase agreement
pursuant to which we sold and issued an aggregate of $5,000,000 of 7.5%
convertible notes due March 31, 2007 and warrants to purchase an aggregate
of
3,863,634 shares of common stock of Access. Net proceeds to Access were $4.5
million. The notes and warrants were sold in a private placement to a group
of
accredited investors led by SCO and affiliates.
All
of
the notes mature on March 31, 2007, are convertible into Access common stock
at
a fixed conversion rate of $1.10 per share, bear interest of 7.5% per annum
and
are secured by certain assets of Access. Each note may be converted at the
option of the noteholder or Access under certain circumstances as set forth
in
the notes.
Each
noteholder received a warrant to purchase a number of shares of common stock
of
Access equal to 75% of the total number shares of Access common stock into
which
such holder's note is convertible. Each warrant has an exercise price of
$1.32
per share and is exercisable at any time prior to February 16, 2012, October
24,
2012 and December 6, 2012. In the event SCO and its affiliates were to convert
all of their notes and exercise all of their warrants, they would own
approximately 74.1% of the voting securities of Access.
In
connection with its sale and issuance of notes and warrants, Access entered
into
an investors rights agreement whereby it granted SCO the right to designate
two
individuals to serve on the Board of Directors of Access while the notes
are
outstanding, and also granted registration rights with respect to the shares
of
common stock of Access underlying the notes and warrants.
The
Company believes that based on the funds available the Company will have
the
ability to pay its projected net cash burn rate of $750,000 per month for
seven
months. We will have to raise more funds to cover future months net cash
burn
rate and to pay our debt service or attempt to restructure the convertible
notes.
F-13
Access
Pharmaceuticals, Inc. and
Subsidiaries
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Three
years ended December 31, 2006
NOTE
3 - RELATED PARTY
TRANSACTIONS
Stephen
B. Howell, M.D., a Director, receives payments for consulting services and
reimbursement of direct expenses and has also received warrants for his
consulting services. Dr. Howell’s payments for consulting services, expense
reimbursements and warrants are as follows:
|
Year
|
Consulting
Fees
|
Expense
Reimbursement
|
|||||
|
2006
|
$
|
69,000
|
$
|
5,000
|
|||
|
2005
|
79,000
|
5,000
|
|||||
|
2004
|
58,000
|
9,000
|
In
the
event SCO Capital Partners LLC (“SCO”) and its affiliates were to convert all of
their notes and exercise all of their warrants, they would own approximately
74.1% of the voting securities of Access. During 2006 SCO and affiliates
were
paid $415,000 in fees for the convertible notes that Access issued and were
paid
$131,000 in investor relations fees.
See
Note
9 for a discussion of our Restricted Stock Purchase Program.
NOTE
4 - PROPERTY AND
EQUIPMENT
|
Property
and equipment consists of the following:
|
December
31,
|
||||||
|
2006
|
|
|
2005
|
||||
|
Laboratory
equipment
|
$
|
1,090,000
|
$
|
1,090,000
|
|||
|
Laboratory
and building improvements
|
167,000
|
167,000
|
|||||
|
Furniture
and equipment
|
134,000
|
138,000
|
|||||
|
|
1,391,000
|
1,395,000
|
|||||
|
Less
accumulated depreciation and amortization
|
1,179,000
|
1,095,000
|
|||||
|
Net
property and equipment
|
$
|
212,000
|
$
|
300,000
|
|||
Depreciation
and amortization on property and equipment was $91,000, $225,000, and $244,000
for the years ended December 31, 2006, 2005 and 2004, respectively.
NOTE
5 - 401(k)
PLAN
We
have a
tax-qualified employee savings and retirement plan (the “401(k) Plan”) covering
all our employees. Pursuant to the 401(k) Plan, employees may elect to reduce
their current compensation by up to the statutorily prescribed annual limit
($15,000 in 2006; $14,000 in 2005; and $13,000 in 2004) and to have the amount
of such reduction contributed to the 401(k) Plan. We have a 401(k) matching
program whereby we contribute for each dollar a participant contributes a
like
amount, with a maximum contribution of 2% of a participant’s earnings. The
401(k) Plan is intended to qualify under Section 401 of the Internal Revenue
Code so that contributions by employees or by us to the 401(k) Plan, and
income
earned on 401(k) Plan contributions, are not taxable to employees until
withdrawn from the 401(k) Plan, and so that contributions by us, if any,
will be
deductible by us when made. At the direction of each participant, we invest
the
assets of the 401(k) Plan in any of 23 investment options. Company contributions
under the 401(k) Plan were approximately $11,000 in 2006; $31,000 in 2005;
and
$46,000 in 2004.
F-14
Access
Pharmaceuticals, Inc. and
Subsidiaries
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Three
years ended December 31, 2006
NOTE
6 - DISCONTINUED
OPERATIONS
In
October 2005 we sold our oral/topical care business to Uluru, Inc. for up
to
$18.6 million. At the closing of this agreement we received $8.7 million.
In
addition, due to the Amended Asset Sale Agreement in December 2006, we received
$4.9 million and an obligation to receive from Uluru $350,000 on April 8,
2007
for the first and second anniversary payments and settlement of certain
milestones. We recorded $550,000 as revenue for the discontinued operations
in
2006. Any contingent liabilities arise in the future relating to our former
business could reduce future receipts. Additional payments of up to $4.8
million, as amended by the Amended Asset Sale Agreement may be made upon
the
achievement of certain additional sales milestones.
In
September 2005 we closed our Australian laboratory and office, keeping the
vitamin B12 technology.
In
accordance with Statement of Financial Accounting Standards (“SFAS”) No. 144,
“Accounting for the Impairment or Disposal of Long-Lived Assets” operating
results for assets sold or held for sale are presented as discontinued
operations for current and all prior years presented. In accordance with
SFAS
No. 144 the operating results of these assets, along with the gain on sale,
have
been presented in discontinued operations for all periods
presented.
|
2006
|
2005
|
2004
|
||||||||
| Revenues |
$
|
550,000
|
$
|
781,000
|
$
|
549,000
|
||||
|
|
||||||||||
| Expenses | ||||||||||
|
Cost
of
product sales
|
|
(1,012,000
|
)
|
(239,000
|
)
|
|||||
|
Research
and
development
|
(2,501,000
|
)
|
(3,082,000
|
)
|
||||||
|
Depreciation
|
(237,000
|
)
|
(304,000
|
)
|
||||||
|
Total
expenses
|
-
|
(3,750,000
|
)
|
(3,625,000
|
)
|
|||||
|
|
||||||||||
| Income/loss from discontinued operations |
550,000
|
(2,969,000
|
)
|
(3,076,000
|
)
|
|||||
|
|
||||||||||
| Gain on sale of assets |
-
|
12,891,000
|
-
|
|||||||
|
Tax expense
|
(173,000
|
)
|
(4,067,000
|
)
|
-
|
|||||
|
Discontinued operations
|
$
|
377,000
|
$
|
5,855,000
|
$
|
(3,076,000
|
)
|
|||
We
previously had licenses for the oral/topical assets. These licenses were
sold to
Uluru, Inc. in October 2005. In the Asset Sale Agreement between us and Uluru
certain refunds and receipts were incurred before the date of sale and were
assigned to either us or to Uluru. We have $173,000 recorded as a deferred
gain
on the sale until such time as approvals are received.
F-15
Access
Pharmaceuticals, Inc. and
Subsidiaries
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Three
years ended December 31, 2006
NOTE
7 - DEBT
On
September 20, 2000, we completed a $13.5 million convertible note offering.
The
offering was placed with three investors. One investor was repaid in 2005,
$4,015,000. Our other convertible notes are due in two parts. The notes bear
interest at 7.7% per annum with $733,000 of interest due annually on September
13th.
$4,015,000
due on April 28,
2007.
This
investor’s notes have a fixed conversion price of $5.00 per share of common
stock and may be converted by the note holder or us under certain circumstances
as defined in the note. Upon a change of control, this investor is not required
to automatically convert the note unless the amount payable to the investor
upon
change of control, issuable upon conversion of the note equals or exceeds
$7.50.
If the notes are not converted we will have to repay the notes on the due
dates.
The investor’s notes were amended November 3, 2005 extending the term and
adjusting the conversion price from $27.50 to $5.00 per common share. The
amendment and modification resulted in us recording additional debt discount
of
$2.1 million, which will be accreted to interest expense to the revised maturity
date. The interest due at December 31, 2006 was $92,000.
$5,500,000
due on September
13, 2010.
This
investor delayed his interest payment which was due in 2005 and 2006 until
September 13, 2007 or earlier if the Company raises more than $5.0 million
in
funds. The capitalized interest was $880,000 and interest on the capitalized
interest was $26,000 at December 31, 2006. The interest due on the convertible
note was $126,000 at December 31, 2006. This note has a fixed conversion
price
of $27.50 per share of common stock and may be converted by the note holder
or
us under certain circumstances as defined in the note. If the notes are not
converted we will have to repay the notes on the due dates.
$6,000,000
due on March 31,
2007.
The
notes were sold in February 2006 in a private placement to a group of accredited
investors led by SCO Capital Partners LLC and affiliates. We entered into
a note
and purchase agreement to which we sold and issued an aggregate of $5 million
of
7.5% convertible notes due March 31, 2007 and warrants to purchase 3,863,634
shares of common stock of Access. Net proceeds to Access were $4.5
million.
On
October 24, 2006, we entered into a note and warrant purchase agreement pursuant
to which we sold and issued an aggregate of $500,000 of 7.5% convertible
notes
due March 31, 2007 and warrants to purchase 386,364 shares of common stock
of
Access. Net proceeds to Access were $450,000. On December 6, 2006, we entered
into a note and warrant purchase agreement pursuant to which we sold and
issued
an aggregate of $500,000 of 7.5% convertible notes due March 31, 2007 and
warrants to purchase 386,364 shares of common stock of Access. Net proceeds
to
Access were $450,000. Interest due at December 31, 2006 on all notes with
SCO
and affiliates was $336,000.
All
these
notes with SCO and affiliates have a fixed conversion price of $1.10 per
share
of common stock and may be converted by the note holder or us under certain
circumstances as defined in the note. If the notes are not converted we will
have to repay the notes on the due dates.
The
Secured Convertible Notes include warrants and a conversion feature. Until
September 30, 2006 we accounted for the warrants and conversion feature as
liabilities and recorded at fair value. From the date of issuance to September
30, 2006, the fair value of these instruments increased resulting in a net
unrealized loss of $1.1 million. On October 1, 2006, we adopted the
provisions of EITF 00-19-2, “Accounting
for Registration Payment
Arrangements” (EITF
00-19-2), which requires that contingent obligations to make future payments
under a registration payment arrangement be recognized and measured separately
in accordance with SFAS No. 5, “Accounting
for
Contingencies.”
Under
previous guidance, the fair value of the warrant was recorded as a current
liability in our balance sheet, due to a potential cash payment feature in
the
warrant. Access may be required to pay in cash, up to 2% per month, as defined,
as liquidated damages for failure to file a registration statement timely
as
required by an investor rights agreement. The current liability was
marked-to-market at each quarter end, using the Black-Scholes option-pricing
model, with the change being recorded to general and administrative expenses.
Under the new guidance in EITF 00-19-2, as we believe the likelihood of such
a
cash payment to
F-16
Access
Pharmaceuticals, Inc. and
Subsidiaries
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Three
years ended December 31, 2006
NOTE
7 - DEBT -
continued
not
be
probable, have not recognized a liability for such obligations. Accordingly,
a
cumulative-effect adjustment of $1.4 million was made as of October 1, 2006
to accumulated deficit, representing the difference between the initial value
of
this warrant and its fair value as of this date and recorded to equity.
Subsequent
to the adoption of EITF 00-19-2 on October 1, 2006, the Company has accounted
for the $6,000,000 notes under EITF Issue No. 00-27, Application
of Issue No. 98-5 to
Certain Instruments.
The
value of the warrants was valued using a Black-Scholes option-pricing model
with
the following assumptions with a weighted average volatility of
120%,
expected
life of 6 years, expected yield of 0% and risk free rate of 5.0%. At December
31, 2006, approximately $1.6M of
debt
discount related to the warrants and embedded conversion feature had not
been
amortized to interest expense. This will be amortized over the remaining
life of
the debt through March 31, 2007.
On
September 20, 2001, we completed a $600,000 installment loan with a bank.
The
note was paid in full in 2006.
NOTE
8 - COMMITMENTS AND
CONTINGENCIES
Future
maturities of the note payable and other obligations are as
follows:
|
Future
Maturities
|
Debt
|
|
|
2007
|
10,895,000
|
|
|
2010
|
5,500,000
|
The
debt
of $4,015,000 is discounted and at December 31, 2006 is on the balance sheet
as
$3,559,000.
The
debt
of $6,000,000 is discounted and at December 31, 2006 is on the balance sheet
as
$4,394,000.
Operating
Leases
At
December 31, 2006, we have commitments under noncancelable operating leases
for
office and research and development facilities until December 31, 2007 totaling
$75,000. Rent expense for the years ended December 31, 2006, 2005 and 2004
was
$94,000, $168,000 and $166,000, respectively. We also have two other
noncancelable operating leases - one lease for a fire alarm system totaling
$12,000 ending in 2008 (expensing $7,000 in 2007 and $5,000 in 2008) and
one lease for a copier totaling $48,000 ending in 2011 (with $9,600
expensed each year).
Legal
The
Company is not currently subject to any material pending legal
proceedings.
NOTE
9 - STOCKHOLDERS'
EQUITY
Restricted
Stock Purchase
Program
On
October 12, 2000, the Board of Directors authorized a Restricted Stock Purchase
Program. Under the Program, the Company’s executive officers and corporate
secretary were given the opportunity to purchase shares of common stock in
an
individually designated amount per participant determined by the Compensation
Committee of the Board of Directors. A total of 38,000 shares were purchased
under the Program by four
eligible participants at $27.50 per share, the fair market value of the common
stock on October 12, 2000, for an aggregate consideration of $1,045,000.
The
purchase price was paid through the participants’ delivery of a 50%-recourse
promissory note payable to the Company for three
F-17
Access
Pharmaceuticals, Inc. and
Subsidiaries
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Three
years ended December 31, 2006
NOTE
9 - STOCKHOLDERS' EQUITY -
Continued
executive
officer participants and a full-recourse promissory note payable to the Company
for one participant. Each note bears interest at 5.87% compounded semi-annually
and has a maximum term of ten years. The notes are secured by a pledge of
the
purchased shares to the Company. The Company recorded the notes receivable
from
participants in this Program of $1,045,000 as a reduction of equity in the
Consolidated Balance Sheet. Interest on the notes is neither being collected
nor
accrued. The stock granted under the Program is fully vested at December
31,
2006.
Warrants
There
were warrants to purchase a total of 4,826,517 shares of common stock
outstanding at December 31, 2006. All warrants were exercisable at December
31,
2006. The warrants had various prices and terms as follows:
| Summary of Warrants |
|
Outstanding
|
Exercise
Price
|
Expiration
Date
|
||||||||
|
2006
convertible note (a)
|
3,863,634
|
$
|
1.32
|
2/16/12
|
||||||||
|
2006
convertible note (a)
|
386,364
|
1.32
|
10/24/12
|
|||||||||
|
2006
convertible note (a)
|
386,364
|
1.32
|
12/06/12
|
|||||||||
|
2006
investor relations advisor (b)
|
50,000
|
2.70
|
12/27/11
|
|||||||||
|
2004
offering (c)
|
89,461
|
35.50
|
2/24/09
|
|||||||||
|
2004
offering (c)
|
31,295
|
27.00
|
2/24/09
|
|||||||||
|
2003
financial advisor (d)
|
14,399
|
19.50
|
10/30/08
|
|||||||||
|
2002
scientific consultant (e)
|
2,000
|
24.80
|
2/01/09
|
|||||||||
|
2001
scientific consultant (f)
|
3,000
|
15.00
|
1/1/08
|
|||||||||
|
Total
|
4,826,517
|
|||||||||||
| a) |
In
connection with the convertible note offerings in 2006, warrants
to
purchase a total of 4,636,362 shares of common stock were issued.
All of
the warrants are exercisable immediately and expire six years from
date of
issue.
|
| b) |
During
2006, an investor relations advisor received warrants to purchase
50,000
shares of common stock at an exercise price of $2.70 per share
at any time
from December 27, 2006 until December 27, 2011, for investor relations
consulting services to be rendered in 2007. All of the warrants
were
exercisable at December 31, 2006. The fair value of the warrants
was $2.00
per share on the date of the grant using the Black-Scholes pricing
model
with the following assumptions: expected dividend yield 0.0%, risk-free
interest rate 4.58%, expected volatility 138% and a term of 2.5
years.
|
| c) |
In
connection with offering of common stock in 2004, warrants to purchase
a
total of 120,756 shares of common stock were issued. All of the
warrants
are exercisable and expire five years from date of
issuance.
|
| d) |
During
2003, financial advisors received warrants to purchase 14,399 shares
of
common stock at any time until October 30, 2008, for financial
consulting
services rendered in 2003 and 2004. All the warrants are exercisable.
The
fair value of the warrants was $14.10 per share on the date of
the grant
using the Black-Scholes pricing model with the following assumptions:
expected dividend yield 0.0%, risk-free interest rate 2.9%, expected
volatility 92% and a term of 5 years.
|
F-18
Access
Pharmaceuticals, Inc. and
Subsidiaries
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Three
years ended December 31, 2006
NOTE
9 - STOCKHOLDERS' EQUITY -
Continued
| e) |
During
2002, a director who is also a scientific advisor received warrants
to
purchase 2,000 shares of common stock at an exercise price of $24.55
per
share at any time until February 1, 2009, for scientific consulting
services rendered in 2002. The fair value of the warrants was $18.50
per
share on the date of the grant using the Black-Scholes pricing
model with
the following assumptions: expected dividend yield 0.0%, risk-free
interest rate 3.90%, expected volatility 81% and a term of 7 years.
|
| f) |
During
2001, a director who is also a scientific advisor received warrants
to
purchase 3,000 shares of common stock at an exercise price of $15.00
per
share at any time until January 1, 2008, for scientific consulting
services rendered in 2001. The fair value of the warrants was $13.70
per
share on the date of the grant using the Black-Scholes pricing
model with
the following assumptions: expected dividend yield 0.0%, risk-free
interest rate 5.03%, expected volatility 118% and a term of 7 years.
|
2001
Restricted Stock
Plan
We
have a
restricted stock plan, the 2001 Restricted Stock Plan, as amended, under
which
80,000 shares of our authorized but unissued common stock were reserved for
issuance to certain employees, directors, consultants and advisors. The
restricted stock granted under the plan generally vests, 25% two years after
the
grant date with additional 25% vesting every anniversary date. All stock
is
vested after five years. At December 31, 2006 there were 27,182 shares issued
and 52,818 shares available for grant under the 2001 Restricted Stock
Plan.
NOTE
10 - STOCK OPTION
PLANS
We
have
various stock-based employee compensation plans described below:
2005
Equity Incentive
Plan
We
have a
stock awards plan, (the “2005 Equity Incentive Plan”), under which 1,000,000
shares of our authorized but unissued common stock were reserved for issuance
to
employees of, or consultants to, one or more of the Company and its affiliates,
or to non-employee members of the Board or of any board of directors (or
similar
governing authority) of any affiliate of the Company. The 2005 Equity Incentive
Plan replaced the previously approved stock option plan (the 1995 Stock Awards
Plan").
For
the
2005 Equity Incentive Plan, the fair value of options was estimated at the
date
of grant using the Black-Scholes option pricing model with the following
weighted average assumptions used for grants in fiscal 2006: dividend yield
of
0%; volatility of 127%; risk-free interest rate of 4.85%; and expected lives
of
1.6 years. The weighted average fair value of options granted was $0.36 per
share during 2006. The assumptions for grants in fiscal 2005 were: dividend
yield of 0%; volatility of 113%; risk-free interest rate of 4.71%; and expected
lives of four years. The weighted average fair value of options granted was
$8.50 per share during 2005.
F-19
Access
Pharmaceuticals, Inc. and
Subsidiaries
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Three
years ended December 31, 2006
NOTE
10 - STOCK OPTION PLANS -
Continued
Summarized
information for the 2005 Equity Incentive Plan is as follows:
|
Weighted-
|
|||
|
average
|
|||
|
exercise
|
|||
|
Options
|
price
|
||
|
Outstanding
options at January 1, 2005
|
-
|
$
-
|
|
|
Granted,
fair value of $8.50 per share
|
50,000
|
5.45
|
|
|
Outstanding
options at December 31, 2005
|
50,000
|
5.45
|
|
|
Granted,
fair value of $ 0.36 per share
|
753,872
|
1.32
|
|
|
Forfeited
|
(1,200)
|
3.15
|
|
|
Outstanding
options at December 31, 2006
|
802,672
|
1.04
|
|
|
Exercisable
at December 31, 2005
|
14,000
|
5.45
|
|
|
Exercisable
at December 31, 2006
|
204,718
|
2.00
|
The
intrinsic value of options under this plan related to the outstanding and
exercisable options were $1,554,000 and $281,000, respectively, at December
31,
2006.
Further
information regarding options outstanding under the 2005 Equity Incentive
Plan
at December 31, 2006 is summarized below:
|
Number
of
|
Weighted
average
|
Number
of
|
Weighted
aververage
|
|||
|
|
options
|
Remaining
|
Exercise
|
options
|
Remaining
|
Exercise
|
|
Range
of excercise prices
|
outstanding
|
life
in years
|
price
|
exerciseable
|
life
in years
|
price
|
|
$0.63
- 0.85
|
717,000
|
9.6
|
$0.63
|
129,250
|
9.6
|
$0.63
|
|
$3.15
- 5.45
|
85,672
|
8.9
|
4.49
|
75,468
|
8.9
|
4.36
|
|
802,672
|
204,718
|
|||||
2000
Special Stock Option
Plan
On
February 11, 2000 we adopted the 2000 Special Stock Option Plan and Agreement
(the “Plan”). The Plan provides for the award of options to purchase 100,000
shares of the authorized but unissued shares of common stock of the Company.
At
December 31, 2006, there were no additional shares available for grant under
the
Plan.
Under
the
2000 Special Stock Option Plan, 100,000 options were issued in 2000 and are
outstanding at December 31, 2006. All of the options in the 2000 Special
Stock
Option Plan were exercisable at December 31, 2006, 2005 and 2004. All of
the
options expire on June 30, 2007 and have an exercise price of $12.50 per
share.
1995
Stock Awards
Plan
Under
the
1995 Stock Awards Plan, as amended, 500,000 shares of our authorized but
unissued common stock were reserved for issuance to optionees including
officers, employees, and other individuals performing services for us. At
December 31, 2006, there were no additional shares available for grant under
the
1995 Stock Awards Plan. A total of 360,917 options were outstanding under
this
plan at December 31, 2006.
Options
granted under all the plans generally vest ratably over a four to five year
period and are generally exercisable over a ten-year period from the date
of
grant. Stock options were generally granted with an exercise price equal
to the
market value at the date of grant.
F-20
Access
Pharmaceuticals, Inc. and
Subsidiaries
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Three
years ended December 31, 2006
NOTE
10 - STOCK OPTION PLANS -
Continued
Under
the
1995 Stock Awards Plan, the fair value of options was estimated at the date
of
grant using the Black-Scholes option pricing model with the following weighted
average assumptions used for grants in fiscal 2005 and 2004, respectively:
dividend yield of 0% for both periods; volatility of 104% and 41%; risk-free
interest rates of 4.15% and 3.61%, respectively, and expected lives of four
years for all periods. The weighted average fair values of options granted
were
$6.45 and $10.90 per share during 2005 and 2004, respectively.
|
Weighted-
|
||
|
average
|
||
|
exercise
|
||
|
Options
|
price
|
|
|
Outstanding
options at January 1, 2004
|
410,725
|
$
17.25
|
|
Granted,
fair value of $10.90 per share
|
62,840
|
28.75
|
|
Exercised
|
(21,939)
|
11.90
|
|
Forfeited
|
(15,196)
|
21.05
|
|
Outstanding
options at December 31, 2004
|
436,430
|
18.80
|
|
Granted,
fair value of $6.45 per share
|
49,700
|
12.05
|
|
Forfeited
|
(55,859)
|
17.30
|
|
Outstanding
options at December 31, 2005
|
430,271
|
18.20
|
|
Forfeited
|
(69,354)
|
19.12
|
|
Outstanding
options at December 31, 2006
|
360,917
|
18.03
|
|
Exercisable
at December 31, 2004
|
334,232
|
18.20
|
|
Exercisable
at December 31, 2005
|
406,760
|
18.40
|
|
Exercisable
at December 31, 2006
|
349,990
|
18.12
|
There was no intrinsic value related to outstanding or exercisable options under this plan at December 31, 2006.
Further
information regarding options outstanding under the 1995 Stock Awards Plan
at
December 31, 2006 is summarized below:
|
Range
of
|
Number
of
|
Weighted
average
|
Number
of
|
Weighted
average
|
||
|
exercise
|
shares
|
Remaining
|
Exercise
|
shares
|
Remaining
|
Exercise
|
|
prices
|
outstanding
|
life
in years
|
price
|
exercisable
|
life
in years
|
Price
|
|
$10.00
- 12.50
|
147,640
|
3.6
|
$11.15
|
139,032
|
3.3
|
$11.12
|
|
$14.05
- 18.65
|
112,717
|
1.9
|
16.61
|
112,717
|
1.9
|
16.61
|
|
$20.25
- 34.38
|
100,560
|
2.1
|
29.73
|
98,241
|
2.0
|
29.74
|
|
|
|
|
|
|
|
|
|
|
360,917
|
|
|
349,990
|
|
|
F-21
Access
Pharmaceuticals, Inc. and
Subsidiaries
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Three
years ended December 31, 2006
NOTE
11 - INCOME
TAXES
Income
tax expense differs from the statutory amounts as follows:
|
2006
|
2005
|
2004
|
||||||||
|
Income
taxes at U.S. statutory rate
|
$
|
(4,378,000
|
)
|
$
|
(438,000
|
)
|
$
|
(3,442,000
|
)
|
|
|
Change
in valuation allowance
|
3,972,000
|
(2,051,000
|
)
|
895,000
|
||||||
|
Change
in miscellaneous items
|
(130,000) |
397,000
|
598,000
|
|||||||
|
Benefit
of foreign losses not recognized
|
58,000 |
304,000
|
-
|
|||||||
|
Expenses
not deductible
|
240,000 |
738,000
|
7,000
|
|||||||
|
Expiration
of net operating loss and general
|
||||||||||
|
business
credit carryforwards, net of revisions
|
238,000
|
1,050,000
|
1,942,000
|
|||||||
|
Total
tax expense
|
$
|
-
|
$
|
-
|
$
|
-
|
||||
Deferred
taxes are provided for the temporary differences between the financial reporting
bases and the tax bases of our assets and liabilities. The temporary differences
that give rise to deferred tax assets were as follows:
|
December
31,
|
||||||||||
|
2006
|
2005
|
2004
|
||||||||
|
Deferred
tax assets (liabilities)
|
||||||||||
|
Net
operating loss carryforwards
|
$
22,634,000
|
$
20,261,000
|
$
20,808,000
|
|||||||
|
General
business credit carryforwards
|
2,402,000
|
2,261,000
|
2,094,000
|
|||||||
|
Deferred
gain on sale of oral/topical care assets
|
-
|
(1,490,000
|
)
|
-
|
||||||
|
Property,
equipment and goodwill
|
46,000
|
78,000
|
259,000
|
|||||||
|
Gross
deferred tax assets
|
25,082,000
|
21,110,000
|
23,161,000
|
|||||||
|
Valuation
allowance
|
(25,082,000
|
)
|
(21,110,000
|
)
|
(23,161,000
|
)
|
||||
|
Net
deferred taxes
|
$
|
-
|
$
|
-
|
$
|
-
|
||||
At
December 31, 2006, we had approximately $66,569,000 of net operating loss
carryforwards and approximately $2,402,000 of general business credit
carryforwards. These carryforwards expire as follows:
|
|
Net
operating
loss
carryforwards
|
General
business
credit
carryforwards
|
|||||
|
2007
|
$
|
994,000
|
$
|
26,000
|
|||
|
2008
|
4,004,000
|
138,000
|
|||||
|
2009
|
1,661,000
|
185,000
|
|||||
|
2010
|
2,171,000
|
140,000
|
|||||
|
2011
|
4,488,000
|
13,000
|
|||||
|
Thereafter
|
53,251,000
|
1,900,000
|
|||||
|
$
|
66,569,000
|
$
|
2,402,000
|
||||
As
a
result of a merger on January 25, 1996, a change in control occurred for
federal
income tax purposes which limits the utilization of pre-merger net operating
loss carryforwards of approximately $3,100,000 to approximately $530,000
per
year.
F-22
Access
Pharmaceuticals, Inc. and
Subsidiaries
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Three
years ended December 31, 2006
NOTE
12 - QUARTERLY FINANCIAL DATA
(UNAUDITED)
Our
results of operations by quarter for the years ended December 31, 2006 and
2005
were as follows (in thousands, except per share amounts):
|
2006
Quarter Ended
|
|||||||||||||
|
March
31
|
June
30
|
September
30
|
December
31
|
||||||||||
|
Loss
from operations
|
$
|
(4,856
|
)
|
$
|
(3,331
|
)
|
$
|
(2,015
|
)
|
$
|
(3,222
|
)
|
|
|
Discontinued
operations
|
-
|
-
|
-
|
550
|
|||||||||
|
Net
loss
|
$
|
(4,856
|
)
|
$
|
(3,331
|
)
|
$
|
(2,015
|
)
|
$
|
(2,672
|
)
|
|
|
Basic
and diluted income/loss per common share
|
$
|
(1.38
|
)
|
$
|
(0.94
|
)
|
$
|
(0.57
|
)
|
$
|
(0.76
|
)
|
|
|
|
2005
Quarter Ended
|
||||||||||||
|
|
March
31
|
|
|
June
30
|
|
|
September30
|
|
|
December31
|
|||
|
Loss
from operations
|
$
|
(1,616
|
)
|
$
|
(2,988
|
)
|
$
|
(1,612
|
)
|
$
|
(1,339
|
)
|
|
|
Discontinued
operations
|
(806
|
)
|
(798
|
)
|
(451
|
)
|
7,910
|
||||||
|
Net
loss/income
|
$
|
(2,422
|
)
|
$
|
(3,786
|
)
|
$
|
(2,063
|
)
|
$
|
6,571
|
||
|
Basic
and diluted loss per
common
share
|
$
|
(0.78
|
)
|
$
|
(1.21
|
)
|
$
|
(0.65
|
)
|
$
|
2.11
|
||
NOTE
13 - SUBSEQUENT EVENTS
(UNAUDITED)
On
March 30, 2007, Access Pharmaceuticals, Inc. ("Access")
and SCO Capital Partners LLC and affiliates ("SCO") agreed to extend the
maturity date of an aggregate of $6,000,000 of 7.5% convertible notes to
April
27, 2007 from March 31, 2007.
On
February 21, 2007 we announced we had entered into a non-binding letter of
intent to acquire Somanta Pharmaceuticals, Inc. Pursuant to the terms of
the
non-binding letter of intent, upon consummation of the acquisition, Somanta’s
preferred and common shareholders would receive an aggregate of 1.5 million
shares of Access’ common shares which would represent approximately 13% of the
combined company assuming the conversion of Access’ existing convertible debt
under existing terms of conversion. The closing of the transaction is subject
to
numerous conditions including the execution of a definitive Merger Agreement,
receipt of necessary approvals as well as completion of our due diligence
investigation. There can be no assurance that the transaction will be
consummated or if consummated, that it will be on the terms described
herein.
