UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
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Item 7.01 | Regulation FD Disclosure. |
Abeona Therapeutics Inc. (the “Company”) hereby furnishes the Phase 3 VIITAL Study Topline Results Presentation the Company expects to present to analysts and investors on or after November 3, 2022. The Company expects to use the Phase 3 VIITAL Study Topline Results Presentation, in whole or in part, and possibly with modifications, from time to time in connection with presentations to potential investors, strategic partners, industry analysts and others. The Phase 3 VIITAL Study Topline Results Presentation is attached hereto as Exhibit 99.1 and is incorporated by reference herein, and is available under the “Company Information” tab in the “Investors & Media” section of the Company’s website, located at www.abeonatherapeutics.com.
By furnishing the information contained in this Current Report on Form 8-K, the Company makes no admission as to the materiality of any information in this report that is required to be disclosed solely by reason of Regulation FD.
The information contained in the Phase 3 VIITAL Study Topline Results Presentation is summary information that is intended to be considered in the context of the Company’s Securities and Exchange Commission (“SEC”) filings and other public announcements that the Company may make, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in this report, except as may be required by the federal securities laws, although it may do so from time to time as its management believes is warranted. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure.
The information furnished pursuant to Item 7.01 of 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 8.01 | Other Events. |
On November 3, 2022, the Company issued a press release entitled “Abeona Therapeutics Announces Positive Topline Results with Both Co-Primary Endpoints Met in Pivotal Phase 3 VIITAL™ Study of EB-101.” The full text of the press release is included as Exhibit 99.2 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 | Phase 3 VIITAL Study Topline Results Presentation | |
99.2 | Press release dated November 3, 2022 | |
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: November 3, 2022