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| CIK | 318306 |
SEC Filings
All companies that sell securities in the United States must register with the Securities and Exchange Commission (SEC) and file reports on a regular basis.
These reports include company annual reports (10K, 10Q), news updates (8K), investor presentations (found in 8Ks), insider trades (form 4), ownership reports (13D, and 13G), and reports related to the specific securities sold, such as registration statements and prospectus. This page shows recent SEC filings related to Abeona Therapeutics Inc.
SEC Filings (Chronological Order)
Halaman ini menyediakan daftar lengkap dan kronologis dari Pengajuan SEC, tidak termasuk pengajuan kepemilikan yang kami sediakan di tempat lain.
| August 14, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-15771 ABEONA THERAPEUTICS INC. |
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| August 14, 2025 |
Exhibit 99.1 Abeona Therapeutics® Reports Second Quarter 2025 Financial Results and Corporate Updates - Received FDA approval for ZEVASKYN™ (prademagene zamikeracel), the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB) - - U.S. launch on track and first ZEVASKYN patient treatment ex |
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| August 14, 2025 |
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): August 14, 2025 ABEONA THERAPEUTICS INC. |
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| August 14, 2025 |
Priority Review Voucher Asset Purchase Agreement dated May 9, 2025.* Exhibit 10.1 Execution Version Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) is the type of information that the registrant treats as private or confidential. [***] denotes omissions. ASSET PURCHASE AGREEMENT This ASSET PURCHASE AGREEMENT (this “Agreement”) is made and entered into as of May 9, 2025 (the “Effective Date”), by and bet |
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| July 18, 2025 |
Exhibit 4.1 THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE BEEN ACQUIRED FOR INVESTMENT AND NOT WITH A VIEW TO, OR IN CONNECTION WITH, THE SALE AND DISTRIBUTION THEREOF, AND HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”) OR ANY STATE SECURITIES LAWS. SUCH SECURITIES MAY NOT BE SOLD OR TRANSFERRED IN THE ABSENCE OF (A) SUCH REGISTRATION, (B) AN OPI |
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| July 18, 2025 |
Exhibit 4.2 THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE BEEN ACQUIRED FOR INVESTMENT AND NOT WITH A VIEW TO, OR IN CONNECTION WITH, THE SALE AND DISTRIBUTION THEREOF, AND HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”) OR ANY STATE SECURITIES LAWS. SUCH SECURITIES MAY NOT BE SOLD OR TRANSFERRED IN THE ABSENCE OF (A) SUCH REGISTRATION, (B) AN OPI |
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| July 18, 2025 |
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 18, 2025 ABEONA THERAPEUTICS INC. |
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| July 18, 2025 |
Exhibit 10.1 FIRST AMENDMENT TO LOAN AND SECURITY AGREEMENT AND SUPPLEMENT This First Amendment to Loan and Security Agreement and Supplement (this “Amendment”) is dated as of July 18, 2025 (the “First Amendment Date”), and is entered into by and among Abeona Therapeutics, Inc., a Delaware corporation (“Company”), MacroChem Corporation, a Delaware corporation, and Abeona Therapeutics LLC, an Ohio |
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| July 2, 2025 |
Exhibit 99.1 Abeona Therapeutics® Closes Sale of Rare Pediatric Disease Priority Review Voucher for $155 Million Cash resources totaled approximately $225 million as of June 30, 2025 CLEVELAND, July 2, 2025 – Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the closing of the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $155 million on June 27, 2025 |
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| July 2, 2025 |
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): June 27, 2025 ABEONA THERAPEUTICS INC. |
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| May 19, 2025 |
Submission of Matters to a Vote of Security Holders 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 19, 2025 ABEONA THERAPEUTICS INC. |
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| May 15, 2025 |
Exhibit 99.1 Abeona Therapeutics® Reports First Quarter 2025 Financial Results and Corporate Updates - Received approval by U.S. Food and Drug Administration (FDA) for ZEVASKYN™ (prademagene zamikeracel), the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB) - - U.S. launch of ZEVASKY |
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| May 15, 2025 |
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 15, 2025 ABEONA THERAPEUTICS INC. |
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| May 15, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-15771 ABEONA THERAPEUTICS INC. |
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| May 12, 2025 |
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. |
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| May 12, 2025 |
Abeona Therapeutics® Enters into Agreement to Sell Priority Review Voucher for $155 Million Exhibit 99.1 Abeona Therapeutics® Enters into Agreement to Sell Priority Review Voucher for $155 Million CLEVELAND, May 12, 2025 – Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced it has entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $155 million upon the closing of the transaction. Abeona was awarded |
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| April 29, 2025 |
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): April 29, 2025 ABEONA THERAPEUTICS INC. |
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| April 29, 2025 |
Webcast Presentation dated April 29, 2025 Exhibit 99.1 |
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| April 29, 2025 |
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): April 29, 2025 ABEONA THERAPEUTICS INC. |
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| April 29, 2025 |
Exhibit 99.1 U.S. FDA Approves ZEVASKYN™ (prademagene zamikeracel), the First and Only Cell-Based Gene Therapy for Patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB) - ZEVASKYN fills a critical need for people living with RDEB, a debilitating dermatological condition with no cure - - Approval based on the pivotal Phase 3 VIITAL™ study, showing ZEVASKYN resulted in significant wound he |
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| April 9, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confide |
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| March 20, 2025 |
Subsidiaries of the registrant EXHIBIT 21 Subsidiaries of the Registrant Abeona Therapeutics LLC, an Ohio company MacroChem Corporation, a Delaware company |
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| March 20, 2025 |
Exhibit 99.1 Abeona Therapeutics® Reports Full Year 2024 Financial Results, Provides Pz-cel Regulatory Update and Commercial Launch Plans FDA priority review of pz-cel Biologics License Application (BLA) progressing with Prescription Drug User Fee Act (PDUFA) target action date of April 29, 2025 Launch preparations on track toward goal to treat first patient in 3Q 2025 CLEVELAND, March 20, 2025 – |
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| March 20, 2025 |
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): March 20, 2025 ABEONA THERAPEUTICS INC. |
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| March 20, 2025 |
Policy on Insider Trading and Confidentiality EXHIBIT 19 ABEONA THERAPEUTICS INC. POLICY ON INSIDER TRADING AND CONFIDENTIALITY I. Purpose The purpose of this Policy on Insider Trading and Confidentiality (the “Policy”) is to provide guidelines with respect to securities of Abeona Therapeutics Inc. (“Abeona” or “Company”) and the handling of confidential and material nonpublic information about the Company and the companies with which the Com |
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| March 20, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-15771 ABEONA THERAPEUTICS INC. |
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| March 20, 2025 |
Policy Relating to Recovery of Erroneously Awarded Compensation EXHIBIT 97 COMPENSATION RECOUPMENT POLICY OF Abeona Therapeutics Inc. ARTICLE A PURPOSE AND GENERAL TERMS x Any capitalized terms used, but not immediately defined, in this Policy have the meanings set forth in Section A-8 or Section B-1, as applicable. Section A-1. Purpose. The Board of Directors (the “Board”) of Abeona Therapeutics Inc. (the “Company”), on recommendation of its Compensation Comm |
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| January 6, 2025 |
Exhibit 107 Calculation of Filing Fee Table Form S-8 (Form Type) ABEONA THERAPEUTICS INC. |
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| January 6, 2025 |
As filed with the Securities and Exchange Commission on January 6, 2025. As filed with the Securities and Exchange Commission on January 6, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-8 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Abeona Therapeutics Inc. (Exact name of registrant as specified in its charter) Delaware 83-0221517 (State or other jurisdiction of incorporation or organization) (I.R. |
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| December 20, 2024 |
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): December 20, 2024 ABEONA THERAPEUTICS INC. |
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| November 14, 2024 |
SC 13G/A 1 p24-3227sc13ga.htm ABEONA THERAPEUTICS INC. SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 3)* Abeona Therapeutics Inc. (Name of Issuer) Common Stock, par value $0.01 per share (Title of Class of Securities) 00289Y206 (CUSIP Number) September 30, 2024 (Date of Event Which Requires Filing of this Statement |
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| November 14, 2024 |
Financial Statements and Exhibits, Results of Operations and Financial Condition 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): November 14, 2024 ABEONA THERAPEUTICS INC. |
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| November 14, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-15771 ABEONA THERAPEUTICS INC. |
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| November 14, 2024 |
Exhibit 99.1 Abeona Therapeutics® Reports Third Quarter 2024 Financial Results and Recent Corporate Updates FDA accepts BLA resubmission of pz-cel in recessive dystrophic epidermolysis bullosa and sets PDUFA target action date of April 29, 2025 Company makes significant progress toward potential commercialization of pz-cel in 2025; Builds momentum with payor discussions and target treatment center |
