If the filing person has previously filed a statement on Schedule 13G to report the acquisition that is the subject of this Schedule 13D, and is filing this schedule because of §§240.13d-1(e), 240.13d-1(f) or 240.13d-1(g), check the following box.o

Note: Schedule filed in paper format shall include a signed original and five copies of the schedule, including all exhibits. See §240.13d-7 for other parties to whom copies are to be sent.

*The remainder of this cover page shall be filled out for a reporting person’s initial filing on this form with respect to the subject class of securities, and for any subsequent amendment containing information which would alter the disclosures provided in a prior cover page.

The information required in the remainder of this cover page shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934 (“Act”) or otherwise subject to the liabilities of that section of the Act but shall be subject to all other provisions of the Act (however, see the Notes).

The class of equity securities to which this Schedule 13D (this “Statement”) relates is the common stock, $0.01 par value per share (the “Common Stock”), of Abeona Therapeutics Inc., a Delaware corporation (the “Company” or the “Issuer”). The address of the principal executive office of the Issuer is 1330 Avenue of the Americas, 33^rd Floor, New York, NY 10019.

This Statement is being filed jointly on behalf of the following persons (collectively, the “Reporting Persons”): (i) Great Point Partners, LLC, a Delaware limited liability company (“Great Point”); (ii) Dr. Jeffrey R. Jay, an individual (“Dr. Jay”), and (iii) Mr. David Kroin, an individual (“Mr. Kroin”).

The business address of each Reporting Person is 165 Mason Street, 3rd Floor, Greenwich, CT 06830.

During the last five years, none of the Reporting Persons nor any of the Clients (as defined below) has been convicted in any criminal proceeding (excluding traffic violations or similar misdemeanors).

During the last five years, none of the Reporting Persons nor any of the Clients (as defined below) has been party to a civil proceeding of a judicial or administrative body of competent jurisdiction as a result of which such person was or is subject to a judgment, decree or final order enjoining future violations of, or prohibiting or mandating activities subject to, federal or state securities laws or finding any violation with respect to such laws.

Each of Dr. Jay and Mr. Kroin is a United States citizen.

Biomedical Value Fund, L.P. (“BVF”) used its own funds to purchase 2,409,146 shares of Common Stock (the “BVF Shares”) and warrants to purchase an additional 3,011,696 shares of Common Stock (the “BVF Warrants”). Biomedical Offshore Value Fund, Ltd. (“BOVF”) used its own funds to purchase 3,116,022 shares of Common Stock (the “BOVF Shares”) and warrants to purchase an additional 3,895,368 shares of Common Stock (the “BOVF Warrants”). GEF-SMA, L.P. (“GEF-SMA”) used its own funds to purchase 1,687,844 shares of Common Stock (the “GEF-SMA Shares”) and warrants to purchase an additional 2,109,991 shares of Common Stock (the “GEF-SMA Warrants” and together with the BOVF Warrants and the BFV Warrants, the “GPP Warrants”).³

See Item 5 below for information with respect to Great Point, Dr. Jay and Mr. Kroin.

The purpose for which the Common Stock was acquired by the Reporting Persons is for investment. As such, in the ordinary course of their business, the Reporting Persons will continuously evaluate the financial condition, results of operations, business and prospects of the Issuer, the securities markets in general and the market for the Common Stock in particular, conditions in the economy and the financial institutions industry generally and other investment opportunities, all with a view to determining whether to hold, decrease or increase its investment in the Common Stock, through open market, privately

negotiated or any other transactions. In the ordinary course of evaluating its investment, representatives of the Reporting Persons may from time to time seek to (or be invited to) discuss the business and policies of the Issuer with the management of the Issuer. Except as set forth in Item 6, the securities of the Issuer are held for passive investment purposes.

BVF is the record holder of the BVF Shares. Such shares constitute 2.89% of the shares of Common Stock outstanding, computed in accordance with Rule 13d-3. BVF shares voting and dispositive power over the BVF Shares.

BVF is the record holder of the BVF Warrants. As a result of the Beneficial Ownership Cap, 416,481 shares underlying such warrants are exercisable, which constitutes 0.49% of the shares of Common Stock outstanding, computed in accordance with Rule 13d-3.

BOVF is the record holder of the BVF Shares. Such shares constitute 3.73% of the shares of Common Stock outstanding, computed in accordance with Rule 13d-3. BOVF shares voting and dispositive power over the BOVF Shares.

BOVF is the record holder of the BOVF Warrants. As a result of the Beneficial Ownership Cap, 538,682 shares underlying such warrants are exercisable, which constitutes 0.64% of the shares of Common Stock outstanding, computed in accordance with Rule 13d-3.

GEF-SMA is the record holder of the GEF-SMA Shares. Such shares constitute 2.02% of the shares of Common Stock outstanding, computed in accordance with Rule 13d-3. GEF-SMA shares voting and dispositive power over the GEF-SMA Shares.

GEF-SMA is the record holder of the GEF-SMA Warrants. As a result of the Beneficial Ownership Cap, 291,786 shares underlying such warrants are exercisable, which constitutes 0.34% of the shares of Common Stock outstanding, computed in accordance with Rule 13d-3.

