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Abeona Therapeutics(ABEO) - 2024 Q3 - Quarterly Report
ABEOAbeona Therapeutics(ABEO)2024-11-14 12:30

Financial Performance - The net loss for the three months ended September 30, 2024, was 30.269million,comparedtoalossof30.269 million, compared to a loss of 11.836 million for the same period in 2023, reflecting a 156% increase in losses[12]. - The net loss for the nine months ended September 30, 2024 and 2023, respectively, was 54.4millionand54.4 million and 37.6 million, with an accumulated deficit of approximately 804.0millionasofSeptember30,2024[26].−ThebasicanddilutedlosspercommonshareforthethreemonthsendedSeptember30,2024,was804.0 million as of September 30, 2024[26]. - The basic and diluted loss per common share for the three months ended September 30, 2024, was (0.63), compared to (0.48)forthesameperiodin2023[12].−Thecompanyhasincurredsignificantoperatinglossesandnegativecashflowsfromoperationssinceinception,whichareexpectedtocontinuefortheforeseeablefuture[25].−Thecompanyhasincurredrecurringlossessinceinceptionandexpectstocontinuegeneratingoperatinglossesfortheforeseeablefuture[26].AssetsandLiabilities−AsofSeptember30,2024,totalcurrentassetsincreasedto(0.48) for the same period in 2023[12]. - The company has incurred significant operating losses and negative cash flows from operations since inception, which are expected to continue for the foreseeable future[25]. - The company has incurred recurring losses since inception and expects to continue generating operating losses for the foreseeable future[26]. Assets and Liabilities - As of September 30, 2024, total current assets increased to 112.657 million from 55.737millionasofDecember31,2023,representinga10255.737 million as of December 31, 2023, representing a 102% increase[9]. - Total liabilities rose to 74.819 million from 49.176million,markinga5249.176 million, marking a 52% increase[10]. - The total stockholders' equity increased significantly to 45.773 million from 14.826million,representinga20814.826 million, representing a 208% increase[11]. - Total assets measured at fair value as of September 30, 2024, were 109,168 million, an increase from 72,305millionasofDecember31,2023[51].−TotalliabilitiesmeasuredatfairvalueasofSeptember30,2024,were72,305 million as of December 31, 2023[51]. - Total liabilities measured at fair value as of September 30, 2024, were 38,789 million, up from 31,352millionasofDecember31,2023[55].CashFlowandInvestments−Cashandcashequivalentsincreasedto31,352 million as of December 31, 2023[55]. Cash Flow and Investments - Cash and cash equivalents increased to 15.726 million as of September 30, 2024, from 14.473millionasofDecember31,2023,ariseof914.473 million as of December 31, 2023, a rise of 9%[9]. - As of September 30, 2024, the Company had cash, cash equivalents, restricted cash, and short-term investments totaling 110.0 million, expected to fund operations for at least the next 12 months[26]. - The total cash, cash equivalents, and restricted cash at the end of the period is 16,064,000,comparedto16,064,000, compared to 5,050,000 at the end of the prior year[20]. - Total available-for-sale short-term investments amounted to 93.975millionasofSeptember30,2024,withunrealizedlossesprimarilyduetochangesininterestrates[42].ResearchandDevelopment−ResearchanddevelopmentexpensesfortheninemonthsendedSeptember30,2024,totaled93.975 million as of September 30, 2024, with unrealized losses primarily due to changes in interest rates[42]. Research and Development - Research and development expenses for the nine months ended September 30, 2024, totaled 25.366 million, up from 23.712millioninthesameperiodof2023,indicatinga723.712 million in the same period of 2023, indicating a 7% increase[12]. - The company is developing pz-cel, an autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa (RDEB)[21]. - The reimbursement of development and transition costs from Ultragenyx is recognized as a reduction of research and development costs[109]. Stock and Equity - The company issued 12,285,056 shares of common stock in connection with an underwritten offering, net of offering costs, during the reporting period[16]. - The Company sold 1,902,376 shares under the ATM Agreement during the nine months ended September 30, 2024, resulting in net proceeds of 10.0 million[84]. - The Company sold 3,284,407 shares and pre-funded warrants for an aggregate purchase price of 25.0milliongrossonJuly6,2023[89].−TheCompanysold12,285,056sharesandpre−fundedwarrantsforanaggregatepurchasepriceof25.0 million gross on July 6, 2023[89]. - The Company sold 12,285,056 shares and pre-funded warrants for an aggregate purchase price of 75.0 million gross on May 7, 2024[90]. Revenue and Licensing - The company reported no license and other revenues for the three months ended September 30, 2024, compared to 3.5millionforthesameperiodin2023[12].−TheCompanyrecognizednorevenuefromthesublicenseagreementsforthethreeandninemonthsendedSeptember30,2024and2023[103].−ThetransactionpriceforthesublicenseagreementrelatedtoCLN1diseaseincludes3.5 million for the same period in 2023[12]. - The Company recognized no revenue from the sublicense agreements for the three and nine months ended September 30, 2024 and 2023[103]. - The transaction price for the sublicense agreement related to CLN1 disease includes 7.0 million of fixed consideration and up to 56.0millionofvariableconsideration[102].−UndertheUltragenyxLicenseAgreement,theCompanyiseligibletoreceivetieredroyaltiesfrommid−single−digitupto1056.0 million of variable consideration[102]. - Under the Ultragenyx License Agreement, the Company is eligible to receive tiered royalties from mid-single-digit up to 10% on net sales and up to 30.0 million in commercial milestone payments[108]. Risks and Future Outlook - The company has highlighted potential risks including the timing and outcome of the FDA's review of its Biologics License Application for pz-cel, which could materially affect performance[7]. - The Company resubmitted its Biologics License Application (BLA) for pz-cel on October 28, 2024, with a target action date of April 29, 2025, set by the FDA[110]. - The BLA resubmission follows a Type A meeting with the FDA in August 2024, aligning on additional information required for Chemistry Manufacturing and Controls (CMC)[111]. Operating Costs and Expenses - Total operating lease costs for the nine months ended September 30, 2024, were 1,308million,adecreasefrom1,308 million, a decrease from 1,379 million in the same period of 2023[68]. - The Company incurred stock-based compensation expense of 4,673,000fortheninemonthsendedSeptember30,2023,comparedto4,673,000 for the nine months ended September 30, 2023, compared to 3,254,000 for the same period in 2022[20]. - Total stock-based compensation expense for the three months ended September 30, 2024 was 1.804million,comparedto1.804 million, compared to 1.557 million for the same period in 2023[95].