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| November 12, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confid |
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| November 12, 2024 |
Exhibit 99.1 Abeona Therapeutics® Announces FDA Acceptance of BLA Resubmission of Pz-cel for the Treatment of Recessive Dystrophic Epidermolysis Bullosa FDA assigns PDUFA target action date of April 29, 2025 CLEVELAND, Nov 12, 2024 – Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Abeona’s resubmission of its Biologic |
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| November 12, 2024 |
Financial Statements and Exhibits, Other Events 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): November 8, 2024 ABEONA THERAPEUTICS INC. |
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| October 29, 2024 |
Exhibit 99.1 Abeona Therapeutics® Completes Pz-cel Biologics License Application Resubmission to U.S. Food and Drug Administration CLEVELAND, Oct 29, 2024 – Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the Company has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA or Agency) for prademagene zamikeracel (pz-cel), its investigational |
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| October 29, 2024 |
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): October 28, 2024 ABEONA THERAPEUTICS INC. |
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| October 8, 2024 |
ABEO / Abeona Therapeutics Inc. / INTEGRATED CORE STRATEGIES (US) LLC Passive Investment SC 13G/A 1 ABEOSC13GA2.htm UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (AMENDMENT NO. 2) ABEONA THERAPEUTICS INC. (Name of Issuer) COMMON STOCK, PAR VALUE $0.01 PER SHARE (Title of Class of Securities) 00289Y206 (CUSIP Number) SEPTEMBER 30, 2024 (Date of event which requires filing of this statement) Check the appro |
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| August 14, 2024 |
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): August 8, 2024 ABEONA THERAPEUTICS INC. |
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| August 14, 2024 |
Exhibit 99.1 Abeona Therapeutics® Announces Appointment of Bernhardt Zeiher, MD, FCCP, FACP, and Eric Crombez, MD to its Board of Directors CLEVELAND, August 14, 2024 – Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the appointment of Bernhardt G. Zeiher, MD, FCCP, FACP, and Eric Crombez, MD as new independent members to its Board of Directors. Dr. Zeiher brings more than 20 years of drug |
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| August 12, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-15771 ABEONA THERAPEUTICS INC. |
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| August 12, 2024 |
Results of Operations and Financial Condition, Financial Statements and Exhibits 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): August 12, 2024 ABEONA THERAPEUTICS INC. |
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| August 12, 2024 |
Exhibit 99.1 Abeona Therapeutics® Reports Second Quarter 2024 Financial Results and Concludes Type A Meeting with FDA to Align on Upcoming Pz-cel BLA Resubmission Significant progress addressing CMC items noted in CRL BLA resubmission remains on track for 2H 2024 CLEVELAND, August 12, 2024 – Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the second quarter of 2024 and |
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| July 9, 2024 |
Exhibit 3.1 AMENDED AND RESTATED BYLAWS OF ABEONA THERAPEUTICS INC. ARTICLE I. Offices and Agents 1. Principal Office. The principal office of the Corporation may be located within or without the State of Delaware, as designated by the board of directors. The Corporation may have other offices and places of business at such places within or without the State of Delaware as shall be determined by t |
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| July 9, 2024 |
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 5, 2024 ABEONA THERAPEUTICS INC. |
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| June 21, 2024 |
Filed Pursuant to Rule 424(b)(5) Registration No. 333-280134 Prospectus $75,000,000 Common Stock We have entered into an Open Market Sale AgreementSM dated August 17, 2018, as amended on November 19, 2021 (the “Sale Agreement”), with Jefferies LLC (the “Agent”), relating to the sale of shares of our common stock offered by this prospectus. In accordance with the terms of the Sale Agreement, we may |
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| June 17, 2024 |
ABEONA THERAPEUTICS INC. 6555 Carnegie Avenue, 4th Floor Cleveland, OH 44103 ABEONA THERAPEUTICS INC. 6555 Carnegie Avenue, 4th Floor Cleveland, OH 44103 June 17, 2024 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Abeona Therapeutics Inc. Registration Statement on Form S-3 File No. 333-280134 Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as |
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| June 17, 2024 |
As filed with the Securities and Exchange Commission on June 17, 2024 As filed with the Securities and Exchange Commission on June 17, 2024 Registration No. |
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| June 17, 2024 |
Exhibit 107 Calculation of Filing Fee Table Form S-3 (Form Type) Abeona Therapeutics Inc. |
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| June 12, 2024 |
Exhibit 4.1 ABEONA THERAPEUTICS INC. Issuer AND [TRUSTEE], Trustee INDENTURE Dated as of , 20 Debt Securities TABLE OF CONTENTS Page ARTICLE 1 DEFINITIONS 1 Section 1.01 Definitions of Terms 1 ARTICLE 2 ISSUE, DESCRIPTION, TERMS, EXECUTION, REGISTRATION AND EXCHANGE OF SECURITIES 5 Section 2.01 Designation and Terms of Securities 5 Section 2.02 Form of Securities and Trustee’s Certificate 7 Sectio |
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| June 12, 2024 |
As filed with the Securities and Exchange Commission on June 12, 2024 As filed with the Securities and Exchange Commission on June 12, 2024 Registration No. |
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| June 12, 2024 |
Exhibit 107 Calculation of Filing Fee Table Form S-3 (Form Type) Abeona Therapeutics Inc. |
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| June 3, 2024 |
ABEO / Abeona Therapeutics Inc. / Adage Capital Management, L.P. Passive Investment SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 8)*, ** Abeona Therapeutics Inc. (Name of Issuer) Common Stock, par value $0.01 per share (Title of Class of Securities) 00289Y206 (CUSIP Number) May 31, 2024 (Date of Event Which Requires Filing of This Statement) Check the appropriate box to designate the rule pursuan |
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| June 3, 2024 |
JOINT FILING AGREEMENT PURSUANT TO RULE 13d-1(k) EX-1 2 p24-2014exhibit99.htm JOINT FILING AGREEMENT EXHIBIT 1 JOINT FILING AGREEMENT PURSUANT TO RULE 13d-1(k) The undersigned acknowledge and agree that the foregoing statement on Schedule 13G is filed on behalf of each of the undersigned and that all subsequent amendments to this statement on Schedule 13G shall be filed on behalf of each of the undersigned without the necessity of filing additio |
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| May 15, 2024 |
Exhibit 99.1 Abeona Therapeutics Reports First Quarter 2024 Financial Results and Recent Corporate Progress BLA resubmission anticipated in second half of 2024 Closed $75 million underwritten offering in May, extending expected cash runway into 2026 CLEVELAND, May 15, 2024 – Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the first quarter of 2024 and recent corporate |
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| May 15, 2024 |
Results of Operations and Financial Condition, Financial Statements and Exhibits 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 15, 2024 ABEONA THERAPEUTICS INC. |
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| May 15, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-15771 ABEONA THERAPEUTICS INC. |
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| May 15, 2024 |
As filed with the Securities and Exchange Commission on May 15, 2024. As filed with the Securities and Exchange Commission on May 15, 2024. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-8 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Abeona Therapeutics Inc. (Exact name of registrant as specified in its charter) Delaware 83-0221517 (State or other jurisdiction of incorporation or organization) (I.R.S. |
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| May 15, 2024 |
Exhibit 107 Calculation of Filing Fee Table Form S-8 (Form Type) ABEONA THERAPEUTICS INC. |
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| May 13, 2024 |
ABEO / Abeona Therapeutics Inc. / SUVRETTA CAPITAL MANAGEMENT, LLC Passive Investment SC 13G 1 d1104480213g.htm UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No.)* Abeona Therapeutics Inc. (Name of Issuer) Common Stock, $0.01 par value (Title of Class of Securities) 00289Y206 (CUSIP Number) May 3, 2024 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designa |
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| May 3, 2024 |
Exhibit 99.1 Abeona Therapeutics Announces Pricing of $75 Million Underwritten Offering of Common Stock and Pre-Funded Warrants CLEVELAND, May 3, 2024 – Abeona Therapeutics Inc. (Nasdaq: ABEO) (“Abeona” or the “Company”) today announced the pricing of an underwritten offering of 12,285,056 shares of its common stock and, in lieu of common stock, pre-funded warrants to purchase 6,142,656 shares of |
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| May 3, 2024 |
12,285,056 Shares of Common Stock Pre-funded Warrants to Purchase 6,142,656 Shares of Common Stock Filed Pursuant to Rule 424(b)(5) Registration No. 333-256850 PROSPECTUS SUPPLEMENT (To Prospectus dated October 22, 2021) 12,285,056 Shares of Common Stock Pre-funded Warrants to Purchase 6,142,656 Shares of Common Stock We are offering 12,285,056 shares of our common stock and, in lieu of common stock, pre-funded warrants to purchase 6,142,656 shares of our common stock. The purchase price of eac |
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| May 3, 2024 |
Entry into a Material Definitive Agreement, Other Events, Financial Statements and Exhibits 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 3, 2024 ABEONA THERAPEUTICS INC. |
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| May 3, 2024 |
Underwriting Agreement, dated May 3, 2024 Exhibit 1.1 12,285,056 Shares of Common Stock and Pre-Funded Warrants to Purchase 6,142,656 Shares of Common Stock Abeona Therapeutics Inc. UNDERWRITING AGREEMENT May 3, 2024 Stifel, Nicolaus & Company, Incorporated 787 7th Avenue, 32nd Floor New York, New York 10019 Ladies and Gentlemen: Introductory. Abeona Therapeutics Inc., a Delaware corporation (the “Company”), proposes to issue and sell to |
