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NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended
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Jun. 30, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
Background | 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 for pz-cel, an autologous, cell-based gene 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 ophthalmic diseases with high unmet need using novel AIM™ capsids that the Company has exclusively licensed from the University of North Carolina at Chapel Hill and developed internally through its AAV vector research programs.
Basis of Presentation | 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, 2023 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 for the year ended December 31, 2023, which was filed with the SEC on March 18, 2024.
Liquidity | Liquidity In accordance with Accounting Standards Codification (“ASC”) 205-40, Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the accompanying unaudited interim condensed consolidated financial statements were issued. As a biopharmaceutical organization, the Company has devoted substantially all of its resources since inception to research and development activities for pz-cel and other product candidates, business planning, raising capital, establishing its intellectual property portfolio, acquiring or discovering product candidates, and providing general and administrative support for these operations. As a result, the Company has incurred significant operating losses and negative cash flows from operations since its inception and anticipates such losses and negative cash flows will continue for the foreseeable future. Since its inception, the Company has funded its operations primarily with proceeds from sales of shares of its stock. The Company has incurred recurring losses since its inception, including net losses of $24.2 million and $25.8 million for the six months ended June 30, 2024 and 2023, respectively. As of June 30, 2024, the Company had an accumulated deficit of approximately $773.7 million. To date the Company has not generated any significant revenues and expects to continue to generate operating losses for the foreseeable future. As of the issuance date of these unaudited interim condensed consolidated financial statements, the Company expects that its existing cash, cash equivalents, restricted cash and short-term investments of $123.0 million as of June 30, 2024, will be sufficient to fund its operating expenses and capital expenditure requirements for at least the next 12 months from the issuance date of these condensed consolidated financial statements. While the Company believes its capital resources are sufficient to fund the Company’s on-going operations for the next 12 months from the issuance date of these unaudited condensed consolidated financial statements, the Company’s liquidity could be materially affected over this period by: (1) its ability to raise additional capital through equity offerings, debt financings, or other non-dilutive third-party funding; (2) costs associated with new or existing strategic alliances, or licensing and collaboration arrangements; (3) negative regulatory events or unanticipated costs related to pz-cel; (4) any other unanticipated material negative events or costs. One or more of these events or costs could materially affect the Company’s liquidity. If the Company is unable to meet its obligations when they become due, the Company may have to delay expenditures, reduce the scope of its research and development programs, or make significant changes to its operating plan. The accompanying unaudited interim condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Use of Estimates | 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 Other receivables include employee retention credits (“ERC”), sublease rent receivables and other miscellaneous receivables. As of June 30, 2024 and December 31, 2023, the Company had ERC receivables of $1.6 million and $2.1 million, respectively.
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies There have been no new or material changes to the significant accounting policies discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 that are of significance, or potential significance, to the Company.
Credit Losses | Credit Losses The Company reviews its available-for-sale investments for credit losses on a collective basis by major security type and in line with the Company’s investment policy. As of June 30, 2024, the Company’s available-for-sale investments were in certificates of deposits and securities that are issued by the U.S. treasury and U.S. federal agencies, are highly rated, and have a history of zero credit losses. The Company reviews the credit quality of its accounts receivables by monitoring the aging of its accounts receivable, the history of write offs for uncollectible accounts, and the credit quality of its significant customers, the current economic environment/macroeconomic trends, supportable forecasts, and other relevant factors. The Company’s accounts receivable are with customers that do not have a history of uncollectibility nor a history of significantly aged accounts receivables. As of June 30, 2024, the Company did not recognize a credit loss allowance for its investments or accounts receivable.
Net Income (Loss) Per Share | Net Income (Loss) Per Share Basic net income (loss) per share is computed by dividing net income (loss) attributable to common shareholders by the weighted-average number of shares of common stock outstanding during the period. The weighted average number of shares of common stock includes the weighted average effect of outstanding pre-funded warrants for the purchase of shares of common stock for which the remaining unfunded exercise price is $0.0001 or less per share. Diluted net income (loss) per share is computed based on the weighted average number of shares of common stock plus the effect of dilutive potential commons shares outstanding during the period using the treasury stock method and if-converted method. Dilutive potential securities result from outstanding restricted stock, stock options, stock purchase warrants and conversion features in the Company’s loan agreement. When the Company has a net loss during the period, 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. A reconciliation of the numerators and the denominators of the basic and diluted net income (loss) per share computations is as follows (in thousands, except per share amounts): SCHEDULE OF COMPUTATION OF THE NUMERATORS AND DENOMINATORS USED IN THE BASIC AND DILUTED NET LOSS PER SHARE AMOUNTS
