SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): July 25, 2019
ABEONA THERAPEUTICS INC.
(Exact name of registrant as specified in its charter)
|(State or other jurisdiction of
|(Commission File Number)||(I.R.S. Employer Identification No.)|
1330 Avenue of the Americas, 33rd Floor,
New York, NY 10019
(Address of principal executive offices) (Zip Code)
(Registrant’s telephone number, including area code)
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||Nasdaq Capital Markets|
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 7.01.||Regulation FD Disclosure.|
On July 25, 2019, Abeona Therapeutics Inc. (the “Company”) issued a press release regarding data from its ongoing Phase 1/2 clinical trial evaluating ABO-102, the Company’s investigational one-time, adeno-associated virus gene therapy for Sanfilippo syndrome type A, also known as MPS IIIA. The full text of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein.
The information furnished pursuant to this Current Report on Form 8-K, including Exhibit 99.1 hereto, shall not be considered “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference into future filings by the Company under the Securities Act of 1933, as amended, or under the Exchange Act, unless the Company expressly sets forth in such future filings that such information is to be considered “filed” or incorporated by reference therein.
|Item 9.01.||Financial Statements and Exhibits.|
|99.1||Press release, dated July 25, 2019.|
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.|
|By:||/s/ Neena M. Patil|
|Name:||Neena M. Patil|
|Title:||General Counsel and Corporate Secretary|
Date: July 25, 2019