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Alumis Inc.(ALMS) - 2024 Q3 - Quarterly Report
ALMSAlumis Inc.(ALMS)2024-11-13 21:24

Financial Performance - The company reported a net loss of 93.1millionforthethreemonthsendedSeptember30,2024,comparedtoanetlossof93.1 million for the three months ended September 30, 2024, compared to a net loss of 43.4 million for the same period in 2023, representing a 114% increase in losses year-over-year[132]. - For the nine months ended September 30, 2024, the net loss was 199.5million,upfrom199.5 million, up from 115.7 million in the same period of 2023, indicating a 72% increase in losses[132]. - As of September 30, 2024, the company had an accumulated deficit of 563.8million,primarilyduetoresearchanddevelopmentexpenses[132].−NetlossforthethreemonthsendedSeptember30,2024,was563.8 million, primarily due to research and development expenses[132]. - Net loss for the three months ended September 30, 2024, was 93.1 million, representing a 115% increase from a net loss of 43.4millionintheprioryear[155].−Netcashusedinoperatingactivitieswas43.4 million in the prior year[155]. - Net cash used in operating activities was 180.3 million for the nine months ended September 30, 2024, compared to 96.2millionforthesameperiodin2023[192].RevenueGeneration−Thecompanyhasnotgeneratedanyrevenuefromproductsalessinceitsinceptionanddoesnotexpecttodosountilregulatoryapprovalisobtainedforitsproductcandidates[134].−Thecompanyhasnotgeneratedanyrevenuefromproductsalessinceinceptionanddoesnotexpecttodosountilobtainingregulatoryapprovalforitsproductcandidates[187].Expenses−Researchanddevelopmentexpensesincreasedby13296.2 million for the same period in 2023[192]. Revenue Generation - The company has not generated any revenue from product sales since its inception and does not expect to do so until regulatory approval is obtained for its product candidates[134]. - The company has not generated any revenue from product sales since inception and does not expect to do so until obtaining regulatory approval for its product candidates[187]. Expenses - Research and development expenses increased by 132% to 87.8 million for the three months ended September 30, 2024, compared to 37.8millionforthesameperiodin2023[155].−Generalandadministrativeexpensesroseby7737.8 million for the same period in 2023[155]. - General and administrative expenses rose by 77% to 10.6 million for the three months ended September 30, 2024, from 6.0millionintheprioryear[155].−TotaloperatingexpensesforthethreemonthsendedSeptember30,2024,were6.0 million in the prior year[155]. - Total operating expenses for the three months ended September 30, 2024, were 98.4 million, a 125% increase from 43.8millioninthesameperiodof2023[155].−ResearchanddevelopmentexpensesfortheninemonthsendedSeptember30,2024,increasedby7343.8 million in the same period of 2023[155]. - Research and development expenses for the nine months ended September 30, 2024, increased by 73% to 178.4 million from 103.1millioninthesameperiodof2023[156].−CRO,CMO,andclinicaltrialsexpensesincreasedby103.1 million in the same period of 2023[156]. - CRO, CMO, and clinical trials expenses increased by 21.4 million for the three months ended September 30, 2024, primarily due to the timing and progression of clinical trials[162]. - Personnel-related costs increased by 5.0millionforthethreemonthsendedSeptember30,2024,primarilyduetoincreasedheadcountandstock−basedcompensation[163].−TotalexternalresearchanddevelopmentexpensesforthethreemonthsendedSeptember30,2024,were5.0 million for the three months ended September 30, 2024, primarily due to increased headcount and stock-based compensation[163]. - Total external research and development expenses for the three months ended September 30, 2024, were 69.9 million, up from 24.9millioninthesameperiodof2023[170].−Generalandadministrativeexpensesincreasedby24.9 million in the same period of 2023[170]. - General and administrative expenses increased by 4.6 million, reaching 10.6millionforthethreemonthsendedSeptember30,2024,comparedto10.6 million for the three months ended September 30, 2024, compared to 6.0 million for the same period in 2023[171]. - Personnel-related expenses rose by 3.5millionto3.5 million to 6.4 million for the three months ended September 30, 2024, primarily due to increased headcount and stock-based compensation[172]. Financing Activities - The company raised 233.3millioninnetproceedsfromitsinitialpublicoffering(IPO)andaconcurrentprivateplacement,completedinJuly2024[130].−Netcashprovidedbyfinancingactivitieswas233.3 million in net proceeds from its initial public offering (IPO) and a concurrent private placement, completed in July 2024[130]. - Net cash provided by financing activities was 492.4 million for the nine months ended September 30, 2024, including 193.3millionfromtheIPO[197].−Thecompanyplanstomonitorexpensesandmayraiseadditionalcapitalthroughpublicandprivateequity,debtfinancings,andstrategicalliances[184].ClinicalDevelopment−TheongoingPhase3ONWARDclinicalprogramforESK−001isexpectedtoreporttoplineresultsinthefirsthalfof2026[127].−ThePhase1programforA−005wasinitiatedinApril2024,withinitialresultsexpectedbytheendof2024[127].−Thecompanyincurredamilestonepaymentof193.3 million from the IPO[197]. - The company plans to monitor expenses and may raise additional capital through public and private equity, debt financings, and strategic alliances[184]. Clinical Development - The ongoing Phase 3 ONWARD clinical program for ESK-001 is expected to report topline results in the first half of 2026[127]. - The Phase 1 program for A-005 was initiated in April 2024, with initial results expected by the end of 2024[127]. - The company incurred a milestone payment of 23.0 million in August 2024 related to the first administration of ESK-001 in a Phase 3 clinical trial[185]. - A milestone payment of 37.0millionwasincurredduringtheyearendedDecember31,2022,andasubsequentpaymentof37.0 million was incurred during the year ended December 31, 2022, and a subsequent payment of 23.0 million was made in August 2024 related to the first administration of ESK-001 in a Phase 3 clinical trial[201]. Cash and Liquidity - The company had cash, cash equivalents, and marketable securities of $361.9 million as of September 30, 2024, expected to meet operating and capital requirements for at least 12 months[184]. - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to delay the adoption of certain accounting standards[206]. Economic and Market Conditions - Macroeconomic conditions, including rising inflation and geopolitical tensions, may impact the company's ability to obtain financing and could affect its business operations[141]. - The company does not believe that a hypothetical 10% increase or decrease in interest rates would have a material effect on its financial statements[211]. - Foreign currency transaction gains and losses have not been material to the company's consolidated financial statements, and it does not have a formal hedging program[212]. - The company has not experienced a material effect from inflation on its business or financial condition[213]. Internal Controls - There were no changes in the company's internal control over financial reporting during the quarter ended September 30, 2024, that materially affected its internal control[216].