SB-2: Optional form for registration of securities to be sold to the public by small business issuers
Published on December 10, 2007
As
filed with the Securities and Exchange Commission on __________
Registration
Number 333-____
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
SB-2
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
ACCESS
PHARMACEUTICALS, INC.
(Exact
Name of Registrant as Specified in its Charter)
|
Delaware
|
3841
|
83-0221517
|
||
|
(State
or other jurisdiction of
incorporation
or organization)
|
(Primary
Standard Industrial
Classification
Code Number)
|
(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.
ྑ
If
delivery of the Prospectus is expected to be made pursuant to Rule 434,
please check the following box. ྑ
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
|
10,757,864
(1)
|
$2.60
(5)
|
$27,970,447
|
$
859 (5)
|
||||
|
Common
stock, $0.01 par value per share
|
3,649,880
(2)
|
$2.60
(5)
|
$
9,489,688
|
$
292 (5)
|
||||
| Common stock, $0.01 par value per share | 772,728 (3) | $2.60 (5) | $ 2,009,093 | $ 62 (5) | ||||
| Common stock, $0.01 par value per share | 1,380,047 (4) | $2.60 (5) | $ 3,588,123 | $ 111 (5) | ||||
|
Total
Common stock, $0.01 par value per share
|
16,560,519
|
$43,057,351
|
$
1,324 (5)
|
|||||
(1) 10,757,864
shares are
issuable to selling stockholders upon
conversion of Series A Preferred Stock.
(2) 3,649,880
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) 772728
shares
are issuable to selling stockholders upon exercise
of warrants for the purchase of shares of the Registrant's Common Stock at
$1.35
per share.
(4) 1,380,047 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 December 7, 2007.
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 ________, 2007
PROSPECTUS
ACCESS
PHARMACEUTICALS, INC.
16,560,519
Shares of Common Stock
This
Prospectus relates to the offer and sale of up to 16,560,519 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, Dennis Lavalle, Lake End
Capital LLC, 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 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 December 7, 2007, the last reported sale price of our common stock was $2.57
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 6.
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 , 2007.
|
Page
|
|
| PROSPECTUS SUMMARY |
1
|
|
EXPLANATORY
NOTE
|
1
|
|
ABOUT
ACCESS
|
1
|
|
SUMMARY
OF THE OFFERING
|
4
|
|
SUMMARY
CONDENSED CONSOLIDATED FINANCIAL INFORMATION
|
5
|
| RISK FACTORS | 6 |
| FORWARD-LOOKING STATEMENTS | 15 |
| SELLING STOCKHOLDERS | 16 |
| USE OF PROCEEDS | 18 |
| PLAN OF DISTRIBUTION | 18 |
| MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND | |
|
RESULTS
OF OPERATIONS
|
21 |
| DESCRIPTION OF BUSINESS | 32 |
| MANAGEMENT - DIRECTORS AND EXECUTIVE OFFICERS | 45 |
| LEGAL PROCEEDINGS | 57 |
| SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT | 57 |
| CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS | 62 |
| MARKET FOR OUR COMMON STOCK | 63 |
| SELECTED CONDENSED CONSOLIDATED FINANCIAL INFORMATION | 65 |
| SUPPLEMENTARY FINANCIAL INFORMATION | 65 |
| QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK | 65 |
| DESCRIPTION OF SECURITIES | 67 |
| EXPERTS | 69 |
| LEGAL MATTERS | 69 |
| WHERE YOU CAN FIND MORE INFORMATION | 69 |
| 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.
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 6 and our financial
statements and the notes to those financial statements beginning on F-1 before
making an investment decision.
EXPLANATORY
NOTE
Of
the
16,560,519 shares being registered for sale in this offering:
(1)
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 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.
(2)
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.
(3)
4,978,995 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 1,499,999 shares underlying Series
A
Preferred Stock and common stock warrants by purchased by SCO and affiliates
and
3,478,996 shares underlying Series A Preferred Stock and common stock warrants
purchased by new investors.
(4)
1,380,047 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 cash. The common stock dividend shares being
resitered represents anticipated dividends on the Series A Preferred Stock
over
2 years assuming a fixed market price of $2.70 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 2006 for the aggregate issuance of $1,000,000
of convertible prommissory notes.
ABOUT
ACCESS
Company
Overview
Access
Pharmaceuticals, Inc. (“Access”) is a Delaware corporation. Access is an
emerging biopharmaceutical company developing products for use in the treatment
of cancer, the supportive care of cancer, and other disease states. Access’
product for the management of oral mucositis, MuGard™, has received marketing
clearance by the FDA as a device. Access’ lead clinical development program for
the drug candidate ProLindac™ (formerly known as AP5346) is in Phase 2 clinical
testing. Access also has advanced drug delivery technologies including
Cobalamin™ mediated oral drug delivery and targeted delivery.
Together
with Access’ subsidiaries, Access has proprietary patents or rights to one
technology approved for marketing and three drug delivery technology
platforms:
• MuGard™
(mucoadhesive liquid technology),
•
synthetic polymer targeted delivery,
•
Cobalamin-mediated oral delivery,
•
Cobalamin-mediated targeted delivery.
1
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
|
||||
|
Oral
Insulin
|
Access
|
Cobalamin
|
Diabetes
|
Pre-Clinical
|
||||
|
Oral
Delivery System
|
Access
|
Cobalamin
|
Various
|
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
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 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.
