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Adverum Biotechnologies(ADVM) - 2024 Q3 - Quarterly Report
ADVMAdverum Biotechnologies(ADVM)2024-11-04 21:44

Financial Performance - As of September 30, 2024, the company had an accumulated deficit of 990.2millionandhasnotgeneratedpositivecashflowornetincomesinceinception[52].−Thecompanyreportedanetlossof990.2 million and has not generated positive cash flow or net income since inception[52]. - The company reported a net loss of 70.4 million for the nine months ended September 30, 2024, primarily due to ongoing research and development activities[73]. - Net loss before income taxes improved by 5.7millionto5.7 million to (27.1) million for the three months ended September 30, 2024, compared to (32.9)millionforthesameperiodin2023[61].−LicenserevenueforthethreemonthsendedSeptember30,2024,was(32.9) million for the same period in 2023[61]. - License revenue for the three months ended September 30, 2024, was 1.0 million, a decrease of 2.6millioncomparedto2.6 million compared to 3.6 million for the same period in 2023[62]. - The company has not generated any revenue from product sales to date, relying instead on research, collaboration, and license arrangements[54]. Cash Flow and Financing - As of September 30, 2024, the company had 153.2millionincash,cashequivalents,andshort−terminvestments,sufficienttofundoperationsintolate2025[53].−DuringtheninemonthsendedSeptember30,2024,netcashusedinoperatingactivitieswas153.2 million in cash, cash equivalents, and short-term investments, sufficient to fund operations into late 2025[53]. - During the nine months ended September 30, 2024, net cash used in operating activities was 64.2 million, compared to 69.6millionforthesameperiodin2023[73].−NetcashprovidedbyfinancingactivitiesfortheninemonthsendedSeptember30,2024,was69.6 million for the same period in 2023[73]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was 119.8 million, mainly from the issuance of common stock and pre-funded warrants[75]. - The company expects that its existing cash and cash equivalents will be sufficient to fund operations into late 2025, but may need to raise additional funds sooner due to various risks and uncertainties[70]. - The company has a sales agreement with Cowen & Company to sell up to 100.0millionofcommonstockinan"at−the−market"offering,butnosaleshavebeenmadeasofNovember4,2024[70].ResearchandDevelopment−TheLUNAPhase2trialofIxo−vecwasfullyenrolledwith60subjects,andinterimanalysisindicatedmaintenanceofvisualandanatomicoutcomes[49].−ThecompanyplanstoinitiateaPhase3clinicaltrialofIxo−vecinwetAMDinthefirsthalfof2025[49].−Ixo−vechasreceivedmultipleregulatorydesignations,includingFastTrackdesignationfromtheFDAandPRIMEdesignationfromtheEMA[50].−Researchanddevelopmentexpensesincludepersonnel−relatedcosts,stock−basedcompensation,andexternalcontractresearchexpenses,withsignificantspendingexpectedasthecompanyadvancesintoPhase3trials[55].−Researchanddevelopmentexpensesdecreasedby100.0 million of common stock in an "at-the-market" offering, but no sales have been made as of November 4, 2024[70]. Research and Development - The LUNA Phase 2 trial of Ixo-vec was fully enrolled with 60 subjects, and interim analysis indicated maintenance of visual and anatomic outcomes[49]. - The company plans to initiate a Phase 3 clinical trial of Ixo-vec in wet AMD in the first half of 2025[49]. - Ixo-vec has received multiple regulatory designations, including Fast Track designation from the FDA and PRIME designation from the EMA[50]. - Research and development expenses include personnel-related costs, stock-based compensation, and external contract research expenses, with significant spending expected as the company advances into Phase 3 trials[55]. - Research and development expenses decreased by 0.3 million to 20.4millionforthethreemonthsendedSeptember30,2024,from20.4 million for the three months ended September 30, 2024, from 20.7 million for the same period in 2023[65]. - Research and development expenses for the nine months ended September 30, 2024, were 52.9million,adecreaseof52.9 million, a decrease of 9.5 million from 62.4millionforthesameperiodin2023[65].GeneralandAdministrativeExpenses−Generalandadministrativeexpensesdecreasedby62.4 million for the same period in 2023[65]. General and Administrative Expenses - General and administrative expenses decreased by 4.0 million to 9.8millionforthethreemonthsendedSeptember30,2024,from9.8 million for the three months ended September 30, 2024, from 13.8 million for the same period in 2023[66]. - General and administrative expenses for the nine months ended September 30, 2024, were 25.0million,adecreaseof25.0 million, a decrease of 14.0 million from 39.0millionforthesameperiodin2023[66].OtherIncomeandExpenses−Otherincome,netincreasedby39.0 million for the same period in 2023[66]. Other Income and Expenses - Other income, net increased by 0.4 million to 2.1millionforthethreemonthsendedSeptember30,2024,from2.1 million for the three months ended September 30, 2024, from 1.7 million for the same period in 2023[67]. - Other income, net increased by 2.1millionto2.1 million to 6.5 million for the nine months ended September 30, 2024, from 4.4millionforthesameperiodin2023[67].−Totaloperatingexpensesdecreasedby4.4 million for the same period in 2023[67]. - Total operating expenses decreased by 4.3 million to 30.2millionforthethreemonthsendedSeptember30,2024,from30.2 million for the three months ended September 30, 2024, from 34.5 million for the same period in 2023[61]. - Sublease income was 1.5millionforthethreemonthsendedSeptember30,2024,comparedto1.5 million for the three months ended September 30, 2024, compared to 1.3 million for the same period in 2023[61]. - The company reported 14.2millioninnon−cashchargesduringtheninemonthsendedSeptember30,2024,primarilyrelatedtostock−basedcompensation[73].MarketandManufacturing−Thecompanyutilizesthird−partycontractresearchorganizationsforclinicaldevelopmentanddoesnothaveitsownoperationalclinicalorcommercialmanufacturingfacilities[52].−Thecompanyaimstoimprovemanufacturingprocessesforlarge−scaleproductiontoaddresstheneedsofprevalentdiseaseslikewetAMD[51].−Thecompanyincurred14.2 million in non-cash charges during the nine months ended September 30, 2024, primarily related to stock-based compensation[73]. Market and Manufacturing - The company utilizes third-party contract research organizations for clinical development and does not have its own operational clinical or commercial manufacturing facilities[52]. - The company aims to improve manufacturing processes for large-scale production to address the needs of prevalent diseases like wet AMD[51]. - The company incurred 37.4 million in net purchases from marketable securities during the nine months ended September 30, 2024, compared to $107.4 million in net maturities in the same period of 2023[74].