F-23
Access
Pharmaceuticals, Inc. and Subsidiaries
Condensed
Consolidated Balance Sheets
|
|
September
30, 2007
|
December
31, 2006
|
|||||
|
ASSETS
|
(unaudited)
|
(audited)
|
|||||
|
Current
assets
Cash
and cash equivalents
Short
term investments, at cost
Receivables
Prepaid
expenses and other current assets
|
$
|
661,000
515,000
861,000
530,000
|
$
|
1,194,000
3,195,000
359,000
283,000
|
|||
|
Total
current assets
|
2,567,000
|
5,031,000
|
|||||
|
Property
and equipment, net
|
156,000
|
212,000
|
|||||
|
Debt
issuance costs, net
|
-
|
158,000
|
|||||
|
Patents,
net
|
752,000
|
878,000
|
|||||
|
Licenses,
net
|
-
|
25,000
|
|||||
|
Other
assets
|
25,000
|
122,000
|
|||||
|
Total
assets
|
$
|
3,500,000
|
$
|
6,426,000
|
|||
|
LIABILITIES
AND STOCKHOLDERS' DEFICIT
|
|||||||
|
Current
liabilities
Accounts
payable and accrued expenses
Accrued
interest payable
Deferred
revenues
Current
portion of long-term debt, net of discount $0 at
September
30, 2007 and $2,062,000 at December 31, 2006
|
$
|
1,595,000
1,023,000
1,167,000
11,406,000
|
$
|
1,226,000
581,000
173,000
8,833,000
|
|
||
|
Total
current liabilities
|
15,191,000
|
10,813,000
|
|||||
|
Long-term
debt
|
5,500,000
|
5,500,000
|
|||||
|
Total
liabilities
|
20,691,000
|
16,313,000
|
|||||
|
Commitments
and contingencies
|
-
|
-
|
|||||
|
Stockholders'
deficit
Preferred
stock - $.01 par value; authorized 2,000,000 shares;
none
issued or outstanding
Common
stock - $.01 par value; authorized 100,000,000 shares;
issued,
3,575,114 at September 30, 2007 and 3,535,108 at
December
31, 2006
Additional
paid-in capital
Notes
receivable from stockholders
Treasury
stock, at cost - 163 shares
Accumulated
deficit
|
-
36,000
69,687,000
(1,045,000
(4,000
(85,865,000
|
)
)
)
|
-
35,000
68,799,000
(1,045,000
(4,000
(77,672,000
|
)
)
)
|
|||
|
Total
stockholders' deficit
|
(17,191,000
|
)
|
(9,887,000
|
)
|
|||
|
Total
liabilities and stockholders' deficit
|
$
|
3,500,000
|
$
|
6,426,000
|
|||
The
accompanying notes are an integral part of these statements.
F-24
Access
Pharmaceuticals, Inc. and
Subsidiaries
Condensed
Consolidated Statements of Operations
(unaudited)
|
Three
months ended
|
Nine
months ended
|
||||||||||||
|
September
30,
|
September
30
|
||||||||||||
|
2007
|
2006
|
2007
|
2006
|
||||||||||
|
Revenues
|
|||||||||||||
|
License
revenues
|
$
|
6,000
|
$
|
-
|
$ | 6,000 |
$
|
-
|
|||||
|
Expenses
|
|||||||||||||
|
Research
and development
|
596,000
|
379,000
|
1,532,000 |
1,769,000
|
|||||||||
|
General
and administrative
|
1,000,000
|
800,000
|
3,252,000 |
2,129,000
|
|||||||||
|
Depreciation
and amortization
|
61,000
|
77,000
|
210,000 |
231,000
|
|||||||||
|
Total
expenses
|
1,657,000
|
1,256,000
|
4,994,000 |
4,129,000
|
|||||||||
|
Loss
from operations
|
(1,651,000
|
)
|
(1,256,000
|
)
|
(4,988,000 | ) |
(4,129,000
|
)
|
|||||
|
Interest
and miscellaneous income
|
12,000
|
86,000
|
72,000 |
278,000
|
|||||||||
|
Interest
and other expense
|
(318,000
|
)
|
(1,976,000
|
)
|
(3,277,000 | ) |
(5,244,000
|
)
|
|
Unrealized
gain (loss) on fair value of
warrants
and conversion feature
|
-
|
|
1,131,000
|
|
-
|
|
(1,107,000
|
)
|
|||||
|
(306,000
|
) |
(759,000
|
) | (3,205,000 | ) |
(6,073,000
|
) | ||||||
|
Net
loss
|
$
|
(1,957,000
|
)
|
$
|
(2,015,000
|
)
|
$
|
(8,193,000
|
)
|
$
|
(10,202,000
|
)
|
|
|
Basic
and diluted loss per common share
Net
loss allocable to common
shareholders
|
$
|
(0.55
|
)
|
$
|
(0.57
|
)
|
|
|
|
$
|
(2.89
|
)
|
|
|
Weighted
average basic and diluted
common
shares outstanding
|
3,575,114
|
3,534,408
|
3,544,181
|
3,530,941
|
The
accompanying notes are an integral part of these statements.
F-25
Access
Pharmaceuticals, Inc. and
Subsidiaries
Condensed
Consolidated Statements of Cash Flows
(unaudited)
|
Nine
months ended September 30,
|
|||||||
|
2007
|
2006
|
||||||
|
Cash
flows from operating activities:
|
|||||||
|
Net
loss
|
$
|
(8,193,000
|
)
|
$
|
(10,202,000
|
)
|
|
|
Adjustments
to reconcile net loss to cash used
in
operating activities:
|
|||||||
|
Depreciation
and amortization
|
210,000
|
230,000
|
|||||
|
Stock
option expense
|
810,000
|
171,000
|
|||||
|
Stock
compensation expense
|
-
|
69,000
|
|||||
|
Stock
issued for compensation
|
44,000
|
-
|
|||||
|
Amortization
of debt costs and discounts
|
2,316,000
|
4,192,000
|
|||||
|
Unrealized
loss on fair value of warrants and
conversion
feature
|
-
|
1,107,000
|
|||||
|
Loss on
sale of asset
|
2,000
|
|
-
|
||||
|
Change
in operating assets and liabilities:
|
|||||||
|
Receivables
|
(502,000
|
)
|
14,000
|
||||
|
Prepaid
expenses and other current assets
|
(247,000
|
)
|
143,000
|
||||
|
Other
assets
|
1,000
|
128,000
|
|||||
|
Accounts
payable and accrued expenses
|
369,000
|
(849,000
|
)
|
||||
|
Accrued
interest payable
|
953,000
|
805,000
|
|||||
|
Deferred
revenue
|
994,000
|
-
|
|||||
|
Net
cash used in operating activities
|
(3,243,000
|
)
|
(4,192,000
|
)
|
|||
|
Cash
flows from investing activities:
|
|||||||
|
Capital
expenditures
|
(18,000
|
)
|
(3,000
|
)
|
|||
|
Proceeds
from sale of asset
|
13,000
|
-
|
|||||
|
Redemptions
of short term investments and
certificates
of deposit, net
|
2,680,000
|
(98,000
|
)
|
||||
|
Net
cash provided by (used in) investing activities
|
2,675,000
|
(101,000
|
)
|
||||
|
Cash
flows from financing activities:
|
|||||||
|
Payments
of notes payable
|
-
|
(106,000
|
)
|
||||
|
Proceeds
from secured convertible notes payable
|
-
|
4,532,000
|
|||||
|
Exercise
of stock options
|
35,000
|
-
|
|||||
|
Net
cash provided by financing activities
|
35,000
|
4,426,000
|
|||||
|
Net
(decrease) increase in cash and cash equivalents
|
(533,000
|
)
|
133,000
|
||||
|
Cash
and cash equivalents at beginning of period
|
1,194,000
|
349,000
|
|||||
|
Cash
and cash equivalents at end of period
|
$
|
661,000
|
$
|
482,000
|
|||
|
Supplemental
cash flow
information:
|
|||||||
|
Cash
paid for
interest
|
$
|
5,000
|
$
|
5,000
|
|||
|
Accrued
interest
capitalized
|
511,000 | - |
The
accompanying notes are an integral part of these statements
F-26
Access
Pharmaceuticals, Inc. and
Subsidiaries
Notes
to
Condensed Consolidated Financial Statements
Nine
Months Ended September 30, 2007 and 2006
(unaudited)
| (1) |
Interim
Financial
Statements
|
The
consolidated balance sheet as of September 30, 2007 and the consolidated
statements of operations and cash flows for the three and nine months ended
September 30, 2007 and 2006 were prepared by management without audit. In
the
opinion of management, all adjustments, consisting only of normal recurring
adjustments, except as otherwise disclosed, necessary for the fair presentation
of the financial position, results of operations, and changes in financial
position for such periods, have been made. All share and per share information
reflect a one for five reverse stock split effected on June 5,
2006.
Certain
information and footnote disclosures normally included in financial statements
prepared in accordance with accounting principles generally accepted in the
United States of America have been condensed or omitted. It is suggested
that
these interim financial statements be read in conjunction with the consolidated
financial statements and notes thereto included in our Annual Report on Form
10-KSB for the year ended December 31, 2006. The results of operations for
the
period ended September 30, 2007 are not necessarily indicative of the operating
results which may be expected for a full year. The consolidated balance sheet
as
of December 31, 2006 contains financial information taken from the audited
financial statements as of that date.
The
report of our independent registered public accounting firm for the fiscal
year
ended December 31, 2006 contained a fourth explanatory paragraph to reflect
its
significant doubt about our ability to continue a going concern as a result
of
our history of losses and our liquidity position, as discussed herein and
in
this Form 10-QSB. If we are unable to obtain adequate capital funding in
the
future, we may not be able to continue as a going concern, which would have
an
adverse effect on our business and operations, and investors’ investment in us
may decline.
(2) Intangible
Assets
Intangible
assets consist of the following (in thousands):
|
September
30,
2007
|
December
31,
2006
|
||||||||||||
|
Gross
carrying
value
|
Accumulated
amortization
|
Gross
carrying
value
|
Accumulated
amortization
|
||||||||||
|
Amortizable
intangible assets
Patents
Licenses
|
$
|
1,680
-
|
$
|
928
-
|
$
|
1,680
500
|
$
|
802
475
|
|||||
|
Total
|
$ | $1,680 |
$
|
928
|
$
|
2,180
|
$
|
1,277
|
|||||
F-27
Amortization
expense related to intangible assets totaled $42,000 and $54,000 for each
of the
three months ended September 30, 2007 and 2006, respectively and totaled
$151,000 and $163,000 for each of the nine months ended September 30, 2007
and
2006. The aggregate estimated amortization expense for intangible assets
remaining as of September 30, 2007 is as follows (in
thousands):
| 2007 | $ | 42 | ||
| 2008 | 168 | |||
| 2009 | 168 | |||
| 2010 | 168 | |||
| 2011 | 168 | |||
| Thereafter | 38 | |||
| Total | $ | 752 |
(3) Liquidity
The
Company incurred significant losses from continuing operations of $2.0 million
for the quarter ended September 30, 2007, $8.2 million for the nine months
ended
September 30, 2007, $13.3 million for the year ended December 31, 2006 and
$7.6
million for the year ended December 31, 2005. Additionally, at September
30,
2007, our working capital deficit is $12.6 million. As of September 30, 2007,
we
did
not have
sufficient funds to repay our convertible notes at their maturity and support
our working capital and operating requirements. See Note (7) Subsequent
Events for the changes in our cash position and convertible notes. Our
funds at November 14, 2007 will allow us to support our working capital and
operating requirements through December 2008.
(4)
Stock
Based
Compensation
For
the
third quarter, we recognized stock-based compensation expense of $207,000
in
2007 and $49,000 in 2006. For the nine months we recognized stock-based
compensation expense of $810,000 in 2007 and $171,000 in 2006. For the third
quarter of 2007, we granted 25,000 stock options under our 2005 Equity Incentive
Plan at a weighted average exercise price of $3.03.
Our
weighted average Black-Scholes fair value assumptions are as follows:
|
|
|
9/30/07
|
|
|||
|
Expected
life
|
|
2.0
yrs.
|
|
|||
|
Risk
free interest rate
|
|
4.63
|
%
|
|||
|
Expected
volatility(a)
|
|
141
|
%
|
|||
|
Expected
dividend yield
|
|
0.0
|
%
|
|||
|
(a)
|
Reflects
movements in our stock price over the most recent historical period
equivalent to the expected life.
|
F-28
(5)
Income
Taxes
In
2006,
the Financial Accounting Standards Board issued FASB Interpretation No. 48
(FIN 48),
which
clarifies the accounting for uncertainty in tax positions. FIN 48 requires
that
we recognize in our financial statements the impact of a tax position, if
that
position is more likely than not of being sustained on audit, based on the
technical merits of the position. We adopted the provisions of FIN 48 as
of the
beginning of our 2007 fiscal year. There was no effect as a result of our
adoption of FIN 48.
As
of the
beginning of our 2007 fiscal year, due to our cumulative net losses we do
not
have any reserves for income taxes because no taxes are due.
We
file
income tax returns in the U.S. federal jurisdiction and various state
jurisdictions. A number of years may elapse before an uncertain tax position
is
audited and finally resolved. While it is often difficult to predict the
final
outcome or the timing of resolution of any particular uncertain tax position,
we
believe that our reserves for income taxes reflect the most probable outcome.
We
adjust these reserves, as well as the related interest, in light of changing
facts and circumstances. Settlement of any particular position would usually
require the use of cash. The resolution of a matter would be recognized as
an
adjustment to our provision for income taxes and our effective tax rate in
the
period of resolution.
(6)
Debt
|
September
30,
2007
|
December
31,
2006
|
||||||
|
Convertible
note - Oracle and affiliates
|
$
|
4,015,000
|
$
|
4,015,000
|
|||
|
Convertible
note
|
5,500,000
|
5,500,000
|
|||||
|
Convertible
note
|
1,391,000
|
880,000
|
|||||
|
10,906,000
|
10,395,000
|
||||||
|
Discount
|
-
|
(456,000
|
)
|
||||
|
10,906,000
|
9,939,000
|
||||||
|
Convertible
note - SCO and affiliates
|
6,000,000
|
6,000,000
|
|||||
|
Discount
|
-
|
(1,606,000
|
)
|
||||
|
6,000,000
|
4,394,000
|
||||||
|
Total
|
$
|
16,906,000
|
$
|
14,333,000
|
|||
|
Short
term
|
$
|
11,406,000
|
$
|
8,833,000
|
|||
|
Long
term
|
5,500,000
|
5,500,000
|
|||||
|
Total
|
$
|
16,906,000
|
$
|
14,333,000
|
|||
F-29
(7)
Subsequent
Events
On
October 24, 2007, Access and SCO Capital Partners LLC and affiliates (“SCO”)
agreed to extend the maturity date of an aggregate principal amount of
$6,000,000 of 7.5% convertible notes to November 15, 2007 from October 25,
2007.
On
October 24, 2007, Access and Oracle Partners LP and affiliates (“Oracle”) agreed
to extend the maturity date of an aggregate principal amount of $4,015,000
of
7.7% convertible notes to November 16, 2007 from October 26, 2007.
On
November 7, 2007, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 954.0001 shares
of a newly created series of our preferred stock, designated “Series A
Cumulative Convertible Preferred Stock”, par value $0.01 per share, for an issue
price of $10,000 per share, (the “Series A Preferred Stock”) and agreed to issue
warrants to purchase 1,589,999 shares of our common stock at an exercise
price
of $3.50 per share, for an aggregate purchase price of $9,540,001.
As
a
condition to closing, SCO Capital Partners, LLC and affiliates, along with
the
other holders of an aggregate of $6,000,000 Secured Convertible Notes,
also
exchanged their notes and accrued interest for an additional 1,836.0512
shares
of Series A Preferred Stock and were issued warrants to purchase 1,122,031
shares of our common stock at an exercise price of $3.50 per share, and
Oracle
Partners LP and affiliates, along with the other holders of an aggregate
of
$4,015,000 Convertible Notes also exchanged their notes and accrued interest
for
437.3104 shares of the Series A Preferred Stock and were issued warrants
to
purchase 728,850 shares of our common stock at an exercise price of $3.50
per
share. SCO Capital Partners, LLC currently has a designee serving on our
Board
of Directors. In connection with the exchange of the notes, all security
interests and liens relating thereto were terminated.
F-30
INDEX
TO SOMANTA FINANCIAL STATEMENTS
SOMANTA
PHARMACEUTICALS, INC. AND SUBSIDIARIES
|
Report
of Independent Registered Public Accounting Firm
|
F-32 |
|
Consolidated
Balance Sheet as of April 30, 2007
|
F-33 |
|
Consolidated
Statements of Operations for the years ended April 30, 2007 and
2006 and
for the period from inception of operations (April 19, 2001)
to April 30,
2007
|
F-34 |
|
Consolidated
Statements of Stockholders’ Deficit for the period from inception of
operations (April 19, 2001) to April 30, 2007
|
F-35 |
|
Consolidated
Statements of Cash Flows for the years ended April 30, 2007 and
2006 and
for the period from inception of operations (April 19, 2001)
to April 30,
2007
|
F-37
|
|
Notes
to Consolidated Financial Statements as of April 30, 2007
|
F-38 |
|
Condensed
Consolidated Balance Sheets at October 31, 2007
(unaudited)
|
F-63
|
|
Condensed
Consolidated Statements of Operations for the Three and Six
Months Ended
October 31, 2007 and 2006 and for the Period from Inception
of Operations
(April 19, 2001) to October 31, 2007 (unaudited)
|
F-64
|
|
Condensed
Consolidated Statement of Stockholders’ Deficit for the Period from
Inception of Operations (April 19, 2001) to October 31, 2007
(unaudited)
|
F-66
|
|
Condensed
Consolidated Statements of Cash Flows for the Six Months Ended
October 31,
2007 and 2006 and for the Period from Inception of Operations
(April 19,
2001) to October 31, 2007 (unaudited)
|
F-69
|
|
Notes
to Condensed Consolidated Financial Statements as of October
31,
2007
|
F-70
|
F-31
Report
of Independent Registered Public Accounting Firm
To
the
Board of Directors of Somanta Pharmaceuticals, Inc.
Irvine,
California
We
have
audited the accompanying consolidated balance sheet of Somanta Pharmaceuticals,
Inc., formerly Hibshman Optical Corp. (a development stage company) as
of April
30, 2007, and the related consolidated statements of operations and consolidated
stockholders’ deficit and consolidated cash flows for the years ended April 30,
2007 and 2006, and for the period from inception of operations (April 19,
2001)
to April 30, 2007. These consolidated financial statements are the
responsibility of the Company’s management. Our responsibility is to express an
opinion on these consolidated financial statements based on our
audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that
we plan
and perform the audits to obtain reasonable assurance about whether the
financial statements are free of material misstatement. The Company is
not
required to have, nor were we engaged to perform, an audit of its internal
control over financial reporting. Our audits included consideration of
internal
control over financial reporting as a basis for designing audit procedures
that
are appropriate in the circumstances, but not for the purpose of expressing
an
opinion on the effectiveness of the Company’s internal control over financial
reporting. Accordingly, we express no such opinion. An audit includes examining,
on a test basis, evidence supporting the amounts and disclosures in the
financial statements. An audit also includes assessing the accounting principles
used and significant estimates made by management, as well as evaluating
the
overall financial statement presentation. We believe that our audits provide
a
reasonable basis for our opinion.
In
our
opinion, the consolidated financial statements referred to above present
fairly,
in all material respects, the financial position of Somanta Pharmaceuticals,
Inc. as of April 30, 2007, and the results of its operations and its cash
flows
for the years ended April 30, 2007 and 2006, and for the period from inception
of operations (April 19, 2001) to April 30, 2007, in conformity with accounting
principles generally accepted in the United States of America.
The
accompanying consolidated financial statements have been prepared assuming
that
the Company will continue as a going concern. As discussed in Note 1 to
the
consolidated financial statements, the Company’s operating losses, negative
working capital and stockholders’ deficit raise substantial doubt about its
ability to continue as a going concern. Management’s plans regarding those
matters also are described in Note 1. The consolidated financial statements
do
not include any adjustments that might result from the outcome of this
uncertainty.
As
discussed in Note 2 to the consolidated financial statements, in 2006 the
Company adopted Statement of Financial Accounting Standards No. 123 (Revised
2004), Share-Based Payments.
|
/s/ STONEFIELD
JOSEPHSON, INC.
|
|
|
Irvine,
California
|
|
|
June
27, 2007
|
F-32
Somanta
Pharmaceuticals,
Inc.
(Formerly
Hibshman Optical
Corp.)
(A
Development Stage
Company)
Consolidated
Balance
Sheet
April 30,
2007
|
Assets
|
||||
|
Current
assets:
|
||||
|
Cash
|
$
|
5,385
|
||
|
Prepaid
expenses
|
43,308
|
|||
|
Total
current assets
|
48,693
|
|||
|
Office
equipment,
net of accumulated depreciation of $6,750
|
16,560
|
|||
|
Other
assets:
|
||||
|
Restricted
funds
|
2,000
|
|||
|
Deposits
|
73
|
|||
|
Total
other assets
|
2,073
|
|||
|
Total
assets
|
$
|
67,326
|
||
|
Liabilities
and Stockholders’
Deficit
|
||||
|
Current
liabilities:
|
||||
|
Accounts
payable
|
$
|
774,022
|
||
|
Due
to related parties
|
241,874
|
|||
|
Accrued
expenses
|
811,539
|
|||
|
Accrued
research and development expenses
|
554,733
|
|||
|
Note
payable
|
33,462
|
|||
|
Liquidated
damages related to Series A preferred stock and warrants
|
35,200
|
|||
|
Deferred
revenue
|
7,143
|
|||
|
Warrant
liabilities
|
5,786,844
|
|||
|
Total
current liabilities
|
8,244,817
|
|||
|
Stockholders’
deficit:
|
||||
|
Preferred
stock,$0.001 par value, 20,000,000 shares authorized Series
A Convertible
Preferred Stock, $0.001 par value, 2,000 shares designated,
591.6318
shares issued and outstanding
|
1
|
|||
|
Common
Stock, $0.001 par value, 100,000,000 shares authorized, 14,292,603
shares
issued and outstanding
|
14,293
|
|||
|
Additional
paid-in capital
|
7,604,360
|
|||
|
Deficit
accumulated during the development stage
|
(15,796,145
|
)
|
||
|
Total
stockholders’ deficit
|
(8,177,491
|
)
|
||
|
Total
liabilities and
stockholders’ deficit
|
$
|
67,326
|
||
The
accompanying notes are an integral part of these consolidated
financial statements.
F-33
Somanta
Pharmaceuticals, Inc.
(Formerly
Hibshman Optical Corp.)
(A
Development Stage Company)
Consolidated
Statements of
Operations
Years
ended April 30, 2007 and
2006 and for the Period from Inception of Operations
(April
19, 2001) to April 30,
2007
|
From
Inception
of
Operations(April
19,
2001)
to
April
30, 2007
|
||||||||||
|
Year
ended April
30,
|
||||||||||
|
2007
|
2006
|
|||||||||
|
Revenue
|
$
1,429
|
$
1,428
|
$
2,857
|
|||||||
|
Operating
expenses:
|
||||||||||
|
General
and
administrative
|
(3,312,660
|
) |
(2,845,634
|
) |
(7,337,118
|
) | ||||
|
Research
and
development
|
(1,239,146
|
)
|
(1,264,225
|
)
|
(3,100,647
|
)
|
||||
|
Loss
from
operations
|
(4,550,377
|
)
|
(4,108,431
|
)
|
(10,434,908
|
)
|
||||
|
Other
income
(expense):
|
||||||||||
|
Interest
income
|
28,084
|
12,348
|
40,432
|
|||||||
|
Interest
expense
|
(54
|
)
|
(1,016,020
|
)
|
(1,016,074
|
)
|
||||
|
Liquidated
damages
|
(35,200
|
)
|
—
|
(35,200
|
)
|
|||||
|
Change
in fair value of warrant
liabilities
|
(2,931,118
|
)
|
137,543
|
(2,793,575
|
)
|
|||||
|
Gain
on settlement of
debt
|
—
|
5,049
|
5,049
|
|||||||
|
Currency
translation
loss
|
(3,255
|
)
|
(30,241
|
)
|
(33,496
|
)
|
||||
|
Loss
before income
taxes
|
(7,491,920
|
)
|
(4,999,752
|
)
|
(14,267,772
|
)
|
||||
|
Income
taxes
|
(3,717
|
)
|
(2,339
|
)
|
(6,056
|
)
|
||||
|
Net
loss
|
(7,495,637
|
)
|
(5,002,091
|
)
|
(14,273,828
|
)
|
||||
|
Deemed
dividends on convertible
preferred stock
|
—
|
(1,522,317
|
)
|
(1,522,317
|
)
|
|||||
|
Net
loss applicable to common
shareholders
|
$
|
(7,495,637
|
)
|
$
|
(6,524,408
|
)
|
$
|
(15,796,145
|
)
|
|
|
Net
loss per share—basic and
diluted
|
$
|
(0.56
|
)
|
$
|
(0.47
|
)
|
$
|
(1.24
|
)
|
|
|
Weighted
average number of
shares outstanding—basic and diluted
|
14,278,247
|
14,274,365
|
13,247,052
|
|||||||
The
accompanying notes are an integral part of these consolidated financial
statements.
F-34
Somanta
Pharmaceuticals, Inc.
(Formerly
Hibshman Optical Corp.)
(A
Development Stage Company)
Consolidated
Statement of
Stockholders’ Deficit—(Continued)
For
the Period from Inception of
Operations (April 19, 2001) to April 30, 2006
|
|
|
Peferred Stock
|
Common Stock
|
Additional
Paid-in
|
Shares
to be
|
Subscription
|
Deferred
Equity-
Based
|
Accumulated
Other
Comprehensive
Loss-foreign
Currency
|
Deficit
Accumulated
During
Development
|
Total
Stockholders'
Equity/
|
||||||||||||||||||||||||
|
Shares
|
Amount |
Shares
|
Amount |
Capital
|
Issued
|
Receivable
|
Expense
|
Translation
|
Stage
|
(Deficit)
|
||||||||||||||||||||||||
|
Balance
at April 19, 2001(Inception)
|
|
-
|
$
-
|
|
$
-
|
$
-
|
$
-
|
$
-
|
$
-
|
$
-
|
$
-
|
$
-
|
||||||||||||||||||||||
|
Shares
issued for cash at $.0326
|
4,299,860
|
4,300
|
135,680
|
|
(97,245)
|
|
|
|
42,735
|
|||||||||||||||||||||||||
|
Shares
issued for services at $.0139
|
514,674
|
515
|
11,801
|
|
|
(11,177)
|
|
|
1,139
|
|||||||||||||||||||||||||
|
Amortization
of deferred expense
|
521
|
|
|
521
|
||||||||||||||||||||||||||||||
|
Comprehensive
loss—foreign currency translation adjustment
|
29,905
|
|
29,905
|
|||||||||||||||||||||||||||||||
|
Net
loss for the period from inception to April 30, 2002
|
(95,901)
|
(95,901)
|
||||||||||||||||||||||||||||||||
|
Balance
at April 30, 2002
|
—
|
—
|
4,814,534
|
4,815
|
147,481
|
—
|
(97,245)
|
(10,656)
|
29,905
|
(95,901)
|
(21,601)
|
|||||||||||||||||||||||
|
Shares
issued for cash at $1.0677
|
14,601
|
15
|
15,575
|
|
|
|
|
|
15,590
|
|||||||||||||||||||||||||
|
Shares
issued for services at $.0214
|
219,010
|
219
|
4,472
|
|
|
(3,127)
|
|
|
1,564
|
|||||||||||||||||||||||||
|
Amortization
of deferred expense
|
3,808
|
|
|
3,808
|
||||||||||||||||||||||||||||||
|
Receipt
of cash for subscription receivable
|
91,517
|
|
|
|
91,517
|
|||||||||||||||||||||||||||||
|
Comprehensive
loss—foreign currency translation adjustment
|
1,534
|
|
1,534
|
|||||||||||||||||||||||||||||||
|
Net
loss for the year ended April 30, 2003
|
(111,456)
|
(111,456)
|
||||||||||||||||||||||||||||||||
|
Balance
at April 30, 2003
|
—
|
—
|
5,048,145
|
5,049
|
167,528
|
—
|
(5,728)
|
(9,975)
|
31,439
|
(207,357)
|
(19,044)
|
|||||||||||||||||||||||
|
Shares
issued for cash at $1.2479
|
350,164
|
350
|
436,637
|
|
(81,464)
|
|
|
|
355,523
|
|||||||||||||||||||||||||
|
Shares
issued for services at $1.2587
|
22,233
|
22
|
27,962
|
|
|
(25,216
|
)
|
|
|
2,768
|
||||||||||||||||||||||||
|
Amortization
of deferred expense
|
7,691
|
|
|
7,691
|
||||||||||||||||||||||||||||||
|
Exchange
for loan payment and compensation
|
181,371
|
|
2,909
|
|
|
|
184,280
|
|||||||||||||||||||||||||||
|
Comprehensive
loss—foreign currency translation adjustment
|
(51,651
|
)
|
|
(51,651
|
)
|
|||||||||||||||||||||||||||||
|
Net
loss for the year ended April 30, 2004
|
(439,453
|
)
|
(439,453
|
)
|
||||||||||||||||||||||||||||||
|
Balance
at April 30, 2004
|
—
|
—
|
5,420,542
|
5,421
|
813,498
|
—
|
(84,283
|
)
|
(27,500
|
)
|
(20,212
|
)
|
(646,810
|
)
|
40,114
|
|||||||||||||||||||
|
Shares
issued for cash at $1.3218
|
374,073
|
374
|
494,069
|
|
|
|
|
|
494,443
|
|||||||||||||||||||||||||
|
Shares
issued for services at $1.2308
|
21,901
|
22
|
26,933
|
|
|
|
|
|
26,955
|
|||||||||||||||||||||||||
|
3,650
shares to be issued for service at $1.4973
|
5,465
|
|
|
|
|
5,465
|
||||||||||||||||||||||||||||
|
Amortization
of deferred expense
|
26,939
|
|
|
26,939
|
||||||||||||||||||||||||||||||
|
Receipt
of cash for subscription receivable
|
84,283
|
|
|
|
84,283
|
|||||||||||||||||||||||||||||
|
Options
issued for services
|
257,515
|
|
|
|
|
|
257,515
|
|||||||||||||||||||||||||||
|
Comprehensive
loss—foreign currency translation adjustment
|
(5,719
|
)
|
|
(5,719
|
)
|
|||||||||||||||||||||||||||||
|
Net
loss for the year ended April 30, 2005
|
(1,129,290
|
)
|
(1,129,290
|
)
|
||||||||||||||||||||||||||||||
|
Balance
at April 30, 2005
|
—
|
—
|
5,816,516
|
5,817
|
1,592,015
|
5,465
|
—
|
(561
|
)
|
(25,931
|
)
|
(1,776,100
|
)
|
(199,295
|
)
|
|||||||||||||||||||
The
accompanying notes are an integral part of these consolidated financial
statements.
F-35
Somanta
Pharmaceuticals, Inc.
(Formerly
Hibshman Optical Corp.)