2
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
19, 2007, we announced we had entered into an agreement to acquire Somanta
Pharmaceuticals, Inc. Pursuant to the terms of the merger agreement, upon
consummation of the acquisition, Somanta’s preferred and common shareholders
would receive an aggregate of 1.5 million shares of Access’ common stock. The
Somanta stockholders approved the proposed transaction at the stockholders’
meeting on August 17, 2007. The closing of the transaction is subject to
numerous conditions including receipt of necessary approvals. There can be
no
assurance that the transaction will be consummated or if consummated that it
will be on the terms described herein. Each of the parties currently has the
right to terminate the Merger Agreement.
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.
3
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 16,560,519 shares of common stock,
consisting of (1) 10,757,864 shares are issuable to selling stockholders
upon conversion of Series A Preferred Stock, (2) 3,649,880 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 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) 1,380,047 shares of Common Stock that may
be ssued as dividends on the Series A Preferred Stock.
In
connection with the Closing, our Board of Directors approved any actions
necessary to cancel, redeem or amend our shareholders rights plan to accommodate
the issuance of the Series A Preferred Stock and warrants.
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:
|
16,560,519
shares, which includes 10,757,864 shares issuable upon conversion
of
Series A Preferred Stock, 3,649,880 issuable upon exercise of
warrants, 1,380,047 shares to be issued as dividends and 772,728
issuable
upon exercise of warrants as described
above.
|
|
Common
stock outstanding:
|
As
of December 10, 2007, 3,575,114 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 $13,817,763 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 $13,817,763 in
cash. We
intend to use these proceeds, if any, for general corporate
purposes.
|
|
OTC
Bulletin Board Symbol:
|
ACCP:OB
|
4
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
|
5
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 $435,000 per month. Access projects its net cash burn rate
from operations for the next 13 months to be approximately $525,000 per month.
Capital expenditures are forecasted to be minor for the next 13 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 through the
end
of 2008. 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.
6
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, if the merger is consummated, 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.
|
We
cannot
assure you that the combination of Somanta with Access will be completed, and
if
it is whether it will result in the realization of the full benefits anticipated
from the merger. At this time each of Access and Somanta may terminate the
Merger Agreement.
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.
7
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.
8
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.
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.
-
Cobalamin™ mediated delivery technology 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.
9
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.
10
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.
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.
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.
|
11
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.
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 13 U.S. patents and to 9
U.S.
patent applications now pending, and 4 European patents and 12 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,
|
| · |
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, Stephen R. Seiler. 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
Stephen R. Seiler, 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.
Seiler’s, 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.
12
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 77.0%, 43.0%, 2835&, 21.9%
and 17.3%, respectively, of Access’ common stock as of December 10, 2007.
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.
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.
13
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 3,575,114 shares of Access common stock that are outstanding as of
December 10, 2007, 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 3,575,114
shares of common stock outstanding as of December 10, 2007, 3,575,114 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
10,757,864 shares issuable upon conversion of our outstanding preferred stock
and 8,376,397 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 16,560,519 shares
of
our common stock being registered in this offering. That means that up to
16,560,519 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.
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.
14
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.
15
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 | 2.2% | 9,091 | 2.0% |
|
Beach
Capital LLC (3)
|
1,040,405 | 22.5% |
608,587
|
10.8% |
|
Brio
Capital LP (4)
|
75,000
|
2.1% |
75,000
|
- |
|
Catalytix
LDC Life Science
Hedge AC (5)
|
24,999
|
*
|
24,999
|
-
|
|
Cobblestone
Asset Mangement LLC (6)
|
155,450
|
4.2% |
125,000
|
* |
|
Cranshire
Capital, LP (7)
|
250,000 | 6.5% |
250,000
|
- |
|
Credit
Suisse Securities (USA) LLC (8)
|
500,000 | 12.3% |
500,000
|
- |
|
Enable
Growth Partners LP (9)
|
249,999
|
6.5% |
249,999
|
- |
| Howard Fischer (10) | 54,545 | 1.5% | 9,091 | 1.3% |
|
Lake
End Capital LLC (11)
|
1,426,216 | 28.5% |
994,398
|
10.8% |
|
Dennis
Lavalle (12)
|
45,000 | 1.2% |
45,000
|
- |
|
Midsummer
Investment, Ltd (13)
|
750,000 | 17.3% |
750,000
|
- |
|
Oracle
Institutional Partners LP (14)
|
390,828 | 9.9% |
380,399
|
* |
|
Oracle
Offshore Ltd. (15)
|
76,893 | 2.1% |
71,886
|
*
|
|
Oracle
Partners, LP (16)
|
1,622,482 | 32.8% |
1,374,831
|
6.9% |
|
Perceptive
Life Sciences
Master Fund Ltd (17)
|
999,999
|
21.9%
|
999,999
|
-
|
|
Rockmore
Investment
Master Fund Ltd (18)
|
249,999
|
6.5%
|
249,999
|
-
|
|
Rodman
& Renshaw LLC (19)
|
109,000
|
3.0% |
109,000
|
- |
|
SAM
Oracle Investments, Inc (20)
|
389,169 | 9.9% |
359,433
|
* |
|
SCO
Capital Partners, LLC (21)
|
9,993,760 | 73.7% |
6,993,761
|
45.6% |
| SCO Capital Partners LP (22) | 999,999 | 21.9% | 999,999 | - |
|
Total:
|
19,484,268 |
|
15,180,472
|
|
--------------------
| (1) |
Applicable
percentage of ownership is based on 3,575,114 shares of common stock
outstanding as of December 10, 2007, together with securities exercisable
or convertible into shares of common stock within 60 days of December
10,
2007, 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.
