Material Agreement · Company Update

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549   FORM 8-K   CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934   Date of report (Date of earliest event reported): May 9, 2025   ABEONA THERAPEUTICS INC. (Exact name of registrant as specified in its charter)   Delaware   001-15771   83-0221517 (State or other jurisdiction of incorporation)   (Commission File Number)   (I.R.S. Employer Identification No.)   6555 Carnegie Ave , 4th Floor Cleveland , OH 44103 (Address of principal executive offices) (Zip Code)   (646) 813-4701 (Registrant’s telephone number, including area code)   N/A (Former name or former address, if changed since last report)   Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):   ☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)     ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)     ☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))     ☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))   Securities registered pursuant to Section 12(b) of the Act:   Title of Each Class   Trading Symbol   Name of each exchange on which registered Common Stock, $0.01 par value   ABEO   The Nasdaq Capital Market   Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).   Emerging growth company ☐   If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐             Item 1.01 Entry into a Material Definitive Agreement   On May 9, 2025, Abeona Therapeutics Inc. (the “Company”) entered into an asset purchase agreement (the “PRV Asset Purchase Agreement”), pursuant to which the Company agreed to sell a Rare Pediatric Disease Priority Review Voucher (“PRV”) to the buyer. The Company was awarded the voucher by the U.S. Food and Drug Administration (“FDA”) on April 28, 2025, upon approval of the Company’s biologics license application for ZEVASKYN™ (prademagene zamikeracel). Pursuant to the PRV Asset Purchase Agreement, the buyer agreed to pay the Company $155 million, payable in cash, upon the closing of the sale.   The PRV Asset Purchase Agreement contains customary representations, warranties, covenants, and indemnification provisions subject to certain limitations. The transaction remains subject to customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.   The foregoing description of the PRV Asset Purchase Agreement does not purport to be complete and is qualified in its entirety by the full text of the PRV Asset Purchase Agreement, a copy of which will be filed with the Company’s Quarterly Report on Form 10-Q for the three months ended June 30, 2025.   Item 8.01 Other Events.   On May 12, 2025, Abeona Therapeutics Inc. issued a press release entitled “Abeona Therapeutics® Enters into Agreement to Sell Priority Review Voucher for $155 Million.” A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.   Item 9.01 Financial Statements and Exhibits.   (d) Exhibits.   Exhibit No.   Description 99.1   Press release dated May 12, 2025, entitled “Abeona Therapeutics® Enters into Agreement to Sell Priority Review Voucher for $155 Million.” 104   Cover Page Interactive Data File (embedded within the Inline XBRL document)         SIGNATURE   Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.     Abeona Therapeutics Inc.   (Registrant)         By: /s/ Joseph Vazzano   Name: Joseph Vazzano   Title: Chief Financial Officer Date: May 12, 2025