(A
Development Stage Company)
Consolidated
Statement of
Stockholders’ Deficit—(Continued)
For
the Period from Inception of
Operations (April 19, 2001) to April 30, 2007
|
|
|
Preferred
|
Stock
|
Common
|
Stock
|
Additional
Paid-in
|
Shares
to
be
|
Subscription
|
Deferred
Equity
Based-
|
Accumulated
other
Comprehensive
Loss-Foreign
Currency
Translation
|
|
Deficit
Accumulated
During
Development
|
|
Total
Stockholders'
Equity
|
||||||||||||||||||||
|
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Capital
|
|
Issued
|
|
Receivable
|
|
Expense
|
|
Adjustments
|
Stage
|
(Deficit)
|
||||||||||||||
|
Write
off foreign currency translation adjustment
|
25,931
|
25,931
|
||||||||||||||||||||||||||||||||
|
Shares
issued for cash at $1.5656
|
12,669
|
13
|
19,821
|
19,834
|
||||||||||||||||||||||||||||||
|
Shares
issued for prior service
|
3,650
|
3
|
5,462
|
(5,465
|
) |
—
|
||||||||||||||||||||||||||||
|
Amortization
of deferred expense
|
561
|
561
|
||||||||||||||||||||||||||||||||
|
Options
issued for services
|
300,616
|
300,616
|
||||||||||||||||||||||||||||||||
|
Recapitalization
with Bridge Oncology
|
7,865,000
|
7,865
|
(92,335
|
) |
(84,470
|
) | ||||||||||||||||||||||||||||
|
Beneficial
conversion feature associated with convertible debt
financing
|
364,721
|
364,721
|
||||||||||||||||||||||||||||||||
|
Convertible
Series A Preferred Stock issued for cash at $10,000 (net
of issuance costs
of $544,169)
|
464.0000
|
0.464
|
4,095,830
|
4,095,830
|
||||||||||||||||||||||||||||||
|
Convertible
Series A Stock issued on conversion of notes payable
|
128.6318
|
0.1286
|
1,286,318
|
1,286,318
|
||||||||||||||||||||||||||||||
|
Deemed
dividend on account of beneficial conversion feature associated
with
issuance of Convertible Series A Preferred Stock
|
1,522,317
|
(1,522,317
|
)
|
—
|
||||||||||||||||||||||||||||||
|
Issuance
costs on warrants issued to placement agent in connection
with the
Convertible Series A Preferred Stock
|
(429,757
|
)
|
(429,757
|
)
|
||||||||||||||||||||||||||||||
|
Discount
on warrant issued with Convertible Series A Preferred
Stock
|
(2,048,531
|
)
|
(2,048,531
|
)
|
||||||||||||||||||||||||||||||
|
Recapitalization
with Hibshman Optical Corp.
|
576,700
|
577
|
(7,708
|
)
|
(7,131
|
)
|
||||||||||||||||||||||||||||
|
Warrant
expense
|
92,689
|
92,689
|
||||||||||||||||||||||||||||||||
|
Net
loss for the year ended April 30, 2006
|
(5,002,091
|
)
|
(5,002,091
|
)
|
||||||||||||||||||||||||||||||
|
Balance
at April 30, 2006
|
592.6318
|
$
|
0.5926
|
14,274,534
|
$
|
14,275
|
$
|
6,701,458
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
(8,300,508
|
)
|
$
|
(1,584,775
|
)
|
||||||||||||
|
Options
issued for services
|
739,000
|
739,000
|
||||||||||||||||||||||||||||||||
|
Warrant
expense
|
163,920
|
163,920
|
||||||||||||||||||||||||||||||||
|
Conversion
of preferred stock
|
(1.000
|
)
|
(.0010
|
)
|
18,069
|
18
|
(18
|
)
|
—
|
|||||||||||||||||||||||||
|
Net
loss for the year ended April 30, 2007
|
(7,495,637
|
)
|
(7,495,637
|
)
|
||||||||||||||||||||||||||||||
|
Balance
at April 30, 2007
|
591.6318
|
$
|
0.5916
|
14,292,603
|
$
|
14,293
|
$
|
7,604,360
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
(15,796,145
|
)
|
$
|
(8,177,492
|
)
|
||||||||||||
F-36
Somanta
Pharmaceuticals, Inc.
(Formerly
Hibshman Optical Corp.)
(A
Development Stage Company)
Consolidated
Statements of Cash
Flows
Years
ended April 30, 2007 and 2006
and for the Period from Inception of Operations
(April
19, 2001) to April 30,
2007
|
Year
ended April
30,
|
From
Inception
of
operations
(April
19, 2001)
to
|
|||||||||
|
2007
|
2006
|
April
30,
2007
|
||||||||
|
Cash
flows provided by (used
for) operating activities:
|
||||||||||
|
Net
loss
|
$
|
(7,495,637
|
)
|
$
|
(5,002,091
|
)
|
$
|
(14,273,828
|
)
|
|
|
Adjustments
to reconcile net
loss to net cash provided by (used for) operating
activities:
|
||||||||||
|
Depreciation
|
5,462
|
1,496
|
6,994
|
|||||||
|
Gain
on sale of equipment
|
(622
|
)
|
—
|
(622
|
)
|
|
Amortization
of stock based expense
|
—
|
561
|
39,520
|
|||||||
|
Write
off foreign currency translation adjustment
|
—
|
25,931
|
25,931
|
|||||||
|
Change
in fair value of warrant liabilities
|
2,931,118
|
(137,543
|
)
|
2,793,575
|
|
|||||
|
Shares
issued for services and compensation
|
—
|
—
|
219,262
|
|||||||
|
Gain
on settlement of debts
|
—
|
(5,049
|
)
|
(5,049
|
)
|
|||||
|
Options
expense
|
739,000
|
300,616
|
1,297,131
|
|||||||
|
Warrant
expense
|
163,920
|
92,689
|
256,609
|
|||||||
|
Interest
expense related to beneficial conversion feature on
convertible
note
|
—
|
364,721
|
364,721
|
|||||||
|
Interest
expense related to warrants issued on convertible note
|
—
|
514,981
|
514,981
|
|||||||
|
Changes
in assets and
liabilities:
|
||||||||||
|
(Increase)
decrease in
assets—
|
||||||||||
|
VAT
receivable
|
1,628
|
61,952
|
3,444
|
|||||||
|
Restricted
funds
|
150,048
|
(152,048
|
)
|
(2,000
|
)
|
|||||
|
Prepaid
expenses
|
47,767
|
(82,166
|
)
|
(43,037
|
)
|
|||||
|
Deposits
|
2,627
|
(2,700
|
)
|
(73
|
)
|
|||||
|
Increase
(decrease) in
liabilities:
|
||||||||||
|
Accounts
payable
|
516,222
|
199,086
|
776,723
|
|||||||
|
Accrued
liabilities
|
1,052,994
|
137,846
|
1,354,412
|
|||||||
|
Liquidated
damages
|
35,200
|
—
|
35,200
|
|||||||
|
Deferred
revenue
|
(1,429
|
)
|
8,572
|
7,143
|
||||||
|
Due
to officer and related party
|
233,874
|
(186,263
|
)
|
95,980
|
||||||
|
Net
cash used for operating activities
|
(1,617,828
|
)
|
(3,859,409
|
)
|
(6,532,983
|
)
|
||||
|
Cash
flows used for investing
activities:
|
||||||||||
|
Purchase
of equipment
|
—
|
(21,391
|
)
|
(24,824
|
)
|
|||||
|
Sale
of equipment
|
2,000
|
—
|
2,000
|
|||||||
|
Net
cash used for investing activities
|
2,000
|
(21,391
|
)
|
(22,824
|
)
|
|||||
|
Cash
flows provided by
financing activities:
|
||||||||||
|
Loan
payable—related party
|
—
|
—
|
79,402
|
|||||||
|
Loan
payment—related party
|
—
|
—
|
(7,367
|
)
|
||||||
|
Proceeds
from convertible note-related party
|
—
|
1,250,000
|
1,250,000
|
|||||||
|
Proceeds
from note payable - related party
|
33,462
|
—
|
33,462
|
|||||||
|
Proceeds
from issuance of common stock
|
—
|
19,834
|
928,125
|
|||||||
|
Proceeds
from issuance of preferred stock
|
—
|
4,095,831
|
4,095,831
|
|||||||
|
Cash
received for subscription receivable
|
—
|
—
|
175,801
|
|||||||
|
Net
cash provided by financing activities
|
33,462
|
5,365,665
|
6,555,254
|
|||||||
|
Effect
of exchange rate changes
on cash
|
—
|
—
|
5,938
|
|||||||
|
Increase
(decrease) in
cash
|
(1,582,366
|
)
|
1,484,865
|
5,385
|
||||||
|
Cash,
beginning of year
|
1,587,750
|
102,885
|
—
|
|||||||
|
Cash,
end of year
|
$
|
5,385
|
$
|
1,587,750
|
$
|
5,385
|
||||
|
Supplemental
disclosure of cash
flow information:
|
||||||||||
|
Interest
paid
|
54
|
$
|
1,016,020
|
$
|
1,016,074
|
|||||
|
Income
tax paid
|
$
|
3,717
|
$
|
2,339
|
$
|
6,056
|
||||
|
Supplemental
disclosure of
non-cash operating and financing activities:
|
||||||||||
|
Loan
reduction with shares
|
$
|
—
|
$
|
—
|
$
|
2,909
|
||||
|
Issuance
of warrants in conjunction with convertible preferred
stock
|
$
|
—
|
$
|
2,341,785
|
$
|
2,341,785
|
||||
|
Deemed
dividends related to convertible preferred stock
|
$
|
—
|
$
|
1,522,317
|
$
|
1,522,317
|
||||
|
Conversion
of note and accrued interest
|
$
|
—
|
$
|
1,286,318
|
$
|
1,286,318
|
The
accompanying notes are an integral part of these consolidated
financial
statements.
F-37
Somanta
Pharmaceuticals,
Inc.
(Formerly
Hibshman Optical
Corp.)
(A
Development Stage
Company)
Notes
to Consolidated Financial
Statements
1. ORGANIZATION,
BASIS OF PRESENTATION
AND NATURE OF OPERATIONS
Organization
Somanta
Pharmaceuticals, Inc. is a Delaware corporation that was formed
for the purpose
of effecting the reincorporation of Hibshman Optical Corp., a New
Jersey
corporation, into the State of Delaware and for the purpose of
consummating a
business combination via a reverse merger of Somanta Incorporated
and Hibshman
Optical Corp. Pursuant to this reverse merger, Somanta Incorporated became
the wholly-owned subsidiary of Somanta Pharmaceuticals, Inc. and
the sole
operating subsidiary of Somanta Pharmaceuticals, Inc. For financial
reporting purposes, this transaction has been reflected in the
accompanying
financial statements as a recapitalization of Somanta Incorporated
and the
financial statements of Somanta Pharmaceuticals, Inc. reflect the
historical
financial information of Somanta Incorporated. References herein to the
“Company” or “Somanta” are intended to refer to each of Somanta Pharmaceuticals,
Inc. and its wholly owned subsidiary Somanta Incorporated, as well
as Somanta
Incorporated’s wholly-owned subsidiary Somanta Limited.
Hibshman
Optical Corp. was originally incorporated in the State of New Jersey
in 1991
under the name PRS Sub I, Inc. The name was subsequently changed to Service
Lube, Inc., then to Fianza Commercial Corp. and then to Hibshman
Optical
Corp. The business plan since that time had been to seek to enter into
a
business combination with an entity that had ongoing operations
through a
reverse merger or other similar type of transaction.
Somanta
Incorporated was incorporated as Somantis Limited under the laws
of England and
Wales on April 19, 2001. Somantis Limited changed its name to Somanta
Limited on March 14, 2005, and performed business as a United Kingdom
entity through the fiscal year ending April 30, 2005. On
August 22, 2005, Somanta Limited became a wholly owned subsidiary of Bridge
Oncology Products, Inc. (“BOPI”), a privately held Delaware corporation,
pursuant to a share exchange with BOPI.; however, Somanta Limited
was deemed the
accounting acquirer in this share exchange transaction. On August 24,
2005, the name of BOPI was changed to Somanta Incorporated.
Somanta
Pharmaceuticals, Inc. is a development stage biopharmaceutical
company engaged
in the development of products for the treatment of cancer. The
Company has
in-licensed five product development candidates from academic and
research
institutions in the United States and Europe designed for use in
anti-cancer
therapy in order to advance them along the regulatory and clinical
pathways
toward commercial approval. The Company intends to obtain approval
from the
United States Food and Drug Administration (“FDA”) and from the European
Medicines Evaluation Agency (“EMEA”) for the products.
Somanta
is a development stage enterprise since the Company has not generated
revenue
from the sale of its products, and its efforts have been principally
devoted to
identification, licensing and clinical development of its products
as well as
raising capital through April 30, 2007. Accordingly, the financial
statements have been prepared in accordance with the provisions
of Statement of
Financial Accounting Standards (SFAS) No. 7, “Accounting and Reporting by
Development Stage Enterprises.”
Basis
of
Presentation
The
preparation of financial statements in conformity with generally
accepted
accounting principles requires management to make estimates and
assumptions that
affect the amounts reported in the financial statements and accompanying
notes. Actual results could differ from those estimates. In the
opinion of management, all adjustments (consisting solely of normal
recurring
adjustments) considered necessary for a fair presentation have
been
included.
Going
Concern
The
Company reported a net loss and net loss applicable to common shareholders
of
$7,495,637 for the year ended April 30, 2007. The net loss from date of
inception, April 19, 2001 to April 30, 2007, totaled $14,273,828 (net
loss applicable to common shareholders of $15,796,145). The Company’s operating
activities have used cash since its inception. These losses raise
substantial
doubt about the Company’s ability to continue as a going concern.
F-38
On
April
18, 2007, the Company, Somanta Incorporated, a wholly-owned
subsidiary of the
Company and Somanta Limited, a wholly-owned subsidiary
of Somanta Incorporated,
and Access Pharmaceuticals, Inc. (“Access”) and Somanta Acquisition Corporation
(“Merger Sub”), a wholly-owned subsidiary of Access and a Delaware
corporation,
entered into an Agreement and Plan of Merger (the “Merger Agreement”). Pursuant
to the terms and subject to the conditions set forth
in the Merger Agreement,
Merger Sub will merge with and into Somanta, with Somanta
continuing as the
surviving corporation and becoming a wholly-owned subsidiary
of Access (the
“Merger”). The Board of Directors of Somanta has approved the
Merger and the
Merger Agreement.
In
connection with the Merger, all of Somanta’s common stock that is outstanding at
the effective time of the Merger (the “Effective Time”) will be converted into
500,000 shares of Access common stock. No fractional
shares of Access common
stock will be issued as a result of the Merger. In addition,
all of Somanta’s
preferred stock, included accrued and unpaid dividends,
that is outstanding at
the Effective Time of the Merger will be converted into
1,000,000 shares of
Access’ common stock. No shares of Access preferred stock will
be issued as a
result of the Merger.
On
April
26, 2007, the Company entered into a Note Purchase Agreement,
a Security
Agreement, a Patent Collateral Assignment and Security
Agreement and a Trademark
Collateral Security and Pledge Agreement (collectively,
the “Loan Documents”)
with Access Pharmaceuticals, Inc. as more fully described
in Note 15. Under the
terms of the Loan Documents, Access initially loaned
the Company $33,462.
Access, in its sole discretion, may from time to time
advance additional loan
amounts to the Company. All amounts loaned to the Company
by Access are secured
by substantially all of the assets of the Company pursuant
to the terms of the
Loan Documents. The Note bears interest at 10% and is
repayable at the earlier
of: (i) August 31, 2007, or (ii) the date of the termination
of the Agreement
and Plan of Merger dated as of August 18, 2007 between
the Company and
Access.
If
the
merger fails to close, the Company expects that it will
no longer be able to
operate its business and will not have the resources
to repay the
loan.
The
financial statements do not include any adjustments to
reflect the possible
future effects on the recoverability and classification
of assets or the amounts
and classification of liabilities that may result from
the possible inability of
the Company to continue as a going concern.
Reclassifications
For
comparative purposes, prior periods’ consolidated financial statements have been
reclassified to conform with report classifications of
the current
period.
2. Significant
Accounting
Policies
Cash
and Cash
Equivalents
The
Company considers all highly liquid financial instruments
with a maturity of
three months or less when purchased to be cash equivalents.
At April 30,
2007, there were no cash equivalents.
F-39
Office
Equipment
Office
equipment is recorded at cost, net of accumulated depreciation.
Depreciation on
equipment is calculated using the straight-line method
over the estimated useful
lives of the assets, five years. The Company recorded
depreciation expense for
the years ended April 30, 2007 and 2006 of $5,462 and $1,496,
respectively.
Intangible
Assets—Patents and
Licenses
All
patent and license costs are charged to expense when
incurred.
Revenue
Recognition
The
Company recognizes revenue from licensing its proprietary
technology in
accordance with SEC staff Accounting Bulletin No. 104 (“SAB 104”). SAB 104
requires revenue to be recognized when all of the following
criteria are met:
persuasive evidence of an arrangement exists, delivery
has occurred or services
have been rendered, the price is fixed or determined,
and collection is
reasonably assured. Licensing fees, including upfront
payments upon execution of
a new agreement, are recognized ratably over the license
term of such
agreement.
Research
and
Development
All
research and development costs consist of expenditures
for royalty payments,
licensing fees, contracted research by third parties
and the fees and expense of
consultants to manage the research and development
efforts.
Stock
Based
Compensation
On
December 16, 2004, the FASB issued SFAS No. 123 (revised 2004),
“Share-Based Payment” (SFAS 123R). SFAS 123R eliminates the alternative
of
applying the intrinsic value measurement provisions
of APB 25 to stock
compensation awards issued to employees. Rather,
the new standard requires
enterprises to measure the cost of employee services
received in exchange for an
award of equity instruments based on the grant-date
fair value of the award.
That cost will be recognized over the period during
which an employee is
required to provide services in exchange for the
award, known as the requisite
service period (usually the vesting period). On April 14, 2005, the
Securities and Exchange Commission announced the
adoption of a rule that defers
the required effective date of SFAS 123R. The SEC
rule provides that SFAS 123R
is now effective for registrants as of the beginning
of the first fiscal year
beginning after June 15, 2005.
Effective May 1,
2006, the Company adopted SFAS 123R and accordingly has adopted the
modified prospective application method. Under this
method, SFAS 123R is applied
to new awards and to awards modified, repurchased,
or cancelled after the
effective date. Additionally, compensation cost for
the portion of awards that
are outstanding as of the date of adoption for which
the requisite service has
not been rendered (such as unvested options) is recognized
over a period of time
as the remaining requisite services are rendered.
The amounts recorded as
expense in the years ended April 30, 2007 and 2006
was $739,000 and $300,615,
respectively. As of April 30, 2007, there were 3,483,163 options
outstanding.
Prior
to May 1, 2006, the Company accounted for its employee stock option
plan in accordance with the provisions of SFAS No. 123, “Accounting
for Stock-Based
Compensation,”
and
SFAS No. 148, “Accounting
for Stock-Based
Compensation - Transition and Disclosure.”
Translation
of Foreign Currency in
Financial Statements
From
inception through the fiscal year ended April 30, 2005, the functional
currency of the Company was the United Kingdom pound
and its reporting currency
was United States dollar.
F-40
Assets
and liabilities of foreign operations where the functional
currency is other
than the U.S. dollar are translated at fiscal year-end
rates of exchange, and
the related revenue and expense amounts are translated
at the weighted average
rates of exchange during the fiscal year. Translation
adjustments arising from
differences in exchange rates from these transactions
are reported as
accumulated other comprehensive loss—foreign currency translation adjustment in
the statement of stockholders’ deficit. The currency exchange rate as of
April 30, 2005 was $1.9122.
On
August 22, 2005, the Company, then known as Somanta Limited,
took part in a
share exchange with Bridge Oncology Products, Inc.,
a Delaware company, and
became a subsidiary of Bridge Oncology Products,
Inc. (Note 10). As a
result of this transaction, Somanta Limited became
a wholly owned subsidiary of
a U.S. entity and accordingly changed its functional
currency to the U.S. dollar
as of the fiscal year beginning May 1, 2005.
Use
of Estimates
The
preparation of financial statements in conformity
with accounting principles
generally accepted in the United States of America
requires management to make
estimates and assumptions that affect the reported
amounts of assets and
liabilities at the date of the consolidated financial
statements and the
reported amounts of revenues and expenses during
the reporting period. Actual
results could differ from those estimates.
Income
Taxes
Deferred
taxes are provided for on a liability method for
temporary differences between
the financial reporting and tax basis of assets and
liabilities that will result
in taxable or deductible amounts in the future. Deferred
tax assets are reduced
by a valuation allowance when, in the opinion of
management, it is more likely
than not that some portion or all of the deferred
tax assets will be
realized.
Income
taxes are calculated in accordance with the tax laws
of the United States for
the years ended April 30, 2007 and April 30, 2006. Since the Company
had net losses for the years ended April 30, 2007 and 2006, provisions for
income taxes in the financial statements include only
state minimum taxes for
the year ended April 30, 2007.
Segment
Reporting
The
Company has adopted SFAS No. 131, “Disclosures about Segments of an
Enterprise and Related Information.” Since the Company operates in one business
segment dedicated to development of therapeutic candidates
for the treatment of
cancers, segment disclosure has not been presented.
Fair
Value of Financial
Instruments
Statement
of Financial Accounting Standard No. 107, Disclosures about Fair Value of
Financial Instruments, requires that the company disclose
estimated fair values
of financial instruments. The carrying amounts reported
in the balance sheets
for current assets and current liabilities qualifying
as financial instruments
are a reasonable estimate of fair value.
Basic
and diluted net loss per
share
Net
loss
per share is calculated in accordance with the Statement
of Financial Accounting
Standards No. 128 (SFAS No. 128), Basic net loss per share is based
upon the weighted average number of common shares outstanding.
Diluted net loss
per share is based on the assumption that all potential
dilutive convertible
shares and stock options or warrants were converted
or exercised. The
calculation of diluted net loss per share excludes
potential common stock
equivalents if the effect is anti-dilutive. The Company’s weighted common shares
outstanding for basic and dilutive were the same since
the effect of common
stock equivalents was anti-dilutive.
The
Company has the following dilutive convertible shares,
stock options and
warrants as of April 30, 2007 and 2006 which were excluded from the
calculation since the effect is anti-dilutive.
|
2007
|
2006
|
|
|
Convertible
preferred stock
|
9,859,125
|
9,877,194
|
|
Stock
options
|
3,483,163
|
3,825,249
|
|
Warrants
|
7,102,838
|
6,952,838
|
|
Total
|
20,445,126
|
20,655,281
|
F-41
The
Company’s undeclared dividend on it’s Preferred Stock amounting to $115,604 was
included in the computation of net loss per share in
accordance with SFAS
No. 129 for the year ended April 30, 2006.
The
Company’s undeclared dividends on its Preferred Stock amounting
to $474,104 for
the year ended April 30, 2007 was included in the computation
of net loss per
share in accordance with SFAS No. 129.
Aggregate
undeclared dividends on Preferred Stock amounting to
$589,708 are included in
the computation of net loss per share for the period
from inception (April 19,
2001) to April 30, 2007.
Recent
Accounting
Pronouncements
In
February 2006, the FASB issued SFAS 155 “Accounting
for Certain Hybrid
Financial Instruments,”
an
amendment of FASB Statements No. 133 and in February 2006, the FASB issued
SFAS 155, “Accounting for Certain Hybrid Financial Instruments,” an amendment of
FASB Statements No. 133 and 140. This Statement amends FASB Statements
No. 133, “Accounting for Derivative Instruments and Hedging Activities,”
and No. 140, “Accounting for Transfers and Servicing of Financial
Assets
and Extinguishments of Liabilities”. This Statement resolves issues addressed in
Statement 133 Implementation Issue No. D1, Application of Statement 133 to
Beneficial Interests in Securitized Financial Assets.
This
Statement:
|
a.
|
Permits
fair value remeasurement for any hybrid financial
instrument that contains
an embedded derivative that otherwise would
require
bifurcation;
|
|
|
b.
|
Clarifies
which interest-only strips and principal-only
strips are not subject to
the requirements of Statement
133;
|
|
c.
|
Establishes
a requirement to evaluate interests in
securitized financial assets to
identify interests that are freestanding
derivatives or that are hybrid
financial instruments that contain an embedded
derivative requiring
bifurcation;
|
|
|
d.
|
Clarifies
that concentrations of credit risk in the
form of subordination are not
embedded derivatives; and
|
|
|
e.
|
Amends
Statement 140 to eliminate the prohibition
on a qualifying special-purpose
entity from holding a derivative financial
instrument that pertains to a
beneficial interest other than another
derivative financial
instrument.
|
This
Statement is effective for all financial instruments
acquired or issued after
the beginning of an entity’s first fiscal year that begins after
September 15, 2006. The fair value election provided for in
paragraph 4(c)
of this Statement may also be applied upon adoption
of this Statement for hybrid
financial instruments that had been bifurcated under
paragraph 12 of Statement
133 prior to the adoption of this Statement. Earlier
adoption is permitted as of
the beginning of an entity’s fiscal year, provided the entity has not yet issued
financial statements, including financial statements
for any interim period for
that fiscal year. Provisions of this Statement may
be applied to instruments
that an entity holds at the date of adoption on an
instrument-by-instrument
basis. The Company is currently evaluating the impact
of SFAS
155.
In
March
2006, the FASB issued SFAS No. 156 (“FAS 156”), “Accounting
for Servicing
of Financial
Assets-An Amendment of
FASB Statement No. 140.”
Among
other requirements, FAS 156 requires a company to
recognize a servicing asset or
servicing liability when it undertakes an obligation
to service a financial
asset by entering into a servicing contract under
certain situations. Under FAS
156 an election can also be made for subsequent fair
value measurement of
servicing assets and servicing liabilities by class,
thus simplifying the
accounting and providing for income statement recognition
of potential
offsetting changes in the fair value of servicing
assets, servicing liabilities
and related derivative instruments. The Statement
will be effective beginning
the first fiscal year that begins after September 15, 2006. The Company
does not expect the adoption of FAS 156 will have
a material impact on the
financial position or results of operations.
F-42
In
June
2006, the FASB issued FASB Interpretation (FIN) No. 48, “Accounting
for Uncertainty
in
Income
Taxes”
that
provides guidance on the accounting for uncertainty
in income taxes recognized
in financial statements. The interpretation will
be adopted by us on May 1,
2007. We are currently evaluating the impact of adopting
FIN 48; however, we do
not expect the adoption of this provision to have
a material effect on our
financial position, results of operations or cash
flows.
In
July
2006, the FASB issued FASB Staff Position (FSP) No.
FAS 13-2, “Accounting
for a Change or Projected
Change in the Timing of Cash Flows Relating to Income
Taxes Generated by a
Leveraged
Lease
Transaction,”
that
provides guidance on how a change or a potential
change in the timing of cash
flows relating to income taxes generated by a leveraged
lease transaction
affects the accounting by a lessor for the lease.
This staff position will be
adopted by us on May 1, 2007. The Company is currently evaluating the
impact of adopting this FSP; however, the Company
does not expect the adoption
of this provision to have a material effect on the
financial position, results
of operations or cash flows.
In
September 2006, the FASB issued Statement No. 157, “Fair
Value
Measurements”
(SFAS
157). This Statement defines fair value, establishes
a framework for measuring
fair value in generally accepted accounting principles
(GAAP), and expands
disclosures about fair value measurements. This Statement
applies under other
accounting pronouncements that require or permit
fair value measurements, the
Board having previously concluded in those accounting
pronouncements that fair
value is the relevant measurement attribute. Accordingly,
this Statement does
not require any new fair value measurements. However,
for some entities, the
application of this Statement will change current
practice. This Statement is
effective for financial statements issued for fiscal
years beginning after
November 15, 2007, and interim periods within those fiscal
years. The
Company does not expect the adoption of SFAS No. 157 to have a material
impact on the consolidated financial statements.
In
September 2006, the FASB issued Statement No. 158, “Employers’
Accounting
for Defined
Benefit Pension and Other Postretirement Plans—an amendment of FASB Statements
No. 87, 88, 106, and 132(R)”
(SFAS
158). This Statement improves financial reporting
by requiring an employer to
recognize the over funded or under funded status
of a defined benefit
postretirement plan (other than a multiemployer plan)
as an asset or liability
in its statement of financial position and to recognize
changes in that funded
status in the year in which the changes occur through
comprehensive income of a
business entity or changes in unrestricted net assets
of a not-for-profit
organization. This Statement also improves financial
reporting by requiring an
employer to measure the funded status of a plan as
of the date of its year-end
statement of financial position, with limited exceptions.
This Statement is
effective as of the end of the fiscal year ending
after December 15, 2006.
The Company does not have any defined benefit plans,
or other post-retirement
plans. Therefore, the Company does not expect SFAS
No. 158 to have any
impact on the consolidated financial statements.
In
February 2007, the FASB issued SFAS No. 159, “The
Fair Value Option for Financial
Assets and Financial Liabilities”. The
objective of this statement is to improve financial
reporting by providing
entities with the opportunity to mitigate volatility
in reported earnings caused
by measuring related assets and liabilities differently
without having to apply
complex hedge accounting provisions. This Statement
is expected by the Board to
expand the use of fair value measurement, consistent
with the Board’s long-term
measurement objectives for accounting for financial
instruments. This statement
is effective for fiscal years beginning after November
15, 2007. The Company is
currently evaluating the impact of adopting this
statement; however, the Company
does not expect the adoption of this provision
to have a material effect on its
financial position, results of operations or cash
flow.
3. ACCRUED
EXPENSES
Accrued
expenses consist of the following at April 30, 2007:
|
Payroll
& vacation
|
$
|
472,014
|
||
|
Accounting
& legal
|
326,325
|
|||
|
Consultant
|
13,200
|
|||
|
$
|
811,539
|
F-43
4. WARRANT
LIABILITIES
The
Company issued 6,792,852 warrants in conjunction
with convertible note (Note 10)
and private placement (Note 11). These warrants
have registration rights for the
underlying shares. EITF 00-19 provides that contracts
that include any provision
that could require net-cash settlement cannot be
accounted for as equity of the
Company. The warrant agreements require net cash
settlement, at the option of
the holders, in the event the Company fails to
issue and deliver common stock on
exercise of the warrants within three business
days of receipt of a written
exercise notice by a holder. Pursuant to EITF 00-19,
the fair value of the
warrants revalued at April 30, 2007 was recorded as a warrant liability
amounting $5,786,844. The change in fair value
of warrant liabilities from April
30, 2006 to April 30, 2007 in the amount of $2,931,118
was recorded as other
expense in the consolidated statements of operations
for the year ended April
30, 2007. The change in fair value from the issuance
date to April 30, 2006 in
the amount of $137,543 was recorded as other income
in the consolidated
statements of operations for the year ended April
30, 2006.
In
the
year ended April 30, 2007, the Company issued warrants
to non-employees to
purchase up to 150,000 common shares over a period
of six years at a price of
$.01. The Company recorded $163,920 to permanent
equity as, pursuant to EITF
00-19, no criteria were met requiring liability
classification.
5. RELATED
PARTY
TRANSACTIONS
Fees
Paid to Related
Parties
Pursuant
to a financial advisory agreement dated March 2005
between Bridge Oncology and
SCO Financial Group LLC (SCO), which the Company
has assumed, the Company
compensates SCO with a monthly fee of $12,500 and
an annual grant of warrants
(Note 4) to purchase 150,000 shares of Company
common stock at an exercise price
of $.01 for the term of the agreement for financial
advisory services.
The
Company recorded advisory service fees totaling
$150,000 and $112,500 to SCO for
the years ended April 30, 2007 and 2006, respectively.
The Company recorded
non-cash advisory service fees to SCO related to
the warrant grants totaling
$163,920 (Note 4) and $88,734 for the years ended
April 30, 2007 and 2006,
respectively.