|
|
|
16
|
(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 5,551,770 shares of Access’ Common
Stock and 6,410,436 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)
|
Lake
End Capital LLC is known to beneficially own warrants to purchase
an
aggregate of 716,482 shares of Access’ Common Stock and Series A Preferred
Stock which may be converted into an aggregate of 709,734 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 747,302
of Access’ Common Stock and 709,734 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.
|
|
(12)
|
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.
|
|
(13)
|
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.
|
|
(14)
|
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.
|
|
(15)
|
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.
|
|
(16)
|
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.
|
17
|
(17)
|
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.
|
|
(18)
|
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.
|
|
(19)
|
Rodman
& Renshaw LLC is known to beneficially own warrants to purchase an
aggregate of 109,000 shares of Access’ Common
Stock.
|
|
(20)
|
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.
|
|
(21)
|
SCO
Capital Partners LLC is known to directly beneficially own warrants
to
purchase an aggregate of 4,783,240 shares of Access’ Common Stock and
Series A Preferred Stock which may be converted into an aggregate
of
5,229,470 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 5,551,770
shares of
Access’ Common Stock and 6,410,436 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.
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|
(22)
|
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 5,551,770 shares of Access’
Common Stock and 6,410,436 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.
|
18
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.
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.
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.
19
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:
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-
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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);
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purchases
by a broker-dealer as principal and resale by such broker-dealer,
including resales for its account, pursuant to this
prospectus;
|
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ordinary
brokerage transactions and transactions in which the broker solicits
purchases;
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through
options, swaps or derivatives;
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in
privately negotiated transactions;
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in
making short sales or in transactions to cover short sales; and
|
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-
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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.
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20
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).
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:
21
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the
name of each such selling security holder and of the participating
broker-dealer(s);
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-
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the
number of shares involved;
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the
initial price at which the shares were
sold;
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the
commissions paid or discounts or concessions allowed to the
broker-dealer(s), where applicable;
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that
such broker-dealer(s) did not conduct any investigation to verify
the
information set out or incorporated by reference in this prospectus;
and
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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.
22
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 developing products for use in the
treatment of cancer, the supportive care of cancer, and other disease states.
Our product for the management of oral mucositis, MuGard™, has received
marketing clearance by the FDA as a device. Our lead clinical development
program for the drug candidate ProLindac™ (formerly known as AP5346) is in Phase
2 clinical testing. Access also has advanced drug delivery technologies
including Cobalamin™-mediated oral drug delivery and targeted
delivery.
Together
with our subsidiaries, we have proprietary patents or rights to one technology
approved for marketing and three drug delivery technology
platforms:
• MuGard
(mucoadhesive liquid technology),
•
synthetic polymer targeted delivery,
•
Cobalamin-mediated oral delivery,
•
Cobalamin-mediated targeted delivery.
Products
We
have
used our drug delivery technologies to develop the following products and
product candidates:
ACCESS
PRODUCT PORTFOLIO
|
Compound
|
|
Originator
|
|
Technology
|
|
Indication
|
|
FDA
Filing
|
|
Clinical
Stage
(1)
|
|
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|
|
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MuGard™
|
Access
|
Mucoadhesive
Liquid
|
Mucositis
|
510(k)
|
Marketing
clearance
received
|
|||||
|
ProLindacTM
(Polymer
Platinate,
AP5346) (2)
|
|
Access
- U London
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Synthetic
polymer
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Cancer
|
|
Clinical
Development(3)
|
|
Phase
2
|
|
Oral
Insulin
|
Access
|
Cobalamin
|
Diabetes
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Research
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Pre-Clinical
|
|||||
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Oral
Delivery System
|
Access
|
Cobalamin
|
Various
|
Research
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Pre-Clinical
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|||||
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Cobalamin-Targeted
Therapeutics
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Access
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Cobalamin
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Anti-tumor
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Research
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Pre-Clinical
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(1)
For more information, see “Form 10-KSB, 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.
(3)
Clinical study being conducted in Europe.
23
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.
Recent
Events
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.
24
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
19, 2007, we announced we had entered into an agreement to acquire Somanta
Pharmaceuticals, Inc. Pursuant to the terms of the merger agreement, upon
consummation of the acquisition, Somanta’s preferred and common shareholders
would receive an aggregate of 1.5 million shares of Access’ common
stock. The Somanta stockholders approved the proposed transaction at the
stockholders’ meeting on August 17, 2007. The closing of the transaction is
subject to numerous conditions including receipt of necessary approvals. There
can be no assurance that the transaction will be consummated or if consummated
that it will be on the terms described herein. Each of the parties currently
has
the right to terminate the Merger Agreement.
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.
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.
25
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.
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).
|
26
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.
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.
27
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.
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.
28
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.
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 funding for operations during the quarter
ended September 30, 2007. As
of
November 30, 2007, our cash and cash equivalents and short-term investments
were
$7,271,000 and our net cash burn rate for the nine months ending September
30,
2007 was approximately $435,000 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 December 10, 2007 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
December 10, 2007, 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 through December 2008. 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.
29
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;
|
| · |
the
ability to merge with Somanta Pharmaceuticals, Inc. and integrate
their
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:
|
Twleve
Months ended
|
Nine
Months ended
|
Inception
To
|
|||||||||||
|
December
31,
|
September 30, |
Date
(1)
|
|||||||||||
|
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.
|
30
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.
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.
31
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.
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.
32
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.
