Enanta Pharmaceuticals Inc 2025年度报告

To Our Shareholders, All of us at Enanta are committed to leveraging our expertise in smallmolecule drug discovery to develop novel, best-in-class medicinesto transform the lives of patients with viral infections andimmunological diseases. Aswe reflect on 2025,we made significantprogressacross our pipeline,laying a strongfoundation.Looking to 2026,I am confidentthat we are poised to achieve meaningful valuecreation, and I could not be more optimistic for theyear ahead. demonstratingthat treatment with zelicapaviris associated with shortened time to completeresolutionof RSV symptoms—defined as allsymptoms absent and patient discharged fromhospital. Overall, we are proud that zelicapavir hasbeen dosed in more than 700 people and continuesto be well-tolerated with a favorable safety profile. Atthe core of our efforts in virology is ourcommitment to delivering the first treatment forrespiratory syncytial virus (RSV) to patients. Thereis a significant unmet need for RSV treatments,despite the availability of vaccines and prophylacticmonoclonalantibodies.Our two clinical-stagecandidates for the treatment of RSV—zelicapavir,an N-protein inhibitor, and EDP-323, an L-proteininhibitor—hold significant promise to advancepatient care in RSV. Oursecond RSV candidate,EDP-323,has thepotential to be a best-in-disease treatment. Wepresentednew data at IDWeek™from thepreviously disclosed successful Phase 2a humanchallenge study, including a post-hoc post-exposureprophylaxisanalysis suggesting that EDP-323mayalso be effective in preventing infectionafter exposure. Among 68 RSV-exposed subjectsrandomizedto receive EDP-323 or placebo,26% of placebo recipients became infected versus0% of EDP-323 recipients (p<0.001). These resultsare highly encouraging and support further clinicaldevelopment of EDP-323. InSeptember,we reached a major milestoneby reporting data for zelicapavir, a culminationofyears of dedication and perseverance fromour team. These positive data from RSVHR, ourPhase 2b study of zelicapavir in a high-risk adultoutpatientpopulation,represent the first timean antiviral treatment demonstrated a clinicallymeaningful benefit in high-risk adult outpatientswith RSV. Specifically, zelicapavir demonstratedan improvement of 6.7 days in time to completeresolution of all 13 RSV symptoms compared toplacebo, for patients with congestive heart failure,chronic obstructive pulmonary disease or age 75or older, termed the HR3 population. Additionally,zelicapavir shortened time to complete resolutionof the 29-parameter total RiiQ™ symptom scaleby 7.2 days in the HR3 population compared toplacebo. RSVHR also met key secondary endpoints,including a reduction in hospitalization and antiviraleffects.We believe the totality of these dataidentified multiple potential registration endpointsfor a Phase 3 trial. Lookingforward,we are continuing Phase 3-enablingactivities,including aligning with theU.S. Food and Drug Administration on an adultPhase 3 trial design and on an overall pathway toregistration. In parallel, we are exploring businessdevelopmentopportunities related to our RSVprogram.With zelicapavir and EDP-323,wehave the leading RSV treatment portfolio in theindustry and are committed to ensuring thesedrugs reach patients while maximizing value forour shareholders. Turning to immunology, we are focused on thetreatment of type 2 immune driven diseases, inareas with significant unmet need. Our team isleveraging deep expertise in medicinal chemistryto design oral molecules that are highly potentand selective with optimized preclinical profiles.Currently, we are advancing programs targetingKIT, STAT6 and MRGPRX2 inhibition. We also presented new data at IDWeek™ buildingon previously reported positive results from thePhase 2 study of zelicapavir in pediatric patients, In November, we announced EDP-978, a novel,potent and selective oral KIT inhibitor, as our clinical candidate for the treatment of chronicspontaneous urticaria and potentially other mast-cell-drivendiseases.EDP-978demonstratesnanomolar potency, sub-nanomolar activityin vivo,high selectivity for KIT versus other kinases, andfavorablein vitro and in vivo ADME propertiespreclinically.We are on track to submit anInvestigational New Drug (IND) application in thefirst quarter of 2026, with topline Phase 1 dataexpected in the fourth quarter of 2026. Circuit, having filed our notice of appeal in the firstquarter of 2025 and completed the briefing phasein the first half of 2025. Financially, we ended 2025 in a solid positionwith $188.9 million in cash, cash equivalents andmarketablesecurities,further strengthened by$74.5 million in gross proceeds from an upsizedpublic offering in October. Based on our operatingplan, we believe our existing financial resources,including cash flows from the retained portion ofour royalties from AbbVie’s sales of MAVYRET®/MAVIRET® (glecaprevir/pibrentasvir), will enable usto fund our programs into fiscal 2029. MAVYRET®/MAVIRET®(glecaprevir/