{"url_path":"/sec/abeo/8-k/2026-06-04/item-8-01","section_key":"item-8-01","section_title":"Item 8.01 Other Events**","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-06-04","source_url":"https://www.sec.gov/Archives/edgar/data/318306/0001493152-26-027197-index.html","accession_number":"0001493152-26-027197","cik":"0000318306","ticker":"ABEO","issuer_name":"ABEONA THERAPEUTICS INC.","edgar_url":"https://www.sec.gov/Archives/edgar/data/318306/0001493152-26-027197-index.html","primary_entity_key":"0000318306","primary_entity_name":"ABEONA THERAPEUTICS INC."},"word_count":480,"has_tables":true,"body_markdown":"**Item\n8.01. Other Events**\n\n \n\nOn\nJune 3, 2026, Abeona Therapeutics Inc. (the “Company”) participated in a pre-Investigational New Drug application (“Pre-IND”)\nmeeting with the U.S. Food and Drug Administration (“FDA”) regarding ABO-701, a recently licensed radically novel engineered\nT-cell therapy, targeting Prostate-Specific Membrane Antigen to treat prostate cancer. While official minutes of the meeting have not\nyet been received, we believe the meeting was constructive and continues to target submission of an IND application for ABO-701 in 2027,\nconsistent with our previously stated timeline.\n\n \n\nWe\ncan provide no assurance that the FDA will not require additional studies, data, or information before accepting an IND submission for\nABO-701, or that any IND submission, if submitted, will be accepted by the FDA or result in authorization to commence clinical trials.\nOur development plans remain subject to ongoing evaluation and may be revised based on, among other things, feedback received from the\nFDA, results of preclinical studies, manufacturing considerations, and other factors.\n\n \n\n*Cautionary\nNote Regarding Forward-Looking Statements*\n\n \n\nThis\nCurrent Report on Form 8-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended,\nand Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include, but are not limited to, statements\nregarding the Company’s expectations with respect to the timing of the IND submission for ABO-701, the Company’s clinical\nand regulatory development plans, and other statements that are not historical facts. These forward-looking statements are based on the\nCompany’s current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results\nto differ materially from those described in the forward-looking statements, including, but not limited to: the Company’s ability\nto successfully advance ABO-701 through preclinical development; the timing, scope, and outcome of regulatory interactions, including\nreceipt of official minutes from the Pre-IND meeting; the FDA’s acceptance of any IND submission; the Company’s ability to\naccess additional financial resources or its financial flexibility to reduce operating expenses if required; the Company’s ability\nto obtain additional equity funding from current or new stockholder; and other risks and uncertainties described in the Company’s\nfilings with the Securities and Exchange Commission (the “SEC”), including the “Risk Factors” section of the\nCompany’s most recent Annual Report on Form 10-K and subsequent periodic reports. The Company cautions investors not to place undue\nreliance on the forward-looking statements contained in this report. The Company disclaims any obligation to update such statements to\nreflect events that occur or circumstances that exist after the date on which they were made, except as required by law.\n\n \n\n \n\n \n\n \n\n**SIGNATURE**\n\n \n\nPursuant\nto the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by\nthe undersigned hereunto duly authorized.\n\n \n\n \nAbeona Therapeutics Inc.\n\n \n(Registrant)\n\n \n \n \n\n \nBy:\n*/s/\nJoseph Vazzano*\n\n \nName:\nJoseph\nVazzano\n\n \nTitle:\n\nChief\nFinancial Officer\n\n \n\nDate:\nJune 4, 2026"}