NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES | NOTE 1 – NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES Background Abeona Therapeutics Inc. (together with the Company’s subsidiaries, “Abeona” or the “Company”), a Delaware corporation, is a clinical-stage biopharmaceutical company developing cell and gene therapies for life-threatening diseases. The Company’s lead clinical program is EB-101, an autologous, engineered cell therapy currently in development for recessive dystrophic epidermolysis bullosa (“RDEB”). The Company’s development portfolio also features adeno-associated virus (“AAV”)-based gene therapies designed to treat highly unmet, medically needed ophthalmic diseases using the novel AIM™ capsid platform that the Company has exclusively licensed from the University of North Carolina at Chapel Hill, and internal AAV vector research programs. Basis of Presentation The Company’s unaudited interim condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). All intercompany balances and transactions have been eliminated in consolidation. In the opinion of management, all adjustments, consisting only of normal recurring adjustments, except as otherwise disclosed, necessary for the fair presentation of the financial position, results of operations, and changes in financial position for such periods, have been made. These unaudited interim condensed consolidated financial statement results are not necessarily indicative of results to be expected for the full fiscal year or any future period. Certain information that is normally required by U.S. GAAP has been condensed or omitted in accordance with rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). The December 31, 2022 condensed consolidated balance sheet was derived from the audited statements, but does not include all disclosures required by U.S. GAAP. Therefore, these unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K/A for the year ended December 31, 2022, which was filed with the SEC on April 10, 2023. Reverse Stock Split As described in Note 1 to the consolidated financial statements included in the Company’s 2022 Annual Report on Form 10-K/A, on June 30, 2022, the Company filed a Certificate of Amendment to the Company’s Restated Certificate of Incorporation with the Secretary of State of the State of Delaware (the “Certificate of Amendment”), to effectuate a reverse stock split of the Company’s outstanding common stock, par value $ 0.01 exchange ratio of 25-to-1 (the “Reverse Stock Split”) 200,000,000 Uses and Sources of Liquidity The unaudited interim condensed consolidated financial statements have been prepared on the going concern basis, which assumes the Company will have sufficient cash to pay its operating expenses, as and when they become payable, for a period of at least 12 months from the date the financial report is issued. As of June 30, 2023, the Company had cash, cash equivalents, restricted cash and short-term investments of $ 37.1 22.0 The Company is subject to a number of risks similar to other life science companies, including, but not limited to, risks related to the successful discovery and development of product candidates, obtaining the necessary regulatory approval to market the Company’s product candidates, raising additional capital to continue to fund the Company’s operations, development of competing drugs and therapies and protection of proprietary technology. As a result of these and other risks and the related uncertainties, there can be no assurance of the Company’s future success. Subsequent to June 30, 2023, as described in Note 12, the Company raised $ 25.0 23.0 The Company believes that its current cash and cash equivalents, restricted cash and short-term investments are sufficient resources to fund operations through at least the next 12 months from the date of this quarterly report on Form 10-Q. The Company may need to secure additional funding to carry out all of its planned research and development and commercialization activities. If the Company is unable to obtain additional financing or generate license or product revenue, the lack of liquidity and sufficient capital resources could have a material adverse effect on its future prospects. Use of Estimates The preparation of unaudited interim condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amount of assets and disclosure of contingent assets and liabilities at the date of the unaudited interim condensed consolidated financial statements and the reported amounts of revenue and expenses during the reported period. Actual results could differ from these estimates and assumptions. Other receivables Other receivables include employee retention credits (“ERC”), sublease rent receivables and other miscellaneous receivables. As of June 30, 2023 and December 31, 2022, the Company had ERC receivables of $ 2.1 nil Summary of Significant Accounting