Celcuity Inc. · NASDAQ:CELC

Celcuity — Investor Conference Call (June 2026)

39 slides from Celcuity's conference presentation, Jun 2, 2026

  1. Slide 1: Phase 3 VIKTORIA-1 HR+/HER2-/PIK3CA Mutant Trial Results

    Phase 3 VIKTORIA-1 HR+/HER2-/PIK3CA Mutant Trial Results Gedatolisib is an investigational agent and is not approved by any regulatory agency as a treatment for any indication. June 2, 2026

  2. Slide 2: Forward-Looking Statements

    Forward-Looking Statements This presentation contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to Celcuity’s business, operations, and financial condition, and include but are not limit

  3. Slide 3: Agenda

    Overview Brian Sullivan Chief Executive Officer and Co-Founder VIKTORIA-1 PIK3CA MT Study Sara Hurvitz, MD, FACP Senior Vice President, Clinical Research Division Fred Hutch Cancer Center Treatment Landscape Sara Tolaney, MD, MPH Chief of the Division of Breast Oncology Dana-Farber Cancer Institute

  4. Slide 4: Brian Sullivan

    Brian Sullivan Chief Executive Officer and Co-Founder 4

  5. Slide 5: Phase 3 VIKTORIA-1 Study with Gedatolisib: PIK3CA MT Cohort Data

    Phase 3 VIKTORIA-1 Study with Gedatolisib: PIK3CA MT Cohort Data In patients with HR+/HER2-/PIK3CA mutant (MT) BOTH THE GEDATOLISIB-TRIPLET advanced breast cancer (ABC), the gedatolisib-triplet AND GEDATOLISIB-DOUBLET met the study’s Doubled the likelihood of survival primary endpoint without diseas

  6. Slide 6: VIKTORIA-1 Achieved Several Milestones in HR+/HER2-/PIK3CA MT ABC

    VIKTORIA-1 Achieved Several Milestones in HR+/HER2/PIK3CA MT ABC >11 months median 49% objective progression free 1st Phase 3 trial to survival for triplet response rate for demonstrate and doublet is triplet is highest superiority of one highest reported reported PAM inhibitor versus by any Phase 3

  7. Slide 7: Randomized Phase 3 study of gedatolisib + fulvestrant ± palbociclib (VIKTORIA-1 Study 2)

    A randomized, open-label, Phase 3 study of gedatolisib + fulvestrant ± palbociclib vs. standard of care in HR+/HER2/- PIK3CA-mutant advanced breast cancer (VIKTORIA-1 Study 2) Sara A. Hurvitz, MD, FACP Senior Vice President, Clinical Research Division Fred Hutch Cancer Center Professor and Head, Hem

  8. Slide 8: Background

    8 Background  The PI3K/AKT/mTOR (PAM) pathway drives breast cancer growth and contributes to endocrine and CDK4/6i resistance in HR+/HER2- ABC  After CDK4/6i, patients with PIK3CA-mutant (MT) disease generally derive modest benefit from PI3Kα and AKT inhibitors and may experience significant toxic

  9. Slide 9: VIKTORIA-1 Study 2 (PIK3CA MT): Phase 3 Clinical Trial of Gedatolisib

    VIKTORIA-1 Study 2 (PIK3CA MT): Phase 3 Clinical Trial of Gedatolisib HR+/HER2- ADVANCED BREAST CANCER Arm D PRIMARY Gedatolisib | 180mg IV once weekly, 3 weeks on, 1 week off ENDPOINTS Eligibility Criteria: Palbociclib | 125mg daily, 21 days on, 7 days off  PFS (BICR)  Pre- & postmenopausal women

  10. Slide 10: Statistical Considerations

    Statistical Considerations VIKTORIA-1 Study 2  Primary endpoint – PFS by blinded independent central review (BICR) – One-sided overall alpha of 0.025 – 95% power to detect HR=0.56 for gedatolisib triplet vs. alpelisib + fulvestrant  Key secondary endpoints (hierarchical order) − OS for gedatolisib

  11. Slide 11: Patient Disposition

    Patient Disposition Randomized 3:1:3 (N=362) Gedatolisib + palbociclib + Gedatolisib + fulvestrant Alpelisib + Fulvestrant fulvestrant (n=52) (n=155) (n=155) Received allocated treatment n=153 Received allocated treatment n=52 Received allocated treatment n=152 Discontinued study treatment n=109 Dis

