ABEONA THERAPEUTICS INC.

To the stockholders and the Board of Directors of Abeona Therapeutics Inc

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of Abeona Therapeutics Inc (the “Company”) as of December 31, 2024 and 2023, the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America.

Basis for Opinion

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

Critical Audit Matter

The critical audit matter communicated below is a matter arising from the current-period audit of the financial statements that was communicated or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.

Loan and Security Agreement and Common Stock Warrants — Refer to Notes 9 and 10 to the financial statements

Critical Audit Matter Description

As more fully described in Notes 9 and 10 to the financial statements, on January 8, 2024, the Company entered into a Loan and Security Agreement, as supplemented by a Supplement, with Avenue Venture Opportunities Fund, L.P. and Avenue Venture Opportunities Fund II, L.P. The Loan Agreement provides for senior secured term loans in an aggregate principal amount up to $50 million. Pursuant to the Supplement to the Loan and Security Agreement, Avenue also has the right to convert up to $3 million of the outstanding principal of the Loans into shares of Company common stock (the “Conversion Right”) at a price per share equal to 120% of the exercise price of the Warrants at any time while the Loans are outstanding, subject to certain terms and conditions, including ownership limitations. On January 8, 2024, in connection with entering into the Loan and Security Agreement, the Company issued to each of Avenue and Avenue II warrants to purchase up to $480,000 and $1,920,000 worth of shares, respectively, of Company common stock.

We identified the assessment of the accounting for the Loan and Security Agreement and related Common Stock Warrants as a critical audit matter because of the complexity in applying the accounting framework and the significant judgments made by management in the determination of the existence of embedded derivative liabilities and classification of the Common Stock Warrants related to the Loan and Security Agreement. Auditing these conclusions required a high degree of auditor judgment and an increased extent of effort.

How the Critical Audit Matter Was Addressed in the Audit

Our audit procedures related to accounting for the Loan and Security Agreement and Common Stock Warrants included the following, among others:

/s/Deloitte & Touche LLP

Morristown, New Jersey

March 19, 2025

We have served as the Company’s auditor since 2023.