The
Company recorded board of director fees of $76,000
and $38,187 for the years
ended April 30, 2007 and 2006, respectively.
Agreement
with Related
Party
Virium
Pharmaceuticals,
Inc.
The
Company entered into an exclusive co-development
and sublicense agreement in
February 2005 with a related entity, Virium Pharmaceuticals,
Inc. These two
entities share a common director and their largest
single shareholder, SCO
Capital Partners LLC. On May 19, 2005, the Company paid $50,000 to this
related party to in-license phenylbutyrate and
expensed this
amount.
6. LEASES
The
lease
on the Company’s London office space of approximately 500 sq.
ft. for its United
Kingdom operations is an operating lease which
expired on May 16, 2007.
Lease expense for the years ended April 30, 2007 and 2006 were $22,370 and
$26,724, respectively.
F-44
7. INCOME
TAXES
The
significant components of the Company’s income tax provision (benefit) at
April 30, 2007 and April 30, 2006 are as follows:
|
April
30,
2007
|
April
30,
2006
|
||||||
|
Current
Taxes:
|
|||||||
|
Federal
|
$
|
—
|
$
|
—
|
|||
|
State
|
3,717
|
2,339
|
|||||
|
Foreign
|
—
|
—
|
|||||
|
Total
|
$
|
3,717
|
$
|
2,339
|
|||
|
Deferred
Taxes:
|
|||||||
|
Federal
|
—
|
—
|
|||||
|
State
|
—
|
—
|
|||||
|
Foreign
|
—
|
—
|
|||||
|
Total
|
—
|
—
|
The
principal components of the Company’s deferred tax assets at April 30, 2007
and April 30, 2006 are as follows:
|
April
30,
2007
|
April
30,
2006
|
||||||
|
US
Net Operating Loss Carryforwards
at statutory rate
|
$
|
2,602,000
|
$
|
1,107,000
|
|
UK
Net Operating Loss Carryforwards
at statutory rate
|
703,000
|
703,000
|
|
Total
|
3,305,000
|
1,810,000
|
|
Less
Valuation Allowance
|
(3,305,000
|
)
|
(1,810,000
|
)
|
|
Net
Deferred Tax assets
|
$
|
—
|
$
|
—
|
A
reconciliation of the provision (benefit) for income
taxes to the amount
computed by applying the statutory income tax rate
to the loss before income
taxes is as follows:
|
April
30,
2007
|
April
30,
2006
|
||||||
|
Income
tax (benefit) expense at statutory
rate
|
$
|
(2,549,000
|
)
|
(1,701,000
|
)
|
|
Non
Deductible Expenses at statutory rate
|
1,050,000
|
335,000
|
|
Other
|
4,000
|
18,000
|
|
Change
in valuation allowance at statutory
rate
|
1,495,000
|
1,348,000
|
|||||
| $ | - | $ |
The
Company has established a valuation allowance against
its deferred tax asset,
due to the uncertainty of the realization of the
asset. Management periodically
evaluates the recoverability of the deferred tax
asset. At such time as it is
determined that it is more likely than not that
deferred tax assets are
realizable, the valuation allowance will be reduced.
At
April 30, 2007 and 2006, the Company had US net operating
loss
carryforwards of approximately $7,652,000 and $3,256,000
respectively, which may
be available to offset future taxable income for
tax purposes. These net
operating loss carryforwards expire through 2026.
At April 30, 2007 and
2006, the Company also had UK net operating loss
carryforwards of approximately
$2,696,000.
The
Internal Revenue Code limits the availability of
net operating losses that arose
prior to certain cumulative changes in a corporation’s ownership resulting in a
change of control of the Company. The Company’s use of $167,000 of its prior net
operating loss carryforwards will be significantly
limited, because the Company
underwent “ownership changes” during the fiscal year ended April 30, 2006.
Further, the use of UK net operating loss carryforwards
may be
limited.
F-45
8. STOCKHOLDERS’
TRANSACTIONS
Common
Stock
From
inception through April 30, 2003, the Company financed its operations
through the sale of 4,314,461 shares of common
stock to individual investors at
prices in United Kingdom Pounds translated into
US Dollars ranging from
approximately $0.03, to $1.10, for a total of $155,570.
Of this total, $5,728
remained unpaid at the end April 30, 2003 and was recorded as subscription
receivable. In addition, 733,684 shares were issued
at $0.03 for the services of
consultants, for a total of $17,007. Of this total, $9,975 was recorded to
deferred equity-based expense, because some services
were performed in the
subsequent years. The services were accounted for at the fair value
of the
common stock issued, measured at the dates the
commitments for service were
reached with the contractors. The fair value of these shares was determined
as equal to the value at which shares were being
sold to unaffiliated investors
at the times of the commitments for service.
For
the
year ending April 30, 2004, the Company completed additional sales
of
350,164 shares of common stock at approximately
$1.23 for a total of $436,987.
At the end of April 30, 2004, the amount remaining unpaid for all prior
equity sales was $84,283 and was recorded as subscription
receivable. The
Company issued 22,233 shares of common stock at
approximately $1.23 for the
services of a consultant, for a total of $27,985. Of this total, $25,216
was recorded as deferred equity-based expense.
During the year ended
April 30, 2004, 146,007 issued shares were purchased
by the President and
Chief Executive Officer of the Company from an
individual who had not paid for
the shares. The fair value of these shares was determined as
equal to the
value at which shares were being sold to all other
unaffiliated investors at the
time of this share purchase. The Company recorded
the difference between the
purchase price and the fair value of the shares
as compensation expense
amounting to $181,371.
For
the
year ending April 30, 2005, the Company sold 374,074 shares to individual
investors at approximately $1.33, for a total of
$494,443. In this period,
21,901 shares of common stock were issued at approximately
$1.23 per share for
the services of a consultant, for a total of $26,955.
During
the year ended April 30, 2006, the Company sold 12,669 shares to an
individual investor at approximately $1.57, for
a total of $19,834. In this
period, 3,650 shares of common stock were issued
at approximately $1.50 in
satisfaction of the shares to be issued at April 30, 2005 for a balance of
$5,465.
Stock-Based
Compensation
The
Board
of Directors adopted and the stockholders approved
the 2005 Equity Incentive
Plan in June 2005. The plan was adopted to recognize the contributions
made
by the Company’s employees, officers, consultants, and directors,
to provide
those individuals with additional incentive to
devote themselves to its future
success, and to improve the Company’s ability to attract, retain and motivate
individuals upon whom the Company’s growth and financial success
depends. Under the plan, stock options may be granted as
approved by the
Board of Directors or the Compensation Committee. There are 8,000,000
shares reserved for grants of options under the
plan, of which 2,204,701 have
been issued as substitutions with the exact same
terms for the 2,204,701
previously issued options outstanding as of April 30, 2005. Stock options
vest pursuant to individual stock option agreements. No options granted
under the plan are exercisable after the expiration
of ten years (or less in the
discretion of the Board of Directors or the Compensation
Committee) from the
date of the grant. The plan will continue in effect until terminated
or
amended by the Board of Directors or until expiration
of the plan on
August 31, 2015.
On
April
13, 2007, the Company’s Board of Directors approved a merger agreement
with
Access Pharmaceuticals, Inc, as more fully described
in Note 15. Under the terms
of that agreement Access will not assume, or provide
a substitute option, for
any of the Company’s stock options. Rather, all of the outstanding options
to purchase Company common stock issued pursuant
to the Company’s 2005 Equity
Incentive Plan will be cancelled prior to the closing
of the transaction in
accordance with Section 11.3(d) of the Equity Incentive
Plan. As a result,
pursuant to the terms of Section 11.3(d) of the
Equity Incentive Plan, the
Company’s Board of Directors has resolved to: (i) allow
the immediate and
accelerated vesting of all of the options granted,
and (ii) allowed the exercise
of the option in whole or in part until May 31,
2007. Based on FAS 123(R), no
incremental expense was recorded for these options
with accelerated vesting as
the fair value of the modified options was less
than the fair value of the
original options calculated immediately before
the terms were modified. None of
the options were exercised thru May 31, 2007. Additional
expenses of $507,284
was due to the acceleration of the vesting.
FAS
123(R) requires the use of a valuation model to
calculate the fair value of each
stock-based award. Since May 1, 2003, the Company has used the
Black-Scholes model to estimate the fair value
of stock options granted. For the
valuation of stock-based awards granted in the
years ended April 30, 2007 and
2006, respectively, the Company used the following
significant
assumptions:
F-46
Compensation
Amortization
Period.
All
stock-based compensation is amortized over the
requisite service period of the
options, which is generally the same as the vesting
period of the options. For
all stock options, the Company amortizes the
fair value on a straight-line basis
over the service periods.
Expected
Term or
Life.
The
expected term or life of stock options granted
or stock purchase rights issued
represents the expected weighted average period
of time from the date of grant
to the estimated date that the stock option would
be fully exercised. To
calculate the expected term, the Company used
the total of one-half of the
option term and one-half of the vesting periods.
Expected
Volatility.
Expected volatility is a measure of the amount
by which the Company’s stock
price is expected to fluctuate. The Company’s stock is currently traded on the
over-the -counter bulletin board under the trading
symbol “SMPM”. The Company
estimated the expected volatility of the stock
options at grant date using the
daily stock price of three comparable companies
over a recent historical period
equal to the Company’s expected term.
Risk-Free
Interest Rate.
The
risk-free interest rate used in determining the
fair value of our stock-based
awards is based on the implied yield on U.S.
Treasury zero-coupon issues with
remaining terms equivalent to the expected term
of our stock-based
awards.
Expected
Dividends.
The
Company has never paid any cash dividends on
common stock and does not
anticipate paying any cash dividends in the foreseeable
future. Consequently,
the Company used an expected dividend yield of
zero in valuation
models.
Expected
Forfeitures.
As
stock-based compensation expense recognized in
the consolidated statements of
operations for year ended April 30, 2007 is based
on awards that are ultimately
expected to vest, it should be reduced for estimated
forfeitures.
FAS 123(R) requires forfeitures to be estimated at
the time of grant and
revised, if necessary, in subsequent periods
if actual forfeitures differ from
those estimates. Pre-vesting forfeitures were
estimated to be 0% for stock
options granted for the year ended April 30,
2007 based upon historical
forfeitures.
Summary
of Significant Assumptions
of the Valuation of Stock-Based Awards. The
weighted-average estimated fair value of stock
options granted during the year
ended April 30, 2007 and 2006 was $0.43 and $0.42
per share, respectively. The
fair value for these stock options was estimated
at the date of grant with the
following weighted-average assumptions for the
years ended April 30, 2007 and
April 30, 2006, respectively:
|
Year
ended
April
30,
|
||
|
2007
|
2006
|
|
|
Expected
volatility
|
80.17
to 81.38%
|
101.80%
|
|
Weighted-average
volatility
|
80.41%
|
101.80%
|
|
Expected
dividend yield
|
0%
|
0%
|
|
Expected
term in years
|
6.0
|
6.0
to 7.0
|
|
Risk-free
interest rate
|
4.8%
to 5.1%
|
4.1%
to 4.6%
|
During
the years ended April 30, 2007 and 2006, the
Company recognized compensation
costs related to stock options of $739,000 and
$300,615,
respectively.
F-47
The
following table summarizes activity for stock
options issued to employees,
consultants and directors for the years ended
April 30, 2007 and
2006:
|
Shares
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term
(Years)
|
Aggregate
Intrinsic
Value
|
||||||||||
|
Outstanding
at April 30, 2005
|
2,204,701
|
$
|
1.23
|
7.6
|
$
|
44,094
|
|||||||
|
Granted
|
1,781,170
|
0.60
|
|||||||||||
|
Exercised
|
—
|
||||||||||||
|
Forfeited
|
(160,622
|
)
|
1.23
|
||||||||||
|
Expired
|
—
|
||||||||||||
|
Outstanding
at April 30, 2006
|
3,825,249
|
0.94
|
7.9
|
$
|
65,696
|
||||||||
|
Granted
|
122,500
|
0.60
|
|||||||||||
|
Exercised
|
—
|
||||||||||||
|
Forfeited
|
(339,417
|
)
|
0.60
|
||||||||||
|
Expired
|
(125,169
|
)
|
1.15
|
||||||||||
|
Outstanding
at April 30, 2007
|
3,483,163
|
$
|
0.95
|
0.1
|
$
|
1,040,399
|
|||||||
|
Exercisable
at April 30, 2007
|
3,483,163
|
$
|
0.95
|
0.1
|
$
|
1,040,399
|
|||||||
The
aggregate intrinsic value represents the difference
between the stock price on
the last day of the fiscal year, April 30,
2007, which was $1.25, and the
exercise price multiplied by the number of
options outstanding.
The
following table summarizes information about
non-vested Company stock options as
of April 30, 2007 (unaudited):
|
Shares
|
Weighted
Average
Grant
Date Fair
Value
|
||||||
|
Non-vested
at April 30, 2006
|
1,849,128
|
$
|
0.43
|
|
Granted
|
122,500
|
$
|
0.43
|
||||
|
Vested
|
(1,632,211
|
)
|
$
|
0.48
|
|||
|
Forfeited
|
(339,417
|
)
|
$
|
0.18
|
|||
|
Non-vested
at April 30, 2007
|
-0-
|
Stock
Warrants
Through
the year ended April 30, 2005, the Company issued no warrants. During
the
year ended April 30, 2006, the Company issued warrants to non-employees
to
purchase up to 6,952,838 common shares over
periods ranging from 5 to 7 years at
prices ranging from $0.01 to $2.25. Included
in the warrants issued were
warrants to a non-employee to purchase up to
9,987 common shares over a five
year period at a price of $2.25. In the year
ended April 30, 2007, the Company
issued warrants to non-employees to purchase
up to 150,000 common shares over a
period of six years at a price of $.01 (Note
4). In accordance with EITF 96-18,
the Company determined that the fair value
of the equity instrument issued was
more reliably measured because it was difficult
to determine the value of the
services performed. In accordance with FASB
Statement No. 123R, the Company
has expensed the fair value of all the warrants
issued during the year. The fair
value was estimated using the Black-Scholes
valuation method. The assumptions
utilized in the valuation model were a dividend
yield of zero, volatility
factors ranging from 76.5 to 97.2%, the risk-free
interest rates prevailing at
the warrant issuance dates, which ranged from
4.1 to 4.9%, and expected warrant
lives ranging from 2.5 to 3.5 years. The fair
market value of the warrants used
in the Black-Scholes valuation model was equal
to the most recent value at which
shares were being sold to unaffiliated investors.
F-48
The
following table summarizes the activity for warrants
issued during the years
ended April 30, 2007 and 2006.
|
Shares
|
Wtd.
Avg.
Exercise
Price
|
||||||
| Outstanding April 30, 2005 |
—
|
||||||
|
Granted
|
6,952,838
|
$
|
.62
|
||||
|
Exercised
|
—
|
| Forfeited |
—
|
||||||
|
Expired
|
—
|
||||||
|
Outstanding
April 30, 2006
|
6,952,838
|
$
|
.62
|
||||
|
Granted
|
150,000
|
$
|
.01
|
||||
|
Exercised
|
—
|
||||||
|
Forfeited
|
—
|
||||||
|
Expired
|
—
|
||||||
|
Outstanding
April 30, 2007
|
7,102,838
|
$
|
.61
|
The
following table summarizes information about warrants
outstanding as of
April 30, 2007:
|
Warrants
Outstanding
|
Warrants
Exercisable
|
||||
|
Exercise
Prices
|
Number
Outstanding
|
Wtd.
Avg
Remaining
Contr.
Life
|
Wtd.
Avg
Exercise
Price
|
Number
Exercisable
|
Wtd.
Avg
Exercise
Price
|
|||||||||||
|
$0.01
|
1,166,534
|
5.8
years
|
$
|
0.01
|
1,166,534
|
$
|
0.01
|
|||||||||
|
$0.60
|
987,720
|
4.8
years
|
$
|
0.60
|
987,720
|
$
|
0.60
|
|||||||||
|
$0.75
|
4,938,597
|
4.8
years
|
$
|
0.75
|
4,938,597
|
$
|
0.75
|
|||||||||
|
$2.25
|
9,987
|
3.1
years
|
$
|
2.25
|
9,987
|
$
|
2.25
|
9. SHARE
EXCHANGE AGREEMENT AND PLAN OF
MERGER AGREEMENT
On
August 22, 2005, Somanta Limited, a company organized
under the laws of
England and Wales, became a wholly-owned subsidiary
of Bridge Oncology Products,
Inc. (“BOPI”), a privately held Delaware corporation pursuant
to a share
exchange with BOPI. BOPI was formed in February 2005, and its only
operation was to in-license a product development
candidate for development
outside the United States and Canada.
Under
the
terms of a Share Exchange Agreement by and among
BOPI, Somanta Limited, and the
shareholders and option holders of Somanta Limited,
BOPI (i) issued
5,832,834 shares of BOPI to the twenty-five holders
of 79,898,686 ordinary
shares of Somanta Limited and (ii) issued substitute options to purchase
2,032,166 shares of BOPI to the eleven holders
of Somanta Limited options
covering 27,836,800 ordinary shares of Somanta
Limited. The exchange ratio in
the share exchange was 1 share of BOPI for each
13.698 shares of Somanta
Limited. As a result of this share exchange, the
shareholders of Somanta Limited
owned 50% of the fully diluted ownership of BOPI,
and the holders of BOPI owned
the remaining 50%.
Somanta
Limited options were all priced at 5 pence pursuant
to Somanta Limited’s Board
resolution dated May 18, 2005. These option grant prices were converted
into US dollars at the exchange rate on June 13, 2005, to $0.09 per
share. After the exchange ratio from the share exchange
was applied, these
options now have an exercise price of $1.232828
per share for each BOPI option
issued in the share exchange.
The
acquisition was accounted for as a recapitalization,
as described in FASB 141,
17-3. This transaction is treated as a capital
transaction in substance, rather
than a business combination. That is, the transaction
is equivalent to Somanta
Limited issuing stock for the net monetary assets
of BOPI, accompanied by a
recapitalization. The assets of BOPI were recorded
at the historical value. The
intangible asset on BOPI’s books was written off to the income statement
on the
date of the acquisition (August 22, 2005). Accordingly, the historical
financial statements of Somanta Limited became
the historical financial
statements of BOPI after this transaction. In accounting
for this transaction,
since Somanta Limited is deemed to be the purchaser
and surviving company, its
net assets have been included in the consolidated
balance sheets at their
historical book values.
F-49
On
August 24, 2005, the name of BOPI was changed to Somanta
Incorporated
(“SI”).
On
September 7, 2005, SI entered into a letter of intent to
effect a merger
with Hibshman Optical Corp (“Hibshman”), a New Jersey corporation, and a public
reporting company that did not have a market
for its common stock. Hibshman
was formed in 1991 under the name PRS Sub I,
Inc., as a subsidiary of People
Ridesharing Systems, Inc. (“PRS”), a public corporation that had filed for
Bankruptcy in 1989. In March 1992, the name of
PRS Sub I was changed to Service
Lube, Inc., in anticipation of becoming an operating
business. In April 1992 the
name was changed to Fianza Commercial Corp. Again
in April 1992 the name was
changed to Hibshman. Hibshman never had an operating
business, its stock never
traded publicly, and its shareholders never received
stock
certificates.
On
September 27, 2005, Hibshman, pursuant to an action taken
by the written
consent of its board and shareholders, adopted
an Agreement and Plan of Merger
to effect the reincorporation of Hibshman into
Delaware prior to the merger with
SI. Hibshman formed a new Delaware corporation
which was a wholly owned
subsidiary of Hibshman (“Delaware NewCo”). At the closing of the
reincorporation, Hibshman merged into Delaware
NewCo and each outstanding
Hibshman share was exchanged for .01305340
of Delaware NewCo shares with each
registered holder of a fractional share being
issued 50 Delaware NewCo shares in
lieu of such fractional share. Delaware NewCo was the surviving entity and
the successor issuer under the Exchange Act
and had 576,700 outstanding
shares. Delaware NewCo was named “Somanta Pharmaceuticals,
Inc.”
On
January 31, 2006, pursuant to an Agreement and Plan
of Merger by and among
Delaware NewCo, SI, and Somanta Merger Sub
(“Merger Sub”), a wholly-owned
subsidiary of Delaware NewCo, SI merged with
Merger Sub and became a
wholly-owned subsidiary of Delaware NewCo. In connection with this merger
transaction, Delaware NewCo issued to the holders
of SI capital stock an
aggregate of 13,697,834 shares of Delaware
NewCo common stock and assumed the SI
2005 Equity Incentive Plan and all options
outstanding thereunder which options
became options to purchase 3,831,864 shares
of Delaware NewCo common stock. As a
result, (i) the shareholders and optionholders of SI owned
approximately
97% of the total outstanding common stock of
Delaware NewCo on a fully diluted
basis, (ii) Delaware NewCo assumed the SI 2005 Equity Incentive
Plan and
reserved 8,000,000 common shares for issuance
under the Plan, and
(iii) Delaware NewCo changed its name to Somanta
Pharmaceuticals,
Inc.
The
acquisition was accounted for as a recapitalization,
as described in FASB 141,
17-3. This transaction is treated as a capital
transaction in substance, rather
than a business combination. That is, the transaction
is equivalent to Somanta
Incorporated issuing stock for the net monetary
assets of Hibshman Optical
Corp., accompanied by a recapitalization. Accordingly,
the historical financial
statements of Somanta Incorporated became the
historical financial statements of
Hibshman Optical Corp. after this transaction.
In accounting for this
transaction, since Somanta Incorporated is
deemed to be the purchaser and
surviving company, its net assets have been
included in the consolidated balance
sheets at their historical book values. Somanta
Pharmaceuticals, Inc., elected
to change the fiscal year end from December 31 to April 30 of Somanta
Incorporated.
10. CONVERTIBLE
NOTE
On
August 23, 2005, Bridge Oncology Products, Inc. (“BOPI”) issued a
$1,000,000 secured convertible note to SCO
Capital Partners LLC
(“SCO”). The note was secured by BOPI’s assets, carries an annual interest
rate of 7.5%, and was due at the earlier of
(i) BOPI’s completion of a
qualified equity financing of at least $10,000,000
or (ii) August 23,
2006. SCO had the option to be repaid in cash or
to convert the debt into
the shares of a qualified equity financing
at the lowest price paid by
institutional investors.
On
November 7, 2005, SCO agreed to expand its secured convertible
note to SI
from $1,000,000 up to $1,250,000. Under the
terms of the revised arrangement
with SI, the security and interest rate remained
unchanged. The terms were
amended to require repayment at the earlier
of (i) SI’s completion of an
equity financing of at least $5,000,000 or
(ii) February 28,
2006. Consistent with the secured convertible note
above, SCO had the
option to be repaid in cash or to convert the
debt into the shares of a
qualified equity financing at the lowest price
paid by institutional
investors.
F-50
In
addition, for each $50,000 borrowed on the
additional $250,000 line of credit,
the Company agreed to issue a six-year warrant
to purchase 173,307 shares of
common stock in the amount of 1% of the Company’s fully diluted common shares
outstanding at an exercise price of $0.01 per
share. SI has drawn an
additional $250,000 under this arrangement,
for a total amount outstanding of
$1,250,000 and has issued warrants to purchase
a total of 866,534 shares of
common stock to SCO. These warrants are immediately
exercisable upon issuance
and expire on November 8, 2012. The fair market value of these warrants,
as
discussed further below, was estimated to be
$0.59 per share at the issuance
date and re-measured at $0.59 as of April 30, 2006. The assumptions used in
the Black-Scholes model were risk-free interest
rate of 4.5% at the time of
issuance and 4.95% at April 30, 2006, volatility factors of 97.24% at the
issuance and 76.63% at April 30, 2006, calculated as the weighted average
of the stock price volatility of ranked comparable
public companies, and
contractual terms equal to the exercise periods
of the respective warrants. The
fair value of the common stock as used in this
calculation was $.60 per share,
as negotiated between the Company and the Series
A Convertible Preferred Stock
investors. None of these warrants have been
exercised as of April 30,
2007.
These
warrants have registration rights for the
underlying shares. The investor rights
agreement for the warrant requires the Company
pay a penalty in cash as
liquidated damages if the underlying shares
are not registered in a Registration
Statement and such Registration Statement
is not declared effective on or prior
to the 90th
day
following the initial closing date. The Company
will be required to pay, in
cash, liquidated damages for such failure,
equal to 1% of the holder’s
subscription amount. Pursuant to Emerging Issues Task Force (EITF)
No.
00-19, Accounting
for Derivative Financial
Instruments Indexed to, and Potentially Settled
in, a Company’s Own
Stock,
the
fair value of the warrants at the issuance
was recorded as a warrant liability,
as 1) the shares are required to be registered
and 2) net cash settlement could
occur. EITF 00-19 provides that contracts that include
any
provision that could require net-cash settlement
cannot be accounted for as
equity of the Company. The warrant agreements
require net cash settlement, at
the option of the holders, in the event the
Company fails to issue and deliver
common stock on exercise of the warrants
within three business days of receipt
of a written exercise notice by a holder
and the holder purchases shares of
common stock to deliver in satisfaction of
a sale of the shares of warrants
stock which the holder anticipated to receive
upon exercise.
In
accordance with Statement of Financial Accounting
Standards No. 133,
Accounting
for Derivative
Instruments and Hedging Activities,
(“FASB
133”), the Company determined that the conversion
feature of the notes did not
meet the criteria for bifurcation of the
conversion option, as the debt met the
definition of “conventional convertible debt”, as defined under EITF 00-19, and
therefore the conversion feature of the debt
did not need to be bifurcated and
accounted for as a derivative.
In
accordance with EITF No. 00-27, Application
of Issue No. 98-5
to Certain Convertible Instruments, which
provides guidance on the calculation of a
beneficial conversion feature on a
convertible instrument, the Company has determined
that the convertible note
payable had a non-cash beneficial conversion
feature of $364,721, which was
determined once the qualified equity financing
was finalized. The beneficial
conversion feature was calculated on the
note commitment date but recognized
when the contingency of conversion was resolved
and was determined based on the
difference between the calculated conversion
value after the allocation of the
full fair value of the warrants of $514,981
to the debt as debt discount and the
fair value of the Company’s common stock of $0.60 per share. The value of
the Company’s common stock of $0.60 per share was based
on the value of common
stock obtained through negotiation for independent
sales of common stock to
unaffiliated investors. After the allocation of proceeds between
the debt
and warrants are made, conversion price of
$0.425 was calculated based on the
allocated amount to debts divided by 2,083,333,
the total number of shares into
which the note is convertible. The calculated
amount of $0.175, the difference
of the fair value of the common stock of
$0.60 and the effective conversion
price of $0.425, represents the beneficial
value per share. This beneficial
value was applied to the total shares into
which the note is convertible, to
calculate the beneficial conversion feature.
The proceeds of $1,250,000 on the
note were recorded net of the discount of
$364,721 on account of the beneficial
conversion feature and discount of $514,981
on account of the full fair value of
the warrants. In conjunction with the private
placement (Note 12), the debt and
accrued interest was converted into 128.6318
shares of Series A Convertible
Preferred Stock. The discounts on account
of the beneficial conversion feature
and fair value of the warrants have been
recognized as additional interest
expense on conversion.
F-51
11. PRIVATE
PLACEMENT
On
January 31, 2006, Somanta Pharmaceuticals, Inc. completed a private
placement of 592.6318 shares of its Series A Convertible Preferred
Stock (“Series A Preferred”) at a price of $10,000 per share, including
six-year
warrants to purchase an additional 4,938,598
shares of its common
stock. The Series A Preferred shares consisted of
464 shares purchased by
investors which are convertible into 7,733,333
shares of common stock and
128.6318 shares that gave effect to the conversion
amount of $1,286,318,
representing the value of the converted note
of $1,250,000 (Note 11) and the
associated accrued interest of $36,318. The total 592.6318 preferred shares
are convertible into 9,877,197 common shares.
Gross proceeds to Somanta were
$4,640,000, including $3,671,209 in cash,
payments to various vendors amounting
$968,791, which included cash payment of
$624,105 to SCO Securities, LLC, its
placement agent.
The
Series A Preferred is initially convertible
into 9,877,197 shares of the
Company’s common stock at a conversion price of $0.60
per share. The conversion
value is subject to adjustment. The exercise
price for the warrants is $0.75 per
share and they are immediately exercisable
upon issuance. The fair market value
of these warrants, as discussed further below,
was estimated to be $0.41 per
share at the issuance date. The warrants expire on January 31,
2012. None of the warrants have been exercised
as of April 30,
2007.
Holders
of the Series A Preferred stock are entitled
to receive dividends at 8% per
annum. Dividends will accrue and will be
cumulative from the date of issuance,
whether or not earned or declared by the
Board of Directors. Dividends can be
paid at the Company’s option either in cash or shares of the
Company’s common
stock on April 30 and October 31 of each year. The holders of the
Series A Preferred stock have full voting
rights and powers, subject to the
Beneficial Ownership Cap, equal to the voting
rights and powers of the Common
stock holders.
F-52
The
Series A Preferred stockholders have a
liquidation preference, in the event of
any voluntary or involuntary liquidation,
dissolution or winding up of the
Corporation, senior to the holders of common
stock in an amount equal to $10,000
per share of preferred stock plus any accumulated
and unpaid dividends on the
preferred stock. In the alternative, the holders of the
Series A Preferred
may elect to receive the amount per share
that would be distributed among the
holders of the preferred stock and common
stock pro rata based on the number of
shares of the common stock held by each
holder assuming conversion of all
preferred stock, if such amount is greater
than the amount such holder would
receive pursuant to the liquidation preference.
A change of Control of the
Corporation will not be deemed a liquidation.
The
Series A Preferred Stock is not redeemable
for cash. The holder of any
share or shares of Series A Preferred can,
at the holder’s option, at any time
convert all or any lesser portion of such
holder’s shares of Series A Preferred
stock into such number of shares of common
stock as is determined by dividing
the aggregate liquidation preference of
the shares of preferred stock to be
converted plus accrued and unpaid dividends
thereon by the conversion value then
in effect for such Preferred Stock (“Conversion Value”). The Company can, on the
occurrence of a conversion triggering event,
elect to convert all of the
outstanding preferred stock into common
stock. A conversion triggering event is
(i) a time when the registration statement
covering the shares of common
stock into which the Series A Preferred
is convertible is effective and sales
may be made pursuant thereto or all of
the shares of common stock into which the
Series A Preferred is convertible may be
sold without restriction pursuant to
Rule 144(k) promulgated by the SEC and
the daily market price of the common
stock, after adjusting for stock splits,
reverse splits, stock dividends and the
like is $5 or more for a period of 30 of the immediately preceding
60
consecutive trading days and the volume
of common stock traded on the applicable
stock exchange on each such trading day
is not less than 100,000 shares, or
(ii) a time when the Company consummates a sale
of common stock in a firm
commitment underwritten public offering
in which the offering price before
deduction of expenses of the common stock
is greater than 200% of the Conversion
Value and the aggregate gross proceeds
of the offering to the Company are
greater than $25 million.
All
the
outstanding preferred stock will be automatically
converted to common stock upon
an occurrence of a qualified change of
control provided that upon consummation
of a qualified change of control the holders
of the shares issuable on automatic
conversion shall be entitled to receive
the same per share consideration as the
qualified change of control transaction
consideration. The holders of the Series
A Preferred may require the Company to
redeem the shares upon the Company’s
failure or refusal to convert any shares
of Preferred Stock in accordance with
the terms of issue, or by providing a written
notice to that
effect.
