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 Conference call and webcast on Tuesday, April 23, 2024 at 8:30 a.m. ET to provide details on the requested CMC information CLEVELAND, April 22, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutic ...

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 full year of 2023 and provided an update on progress toward achieving key corporate objectives. Abeona also ann ...

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. (Exact name of registrant as specified in its charter) Delaware 83-0221517 (State or Oth ...

CLEVELAND, March 18, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today reported financial results for the full year of 2023 and provided an update on progress toward achieving key corporate objectives. Abeona also announced today that the U.S. Food and Drug Administration (FDA) has completed a Pre-License Inspection (PLI) of its Cleveland, Ohio manufacturing facility related to the Company's Biologics License Application (BLA) for pz-cel (prademagene zamikeracel) for recessive dystrophic ...

CLEVELAND, March 05, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced it has granted equity awards to new non-executive employees who joined the Company. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4). On February 29, 2024, the Compensation Committee of Abeona's Board of Directors granted restricted stock equity awards as a material inducement to employment to three individuals hired by Abeona, which equity awards relate to, in the aggregate, ...

FDA Review Progress - The FDA has completed both the Bioresearch Monitoring (BIMO) inspection and the mid-cycle review meeting for Abeona Therapeutics' Biologics License Application (BLA) for pz-cel, targeting a PDUFA action date of May 25, 2024 [1][3] - The BIMO inspection, conducted from January 22 to January 24, 2024, at Abeona's headquarters, reviewed clinical study practices and did not result in any observations or FDA Form 483s [2] - The FDA confirmed no plans to convene an Advisory Committee for pz-cel and indicated that Risk Evaluation and Mitigation Strategies (REMS) are not anticipated at this time [3] Company Overview - Abeona Therapeutics is a clinical-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases, including recessive dystrophic epidermolysis bullosa (RDEB) [4] - The company's investigational therapy, pz-cel, is an autologous, COL7A1 gene-corrected epidermal sheet currently under FDA review with Priority Review status [4] - Abeona operates a fully integrated cell and gene therapy cGMP manufacturing facility, which supported the Phase 3 VIITAL™ trial and is capable of commercial production upon FDA approval [4] Development Pipeline - Abeona's development portfolio includes AAV-based gene therapies for ophthalmic diseases with high unmet medical needs [4] - The company is evaluating next-generation AAV capsids to improve tropism profiles for various devastating diseases [4]

CLEVELAND, Jan. 08, 2024 (GLOBE NEWSWIRE) -- 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 $10 million of committed capital, and an additional accordion option to upsize the credit facility by an additional $20 million upon satisfaction of certain terms and con ...

Abeona Therapeutics Inc. (NASDAQ:ABEO) Q3 2023 Results Conference Call November 13, 2023 8:30 AM ET Company Participants Greg Gin - Vice President of Investor Relations & Corporate Communications Vishwas Seshadri - President, CEO and Director Madhav Vasanthavada - Chief Commercial Officer & Head of Business Development Joseph Vazzano - Chief Financial Officer Conference Call Participants Kristen Kluska - Cantor Fitzgerald Operator Greetings, and welcome to the Abeona Therapeutics Third Quarter 2023 Conferen ...

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. (Exact name of registrant as specified in its charter) Delaware 83-0221517 (State or other juri ...

Abeona Therapeutics Inc. (NASDAQ:ABEO) Q2 2023 Results Conference Call August 8, 2023 8:30 AM ET Company Participants Greg Gin - Vice President of Investor Relations and Corporate Communications Vish Seshadri - Chief Executive Officer Joe Vazzano - Chief Financial Officer Madhav Vasanthavada - Vice President, Business Development Brian Kevany - Chief Technical Officer Conference Call Participants Maury Raycroft - Jefferies Kristen Kluska - Cantor Fitzgerald David Bautz - Zacks Small Capital Research Operato ...