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Enanta Pharmaceuticals(ENTA) - 2025 Q1 - Quarterly Report
ENTAEnanta Pharmaceuticals(ENTA)2025-02-12 21:00

Financial Position - As of December 31, 2024, the company had 216.7millionincash,cashequivalents,andshort−termmarketablesecurities,expectedtofundoperationsintofiscal2028[72].−Thecompanyreceiveda216.7 million in cash, cash equivalents, and short-term marketable securities, expected to fund operations into fiscal 2028[72]. - The company received a 200 million cash payment in April 2023 from a royalty sale agreement, which will impact future royalty payments[81][100]. - The company has funded operations primarily through royalty payments from AbbVie and the 200millionreceivedfromtheroyaltysaleagreement,enablingfundingintofiscal2028[85].−Cashusedinoperatingactivitieswas200 million received from the royalty sale agreement, enabling funding into fiscal 2028[85]. - Cash used in operating activities was 16.8 million for the three months ended December 31, 2024, a decrease of 8.2millioncomparedto8.2 million compared to 25.0 million for the same period in 2023[110]. - Cash provided by investing activities was 68.9millionforthethreemonthsendedDecember31,2024,anincreaseof68.9 million for the three months ended December 31, 2024, an increase of 82.0 million compared to cash used in investing activities of 13.1millionforthesameperiodin2023[112].−Cashusedinfinancingactivitiesdecreasedby13.1 million for the same period in 2023[112]. - Cash used in financing activities decreased by 2.4 million to 5.0millionforthethreemonthsendedDecember31,2024,comparedto5.0 million for the three months ended December 31, 2024, compared to 7.4 million for the same period in 2023[113]. - Total estimated minimum lease payments for the next five years are projected to be 6.7millionfor2025,6.7 million for 2025, 8.5 million for 2026, 8.7millionfor2027,8.7 million for 2027, 9.0 million for 2028, and 9.3millionfor2029[120].ResearchandDevelopment−ThecompanyisdevelopingtwoclinicalstageproductcandidatesforRSV:zelicapavirandEDP−323,bothofwhichhavereceivedFastTrackdesignationfromtheFDA[74].−Zelicapavirdemonstratedaviralloaddeclineof1.0logatDay3and1.4logatDay5inaPhase2study,withafavorablesafetyprofileobservedacrossallagegroups[75].−EDP−323achievedstatisticallysignificantreductionsinviralloadandclinicalsymptomsinaPhase2achallengestudy,withap−valueof<0.0001comparedtoplacebo[76].−EDP−235,anoralinhibitortargetingSARS−CoV−2,showedadose−dependentimprovementintotalsymptomscore,achievingstatisticalsignificance(p<0.05)inthe400mgtreatmentgroup[76].−ThecompanyplanstoselectaleaddevelopmentcandidatefororalSTAT6inhibitorsinthesecondhalfof2025,focusingontype2immune−drivendiseases[76].−Thecompanyhasongoingdevelopmentprogramstargetingchronicspontaneousurticaria(CSU)andatopicdermatitis(AD),withCSUaffectingapproximately1.75−3.5millionpeopleintheU.S.[70][71].−ThecompanyexpectstocompleteenrollmentforaPhase2bstudyofzelicapavirinhigh−riskadultsbytheendofthecurrentNorthernHemisphereRSVseason,withtoplinedataexpectedinQ32025[75].−ThecompanyisfocusingoncollaborationstoprogressEDP−235intoPhase3studies,asitwillnotadvancethiscandidateindependently[77].−ThecompanyhasidentifiednoveloralKITinhibitorsforpreclinicaldevelopment,withaleadcandidateselectedinQ42024[77].−Thecompanyplanstoexpanditspresenceinimmunologywiththeintroductionofathirdprogramin2025[78].−ThecompanyisconductingaPhase2bstudyofzelicapavirinhigh−riskadultsandhascompletedaPhase2bstudyinpediatricpatients[83].ExpensesandRevenue−RoyaltyrevenueforthethreemonthsendedDecember31,2024,was9.3 million for 2029[120]. Research and Development - The company is developing two clinical stage product candidates for RSV: zelicapavir and EDP-323, both of which have received Fast Track designation from the FDA[74]. - Zelicapavir demonstrated a viral load decline of 1.0 log at Day 3 and 1.4 log at Day 5 in a Phase 2 study, with a favorable safety profile observed across all age groups[75]. - EDP-323 achieved statistically significant reductions in viral load and clinical symptoms in a Phase 2a challenge study, with a p-value of <0.0001 compared to placebo[76]. - EDP-235, an oral inhibitor targeting SARS-CoV-2, showed a dose-dependent improvement in total symptom score, achieving statistical significance (p<0.05) in the 400 mg treatment group[76]. - The company plans to select a lead development candidate for oral STAT6 inhibitors in the second half of 2025, focusing on type 2 immune-driven diseases[76]. - The company has ongoing development programs targeting chronic spontaneous urticaria (CSU) and atopic dermatitis (AD), with CSU affecting approximately 1.75-3.5 million people in the U.S.[70][71]. - The company expects to complete enrollment for a Phase 2b study of zelicapavir in high-risk adults by the end of the current Northern Hemisphere RSV season, with topline data expected in Q3 2025[75]. - The company is focusing on collaborations to progress EDP-235 into Phase 3 studies, as it will not advance this candidate independently[77]. - The company has identified novel oral KIT inhibitors for preclinical development, with a lead candidate selected in Q4 2024[77]. - The company plans to expand its presence in immunology with the introduction of a third program in 2025[78]. - The company is conducting a Phase 2b study of zelicapavir in high-risk adults and has completed a Phase 2b study in pediatric patients[83]. Expenses and Revenue - Royalty revenue for the three months ended December 31, 2024, was 16.96 million, a decrease of 1.04millionfrom1.04 million from 18.00 million in the same period of 2023[86][98]. - Research and development expenses for the three months ended December 31, 2024, decreased by 8.7millionto8.7 million to 27.66 million compared to 36.37millioninthesameperiodof2023[101].−Thecompanyexpectsareductioninexternalresearchanddevelopmentexpensesinthenext12months,primarilyduetothecompletionofkeystudies[84][91].−ThetotalrevenuerecognizedforthethreemonthsendedDecember31,2024,was36.37 million in the same period of 2023[101]. - The company expects a reduction in external research and development expenses in the next 12 months, primarily due to the completion of key studies[84][91]. - The total revenue recognized for the three months ended December 31, 2024, was 16.96 million, attributed to AbbVie's lower reported HCV sales compared to the previous year[98]. - Research and development expenses in the virology program decreased by 9million,mainlyduetothetimingofclinicaltrials[102].−Immunologyprogramcostsincreasedby9 million, mainly due to the timing of clinical trials[102]. - Immunology program costs increased by 2.5 million due to scale-up and IND-enabling activities related to the KIT program and initiation of preclinical studies for the STAT6 program[103]. - Other program costs decreased by 2.2millionduetothecompletionofdiscoveryandoptimizationactivitiesrelatedtotheSTAT6program[104].−Generalandadministrativeexpensesdecreasedby2.2 million due to the completion of discovery and optimization activities related to the STAT6 program[104]. - General and administrative expenses decreased by 3.7 million for the three months ended December 31, 2024, primarily due to a decrease in legal expenses related to a patent infringement suit against Pfizer[105]. - Interest expense decreased by $1.5 million for the three months ended December 31, 2024, due to the paydown of obligations associated with a royalty sale agreement[106].