Celcuity（CELC）：2L PIK3CAwt mBC三期数据预计2025年第三季度公布

2024A2025E2026E(2.83)(3.45)(3.19)(2.83)(3.44)(3.42)NMNMNM 2027E(0.71)(1.03)NM Maury Raycroft, Ph.D. * | Equity Analyst(212) 323-3990 | mraycroft@jefferies.comAmin Makarem, Ph.D. * | Equity Associate+1 (332) 236-6822 | amakarem@jefferies.comFarzin Haque, Ph.D. * | Equity Analyst+1 (212) 778-8349 | fhaque@jefferies.comJames Stamos, Ph.D. * | Equity Associate(212) 323-7644 | jstamos@jefferies.comAmy Qian, Ph.D. * | Equity Associate+1 (212) 707-6465 | aqian@jefferies.com To compare BICR results of VIKTORIA-1 w/ other trials, mgmt emphasized that HR is the mostsuitable metric -- this is b/c it accounts for relative differences in pt populations and offers themost appropriate measure for risk reduction.By using HR, the results of VIKTORIA-1 can be moreeffectively compared w/ EMBER-3 and postMONARCH.Though many SERDs are in development for 1L+2L mBC, our view is that the current SERDlandscape does not pose a major threat to gedatolisib, given that we expect future SERDpositioning+use will primarily be in ESR1mut pts rather than WT pts.Notably, ESR1mut ptsconstitute only ~33% of the total PIK3CAwt population.CELC plans to file a request for RTOR if the trial is successful -- once the request is submittedFDA notification on eligibility is expected w/in 30 days.The NDA could be submitted over 3-5mosw/ a decision pot'ly in 4-5mos once application is completed.If eligible for RTOR, we believe approvalcould occur by mid-'26.PIK3CAmut portion of V-1 ph.III is expected to readout 4Q25.Mgmt is confident in the timing asthere are only 2 arms in this trial being evaluated in the primary analysis vs the PIK3CAwt portionthat has 3 arms.CELC plans to report mCRPC ph.Ib/II data late-2Q25 from 36 pts enrolled across 2 dosingcohorts, 20mg & 180mg geda (plus daro).We expect co will show landmark 6-mos rPFS plussafety. PSA not expected to show meaningful differences, since geda does not tgt AR.Financials:Cash $205.7M; runway through 2026; OpEx $36M (vs our $38M est);Model changes:PT stays $33.Please see important disclosure information on pages 6 - 11 of this report.This report is intended for Jefferies clients only. Unauthorized distribution is prohibited. The Long View: CelcuityInvestment Thesis / Where We Differ•We believe geda's pan-PI3K/mTOR inh approach is differentiated,contributing both to efficacy and addressable market (MT+WT). Gedaefficacy/safety profile looks competitive against AKT inh and mut-selectivePI3K inh•We expect VIKTORIA-1 Ph.III testing Geda+CDK4/6+ER in 2L HR+ HER2-PIK3CAwt aBC could be a success, opening a significant market oppty forgeda beyond PIK3CAmut.•Also, Geda+CDK4/6+ER combo set up an upside scenario in 1L aBC withthe VIKTORIA-2 trial.Base Case,$33, +204%•Gedatolisib ph.III 2L mutation pop finishesenrollment without delays, and CELC reports(+)ve readouts in WT and mut populations•No safety surprises•PT $33Sustainability Matters•Top Material Issue(s): Based on our analyses, we think1)Business Ethics:CELC established aCode of Business Ethics and assigned the oversight to the Compensation, Nomination & CorporateGovernance Committee;2)Product Quality & Safety:CELC follows Good Clinical Practice (GCP)guidelines for the studies and those patients provide their informed consent in writing.3) Diversity,Equity, & Inclusion:Board of directors considers diversity in selecting new board members to enhanceoverall composition of board.•Company Target(s):Not disclosed•Qs to Mgmt:1)Can you talk about any recent improvements on product quality and safety?2)Can youtalk about opportunities to improve the energy, water, and materials use, greenhouse gas emissions,material and/or hazardous waste for your ESG initiatives?3)Can you talk about near and longer termsinvestments for your ESG initiatives?4)Can you talk about implementing the ESG strategies to yourpipeline developments and employee’s development?•Linkto ESG Industrial Sector FrameworkPlease see important disclosure information on pages 6 - 11 of this report.This report is intended for Jefferies clients only. Unauthorized distribution is prohibited. Upside Scenario,$89, +720%•Geda VIKTORIA-1 2L ph.III data report best-case efficacy+safety•Geda's VIKTORIA-2 1L ph.III enrolls faster thanexpected and shows strong efficacy•Geda develops and wins in add'l hormone-driven cancers•PT $89 Downside Scenario,$7, -36%•Geda ph.III fails in WT readout on efficacy, soPOS for MT readout would be decreased•Geda's ph.III profile demonstrates unexpectedAEs•PT $7Catalysts•3Q25– Ph.III PIK3CA WT BC readout•4Q25– ph.III PIK3CA MT BC readout•2Q25– ph.I/II CRPC initial data 3 Pipeline and Milestones:.MilestonesProductPipelineProductGedatolisibGedatolisibGedatolisibCELsignia CDxGedatolisibSource: Jefferies, company reportsPlease see important disclosure information on pages 6 - 11 of this report.This report is intended for Jefferies clients only. Unauthorized distribution is prohibited. INCOME STATEMENT:.Celcuity Statement of Operations($ in thousands, except per share data)Reve