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
Contractual
Obligations
The
Company’s contractual obligations as of November 30, 2007 are set forth below.
| Payment Due by Period | ||||||||||
|
Less
Than 1
|
||||||||||
|
Total
|
Year
|
1-4
Years
|
||||||||
|
Long-Term
Debt
Obligations
|
$
|
5,564,000
|
$
|
64,000
|
$
|
5,500,000
|
||||
|
Interest
|
1,976,000
|
522,000
|
1,454,000
|
|||||||
|
Lease
Obligations
|
125,000
|
90,000
|
35,000
|
|||||||
|
Total
|
$
|
7,665,000
|
$
|
676,000
|
$
|
6,89,000
|
||||
33
DESCRIPTION
OF BUSINESS
Business
Access
Pharmaceuticals, Inc. (“Access” or the “Company”) is a Delaware corporation. We
are an emerging biopharmaceutical company developing products for use in the
treatment of cancer, the supportive care of cancer, and other disease states.
Our product for the management of oral mucositis, MuGard™, has received
marketing clearance by the FDA as a device. Our lead clinical development
program for the drug candidate ProLindac™ (formerly known as AP5346) is in Phase
2 clinical testing. Access also has advanced drug delivery technologies
including Cobalamin™-mediated oral drug delivery and targeted
delivery.
Together
with our subsidiaries, we have proprietary patents or rights to one technology
approved for marketing and three drug delivery technology
platforms:
• MuGard™
(mucoadhesive liquid technology),
•
synthetic polymer targeted delivery,
•
Cobalamin-mediated oral delivery,
•
Cobalamin-mediated targeted delivery.
Products
We
have
used our drug delivery technologies to develop the following products and
product candidates:
ACCESS
DRUG PORTFOLIO
|
Compound
|
Originator
|
Technology
|
Indication
|
FDA
Filing
|
Clinical
Stage
(1)
|
|||||
|
MuGard™
|
Access
|
Mucoadhesive
liquid
|
Mucositis
|
510(k)
|
Marketing
clearance
received
|
|||||
|
ProLindacTM
(Polymer
Platinate,
AP5346) (2)
|
Access
- U London
|
Synthetic
polymer
|
Cancer
|
Clinical
Development(3)
|
Phase
2
|
|||||
|
Oral
Insulin
|
Access
|
Cobalamin
|
Diabetes
|
Research
|
Pre-Clinical
|
|||||
|
Oral
Delivery System
|
Access
|
Cobalamin
|
Various
|
Research
|
Pre-Clinical
|
|||||
|
Cobalamin-Targeted
Therapeutics
|
Access
|
Cobalamin
|
Anti-tumor
|
Research
|
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.
(3)
Clinical studies being conducted in Europe and US.
34
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 that 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.
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.
35
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 is generating 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.
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.
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
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.
36
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.
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 development program. 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.
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.
37
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
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; and
•
Cobalamin™-Mediated Targeted Delivery Technology.
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 renally cleared from the body. 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 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.
38
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 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.
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 that 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 Cobalamin-drug
conjugates.
39
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 molecules on cancer cells,
which makes them more sensitive to treatment regimes that target surface
molecules 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.
•
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 molecule 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 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.
40
Other
Key Developments
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 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
19, 2007, we announced we had entered into an agreement to acquire Somanta
Pharmaceuticals, Inc. Pursuant to the terms of the merger agreement, upon
consummation of the acquisition, Somanta’s preferred and common shareholders
would receive an aggregate of 1.5 million shares of Access’ common stock. The
Somanta stockholders approved the proposed transaction at the stockholders’
meeting on August 17, 2007. The closing of the transaction is subject to
numerous conditions including receipt of necessary approvals. There can be
no
assurance that the transaction will be consummated or if consummated that it
will be on the terms described herein. Each of the parties currently has the
right to terminate the Merger Agreement.
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.
41
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.
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.
42
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.
|
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.
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.
43
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.
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.
44
Employees
As
of
December 10, 2007, 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.
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 2007. Adjacent space may be available
for
expansion which Access believes would accommodate growth for the foreseeable
future. Access anticipates renewing its current lease for an additional one
year
on terms substantially similar to those in the current lease
agreement.
Access
believes that its existing properties are suitable for the conduct of its
business and adequate to meet its present needs.
45
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.
46
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:
| Jeffrey B. Davis | 44 | Chairman of the Board | |
| Stephen R. Seiler | 51 | President, 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.
Jeffrey B. Davis became a director in March 2006. Mr. Davis is
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.
Mr. Stephen R. Seiler has been Access’ President and Chief Executive Officer and a Director since January 2007. Mr. Seiler is also a member of the Executive Committee. Prior thereto, Mr. Seiler had been Acting Chief Executive Officer of Effective Pharmaceuticals, Inc. and advising other companies in the healthcare field. From 2001 until 2004 he was Chief Executive Officer of Hybridon, Inc. (now Idera Pharmaceuticals, Inc.). Mr. Seiler was Executive Vice President, Planning, Investment & Development at Elan Corporation plc from 1995 until 2001. He also worked as an investment banker at Paribas Capital Markets in both London and New York from 1991 to 1995 where he was founder and head of Paribas’ pharmaceutical investment banking group. Mr. Seiler holds a BA (Summa Cum Laude) from the University of Notre Dame and a JD (Honors) from Georgetown University.
47
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.
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.
48
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.