F-53
The
Series A Preferred has been classified
as equity, as the Series A Preferred
stock is not redeemable. In accordance with EITF No. 00-27, Application
of Issue No. 98-5
to Certain Convertible Instruments, the
Company has determined that the Series
A Preferred had a beneficial conversion
feature of $1,522,317 as of the date of
issuance. As such, the Company recorded
a non-cash deemed dividend of $1,522,317
resulting from the difference between
the conversion price determined after allocation
of the full fair value of the
warrants of $0.41 at the issuance date,
revalued at $0.78 as of April 30,
2007, and the fair value of common stock
of $0.60. The carrying value of the
Series A Preferred of $5,926,318 was recorded
net of the deemed dividend of
$1,522,317 and a discount of $2,048,531
at the issuance date. The change in fair
value of the warrants was recorded as other
income in the consolidated statement
of operations for the year ended April 30, 2007.
The
holders of the Series A Preferred and warrants
have registration rights which
obligate the Company to file a registration
statement with the Securities and
Exchange Commission (“SEC”) covering the resale of the common stock
issuable
upon conversion of the Series A Preferred
and the common stock issuable upon
exercise of the warrants (as well as certain
other securities of the Company)
within 30 days after the closing of the
private placement. In the event the
registration statement is not filed within
such thirty day period or if the
registration statement is not effective
within 120 days after the date it is
filed, or a registration statement, once
declared effective ceases to remain
effective during the period that the securities
covered by the agreement are not
sold, the Company will be required to pay,
in cash, liquidated damages for such
failure, equal to 1% of the holders of
the Series A Preferred investment amount
for each thirty day period in which the
registration statement is not filed or
effective, or maintained effective, as
the case may be. This penalty obligation
expired on January 31, 2007 since the SEC declared the Registration
Statement effective on August 10, 2006.
In
accordance with EITF Issue 05-4, The
Effect of a Liquidated Damages
Clause on a Freestanding Financial Instrument
Subject to Issue No.
00-19,
the
Company believes that the effect of the
liquidated damages should be treated
under the first view (View A), which states
that a registration rights agreement
should be treated as a combined unit together
with the underlying financial
instruments, warrants and derivative debenture
and evaluated as a single
instrument under EITF Issue 00-19 and FAS
133. The Company concluded that this
view is the most appropriate for the transaction. The Registration Rights
Agreement and the financial instruments
to which it pertains (the warrants and
the preferred stock) were considered a
combined instrument and accounted for
accordingly. The SEC declared the Registration Statement
effective on
August 10, 2006. As a result, during the quarter
ended July 31, 2006,
the Company accrued a liability of liquidated
damages of $120,502. During the
quarter ended October 31, 2006 an agreement was reached with
SCO on the
liquidated damages matter. The agreement
concluded that since the securities
owned by SCO Capital Partners,
LLC were not registered because SCO voluntarily
withdrew them from the
Registration because of the resale restrictions
required by the SEC, the Company
is not obligated for any liquidated damages
pertaining specifically to SCO
Capital Partners, LLC. Accordingly, the
Company reversed out $85,302 of
liquidated damages in the prior quarter
ended October 31,
2006.
F-54
The
Company also issued six year warrants
to its placement agent to purchase 987,720
common shares at $0.60 per share to SCO
Securities LLC, as part of the success
fees of 10% of the aggregate value of
the transaction at sales price of common
stock. These warrants are immediately
exercisable upon issuance. The fair value
of these warrants at the date of issuance
was estimated to be $0.44 per share
and revalued at $0.41 as of April 30, 2006 and has been recorded as
issuance costs and offset against the
proceeds of the Series A Preferred. On
February 27, 2007, the Company issued
a six year warrant to SCO Financial Group
to purchase 150,000 common shares at
$.01 per share.
The
fair
value of warrants issued in connection
with the issue of convertible debt and
convertible preferred stock, including
the agent warrants, was estimated at
the
date of grant and revalued at April 30,
2007 using a Black Scholes option
pricing model with the following assumptions:
a risk free interest rate of
approximately 4.5% at the issuance date
and 4.6% on April 30, 2007, no dividend
yield, volatility factors of 81.89% to
97.24% at the issuance date
and 50.89% to 60.56% at April 30, 2007, contractual
terms of 6 and 7 years
and expected terms based upon the formula
prescribed in SEC Staff Accounting
Bulletin 107 of 3 years and 3.5 years. These assumptions use the interest
rate prevailing at the time of issuance,
volatility factors calculated as the
weighted average of the stock price volatility
of ranked comparable public
companies, and contractual terms equal
to the exercise periods of the respective
warrants. The fair value of the common
stock as used in this calculation was
$.60 per share at the issuance date,
as negotiated between the Company and
unaffiliated third party Series A investors,
and $1.25 on April 30, 2007. The
change in fair value of the warrants
for the year ended April 30, 2007 of
$2,931,118 was reported in other expense
and disclosed in the financial
statements.
The
fair
value of the above warrants has been
classified as a liability pursuant to
EITF
00-19 as described in Note 4 for the
years ended April 30, 2007.
The
fair
value of the warrants was reassessed
at the end of the fiscal year 2007 with
changes in fair value recorded in other
income (expense) and disclosed in the
financial statements.
The
holders of the Series A Preferred Stock
are entitled to receive, when, if and
as
declared by the Board, dividends at 8% per annum cumulative from the date
of issuance of the shares of Preferred
Stock. The board did not declare the
dividends as of April 30 2007. Therefore, a dividend of $589,708
and
$115,604 for the year ended April 30,
2007 and 2006, respectively,
on the Preferred Stock has not been recorded
in the consolidated financial
statements, but in accordance with SFAS
No. 129, the dividend amount has
been included in the calculation of net
loss per share.
F-55
12. SECURED
NOTE
On
April
26, 2007, the Company entered into a
Note Purchase Agreement, a Security
Agreement, a Patent Collateral Assignment
and Security Agreement and a Trademark
Collateral Security and Pledge Agreement
(collectively, the “Loan Documents”)
with Access Pharmaceuticals, Inc. (“Access”). Under the terms of the Loan
Documents, Access initially loaned the
Company $33,462. Access, in its sole
discretion, may from time to time advance
additional loan amounts to the
Company. All amounts loaned to the Company
by Access are secured by
substantially all of the assets of the
Company pursuant to the terms of the
Loan
Documents. The Note bears interest at
10% and is repayable at the earlier of:
(i) August 31, 2007, or (ii) the date
of the termination of the Agreement and
Plan of Merger dated as of August 18,
2007 between the Company and
Access.
13. COMMITMENTS—EMPLOYMENT
AND CONSULTING
AGREEMENTS
In
January 2006, the Company entered into
employment agreements with the Company’s
President and Chief Executive Officer
(“CEO”), and with the Company’s Executive
Chairman, for one year terms. These agreements
were automatically renewed for an
additional on year term on January 31,
2007. Under these agreements, the
President and Executive Chairman are
to be paid annual base salaries of $275,000
and $248,000, respectively. Both officers
are eligible to receive annual bonuses
and additional stock option grants at
the discretion of the Company’s board of
directors. In July 2006, the Company’s CEO and Executive Chairman agreed to
defer 50% of their base salaries until
the completion of the Company’s next fund
raising at which time the deferred amounts
would be repaid and the deferrals
would cease. Effective October 1, 2006, the Company’s CEO and Executive
Chairman agreed to defer 100% of their
base salaries until the completion of
the
Company’s next fund raising, or the completion
of a merger or other
consolidation with another company, at
which time the deferred amounts would
be
repaid and the deferrals would cease.
Effective June 30, 2006, our
Executive Chairman was appointed by our
Board to be our Chief Financial Officer,
Secretary and Treasurer.
In
January 2006, the Company entered into
an employment agreement with the
Company’s Chief Financial Officer (“CFO”). Under the agreement, the CFO was
to be paid an annual base salary of $215,000
and also entitled to receive an
annual bonus and additional stock option
grants at the discretion of the
Company’s board of directors. In June 2006, the
Company’s CFO resigned. The
Company is not obligated to pay him any
severance or other payments as the
result of his departure; however, the
board agreed to amend the terms of his
stock option agreement to immediately
vest him in twenty five percent
(25%) of the shares covered by the option,
or 101,668 shares, and enable
him to exercise such option until June 30, 2007. Based on FAS 123R, no
incremental expense was recorded for
these options with accelerated vesting
as
the fair value of the modified options
was less than the fair value of the
original options calculated immediately
before the terms were
modified.
F-56
In
November 2005, the Company entered into
two consulting agreements: (i) a
Service Provision Agreement with Pharma
Consultancy Limited, a UK company
controlled by Luiz Porto, one of the
Company’s stockholders pursuant to which
the Company will pay Dr. Porto approximately $278,000 per year,
for
services rendered by Dr. Porto to the Company as an independent
consultant
in connection with the management of
the Company’s clinical activities, that
will terminate on December 31, 2006 unless extended by a mutual
written
agreement of the parties and may be terminated,
with or without cause, by giving
the other party thirty (30) days’ prior written notice; and (ii) a
Service Provision Agreement with Gary Bower pursuant
to which the Company
will pay Mr. Bower approximately $156,000 per year
for services rendered by
Mr. Bower to the Company as an independent
consultant in connection with
the pre-clinical activities related to
the manufacturing of the Company’s
product candidates, that will terminate
on December 31, 2006 unless
extended by a mutual written agreement
of the parties and that may be
terminated, with or without cause, by
giving the other party thirty
(30) days’ prior written notice.
The
agreement with Mr. Bower was amended in April 2006 to include
GTE
Consultancy Limited, a company organized
under the laws of United Kingdom and
owned by Mr. Bower, as the service provider pursuant
to the agreement. With
the approval of the Company’s board of directors, both Dr. Porto and
Mr. Bower may also be granted cash bonuses
and stock options in the future.
In July 2006, Pharma Consultancy Limited
and GTE Consultancy Limited amended
their agreements to reduce, effective
September 1, 2006, their consulting
services to the Company by 33%, which
in turn, will reduce the Company’s
payments by approximately $91,000 and
$51,000, respectively, on an annualized
basis. Both agreements expired by there
terms on December 31, 2006 and were not
renewed.
The
Company’s former CFO resigned in August 2005,
in connection with the closing of
the share exchange agreement with Bridge
Oncology. In January 2006, he
entered into a consulting arrangement
with the Company under which he is paid
$5,000 per month retroactive to June
2005. Effective June 1, 2006, the
former CFO agreed to modify his consulting
arrangement to provide his services
for $100 per hour in lieu of a fixed
retainer and was granted options to acquire
25,000 of the Company’s common stock at $.60 per share vesting
quarterly over
twenty four months. Those options expired as of May 31, 2007.
14. SIGNIFICANT
CONTRACTS AND
LICENSES
IN-LICENSING
AGREEMENTS
De
Montfort
University
In
November 2001, the Company entered into
a Patent and Know-how Assignment and
License Agreement with De Montfort University
of Leicester, England, pursuant to
which De Montfort University agreed to
assign to the Company the key patent
related to chloroethylaminoanthraquinone,
a cytotoxic small molecule and to
exclusively license to the Company certain
know-how related to this molecule for
use in field of the treatment of cancer.
In March 2003, the Company amended and
restated that agreement to extend the
time period in which the assignment and
license would be triggered. In October
2005, De Montfort University formally
assigned the patent that covers the molecule
to the Company. Pursuant to the
agreement with De Montfort University,
the Company paid De Montfort an initial
assignment fee of $42,815 in March 2004
and issued 219,010 shares of common
stock to De Montfort valued at $4,677
in December 2001. The Company is not
obligated to make any royalty payments
to De Montfort based on the sale of any
product that is based on this small molecule,
but it is obligated to pay De
Montfort certain milestone payments based
on the achievement of agreed upon
clinical milestones. If the Company successfully
achieves each of these
milestones, it would be obligated to
pay De Montfort a total aggregate amount
of
milestone payments of GBP 250,000, or
approximately $500,000. The Company is
obligated to use its commercial best
efforts to achieve these agreed upon
clinical milestones. The Company has
the right to terminate its agreement
with
De Montfort on 90 days advance notice,
and either party has the right to
terminate the agreement for breach by
the other party upon 90 days advance
notice (60 days for payment failures),
if such breach is not cured within the
notice period.
F-57
Immunodex,
Inc.
On
January 25, 2002, the Company entered into
a Patent Know-How and License
Option Agreement with Immunorex, Inc.
(later renamed Immunodex, Inc.) giving
it
a worldwide, exclusive sublicense,
with the right to further sublicense,
to all
human radioimmunotherapy applications
of certain patents on BrE3 and Mc3
monoclonal antibodies for use in breast
cancer and other types of cancer.
Pursuant to this agreement, the Company
paid Immunodex an initial license fee
of
$10,000 and sold 292,012 shares of
common stock to Immunodex for $5,638.
On
August 16, 2005, the Company entered
into a Patent and Know-how Exclusive
Sublicense Agreement with Immunodex,
Inc. which had essentially the same
terms
and conditions as the 2002 agreement
and which superseded that agreement.
It
also superseded prior agreements dated
March 1, 2002 and September 17,
2002 related to the same subject matter.
Pursuant to this August 2005 agreement,
the Company paid Immunodex an initial
license fee of $300,000. In addition,
the
Company is obligated to pay Immunodex
$150,000 upon the delivery by Immunodex
of
each cell line that is necessary to
manufacture each of the BrE3 and Mc3
monoclonal antibodies. The Company
is further obligated to pay Immunodex
annual
license maintenance fees and all costs
and expenses associated with the
prosecution and maintenance of each
of the patents licensed to the Company
under
the agreement. The Company’s obligation to pay this fee is reduced
at such time
as it begins to sell a product based
on either of the antibodies, and terminates
in its entirety at such time as the
Company is selling products based on
both
antibodies. As noted below, on November
3, 2006 we terminated our license with
respect on one of the monoclonal antibodies
(huBrE-3 mAb), and continue to
develop on Angiolix.
Assuming
that we begin to sell products based
on Angiolix fifteen (15) years after
the
date of the August 2005 agreement,
or August 2020, which is our anticipated
development timetable, we would have
to pay to Immunodex an additional
$2,600,000 in maintenance fees during
that time period. In addition, we are
obligated to pay Immunodex a royalty
based on the net sales, if any, of
products
based on Angiolix. Further, we are
obligated to develop Angiolix on an
agreed
upon timetable. If we fail to achieve
any of the agreed upon clinical
development and regulatory milestones,
Immunodex would then have the right
to
terminate the August 2005 agreement,
and if such a termination occurs, we
would
be obligated to pay Immunodex a termination
fee of up to $500,000. We are also
entitled to terminate the agreement
with respect to Angiolix upon ninety
(90)
days advance notice to Immunodex. If
we do so without cause, we would also
be
required to pay a termination fee of
up to $500,000. Notwithstanding the
foregoing, we do not have to pay a
termination fee with respect to Angiolix
if
the agreement is terminated due to:
(i) negative results of toxicity testing
for
the applicable drug candidate that
the FDA indicates would preclude further
testing of such drug candidate, (ii)
a third party being granted orphan
drug
status by the FDA for a drug that would
preclude us from receiving orphan drug
status with respect to the applicable
drug candidate, or (iii) our inability
to
achieve commercially viable yields
with respect to the manufacture of
the
applicable drug candidate.
If
we
sublicense our rights with respect
to Angiolix, we would be obligated
to pay to
Immunodex a sublicensing fee not to
exceed $1,000,000 for each such sublicense
granted based on payments received
from each such sublicensee.
The
term
of the August 2005 agreement expires
on the latter to occur of: (i) the
expiration of the last to expire licensed
patent, or (ii) fifteen (15) years
after the first commercial sale of
a product covered by the licensed patents.
The August 2005 agreement superseded
prior agreements with Immunodex dated
January 25, 2002, March 1, 2002 and September 17, 2002, in
each case
related to the same subject matter.
In
February 2006, the Company made a deposit
of $150,000 into an escrow account
pursuant to the agreement. This amount
was released on November 7,
2006.
Effective
November 3, 2006, the Company entered into a
Side Amendment to Patent and
Know-how Exclusive Sublicense Agreement
with Immunodex and the Cancer Research
Institute of Contra Costa (“CRICC”) (the “Side Amendment”). Pursuant to the
Side Amendment, the Company has agreed
with Immunodex and CRICC to reduce
the
amount of the annual maintenance fee
under the License Agreement from $250,000
to $200,000 and to defer the annual
maintenance fee that was due in August
2006
until the earlier of (i) the closing of a fundraising resulting
in gross
proceeds to us of at least $5,000,000,
or (ii) January 31, 2007 (the
“2006 Annual Maintenance Fee”). If the Company is unable to timely
pay the 2006
Annual Maintenance Fee, the annual
maintenance fee due under the License
Agreement would revert to $250,000.
F-58
The
Company has retained its rights with
respect to huMc-3 mAb and its product
candidate Angiolix; however, the Company
has agreed to suspend the development
of Angiolix until such time as the
Company has paid the 2006 Annual Maintenance
Fee. In addition, each of the product
development milestones with respect
to
Angiolix set forth in the License Agreement
has been reset to begin at such time
as we make the 2006 Annual Maintenance
Fee payment.
In
addition, the Company agreed to reimburse
Immunodex for certain out of pocket
expenses in the aggregate amount of
approximately $21,000, which amount
was
payable upon the execution of the Side
Amendment.
On
January 18, 2007 the Company entered
into an Amendment to the Side Amendment
which defers the amounts due on January
31, 2007, including the 2006 Annual
Maintenance Fee, until July 31, 2007.
In consideration for the deferral,
the
Company will pay $12,000 for each
month of the deferral. In addition,
the
Company paid $2,050 of patent annuity
payments.
On
November 8, 2006, the Company made application
to the National Institutes
of Health for a non-exclusive license
to certain patents held by NIH related
to
the humanization of Angiolix (huMc-3
mAb). On December 5, 2006 NIH
provided the Company with proposed
terms for a non-exclusive license.
On May 15,
2007, the NIH terminated Somanta’s non-exclusive license application
since
Somanta had not accepted the terms
and had not executed the proposed license
agreement.
The
School of Pharmacy, University
of London (SOP)
In
March
2004, the Company entered into a Patent
and Know-how Assignment and License
Option Agreement with The School of
Pharmacy, University of London. The
Agreement granted to the Company an
option to acquire the rights to the
key
patent application related to di-N-oxides
of chloroethylaminoanthraquinone as
a
bioreductive prodrug and an exclusive
worldwide license to the related know-how
for development and commercialization
in the field of the treatment of cancer.
Pursuant to this agreement, the Company
paid an initial option fee of $44,575
and issued 131,505 shares of common
stock valued at $2,630 to The School
of
Pharmacy. In September 2005, The School
of Pharmacy formally assigned to the
Company the rights to the key patent
application and the relevant know-how
in
the field of the treatment of cancer.
The Agreement obligate the Company
to pay
The School of Pharmacy certain milestone
payments based on the achievement of
agreed upon clinical milestones with
respect to the prodrug. If the Company
successfully achieve each of these
milestones, it would be obligated to
pay The
School of Pharmacy a total aggregate
amount of milestone payments of
GBP 275,000, or approximately $550,000.
The Company is obligated to use its
commercial best efforts to achieve
these agreed upon clinical milestones.
If the
Company fails to achieve any of these
agreed upon clinical milestones, The
School of Pharmacy would have the right
to terminate the know-how license under
the agreement. In addition, the Company
is obligated to pay The School of
Pharmacy a royalty on net sales, if
any, of products based on the prodrug.
The
Company has the right to terminate
the agreement with the The School of
Pharmacy
on 90 days advance notice, and either
party has the right to terminate the
agreement for breach by the other party
upon 90 days advance notice (60 days
for
payment failures), if such breach is
not cured within the notice period.
In
February, 2006, SOP waived the condition
in the agreement that the Company
assign the patent back to SOP if the
Company was unable to complete a
substantial funding by December 31, 2005.
Virium
Pharmaceuticals, Inc.
(Virium)
In
February 2005, Bridge Oncology Products,
Inc. (BOPI), entered into a
Phenylbutyrate Co-development and Sublicense
Agreement with Virium
Pharmaceuticals, Inc. covering the
worldwide rights, excluding the United
States
and Canada, for the treatment of cancer,
autoimmune diseases and other clinical
indications. BOPI paid an upfront license
fee of $50,000. As a result of the
exchange agreement with BOPI, the Company
has succeeded to the rights and
obligations under this Agreement. The
Company’s single largest stockholder, SCO
Capital Partners, LLC, is also the
single largest stockholder of Virium
Pharmaceuticals, Inc., and the companies
share a common director.
F-59
Virium
is
also a party to a sublicense agreement
with VectraMed, Inc. for the rights
to
develop and commercialize PB worldwide
for the treatment of cancer, autoimmune
diseases and other clinical indications.
In turn, VectraMed has obtained its
rights to the product under an Exclusive
Patent License Agreement dated
May 25, 1995 with the U.S. Public Health
Service (“PHS”) representing the
National Institutes of Health. VectraMed
subsequently assigned all its rights
to
PB to Virium pursuant to a novation
agreement dated May 10, 2005. Virium is
in the process of obtaining PHS approval
for this agreement.
The
Company is responsible for the conduct
of clinical trials and patent prosecution
outside the United States and Canada
and payment of royalties to Virium
on net
product sales until such time as the
patents covering such products
expire. These patents expire at various times
between 2011 and
2016.
The
Company’s agreement with Virium does not fully
comply with the sublicensing
requirements set forth in Virium’s agreement with the National Institutes
of
Health because it does not expressly
incorporate by reference all of the
relevant sections of Virium’s license with NIH. The Company is currently
seeking to amend its agreement with
Virium to bring it into full compliance
with
such sublicensing requirements and
to permit the Company to become a direct
licensee of the NIH, should Virium
default on its license with the
NIH.
On
October 20, 2006, NIH conditionally consented
to the sublicense to the
Company. However, the NIH conditions
include an amendment to the Virium
license
to reflect an updated Virium development
plan and milestones, the payment of
$216,971 in past due patent expenses
and the payment of a $5,000 sublicense
royalty. Based on the information provided
by NIH, it appears that about
$200,000 relates to foreign patent
expenses for calendar 2005 which would
be the
Company’s responsibility under its license
agreement
with Virium. Of that amount, approximately
$12,000 relates to foreign patent
maintenance fees and $197,000 largely
relates to foreign patent legal
expenses. Somanta accrued an additional approximately
$38,700 as patent
annuity and legal expense for the year
ended April 30, 2007. Virium advised
Somanta that they satisfied two of
the three conditions to obtaining final
NIH
approval for Somanta’s sublicense. Virium is in the process
of negotiating an
installment payment plan with respect
to the past due patent
expenses.
On
December 6, 2006, the Company signed
a letter of intent (LOI) pertaining
to a
license and collaboration agreement
with Virium covering all formulations
or
drug combinations where Phenylbutyrate
is an active ingredient. Pursuant
to the LOI, in addition to current
worldwide rights, excluding North
America,
involving the current formulation
of Phenylbutyrate, Somanta would
obtain a
participation in any revenue or royalties
derived from sales in North
America. In return, we would grant Virium
a reciprocal participation in
Europe. In the rest of the world, Somanta
and Virium would share revenues
and royalties equally. The LOI’s terms provide that both companies
will, among
other things, share data and jointly
undertake the necessary pre-clinical
and
clinical studies, seek regulatory
approvals and file for patent protection
in
all territories. It also provides
for the formation of a joint development
committee to oversee all aspects
of the development and commercialization
of
Phenylbutyrate. Completion of the
transaction contemplated by the LOI
remains
subject to the negotiation and execution
of a definitive agreement.
COLLABORATIONS
Cancer
Research Institute of Contra
Costa (CRICC)
In
August
2005, the Company entered into an
Agreement Regarding Academic Clinical
Study
with the Cancer Research Institute
of Contra Costa to provide financial
support
for an on-going Phase I-II clinical
trial of patients with recurrent,
metastatic
breast cancer using the humanized
monoclonal antibody BrE-3, labeled
with
Yttrium-90. In this trial, the antibody
is being administered to patients
in
combination with the chemotherapeutic
drug, Xeloda®.
This
agreement superseded a similar agreement
signed in October 2003, which related
to the same subject matter. Pursuant
to this agreement, the Company is
obligated
to reimburse the Cancer Research
Institute of Contra Costa over the
twenty-four
moths after the date of the agreement
for the costs associated with the
treatment of at least 10 patients
with recurrent, metastatic breast
cancer that
are enrolled in the current Phase
I/II clinical trial of Phoenix, which
is being
conducted at New York University/Bellevue
Hospital. The Company does not expect
these reimbursement payments to exceed
$300,000 in the aggregate.
F-60
Effective
November 3, 2006, the Company entered into
a Side Amendment to Patent and
Know-how Exclusive Sublicense Agreement
with Immunodex and the Cancer Research
Institute of Contra Costa (“CRICC”) (the “Side Amendment”). Pursuant to the
Side Amendment, the Company elected
to terminate the License Agreement
with
respect to huBrE-3 mAb product candidate.
As a result, the Company has
terminated all development activities
with respect to huBrE-3 mAb and returned
the related cell lines to Immunodex.
In connection therewith, the Company
has
terminated its financial support
of the clinical trial currently being
conducted
at New York University with respect
to huBrE-3 mAB (the “huBrE-3 mAb Clinical
Trial”). The Company has agreed to pay
a total of $31,400 to CRICC for the
two
patients that were dosed in the huBrE-3
mAb Clinical Trial, which amount
shall
become due and payable at the time
the Company becomes obligated to
make the
2006 Annual Maintenance Fee payment.
University
of Bradford
(“UoB”)
On
March 1, 2006, the Company entered into
an agreement with the University
of
Bradford, Leeds, United Kingdom for
the Company to fund a two-year research
and
development project staffed by UoB
scientists to evaluate di-N-oxides
of
chloroethylaminoanthraquinones as
a bioreductive prodrug and to evaluate
and
provide data on chloroethylaminoanthraquinones
to support the requirements to
initial clinical trials. The Company
paid $84,835 and accrued $180,000
for
project costs based on this agreement
as of April 30, 2007. In May 2007,
UoB
threaten suit for non-payment of
the amounts owed.
Imperial
College of Science,
Technology and Medicine (“Imperial College”)
On
July 27, 2006, the Company entered into
an agreement with Imperial College
and a post-graduate student for the
Company to fund a three-year pre-clinical
research project staffed by Imperial
College scientists to evaluate Angiolix
(huMc-3 mAb) for anti-vascular cancer
therapy. The Company has accrued
$10,000
for the project costs in the year
ended April 30, 2007.
OUT-LICENSING
AGREEMENT
Advanced
Cardiovascular Devices LLC
(ACD)
On
August 31, 2004, the Company entered into
a research collaboration and
license agreement with ACD. Under
the agreement Somanta granted to
ACD an
exclusive license to use Somanta’s intellectual property, including
the licensed
patent and know-how related to
chloroethlylaminoanthraquinone
(see De Montfort
University), a cytotoxic small
molecule, in the field of vascular
disorders
using stents and devices in that
field. The term of this agreement
expires when
the underlying patent expires in
2015. ACD agreed to pay Somanta
a licensing fee
at such time as ACD had received
funding, plus milestones, and royalties
on
future product sales. In August,
2005, ACD paid the Company a non-refundable
licensing fee of $10,000. In addition,
ACD is obligated to develop a product
based on the small molecule pursuant
to an agreed-upon timetable. If
ACD fails
to achieve any of the agreed upon
milestones, the Company would have
the right
to terminate the agreement; provided,
however, that ACD could prevent
the
Company from so terminating the
agreement with respect to the applicable
failure
by paying the Company a fee not
to exceed $500,000 to reinstate
its rights under
the agreement. In addition, ACD
is also obligated to pay the Company
a royalty
based on net sales, if any, of
products based on the small molecule.
Either
party may terminate this agreement
on 30 days advance notice for breach
by the
other party if the breach is not
cured within such 30 day period.
In addition,
ACD may terminate the agreement
upon written notice to the Company
and without
any further obligation if the licensed
technology does not perform to
the
reasonable satisfaction of ACD
or cannot be commercialized because
of safety or
efficacy reasons or because ACD
is unable to raise the funds necessary
to
develop a product based on the
licensed technology.
F-61
15. MERGER
AGREEMENT
On
April
18, 2007, the Company, Somanta
Incorporated, a wholly-owned subsidiary
of the
Company and Somanta Limited, a wholly-owned subsidiary of Somanta
Incorporated, and Access Pharmaceuticals,
Inc. (“Access”) and Somanta
Acquisition Corporation (“Merger Sub”), a wholly-owned subsidiary of
Access and
a Delaware corporation, entered
into an Agreement and Plan of Merger
(the
“Merger Agreement”). Pursuant to the terms and subject
to the conditions set
forth in the Merger Agreement,
Merger Sub will merge with and
into Somanta, with
Somanta continuing as the surviving
corporation and becoming a wholly-owned
subsidiary of Access (the “Merger”). In addition, Access has received
voting
agreements with certain executive
officers, directors and affiliates
of Somanta
representing approximately 81%
of Somanta’s outstanding common and approximately
60% of its outstanding preferred
shares under which the parties,
subject to
certain limited exceptions, have
granted an irrevocable proxy to
Access to vote
their shares in favor of the merger.
In
connection with the Merger, all
of Somanta’s common stock that is outstanding
at
the effective time of the Merger
(the “Effective Time”) will be converted into
500,000 shares of Access common
stock. No fractional shares of
Access common
stock will be issued as a result
of the Merger. In addition, all
of Somanta’s
preferred stock, including accrued
and unpaid dividends, that is outstanding
at
the Effective Time of the Merger
will be converted into 1,000,000
shares of
Access’ common stock. No shares of Access
preferred stock will be issued
as a
result of the Merger.
As
of
April 18, 2007, there were (i)
15,459,137 shares of Somanta’s common stock
outstanding, including 1,166,534
shares issuable upon the exercise
of warrants
that are expected to be exercised
prior to the Effective Time, and
(ii) 591.6
shares of Somanta’s preferred stock outstanding.
Also as of April 18, 2007,
there were outstanding warrants
to purchase 5,936,304 shares of
Somanta’s common
stock that are not expected to
be exercised prior to the Effective
Time and are
expected to be converted into warrants
to purchase approximately 192,000
shares
of Access’ common stock (subject to adjustment
as provided in the Merger
Agreement).
The
completion of the Merger is subject
to various conditions to closing,
including,
without limitation, obtaining the
approval of the Somanta stockholders.
The
Merger is intended to qualify as
reorganization for federal income
tax
purposes.
F-62
Somanta
Pharmaceuticals,
Inc.
(Formerly
Hibshman Optical Corp.)