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| May 3, 2024 |
Exhibit 4.1 PRE-FUNDED COMMON STOCK PURCHASE WARRANT Abeona Therapeutics Inc. Warrant Shares (Subject to Adjustment): Issue Date: May , 2024 THIS PRE-FUNDED COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, [●] or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on |
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| May 3, 2024 |
Results of Operations and Financial Condition, Other Events 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 2, 2024 ABEONA THERAPEUTICS INC. |
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| April 24, 2024 |
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): April 24, 2024 ABEONA THERAPEUTICS INC. |
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| April 22, 2024 |
Other Events, Financial Statements and Exhibits 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): April 22, 2024 ABEONA THERAPEUTICS INC. |
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| April 22, 2024 |
Exhibit 99.1 Abeona Therapeutics Provides Regulatory Update on Pz-cel Receives FDA Complete Response Letter (CRL) based on need for additional CMC information CRL did not identify deficiencies related to clinical efficacy or clinical safety data in BLA, and no new clinical studies requested by FDA to support approval Anticipates completing and submitting requested CMC information in 3Q 2024 Confer |
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| March 19, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confid |
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| March 18, 2024 |
Results of Operations and Financial Condition, Financial Statements and Exhibits 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): March 18, 2024 ABEONA THERAPEUTICS INC. |
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| March 18, 2024 |
Code of Business Conduct and Ethics EXHIBIT 14 Abeona Therapeutics Inc. Code of Business Conduct and Ethics OUR MISSION Our mission to harness the promise of genetic medicine to transform the lives of patients is inspired by our vision, to realize a world where cure is the new standard of care. OUR VALUES Working together to deliver cell and gene therapies for people impacted by serious diseases, and underpinned by our corporate val |
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| March 18, 2024 |
Exhibit 99.1 Abeona Therapeutics Reports Full Year 2023 Financial Results and Announces Completion of FDA Inspections - FDA completed Pre-License Inspection of Abeona’s Cleveland manufacturing facility, as well as inspection of clinical trial sites for pz-cel pivotal Phase 3 VIITAL™ study - CLEVELAND, March 18, 2024 – Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the |
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| March 18, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-15771 ABEONA THERAPEUTICS INC. |
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| March 18, 2024 |
Policy Relating to Recovery of Erroneously Awarded Compensation EXHIBIT 97 COMPENSATION RECOUPMENT POLICY OF Abeona Therapeutics Inc. ARTICLE A PURPOSE AND GENERAL TERMS x Any capitalized terms used, but not immediately defined, in this Policy have the meanings set forth in Section A-8 or Section B-1, as applicable. Section A-1. Purpose. The Board of Directors (the “Board”) of Abeona Therapeutics Inc. (the “Company”), on recommendation of its Compensation Comm |
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| March 18, 2024 |
Policy on Insider Trading and Confidentiality EXHIBIT 19 ABEONA THERAPEUTICS INC. POLICY ON INSIDER TRADING AND CONFIDENTIALITY I. Purpose The purpose of this Policy on Insider Trading and Confidentiality (the “Policy”) is to provide guidelines with respect to securities of Abeona Therapeutics Inc. (“Abeona” or “Company”) and the handling of confidential and material nonpublic information about the Company and the companies with which the Com |
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| March 18, 2024 |
Subsidiaries of the registrant EXHIBIT 21 Subsidiaries of the Registrant Abeona Therapeutics LLC, an Ohio company MacroChem Corporation, a Delaware company |
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| February 14, 2024 |
US00289Y2063 / Abeona Therapeutics Inc / ARMISTICE CAPITAL, LLC Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. |
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| February 14, 2024 |
US00289Y2063 / Abeona Therapeutics Inc / EcoR1 Capital, LLC Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1) Abeona Therapeutics Inc. (Name of Issuer) Common Stock, par value $0.01 per share (Title of Class of Securities) 00289Y206 (CUSIP Number) December 31, 2023 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the |
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| February 14, 2024 |
SC 13G/A 1 tm243309d25sc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* ABEONA THERAPEUTICS INC. (Name of Issuer) Common Stock, $0.01 par value (Title of Class of Securities) 00289Y206 (CUSIP Number) December 31, 2023 (Date of Event which Requires Filing of this Statement) Check the |
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| February 14, 2024 |
SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 2)* Abeona Therapeutics Inc. (Name of Issuer) Common Stock, par value $0.01 per share (Title of Class of Securities) 00289Y206 (CUSIP Number) December 31, 2023 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pursua |
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| February 12, 2024 |
US00289Y2063 / Abeona Therapeutics Inc / Flynn James E Passive Investment SC 13G/A 1 e619238sc13ga-at.htm SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 SCHEDULE 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO RULES 13d-1(b)(c), AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO RULE 13d-2(b) (Amendment No. 2) * Abeona Therapeutics, Inc. (Name of Issuer) Common Stock (Title of Class of Securities) 00289Y206 (CUSIP Number) December 31 |
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| January 10, 2024 |
US00289Y2063 / Abeona Therapeutics Inc / INTEGRATED CORE STRATEGIES (US) LLC Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (AMENDMENT NO. 1) ABEONA THERAPEUTICS INC. (Name of Issuer) COMMON STOCK, PAR VALUE $0.01 PER SHARE (Title of Class of Securities) 00289Y206 (CUSIP Number) DECEMBER 31, 2023 (Date of event which requires filing of this statement) Check the appropriate box to designate the |
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| January 8, 2024 |
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): January 8, 2024 ABEONA THERAPEUTICS INC. |
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| January 8, 2024 |
Abeona Therapeutics Announces $50 Million Credit Facility Exhibit 99.1 Abeona Therapeutics Announces $50 Million Credit Facility CLEVELAND, January 8, 2024 – Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it has entered into a $50 million credit facility with the Avenue Venture Opportunities Fund, L.P. The credit agreement, which has a term of three and a half years, includes a first tranche of $20 million at closing, a second tranche of $1 |
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| January 8, 2024 |
Exhibit 10.2 SUPPLEMENT to the Loan and Security Agreement dated as of January 8, 2024 among Abeona Therapeutics Inc. (“Company”), MacroChem Corporation and Abeona Therapeutics LLC (together with Company, each, individually, a “Borrower”, and collectively, “Borrower”) Avenue Venture Opportunities Fund, L.P. II, L.P., a Delaware limited partnership (“Avenue 2”), as a lender and Avenue Venture Oppor |
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| January 8, 2024 |
Exhibit 10.1 LOAN AND SECURITY AGREEMENT Dated as of January 8, 2024 between ABEONA THERAPEUTICS INC., a Delaware corporation (“Company”), MACROCHEM CORPORATION, a Delaware corporation (“Macrochem”), as a borrower ABEONA THERAPEUTICS LLC, an Ohio limited liability company (“Abeona OH”), as a borrower (together with Company and Macrochem, each individually, a “Borrower”, and collectively, “Borrower |
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| January 8, 2024 |
Exhibit 4.1 THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE BEEN ACQUIRED FOR INVESTMENT AND NOT WITH A VIEW TO, OR IN CONNECTION WITH, THE SALE AND DISTRIBUTION THEREOF, AND HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”) OR ANY STATE SECURITIES LAWS. SUCH SECURITIES MAY NOT BE SOLD OR TRANSFERRED IN THE ABSENCE OF (A) SUCH REGISTRATION, (B) AN OPI |
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| January 8, 2024 |
Exhibit 4.2 THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE BEEN ACQUIRED FOR INVESTMENT AND NOT WITH A VIEW TO, OR IN CONNECTION WITH, THE SALE AND DISTRIBUTION THEREOF, AND HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”) OR ANY STATE SECURITIES LAWS. SUCH SECURITIES MAY NOT BE SOLD OR TRANSFERRED IN THE ABSENCE OF (A) SUCH REGISTRATION, (B) AN OPI |
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| December 4, 2023 |
US00289Y2063 / Abeona Therapeutics Inc / INTEGRATED CORE STRATEGIES (US) LLC Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 ABEONA THERAPEUTICS INC. (Name of Issuer) COMMON STOCK, PAR VALUE $0.01 PER SHARE (Title of Class of Securities) 00289Y206 (CUSIP Number) NOVEMBER 27, 2023 (Date of event which requires filing of this statement) Check the appropriate box to designate the rule pursuant to w |
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| November 27, 2023 |
Other Events, Financial Statements and Exhibits 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): November 27, 2023 ABEONA THERAPEUTICS INC. |
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| November 27, 2023 |
Exhibit 99.1 Abeona Therapeutics Announces FDA Accepts and Grants Priority Review for Pz-cel Biologics License Application (BLA) - PDUFA target action date is May 25, 2024 - - FDA does not currently plan to hold Advisory Committee meeting for pz-cel BLA - CLEVELAND, November 27, 2023 – Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the U.S. Food and Drug Administration (FDA) has acce |
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| November 13, 2023 |
Exhibit 99.1 Abeona Therapeutics Reports Third Quarter 2023 Financial Results and Corporate Developments Abeona’s first-ever U.S. Biologics License Application (BLA) submission completed in September 2023 FDA decision on priority review and acceptance of BLA for pz-cel (prademagene zamikeracel, formerly known as EB-101) in recessive dystrophic epidermolysis bullosa (RDEB) expected by late-November |
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| November 13, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-15771 ABEONA THERAPEUTICS INC. |
