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Adverum Biotechnologies(ADVM) - 2025 Q1 - Quarterly Report

Financial Performance - As of March 31, 2025, the company had an accumulated deficit of 1.1billionandhasnotgeneratedpositivecashflowornetincomesinceinception[76].TheoperatinglossforthethreemonthsendedMarch31,2025,was1.1 billion and has not generated positive cash flow or net income since inception [76]. - The operating loss for the three months ended March 31, 2025, was 48.2 million, an increase of 19.0millionfromtheoperatinglossof19.0 million from the operating loss of 29.2 million in the same period of 2024 [89]. - Net loss for the three months ended March 31, 2025, was 47.0million,comparedtoanetlossof47.0 million, compared to a net loss of 27.1 million for the same period in 2024, reflecting an increase of 19.9million[89].Thecompanyexpectstocontinueincurringnetlossesandoperatingcashoutflowsforatleastthenextseveralyearsasitdevelopsitsproductcandidates[97].Generalandadministrativeexpensesincreasedby19.9 million [89]. - The company expects to continue incurring net losses and operating cash outflows for at least the next several years as it develops its product candidates [97]. - General and administrative expenses increased by 5.7 million to 19.5millionforthethreemonthsendedMarch31,2025,from19.5 million for the three months ended March 31, 2025, from 13.8 million in the same period of 2024 [92]. - Other income, net decreased by 0.9millionto0.9 million to 1.2 million for the three months ended March 31, 2025, from 2.1millionforthesameperiodin2024[93].CashFlowandFundingCashandcashequivalentsdecreasedto2.1 million for the same period in 2024 [93]. Cash Flow and Funding - Cash and cash equivalents decreased to 83.1 million as of March 31, 2025, down from 125.7millionasofDecember31,2024[94].Netcashusedinoperatingactivitieswas125.7 million as of December 31, 2024 [94]. - Net cash used in operating activities was 42.8 million for the three months ended March 31, 2025, compared to 23.2millionforthesameperiodin2024[105].Thecompanyplanstoraisesubstantialadditionalfundingtofinanceoperationsthroughvariousmeans,includingpublicorprivateequityordebtfinancings[98].ForthethreemonthsendedMarch31,2024,thenetcashusedinoperatingactivitieswas23.2 million for the same period in 2024 [105]. - The company plans to raise substantial additional funding to finance operations through various means, including public or private equity or debt financings [98]. - For the three months ended March 31, 2024, the net cash used in operating activities was 23.2 million, primarily due to a net loss of 27.1millionfromongoingresearchanddevelopmentactivities[107].ThenetcashprovidedbyfinancingactivitiesforthethreemonthsendedMarch31,2024wasprimarily27.1 million from ongoing research and development activities [107]. - The net cash provided by financing activities for the three months ended March 31, 2024 was primarily 119.7 million from the issuance of common stock and Pre-Funded Warrants in Private Placements [109]. - Additionally, 0.1millionwasgeneratedfromtheexerciseofstockoptionsduringthesameperiod[109].ResearchandDevelopmentThecompanyannouncedtopline52weekresultsfromtheLUNAPhase2clinicaltrial,showingareductioninannualizedantiVEGFinjectionratesof880.1 million was generated from the exercise of stock options during the same period [109]. Research and Development - The company announced top-line 52-week results from the LUNA Phase 2 clinical trial, showing a reduction in annualized anti-VEGF injection rates of 88% for the 6E10 dose and 92% for the 2E11 dose [72]. - Nearly 50% of patients treated with Ixo-vec were injection-free through four years following treatment in the OPTIC trial [71]. - The company plans to initiate the AQUARIUS Phase 3 trial in the second half of 2025, following the initiation of the ARTEMIS trial in February 2025 [73]. - The LUNA trial enrolled 60 subjects, randomized between two doses, and assessed visual and anatomic outcomes at 52 weeks [72]. - The FDA granted Ixo-vec Fast Track designation in September 2018 and Regenerative Medicine Advanced Therapy designation in August 2024 [74]. - Research and development expenses include personnel-related costs, stock-based compensation, and external contract research expenses [81]. - Research and development expenses increased by 13.3 million to 28.7millionforthethreemonthsendedMarch31,2025,comparedto28.7 million for the three months ended March 31, 2025, compared to 15.4 million for the same period in 2024 [90]. Operational Status - The company has not generated any revenue from product sales to date, relying on research and collaboration arrangements for revenue [80]. - The company currently has no operational clinical or commercial manufacturing facilities, relying on third-party contractors for clinical manufacturing [78].