Workflow
Adicet Bio(ACET) - 2025 Q1 - Quarterly Report
ACETAdicet Bio(ACET)2025-05-06 20:07

Financial Performance - The company reported a net loss of 28.2millionforthethreemonthsendedMarch31,2025,comparedtoanetlossof28.2 million for the three months ended March 31, 2025, compared to a net loss of 28.0 million for the same period in 2024, representing a 1% increase in loss [139]. - Total operating expenses for the three months ended March 31, 2025, were 29.9million,adecreaseof29.9 million, a decrease of 986,000, or 3%, compared to the same period in 2024 [139]. - General and administrative expenses increased by less than 0.1million,or10.1 million, or 1%, to 7.1 million for the three months ended March 31, 2025 [141]. - The company reported losses of 28.2millionforthethreemonthsendedMarch31,2025,withanaccumulateddeficitof28.2 million for the three months ended March 31, 2025, with an accumulated deficit of 526.1 million as of the same date [150]. - Net cash used in operating activities was 25.4millionforthethreemonthsendedMarch31,2025,comparedto25.4 million for the three months ended March 31, 2025, compared to 22.8 million for the same period in 2024 [158][159]. - The company incurred net cash used in investing activities of 2.9millionforthethreemonthsendedMarch31,2025,primarilyduetopurchasesofshort−termtreasurysecuritiesandlabequipment[160].ResearchandDevelopment−Researchanddevelopmentexpensesdecreasedby2.9 million for the three months ended March 31, 2025, primarily due to purchases of short-term treasury securities and lab equipment [160]. Research and Development - Research and development expenses decreased by 1.1 million, or 5%, to 22.8millionforthethreemonthsendedMarch31,2025,primarilyduetoadecreaseinexpensesrelatedtocontractdevelopmentandmanufacturingorganizations(CDMOs)[140].−ThecompanyreceivedFDAclearanceforitsINDapplicationforADI−001inlupusnephritisinDecember2023andexpandeditsclinicaldevelopmentprogramtoincludeadditionalautoimmunediseasesinAugust2024[123].−ADI−270,targetingCD70forrenalcellcarcinoma(RCC),receivedFDAclearanceforitsINDapplicationinJune2024andFastTrackDesignationinJuly2024[126].−ThecompanyplanstofileonenewInvestigationalNewDrug(IND)applicationevery12−18monthsaspartofitsongoingdevelopmentstrategy[122].−Thecompanyhasincurredsignificantlossesanddoesnotexpecttogeneratesubstantialproductrevenueuntilregulatoryapprovalsareobtainedforitsproductcandidates[152].CapitalandFunding−Thecompanyraisedapproximately22.8 million for the three months ended March 31, 2025, primarily due to a decrease in expenses related to contract development and manufacturing organizations (CDMOs) [140]. - The company received FDA clearance for its IND application for ADI-001 in lupus nephritis in December 2023 and expanded its clinical development program to include additional autoimmune diseases in August 2024 [123]. - ADI-270, targeting CD70 for renal cell carcinoma (RCC), received FDA clearance for its IND application in June 2024 and Fast Track Designation in July 2024 [126]. - The company plans to file one new Investigational New Drug (IND) application every 12-18 months as part of its ongoing development strategy [122]. - The company has incurred significant losses and does not expect to generate substantial product revenue until regulatory approvals are obtained for its product candidates [152]. Capital and Funding - The company raised approximately 19.3 million in net proceeds through the JonesTrading ATM Program in January 2024 before transitioning to the Jefferies ATM Program [146]. - The company completed a public offering of 32,379,667 shares at a price of 2.40pershare,resultinginnetproceedsofapproximately2.40 per share, resulting in net proceeds of approximately 91.7 million after underwriting discounts and expenses [147]. - As of March 31, 2025, the company had cash, cash equivalents, and short-term investments totaling 150.4million,whichisexpectedtocoveroperationalneedsforatleastthenexttwelvemonths[148][151].−Thecompanyanticipatesneedingtoraisesubstantialadditionalcapitaltofundoperationsandproductdevelopmentintheforeseeablefuture[153].ComplianceandRegulations−ThecompanyreceivedanotificationfromNasdaqregardingnon−compliancewiththeminimumbidpricerequirement,withadeadlinetoregaincompliancebyOctober6,2025[164].−Thecompanyisclassifiedasa"smallerreportingcompany,"allowingittotakeadvantageofreduceddisclosurerequirements[168].EconomicFactors−Inflationhasgenerallyaffectedthecompanybyincreasinglabor,clinicaltrial,andmanufacturingcosts[175].−Thecompanydoesnotbelievethatinflationhadamaterialeffectonitsbusiness,financialcondition,orresultsofoperationsduringthethreemonthsendedMarch31,2025[175].−Thecompanyintendstoretainandcontinueusingitsequipment,furniture,fixtures,andofficeequipment,whichmitigatestheimpactofinflationonoperations[175].−Foreigncurrencyexchangeratefluctuationshavenothadasignificantimpactonthecompany′sresultsofoperationsforanyperiodspresented[174].CashManagement−AsofMarch31,2025,thecompanyhad150.4 million, which is expected to cover operational needs for at least the next twelve months [148][151]. - The company anticipates needing to raise substantial additional capital to fund operations and product development in the foreseeable future [153]. Compliance and Regulations - The company received a notification from Nasdaq regarding non-compliance with the minimum bid price requirement, with a deadline to regain compliance by October 6, 2025 [164]. - The company is classified as a "smaller reporting company," allowing it to take advantage of reduced disclosure requirements [168]. Economic Factors - Inflation has generally affected the company by increasing labor, clinical trial, and manufacturing costs [175]. - The company does not believe that inflation had a material effect on its business, financial condition, or results of operations during the three months ended March 31, 2025 [175]. - The company intends to retain and continue using its equipment, furniture, fixtures, and office equipment, which mitigates the impact of inflation on operations [175]. - Foreign currency exchange rate fluctuations have not had a significant impact on the company's results of operations for any periods presented [174]. Cash Management - As of March 31, 2025, the company had 2.9 million of restricted cash held in cash collateral accounts following the termination of a loan agreement [127]. - The company has restricted cash of $2.9 million held in cash collateral accounts as of March 31, 2025 [149]. - The company's assets are primarily monetary, consisting of cash, cash equivalents, and short-term investments in treasury securities [175]. - The company incurs a majority of its general and administrative expenses and research and development costs in U.S. Dollars [174].