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| November 13, 2023 |
Results of Operations and Financial Condition, Financial Statements and Exhibits 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): November 13, 2023 ABEONA THERAPEUTICS INC. |
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| October 18, 2023 |
Exhibit 16.1 October 17, 2023 Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549 Re: Abeona Therapeutics, Inc., Changes in Registrant’s Certifying Accountant Commissioners: We have read the statements made by Abeona Therapeutics, Inc. pursuant to Item 4.01(b) of Form 8-K dated October 17, 2023, which we understand will be filed with the Securities and Exchange Commission. W |
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| October 18, 2023 |
Changes in Registrant's Certifying Accountant, Financial Statements and Exhibits 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): October 16, 2023 ABEONA THERAPEUTICS INC. |
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| October 10, 2023 |
As filed with the Securities and Exchange Commission on October 10, 2023 As filed with the Securities and Exchange Commission on October 10, 2023 Registration No. |
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| October 10, 2023 |
Exhibit 99.2 Abeona Therapeutics Inc. 2023 Employment Inducement Equity Incentive Plan Restricted Stock Award Agreement Recitals A. The Board of Directors of Abeona Therapeutics Inc., a Delaware corporation, and any successor corporation to all or substantially all of the assets or voting stock of the Corporation has adopted the Plan for the purpose of providing new employees of the Corporation or |
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| October 10, 2023 |
Exhibit 107 Calculation of Filing Fee Table Form S-8 (Form Type) ABEONA THERAPEUTICS INC. |
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| October 10, 2023 |
Exhibit 99.1 ABEONA THERAPEUTICS INC. 2023 EMPLOYMENT INDUCEMENT EQUITY INCENTIVE PLAN Section 1. Effectiveness and Purpose. Effective as of the Effective Date, the Abeona Therapeutics Inc. 2023 Employment Inducement Equity Incentive Plan (as may be amended from time to time, the “Plan”) is hereby established. The purpose of the Plan is to provide new employees of Abeona Therapeutics Inc., a Delaw |
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| August 8, 2023 |
EXHIBIT 10.5 June 15, 2023 Brendan O’Malley Re: Retention Bonus Dear Brendan, We consider your continued service and dedication to Abeona Therapeutics Inc. (“Abeona” or the “Company”) essential to our business and future success. To incentivize you to remain employed with Abeona, we are pleased to inform you of Abeona’s retention bonus, as described herein. In recognition of your continued service |
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| August 8, 2023 |
EXHIBIT 10.4 June 15, 2023 Joseph Vazzano Re: Retention Bonus Dear Joseph, We consider your continued service and dedication to Abeona Therapeutics Inc. (“Abeona” or the “Company”) essential to our business and future success. To incentivize you to remain employed with Abeona, we are pleased to inform you of Abeona’s retention bonus, as described herein. In recognition of your continued service wi |
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| August 8, 2023 |
Financial Statements and Exhibits, Results of Operations and Financial Condition 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): August 8, 2023 ABEONA THERAPEUTICS INC. |
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| August 8, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-15771 ABEONA THERAPEUTICS INC. |
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| August 8, 2023 |
Exhibit 99.1 Abeona Therapeutics Reports Second Quarter 2023 Financial Results On track for Biologics License Application (BLA) submission in third quarter of 2023 Proceeds from $25 million registered direct offering in July allow initiation of pre-commercial launch activities for EB-101 Cash on hand plus proceeds from registered direct offering projected to fund operations into the fourth quarter |
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| August 8, 2023 |
EXHIBIT 10.3 June 15, 2023 Vishwas Seshadri Re: Retention Bonus Dear Vishwas, We consider your continued service and dedication to Abeona Therapeutics Inc. (“Abeona” or the “Company”) essential to our business and future success. To incentivize you to remain employed with Abeona, we are pleased to inform you of Abeona’s retention bonus, as described herein. In recognition of your continued service |
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| July 7, 2023 |
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 7, 2023 ABEONA THERAPEUTICS INC. |
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| July 7, 2023 |
Exhibit 99.1 Abeona Therapeutics Announces Closing of $25 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules CLEVELAND, July 7, 2023 – Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the closing of its previously announced registered direct offering for total gross proceeds of $25 million, before deducting the placement agents’ fees and other offering expenses. “Our exist |
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| July 6, 2023 |
SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 7)* Abeona Therapeutics Inc. (Name of Issuer) Common Stock, par value $0.01 per share (Title of Class of Securities) 00289Y206 (CUSIP Number) July 3, 2023 (Date of Event Which Requires Filing of This Statement) Check the appropriate box to designate the rule pursuant to |
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| July 3, 2023 |
Exhibit 4.1 PRE-FUNDED COMMON STOCK PURCHASE WARRANT Abeona Therapeutics Inc. Warrant Shares (Subject to Adjustment): Issue Date: July , 2023 THIS PRE-FUNDED COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, [●] or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time o |
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| July 3, 2023 |
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. |
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| July 3, 2023 |
Exhibit 99.1 Abeona Therapeutics Announces $25 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules CLEVELAND, July 3, 2023 – Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it has raised $25 million at-the-market from select existing investors, primarily to fund initiation of the Company’s launch preparations in anticipation of the EB-101 Biologics License Appli |
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| July 3, 2023 |
Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of July 3, 2023, between Abeona Therapeutics Inc., a Delaware corporation (the “Company”), and the purchasers identified on the signature pages hereto (including their respective successors and assigns, the “Purchasers”). WHEREAS, subject to the terms and conditions set forth in this Agreem |
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| July 3, 2023 |
3,284,407 Shares of Common Stock Pre-funded warrants to purchase 2,919,140 Shares of Common Stock Filed Pursuant to Rule 424(b)(5) Registration No. 333-256850 Prospectus Supplement (To Prospectus dated October 22, 2021) 3,284,407 Shares of Common Stock Pre-funded warrants to purchase 2,919,140 Shares of Common Stock We are offering 3,284,407 shares of our common stock and, in lieu of common stock, pre-funded warrants to purchase 2,919,140 shares of our common stock, in a registered direct offe |
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| June 7, 2023 |
Up to $106,000,000 Common Stock Filed Pursuant to Rule 424(b)(5) Registration No. 333-256850 PROSPECTUS SUPPLEMENT (To Prospectus dated October 22, 2021, as supplemented by Prospectus Supplement No. 1 dated November 19, 2021, Prospectus Supplement No. 2 dated July 19, 2022, Prospectus Supplement No. 3 dated October 12, 2022 and Prospectus Supplement No. 4 dated March 29, 2023) Up to $106,000,000 Common Stock This prospectus supp |
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| May 19, 2023 |
Exhibit 99.1 ABEONA THERAPEUTICS INC. 2023 EQUITY INCENTIVE PLAN Section 1. Effectiveness and Purpose. Effective as of the Effective Date, the Abeona Therapeutics Inc. 2023 Equity Incentive Plan (as may be amended from time to time, the “Plan”) is hereby established. The purpose of the Plan is to provide employees of Abeona Therapeutics Inc., a Delaware corporation (together with its successors, t |
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| May 19, 2023 |
As filed with the Securities and Exchange Commission on May 19, 2023 As filed with the Securities and Exchange Commission on May 19, 2023 Registration No. |
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| May 19, 2023 |
Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) Abeona Therapeutics Inc. |
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| May 17, 2023 |
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 17, 2023 ABEONA THERAPEUTICS INC. |
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| May 11, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-15771 ABEONA THERAPEUTICS INC. |
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| May 11, 2023 |
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 11, 2023 ABEONA THERAPEUTICS INC. |
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| May 11, 2023 |
Exhibit 99.1 Abeona Therapeutics Reports First Quarter 2023 Financial Results Continues to make progress toward Biologics License Application (BLA) submission for EB-101 in late-2Q/early-3Q 2023; submitted request for pre-BLA meeting Additional Phase 3 VIITAL™ study results presented at International Societies for Investigative Dermatology 2023 Meeting further highlights EB-101 value proposition i |
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| April 13, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confid |
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| April 11, 2023 |
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): April 6, 2023 ABEONA THERAPEUTICS INC. |
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| April 10, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K/A (Amendment No. 1) UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K/A (Amendment No. |
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| March 29, 2023 |
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): March 29, 2023 ABEONA THERAPEUTICS INC. |
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| March 29, 2023 |