BVF, BOVF and GEF-SMA (BVF, BOVF, and GEF-SMA, collectively, the “Clients”), and the Clients’ respective general partners have granted full investment and voting authority and discretion to Great Point, as a result of which Great Point may be deemed to be the beneficial owner of the BVF Shares, the BOVF Shares and the GEF-SMA Shares. Each of Dr. Jay, as senior managing member of Great Point, and Mr. Kroin, and special managing member of Great Point, has shared voting and investment power with respect to the BVF Shares, the BOVF Shares, and the GEF-SMA Shares and may be deemed to be the beneficial owner of such shares. Great Point, Dr. Jay and Mr. Kroin disclaim beneficial ownership of the BVF Shares, the BOVF Shares and the GEF-SMA Shares except to the extent of any pecuniary interest, and this statement shall not be deemed to be an admission that they are the beneficial owners of such securities.

Pursuant to the letter agreement attached hereto as Exhibit B (the “Letter Agreement”), the Issuer and the Reporting Persons have agreed that (i) the Reporting Persons have the right to identify two candidates to be nominated and, subject to qualification, elected to vacancies on the Issuer’s board of directors, including the Executive Chairman of the Issuer’s board of directors (but the Reporting Persons

have no current expectation that such nominees will be affiliates of the Reporting Persons), and (ii) until the election of an Executive Chairman so nominated by the Reporting Persons, the Issuer will not, without the Reporting Persons’ prior written consent, enter into any material transaction to commercialize or develop any of Issuer’s material intellectual property or technology. Once the Issuer’s obligations under the Letter Agreement are fully performed, the Reporting Persons will have no further rights thereunder. The foregoing description of the Letter Agreement does not purport to be complete and is qualified in their entirety by reference to the full texts of the Letter Agreement, which is incorporated by reference as Exhibit B and is incorporated herein by reference.

Signature

After reasonable inquiry and to the best of my knowledge and belief, I certify that the information set forth in this statement is true, complete and correct.

Date: December 30, 2019

Exhibit A

AGREEMENT REGARDING THE JOINT FILING OF SCHEDULE 13D

The undersigned hereby agree as follows:

Exhibit B

Abeona Therapeutics Inc.
1330 Avenue of the Americas, 33rd Floor
New York, NY 10019

December 20, 2019

Biomedical Value Fund, L.P.

Biomedical Offshore Value Fund, Ltd.

and

GEF-SMA, L.P.

c/o Great Point Partners LLC

165 Mason Street, 3^rd Floor

Greenwich, Connecticut 06830

Ladies and Gentlemen:

Abeona Therapeutics Inc., a Delaware corporation (the “Company”), is contemplating an offering of shares of common stock, par value $0.01 per share (“Common Stock”), and warrants to purchase shares of Common Stock as described in the Company’s Prospectus Supplement, dated December 20, 2019, to the Prospectus dated June 7, 2018 (the “Offering”). In consideration for Biomedical Value Fund, L.P., Biomedical Offshore Value Fund, Ltd. and GEF-SMA, L.P. (collectively, “Purchaser”) purchasing in the aggregate at least $31 million in Common Stock and/or warrants in the Offering, the Company and Purchaser agree as follows:

to be reasonable and market standard for such position; provided, however, that in any event the compensation paid by the Company to its previous Chairman of the Board and Executive Chairman shall be deemed reasonable and market standard for such purposes.

2.            Purchaser Consent Right. From the date hereof until the election of the Chairman Candidate pursuant to paragraph 1(a)(iii)(B), the Company shall not, without the prior written consent of Purchaser, enter into any material transaction with respect to the commercialization or development of any material intellectual property or technology of the Company, or enter into any binding agreement, commitment or obligation with respect to any such material transaction.

3.            Miscellaneous. This letter agreement constitutes the entire agreement between the parties hereto pertaining to the subject matter hereof, and supersedes all prior and contemporaneous agreements, understandings, negotiations and discussions of the parties, whether written or oral, with respect to the subject matter hereof. Each party has been represented and advised by independent counsel of its choice in connection with the execution of this letter agreement and has cooperated in the drafting and preparation of this letter agreement. Accordingly, any law that would require interpretation of this letter agreement, including any ambiguous, vague or conflicting term herein, against the drafter should not apply and is expressly waived. This letter agreement shall be deemed to have been made and performed in, and shall be governed and construed in accordance with the laws of, the State of New York, without regard to conflicts of law principles. Nothing in this letter agreement is intended to or shall confer upon any third party any benefits, rights or remedies of any nature whatsoever under or by reason of this letter agreement. This letter agreement may be executed in any number of counterparts and by the parties hereto in separate counterparts, each of which when so executed will be deemed to be an original and all of which taken together shall constitute one and the same agreement. Facsimile or electronic signatures hereto shall be deemed to have the same force and effect as original signatures.

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Agreed and acknowledged as of the date first set forth above by:

BIOMEDICAL VALUE FUND, L.P.

BIOMEDICAL OFFSHORE VALUE FUND, LTD.

GEF-SMA, L.P.