Abeona Therapeutics Inc. 2026年季度报告

FORM 10-Q INDEXPageNo.PART I - FINANCIAL INFORMATIONItem 1.Financial Statements:3Unaudited Condensed Consolidated Balance Sheets as of March 31, 2026 and December 31, 20253Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three monthsended March 31, 2026 and 20254Unaudited Condensed Consolidated Statements of Stockholders’ Equity for the three months ended March 31,2026 and 20255Unaudited Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2026 and20256Notes to Unaudited Condensed Consolidated Financial Statements7Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations29Item 3.Quantitative and Qualitative Disclosures About Market Risk34Item 4.Controls and Procedures34PART II - OTHER INFORMATIONItem 1.Legal Proceedings35Item 1A.Risk Factors35Item 5.Other Information35Item 6.Exhibits36SIGNATURES371 FORWARD-LOOKING STATEMENTS ThisQuarterly Report on Form 10-Q(including information incorporated by reference)contains statements that expressmanagement’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future resultsand therefore are, or may be deemed to be, “forward-looking statements” within the meaning of Section 27A of the Securities Act of1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Words such as “expects,” “anticipates,”“intends,” “plans,” “believes,” “could,” “would,” “seeks,” “estimates,” and variations of such words and similar expressions, andthe negatives thereof, are intended to identify such forward-looking statements. Such “forward-looking statements” speak only as of Forward-looking statements necessarily involve risks and uncertainties, and our actual results could differ materially from thoseanticipated in forward-looking statements due to a number of factors. These statements include statements about: our ability to successfullycommercialize ZEVASKYN®andgenerate future revenue;the deprioritization of our AAV-based ophthalmologyprograms; the development of ABO-701; our pipeline of product candidates, including the achievement of or expected timing, progressand results of clinical development, clinical trials and potential regulatory approvals; our estimates regarding expenses, capitalrequirements, and needs for additional financing; anticipated losses and negative cash flows; the potential effects on the relativeequity ownership of existing investors resulting from any future sales of equity securities; the potential effects of fundraising activities Important factors that could affect performance and cause results to differ materially from management’s expectations are describedin the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results ofOperations” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as updated from time to time in the Company’s SEC filings, including this Quarterly Report on Form 10-Q. These factors include: our ability to maintainexisting and obtain additional regulatory approvals of ZEVASKYN®and any future product candidates; our ability to successfully commercialize and market ZEVASKYN®and any future product candidates, if approved, and the timing of any commercialization and marketing efforts; our ability to manufacture sufficient batches of ZEVASKYN®to meet demand; our ability to activate additional qualified treatment centers to administer ZEVASKYN®on patients; our ability submit an investigational new drug application forABO-701 and enroll patients in new clinical trials; our ability to access our existing at-the-market sale agreement; our ability toaccess additional financial resources and/or our financial flexibility to reduce operating expenses if required; our ability to obtainadditional equity funding from current or new stockholders; the potential impact of unpredicted changes in the structure and/oradministration of the United States government or its agencies; our ability to out-license technology and/or other assets, deferringand/or eliminating planned expenditures, restructuring operations and/or reducing headcount, and sales of assets; the dilutive effectthat raising additional funds by selling additional equity securities would have on the relative equity ownership of our existinginvestors, including under our existing at-the-market sale agreement; the outcome of any interactions with the FDA or other This Quarterly Report on Form 10-Q includes our trademarks, trade names and service marks, such as “ZEVASKYN® ” and“AIM™,” which are protected under applicable intellectual property laws and are the property of Abeona Therapeutics Inc. or itssubsidiaries. Solely for convenience, trademarks, trade names and service marks referred to in this report appear without the ® and ™symbols, but such references are not intended to indicate, in any way, that we will