Filed Pursuant to Rule 424(b)(5) Registration No. 333-256850 PROSPECTUS SUPPLEMENT (To Prospectus dated October 22, 2021, as supplemented by Prospectus Supplement No. 1 dated November 19, 2021, Prospectus Supplement No. 2 dated July 19, 2022 and Prospectus Supplement No. 3 dated October 12, 2022) Up to $4,872,300 Common Stock This prospectus supplement amends and supplements the information in the |
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| March 29, 2023 |
Subsidiaries of the registrant EXHIBIT 21 Subsidiaries of the Registrant Abeona Therapeutics LLC, an Ohio company MacroChem Corporation, a Delaware company |
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| March 29, 2023 |
Amended and Restated Bylaws of Abeona Therapeutics Inc. Exhibit 3.3 AMENDED AND RESTATED BYLAWS OF ABEONA THERAPEUTICS INC. ARTICLE I. Offices and Agents 1. Principal Office. The principal office of the Corporation may be located within or without the State of Delaware, as designated by the board of directors. The Corporation may have other offices and places of business at such places within or without the State of Delaware as shall be determined by t |
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| March 29, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-15771 ABEONA THERAPEUTICS INC. |
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| March 29, 2023 |
Exhibit 99.1 Abeona Therapeutics Reports Full Year 2022 Financial Results and Provides Corporate Update Expects to submit BLA for EB-101 to FDA in late-2Q/early-3Q 2023 based on positive Phase 3 VIITAL™ study results announced in 4Q 2022 Advancing AAV-based gene therapy candidates toward IND studies in Stargardt Disease, X-linked Retinoschisis, and Autosomal Dominant Optic Atrophy Strengthened sen |
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| March 22, 2023 |
Exhibit 107 CALCULATION OF REGISTRATION FEE Form S-8 (Form Type) Abeona Therapeutics Inc. |
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| March 22, 2023 |
Registration No. 333- As filed with the Securities and Exchange Commission on March 22, 2023 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-8 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Abeona Therapeutics Inc. (Exact name of registrant as specified in its charter) Delaware 51-0407811 (State or other jurisdiction of incorporation or organization) (IRS Em |
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| March 13, 2023 |
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): March 13, 2023 ABEONA THERAPEUTICS INC. |
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| February 14, 2023 |
SC 13G 1 tm236168d30sc13g.htm SC 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* ABEONA THERAPEUTICS INC (Name of Issuer) Common Stock, $0.01 par value (Title of Class of Securities) 00289Y206 (CUSIP Number) December 31, 2022 (Date of Event which Requires Filing of this Statement) Check the appropr |
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| February 14, 2023 |
US00289Y2063 / Abeona Therapeutics Inc / ARMISTICE CAPITAL, LLC Passive Investment SC 13G 1 armistice-abeo123122.htm UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* ABEONA THERAPEUTICS INC. (Name of Issuer) Common Stock, $0.01 par value (Title of Class of Securities) 00289Y206 (CUSIP Number) December 31, 2022 (Date of Event Which Requires Filing of this Statement) Check the appropriate |
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| February 14, 2023 |
SC 13G/A 1 pt7213ga.htm SCHEDULE 13G/A, AMENDMENT #2 240.13d-102 Schedule 13G - Information to be included in statements filed pursuant to 240.13d-1(b), (c), and (d) and amendments thereto filed pursuant to 240.13d-2. Securities and Exchange Commission, Washington, D.C. 20549 Schedule 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* (Name of Issuer) Abeona Therapeutics Inc. (Title |
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| February 10, 2023 |
US00289Y2063 / Abeona Therapeutics Inc / Flynn James E Passive Investment SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 SCHEDULE 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO RULES 13d-1(b)(c), AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO RULE 13d-2(b) (Amendment No. |
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| February 9, 2023 |
SC 13G/A 1 p23-0743sc13ga.htm ABEONA THERAPEUTICS INC. SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 6)* Abeona Therapeutics Inc. (Name of Issuer) Common Stock, $0.01 par value (Title of Class of Securities) 00289Y206 (CUSIP Number) December 31, 2022 (Date of Event Which Requires Filing of This Statement) Check the |
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| January 10, 2023 |
ABEO / Abeona Therapeutics Inc / HIRSCHMAN ORIN Passive Investment SC 13G/A 1 formsc13ga.htm UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G/A Amendment No.1 Under the Securities Exchange Act of 1934 Abeona Therapeutics Inc. (Name of Issuer) Common Shares (Title of Class of Securities) 00289Y107 (CUSIP Number) December 31, 2022 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the r |
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| December 6, 2022 |
Abeona Therapeutics Inc. 1330 Avenue of the Americas, 33rd Floor New York, NY 10019 CORRESP 1 filename1.htm Abeona Therapeutics Inc. 1330 Avenue of the Americas, 33rd Floor New York, NY 10019 December 6, 2022 U.S. Securities and Exchange Commission Division of Corporate Finance 100 F Street NE Washington, DC 20549 Attention: Tim Buchmiller VIA EDGAR Re: Abeona Therapeutics Inc. Registration Statement on Form S-3 Filed on December 1, 2022 File No. 333-268619 Dear Mr. Buchmiller: I |
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| December 1, 2022 |
As filed with the Securities and Exchange Commission on November 30, 2022 As filed with the Securities and Exchange Commission on November 30, 2022 Registration No. |
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| December 1, 2022 |
Exhibit 107 Calculation of Filing Fee Tables S-3 (Form Type) Abeona Therapeutics Inc. |
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| November 16, 2022 |
US00289Y2063 / Abeona Therapeutics Inc / Flynn James E Passive Investment SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 SCHEDULE 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO RULES 13d-1(b)(c), AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO RULE 13d-2(b) (Amendment No. |
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| November 14, 2022 |
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): November 14, 2022 ABEONA THERAPEUTICS INC. |
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| November 14, 2022 |
Exhibit 99.1 Abeona Therapeutics Reports Third Quarter 2022 Financial Results Following positive topline data from Phase 3 VIITAL™ study of EB-101 with both co-primary endpoints met, Abeona plans to submit BLA to U.S. FDA in 2Q 2023 Company well-funded with expected cash runway into 3Q 2024 NEW YORK and CLEVELAND, November 14, 2022 – Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced financia |
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| November 14, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-15771 ABEONA THERAPEUTICS INC. |
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| November 14, 2022 |
US00289Y2063 / Abeona Therapeutics Inc / EcoR1 Capital, LLC Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. ) Abeona Therapeutics Inc. (Name of Issuer) Common Stock, par value $0.01 per share (Title of Class of Securities) 00289Y206 (CUSIP Number) November 3, 2022 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the ru |
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| November 10, 2022 |
240.13d-102 Schedule 13G - Information to be included in statements filed pursuant to 240.13d-1(b), (c), and (d) and amendments thereto filed pursuant to 240.13d-2. Securities and Exchange Commission, Washington, D.C. 20549 Schedule 13G Under the Securities Exchange Act of 1934 (Amendment No.)* (Name of Issuer) Abeona Therapeutics Inc. (Title of Class of Securities) Common Stock, Par Value $0.01 P |
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| November 10, 2022 |
Exhibit 99.1 JOINT FILING AGREEMENT The undersigned hereby agree that the foregoing statement on Schedule 13G is filed on behalf of each of the undersigned in accordance with the provisions of Rule 13d-1(k) under the Securities Exchange Act of 1934, as amended, and that all subsequent amendments to this statement on Schedule 13G may be filed on behalf of each of the undersigned without the necessi |
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| November 4, 2022 |
ABEO / Abeona Therapeutics Inc / HIRSCHMAN ORIN Passive Investment SC 13G 1 formsc13g.htm UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 Abeona Therapeutics Inc. (Name of Issuer) Common Shares (Title of Class of Securities) 00289Y107 (CUSIP Number) November 3, 2022 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant to which |
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| November 3, 2022 |
Abeona Therapeutics Announces $35 Million Private Placement Financing Exhibit 99.1 Abeona Therapeutics Announces $35 Million Private Placement Financing NEW YORK and CLEVELAND, Nov. 3, 2022 (GLOBE NEWSWIRE) ? Abeona Therapeutics Inc. (Nasdaq: ABEO) announced today that it has entered into a securities purchase agreement to sell 7,065,946 shares of its common stock, and, in lieu of shares of common stock, pre-funded warrants exercisable for 543,933 shares of common s |
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| November 3, 2022 |
Exhibit 99.2 Abeona Therapeutics Announces Positive Topline Results with Both Co-Primary Endpoints Met in Pivotal Phase 3 VIITAL™ Study of EB-101 Co-primary endpoint measuring >50% wound healing, other endpoints measuring >75% and complete wound healing at six months all met Co-primary endpoint measuring pain reduction at six months met; greater magnitude of pain reduction benefit was observed in |
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| November 3, 2022 |
Form of Registration Rights Agreement Exhibit 4.3 REGISTRATION RIGHTS AGREEMENT This Registration Rights Agreement (this ?Agreement?) is made and entered into as of November [], 2022, between Abeona Therapeutics Inc., a Delaware corporation (the ?Company?), and each of the purchasers signatory hereto (each such purchaser, a ?Purchaser? and, collectively, the ?Purchasers?). This Agreement is made pursuant to the Securities Purchase Agr |
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| November 3, 2022 |
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): November 3, 2022 ABEONA THERAPEUTICS INC. |
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| November 3, 2022 |
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): November 3, 2022 ABEONA THERAPEUTICS INC. |
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| November 3, 2022 |