|  | 2024 |  |  | 2023 |  |  | 2024 |  |  | 2023 |
|  | For the three months ended June 30, |  |  | For the six months ended June 30, |
|  | 2024 |  |  | 2023 |  |  | 2024 |  |  | 2023 |
Numerator: |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Net income (loss) used for basic net income (loss) per share |  | $ | 7,406 |  |  | $ | (16,654 | ) |  | $ | (24,172 | ) |  | $ | (25,761 | )
Effect of dilutive securities: |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Fair value adjustments for warrant and derivative liabilities |  |  | (20,854 | ) |  |  | — |  |  |  | — |  |  |  | — |
Numerator for dilutive net income (loss) per share - net income available for common shareholders’ after the effect of dilutive securities |  | $ | (13,448 | ) |  | $ | (16,654 | ) |  | $ | (24,172 | ) |  | $ | (25,761 | )
Denominator: |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Weighted average number of common shares outstanding - basic |  |  | 40,010,481 |  |  |  | 18,017,874 |  |  |  | 33,662,908 |  |  |  | 17,464,026 |
Effect of dilutive shares: |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Shares of common stock issuable upon exercise of stock options |  |  | 178,931 |  |  |  | — |  |  |  | — |  |  |  | — |
Shares of common stock underlying restricted stock |  |  | 2,293,570 |  |  |  | — |  |  |  | — |  |  |  | — |
Shares of common stock issuable upon exercise of warrants |  |  | 8,165,236 |  |  |  | — |  |  |  | — |  |  |  | — |
Shares of common stock issuable upon exercise of conversion feature of loan agreement |  |  | 578,497 |  |  |  | — |  |  |  | — |  |  |  | — |
Dilutive potential common shares |  |  | 11,216,234 |  |  |  | — |  |  |  | — |  |  |  | — |
Denominator for dilutive net income (loss) per share - adjusted weighted average shares used in computing net income (loss) per share - dilutive |  |  | 51,226,715 |  |  |  | 18,017,874 |  |  |  | 33,662,908 |  |  |  | 17,464,026 |
Earnings per share: |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Basic income (loss) per common share |  | $ | 0.19 |  |  | $ | (0.92 | ) |  | $ | (0.72 | ) |  | $ | (1.48 | )
Dilutive income (loss) per common share |  | $ | (0.26 | ) |  | $ | (0.92 | ) |  | $ | (0.72 | ) |  | $ | (1.48 | )
The following table sets forth the potential securities that could potentially dilute basic 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
|  | 2024 |  |  | 2023 |  |  | 2024 |  |  | 2023 |
|  | For the three months ended June 30, |  |  | For the six months ended June 30, |
|  | 2024 |  |  | 2023 |  |  | 2024 |  |  | 2023 |
Shares of common stock issuable upon exercise of stock options |  |  | — |  |  |  | 230,723 |  |  |  | 178,859 |  |  |  | 230,723 |
Shares of common stock underlying restricted stock |  |  | — |  |  |  | 2,566,303 |  |  |  | 1,647,666 |  |  |  | 2,566,303 |
Shares of common stock issuable upon exercise of conversion feature of loan agreement |  |  | — |  |  |  | — |  |  |  | 614,251 |  |  |  | — |
Shares of common stock issuable upon exercise of warrants |  |  | 1,788,000 |  |  |  | 9,397,879 |  |  |  | 9,987,560 |  |  |  | 9,397,879 |
Total |  |  | 1,788,000 |  |  |  | 12,194,905 |  |  |  | 12,428,336 |  |  |  | 12,194,905 |
In January 2024 as part of the Loan and Security Agreement, see Note 8, the Company issued warrants to purchase $2,400,000 worth of shares of the Company’s stock which have an exercise price equal to the lesser of (i) $4.75 and (ii) the price per share of the Company’s net bona fide round of equity financing before September 30, 2024 (the “2024 Loan Agreement Warrants”). In connection with the underwritten common stock offering consummated on May 7, 2024 pursuant to the terms of the 2024 Loan Agreement Warrants, the exercise price of the 2024 Loan Agreement Warrants was reduced to the lesser of (i) $4.07 per share and (ii) the price per share of the Company’s next bona fide round of equity financing before September 30, 2024 in which the Company sells or issues shares of its common stock, excluding certain excluded issuances. Utilizing the exercise price of $4.07, which is the only known price at June 30, 2024, the Company included 589,681 of shares of common stock issuable upon exercise of the 2024 Loan Agreement Warrants for the six months ended June 30, 2024 and no shares for the three and six months ended June 30, 2023 in the table above.
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements The Company did not adopt any new accounting pronouncements during the three and six months ended June 30, 2024.
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In December 2023, the FASB issued Accounting Standards Update (“ASU”) No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 is intended to enhance the transparency and decision usefulness of income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information. The standard is effective for annual reporting periods beginning after December 15, 2024, with early adoption permitted. The requirements of this ASU are disclosure related and will not have an impact on the Company’s financial condition, results of operations, or cash flows. The Company is currently evaluating the impact of adopting this ASU on its income tax disclosures. In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which expands disclosures about a public entity’s reportable segments and requires more enhanced information about a reportable segment’s expenses, interim segment profit or loss, and how a public entity’s chief operating decision maker uses reported segment profit or loss information in assessing segment performance and allocating resources. The standard is effective for annual reporting periods beginning after December 15, 2023, and interim periods within years beginning after December 15, 2024, with early adoption permitted. The requirements of this ASU are disclosure related and will not have an impact on the Company’s financial condition, results of operations, or cash flows. The Company is currently evaluating the impact of adopting this ASU on its reportable segment disclosures.

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