49
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
|
$
|
357,385
217,500
|
$
|
100,000
30,000
|
$
|
-
-
|
$
|
81,464
168,468
|
$
|
2,594
1,297
|
$
|
541,443
248,797
|
|||||||||
|
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
|
2006
2005
|
$
|
253,620
250,710
|
$
|
20,000
25,408
|
$
|
-
24,154
|
$
|
40,732
67,619
|
$
|
7,152
7,094
|
$
|
321,504
374,985
|
|||||||||
|
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
|
2006
2005
|
$
|
154,080
152,310
|
$
|
20,000
15,435
|
$
|
-
14,704
|
$
|
40,732
42,262
|
$
|
4,508
4,455
|
$
|
219,320
229,166
|
|||||||||
____________________
|
(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.
|
|
(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)
|
Stephen
R. Seiler became Access’ President and Chief Executive Officer effective
January 4, 2007 and is not included in this table.
|
50
Employment
Agreements
President
and Chief Executive Officer
Access
is
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"). Mr. Seiler is paid
an
annual salary of $350,000 and was granted stock options to purchase 500,000
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
vest
25% on January 4, 2008 and monthly thereafter over a 36 month period. The stock
options are granted under Access’ 2005 Equity Incentive Plan and the 2007
Special Stock Option Plan. Mr. Seiler is entitled to similar employee benefits
as Access’ other executive officers. Under certain circumstances relating to a
change of control of Access, Mr. Seiler may be entitled to receive a payment
equal to his annual salary, acceleration of options and extension of health
care
benefits.
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.
|
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.
51
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.
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.
52
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 10, 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.
53
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 $5,000 above the statutory limit. Under the
plan, each participant is fully vested in his or her deferred salary
contributions, including any matching contributions by us, when contributed.
Participant contributions are held and invested by the participants in the
plan's investment options. The plan also permits Access to make discretionary
contributions and matching contributions, subject to established limits and
a
vesting schedule. In 2006, Access matched 100% of participant contributions
up
to the first two percent of eligible compensation. Access matches participant
contributions at the first four percent of eligible compensation in
2007.
Outstanding
Equity Awards at December 31, 2006
The
following table sets forth certain information regarding outstanding equity
awards held by Access’ named executive officers at December 31,
2006.
|
Option
Awards
|
|||||
|
Name
|
Number
of Securities Underlying Unexercised Options (#)
Exercisable
|
Number
of Securities Underlying Unexercised Options (#)
Unexercisable
|
Equity
Incentive Plan Awards: Number of Securities Underlying Unexercised
Unearned Options (#)
|
Option
Exercise Price ($)
|
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
|
____________________
54
|
(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)
|
Stephen
R. Seiler became Access’ President and Chief Executive Officer effective
January 4, 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
Audit
and Finance Committee is currently comprised of David P. Luci (chairman) and
John J. Meakem, Jr. During 2006, the Audit and Finance Committee was composed
of
four directors, Max
Link,
Ph.D., Stuart M. Duty, John J. Meakem, Jr., and Jeffrey B. Davis.
All of
the current members of the Audit and Finance Committee are independent under
applicable SEC and AMEX rules and regulations. During 2006 Dr. Link, Mr. Duty
and Mr. Meakem were 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. During
2006, the Compensation Committee was composed of Herbert H. McDade, Jr., Jeffrey
B. Davis, J. Michael Flinn and Stephen B. Howell, MD.
The
Nominating and Corporate Governance Committee is currently comprised of John
J.
Meakem, Jr. (chairman), Mark Ahn, PhD and Mark J. Alvino. During 2006 Stuart
M.
Duty was also a member of the committee. 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.
55
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 $556.
|
||
|
(8)
|
Dr.
Cvitkovic and Mr. Luci became directors in 2007.
|
||
|
(9)
|
Dr.
Mazanet was an inside director during 2006 and was not paid directors
fees. She became an outside director in January
2007.
|
56
The
following table summarizes the aggregate number of option awards held by each
director at December 31, 2006. There were no outstanding stock awards held
by
any director at December 31, 2006:
|
Name
|
Number
of Securities Underlying Unexercised Options (#)
Exercisable
|
Number
of Securities Underlying Unexercised Options (#)
Unexercisable
|
Equity
Incentive Plan Awards: Number of Securities Underlying Unexercised
Unearned Options (#)
|
Option
Exercise Price ($)
|
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
|
57
____________________
|
(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.
|
58
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 December 10, 2007 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
|
|
Jeffery
B. Davis (2)
|
30,820
|
*
|
|
Stephen
R. Seiler (3
|
135,417
|
3.7%
|
|
Mark
J. Ahn, Ph. D. (4)
|
25,000
|
*
|
|
Mark
J. Alvino (5)
|
80,525
|
2.2%
|
|
Esteban
Cvitkovic, M.D. (6)
|
37,500
|
1.0%
|
|
Stephen
B. Howell, M.D. (7)
|
53,839
|
1.5%
|
|
David
P. Luci (8)
|
25,000
|
*
|
|
Rosemary
Mazanet, M.D., Ph.D.(9)
|
228,376
|
6.0%
|
|
John
J. Meakem, Jr.
(10)
|
53,536
|
1.5%
|
|
David
P. Nowotnik, Ph.D. (11)
|
149,849
|
4.0%
|
|
Phillip
S. Wise (12)
|
75,000
|
2.0%
|
|
Stephen
B. Thompson (13)
|
117,854
|
3.2%
|
|
SCO Capital Partners LLC, SCO Capital
Partners LP, and Beach Capital LLC (14)
|
12,034,164
|
77.0%
|
|
Larry
N. Feinberg (15)
|
2,479,372
|
43.0%
|
|
Lake
End Capital LLC (16)
|
1,426,216
|
28.5%
|
|
Perceptive
Life Sciences
Master
Fund, Ltd. (17)
|
999,999
|
21.9%
|
|
Midsummer
Investment, Ltd. (18)
|
750,000
|
17.3%
|
|
All
Directors and Executive
Officers
as a group
(consisting
of 12 persons) (19)
|
1,012,717
|
22.3%
|
*
- Less
than 1%
59
| (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
December
10, 2007.