Phase 3 VIITAL Study Topline Results Presentation Exhibit 99.1 |
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| November 3, 2022 |
Securities Purchase Agreement dated November 3, 2022 Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this ?Agreement?) is dated as of November 3, 2022 (the ?Effective Date?), between Abeona Therapeutics Inc., a Delaware corporation (the ?Company?), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a ?Purchaser? and collectively, the ?Purchasers?). WHEREAS, subject |
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| November 3, 2022 |
Exhibit 4.1 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE ?SECURITIES ACT?), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR |
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| November 3, 2022 |
Exhibit 4.2 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE ?SECURITIES ACT?), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR |
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| October 12, 2022 |
Filed Pursuant to Rule 424(b)(5) Registration No. 333-256850 PROSPECTUS SUPPLEMENT (To Prospectus dated October 22, 2021, as supplemented by Prospectus Supplement No. 1 dated November 19, 2021 and Prospectus Supplement No. 2 dated July 19, 2022) Up to $5,575,049 Common Stock This prospectus supplement amends and supplements the information in the prospectus, dated October 22, 2021 (the “Prospectus |
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| August 31, 2022 |
Exhibit 107 Calculation of Filing Fee Table Form S-8 (Form Type) Abeona Therapeutics Inc. |
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| August 31, 2022 |
Abeona Therapeutics Inc. 2015 Equity Incentive Plan, as amended effective August 17, 2022 Exhibit 99.1 ABEONA THERAPEUTICS INC. 2015 EQUITY INCENTIVE PLAN (as amended on August 17, 2022) ARTICLE 1 GENERAL PROVISIONS 1.1 PURPOSE OF THE PLAN This 2015 Equity Incentive Plan (the ?Plan?) is intended to promote the interests of Abeona Therapeutics Inc., a Delaware corporation, by providing eligible persons in the Corporation?s service with the opportunity to acquire a proprietary interest, |
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| August 31, 2022 |
As filed with the Securities and Exchange Commission on August 31, 2022 As filed with the Securities and Exchange Commission on August 31, 2022 Registration No. |
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| August 17, 2022 |
Submission of Matters to a Vote of Security Holders 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): August 17, 2022 ABEONA THERAPEUTICS INC. |
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| August 11, 2022 |
Exhibit 10.3 SPECIFIC TERMS IN THIS AGREEMENT HAVE BEEN REDACTED BECAUSE SUCH TERMS ARE BOTH NOT MATERIAL AND ARE OF A TYPE THAT ABEONA THERAPEUTICS INC. TREATS AS CONFIDENTIAL. THESE REDACTED TERMS HAVE BEEN MARKED IN THIS EXHIBIT AT THE APPROPRIATE PLACE WITH THREE ASTERISKS [***] LICENSE AGREEMENT BETWEEN ULTRAGENYX PHARMACEUTICAL INC. AND ABEONA THERAPEUTICS INC. May 16, 2022 TABLE OF CONTENTS |
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| August 11, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark one) ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 or ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-15771 ABEONA THERAPEUTICS INC. |
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| August 11, 2022 |
Results of Operations and Financial Condition, Financial Statements and Exhibits 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): August 11, 2022 ABEONA THERAPEUTICS INC. |
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| August 11, 2022 |
Exhibit 99.1 Abeona Therapeutics Reports Second Quarter 2022 Financial Results Disposition of MPS programs allows Abeona to extend runway of current cash into 2Q 2023 Phase 3 VIITAL? study topline data expected in late-3Q/early-4Q 2022 upon completion of final patient monitoring visit in mid-September Baseline wound characteristics in VIITAL? reveal significant scope for pain reduction and EB-101 |
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| August 4, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ? Filed by a Party other than the Registrant ?? Check the appropriate box: ? Preliminary Proxy Statement ? Confid |
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| July 20, 2022 |
Abeona Therapeutics Regains Compliance with Nasdaq Listing Requirements Exhibit 99.1 Abeona Therapeutics Regains Compliance with Nasdaq Listing Requirements NEW YORK and CLEVELAND, July 20, 2022 ? Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it received notice from The Nasdaq Stock Market LLC (Nasdaq) on July 19, 2022 informing Abeona that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) (the ?Rule? |
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| July 20, 2022 |
Other Events, Financial Statements and Exhibits 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 19, 2022 ABEONA THERAPEUTICS INC. |
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| July 19, 2022 |
Filed Pursuant to Rule 424(b)(5) Registration No. 333-256850 PROSPECTUS SUPPLEMENT (To Prospectus Supplement dated November 19, 2021 To Prospectus dated October 22, 2021) Up to $9,584,554 Common Stock This prospectus supplement amends and supplements the information in the prospectus, dated October 22, 2021, filed with the Securities and Exchange Commission as a part of our registration statement |
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| July 11, 2022 |
DEF 14A 1 ny20004583x1def14a.htm DEF 14A TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check |
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| June 30, 2022 |
Certificate of Amendment to Restated Certificate of Incorporation of Abeona Therapeutics Inc. EX-3.1 2 ex3-1.htm Exhibit 3.1 Certificate of Amendment to Restated Certificate of Incorporation of Abeona Therapeutics Inc. Abeona Therapeutics Inc. (the “Corporation”), a corporation organized and existing under the General Corporation Law of the State of Delaware (the “DGCL”), does hereby certify that: 1. The name of the Corporation is Abeona Therapeutics Inc. 2. The Restated Certificate of Inc |
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| June 30, 2022 |
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): June 30, 2022 ABEONA THERAPEUTICS INC. |
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| June 14, 2022 |
Submission of Matters to a Vote of Security Holders 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): June 14, 2022 ABEONA THERAPEUTICS INC. |
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| May 19, 2022 |
Exhibit 99.1 Abeona Therapeutics Granted Second 180-Day Period by Nasdaq to Regain Compliance with Minimum Bid Price Rule NEW YORK, NY and CLEVELAND, OH, May 19, 2022 ? Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in cell and gene therapy, today announced that the Company has been granted an additional 180-day period from Nasdaq?s Listing Qualification Department, through Nov |
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| May 19, 2022 |
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 17, 2022 ABEONA THERAPEUTICS INC. |
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| May 17, 2022 |
Exhibit 99.1 Ultragenyx Acquires Global Rights to AAV Gene Therapy ABO-102 for Sanfilippo Syndrome Type A (MPS IIIA) from Abeona Therapeutics ABO-102 / UX111 is being evaluated in ongoing pivotal Transpher A trial in patients with MPS IIIA Interim data featured in encore oral presentation at American Society of Gene & Cell Therapy (ASGCT) today NOVATO, Calif., NEW YORK, NY and CLEVELAND, OH ? MAY |
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| May 17, 2022 |
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 16, 2022 ABEONA THERAPEUTICS INC. |
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| May 13, 2022 |
Exhibit 10.1 VIA EMAIL February 28, 2022 Joseph W. Vazzano, CPA Dear Joseph: This letter agreement sets forth the terms of your employment as Senior Vice President, Chief Financial Officer, effective March 7, 2022 (the ?Effective Date?). 1. Duties; Best Efforts. As Senior Vice President, Chief Financial Officer, you shall have the duties, responsibilities, and authority commensurate therewith, and |
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| May 13, 2022 |
Exhibit 99.1 Abeona Therapeutics Reports First Quarter 2022 Financial Results Disposition of MPS programs to reduce operating expenses and extend projected cash runway into 2Q 2023 Focus R&D resources on EB-101 pivotal phase 3 VIITAL? topline data expected in 3Q 2022 NEW YORK and CLEVELAND, May 13, 2022 ? Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in cell and gene therapy, |
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| May 13, 2022 |
Results of Operations and Financial Condition, Financial Statements and Exhibits 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 13, 2022 ABEONA THERAPEUTICS INC. |
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| May 13, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark one) ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 or ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-15771 ABEONA THERAPEUTICS INC. |
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| May 13, 2022 |
Amended and Restated Bylaws of Abeona Therapeutics Inc. Exhibit 3.2 AMENDED AND RESTATED BYLAWS OF ABEONA THERAPEUTICS INC. ARTICLE I. Offices and Agents 1. Principal Office. The principal office of the Corporation may be located within or without the State of Delaware, as designated by the board of directors. The Corporation may have other offices and places of business at such places within or without the State of Delaware as shall be determined by t |
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| May 13, 2022 |
Amended and Restated Certificate of Incorporation of Abeona Therapeutics Inc. Exhibit 3.1 AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF ABEONA THERAPEUTICS INC. Abeona Therapeutics Inc., a corporation organized and existing under the General Corporation Law of the State of Delaware (the ?Corporation?), does hereby certify: 1. The original Certificate of Incorporation of the Corporation was filed with the Secretary of State of Delaware on June 22, 1989 (the ?Original |
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| May 12, 2022 |
TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ? Filed by a Party other than the Registrant ?? Check the appropriate box: ?? ? ? Preliminary Proxy Statement ?? ? ? Confidential, For Use of the Commission Only (as permitted by R |
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| May 2, 2022 |
Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this ?Agreement?) is dated as of April 29, 2022, between Abeona Therapeutics Inc., a Delaware corporation (the ?Company?), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a ?Purchaser? and collectively the ?Purchasers?). Recitals A. The Company and the Purchasers |
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| May 2, 2022 |
Exhibit 3.2 ABEONA THERAPEUTICS INC. CERTIFICATE OF DESIGNATION OF PREFERENCES, RIGHTS AND LIMITATIONS OF SERIES B CONVERTIBLE REDEEMABLE PREFERRED STOCK PURSUANT TO SECTION 151 OF THE delaware GENERAL CORPORATION LAW The undersigned, Joseph Vazzano, does hereby certify that: 1. He is the Chief Financial Officer of Abeona Therapeutics Inc., a Delaware corporation (the ?Corporation?). 2. The Corpor |
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| May 2, 2022 |
Exhibit 10.2 REGISTRATION RIGHTS AGREEMENT This Registration Rights Agreement (this ?Agreement?) is made and entered into as of May 2, 2022, between Abeona Therapeutics Inc., a Delaware corporation (the ?Company?), and each of the several purchasers signatory hereto (each such purchaser, a ?Purchaser? and, collectively, the ?Purchasers?). This Agreement is made pursuant to the Securities Purchase |
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| May 2, 2022 |
Exhibit 3.1 ABEONA THERAPEUTICS INC. CERTIFICATE OF DESIGNATION OF PREFERENCES, RIGHTS AND LIMITATIONS OF SERIES a CONVERTIBLE REDEEMABLE PREFERRED STOCK PURSUANT TO SECTION 151 OF THE delaware GENERAL CORPORATION LAW The undersigned, Joseph Vazzano, does hereby certify that: 1. He is the Chief Financial Officer of Abeona Therapeutics Inc., a Delaware corporation (the ?Corporation?). 2. The Corpor |
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| May 2, 2022 |
Exhibit 99.1 Abeona Therapeutics Announces Pricing of $25 Million Private Placement of Convertible Redeemable Preferred Stock NEW YORK, NY and CLEVELAND, OH, April 29, 2022 ? Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in cell and gene therapy, today announced that it has entered into a securities purchase agreement with certain institutional investors to purchase 1,000,006 |
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| May 2, 2022 |
TABLE OF CONTENTS PRELIMINARY PROXY STATEMENT SUBJECT TO COMPLETION ? DATED MAY 2, 2022 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. |
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| May 2, 2022 |
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): April 29, 2022 ABEONA THERAPEUTICS INC. |
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| April 29, 2022 |
Amendment No. 1 to the Amended and Restated Bylaws of Abeona Therapeutics Inc. Exhibit 3.1 AMENDMENT NO. 1 TO THE AMENDED AND RESTATED BYLAWS OF ABEONA THERAPEUTICS INC. The undersigned, being the duly elected and acting Chief Executive Officer of Abeona Therapeutics Inc., a Delaware corporation (the ?Corporation?), does hereby certify that: 1. The Board of Directors of the Corporation, by unanimous written consent, approved and adopted the following amendments to the Amende |
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| April 29, 2022 |
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): April 25, 2022 ABEONA THERAPEUTICS INC. |
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| March 31, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K (Mark One) ? ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 Or ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-15771 ABEONA THERAPEUTICS INC. |
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| March 31, 2022 |
Subsidiaries of the registrant EXHIBIT 21 Subsidiaries of the Registrant Abeona Therapeutics LLC, an Ohio company Abeona Therapeutics Europe, S.L., a Spanish company MacroChem Corporation, a Delaware company Virium Pharmaceuticals, Inc., a Delaware company |
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| March 31, 2022 |
EXHIBIT 10.14 Certain identified information has been excluded from this exhibit pursuant to Item 601(b)(10)(iv) of Regulation S-K because such information both (i) is not material and (ii) would likely cause competitive harm if publicly disclosed. Excluded information is indicated with brackets and asterisks. SETTLEMENT AGREEMENT AND MUTUAL RELEASE This Settlement Agreement and Mutual Release (?S |
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| March 31, 2022 |
Results of Operations and Financial Condition, Financial Statements and Exhibits 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): March 31, 2022 ABEONA THERAPEUTICS INC. |
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| March 31, 2022 |
EX-10.6 2 ex10-6.htm Exhibit 10.6 October 6, 2021 Vishwas Seshadri Dear Vishwas: This letter agreement sets forth the terms of your employment as Chief Executive Officer (CEO) of Abeona Therapeutics Inc. (the “Company”) effective October 15, 2021 (the “Effective Date”). 1. Duties; Best Efforts. As Chief Executive Officer, you shall perform such duties, functions and responsibilities as are commens |
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| March 31, 2022 |
Exhibit 99.1 Abeona Therapeutics Announces Strategy Update and 2021 Financial Results EB-101 pivotal phase 3 VIITAL™ study in RDEB achieves target enrollment; top-line data expected in third quarter of 2022; gained FDA alignment on CMC requirements for EB-101 including characterization and validation plans Company to focus R&D resources primarily on VIITAL™ data readout while actively pursuing pot |
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| March 31, 2022 |
EX-10.11 3 ex10-11.htm Exhibit 10.11 September 16, 2021 Brendan O’Malley Dear Brendan: This letter agreement sets forth the terms of your employment as SVP, General Counsel, effective September 20, 2021 (the “Effective Date”). 1. Duties; Best Efforts. As the SVP, General Counsel you shall have the duties, responsibilities and authority commensurate therewith, and shall report to the Chief Executiv |
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| March 9, 2022 |
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): March 3, 2022 ABEONA THERAPEUTICS INC. |
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| February 10, 2022 |
SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 5)* Abeona Therapeutics Inc. (Name of Issuer) Common Stock, $0.01 par value (Title of Class of Securities) 00289Y107 (CUSIP Number) December 31, 2021 (Date of Event Which Requires Filing of This Statement) Check the appropriate box to designate the rule pursuant to whic |
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| December 17, 2021 |
Exhibit 4.1 COMMON STOCK PURCHASE WARRANT Abeona Therapeutics Inc. Warrant Shares: Initial Exercise Date: December 21, 2021 THIS COMMON STOCK PURCHASE WARRANT (the ?Warrant?) certifies that, for value received, or its assigns (the ?Holder?) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the date hereof (the ? |
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| December 17, 2021 |
Abeona Therapeutics Announces Pricing of Public Offering of Common Stock and Warrants EX-99.1 5 ex99-1.htm Exhibit 99.1 Abeona Therapeutics Announces Pricing of Public Offering of Common Stock and Warrants NEW YORK and CLEVELAND, Dec. 17, 2021 – Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced the pricing of its underwritten public offering of 44,700,000 shares of its common stock and warrants to purchase 44,700,000 shares |
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| December 17, 2021 |
Underwriting Agreement, dated December 17, 2021 EX-1.1 2 ex1-1.htm Exhibit 1.1 44,700,000 Shares of Common Stock and Warrants to Purchase 44,700,000 Shares of Common Stock Abeona Therapeutics Inc. UNDERWRITING AGREEMENT December 17, 2021 Cantor Fitzgerald & Co. As Representative of the several Underwriters 499 Park Avenue New York, NY 10022 Ladies and Gentlemen: Introductory. Abeona Therapeutics Inc., a Delaware corporation (the “Company”), pro |
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| December 17, 2021 |
44,700,000 Shares of Common Stock Warrants to Purchase up to 44,700,000 Shares of Common Stock Filed Pursuant to Rule 424(b)(5) Registration No. 333-256850 Prospectus Supplement (To Prospectus dated October 22, 2021) 44,700,000 Shares of Common Stock Warrants to Purchase up to 44,700,000 Shares of Common Stock We are offering 44,700,000 shares of our common stock and warrants to purchase up to 44,700,000 shares of our common stock. Each share of common stock we sell will be accompanied by a |
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| December 17, 2021 |
Financial Statements and Exhibits, Other Events 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): December 17, 2021 ABEONA THERAPEUTICS INC. |
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| December 16, 2021 |
SUBJECT TO COMPLETION, DATED DECEMBER 16, 2021 Filed Pursuant to Rule 424(b)(5) Registration No. 333-256850 The information in this preliminary prospectus supplement is not complete and may be changed. This preliminary prospectus supplement and the accompanying prospectus are not an offer to sell these securities and they are not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted. SUBJECT T |
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| December 16, 2021 |
Other Events, Financial Statements and Exhibits 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): December 16, 2021 ABEONA THERAPEUTICS INC. |
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| December 16, 2021 |
Abeona Therapeutics Announces Public Offering of Common Stock and Warrants EX-99.1 2 ex99-1.htm Exhibit 99.1 Abeona Therapeutics Announces Public Offering of Common Stock and Warrants NEW YORK and CLEVELAND, Dec. 16, 2021 – Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that it intends to offer and sell shares of its common stock and warrants to purchase common stock in an underwritten public offering pursuant |
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| November 19, 2021 |
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): November 16, 2021 ABEONA THERAPEUTICS INC. |
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| November 19, 2021 |
EX-1.2 2 ex1-2.htm Exhibit 1.2 AMENDMENT NO. 1 TO OPEN MARKET SALE AGREEMENT November 19, 2021 This Amendment No. 1 (“Amendment No. 1”) amends that certain Open Market Sale Agreement, dated as of August 17, 2018 (the “Agreement”), by and between Abeona Therapeutics Inc. (the “Company”) and Jefferies LLC (the “Agent”). Defined terms used herein and not otherwise defined shall have the meaning assig |
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| November 19, 2021 |