(A
Development Stage Company)
Condensed
Consolidated Balance Sheets
|
(Unaudited)
October
31, 2007
|
(Audited)
April
30,
2007
|
||||||
|
Assets
|
|||||||
|
Current
assets:
|
|||||||
|
Cash
|
$
|
1,424
|
$
|
5,385
|
|||
|
Prepaid
expenses
|
25,391
|
43,308
|
|||||
|
Total
current assets
|
26,815
|
48,693
|
|||||
|
Office
equipment, net of
accumulated depreciation of
$9,441 and $6,750 for the period
ended October
31, 2007 and April 30, 2007,
respectively
|
13,870
|
16,560
|
|||||
|
Other
assets:
|
|||||||
|
Restricted
funds
|
—
|
2,000
|
|||||
|
Deposits
|
73
|
73
|
|||||
|
Total
other assets
|
73
|
2,073
|
|||||
|
Total
assets
|
$
|
40,758
|
$
|
67,326
|
|||
|
Liabilities
and Stockholders’ Deficit
|
|||||||
|
Current
liabilities:
|
|||||||
|
Accounts
payable
|
$
|
1,027,819
|
$
|
774,022
|
|||
|
Due
to related parties
|
281,335
|
241,874
|
|||||
|
Accrued
expenses
|
969,121
|
811,539
|
|||||
|
Accrued
research and development expenses
|
354,733
|
554,733
|
|||||
|
Note
payable
|
822,712
|
33,462
|
|||||
|
Liquidated
damages related to Series A
preferred stock and warrants
|
35,200
|
35,200
|
|||||
|
Deferred
revenue
|
6,429
|
7,143
|
|||||
|
Warrant
liabilities
|
117,636
|
5,786,844
|
|||||
|
Total
current liabilities
|
3,614,985
|
8,244,817
|
|||||
|
Stockholders’
deficit:
|
|||||||
|
Preferred
stock - $0.001 par value, 20,000,000
shares authorized Series A
Convertible Preferred Stock,
$0.001 par value, 2,000 shares
designated,
591.6318 issued and outstanding
as of October 31, 2007 and
April 30,
2007
|
1
|
1
|
|||||
|
Common
stock, $0.001 par value, 100,000,000
shares authorized, 15,459,137
shares
issued and outstanding as of
October 31, 2007 and April
30,
2007
|
15,460
|
14,293
|
|||||
|
Additional
paid-in capital
|
7,614,859
|
7,604,360
|
|||||
|
Deficit
accumulated during development
stage
|
(11,204,549
|
)
|
(15,796,145
|
)
|
|||
|
Total
stockholders’ deficit
|
(3,574,229
|
)
|
(8,177,491
|
)
|
|||
|
Total
liabilities and stockholders’ deficit
|
$
|
40,756
|
$
|
67,326
|
|||
F-63
Somanta
Pharmaceuticals, Inc.
(Formerly
Hibshman Optical Corp.)
(A
Development Stage Company)
Three
Months and Six Months Ended October 31,
2007 and 2006 and for the
Period
from
Inception of Operations
(April
19, 2001) to October 31, 2007
(Unaudited)
|
From Inception
of
Operations
(April 19, 2001) to
October 31,
2007
|
||||||||||||||||
|
Three
Months Ended
October 31,
|
Six
Months Ended
October 31,
|
|||||||||||||||
|
2007
|
2006
|
2007
|
2006
|
|||||||||||||
|
Revenue
|
$
|
357
|
$
|
357
|
$
|
714
|
$
|
714
|
$
|
3,571
|
||||||
|
Operating
expenses:
|
||||||||||||||||
|
General
and administrative
|
(293,809
|
)
|
(874,810
|
)
|
(726,685
|
)
|
(1,700,359
|
)
|
(8,063,803
|
)
|
||||||
|
Research
and development
|
(269,688
|
)
|
(583,318
|
)
|
(321,827
|
)
|
(901,352
|
)
|
(3,422,474
|
)
|
||||||
|
Loss
from operations
|
(563,140
|
)
|
(1,457,771
|
)
|
(1,047,798
|
)
|
(2,600,997
|
)
|
(11,482,706
|
)
|
||||||
|
Other
income (expense):
|
||||||||||||||||
|
Interest
income
|
—
|
11,475
|
5
|
28,554
|
40,437
|
|||||||||||
|
Interest
expense
|
(20,181
|
)
|
—
|
(27,316
|
)
|
—
|
(1,043,390
|
)
|
||||||||
|
Liquidated
damages
|
—
|
85,302
|
—
|
(35,200
|
)
|
(35,200
|
)
|
|||||||||
|
Change
in fair value of warrant liabilities
|
88,157
|
119,762
|
5,669,206
|
394,324
|
2,875,631
|
|||||||||||
|
Gain
on settlement of debt
|
—
|
—
|
—
|
—
|
5,049
|
|||||||||||
|
Currency
translation loss
|
(589
|
)
|
(768
|
)
|
(710
|
)
|
(2,002
|
)
|
(34,206
|
)
|
||||||
|
Income
(loss) before income taxes
|
(495,753
|
)
|
(1,242,000
|
)
|
4,593,387
|
(2,215,321
|
)
|
(9,674,385
|
)
|
|||||||
|
Income
taxes
|
(1,600
|
)
|
—
|
(1,791
|
)
|
(250
|
)
|
(7,847
|
)
|
|||||||
|
Net
income (loss)
|
(497,353
|
)
|
(1,242,000
|
)
|
4,591,596
|
(2,215,571
|
)
|
(9,682,232
|
)
|
|||||||
F-64
|
Deemed
dividends on convertible preferred
stock
|
—
|
—
|
—
|
—
|
(1,522,317
|
)
|
||||||||||
|
Net
income (loss) applicable to
common shareholders
|
$
|
(497,353
|
)
|
$
|
(1,242,000
|
)
|
$
|
4,591,596
|
$
|
(2,215,571
|
)
|
$
|
(11,204,549
|
)
|
||
|
Net
income (loss) per share-basic
|
$
|
(0.03
|
)
|
$
|
(0.09
|
)
|
$
|
0.31
|
$
|
(0.16
|
)
|
$
|
(0.84
|
)
|
||
|
Weighted
average number of shares outstanding—basic
|
14,630,402
|
14,274,534
|
14,630,402
|
14,274,534
|
13,364,892
|
|||||||||||
|
Net
income (loss) per share-diluted
|
$
|
(0.03
|
)
|
$
|
(0.09
|
)
|
$
|
0.19
|
$
|
(0.16
|
)
|
$
|
(0.84
|
)
|
||
|
Weighted
average number of shares outstanding—diluted
|
14,630,402
|
14,274,534
|
23,889,527
|
14,274,534
|
13,364,892
|
The
accompanying notes to condensed consolidated
financial statements are an
integral part of these statements.
F-65
Somanta
Pharmaceuticals, Inc.
(Formerly
Hibshman Optical Corp.)
(A
Development Stage Company)
For
the Period from Inception of Operations
(April 19, 2001) to October 31, 2007
(Unaudited)
|
Additional
Paid-in
Capital
|
Shares
to
be
Issued
|
||||||||||||||||||
|
Preferred
Stock
|
Common
Stock
|
||||||||||||||||||
|
Shares
|
Amount
|
Shares
|
Amount
|
||||||||||||||||
|
Balance
at April 19, 2001 (Inception)
|
—
|
$
|
—
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
|||||||||
|
Shares
issued for cash at $.0326
|
4,299,860
|
4,300
|
135,680
|
—
|
|||||||||||||||
|
Shares
issued for services at $.0139
|
514,674
|
515
|
11,801
|
||||||||||||||||
|
Amortization
of deferred expense
|
|||||||||||||||||||
|
Comprehensive
loss—foreign currency translation
adjustment
|
|||||||||||||||||||
|
Net
loss for the period from inception
to April 30, 2002
|
|||||||||||||||||||
|
Balance
at April 30, 2002
|
—
|
—
|
4,814,534
|
4,815
|
147,481
|
—
|
|||||||||||||
|
Shares
issued for cash at $1.0677
|
14,601
|
15
|
15,575
|
||||||||||||||||
|
Shares
issued for services at $.0214
|
219,010
|
219
|
4,472
|
||||||||||||||||
|
Amortization
of deferred expense
|
|||||||||||||||||||
|
Receipt
of cash for subscription receivable
|
|||||||||||||||||||
|
Comprehensive
loss—foreign currency translation
adjustment
|
|||||||||||||||||||
|
Net
loss for the year ended April
30, 2003
|
|||||||||||||||||||
F-66
|
Balance
at April 30, 2003
|
—
|
—
|
5,048,145
|
5,049
|
167,528
|
—
|
|||||||||||||
|
Shares
issued for cash at $1.2479
|
350,164
|
350
|
436,637
|
||||||||||||||||
|
Shares
issued for services at $1.2587
|
22,233
|
22
|
27,962
|
||||||||||||||||
|
Amortization
of deferred expense
|
|||||||||||||||||||
|
Exchange
for loan payment and compensation
|
181,371
|
||||||||||||||||||
|
Comprehensive
loss—foreign currency translation
adjustment
|
|||||||||||||||||||
|
Net
loss for the year ended April
30, 2004
|
|||||||||||||||||||
|
Balance
at April 30, 2004
|
—
|
—
|
5,420,542
|
5,421
|
813,498
|
—
|
|||||||||||||
|
Shares
issued for cash at $1.3218
|
374,073
|
374
|
494,069
|
||||||||||||||||
|
Shares
issued for services at $1.2308
|
21,901
|
22
|
26,933
|
||||||||||||||||
|
3,650
shares to be issued for service
at $1.4973
|
5,465
|
||||||||||||||||||
|
Amortization
of deferred expense
|
|||||||||||||||||||
|
Receipt
of cash for subscription receivable
|
|||||||||||||||||||
|
Options
issued for services
|
257,515
|
||||||||||||||||||
|
Comprehensive
loss—foreign currency translation
adjustment
|
|||||||||||||||||||
|
Net
loss for the year ended April
30, 2005
|
|||||||||||||||||||
|
Balance
at April 30, 2005
|
—
|
—
|
5,816,516
|
5,817
|
1,592,015
|
5,465
|
|||||||||||||
|
Write
off foreign currency translation
adjustment
|
|||||||||||||||||||
|
Shares
issued for cash at $1.5656
|
12,669
|
13
|
19,821
|
||||||||||||||||
|
Shares
issued for prior service
|
3,650
|
3
|
5,462
|
(5,465
|
)
|
||||||||||||||
|
Amortization
of deferred expense
|
|||||||||||||||||||
|
Options
issued for services
|
300,616
|
||||||||||||||||||
|
Recapitalization
with Bridge Oncology
|
7,865,000
|
7,865
|
(92,335
|
)
|
|
Beneficial
conversion feature associated
with convertible debt
financing
|
364,721
|
||||||||||||||||||
|
Convertible
Series A Preferred shares issued
for cash at $10,000
(net
of issuance costs of $544,169)
|
464
|
0.464
|
4,095,830
|
||||||||||||||||
|
Convertible
Series A Shares issued on conversion
of notes payable
|
128.6318
|
0.1286
|
1,286,318
|
||||||||||||||||
|
Deemed
dividend on account of beneficial
conversion feature associated
with
issuance of Convertible Series
A Preferred Shares
|
1,522,317
|
||||||||||||||||||
|
Issuance
costs on warrants issued to
placement agent in connection
with the
Convertible Series A Preferred
stock
|
(429,757
|
)
|
|||||||||||||||||
|
Discount
on warrant issued with Convertible
Series A Preferred
stock
|
(2,048,531
|
)
|
|||||||||||||||||
|
Recapitalization
with Hibshman Optical Corp.
|
576,700
|
577
|
(7,708
|
)
|
|||||||||||||||
|
Warrant
expense
|
92,689
|
||||||||||||||||||
|
Net
loss for the year ended April
30, 2006
|
|||||||||||||||||||
F-67
|
Balance
at April 30, 2006
|
592.6318
|
.5926
|
14,274,535
|
14,275
|
6,701,458
|
—
|
|||||||||||||
|
Options
issued for services
|
739,000
|
||||||||||||||||||
|
Warrant
expense
|
163,920
|
||||||||||||||||||
|
Conversion
of preferred stock
|
(1.000
|
)
|
(.0010
|
)
|
18,069
|
18
|
(18
|
)
|
|||||||||||
|
Net
loss for the year ended April
30, 2007
|
|||||||||||||||||||
|
Balance
at April 30, 2007
|
591.6318
|
.5916
|
14,292,604
|
14,293
|
7,604,360
|
||||||||||||||
F-68
Somanta
Pharmaceuticals, Inc.
(Formerly
Hibshman Optical Corp.)
(A
Development Stage Company)
Six
Months Ended October 31, 2007 and 2006
and for the Period from Inception of
Operations
(April
19, 2001) to October 31, 2007
(Unaudited)
|
From
Inception of
Operations
(April
19, 2001) to
October
31, 2007
|
||||||||||
|
Six
Months Ended October 31,
|
||||||||||
|
2007
|
2006
|
|||||||||
|
Cash
flows provided by (used for)
operating activities:
|
||||||||||
|
Net
income (loss)
|
$
|
4,591,596
|
$
|
(2,215,571
|
)
|
$
|
(9,682,232
|
)
|
||
|
Adjustments
to reconcile net loss to net
cash provided by (used for)
operating
activities:
|
||||||||||
|
Depreciation
|
2,690
|
2,770
|
9,684
|
|||||||
|
Gain
on sale of equipment
|
—
|
(622
|
)
|
(622
|
)
|
|||||
|
Amortization
of stock based expense
|
—
|
—
|
39,520
|
|||||||
|
Write
off foreign currency translation
adjustment
|
—
|
—
|
25,931
|
|||||||
|
Change
in fair value of warrant liabilities
|
(5,669,206
|
)
|
(394,324
|
)
|
(2,875,631
|
)
|
||||
|
Shares
issued for services and compensation
|
—
|
—
|
219,262
|
|||||||
|
Gain
on settlement of debts
|
—
|
—
|
(5,049
|
)
|
||||||
|
Options
expense
|
—
|
124,376
|
1,297,131
|
|||||||
|
Warrants
expense
|
—
|
—
|
256,609
|
|||||||
|
Interest
expense related to beneficial
conversion feature on convertible
note
|
—
|
—
|
364,721
|
|||||||
|
Interest
expense related to warrants
issued on convertible note
|
—
|
—
|
514,981
|
|||||||
|
Changes
in assets and liabilities:
|
||||||||||
|
(Increase)
decrease in assets -
|
||||||||||
|
VAT
receivable
|
—
|
1,628
|
3,444
|
|||||||
|
Other
receivable
|
—
|
(22,509
|
)
|
—
|
||||||
|
Restricted
funds
|
2,000
|
(2,269
|
)
|
—
|
||||||
|
Prepaid
expenses
|
17,917
|
33,093
|
(25,120
|
)
|
||||||
|
Deposits
|
—
|
—
|
(73
|
)
|
||||||
|
Increase
(decrease) in liabilities:
|
||||||||||
|
Accounts
payable
|
229,784
|
214,931
|
1,012,445
|
|||||||
|
Accrued
liabilities
|
(42,418
|
)
|
783,221
|
1,311,994
|
||||||
|
Liquidated
damages
|
—
|
35,200
|
35,200
|
|||||||
|
Deferred
revenue
|
(714
|
)
|
(714
|
)
|
6,429
|
|||||
|
Due
to officers and related parties
|
75,140
|
152,003
|
171,120
|
|||||||
|
Net
cash used for operating activities
|
(793,211
|
)
|
(1,288,787
|
)
|
(7,320,256
|
)
|
||||
|
Cash
flows used for investing activities:
|
||||||||||
|
Purchase
of equipment
|
—
|
—
|
(24,824
|
)
|
||||||
|
Proceeds
from sale of equipment
|
—
|
2,000
|
2,000
|
|||||||
|
Net
cash used for investing activities
|
—
|
2,000
|
(22,824
|
)
|
||||||
|
Cash
flows provided by financing
activities:
|
||||||||||
|
Loan
payable—related party
|
—
|
—
|
79,402
|
|||||||
|
Loan
payment-related party
|
—
|
—
|
(7,367
|
)
|
||||||
|
Proceeds
from convertible note-related
party
|
—
|
—
|
1,250,000
|
|||||||
|
Proceeds
from note payable
|
789,250
|
—
|
822,712
|
|||||||
|
Proceeds
from issuance of common stock
|
—
|
—
|
928,125
|
|||||||
|
Proceeds
from issuance of preferred
stock
|
—
|
—
|
4,095,831
|
|||||||
|
Cash
received for subscription receivable
|
—
|
—
|
175,801
|
|||||||
|
Net
cash provided by financing
activities
|
789,250
|
—
|
7,344,504
|
|||||||
|
Effect
of exchange rate changes on
cash
|
—
|
—
|
—
|
|||||||
|
Increase
(decrease) in cash
|
(3,961
|
)
|
(1,286,787
|
)
|
1,424
|
|||||
|
Cash,
beginning of
period
|
5,385
|
1,587,751
|
—
|
|||||||
|
Cash,
end of
period
|
$
|
1,424
|
$
|
300,964
|
$
|
1,424
|
||||
|
Supplemental
disclosure of cash flow information:
|
||||||||||
|
Interest
paid
|
$
|
—
|
$
|
—
|
$
|
—
|
||||
|
Income
tax paid
|
$
|
—
|
$
|
—
|
$
|
—
|
||||
|
Supplemental
disclosure of non-cash operating
and financing activities:
|
||||||||||
|
Loan
reduction with shares
|
$
|
—
|
$
|
—
|
$
|
2,909
|
||||
|
Receivable
from issuance of convertible
stock
|
$
|
—
|
$
|
—
|
$
|
—
|
||||
|
Issuance
of warrants in conjunction
with convertible preferred
stock
|
$
|
—
|
$
|
—
|
$
|
2,341,785
|
||||
|
Deemed
dividends related to convertible
preferred stock
|
$
|
—
|
$
|
—
|
$
|
1,522,317
|
||||
|
Conversion
of note and accrued interest
|
$
|
—
|
$
|
—
|
$
|
1,286,318
|
||||
|
Accrued
issuance costs related to convertible
stock
|
$
|
—
|
$
|
—
|
$
|
—
|
||||
The
accompanying notes to condensed consolidated
financial statements are an
integral part of these statements.
F-69
SOMANTA
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
|
1.
|
ORGANIZATION,
BASIS OF PRESENTATION, AND
NATURE OF
OPERATIONS
|
Organization
Somanta
Pharmaceuticals, Inc. is a Delaware corporation
that was formed for the purpose
of effecting the reincorporation of Hibshman
Optical Corp., a New Jersey
corporation, into the State of Delaware
and for the purpose of consummating a
business combination via a reverse merger
of Somanta Incorporated and Hibshman
Optical Corp. Pursuant to this reverse
merger, Somanta Incorporated became the
wholly-owned subsidiary of Somanta Pharmaceuticals,
Inc. and the sole operating
subsidiary of Somanta Pharmaceuticals,
Inc. For financial reporting purposes,
this transaction has been reflected in
the accompanying financial statements
as
a recapitalization of Somanta Incorporated
and the financial statements of
Somanta Pharmaceuticals, Inc. reflect
the historical financial information
of
Somanta Incorporated. References herein
to the “Company” or “Somanta” are
intended to refer to each of Somanta
Pharmaceuticals, Inc. and its wholly
owned
subsidiary Somanta Incorporated, as well
as Somanta Incorporated’s wholly-owned
subsidiary Somanta Limited.
Hibshman
Optical Corp. was originally incorporated
in the State of New Jersey in 1991
under the name PRS Sub I, Inc. The name
subsequently changed to Service Lube,
Inc., then to Fianza Commercial Corp.
and then to Hibshman Optical Corp. The
business plan since that time had been
to seek to enter into a business
combination with an entity that had ongoing
operations through a reverse merger
or other similar type of transaction.
Somanta
Incorporated was incorporated as Somantis
Limited under the laws of England and
Wales on April 19, 2001. Somantis Limited
changed its name to Somanta Limited on
March 14, 2005, and performed business
as a United Kingdom entity through the
fiscal year ending April 30, 2005. On
August 22, 2005, Somanta Limited became
a
wholly owned subsidiary of Bridge Oncology
Products, Inc. (“BOPI”), a privately
held Delaware corporation, pursuant to
a share exchange with BOPI; however,
Somanta Limited was deemed the accounting
acquirer in this share exchange
transaction. On August 24, 2005, the
name of BOPI was changed to Somanta
Incorporated.
Somanta
Pharmaceuticals, Inc. is a development
stage biopharmaceutical company engaged
in the development of products for the
treatment of cancer. The Company has
in-licensed four product development
candidates from academic and research
institutions in the United States and
Europe designed for use in anti-cancer
therapy in order to advance them along
the regulatory and clinical pathways
toward commercial approval. The Company
intends to obtain approval from the
United States Food and Drug Administration
(“FDA”) and from the European
Medicines Evaluation Agency (“EMEA”) for the products.
Somanta
is a development stage enterprise since
the Company has not generated revenue
from the sale of its products, and its
efforts have been principally devoted
to
identification, licensing and clinical
development of its products as well as
raising capital through October 31, 2007.
Accordingly, the financial statements
have been prepared in accordance with
the provisions of Statement of Financial
Accounting Standards (SFAS) No. 7, “Accounting and Reporting by Development
Stage Enterprises.”
F-70
Basis
of Presentation
The
accompanying unaudited condensed interim
consolidated financial statements have
been prepared in accordance with accounting
principles generally accepted in the
United States of America for interim
financial information and with the
instructions to Form 10-QSB and Article
10 of Regulation S-X. Accordingly, they
do not include all of the information
and footnotes required by accounting
principles generally accepted in the
United States of America for complete
financial statements. These condensed
consolidated financial statements should
be read in conjunction with the consolidated
financial statements and notes for
the years ended April 30, 2007 and 2006.
The
preparation of financial statements in
conformity with generally accepted
accounting principles requires management
to make estimates and assumptions that
affect the amounts reported in the financial
statements and accompanying notes.
Actual results could differ from those
estimates. In the opinion of management,
all adjustments (consisting solely of
normal recurring adjustments) considered
necessary for a fair presentation have
been included. Operating results for
the
six months ended October 31, 2007 are
not necessarily indicative of the results
that may be expected for the full fiscal
year ending April 30,
2008.
The
Company reported a net income and net
income applicable to common stockholders
of $4,591,596 for the six month period
ended October 31, 2007. The net loss
from
date of inception, April 19, 2001 to
October 31, 2007, totaled $9,682,232
(net
loss applicable to common stockholders
of $11,204,549). The Company’s operating
activities have used cash since its inception.
These losses raise substantial
doubt about the Company’s ability to continue as a going concern.
On
April 18, 2007, the Company, Somanta
Incorporated, a wholly-owned subsidiary
of
the Company and Somanta Limited, a wholly-owned
subsidiary of Somanta
Incorporated, and Access Pharmaceuticals,
Inc. (“Access”) and Somanta
Acquisition Corporation (“Merger Sub”), a wholly-owned subsidiary of Access
and
a Delaware corporation, entered into
an Agreement and Plan of Merger (the
“Merger Agreement”). Pursuant to the terms and subject
to the conditions set
forth in the Merger Agreement, Merger
Sub will merge with and into Somanta,
with
Somanta continuing as the surviving corporation
and becoming a wholly-owned
subsidiary of Access (the “Merger”). The Board of Directors of Somanta
has
approved the Merger and the Merger Agreement.
On August 17, 2007 the Company’s
stockholders approved the merger.
In
connection with the Merger, all of Somanta’s common stock that is outstanding at
the effective time of the Merger (the
“Effective Time”) will be converted into
500,000 shares of Access common stock.
No fractional shares of Access common
stock will be issued as a result of the
Merger. In addition, all of Somanta’s
preferred stock, included accrued and
unpaid dividends, that is outstanding
at
the Effective Time of the Merger will
be converted into 1,000,000 shares of
Access’ common stock. No shares of Access preferred
stock will be issued as a
result of the Merger.
On
April 26, 2007, the Company entered into
a Note Purchase Agreement, a Security
Agreement, a Patent Collateral Assignment
and Security Agreement and a Trademark
Collateral Security and Pledge Agreement
(collectively, the “Loan Documents”)
with Access Pharmaceuticals, Inc. as
more fully described in Note 7. Under
the
terms of the Loan Documents, Access initially
loaned the Company $33,462
($822,712 at October 31, 2007). Access,
in its sole discretion, may from time
to
time advance additional loan amounts
to the Company. All amounts loaned to
the
Company by Access are secured by substantially
all of the assets of the Company
pursuant to the terms of the Loan Documents.
The Note bears interest at 10% and
is repayable at the earlier of: (i) August
31, 2007, or (ii) the date of the
termination of the Agreement and Plan
of Merger dated as of August 18, 2007
between the Company and Access. No demand
for repayment has been made by Access.
To date the Merger has not closed since
the Company has not been able to meet
one of the key closing conditions.
If
the merger fails to close, the Company
expects that it will no longer be able
to
operate its business and will not have
the resources to repay the
loan.
The
financial statements do not include any
adjustments to reflect the possible
future effects on the recoverability
and classification of assets or the amounts
and classification of liabilities that
may result from the possible inability
of
the Company to continue as a going concern.
Reclassifications
For
comparative purposes, prior periods’ consolidated financial statements have
been
reclassified to conform with report classifications
of the current period. The
Company has reclassified certain expenses
related to the in-licensing of product
candidates, milestone and license maintenance
payments and patent expense from
general and administrative expense to
research and development
expense.
Share-Based
Compensation
On
December 16, 2004, the FASB issued SFAS
No. 123 (revised 2004), “Share-Based
Payment” (SFAS 123R). SFAS 123R eliminates the
alternative of applying the
intrinsic value measurement provisions
of APB 25 to stock compensation awards
issued to employees. Rather, the new
standard requires enterprises to measure
the cost of employee services received
in exchange for an award of equity
instruments based on the grant-date fair
value of the award. That cost will be
recognized over the period during which
an employee is required to provide
services in exchange for the award, known
as the requisite service period
(usually the vesting period). On April
14, 2005, the Securities and Exchange
Commission announced the adoption of
a rule that defers the required effective
date of SFAS 123R. The SEC rule provides
that SFAS 123R is now effective for
registrants as of the beginning of the
first fiscal year beginning after June
15, 2005.
Effective
May 1, 2006, the Company adopted SFAS
123R and accordingly has adopted the
modified prospective application method.
Under this method, SFAS 123R is applied
to new awards and to awards modified,
repurchased, or cancelled after the
effective date. Additionally, compensation
cost for the portion of awards that
are outstanding as of the date of adoption
for which the requisite service has
not been rendered (such as unvested options)
is recognized over a period of time
as the remaining requisite services are
rendered.
Prior
to May 1, 2006, the Company accounted
for its employee stock option plan in
accordance with the provisions of SFAS
No. 123, “Accounting
for Stock-Based
Compensation,” and SFAS No. 148, “Accounting
for Stock-Based
Compensation – Transition and Disclosure.”
F-71
Fair
Value of Financial Instruments
Statement
of Financial Accounting Standard No.
107, Disclosures About Fair Value of
Financial Instruments, requires that
the company disclose estimated fair values
of financial instruments. The carrying
amounts reported in the balance sheets
for current assets and current liabilities
qualifying as financial instruments
are a reasonable estimate of fair value.
Basic
and diluted net income (loss) per share
Net
income (loss) per share is calculated
in accordance with the Statement of
Financial Accounting Standards No. 128
(SFAS No. 128). Basic net income (loss)
per share is based upon the weighted
average number of common shares
outstanding. Diluted net income (loss)
per share is based on the assumption
that
all potential dilutive convertible shares
and stock options or warrants were
converted or exercised.
The
Company has the following dilutive convertible
shares, stock options and
warrants as of October 31, 2007 and 2006
which were excluded from the
calculation for the six months ended
October 31, 2007 and from inception to
date
since the effect is anti-dilutive. For
the six months ended October 31, 2007,
the convertible preferred stock have
been included.
|
2007
|
||||||||||
|
Three
Months
Ended
October 31
|
Six
Months
Ended
October 31
|
2006
|
||||||||
|
Convertible
preferred stock
|
9,859,125
|
9,859,125
|
9,877,194
|
|||||||
|
Stock
options
|
—
|
—
|
3,642,747
|
|||||||
|
Warrants
|
5,936,304
|
7,102,838
|
6,952,838
|
|||||||
|
Total
|
15,795,429
|
16,961,963
|
20,472,779
|
|||||||
The
Company’s undeclared dividends on its Preferred
Stock amounting to $115,605 for
the three months ended October 31, 2007
are included in the computation of net
income per share for the period ended
October 31, 2007 in accordance with SFAS
No. 129.
Aggregate
undeclared dividends on Preferred Stock
amounting to $820,918 are included in
the computation of net loss per share
for the period from inception (April
19,
2001) to October 31, 2007.
Recent
Accounting Pronouncements
In
February 2006, the FASB issued SFAS 155
“Accounting for Certain Hybrid Financial
Instruments,” an amendment of FASB Statement No. 133
and in February 2006, the
FASB issued SFAS 155, “Accounting for Certain Hybrid Financial
Instruments,” an
amendment of FASB Statements No. 133
and 140. This Statement amends FASB
Statements No. 133, “Accounting for Derivative Instruments
and Hedging
Activities,” and No. 140, “Accounting for Transfers and Servicing
of Financial
Assets and Extinguishments of Liabilities”. This Statement resolves issues
addressed in Statement 133 Implementation
Issue No. D1, Application of Statement
133 to Beneficial Interests in Securitized
Financial Assets. This
Statement:
|
a.
|
Permits
fair value remeasurement for
any hybrid financial instrument
that contains
an embedded derivative that
otherwise would require
bifurcation;
|
|
|
b.
|
Clarifies
which interest-only strips
and principal-only strips are
not subject to
the requirements of Statement
133;
|
|
|
c.
|
Establishes
a requirement to evaluate interests
in securitized financial assets
to
identify interests that are
freestanding derivatives or
that are hybrid
financial instruments that
contain an embedded derivative
requiring
bifurcation;
|
|
|
d.
|
Clarifies
that concentrations of credit
risk in the form of subordination
are not
embedded derivatives; and
|
|
|
e.
|
Amends
Statement 140 to eliminate
the prohibition on a qualifying
special-purpose
entity from holding a derivative
financial instrument that pertains
to a
beneficial interest other than
another derivative financial
instrument.
|
F-72
This
Statement is effective for all financial
instruments acquired or issued after
the beginning of an entity’s first fiscal year that begins after
September 15,
2006. The fair value election provided
for in paragraph 4(c) of this Statement
may also be applied upon adoption of
this Statement for hybrid financial
instruments that had been bifurcated
under paragraph 12 of Statement 133 prior
to the adoption of this Statement. Earlier
adoption is permitted as of the
beginning of an entity’s fiscal year, provided the entity has
not yet issued
financial statements, including financial
statements for any interim period for
that fiscal year. Provisions of this
Statement may be applied to instruments
that an entity holds at the date of adoption
on an instrument-by-instrument
basis. The Company has no new instruments
impacted by SFAS 155.
In
March 2006, the FASB issued SFAS No.
156 (“FAS 156”), “Accounting for Servicing
of Financial Assets-An Amendment of FASB
Statement No. 140.” Among other
requirements, FAS 156 requires a company
to recognize a servicing asset or
servicing liability when it undertakes
an obligation to service a financial
asset by entering into a servicing contract
under certain situations. Under FAS
156 an election can also be made for
subsequent fair value measurement of
servicing assets and servicing liabilities
by class, thus simplifying the
accounting and providing for income statement
recognition of potential
offsetting changes in the fair value
of servicing assets, servicing liabilities
and related derivative instruments. The
Statement will be effective beginning
the first fiscal year that begins after
September 15, 2006. The Company does
not
expect the adoption of FAS 156 will have
a material impact on the financial
position or results of operations.
In
June 2006, the FASB issued FASB Interpretation
(FIN) No. 48, “Accounting for
Uncertainty in Income Taxes,” that provides guidance on the accounting
for
uncertainty in income taxes recognized
in financial statements. The
interpretation was adopted by us on May
1, 2007. Because of the Company’s
operating losses, adoption of this provision
does not have material effect on
the financial position, results of operations
or cash flows.
In
July 2006, the FASB issued FASB Staff
Position (FSP) No. FAS 13-2, “Accounting
for a Change or Projected Change in the
Timing of Cash Flows Relating to Income
Taxes Generated by a Leveraged Lease
Transaction,” that provides guidance on how
a change or a potential change in the
timing of cash flows relating to income
taxes generated by a leveraged lease
transaction affects the accounting by
a
lessor for the lease. This staff position
was adopted by us on May 1, 2007. The
Company does not expect the adoption
of this provision to have a material
effect
on the financial position, results of
operations or cash flows.