|
| (2) |
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. 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 5,623,730 shares of Access’ Common Stock and 6,410,434 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.
|
| (3) |
Includes
presently exercisable options for the purchase of 13,542 shares of
Access’
Common Stock pursuant to the 2005 Equity Incentive Plan and 121,875
shares
of Access’ Common Stock pursuant to the 2007 Special Stock Option
Plan.
|
| (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 5,623,730 shares of Access’ Common Stock and 6,410,434 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 37,500 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
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 222,376 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 75,000 shares of
Access’
Common Stock pursuant to the 2005 Equity Incentive Plan and 57,333
shares
of Access’ Common Stock pursuant to the 1995 Stock Option
Plan.
|
| (12) |
Includes
presently exercisable options for the purchase of 75,000 shares of
Access’
Common Stock pursuant to the 2005 Equity Incentive
Plan.
|
| (13) |
Includes
presently exercisable options for the purchase of 75,000 shares of
Access’
Common Stock pursuant to the 2005 Equity Incentive Plan and 33,333
shares
of Access’ Common Stock pursuant to the 1995 Stock Option
Plan.
|
| (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 5,623,730 shares of Access’ Common Stock and 6,410,434 shares of Common Stock issuable to them upon conversion of Series A Preferred Stock. 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. |
| (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 716,482 shares of Access’ Common Stock and 709,734 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.
|
| (18) |
Does
not include shares held by SCO Securities LLC and
affiliates.
|
60
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 1,589,053 options or rights under this plan as of December 10, 2007. The balance of the options outstanding as of December 10, 2007 is 85,947. 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 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
Category
|
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
61
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 all of which 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. All of the options have been granted in the Plan in
January 2007.
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.
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.
62
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.
63
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
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 receives $12,500 per month plus $2,500 for office
expenses until March 31, 2008. 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 77.0% of the voting securities of Access. 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 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.
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.
64
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 2006 and 2005, and for each of the first three quarters of
fiscal year 2007 and as the most recent date of the fourth quarter 2007. 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.
|
Common
Stock
|
||||||||
|
|
High
|
Low
|
||||||
|
Period
Ended
|
||||||||
|
First
quarter March 31, 2007
|
$
|
10.66
|
$
|
2.50
|
||||
|
Second
quarter June 30, 2007
|
6.75
|
4.30
|
||||||
|
Third
quarter September 30, 2007
|
5.16
|
2.10
|
||||||
|
Fourth
quarter to December 7, 2007
|
4.48 | 2.50 | ||||||
|
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
|
||||||
|
Fiscal
Year Ended December 31, 2005
|
||||||||
|
First
quarter
|
$
|
18.30
|
$
|
11.00
|
||||
|
Second
quarter
|
15.05
|
8.80
|
||||||
|
Third
quarter
|
9.95
|
2.80
|
||||||
|
Fourth
quarter
|
8.65
|
2.60
|
||||||
65
Holders
The
number of record holders of Access common stock at December 10, 2007 was
approximately 3,000. On December 7, 2007, the closing price for the common
stock
as quoted on the OTCBB was $2.57. There were 3,575,114 shares of common stock
outstanding at December 10, 2007.
Options
and Warrants
There
are
8,376,397 outstanding warrants and 1,589,053 outstanding options to
purchase Access’ common equity as of December 10, 2007.
Shares
Eligible for Future Sales
Access
has issued 3,575,114 shares of its common stock as of December 10, 2007. 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.
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.
66
SELECTED
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
|
SUPPLEMENTARY
FINANCIAL INFORMATION
The
information required by this item is set forth in Note 12, Quarterly Financial
Data (unaudited) of the notes to our Consolidated Financial Statements appearing
elsewhere in this Prospectus.
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We
invest
any excess cash in certificates of deposit, corporate securities with high
quality ratings, and U.S. government securities. These investments are not
held
for trading or other speculative purposes. These financial investment securities
all mature in 2007 and their estimated fair value approximates cost. Changes
in
interest rates affect the investment income we earn on our investments and,
therefore, impact our cash flows and results of operations. A hypothetical
50
basis point decrease in interest rates would result in a decrease in annual
interest income and a corresponding increase in net loss of approximately
$2,000. The estimated effect assumes no changes in our short-term investments
from December 31, 2006. We do not believe that we are exposed to any market
risks, as defined. We are not exposed to risks for changes in commodity prices,
or any other market risks.
67
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 December 10, 2007 there were 3,575,114 shares of Access’
common stock outstanding and held of record by approximately 3,000 stockholders,
and there were 3,227.3617 shares of its preferred stock
outstanding.
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.
68
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.
69
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.
EXPERTS
The
consolidated financial statements for the years ended December 31, 2006 and
December 31, 2005 included in this prospectus and Registration Statement, were
audited by Whitley Penn LLP and Grant Thornton LLP, respectively, each is an
independent registered public accounting firm, as stated in their reports
appearing with the consolidated financial statements herein and included 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.
70
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.
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.