424B5 1 form424b5.htm Filed Pursuant to Rule 424(b)(5) Registration No. 333-256850 Prospectus Supplement (to Prospectus dated October 22, 2021) $124,601,795 Common Stock We have entered into an Open Market Sale AgreementSM dated August 17, 2018, as amended on November 19, 2021 (the “Sale Agreement”), with Jefferies LLC (the “Agent”), relating to the sale of shares of our common stock offered by th |
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| November 15, 2021 |
Entry into a Material Definitive Agreement 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): November 12, 2021 ABEONA THERAPEUTICS INC. |
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| November 15, 2021 |
Results of Operations and Financial Condition, Financial Statements and Exhibits 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): November 15, 2021 ABEONA THERAPEUTICS INC. |
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| November 15, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark one) ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 or ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-15771 ABEONA THERAPEUTICS INC. |
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| November 15, 2021 |
Letter Agreement, dated August 10, 2021, between the Company and Edward Carr. Exhibit 10.1 August 10, 2021 Edward Carr Dear Edward: This letter agreement sets forth the terms of your employment as SVP, Chief Financial Officer, effective August 10, 2021 (the “Effective Date”). 1. Duties; Best Efforts. As the SVP, Chief Financial Officer you shall have the duties, responsibilities and authority commensurate therewith, and shall report to the Chief Executive Officer of the Com |
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| November 15, 2021 |
EX-99.1 2 ex99-1.htm Exhibit 99.1 Abeona Therapeutics Reports Third Quarter Financial Results Phase 3 VIITAL™ study on track to complete enrollment in first quarter 2022 with final patients identified and under screening Added gene therapy and biopharmaceutical industry veterans to regulatory and quality teams to prepare for two Biologics License Application (BLA) submissions Formally settled disp |
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| October 19, 2021 |
As filed with the Securities and Exchange Commission on October 19, 2021 S-3/A 1 forms-3a.htm As filed with the Securities and Exchange Commission on October 19, 2021 Registration No. 333-256850 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Amendment No. 2 FORM S-3 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ABEONA THERAPEUTICS INC. (Exact name of registrant as specified in its charter) Delaware 83-0221517 (State or other jurisdictio |
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| October 19, 2021 |
Abeona Therapeutics Inc. 1330 Avenue of the Americas, 33rd Floor New York, NY 10019 Abeona Therapeutics Inc. 1330 Avenue of the Americas, 33rd Floor New York, NY 10019 October 19, 2021 U.S. Securities and Exchange Commission Division of Corporate Finance 100 F Street NE Washington, DC 20549 Attention: Chris Edwards VIA EDGAR Re: Abeona Therapeutics Inc. Registration Statement on Form S-3 Filed on June 7, 2021 File No. 333-256850 Dear Mr. Edwards: In accordance with Rule 461 of Re |
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| September 21, 2021 |
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): September 16, 2021 ABEONA THERAPEUTICS INC. |
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| September 21, 2021 |
EX-99.1 2 ex99-1.htm Exhibit 99.1 Abeona Announces New Chairman, Executive Leadership Promotions and Key Talent Additions for Final Push Towards Two Biologics License Application (BLA) Filings Steven H. Rouhandeh to retire as Chairman of the Board; Michael Amoroso appointed Chairman of the Board Vishwas Seshadri, Ph.D., M.B.A. to become Chief Executive Officer Brendan M. O’Malley, J.D., Ph.D. prom |
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| August 30, 2021 |
Abeona Therapeutics Inc. 1330 Avenue of the Americas, 33rd Floor New York, NY 10019 CORRESP 1 filename1.htm Abeona Therapeutics Inc. 1330 Avenue of the Americas, 33rd Floor New York, NY 10019 August 30, 2021 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance 100 F Street NE Washington, DC 20549 Attention: Chris Edwards Re: Abeona Therapeutics Inc. Registration Statement on Form S-3 Filed on June 7, 2021 File No. 333-256850 Dear Mr. Edwards: Reference |
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| August 27, 2021 |
Abeona Therapeutics Inc. 1330 Avenue of the Americas, 33rd Floor New York, NY 10019 CORRESP 1 filename1.htm Abeona Therapeutics Inc. 1330 Avenue of the Americas, 33rd Floor New York, NY 10019 August 27, 2021 U.S. Securities and Exchange Commission Division of Corporate Finance 100 F Street NE Washington, DC 20549 Attention: Chris Edwards VIA EDGAR Re: Abeona Therapeutics Inc. Registration Statement on Form S-3 Filed on June 7, 2021 File No. 333-256850 Dear Mr. Edwards: In accorda |
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| August 27, 2021 |
As filed with the Securities and Exchange Commission on August 27, 2021 As filed with the Securities and Exchange Commission on August 27, 2021 Registration No. |
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| August 13, 2021 |
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): August 10, 2021 ABEONA THERAPEUTICS INC. |
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| July 28, 2021 |
EX-99.1 2 ex99-1.htm Exhibit 99.1 Abeona Therapeutics Reports Second Quarter Financial Results Second clinical trial site activated in EB-101 pivotal Phase 3 VIITAL™ study Successful Type B meeting with U.S. FDA; Transpher A study will serve as the pivotal study for ABO-102 in MPS IIIA; Alignment with FDA on primary study endpoint Focusing resources on completing EB-101 and ABO-102 pivotal, regist |
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| July 28, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark one) ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 or ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-15771 ABEONA THERAPEUTICS INC. |
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| July 28, 2021 |
Results of Operations and Financial Condition, Financial Statements and Exhibits 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 28, 2021 ABEONA THERAPEUTICS INC. |
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| July 16, 2021 |
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 13, 2021 ABEONA THERAPEUTICS INC. |
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| June 7, 2021 |
EXHIBIT 4.4 ABEONA THERAPEUTICS INC. Issuer AND [TRUSTEE], Trustee INDENTURE Dated as of , 20 Debt Securities TABLE OF CONTENTS Page ARTICLE 1 DEFINITIONS 1 Section 1.01 Definitions of Terms 1 ARTICLE 2 ISSUE, DESCRIPTION, TERMS, EXECUTION, REGISTRATION AND EXCHANGE OF SECURITIES 5 Section 2.01 Designation and Terms of Securities 5 Section 2.02 Form of Securities and Trustee?s Certificate 8 Sectio |
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| June 7, 2021 |
As filed with the Securities and Exchange Commission on June 7, 2021 Registration No. |
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| May 28, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 8-K/A (Amendment No. |
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| May 28, 2021 |
Submission of Matters to a Vote of Security Holders 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 26, 2021 ABEONA THERAPEUTICS INC. |
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| May 26, 2021 |
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 25, 2021 ABEONA THERAPEUTICS INC. |
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| May 26, 2021 |
Event Type: Q1 2021 Earnings Call Exhibit 99.1 Event Type: Q1 2021 Earnings Call Date: 2021-05-25 Company: Abeona Therapeutics, Inc. Ticker: ABEO COMPANY PARTICIPANTS Gregory W. Gin - Vice President-Investor Relations & Corporate Communications Michael Amoroso - President & Chief Executive Officer Edward G. Carr - Chief Accounting Officer & Principal Financial Officer Juan Ruiz OTHER PARTICIPANTS Maury Raycroft - Analyst Kristen K |
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| May 18, 2021 |
Results of Operations and Financial Condition, Financial Statements and Exhibits 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 18, 2021 ABEONA THERAPEUTICS INC. |
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| May 18, 2021 |
Exhibit 99.1 Abeona Therapeutics Reports First Quarter Financial Results Patient enrollment ongoing for EB-101 pivotal Phase 3 VIITAL? study Positive interim MPS III data presented at 17th Annual WORLDSymposium; additional neurocognitive assessments of patients treated in high dose cohort 3 in MPS IIIA Transpher A study and additional clinical data from MPS IIIB Transpher B study expected in 2021 |
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| May 17, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark one) ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 or ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-15771 ABEONA THERAPEUTICS INC. |
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| May 17, 2021 |
EX-10.1 2 ex10-1.htm Exhibit 10.1 January 27, 2021 C/O Michael Amoroso Dear Michael, This letter agreement sets forth the terms of your employment as EVP, Chief Operating Officer effective January 27, 2021 (the “Effective Date”). 1. Duties; Best Efforts. As the Chief Operating Officer you shall have the duties, responsibilities and authority commensurate therewith, and shall report to the Board of |
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| May 17, 2021 |
Letter Agreement, dated March 19, 2021, between the Company and Michael Amoroso. Exhibit 10.2 March 19, 2021 C/O Michael Amoroso Dear Michael, I am pleased to offer you the position of Chief Executive Officer of Abeona Therapeutics, Inc. (the ?Company?) effective March 19, 2021 (the ?Effective Date?). 1. Duties; Best Efforts. In the position as Chief Executive Officer, you shall perform such duties, functions and responsibilities as are commensurate with such position, as reas |
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| May 12, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) PROXY STATEMENT PURSUANT TO SECTION 14(a) OF THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. ) Filed by the Registrant ? Filed by a Party other than the Registrant ?? Check the appropriate box: ? Preliminary Proxy Statement ? Confidential, for Use of the Commission Only (as permitted by Rule 14a- |
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| April 19, 2021 |
TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. 1) Filed by the Registrant ? Filed by a Party other than the Registrant ?? Check the appropriate box: ?? Preliminary Prox |
