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Quince Therapeutics(QNCX) - 2024 Q1 - Quarterly Report
QNCXQuince Therapeutics(QNCX)2024-05-13 11:30

Product Development - Quince Therapeutics is focused on developing EryDex, a treatment for A-T, with a global market opportunity exceeding 1billion[145].−ThePhase3NEATclinicaltrialforEryDexisexpectedtobeginenrollmentinQ22024,targetingapproximately86patientsaged6to9and20patientsaged10andolder[161].−EryDexhasreceivedorphandrugdesignationfromtheU.S.FDAandEUECforthetreatmentofA−T[163].−ThepreviousATTeSTPhase3trialinvolved176patientsandevaluatedtwodosesofEryDex,withaprimaryefficacyendpointbasedonneurologicalsymptomsmeasuredbymICARS[166].−ThecompanyplanstosubmitaNewDrugApplication(NDA)totheFDAin2026,contingentonpositiveNEATtrialresults[162].−EryDexisdesignedtoimprovethepharmacokineticsandbiodistributionofDSP,acorticosteroid,toenhancesafetyandefficacy[156].−ThecompanyaimstoexploreadditionalindicationsforEryDexinrarediseaseswherecorticosteroidtreatmentisstandardbutlimitedbysafetyconcerns[154].−TheNEATtrialwillbeconductedunderaSpecialProtocolAssessment(SPA)agreementwiththeFDA,facilitatingNDAsubmissionpost−trial[162].FinancialPerformance−Researchanddevelopmentexpensesincreasedby14.61 billion [145]. - The Phase 3 NEAT clinical trial for EryDex is expected to begin enrollment in Q2 2024, targeting approximately 86 patients aged 6 to 9 and 20 patients aged 10 and older [161]. - EryDex has received orphan drug designation from the U.S. FDA and EU EC for the treatment of A-T [163]. - The previous ATTeST Phase 3 trial involved 176 patients and evaluated two doses of EryDex, with a primary efficacy endpoint based on neurological symptoms measured by mICARS [166]. - The company plans to submit a New Drug Application (NDA) to the FDA in 2026, contingent on positive NEAT trial results [162]. - EryDex is designed to improve the pharmacokinetics and biodistribution of DSP, a corticosteroid, to enhance safety and efficacy [156]. - The company aims to explore additional indications for EryDex in rare diseases where corticosteroid treatment is standard but limited by safety concerns [154]. - The NEAT trial will be conducted under a Special Protocol Assessment (SPA) agreement with the FDA, facilitating NDA submission post-trial [162]. Financial Performance - Research and development expenses increased by 14.6% to 3.7 million for the three months ended March 31, 2024, compared to 3.2millionforthesameperiodin2023[185].−EryDexdevelopmentcostsroseby3.2 million for the same period in 2023 [185]. - EryDex development costs rose by 2.7 million due to Phase 3 NEAT clinical trial start-up costs, primarily from a 2.4millionincreaseinclinicaltrialcosts[186].−Generalandadministrativeexpensesincreasedby29.92.4 million increase in clinical trial costs [186]. - General and administrative expenses increased by 29.9% to 5.0 million for the three months ended March 31, 2024, from 3.8millionforthesameperiodin2023[190].−Afairvalueadjustmentforcontingentconsiderationresultedina3.8 million for the same period in 2023 [190]. - A fair value adjustment for contingent consideration resulted in a 2.5 million charge for the three months ended March 31, 2024, related to the EryDel acquisition [191]. - Interest income increased by 26.7% to 0.887millionforthethreemonthsendedMarch31,2024,comparedto0.887 million for the three months ended March 31, 2024, compared to 0.700 million for the same period in 2023 [185]. - The net loss for the three months ended March 31, 2024, was 11.149million,adecreaseof9.011.149 million, a decrease of 9.0% from a net loss of 12.254 million for the same period in 2023 [185]. - No intangible asset impairment charges were recognized during the three months ended March 31, 2024, compared to a 5.9millionchargeinthesameperiodof2023[193].−ThecompanyanticipatesasignificantincreaseinresearchanddevelopmentexpensesasitpreparestobeginenrollmentforthePhase3NEATclinicaltrial[177].−Personnel−relatedcostsdecreasedby5.9 million charge in the same period of 2023 [193]. - The company anticipates a significant increase in research and development expenses as it prepares to begin enrollment for the Phase 3 NEAT clinical trial [177]. - Personnel-related costs decreased by 0.4 million during the three months ended March 31, 2024, compared to the same period in 2023 [188]. - As of March 31, 2024, the company had an accumulated deficit of 330.8millionandincurredanetlossof330.8 million and incurred a net loss of 11.1 million for the three months ended March 31, 2024 [198]. Funding and Cash Flow - The company has financed operations through the issuance of convertible promissory notes and redeemable convertible preferred stock, receiving net proceeds of approximately 303.9millionsinceinception[199].−Cash,cashequivalents,andshort−terminvestmentswere303.9 million since inception [199]. - Cash, cash equivalents, and short-term investments were 67.8 million as of March 31, 2024, down from 75.1millionasofDecember31,2023[200].−Thecompanybelievesexistingcapitalresourceswillfundoperationsintoatleast2026,excludingcostsassociatedwithin−licensingactivities[201].−Substantialadditionalfundingwillbeneededtosupportongoingoperationsanddevelopmentstrategies,withpotentialrelianceonequityordebtfinancing[202].−Netcashusedinoperatingactivitieswas75.1 million as of December 31, 2023 [200]. - The company believes existing capital resources will fund operations into at least 2026, excluding costs associated with in-licensing activities [201]. - Substantial additional funding will be needed to support ongoing operations and development strategies, with potential reliance on equity or debt financing [202]. - Net cash used in operating activities was 8.4 million for the three months ended March 31, 2024, primarily due to the net loss [209]. - Cash provided by investing activities was 8.9millionforthethreemonthsendedMarch31,2024,mainlyfrommaturitiesofshort−terminvestments[211].−Cashprovidedbyfinancingactivitieswas8.9 million for the three months ended March 31, 2024, mainly from maturities of short-term investments [211]. - Cash provided by financing activities was 0.2 million for the three months ended March 31, 2024, from the exercise of stock options [212]. - The fair value of long-term contingent consideration related to the EryDel acquisition is 60.3million,withashort−termportionof60.3 million, with a short-term portion of 4.7 million as of March 31, 2024 [214]. - The company has approximately $14.3 million in cancellable future operating expense commitments based on existing contracts as of March 31, 2024 [214].