71
|
PAGE
|
|
|
|
|
|
Report
of Independent Registered Public Accounting Firm
|
F-2
|
|
Report
of Independent Registered Public Accounting Firm
|
F-3
|
|
|
|
|
Consolidated
Balance Sheets at December 31, 2006 and 2005
|
F-4
|
|
|
|
|
Consolidated
Statements of Operations and Comprehensive Loss for 2006, 2005
and
2004
|
F-5
|
|
|
|
|
Consolidated
Statement of Stockholders' Equity (Deficit) for 2006, 2005 and
2004
|
F-6
|
|
|
|
|
Consolidated
Statements of Cash Flows for 2006, 2005 and 2004
|
F-7
|
|
|
|
|
Notes
to Consolidated Financial Statements (Three years ended December
31,
2006)
|
F-8
|
|
Condensed
Consolidated Balance Sheets at September 30, 2007
(unaudited)
|
F-18
|
|
|
|
|
Condensed
Consolidated Statements of Operations for September 30, 2007 and
2006
(unaudited)
|
F-19
|
|
|
|
|
Condensed
Consolidated Statements of Cash Flows for September 30, 2007 and
2006
(unaudited)
|
F-20
|
|
|
|
|
Notes
to Condensed Consolidated Financial Statements (Nine Months Ended
September 30, 2007 and 2006) (unaudited)
|
F-21
|
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
Report
of Independent Registered Public Accounting Firm
Board
of Directors and
Shareholders
of Access
Pharmaceuticals, Inc. and Subsidiaries
We
have
audited the accompanying consolidated balance sheets of Access Pharmaceuticals,
Inc. (the “Company”), as of December 31, 2005, and the related consolidated
statements of operations and comprehensive loss, stockholders' equity (deficit),
and cash flows for each of the two years in the period ended December 31,
2005. These 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 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. Our audit 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 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 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 consolidated financial position of Access
Pharmaceuticals, Inc., as of December 31, 2005, and the results of their
consolidated operations and their consolidated cash flows for each of the
two
years in the period ended December 31, 2005, 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 incurred significant
losses in
each of the two years in the period ended December 31, 2005 in the amounts
of
$1.7 million and $10.2 million, respectively; the Company’s total liabilities
exceeded its assets by $4.2 million at December 31, 2005; and its operating
cash
flows were negative $7.3 million and negative $9.1 million for the years
ended
December 31, 2005 and 2004, respectively. These matters, among others describes
in Note 2, raise substantial doubt about the Company’s ability to continue as a
going concern. Management’s plans in regard to these matters are also described
in Note 2. The consolidated financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
/s/
GRANT
THORNTON LLP
Dallas,
Texas
April
25,
2006
F-3
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.
F-4
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.
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.
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.
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.
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.
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.
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
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).
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.
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.
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.
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.
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
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
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.
|
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.
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.
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
|
|
|
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.
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
April
19, 2007, we announced we had entered into an agreement to acquire Somanta
Pharmaceuticals, Inc. Pursuant to the terms of the merger agreement,
upon
consummation of the acquisition, Somanta’s preferred and common shareholders
would receive an aggregate of 1.5 million shares of Access’ common stock. The
Somanta stockholders approved the proposed transaction at the stockholders’
meeting on August 17, 2007. The closing of the transaction is subject
to
numerous conditions including receipt of necessary approvals. There can
be no
assurance that the transaction will be consummated or if consummated
that it
will be on the terms described herein. Each of the parties currently
has the
right to terminate the Merger Agreement.
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.
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.
F-24
Access
Pharmaceuticals, Inc. and Subsidiaries
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Three
years ended December 31, 2006
NOTE
13 - SUBSEQUENT EVENTS (UNAUDITED) - Continued
As
a
condition to closing on the Series A Preferred Stock, 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 Partner, 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.
F-25
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-26
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-27
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-28
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-29
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-29
(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-30
(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-31
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
24. 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
25. 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
26: Recent Sales of Unregistered Securities
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 March 31, 2007 and warrants to purchase an aggregate of 3,863,634 shares of common stock of Access. Net proceeds to Access were $4.557 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
27. 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)
|
II-1
| 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*
|
2001
Restricted Stock Plan (Incorporated by reference to Appendix
A of our
Proxy Statement filed on April 16,
2001)
|
|
10.11*
|
2005
Equity Incentive Plan (Incorporated by reference to Exhibit 1
of our Proxy
Statement filed on April 18, 2005
(2)
|
|
10.12*
|
Employment
Agreement, dated as of June 1, 2005 by and between us and Stephen
B.
Thompson (1)
|
| 10.13 |
Asset
Sale Agreement, dated as of October 12, 2005, between us and
Uluru, Inc.
(1)
|
|
10.14
|
Amendment
to Asset Sale Agreement, dated as of December 8, 2006, between
us and
Uluru, Inc. (3)
|
| 10.15 |
License
Agreement, dated as of October 12, 2005, between us and Uluru,
Inc.
(1)
|
|
10.16
|
Form
of Warrant, dated February 16, 2006, issued by us to certain
Purchasers
(2)
|
|
10.17
|
Form
of Warrant, dated October 24, 2006, issued by us to certain Purchasers
(3)
|
| 10.18 | Investor Rights Agreement, dated October 24, 2006, between us and certain Purchasers |
II-2
|
10.19
|
Form
of Warrant, December 6, 2006, issued by us to certain Purchasers
(3)
|
| 10.20 | Investor Rights Agreement, dated December 6, 2006, between us and certain Purchasers |
|
10.21*
|
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)
|
|
10.22*
|
Employment
Agreement, dated January 4, 2007 by and between us and Stephen
R. Seiler,
President and Chief Executive Officer
(4)
|
|
10.23
|
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)
|
| 10.24 | Preferred Stock and Warrant Purchase Agreement, dated November 7, 2007, between us and certain Purchasers |
|
10.25
|
Investor
Rights Agreement, dated November 10, 2007, between us and certain
Purchasers
|
| 10.26 | Form of Warrant Agreement dated November 10, 2007, between us and certain Purchasers |
|
10.27
|
Board
Designation Agreement, dated November 15, 2007, between us and
SCO Capital
Partners LLC
|
23.1 Consent
of Whitley Penn LLP
23.2 Consent
of Grant Thornton LLP
23.3 Opinion
of Bingham McCutchen LLP regarding the legality of the securities
E
|
*
|
[Management
contract or compensatory plan required to be filed as an Exhibit
to this
Form pursuant to Item 15(c) of the report.]
