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Abeona Therapeutics(ABEO) - 2025 Q1 - Quarterly Report
ABEOAbeona Therapeutics(ABEO)2025-05-15 11:35
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Financial Performance - Net loss for the three months ended March 31, 2025, was 12,029thousand,comparedtoanetlossof12,029 thousand, compared to a net loss of 31,578 thousand for the same period in 2024, representing a 61.9% improvement[15] - The company experienced a net cash used in operating activities of 18,402thousandforthethreemonthsendedMarch31,2025,comparedto18,402 thousand for the three months ended March 31, 2025, compared to 14,538 thousand for the same period in 2024, indicating a 26.5% increase in cash outflow[21] - Abeona Therapeutics reported net losses of 12.0millionand12.0 million and 31.6 million for the three months ended March 31, 2025, and 2024, respectively, with an accumulated deficit of approximately 825.3millionasofMarch31,2025[27]−TotalexpensesforthethreemonthsendedMarch31,2025,were825.3 million as of March 31, 2025[27] - Total expenses for the three months ended March 31, 2025, were 19,727 thousand, compared to 14,330thousandforthesameperiodin2024,reflectinga37.514,330 thousand for the same period in 2024, reflecting a 37.5% increase[15] Assets and Liabilities - Total current assets decreased from 100,853 thousand as of December 31, 2024, to 88,121thousandasofMarch31,2025,adeclineofapproximately12.788,121 thousand as of March 31, 2025, a decline of approximately 12.7%[13] - Total liabilities decreased from 64,900 thousand as of December 31, 2024, to 57,968thousandasofMarch31,2025,areductionofabout10.757,968 thousand as of March 31, 2025, a reduction of about 10.7%[13] - The company’s total stockholders' equity decreased from 44,031 thousand as of December 31, 2024, to 41,396thousandasofMarch31,2025,adecreaseofabout6.041,396 thousand as of March 31, 2025, a decrease of about 6.0%[13] - Cash and cash equivalents decreased from 23,357 thousand as of December 31, 2024, to 15,936thousandasofMarch31,2025,adeclineofapproximately31.715,936 thousand as of March 31, 2025, a decline of approximately 31.7%[13] Research and Development - Research and development expenses increased to 9,941 thousand for the three months ended March 31, 2025, up from 7,207thousandinthesameperiodof2024,anincreaseof38.17,207 thousand in the same period of 2024, an increase of 38.1%[15] - For the three months ended March 31, 2025, total research and development costs amounted to 9.941 million, an increase of 38.1% from 7.207millioninthesameperiodof2024[106]FinancingandCapitalStructure−TheCompanyraised7.207 million in the same period of 2024[106] Financing and Capital Structure - The Company raised 75 million gross from the sale of 12,285,056 shares of common stock and pre-funded warrants on May 7, 2024, with net proceeds of 70.2million[75]−UndertheATMAgreement,theCompanysold1,312,283sharesofcommonstockduringthethreemonthsendedMarch31,2025,resultinginnetproceedsof70.2 million[75] - Under the ATM Agreement, the Company sold 1,312,283 shares of common stock during the three months ended March 31, 2025, resulting in net proceeds of 6.8 million[77] - The Company has a financial covenant requiring it to maintain at least 5millioninunrestrictedcashatalltimes[67]−TheCompanyhasatotalof16,028,297potentialdilutivesecuritiesthatcouldaffectfuturenetlosspersharecalculations[37]DebtandObligations−TheCompanyhasatotallong−termdebtof5 million in unrestricted cash at all times[67] - The Company has a total of 16,028,297 potential dilutive securities that could affect future net loss per share calculations[37] Debt and Obligations - The Company has a total long-term debt of 19,286,000 as of March 31, 2025, with current maturities of 8,148,000[63]−TheCompanyhasatotalprincipalpaymentobligationof8,148,000[63] - The Company has a total principal payment obligation of 20 million, with 5.926millionduein2025,5.926 million due in 2025, 8.889 million in 2026, and 5.185millionin2027[71]−TheeffectiveinterestrateontheCompany′sloansasofMarch31,2025,was22.095.185 million in 2027[71] - The effective interest rate on the Company's loans as of March 31, 2025, was 22.09%[65] Revenue and Milestones - The Company has not recognized any significant revenues to date and may continue to incur operating losses until ZEVASKYN™ can provide sufficient revenue[27] - The Company has not recognized any revenue during the three months ended March 31, 2025, from event-based milestone payments related to the sublicense agreements[95] - The Company is subject to remaining milestone payments totaling approximately 0.2 million due upon FDA approval of ZEVASKYN™ on April 28, 2025[89] Stock and Equity - The weighted average number of common shares outstanding increased from 27,315,537 for the three months ended March 31, 2024, to 49,778,801 for the same period in 2025, an increase of 82.3%[15] - Total stock-based compensation expense for the three months ended March 31, 2025, was 2,701,000,a74.52,701,000, a 74.5% increase from 1,546,000 in the same period of 2024[85] - As of March 31, 2025, there were 5,250,307 restricted stock awards outstanding, with a grant date fair value per unit of 4.79[88]RegulatoryandApprovals−OnApril28,2025,theFDAapprovedZEVASKYN™asthefirstandonlyautologouscell−basedgenetherapyfortreatingwoundsinpatientswithRDEB[108]−TheCompanyenteredintoanexclusivelicenseagreementwithUltragenyxforAAVgenetherapyABO−102,withpotentialroyaltiesrangingfrommid−single−digitpercentagesupto104.79[88] Regulatory and Approvals - On April 28, 2025, the FDA approved ZEVASKYN™ as the first and only autologous cell-based gene therapy for treating wounds in patients with RDEB[108] - The Company entered into an exclusive license agreement with Ultragenyx for AAV gene therapy ABO-102, with potential royalties ranging from mid-single-digit percentages up to 10% on net sales and up to 30 million in commercial milestone payments[100]