In
September 2006, the FASB issued Statement
No. 157, “Fair
Value Measurements”
(SFAS 157). This Statement defines
fair value, establishes a framework for
measuring fair value in generally accepted
accounting principles (GAAP), and
expands disclosures about fair value
measurements. This Statement applies
under
other accounting pronouncements that
require or permit fair value measurements,
the Board having previously concluded
in those accounting pronouncements that
fair value is the relevant measurement
attribute. Accordingly, this Statement
does not require any new fair value measurements.
However, for some entities,
the application of this Statement will
change current practice. This Statement
is effective for financial statements
issued for fiscal years beginning after
November 15, 2007, and interim periods
within those fiscal years. The Company
does not expect the adoption of SFAS
No. 157 to have a material impact on
the
consolidated financial statements.
In
September 2006, the FASB issued Statement
No. 158, “Employers’
Accounting
for Defined
Benefit Pension and Other Postretirement
Plans—an amendment of FASB Statements
No. 87, 88, 106, and 132(R)” (SFAS 158). This Statement improves
financial reporting by requiring an employer
to recognize the over funded or
under funded status of a defined benefit
postretirement plan (other than a
multiemployer plan) as an asset or liability
in its statement of financial
position and to recognize changes in
that funded status in the year in which
the
changes occur through comprehensive income
of a business entity or changes in
unrestricted net assets of a not-for-profit
organization. This Statement also
improves financial reporting by requiring
an employer to measure the funded
status of a plan as of the date of its
year-end statement of financial position,
with limited exceptions. This Statement
is effective as of the end of the fiscal
year ending after December 15, 2006.
The Company does not have any defined
benefit plans, or other post-retirement
plans. Therefore, the Company does not
expect SFAS No. 158 to have any impact
on the consolidated financial
statements.
In
February 2007, the FASB issued SFAS No.
159, “The
Fair Value Option for Financial
Assets and Financial Liabilities”. The objective of this statement
is to
improve financial reporting by providing
entities with the opportunity to
mitigate volatility in reported earnings
caused by measuring related assets and
liabilities differently without having
to apply complex hedge accounting
provisions. This Statement is expected
by the Board to expand the use of fair
value measurement, consistent with the
Board’s long-term measurement objectives
for accounting for financial instruments.
This statement is effective for fiscal
years beginning after November 15, 2007.
The Company is currently evaluating the
impact of adopting this statement; however,
the Company does not expect the
adoption of this provision to have a
material effect on its financial position,
results of operations or cash flow.
F-73
In
December 2007, the FASB issued SFAS No.
141 (Revised 2007), “Business
Combinations”. The
objective of this statement will significantly
change the accounting for
business combinations. Under Statement
141R, an acquiring entity will be
required to recognize all the assets
acquired and liabilities assumed in a
transaction at the acquisition –date fair value will limited exceptions.
Statement 141 applies prospectively to
business combinations for which the
acquisition date is on or after the beginning
of the first annual reporting
period beginning on or after December
15, 2008. The Company does not expect
the
adoption of SFAS No. 141R to have a material
impact on the consolidated
financial statements.
In
December 2007, the FASB issued SFAS No.
160, “Noncontrolling
Interests in
Consolidated Financial Statements-An
Amendment of ARB No. 51". The
objective of this statement is to establish
new accounting and reporting
standards for the Noncontrolling interest
in a subsidiary and for the
deconsolidation of a subsidiary.. Statement
160 is effective for fiscal years,
and interim periods within those fiscal
years, beginning on or after December
15, 2008. The Company does not expect
the adoption of SFAS No. 160 to have
a
material impact on the consolidated financial
statements.
In
late 2007, the Emerging Issues Task Force
(“EITF”) added two new issues to their
agenda. These include EITF Issue No.
07-1, “Accounting
for Collaborative
Arrangements Relating to the Development
and Commercialization of Intellectual
Property”, and EITF Issue No. 07-3, “Accounting
for Nonrefundable
Payments for Goods or Services to be
Used in Future Research and Development
Activities”. The Company expects that its
activities will be subject to
the EITF’s determination on these matter.
|
2.
|
PRIVATE
PLACEMENT
|
On
January 31, 2006, Somanta Pharmaceuticals,
Inc. completed a private placement of
592.6318 shares of its Series A Convertible
Preferred Stock (“Series A
Preferred”) at a price of $10,000 per share, including
six-year warrants to
purchase an additional 4,938,598 shares
of its common stock. The Series A
Preferred shares consisted of 464 shares
purchased by investors which are
convertible into 7,733,333 shares of
common stock and 128.6318 shares that
gave
effect to the conversion amount of $1,286,318,
representing the value of the
converted note of $1,250,000 and the
associated accrued interest of $36,318.
The
total 592.6318 preferred shares are convertible
into 9,877,197 common shares.
Gross proceeds to Somanta were $4,640,000,
including $3,671,209 in cash,
payments to various vendors amounting
$968,791, which included cash payment
of
$624,105 to SCO Securities, LLC, its
placement agent.
The
Series A Preferred is initially convertible
into 9,877,197 shares of the
Company’s common stock at a conversion price
of $0.60 per share. The conversion
value is subject to adjustment. The exercise
price for the warrants is $0.75 per
share and they are immediately exercisable
upon issuance. The fair market value
of these warrants, as discussed further
below, was estimated to be $0.41 per
share. The warrants expire on January
31, 2012. None of the warrants have been
exercised as of October 31, 2007.
Holders
of the Series A Preferred stock are entitled
to receive dividends at 8% per
annum. Dividends will accrue and will
be cumulative from the date of issuance,
whether or not earned or declared by
the Board of Directors. Dividends can
be
paid at the Company’s option either in cash or shares of
the Company’s common
stock on April 30 and October 31 of each
year. The holders of the Series A
Preferred stock have full voting rights
and powers, subject to the Beneficial
Ownership Cap, equal to the voting rights
and powers of the Common stock
holders. The Board of Directors did not
declare the dividends as of October 31,
2007. Therefore, a dividend of $115,605
for the quarter ended October 31, 2007,
and $820,918 for the period from inception
(April 19, 2001) to October 31, 2007
on the Preferred Stock have not been
recorded in the consolidated financial
statements, but in accordance with SFAS
No. 129, the dividend amount has been
included in the calculation of the net
income per share.
The
Series A Preferred stockholders have
a liquidation preference, in the event
of
any voluntary or involuntary liquidation,
dissolution or winding up of the
Corporation, senior to the holders of
common stock in an amount equal to $10,000
per share of preferred stock plus any
accumulated and unpaid dividends on the
preferred stock. In the alternative,
the holders of the Series A Preferred
may
elect to receive the amount per share
that would be distributed among the
holders of the preferred stock and common
stock pro rata based on the number of
shares of the common stock held by each
holder assuming conversion of all
preferred stock, if such amount is greater
than the amount such holder would
receive pursuant to the liquidation preference.
A change of control of the
Corporation will not be deemed a liquidation.
F-74
The
Series A Preferred Stock is not redeemable
for cash. The holder of any share or
shares of Series A Preferred can, at
the holder’s option, at any time convert
all or any lesser portion of such holder’s shares of Series A Preferred Stock
into such number of shares of common
stock as is determined by dividing the
aggregate liquidation preference of the
shares of preferred stock to be
converted plus accrued and unpaid dividends
thereon by the conversion value then
in effect for such Preferred Stock (“Conversion Value”). The Company can, on the
occurrence of a conversion triggering
event, elect to convert all of the
outstanding preferred stock into common
stock. A conversion triggering event
is
(i) a time when the registration statement
covering the shares of common stock
into which the Series A Preferred is
convertible is effective and sales may
be
made pursuant thereto or all of the shares
of common stock into which the Series
A Preferred is convertible may be sold
without restriction pursuant to Rule
144(k) promulgated by the SEC and the
daily market price of the common stock,
after adjusting for stock splits, reverse
splits, stock dividends and the like
is $5 or more for a period of 30 of the
immediately preceding 60 consecutive
trading days and the volume of common
stock traded on the applicable stock
exchange on each such trading day is
not less than 100,000 shares, or (ii)
a
time when the Company consummates a sale
of common stock in a firm commitment
underwritten public offering in which
the offering price before deduction of
expenses of the common stock is greater
than 200% of the Conversion Value and
the aggregate gross proceeds of the offering
to the Company are greater than $25
million.
All
the outstanding preferred stock will
be automatically converted to common
stock
upon an occurrence of a qualified change
of control provided that upon
consummation of a qualified change of
control the holders of the shares issuable
on automatic conversion shall be entitled
to receive the same per share
consideration as the qualified change
of control transaction consideration.
The
holders of the Series A Preferred may
require the Company to redeem the shares
upon the Company’s failure or refusal to convert any shares
of Preferred Stock
in accordance with the terms of issue,
or by providing a written notice to that
effect.
The
Series A Preferred has been classified
as equity, as the Series A Preferred
stock is not redeemable. In accordance
with EITF No. 00–27, Application
of Issue No. 98–5 to
Certain Convertible Instruments, the Company has determined that
the
Series A Preferred had a beneficial conversion
feature of $1,522,317 as of the
date of issuance. As such, the Company
recorded a non-cash deemed dividend of
$1,522,317 resulting from the difference
between the conversion price determined
after allocation of the full fair value
of the warrants of $0.41 and the fair
value of common stock of $0.60. The carrying
value of the Series A Preferred of
$5,926,318 was recorded net of the deemed
dividend of $1,522,317 and a discount
of $2,048,531 on account of the full
fair value of the warrants at the issuance
date.
The
fair value of the above warrants has
been classified as a liability pursuant
to
EITF 00-19.
|
3.
|
LIQUIDATED
DAMAGES AND WARRANT LIABILITIES
|
In
connection with the additional $250,000
line of credit drawn pursuant to a
convertible note which was converted
into Series A Preferred on January 31,
2006
(Note 4), the Company issued warrants
to purchase a total of 866,534 shares
of
common stock at an exercise price of
$0.01 per share to SCO. The warrants
are
immediately exercisable upon issuance
and expire on November 8, 2012. The fair
market value of these warrants, as discussed
further below, was estimated to be
$0.59 per share. The assumptions used
in the Black-Scholes model were risk-free
interest rate of 4.5% at the time of
issuance, volatility factors of 97.24%
calculated as the weighted average of
the stock price volatility of ranked
comparable public companies, and contractual
terms equal to the exercise periods
of the respective warrants. The fair
value of the common stock as used in
this
calculation was $.60 per share, as negotiated
between the Company and the Series
A Convertible Preferred Stock investors.
These warrants were exercised on August
20, 2007 by a partial forgiveness of
$11,666 of debt owed by the Company to
SCO
Financial Group.
The
holders of the Series A Preferred and
warrants have registration rights which
obligate the Company to file a registration
statement with the Securities and
Exchange Commission (“SEC”) covering the resale of the common stock
issuable
upon conversion of the Series A Preferred
and the common stock issuable upon
exercise of the warrants (as well as
certain other securities of the Company)
within 30 days after the closing of the
private placement. In the event the
registration statement is not filed within
such thirty day period or if the
registration statement is not effective
within 120 days after the date it is
filed, or a registration statement, once
declared effective ceases to remain
effective during the period that the
securities covered by the agreement are
not
sold, the Company will be required to
pay, in cash, liquidated damages for
such
failure, equal to 1% of the holders of
the Series A Preferred investment amount
for each thirty day period in which the
registration statement is not filed or
effective, or maintained effective, as
the case may be. The SEC declared the
Registration Statement effective on August
10, 2006.
F-75
In
accordance with EITF Issue 05-4, The
Effect of a Liquidated Damages
Clause on a Freestanding Financial Instrument
Subject to Issue No. 00-19,
the Company believes that the effect
of the liquidated damages should be treated
under the first view (View A), which
states that a registration rights agreement
should be treated as a combined unit
together with the underlying financial
instruments, warrants and derivative
debenture and evaluated as a single
instrument under EITF Issue 00-19 and
FAS 133. The Company concluded that this
view is the most appropriate for the
transaction. The Registration Rights
Agreement and the financial instruments
to which it pertains (the warrants and
the preferred stock) were considered
a combined instrument and accounted for
accordingly. The SEC declared the Registration
Statement effective on August 10,
2006. As a result, during the quarter
ended July 31, 2006, the Company accrued
a
liability of liquidated damages of $120,502.
During the quarter ended October
31, 2006 an agreement was reached with
SCO on the liquidated damages matter.
The
agreement concluded that since the securities
owned by SCO Capital Partners, LLC
were not registered because SCO voluntarily
withdrew them from the Registration
because of the resale restrictions required
by the SEC, the Company is not
obligated for any liquidated damages
pertaining specifically to SCO Capital
Partners, LLC. Accordingly, the Company
reversed out $85,302 of liquidated
damages in the prior quarter ended October
31, 2006.
The
Company also issued six year warrants
to its placement agent to purchase 987,720
common shares at $0.60 per share to SCO
Securities LLC, as part of the success
fees of 10% of the aggregate value of
the transaction at sales price of common
stock. These warrants are immediately
exercisable upon issuance. The fair value
of these warrants at the date of issue
was estimated to be $0.44 per share and
has been recorded as issuance costs and
offset against the proceeds of the
Series A Preferred.
The
fair value of warrants issued in connection
with the issue of convertible debt
and convertible preferred stock, including
the agent warrants, was estimated at
the date of grant and revalued at October
31, 2007 using a Black Scholes option
pricing model with the following assumptions:
a risk free interest rate of
approximately 4.5% at the issuance date
and 3.94% on October 31, 2007, no
dividend yield, volatility factors of
81.89% to 97.24% at the issuance date
and
53.6% at October 31, 2007, contractual
terms of 6 and 7 years and expected terms
based upon the formula prescribed in
SEC Staff Accounting Bulletin 107 of
2.1
years and years. These assumptions use
the interest rate prevailing at the time
of issuance, volatility factors calculated
as the weighted average of the stock
price volatility of ranked comparable
public companies, and contractual terms
equal to the exercise periods of the
respective warrants. The fair value of
the
common stock as used in this calculation
was $.60 per share at the issuance
date, as negotiated between the Company
and unaffiliated third party Series A
investors, and $0.17 on October 31, 2007.
The change in fair value of the
warrants for the three months ended October
31, 2007 of $88,157, was reported in
other income and disclosed in the financial
statements.
The
following table summarizes the activity
for warrants issued during the six month
period ended October 31, 2007.
On
August 20, 2007, SCO Capital Partners
LLC exercised warrants on 1,166,534 shares
of common stock at $.01 per share by
foregiving $11,666 owed by the Company
to
SCO Financial Group LLC.
|
Number
of
shares
|
Weighted
Average
Exercise
Price
|
||||||
|
Balance—April
30, 2007
|
7,102,838
|
0.61
|
|||||
|
Granted
|
—
|
—
|
|||||
|
Exercised
|
1,166,534
|
0.001
|
|||||
|
Forfeited
|
—
|
—
|
|||||
|
Expired
|
—
|
—
|
|||||
|
Balance—October
31, 2007
|
5,936,304
|
0.61
|
|||||
F-76
The
following table summarizes information
about warrants outstanding as of October
31, 2007.
|
Warrants
Outstanding
|
Warrants
Exercisable
|
|||||||||||||||||
|
Exercise
Prices
|
Number
Outstanding
|
Wtd.
Avg
Remaining
Contr.
Life
|
Wtd.
Avg
Exercise
Price
|
Number
Exercisable
|
Wtd.
Avg
Exercise
Price
|
|||||||||||||
|
$
|
0.60
|
987,720
|
4.2
years
|
$
|
0.60
|
987,720
|
$
|
0.60
|
||||||||||
|
$
|
0.75
|
4,938,597
|
4.2
years
|
$
|
0.75
|
4,938,597
|
$
|
0.75
|
||||||||||
|
$
|
2.25
|
9,987
|
2.5
years
|
$
|
2.25
|
9,987
|
$
|
2.25
|
||||||||||
|
4.
|
EMPLOYMENT
AND CONSULTING AGREEMENTS
|
In
January 2006, the Company entered into
employment agreements with the Company’s
President and Chief Executive Officer
(“CEO”), and with the Company’s Executive
Chairman, for one year terms. These agreements
were automatically renewed for an
additional oneyear term on January 31,
2007. Under these agreements, the
President and Executive Chairman are
to be paid annual base salaries of $275,000
and $248,000, respectively. Both officers
are eligible to receive annual bonuses
and additional stock option grants at
the discretion of the Company’s board of
directors. In July 2006, the Company’s CEO and Executive Chairman agreed to
defer 50% of their base salaries until
the completion of the Company’s next fund
raising at which time the deferred amounts
would be repaid and the deferrals
would cease. Effective October 1, 2006,
the Company’s CEO and Executive Chairman
agreed to defer 100% of their base salaries
until the completion of the
Company’s next fund raising, or the completion
of a merger or other
consolidation with another company, at
which time the deferred amounts would
be
repaid and the deferrals would cease.
Effective June 30, 2006, our Executive
Chairman was appointed by our Board to
be our Chief Financial Officer, Secretary
and Treasurer.
|
5.
|
STOCK-
BASED COMPENSATION
|
The
Board of Directors adopted and the stockholders
approved the 2005 Equity
Incentive Plan in June 2005. The plan
was adopted to recognize the contributions
made by the Company’s employees, officers, consultants, and
directors, to
provide those individuals with additional
incentive to devote themselves to its
future success, and to improve the Company’s ability to attract, retain and
motivate individuals upon whom the Company’s growth and financial success
depends. Under the plan, stock options
may be granted as approved by the Board
of Directors or the Compensation Committee.
There are 8,000,000 shares reserved
for grants of options under the plan,
of which 2,204,701 have been issued as
substitutions with the exact same terms
for the 2,204,701 previously issued
options outstanding as of April 30, 2005.
Stock options vest pursuant to
individual stock option agreements. No
options granted under the plan are
exercisable after the expiration of ten
years (or less in the discretion of the
Board of Directors or the Compensation
Committee) from the date of the grant.
The plan will continue in effect until
terminated or amended by the Board of
Directors or until expiration of the
plan on August 31, 2015.
On
April 13, 2007, the Company’s Board of Directors approved a merger
agreement
with Access Pharmaceuticals, Inc, as
more fully described in Note 15. Under
the
terms of that agreement Access will not
assume, or provide a substitute option,
for any of the Company’s stock options. Rather, all of the outstanding
options
to purchase Company common stock issued
pursuant to the Company’s 2005 Equity
Incentive Plan will be cancelled prior
to the closing of the transaction in
accordance with Section 11.3(d) of the
Equity Incentive Plan. As a result,
pursuant to the terms of Section 11.3(d)
of the Equity Incentive Plan, the
Company’s Board of Directors has resolved to:
(i) allow the immediate and
accelerated vesting of all of the options
granted, and (ii) allowed the exercise
of the option in whole or in part until
May 31, 2007. Based on FAS 123(R), no
incremental expense was recorded for
these options with accelerated vesting
as
the fair value of the modified options
was less than the fair value of the
original options calculated immediately
before the terms were modified. None
of
the options were exercised thru May 31,
2007. Additional expense of $507,284
was
recorded in the year ended April 30,
2007 due to the acceleration of the
vesting. There is no stock-based compensation
expense for the three months ended
October 31, 2007.
F-77
|
6.
|
RELATED
PARTY TRANSACTIONS
|
Fees
Paid to Related Parties
Pursuant
to a financial advisory agreement dated
March 2005 between Bridge Oncology and
SCO Financial Group LLC (SCO), which
the Company has assumed, the Company
compensates SCO with a monthly fee of
$12,500 and an annual grant of warrants
to
purchase 150,000 shares of Company common
stock at an exercise price of $.01 for
the term of the agreement for financial
advisory services. The Company recorded
advisory service fees totaling $75,000
and $75,000 to SCO for the six months
ended October 31, 2007 and 2006, respectively.
Agreement
with Related Party
Virium
Pharmaceuticals, Inc.
The
Company entered into an exclusive co-development
and sublicense agreement in
February 2005 with a related entity,
Virium Pharmaceuticals, Inc. These two
entities share a common director and
their largest single shareholder, SCO
Capital Partners LLC. On May 19, 2005,
the Company paid $50,000 to this related
party to in-license phenylbutyrate and
expensed this amount.
|
7.
|
SECURED
NOTE
|
On
April 26, 2007, the Company entered into
a Note Purchase Agreement, a Security
Agreement, a Patent Collateral Assignment
and Security Agreement and a Trademark
Collateral Security and Pledge Agreement
(collectively, the “Loan Documents”)
with Access Pharmaceuticals, Inc. (“Access”). Under the terms of the Loan
Documents, Access initially loaned the
Company $33,462 ($822,712 at October
31,
2007). Access, in its sole discretion,
may from time to time advance additional
loan amounts to the Company. All amounts
loaned to the Company by Access are
secured by substantially all of the assets
of the Company pursuant to the terms
of the Loan Documents. The Note bears
interest at 10% and is repayable at the
earlier of: (i) August 31, 2007, or (ii)
the date of the termination of the
Agreement and Plan of Merger dated as
of August 18, 2007 between the Company
and
Access. To date the Merger has not closed
since the Company has not been able to
meet one of the key closing conditions.
No demand for repayment has been
received from Access.
|
8.
|
MERGER
AGREEMENT
|
On
April 18, 2007, the Company, Somanta
Incorporated, a wholly-owned subsidiary
of
the Company and Somanta Limited, a wholly-owned
subsidiary of Somanta
Incorporated, and Access Pharmaceuticals,
Inc. (“Access”) and Somanta
Acquisition Corporation (“Merger Sub”), a wholly-owned subsidiary of Access
and
a Delaware corporation, entered into
an Agreement and Plan of Merger (the
“Merger Agreement”). Pursuant to the terms and subject
to the conditions set
forth in the Merger Agreement, Merger
Sub will merge with and into Somanta,
with
Somanta continuing as the surviving corporation
and becoming a wholly-owned
subsidiary of Access (the “Merger”). In addition, Access has received voting
agreements with certain executive officers,
directors and affiliates of Somanta
representing approximately 81% of Somanta’s outstanding common and approximately
60% of its outstanding preferred shares
under which the parties, subject to
certain limited exceptions, have granted
an irrevocable proxy to Access to vote
their shares in favor of the merger.
In
connection with the Merger, all of Somanta’s common stock that is outstanding at
the effective time of the Merger (the
“Effective Time”) will be converted into
500,000 shares of Access common stock.
No fractional shares of Access common
stock will be issued as a result of the
Merger. In addition, all of Somanta’s
preferred stock, including accrued and
unpaid dividends, that is outstanding
at
the Effective Time of the Merger will
be converted into 1,000,000 shares of
Access’ common stock. No shares of Access preferred
stock will be issued as a
result of the Merger.
F-78
As
of April 18, 2007, there were (i) 15,459,137
shares of Somanta’s common stock
outstanding, including 1,166,534 shares
issuable upon the exercise of warrants
that are expected to be exercised prior
to the Effective Time, and (ii) 591.6
shares of Somanta’s preferred stock outstanding. Also as
of April 18, 2007,
there were outstanding warrants to purchase
5,936,304 shares of Somanta’s common
stock that are not expected to be exercised
prior to the Effective Time and are
expected to be converted into warrants
to purchase approximately 192,000 shares
of Access’ common stock (subject to adjustment as
provided in the Merger
Agreement). On August 17, 2007, the Company’s stockholders approved the Merger.
On August 20, 2007, SCO Capital Partners
LLC exercised warrants on 1,166,534
shares of common stock at $.01 per share
by forgiving $11,622 owed by the
Company to SCO Financial Group LLC
The
completion of the Merger is subject to
various conditions to closing, including,
without limitation, obtaining the approval
of the Somanta stockholders. The
Merger is intended to qualify as reorganization
for federal income tax purposes.
To date the Merger has not closed since
the Company has not been able to meet
one of the key closing conditions.
|
9.
|
SUBSEQUENT
EVENTS
|
As
of December 19, 2007, the Company had
borrowed $856,064 from Access under the
Secured Note (Footnote 7).
F-79
UNAUDITED
PRO FORMA CONDENSED COMBINED FINANCIAL
STATEMENTS
The
following unaudited pro forma condensed
combined financial statements apply to
the merger between Somanta, a Delaware
corporation, and Access, a Delaware
corporation, by which Somanta became
a wholly owned subsidiary of Access,
and
are based upon the historical condensed
consolidated financial statements and
notes thereto (as applicable) of Access
and Somanta, which are incorporated by
reference into this Registration Statement.
The unaudited pro forma condensed
combined balance sheet gives pro forma
effect to the merger as if the merger
had
been completed on September 30, 2007
and combines Access’s September 30, 2007
audited consolidated balance sheet with
Somanta’s October 31,
2007 audited consolidated balance sheet. The
unaudited pro forma condensed
combined statement of operations gives
pro forma effect to the merger as if
it
had been completed on January 1, 2006
and combines Access’
audited consolidated statement of operations
for the year ended December
31, 2006, with Somanta’s audited consolidated statement of operations
for the
twelve months ended April 30, 2007.
Somanta
preferred and common stockholders are
expected to receive 1,500,000 shares
of
Access common stock for Somanta common
stock they own at the completion of the
merger.
The
pro
forma adjustments are based upon available
information and certain assumptions
that Access believes are reasonable under
the circumstances. A final
determination of fair values relating
to the merger, which cannot be made prior
to the completion of the merger, may
differ materially from the preliminary
estimates and will include management’s final valuation of the fair value of
assets acquired and liabilities assumed.
This final valuation will be based on
the actual net tangible assets of Somanta
that exist as of the date of the
completion of the merger. The final valuation
may change the allocations of the
purchase price, which could affect the
fair value assigned to the assets and
liabilities and could result in a change
to the unaudited pro forma condensed
combined financial statements data.
These
unaudited pro forma condensed combined
financial statements should be read in
conjunction with the historical consolidated
financial statements and related
notes contained in the annual, quarterly
and other reports filed by Access and
Somanta with the SEC.
Pro
Forma Condensed Combined Balance Sheet
As
of September 30, 2007
(Unaudited)
Historical
|
Access
|
Somanta
|
Pro
Forma
Adjustments
|
Pro
Forma
Combined
|
|||||||||||||
|
ASSETS
|
||||||||||||||||
|
Current
assets
|
||||||||||||||||
|
Cash
and cash equivalents
|
$
|
661,000
|
$
|
2,000
|
$
|
663,000
|
||||||||||
|
Short
term investments, at cost
|
515,000
|
-
|
515,000
|
|||||||||||||
|
Receivables
|
861,000
|
-
|
(823,000 | ) |
(d
|
) |
38,000
|
|||||||||
|
Prepaid
expenses and other current
expenses
|
530,000
|
25,000
|
(410,000
|
) |
(c
|
) |
145,000
|
|||||||||
|
Total
current assets
|
2,567,000
|
27,000
|
1,361,000
|
|||||||||||||
|
Property
and equipment, net
|
156,000
|
14,000
|
170,000
|
|||||||||||||
|
Patents
net
|
752,000
|
-
|
752,000
|
|||||||||||||
|
Other
assets
|
25,000
|
-
|
25,000
|
|||||||||||||
|
Total
assets
|
$
|
3,500,000
|
$
|
41,000
|
$
|
2,308,000
|
||||||||||
|
LIABILITIES
AND STOCKHOLDERS’ DEFICIT
|
||||||||||||||||
|
Current
liabilities
|
||||||||||||||||
|
Accounts
payables and accrued expenses
|
$
|
1,595,000
|
$
|
2,353,000
|
(410,000
|
) |
(c,d
|
)
|
$
|
3,538,000
|
||||||
|
Due
to related parties
|
-
|
281,000
|
281,000
|
|||||||||||||
|
Liquidated
damages related to Series A
|
-
|
35,000
|
(35,000
|
)
|
(b
|
)
|
-
|
|||||||||
|
Accrued
interest payable
|
1,023,000
|
-
|
1,023,000
|
|||||||||||||
|
Deferred
revenues
|
1,167,000
|
6,000
|
1,173,000
|
|||||||||||||
| Warrant liabilities | - | 118,000 |
(118,000
|
)
|
(b
|
)
|
- | |||||||||
|
Current
portion of long-term debt
net
of discount
|
11,406,000
|
823,000
|
(823,000
|
)
|
(d
|
)
|
11,406,000
|
|||||||||
|
Total
current liabilities
|
15,191,000
|
3,616,000
|
17,421,000
|
|||||||||||||
|
Long-term
debt
|
5,500,000
|
-
|
5,500,000
|
|||||||||||||
|
Total
liabilities
|
20,691,000
|
3,616,000
|
22,921,000
|
|||||||||||||
|
Stockholders’
deficit
|
||||||||||||||||
|
Preferred
stock
|
-
|
-
|
-
|
|||||||||||||
|
Common
stock
|
36,000
|
15,000
|
15,000
(15,000
|
)
|
(a
(b
|
)
)
|
51,000
|
|||||||||
|
Additional
paid-in capital
|
69,687,000
|
7,615,000
|
7,485,000
(7,615,000
|
)
|
(a
(b
|
)
)
|
77,172,000
|
|||||||||
|
Notes
receivable from stockholders
|
(1,045,000
|
)
|
-
|
(1,045,000
|
)
|
|||||||||||
|
Treasury
stock, at cost
|
(4,000
|
)
|
-
|
(4,000
|
)
|
|||||||||||
|
Accumulated
deficit
|
(85,865,000
|
)
|
(11,205,000
|
)
|
(7,500,000
|
)
|
(a
|
)
|
(96,787,000
|
)
|
||||||
|
(3,422,000
11,205,000
|
)
|
(b
(b
|
)
)
|
|||||||||||||
|
Total
stockholders’ deficit
|
(17,191,000
|
)
|
(3,575,000
|
)
|
(20,613,000
|
)
|
||||||||||
|
Total
liabilities and stockholders’ deficit
|
$
|
3,500,000
|
$
|
41,000
|
$
|
2,308,000
|
||||||||||
See
accompanying Notes to Pro Forma Condensed Combined Balance Sheet
F-80
Notes
to Pro Forma Condensed Combined Balance Sheet
|
|
Note
1: The above statement gives effect to the following pro forma adjustments
necessary to reflect the merger of Access and Somanta, as if the
transaction had occurred September 30, 2007. Somanta statements used
were October 31, 2007.
|
|
|
a)
|
To
record the exchange, for accounting purposes, by Somanta shareholders
of
their common stock (valued at $7,500,000) for 1,500,000 shares of
Access
(or 1,500,000 shares valued at the estimated stock price of $5.00
per
share) and record $1,000,000 in new warrant liability. The value
placed on
the shares was determined based on negotiation between the companies
of
the amount of Access shares to issue to Somanta shareholders and
the
estimated stock price of $5.00 per share. The excess purchase price
over
the fair value of Somanta's assets acquired is being charged to
deficit.
|
|
|
b)
|
To
eliminate the shareholders equity section and warrant liabilities
of
Somanta in connection with the merger and credit the net equity to
combined deficit.
|
|
|
c)
|
Accrual
of $410,000 of estimated legal, accounting and other professional
fees
relating to the merger.
|
|
|
d)
|
Eliminate
intercompany notes receivable and payable of
$823,000.
|
After
the
consummation of the transactions described herein, Access will have 100,000,000
common shares authorized, approximately 5,075,114 common shares issued and
outstanding, 2,000,000 preferred shares authorized and no preferred shares
issued.