|
| (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-KSB for the year ended December 31,
2006.
|
| (4) |
Incorporated
by reference to our Form 10-QSB for the quarter ended March 31,
2007.
|
II-3
Item
28. Undertakings
The
undersigned Registrant hereby undertakes:
(1) To
file,
during any period in which offers or sales are being made pursuant to this
Registration Statement, 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% 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
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, as amended, the Registrant
has duly caused this Registration Statement on Form SB-2 to be signed on
its behalf by the undersigned, thereunto duly authorized, in the City of
Dallas,
State of Texas, on this 10th day of December, 2007.
ACCESS
PHARMACEUTICALS, INC.
| Date December 10, 2007 | By: | /s/ Stephen R. Seiler | |
| Stephen R. Seiler | |||
| President and Chief Financial | |||
| Officer | |||
| Date December 10, 2007 | 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 Stephen R. Seiler 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 SB-2 has been signed below by the following persons in
the capacities and on the dates indicated:
| Date December 10, 2007 |
By:
|
/s/ Mark J. Ahn | ||
| Mark J. Ahn, Director | ||||
| Date December 10, 2007 |
By:
|
/s/ Mark J. Alvino | ||
| Mark J. Alvino, Director | ||||
| Date December 10, 2007 |
By:
|
/s/
Esteban Cvitkovic
|
||
| Esteban Cvitkovic, Director | ||||
| Date December 10, 2007 |
By:
|
/s/ Jeffrey B. Davis | ||
| Jeffrey B. Davis, Director | ||||
| Date December 10, 2007 | By: | /s/ Stephen B. Howell | ||
| Stephen B. Howell, Director | ||||
| Date December 10, 2007 | By: | /s/ David P. Luci | ||
| David P. Luci, Director | ||||
II-5
| Date December 10, 2007 | By: | /s/ Rosemary Mazanet | ||
| Rosemary Mazanet, Director | ||||
| Date December 10, 2007 | By: | /s/ John J. Meakem | ||
| John J. Meakem, Jr., Director | ||||
| Date December 10, 2007 | By: | /s/ Stephen R. Seiler | ||
| Stephen R. Seiler | ||||
| President and Chief Executive, Officer, and Director | ||||
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)
|
|
3.9
|
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*
|
2001
Restricted Stock Plan (Incorporated by reference to Appendix
A of our
Proxy Statement filed on April 16,
2001)
|
|
10.11*
|
2005
Equity Incentive Plan (Incorporated by reference to Exhibit 1
of our Proxy
Statement filed on April 18, 2005
(2)
|
|
10.12*
|
Employment
Agreement, dated as of June 1, 2005 by and between us and Stephen
B.
Thompson (1)
|
| 10.13 |
Asset
Sale Agreement, dated as of October 12, 2005, between us and
Uluru, Inc.
(1)
|
|
10.14
|
Amendment
to Asset Sale Agreement, dated as of December 8, 2006, between
us and
Uluru, Inc. (3)
|
10.15
License
Agreement, dated as of October 12, 2005, between us and Uluru, Inc.
(1)
|
10.16
|
Form
of Warrant, dated February 16, 2006, issued by us to certain
Purchasers
(2)
|
|
10.17
|
Form
of Warrant, dated October 24, 2006, issued by us to certain Purchasers
(3)
|
|
10.18
|
Investor Rights Agreement, dated October 24, 2006, between us and certain Purchasers |
|
10.19
|
Form
of Warrant, December 6, 2006, issued by us to certain Purchasers
(3)
|
| 10.20 | Investor Rights Agreement, dated December 6, 2006, between us and certain Purchasers |
|
10.21*
|
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)
|
|
10.22*
|
Employment
Agreement, dated January 4, 2007 by and between us and Stephen
R. Seiler,
President and Chief Executive Officer
(4)
|
|
10.23
|
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)
|
| 10.24 | Preferred Stock and Warrant Purchase Agreement, dated November 7, 2007, between us and certain Purchasers |
|
10.25
|
Investor
Rights Agreement, dated November 10, 2007, between us and certain
Purchasers
|
| 10.26 | Form of Warrant Agreement dated November 10, 2007, between us and certain Purchasers |
| 10.27 | Board Designation Agreement, dated November 15, 2007, between us and SCO Cpaital Partners LLC |
| 23.1 | Consent of Whitley Penn LLP |
| 23.2 |
Consent
of Grant Thornton LLP
|
| 23.3 |
Opinion
of Bingham McCutchen LLP regarding the legality of the
securities
|
|
*
|
[Management
contract or compensatory plan required to be filed as an Exhibit
to this
Form pursuant to Item 15(c) of the report.]
|
| (5) |
Incorporated
by reference to our Form 10-K for the year ended December 31,
2005.
|
| (6) |
Incorporated
by reference to our Form 10-Q for the quarter ended March 31,
2006.
|
| (7) |
Incorporated
by reference to our Form 10-KSB for the year ended December 31,
2006.
|
| (8) |
Incorporated
by reference to our Form 10-QSB for the quarter ended March 31,
2007.
|