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Aileron Therapeutics(ALRN) - 2024 Q4 - Annual Report
ALRNAileron Therapeutics(ALRN)2025-04-07 20:02

Financial Performance - The company has incurred net losses of 62.9millionand62.9 million and 15.7 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of 351.4millionasofDecember31,2024[559].−ThenetlossfortheyearendedDecember31,2024,was351.4 million as of December 31, 2024[559]. - The net loss for the year ended December 31, 2024, was 62.9 million, compared to a net loss of 15.7millionin2023,reflectinganincreaseinlossesof15.7 million in 2023, reflecting an increase in losses of 47.2 million[583]. - Cash used in operating activities was 22.3millionin2024,comparedto22.3 million in 2024, compared to 19.8 million in 2023, indicating a higher cash burn rate[602]. - Other income for 2024 was 0.7million,upfrom0.7 million, up from 0.5 million in 2023, primarily due to interest income and investment accretion[589]. Cash and Financing - As of December 31, 2024, the company had cash and cash equivalents of 12.9million,whichisexpectedtofundoperationsintoAugust2025,butisinsufficientforcompletingtheplannedPhase2clinicaltrialofLTI−03[560].−Thecompanyhasfinancedoperationsprimarilythrough12.9 million, which is expected to fund operations into August 2025, but is insufficient for completing the planned Phase 2 clinical trial of LTI-03[560]. - The company has financed operations primarily through 145.5 million in net proceeds from sales of common stock and warrants, and 17.7millionfromapublicofferingcompletedinMay2024[558][565].−NetcashprovidedbyfinancingactivitiesfortheyearendedDecember31,2024,was17.7 million from a public offering completed in May 2024[558][565]. - Net cash provided by financing activities for the year ended December 31, 2024, was 17.8 million, an increase from 15.8millionin2023duetoPIPEFinancing[607].−Thecompanyanticipatesneedingtoraiseadditionalcapitalthroughpublicorprivateequityofferings,debtfinancings,orcollaborations[612].ResearchandDevelopment−Thecompanyhastwoproductcandidatesinclinicaldevelopment:LTI−03forIdiopathicPulmonaryFibrosisandLTI−01forloculatedpleuraleffusion,withLTI−01′sclinicaldevelopmenttemporarilydelayed[556][561].−Researchanddevelopmentexpensesprimarilyconsistofcostsrelatedtoclinicaltrials,personnel,andcompliancewithregulatoryrequirements[572][576].−Researchanddevelopmentexpensesincreasedto15.8 million in 2023 due to PIPE Financing[607]. - The company anticipates needing to raise additional capital through public or private equity offerings, debt financings, or collaborations[612]. Research and Development - The company has two product candidates in clinical development: LTI-03 for Idiopathic Pulmonary Fibrosis and LTI-01 for loculated pleural effusion, with LTI-01's clinical development temporarily delayed[556][561]. - Research and development expenses primarily consist of costs related to clinical trials, personnel, and compliance with regulatory requirements[572][576]. - Research and development expenses increased to 14.2 million in 2024 from 4.0millionin2023,ariseof4.0 million in 2023, a rise of 10.3 million, primarily due to new clinical programs acquired in the Lung Acquisition[584]. - The company anticipates continued significant expenses and operating losses as it advances clinical development of lead product candidates LTI-03 and LTI-01[594]. - The company plans to continue research and development of LTI-03 and LTI-01, expecting substantial increases in expenses related to ongoing activities[608]. Impairment and Losses - The impairment loss on intangible assets was identified in the fourth quarter of 2024 when the carrying value of LTI-01 exceeded its fair value[577]. - The company incurred an impairment loss on intangible assets of 37.0millionin2024,linkedtothedelayinclinicaldevelopmentofLTI−01[587].−Animpairmentlossof37.0 million in 2024, linked to the delay in clinical development of LTI-01[587]. - An impairment loss of 37.0 million was recognized for the LTI-01 intangible asset due to a temporary delay in clinical development[626]. General and Administrative Expenses - General and administrative expenses rose to 13.9millionin2024from13.9 million in 2024 from 11.4 million in 2023, an increase of 2.5million,mainlydrivenbyhigheremployee−relatedexpensesandcostsassociatedwiththeLungAcquisition[586].FutureOutlook−Thecompanyanticipatescontinuedoperatinglossesfortheforeseeablefutureduetoongoingresearchanddevelopmentcosts[559].−Futurecapitalrequirementswilldependonvariousfactors,includingclinicaltrialcostsandregulatoryapprovalprocesses[610].OtherInformation−Thecompanyhasfederalnetoperatinglosscarryforwardsof2.5 million, mainly driven by higher employee-related expenses and costs associated with the Lung Acquisition[586]. Future Outlook - The company anticipates continued operating losses for the foreseeable future due to ongoing research and development costs[559]. - Future capital requirements will depend on various factors, including clinical trial costs and regulatory approval processes[610]. Other Information - The company has federal net operating loss carryforwards of 77.3 million and federal research and development tax credit carryforwards of $2.4 million as of December 31, 2024[590]. - The company does not have any off-balance sheet arrangements as of December 31, 2024, and 2023[614]. - The company is classified as a "smaller reporting company," which may allow it to rely on exemptions from certain disclosure requirements[635]. - Management continues to monitor estimates related to financial conditions and will adjust them as necessary based on changing economic conditions[627].