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): July 3, 2023

ABEONA THERAPEUTICS INC.

(Exact name of registrant as specified in its charter)

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):

(17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act:

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. ☐

On July 3, 2023, Abeona Therapeutics Inc. (the “Company”) entered into a securities purchase agreement (the “Purchase Agreement”) with certain existing institutional investors relating to the issuance and sale of an aggregate of (a) 3,284,407 shares of the Company’s common stock (the “Shares”), and (b) pre-funded warrants to purchase 2,919,140 shares of the Company’s common stock (the “Pre-Funded Warrants”) to certain of such investors (the “Offering”). The Shares will be sold to the investors at an offering price of $4.03 per share. The Pre-Funded Warrants will be sold to certain of the investors at an offering price of $4.0299 per Pre-Funded Warrant, which represents the per share offering price for the Company’s common stock less a $0.0001 per share exercise price for each such Pre-Funded Warrant. The Purchase Agreement contains customary representations and warranties, conditions to closing, termination provisions and indemnification obligations, including for liabilities under the Securities Act of 1933, as amended.

The Pre-Funded Warrants are exercisable at any time after the date of issuance. A holder of a Pre-Funded Warrant may not exercise such Pre-Funded Warrant if the holder, together with its affiliates, would beneficially own more than 4.99% (or, at the election of the holder, 9.99%) of the number of shares of the Company’s common stock outstanding immediately after giving effect to such exercise.

The Company estimates that the net proceeds from the Offering will be approximately $22.9 million, after deducting placement agent fees and paying estimated offering expenses. Delivery of the Shares and Pre-Funded Warrants is expected to take place on or about July 6, 2023, subject to customary closing conditions. The Offering is being made pursuant to the shelf registration statement on Form S-3 (File No. 333-256850) previously filed by the Company with the Securities and Exchange Commission (the “SEC”) on June 7, 2021, amended on August 27, 2021, and October 19, 2021, and declared effective by the SEC on October 22, 2021.

The form of Pre-Funded Warrant and the Purchase Agreement are filed as Exhibit 4.1 and Exhibit 10.1, respectively, to this Current Report on Form 8-K. The foregoing description of the respective terms of the Pre-Funded Warrants and the Purchase Agreement is not intended to be complete and is qualified in its entirety by reference to such Exhibits. A copy of the opinion of Willkie Farr & Gallagher LLP relating to the legality of the issuance and sale of the Shares and Pre-Funded Warrants in the Offering is filed as Exhibit 5.1 to this Current Report on Form 8-K.

On July 3, 2023, the Company issued a press release entitled “Abeona Therapeutics Announces $25 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules.” A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

(d) Exhibits.

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.