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Arcellx(ACLX) - 2024 Q3 - Quarterly Report
ACLXArcellx(ACLX)2024-11-07 21:37

Financial Performance - For the nine months ended September 30, 2024, the company reported net losses of 60.3million,comparedto60.3 million, compared to 90.5 million for the same period in 2023, resulting in an accumulated deficit of 449.7million[66].−CollaborationrevenueforthethreemonthsendedSeptember30,2024,was449.7 million[66]. - Collaboration revenue for the three months ended September 30, 2024, was 26.0 million, an increase of 11.0millionfrom11.0 million from 15.0 million in the same period of 2023[85]. - For the nine months ended September 30, 2024, collaboration revenue was 92.7million,anincreaseof92.7 million, an increase of 45.5 million from 47.2millionin2023[90].−Otherincome,netroseto47.2 million in 2023[90]. - Other income, net rose to 8.0 million for the three months ended September 30, 2024, up from 5.5millionin2023,anincreaseof5.5 million in 2023, an increase of 2.5 million[88]. - Other income, net for the nine months ended September 30, 2024, was 24.7million,anincreaseof24.7 million, an increase of 10.3 million from 14.4millionin2023[95].Expenses−Thecompanyexpectstoincursignificantoperatingexpensesandincreasinglossesasitadvancesclinicalprograms,expandsmanufacturinginfrastructure,andhiresadditionalpersonnel[66][68].−Researchanddevelopmentexpensesdecreasedto14.4 million in 2023[95]. Expenses - The company expects to incur significant operating expenses and increasing losses as it advances clinical programs, expands manufacturing infrastructure, and hires additional personnel[66][68]. - Research and development expenses decreased to 39.2 million for the three months ended September 30, 2024, down from 43.8millionin2023,areductionof43.8 million in 2023, a reduction of 4.6 million[93]. - Research and development expenses for the nine months ended September 30, 2024, were 112.4million,anincreaseof112.4 million, an increase of 7.3 million from 105.1millionin2023[93].−Generalandadministrativeexpensesincreasedto105.1 million in 2023[93]. - General and administrative expenses increased to 20.5 million for the three months ended September 30, 2024, compared to 16.0millionin2023,anincreaseof16.0 million in 2023, an increase of 4.5 million[87]. - General and administrative expenses for the nine months ended September 30, 2024, were 64.6million,anincreaseof64.6 million, an increase of 17.6 million from 47.0millionin2023[94].CashandFunding−Thecompanybelievesitscurrentcashandcashequivalentsareadequatetofundoperationsinto2027,butmayrequiresubstantialadditionalfundingforongoingdevelopment[69][68].−AsofSeptember30,2024,thecompanyhadcashandcashequivalentsandmarketablesecuritiestotaling47.0 million in 2023[94]. Cash and Funding - The company believes its current cash and cash equivalents are adequate to fund operations into 2027, but may require substantial additional funding for ongoing development[69][68]. - As of September 30, 2024, the company had cash and cash equivalents and marketable securities totaling 676.7 million[96]. - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling 676.7million,primarilyinvestedinU.S.governmentagencysecuritiesandtreasuries[111].ClinicalDevelopment−Thecompanyisadvancingitsleadprogram,anito−cel,inapivotalPhase2trialforrelapsedorrefractorymultiplemyeloma(rrMM)andhasinitiatedaglobalPhase3trial(iMMagine−3)incollaborationwithKitePharma[63][70].−Thecompanyhastwoclinical−stageARC−SparXprogramsinPhase1trials,targetingBCMAandCD123,withKiteexercisingitsoptiontonegotiatealicenseforACLX−001inNovember2023[64].−ThecompanyhasreceivedFDAclearanceforanINDapplicationforgeneralizedmyastheniagravis,indicatingplanstoevaluateanito−celfornon−oncologyindications[65].TaxandAccounting−Thecompanyrecordedanincometaxexpenseof676.7 million, primarily invested in U.S. government agency securities and treasuries[111]. Clinical Development - The company is advancing its lead program, anito-cel, in a pivotal Phase 2 trial for relapsed or refractory multiple myeloma (rrMM) and has initiated a global Phase 3 trial (iMMagine-3) in collaboration with Kite Pharma[63][70]. - The company has two clinical-stage ARC-SparX programs in Phase 1 trials, targeting BCMA and CD123, with Kite exercising its option to negotiate a license for ACLX-001 in November 2023[64]. - The company has received FDA clearance for an IND application for generalized myasthenia gravis, indicating plans to evaluate anito-cel for non-oncology indications[65]. Tax and Accounting - The company recorded an income tax expense of 0.6 million for the nine months ended September 30, 2024, compared to $41 thousand for the same period in 2023[82]. - The company maintains a full valuation allowance against its net deferred tax assets, indicating uncertainty regarding the realization of tax benefits[83]. - The company’s financial statements are prepared in accordance with GAAP in the United States[108]. - Critical accounting estimates involve significant estimation uncertainty and may materially impact the company's financial condition or results of operations[109]. - There have been no material changes to the company's critical accounting policies and estimates during the nine months ended September 30, 2024[109]. Market Risk - The company's primary exposure to market risk is interest rate sensitivity, particularly due to investments in short-term securities[111]. - The company is exposed to market risk related to changes in interest rates, with available-for-sale securities subject to interest rate risk[111]. - There have been no material changes in information related to market risk disclosures from the end of the preceding year until September 30, 2024[111]. - Recent accounting pronouncements that may impact the company's financial position are disclosed in the Annual Report on Form 10-K for the year ended December 31, 2023[110].