F-81
Pro
Forma Condensed Combined Statement of Operations
For
the Nine Months Ended September 30, 2007
(Unaudited)
Historical
|
Access
|
Somanta
|
Pro
Forma
Combined
|
||||||||
|
Revenue
|
$
|
6,000
|
$
|
1,000
|
$
|
7,000
|
||||
|
Expenses
|
||||||||||
|
Research
and development
|
1,532,000
|
568,000
|
2,100,000
|
|||||||
|
General
and administrative
|
3,252,000
|
1,969,000
|
5,221,000
|
|||||||
|
Depreciation
and amortization
|
210,000
|
-
|
210,000
|
|||||||
|
Total
expenses
|
4,994,000
|
2,537,000
|
7,531,000
|
|||||||
|
Loss
from operations
|
(4,988,000
|
)
|
(2,536,000
|
)
|
(7,524,000
|
)
|
||||
|
Interest
and miscellaneous income
|
72,000
|
12,000
|
84,000
|
|||||||
|
Interest
and other expenses
|
(3,277,000
|
)
|
(27,000
|
) |
(3,304,000
|
)
|
||||
|
Change
in fair value of warrant liabilities
|
-
|
5,807,000
|
|
5,807,000
|
|
|||||
|
Currency
translation loss
|
-
|
(2,000
|
)
|
(2,000
|
)
|
|||||
|
(3,205,000
|
)
|
5,790,000
|
|
2,585,000
|
|
|||||
|
Loss
From Operations
|
(8,193,000
|
)
|
3,254,000
|
|
(4,939,000
|
)
|
||||
|
Income
Tax
|
-
|
-
|
(4,000
|
) | ||||||
|
Net
loss
|
$
|
(8,193,000
|
)
|
$
|
3,254,000
|
|
$
|
(4,943,000
|
)
|
|
|
Basic
and diluted loss per
common
share
|
$
|
(2.31
|
)
|
$
|
0.22
|
|
$
|
(0.98
|
)
|
|
|
Weighted
average basic and
diluted
common shares outstanding
|
3,544,181
|
14,630,402
|
5,044,181
|
|||||||
Notes
to
Pro Forma Condensed Combined Statement of Operations
Note
1:
The above statement gives effect to the merger of Access and Somanta, as if
the
merger had occurred on January 1, 2006. Somanta statements used were for the
nine months ended October 31, 2007.
Note
2:
The pro forma combined-weighted average number of common outstanding shares
is
based on the weighted average number of shares of common stock of Access during
the period plus those shares to be issued in conjunction with the merger. A
reconciliation between Access' historical weighted average shares outstanding
and pro forma weighted average shares outstanding and pro forma weighted average
shares outstanding is as follows:
|
Historical
|
3,544,181
|
|
|
Somanta
equivalent shares giving effect to the merger
|
1,500,000
|
|
|
Total
|
5,044,181
|
.
F-82
Pro
Forma Condensed Combined Statement of Operations
For
the Twelve Months Ended December 31, 2006
(Unaudited)
Historical
|
Access
|
Somanta
|
Pro
Forma
Combined
|
||||||||
|
Revenue
|
$
|
-
|
$
|
1,000
|
$
|
1,000
|
||||
|
Expenses
|
||||||||||
|
Research
and development
|
2,053,000
|
1,239,000
|
3,292,000
|
|||||||
|
General
and administrative
|
2,813,000
|
3,313,000
|
6,126,000
|
|||||||
|
Depreciation
and amortization
|
309,000
|
-
|
309,000
|
|||||||
|
Total
expenses
|
5,175,000
|
4,552,000
|
9,727,000
|
|||||||
|
Loss
from operations
|
(5,175,000
|
)
|
(4,551,000
|
)
|
(9,726,000
|
)
|
||||
|
Interest
and miscellaneous income
|
294,000
|
28,000
|
322,000
|
|||||||
|
Interest
and other expenses
|
(7,436,000
|
)
|
-
|
(7,436,000
|
)
|
|||||
|
Liquidated
damages
|
-
|
(35,000
|
)
|
(35,000
|
)
|
|||||
|
Change
in fair value of warrant liabilities
|
(1,107,000
|
)
|
(2,931,000
|
)
|
(4,038,000
|
)
|
||||
|
Currency
translation loss
|
-
|
(3,000
|
)
|
(3,000
|
)
|
|||||
|
(8,249,000
|
)
|
(2,941,000
|
)
|
(11,190,000
|
)
|
|||||
|
Net
loss before discontinued
operations
and before tax benefit
|
(13,424,000
|
)
|
(7,492,000
|
)
|
(20,916,000
|
)
|
||||
|
Income
tax benefit
|
173,000
|
(4,000
|
)
|
169,000
|
||||||
|
Loss
from continuing operations
|
(13,251,000
|
)
|
(7,496,000
|
)
|
(20,747,000
|
)
|
||||
|
Discontinued
operations, net of
taxes
of $173,000
|
377,000
|
-
|
377,000
|
|||||||
|
Net
loss
|
$
|
(12,874,000
|
)
|
$
|
(7,496,000
|
)
|
$
|
(20,370,000
|
)
|
|
|
Basic
and diluted loss per common share
|
||||||||||
|
Loss
from continuing operations
allocable
to common stockholders
|
$
|
(3.75
|
)
|
$
|
(0.52
|
)
|
$
|
(4.12
|
)
|
|
|
Discontinued
operations
|
0.10
|
-
|
0.07
|
|||||||
|
Net
loss allocable to common stockholders
|
$
|
(3.65
|
)
|
$
|
(0.52
|
)
|
$
|
(4.05
|
)
|
|
|
Weighted
average basic and
diluted
common shares outstanding
|
3,531,934
|
14,274,534
|
5,031,934
|
|||||||
Notes
to
Pro Forma Condensed Combined Statement of Operations
Note
1:
The above statement gives effect to the merger of Access and Somanta, as if
the
merger had occurred on January 1, 2006. Somanta statements used were for the
twelve months ended April 30, 2007.
Note
2:
The pro forma combined-weighted average number of common outstanding shares
is
based on the weighted average number of shares of common stock of Access during
the period plus those shares to be issued in conjunction with the merger. A
reconciliation between Access' historical weighted average shares outstanding
and pro forma weighted average shares outstanding and pro forma weighted average
shares outstanding is as follows:
|
Historical
|
3,531,934
|
|
|
Somanta
equivalent shares giving effect to the merger
|
1,500,000
|
|
|
Total
|
5,031,934
|
F-83
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
13. Other Expenses of Issuance and Distribution
Expenses
of the Registrant in connection with the issuance and distribution of the
securities being registered, are estimated as follows:
|
SEC
Registration Fee
|
$
|
1,324
|
|
|
Printing
and Engraving Expenses
|
$
|
2,500
|
|
|
Legal
Fees and Expenses
|
$
|
20,000
|
|
|
Accountants'
Fees and Expenses
|
$
|
25,000
|
|
|
Miscellaneous
Costs
|
$
|
2,176
|
|
|
Total
|
$
|
51,000
|
Item
14. Indemnification of Directors and Officers
Section 145
of the Delaware General Corporation law empowers a Delaware corporation to
indemnify its officers and directors and certain other persons to the extent
and
under the circumstances set forth therein.
The
Registrant’s Certificate of Incorporation, as amended, and By-laws, as amended,
provide for indemnification of officers and directors of the Registrant and
certain other persons against liabilities and expenses incurred by any of them
in certain stated proceedings and under certain stated conditions.
The
above
discussion of the Registrant's Certificate of Incorporation, as amended,
By-laws, as amended, and Section 145 of the Delaware General Corporation
Law is not intended to be exhaustive and is qualified in its entirety by such
Certificate of Incorporation, By-Laws and statute.
Item
15: Recent Sales of Unregistered Securities
On
February 4, 2008, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 272.5 shares of
our preferred stock, designated “Series A Cumulative Convertible Preferred
Stock”, par value $0.01 per share, for an issue price of $10,000 per share, (the
“Series A Preferred Stock”) and agreed to issue warrants to purchase 545,000
shares of our common stock, which includes placement agent warrants to purchase
90,883 shares of our common stock, at an exercise price of $3.50 per share,
for
an aggregate purchase price for the Series A Preferred Stock and Warrants
of
$2,700,000. The shares of Series A Preferred Stock are convertible into common
stock at the initial conversion price of $3.00 per share.
On
November 7, 2007, we entered into securities purchase agreements (the “Purchase
Agreements”) with accredited investors whereby we agreed to sell 954.0001 shares
of a newly created series of our preferred stock, designated “Series A
Cumulative Convertible Preferred Stock”, par value $0.01 per share, for an issue
price of $10,000 per share, (the “Series A Preferred Stock”) and agreed to issue
warrants to purchase 1,589,999 shares of our common stock at an exercise
price
of $3.50 per share, for an aggregate purchase price for the Series A Preferred
Stock and Warrants of $9,540,001. The shares of Series A Preferred Stock
are
convertible into common stock at the initial conversion price of $3.00 per
share.
On
December 6, 2006, we entered into a note and warrant purchase agreement pursuant
to which we sold and issued an aggregate of $500,000 of 7.5% convertible notes
due November 15, 2007 and warrants to purchase 386,364 shares of common stock
of
Access. Net proceeds to Access were $450,000. The notes and warrants were sold
in a private placement to a group of accredited investors led by SCO Capital
Partners LLC (“SCO”) and affiliates.
On
October 24, 2006, we entered into a note and warrant purchase agreement pursuant
to which we sold and issued an aggregate of $500,000 of 7.5% convertible notes
due November 15, 2007 and warrants to purchase 386,364 shares of common stock
of
Access. Net proceeds to Access were $450,000. The notes and warrants were sold
in a private placement to a group of accredited investors led by SCO and
affiliates.
On
February 16, 2006, the Registrant entered into a note and warrant purchase
agreement pursuant to which it sold and issued an aggregate of $5,000,000 of
7.5% convertible notes due November 15, 2007 and warrants to purchase an
aggregate of 3,863,634 shares of common stock of Access. Net proceeds to Access
were $4.557 million. The notes and warrants were sold in a private placement
to
a group of accredited investors led by SCO and its affiliates.
All
of
the above-described issuances were exempt from registration pursuant to
Section 4(2) of the Securities Act or Rule 506 of Regulation D
promulgated thereunder, as transactions not involving a public
offering.
Item
16. Exhibits
The
following is a list of exhibits filed as a part of this registration
statement:
Exhibit
|
Number
|
Description
of
Document
|
|
2.1
|
Amended
and Restated Agreement of Merger and Plan of Reorganization between
Access
Pharmaceuticals, Inc. and Chemex Pharmaceuticals, Inc., dated as
of
October 31, 1995 (Incorporated by reference to Exhibit A of the our
Registration Statement on Form S-4 dated December 21, 1995, Commission
File No. 33-64031)
|
|
2.2
|
Agreement
and Plan of Merger, by and among Access Pharmaceuticals, Inc., Somanta
Acquisition Corporation, Somanta Pharmaceuticals, Inc. Somanta
Incorporated and Somanta Limited, dated April 18, 2007. (Incorporated
by
reference to Exhibit 2.1 to our Form 8-K dated April 18,
2007)
|
|
3.0
|
Articles
of incorporation and bylaws
|
|
3.1
|
Certificate
of Incorporation (Incorporated by Reference to Exhibit 3(a) of our
Form
8-B dated July 12, 1989, Commission File Number
9-9134)
|
3.2 Certificate
of Amendment of Certificate of Incorporation filed August 21, 1992
|
3.3
|
Certificate
of Merger filed January 25, 1996. (Incorporated by reference to Exhibit
E
of our Registration Statement on Form S-4 dated December 21, 1995,
Commission File No. 33-64031)
|
|
3.4
|
Certificate
of Amendment of Certificate of Incorporation filed January 25, 1996.
(Incorporated by reference to Exhibit E of our Registration Statement
on
Form S-4 dated December 21, 1995, Commission File No.
33-64031)
|
|
3.5
|
Certificate
of Amendment of Certificate of Incorporation filed July 18, 1996.
(Incorporated by reference to Exhibit 3.8 of our Form 10-K for the
year
ended December 31, 1996)
|
|
3.6
|
Certificate
of Amendment of Certificate of Incorporation filed June 18, 1998.
(Incorporated by reference to Exhibit 3.8 of our Form 10-Q for the
quarter
ended June 30, 1998
|
|
3.7
|
Certificate
of Amendment of Certificate of Incorporation filed July 31, 2000.
(Incorporated by reference to Exhibit 3.8 of our Form 10-Q for the
quarter
ended March 31, 2001)
|
|
3.8
|
Certificate
of Designations of Series A Junior Participating Preferred Stock
filed
November 7, 2001 (Incorporated by reference to Exhibit 4.1.h of our
Registration Statement on Form S-8, dated December 14, 2001, Commission
File No. 333-75136)
|
|
3.9
|
Amended
and Restated Bylaws (Incorporated by reference to Exhibit 3.1 of
our Form
10-Q for the quarter ended June 30,
1996)
|
|
3.10
|
Certificate
of Designation of Series A Cumulative Convertible Preferred Stock
filed
November 9, 2007
|
|
5.1**
|
Opinion
of Bingham McCutchen LLP regarding the legality of the
securities.
|
|
10.1*
|
1995
Stock Option Plan (Incorporated by reference to Exhibit F of our
Registration Statement on Form S-4 dated December 21, 1995, Commission
File No. 33-64031
|
|
10.2*
|
Amendment
to 1995 Stock Option Plan (Incorporated by reference to Exhibit 10.25
of
our Form 10-K for the year ended December 31,
2001)
|
|
10.3
|
Lease
Agreement between Pollock Realty Corporation and us dated July 25,
1996
(Incorporated by reference to Exhibit 10.19 of our Form 10-Q for
the
quarter ended September 30, 1996)
|
|
10.4
|
Platinate
HPMA Copolymer Royalty Agreement between The School of Pharmacy,
University of London and the Company dated November 19, 1996 (Incorporated
by reference to Exhibit 10.11 of our Form 10-K for the year ended
December
31, 1996)
|
|
10.5*
|
Employment
Agreement of David P. Nowotnik, PhD (Incorporated by reference to
Exhibit
10.19 of our Form 10-K for the year ended December 31,
1999)
|
|
10.6*
|
401(k)
Plan (Incorporated by reference to Exhibit 10.20 of our Form 10K
for the
year ended December 31, 1999)
|
|
10.7
|
Form
of Convertible Note (Incorporated by reference to Exhibit 10.24 of
our
Form 10-Q for the quarter ended September 30,
2000)
|
|
10.8
|
Rights
Agreement, dated as of October 31, 2001 between the us and American
Stock
Transfer & Trust Company, as Rights Agent (incorporated by reference
to Exhibit 99.1 of our Current Report on Form 8-K dated October 19,
2001)
|
|
10.9
|
Amendment
to Rights Agreement, dated as of February 16, 2006 between us and
American
Stock Transfer & Trust Company, as Rights Agent
(2)
|
|
10.10
|
Amendment
to Rights Agreement, dated as of November 9, 2007 between us and
American
Stock Transfer & Trust Company as Rights
Agent
|
|
10.11*
|
2001
Restricted Stock Plan (Incorporated by reference to Appendix A of
our
Proxy Statement filed on April 16,
2001)
|
|
10.12*
|
2005
Equity Incentive Plan (Incorporated by reference to Exhibit 1 of
our Proxy
Statement filed on April 18, 2005
(2)
|
|
10.13*
|
Employment
Agreement, dated as of June 1, 2005 by and between us and Stephen
B.
Thompson (1)
|
|
10.14
|
Asset
Sale Agreement, dated as of October 12, 2005, between us and Uluru,
Inc.
(1)
|
|
10.15
|
Amendment
to Asset Sale Agreement, dated as of December 8, 2006, between us
and
Uluru, Inc. (3)
|
|
10.16
|
License
Agreement, dated as of October 12, 2005, between us and Uluru, Inc.
(1)
|
|
10.17
|
Form
of Warrant, dated February 16, 2006, issued by us to certain Purchasers
(2)
|
|
10.18
|
Form
of Warrant, dated October 24, 2006, issued by us to certain Purchasers
(3)
|
|
10.19
|
Form
of Warrant, December 6, 2006, issued by us to certain Purchasers
(3)
|
|
10.20*
|
2007
Special Stock Option Plan and Agreement, dated January 4, 2007, by
and
between us and Stephen R. Seiler, President and Chief Executive Officer
(4)
|
|
10.21*
|
Employment
Agreement, dated January 4, 2007 by and between us and Stephen R.
Seiler,
President and Chief Executive Officer
(4)
|
|
10.22
|
Note
Purchase Agreement dated April 26, 2007 between us and Somanta
Pharmaceuticals, Inc. (Incorporated by reference to Exhibit 10.42
of our
Form 10-Q for the quarter ended June 30 30,
2007)
|
|
10.23
|
Preferred
Stock and Warrant Purchase Agreement, dated November 7, 2007, between
us
and certain Purchasers
|
|
10.24
|
Investor
Rights Agreement, dated November 10, 2007, between us and certain
Purchasers
|
|
10.25
|
Form
of Warrant Agreement dated November 10, 2007, between us and certain
Purchasers
|
|
10.26
|
Board
Designation Agreement, dated November 15, 2007, between us and SCO
Capital
Partners LLC
|
|
10.27
|
Amendment
and Restated Purchase Agreement, dated February 4, 2008 between us
and
certain Purchasers
|
|
10.28
|
Amended
and Restated Investor Rights Agreement, dated February 4, 2008 between
us
and certain Purchasers
|
|
10.29
|
Employment
Agreement, dated January 4, 2008 between us and Jeffrey B.
Davis
|
|
23.1
|
Consent
of Whitley Penn LLP
|
|
23.2
|
Consent
of Stonefield Josephson, Inc.
|
|
23.3
|
Opinion
of Bingham McCutchen LLP regarding the legality of the securities
to be
filed with amendment to this Registration
Statement
|
|
Exhib
|
|
*
|
[Management
contract or compensatory plan required to be filed as an Exhibit
to this
Form pursuant to Item 15(c) of the
report.]
|
|
**
|
To
be filed with Amendment to this Registration
Statement
|
|
(1)
|
Incorporated
by reference to our Form 10-K for the year ended December 31,
2005.
|
|
(2)
|
Incorporated
by reference to our Form 10-Q for the quarter ended March 31,
2006.
|
|
(3)
|
Incorporated
by reference to our Form 10-K for the year ended December 31,
2006.
|
|
(4)
|
Incorporated
by reference to our Form 10-Q for the quarter ended March 31,
2007.
|
II-3
Item
17. Undertakings
The
undersigned Registrant hereby undertakes:
(1) To
file, during any period in which offers or sales are being made a post-effective
amendment to this Registration Statement:
(i) to
include any prospectus required by Section 10(a)(3) of the Securities Act
of 1933;
(ii) to
reflect in the prospectus any facts or events arising after the effective date
of the registration statement (or the most recent post-effective amendment
thereof) which, individually or in the aggregate, represent a fundamental change
in the information set forth in the registration statement. Notwithstanding
the
foregoing, any increase or decrease in volume of securities offered (if the
total dollar value of securities offered would not exceed that which was
registered) and any deviation from the low or high end of the estimated maximum
offering range may be reflected in the form of prospectus filed with the
Commission pursuant to Rule 424(b) if, in the aggregate, the changes in
volume and price represent no more than a 20 percent change in the maximum
aggregate offering price set forth in the “Calculation of Registration Fee”
table in the effective registration statement.
(iii) to
include any material information with respect to the plan of distribution not
previously disclosed in this Registration Statement or any material change
to
such information in this Registration Statement.
(2) That,
for the purpose of determining any liability under the Securities Act of 1933,
each such post-effective amendment shall be deemed to be a new Registration
Statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering
thereof.
(3) To
remove from registration by means of a post-effective amendment any of the
securities being registered which remain unsold at the termination of the
offering.
Insofar
as indemnification for liabilities arising under the Securities Act of 1933
may
be permitted to directors, officers and controlling persons of the Registrant
pursuant to the foregoing provisions described in Item 24 above, or otherwise,
the Registrant has been advised that in the opinion of the Securities and
Exchange Commission such indemnification is against public policy as expressed
in the Securities Act and is, therefore, unenforceable.
In
the
event that a claim for indemnification against such liabilities (other than
the
payment by the Registrant of expenses incurred or paid by a director, officer
or
controlling person of the Registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person
in connection with the securities being registered, the Registrant will, unless
in the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in the
Securities Act and will be governed by the final adjudication of such
issue.
Each
prospectus filed pursuant to Rule 424(b) as part of a registration statement
relating to an offering, other than registration statements relying on Rule
430B
or other than prospectuses filed in reliance on Rule 430A, shall be deemed
to be
part of and included in the registration statement as of the date it is first
used after effectiveness. Provided, however, that no statement made in a
registration statement or prospectus that is part of the registration statement
or made in a document incorporated or deemed incorporated by reference into
the
registration statement or prospectus that is part of the registration statement
will, as to a purchaser with a time of contract of sale prior to such first
use,
supersede or modify any statement that was made in the registration statement
or
prospectus that was part of the registration statement or made in any such
document immediately prior to such date of first use.
II-4
A/72419127.4
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, as amended, the Registrant
has duly caused this Registration Statement on Form S-1 to be signed on its
behalf by the undersigned, thereunto duly authorized, in the City of Dallas,
State of Texas, on this 8th day of March, 2008.
ACCESS
PHARMACEUTICALS,
INC.
Date
March 8,
2008 By: /s/ Jeffrey
B.
Davis
Jeffrey
B. Davis
Chief
Executive Officer
Date
March 8,
2008 By: /s/ Stephen
B.
Thompson
Stephen
B. Thompson
Vice
President, Chief
Financial
Officer
and
Treasurer
POWER
OF ATTORNEY
We,
the
undersigned directors of Access Pharmaceuticals, Inc., hereby severally
constitute and appoint Jeffrey B. Davis and Stephen B. Thompson, and both or
either one of them, our true and lawful attorneys-in-fact and agents, with
full
power of substitution and re-substitution in for him and in his name, place
and
stead, and in any and all capacities, to sign any and all amendments (including
post-effective amendments) to this Registration Statement, and any subsequent
registration statements pursuant to Rule 462 of the Securities Act, and to
file
the same, with all exhibits thereto and other documents in connection therewith,
with the Securities and Exchange Commission, granting unto said
attorneys-in-fact and agents, and each of them, full power and authority to
do
and perform each and every act and thing requisite and necessary to be done
in
and about the premises, as fully to all intents and purposes as he might or
could do in person, hereby ratifying and confirming all that each of said
attorneys-in-fact or his substitute or substitutes, may lawfully do or cause
to
be done by virtue hereof.
Pursuant
to the requirements of the Securities Act of 1933, as amended, this Registration
Statement on Form S-1 has been signed below by the following persons in the
capacities and on the dates indicated:
Date
March 8,
2008 By: /s/ Mark
J.
Ahn
Mark
J. Ahn, Director
Date
March 8,
2008 By: /s/ Mark
J.
Alvino
Mark
J. Alvino, Director
Date
March 8,
2008 By: /s/ Esteban
Cvitkovic
Esteban
Cvitkovic,
Director
Date
March 8,
2008 By: /s/ Jeffrey
B.
Davis
Jeffrey
B. Davis,
Director,
Chief
Executive Officer
Date
March 8,
2008 By: /s/ Stephen
B.
Howell
Stephen
B. Howell,
Director
Date March 8,
2008 By: /s/ David
P.
Luci
David
P. Luci, Director
II-5
Date March 8,
2008 By: /s/ Rosemary
Mazanet
Rosemary
Mazanet,
Director
Date March 8,
2008 By: /s/ John
J.
Meakem
John
J. Meakem, Jr.,
Director
Date March 8,
2008 By: /s/ Steven
H.
Rouhandeh
Steven
H. Rouhandeh, Chairman
of
the
Board
II-6
|
|
Exhibit
|
|
Number
|
Description
of
Document
|
|
2.1
|
Amended
and Restated Agreement of Merger and Plan of Reorganization between
Access
Pharmaceuticals, Inc. and Chemex Pharmaceuticals, Inc., dated as
of
October 31, 1995 (Incorporated by reference to Exhibit A of the our
Registration Statement on Form S-4 dated December 21, 1995, Commission
File No. 33-64031)
|
|
2.2
|
Agreement
and Plan of Merger, by and among Access Pharmaceuticals, Inc., Somanta
Acquisition Corporation, Somanta Pharmaceuticals, Inc. Somanta
Incorporated and Somanta Limited, dated April 18, 2007. (Incorporated
by
reference to Exhibit 2.1 to our Form 8-K dated April 18,
2007)
|
|
3.0
|
Articles
of incorporation and bylaws
|
|
3.1
|
Certificate
of Incorporation (Incorporated by Reference to Exhibit 3(a) of our
Form
8-B dated July 12, 1989, Commission File Number
9-9134)
|
3.2 Certificate
of Amendment of Certificate of Incorporation filed August 21, 1992
|
3.3
|
Certificate
of Merger filed January 25, 1996. (Incorporated by reference to Exhibit
E
of our Registration Statement on Form S-4 dated December 21, 1995,
Commission File No. 33-64031)
|
|
3.4
|
Certificate
of Amendment of Certificate of Incorporation filed January 25, 1996.
(Incorporated by reference to Exhibit E of our Registration Statement
on
Form S-4 dated December 21, 1995, Commission File No.
33-64031)
|
|
3.5
|
Certificate
of Amendment of Certificate of Incorporation filed July 18, 1996.
(Incorporated by reference to Exhibit 3.8 of our Form 10-K for the
year
ended December 31, 1996)
|
|
3.6
|
Certificate
of Amendment of Certificate of Incorporation filed June 18, 1998.
(Incorporated by reference to Exhibit 3.8 of our Form 10-Q for the
quarter
ended June 30, 1998
|
|
3.7
|
Certificate
of Amendment of Certificate of Incorporation filed July 31, 2000.
(Incorporated by reference to Exhibit 3.8 of our Form 10-Q for the
quarter
ended March 31, 2001)
|
|
3.8
|
Certificate
of Designations of Series A Junior Participating Preferred Stock
filed
November 7, 2001 (Incorporated by reference to Exhibit 4.1.h of our
Registration Statement on Form S-8, dated December 14, 2001, Commission
File No. 333-75136)
|
|
3.9
|
Amended
and Restated Bylaws (Incorporated by reference to Exhibit 3.1 of
our Form
10-Q for the quarter ended June 30,
1996)
|
|
3.10
|
Certificate
of Designation of Series A Cumulative Convertible Preferred Stock
filed
November 9, 2007
|
|
5.1**
|
Opinion
of Bingham McCutchen LLP regarding the legality of the
securities.
|
|
10.1*
|
1995
Stock Option Plan (Incorporated by reference to Exhibit F of our
Registration Statement on Form S-4 dated December 21, 1995, Commission
File No. 33-64031
|
|
10.2*
|
Amendment
to 1995 Stock Option Plan (Incorporated by reference to Exhibit 10.25
of
our Form 10-K for the year ended December 31,
2001)
|
|
10.3
|
Lease
Agreement between Pollock Realty Corporation and us dated July 25,
1996
(Incorporated by reference to Exhibit 10.19 of our Form 10-Q for
the
quarter ended September 30, 1996)
|
|
10.4
|
Platinate
HPMA Copolymer Royalty Agreement between The School of Pharmacy,
University of London and the Company dated November 19, 1996 (Incorporated
by reference to Exhibit 10.11 of our Form 10-K for the year ended
December
31, 1996)
|
|
10.5*
|
Employment
Agreement of David P. Nowotnik, PhD (Incorporated by reference to
Exhibit
10.19 of our Form 10-K for the year ended December 31,
1999)
|
|
10.6*
|
401(k)
Plan (Incorporated by reference to Exhibit 10.20 of our Form 10K
for the
year ended December 31, 1999)
|
|
10.7
|
Form
of Convertible Note (Incorporated by reference to Exhibit 10.24 of
our
Form 10-Q for the quarter ended September 30,
2000)
|
|
10.8
|
Rights
Agreement, dated as of October 31, 2001 between the us and American
Stock
Transfer & Trust Company, as Rights Agent (incorporated by reference
to Exhibit 99.1 of our Current Report on Form 8-K dated October 19,
2001)
|
|
10.9
|
Amendment
to Rights Agreement, dated as of February 16, 2006 between us and
American
Stock Transfer & Trust Company, as Rights Agent
(2)
|
|
10.10
|
Amendment
to Rights Agreement, dated as of November 9, 2007 between us and
American
Stock Transfer & Trust Company as Rights
Agent
|
|
10.11*
|
2001
Restricted Stock Plan (Incorporated by reference to Appendix A of
our
Proxy Statement filed on April 16,
2001)
|
|
10.12*
|
2005
Equity Incentive Plan (Incorporated by reference to Exhibit 1 of
our Proxy
Statement filed on April 18, 2005
(2)
|
|
10.13*
|
Employment
Agreement, dated as of June 1, 2005 by and between us and Stephen
B.
Thompson (1)
|
10.14 Asset
Sale Agreement, dated as of October 12, 2005, between us and Uluru, Inc.
(1)
|
10.15
|
Amendment
to Asset Sale Agreement, dated as of December 8, 2006, between us
and
Uluru, Inc. (3)
|
10.16 License
Agreement, dated as of October 12, 2005, between us and Uluru, Inc.
(1)
|
10.17
|
Form
of Warrant, dated February 16, 2006, issued by us to certain Purchasers
(2)
|
|
10.18
|
Form
of Warrant, dated October 24, 2006, issued by us to certain Purchasers
(3)
|
|
10.19
|
Form
of Warrant, December 6, 2006, issued by us to certain Purchasers
(3)
|
|
10.20*
|
2007
Special Stock Option Plan and Agreement, dated January 4, 2007, by
and
between us and Stephen R. Seiler, President and Chief Executive Officer
(4)
|
|
10.21*
|
Employment
Agreement, dated January 4, 2007 by and between us and Stephen R.
Seiler,
President and Chief Executive Officer
(4)
|
|
10.22
|
Note
Purchase Agreement dated April 26, 2007 between us and Somanta
Pharmaceuticals, Inc. (Incorporated by reference to Exhibit 10.42
of our
Form 10-Q for the quarter ended June 30 30,
2007)
|
|
10.23
|
Preferred
Stock and Warrant Purchase Agreement, dated November 7, 2007, between
us
and certain Purchasers
|
|
10.24
|
Investor
Rights Agreement, dated November 10, 2007, between us and certain
Purchasers
|
|
10.25
|
Form
of Warrant Agreement dated November 10, 2007, between us and certain
Purchasers
|
|
10.26
|
Board
Designation Agreement, dated November 15, 2007, between us and SCO
Capital
Partners LLC
|
|
10.27
|
Amendment
and Restated Purchase Agreement, dated February 4, 2008 between us
and
certain Purchasers
|
|
10.28
|
Amended
and Restated Investor Rights Agreement, dated February 4, 2008 between
us
and certain Purchasers
|
|
10.29
|
Employment
Agreement, dated January 4, 2008 between us and Jeffrey B.
Davis
|
23.1 Consent
of Whitley Penn LLP
23.2 Consent
of Stonefield Josephson, inc.
23.3 Opinion
of Bingham McCutchen LLP regarding the legality of the securities to be filed
with amendment to this Registration Statement
|
Exhib
|
|
*
|
[Management
contract or compensatory plan required to be filed as an Exhibit
to this
Form pursuant to Item 15(c) of the
report.]
|
|
**
|
To
be filed with Amendment to this Registration
Statement
|
(1) Incorporated
by reference to our Form 10-K for the year ended December 31, 2005.
|
(2)
|
Incorporated
by reference to our Form 10-Q for the quarter ended March 31,
2006.
|
|
(3)
|
Incorporated
by reference to our Form 10-K for the year ended December 31,
2006.
|
|
(4)
|
Incorporated
by reference to our Form 10-Q for the quarter ended March 31,
2007.
|