Policies There have been no new, anticipated or material changes to the significant accounting policies disclosed in the Company’s Annual Report on Form 10-K/A for the year ended December 31, 2022. Correction of Error During the fourth quarter of 2022, the Company identified errors in the accounting for certain common stock warrants that were issued in 2021. The common stock warrants were not indexed to the Company’s own stock and therefore should have been classified as liabilities at their estimated fair value instead of additional paid-in capital. Although the errors were immaterial to prior periods, the 2021 financial statements were restated in accordance with Staff Accounting Bulletin No. 108, “Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements”, due to the significance of the out-of-period correction to the 2021 period. There was no impact to the Company’s consolidated statements of operations and comprehensive loss for 2021. The correction of the error resulted in the Company adjusting its quarterly information presented for the three and six months ended June 30, 2022. The matter was correctly presented in the fiscal year end December 31, 2022 consolidated financial statements included in the Company’s 2022 Annual Report on Form 10-K/A. The following tables present the effects of the correction of the prior period error to the condensed consolidated statement of operations and comprehensive loss (in thousands, except for per share data): SCHEDULE OF EFFECTS OF THE RESTATEMENT TO AMOUNTS IN THE PREVIOUSLY REPORTED CONSOLIDATED FINANCIAL STATEMENTS For the three months ended June 30, 2022 Condensed Consolidated Statement of Operations and Comprehensive Loss As Reported Adjustment As Revised Change in fair value of warrant liabilities $ — $ 4,198 $ 4,198 Net loss $ (8,295 ) $ 4,198 $ (4,097 ) Net loss attributable to Common Shareholders $ (12,077 ) $ 4,198 $ (7,879 ) Basic and diluted loss per common share $ ( 2.08 ) $ 0.72 $ ( 1.36 ) Comprehensive loss $ (12,081 ) $ 4,198 $ (7,883 ) For the six months ended June 30, 2022 Condensed Consolidated Statement of Operations and Comprehensive Loss As Reported Adjustment As Revised Change in fair value of warrant liabilities $ — $ 2,945 $ 2,945 Net loss $ (29,086 ) $ 2,945 $ (26,141 ) Net loss attributable to Common Shareholders $ (32,868 ) $ 2,945 $ (29,923 ) Basic and diluted loss per common share $ ( 5.67 ) $ 0.51 $ ( 5.16 ) Comprehensive loss $ (32,875 ) $ 2,945 $ (29,930 ) The following tables present the effects of the correction of the prior period error to the condensed consolidated cash flow statement (in thousands): For the six months ended June 30, 2022 Condensed Consolidated Cash Flow Statement As Reported Adjustment As Revised Net loss $ (29,086 ) $ 2,945 $ (26,141 ) Adjustments to reconcile net loss to cash used in operating activities: Change in fair value of warrant liabilities $ — $ (2,945 ) $ (2,945 ) Net cash provided by operating activities $ (22,700 ) $ — $ (22,700 ) The following tables present the effects of the correction of the prior period error to the condensed consolidated statement of stockholders’ equity (in thousands): As of June 30, 2022 Condensed Consolidated Statement of Stockholders’ Equity As Reported Adjustment As Revised Additional paid-in capital, December 31, 2021 $ 705,570 $ (9,007 ) $ 696,563 Total stockholders’ equity, December 31, 2021 $ 51,375 $ (9,007 ) $ 42,368 Additional paid-in capital, March 31, 2022 $ 706,433 $ (9,007 ) $ 697,426 Additional paid-in capital, March 31, 2022 $ 31,443 $ (10,260 ) $ 21,183 Net loss $ (29,086 ) $ 2,945 $ (26,141 ) Additional paid-in capital, June 30, 2022 $ 703,379 $ (9,007 ) $ 694,372 Total stockholders’ equity, June 30, 2022 $ 20,086 $ (6,062 ) $ 14,024 Net Loss Per Share Basic and diluted net loss per share is computed by dividing net loss attributable to common shareholders by the weighted-average number of shares of common stock. The Company does not include the potential impact of dilutive securities in diluted net loss per share, as the impact of these items is anti-dilutive. Potential dilutive securities result from outstanding restricted stock, stock options, and stock purchase warrants. The following table sets forth the potential securities that could potentially dilute basic income/(loss) per share in the future that were not included in the computation of diluted net loss per share because to do so would have been anti-dilutive for the periods presented: SCHEDULE OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE For the three and six months ended June 30, 2023 2022 Stock options 230,723 265,411 Restricted stock 2,566,303 61,108 Warrants 9,397,879 1,788,000 Total 12,194,905 2,114,519 New Accounting Pronouncements No new accounting pronouncement issued or effective had, or is expected to have, a material impact on the Company’s condensed consolidated financial statements. |