  12. Slide 12: Baseline Demographics and Disease Characteristics

    Baseline Demographics and Disease Characteristics Gedatolisib + Gedatolisib + palbociclib + Gedatolisib + Alpelisib + palbociclib + Gedatolisib + Alpelisib + fulvestrant fulvestrant Fulvestrant fulvestrant fulvestrant Fulvestrant CHARACTERISTIC (n=155) (n=52) (n=155) CHARACTERISTIC (n=155) (n=52) (n

  13. Slide 13: Primary Endpoint: Progression-Free Survival (BICR)

    Primary Endpoint: Progression-Free Survival (BICR) Gedatolisib Triplet vs. Alpelisib + Fulvestrant Geda + palbo Alpelisib 100 + fulvestrant + fulvestrant (n=155) (n=155) 90 80 11.1 5.6 Median PFS, months (95% CI) (9.0-16.7) (5.2-7.4) Progression-free Survival (%) 70 Adjusted HR (95% CI) 0.50 (0.37-0

  14. Slide 14: PFS in Key Subgroups: Gedatolisib Triplet vs. Alpelisib + Fulvestrant

    PFS in Key Subgroups: Gedatolisib Triplet vs. Alpelisib + Fulvestrant Gedatolisib + Palbociclib + Fulvestrant Alpelisib + Fulvestrant Subgroup n/N n/N Hazard Ratio (95% CI) Age <65 years 53/107 65/97 0.47 (0.32-0.68) ≥65 years 15/48 34/58 0.46 (0.25-0.87) Menopause status Pre/perimenopause 12/25 20/

  15. Slide 15: Secondary Endpoint: Progression-Free Survival (BICR)

    Secondary Endpoint: Progression-Free Survival (BICR) Gedatolisib Doublet vs. Alpelisib + Fulvestrant Gedatolisib Alpelisib 100 + fulvestrant + fulvestrant (n=52) (n=155) 90 11.3 5.6 80 Median PFS, months (95% CI) (9.1-22.1) (5.2-7.4) Progression-free Survival (%) 70 Adjusted HR (95% CI) 0.51 (0.33-0

  16. Slide 16: PFS in Key Subgroups: Gedatolisib Doublet vs. Alpelisib + Fulvestrant

    PFS in Key Subgroups: Gedatolisib Doublet vs. Alpelisib + Fulvestrant Gedatolisib + Fulvestrant Alpelisib + Fulvestrant Subgroup n/N n/N Hazard Ratio (95% CI) Age <65 years 14/27 65/97 0.51 (0.28-0.88) ≥65 years 11/25 34/58 0.63 (0.32-1.31) Menopause status Pre/perimenopause 2/6 20/29 0.26 (0.07-1.1

  17. Slide 17: Key Secondary Endpoint: Overall Survival (Interim Analysis)

    Key Secondary Endpoint: Overall Survival (Interim Analysis) 100 100 90 90 80 80 70 70 Overall Survival (%) Overall Survival (%) 60 60 50 50 40 40 30 30 Geda + Alpelisib + Geda + palbo + Alpelisib + fulvestrant fulvestrant fulvestrant fulvestrant 20 (n=155) (n=155) 20 (n=52) (n=155) mOS, NR 31.1 mOS,

  18. Slide 18: Secondary Endpoint: Tumor Response by BICR

    Secondary Endpoint: Tumor Response by BICR Response evaluable population Geda + Palbo + Fulvestrant Gedatolisib + Fulvestrant Alpelisib + Fulvestrant Endpoint, % (n=133) (n=42) (n=127) Best Overall Response Complete response 0 0 0.8 Partial response 48.9 35.7 25.2 Stable disease 33.8 50.0 44.9 Durab

  19. Slide 19: Duration of Response

    Duration of Response Geda + palbo + Alpelisib + Geda + Alpelisib + fulvestrant fulvestrant fulvestrant fulvestrant (n=65) (n=33) (n=15) (n=33) 100 100 mDOR, 15.7 7.5 mDOR, 24.2 7.5 90 months (95% CI) (9.2-20.6) (5.5-15.8) months (95% CI) (7.4-NE) (5.5-15.8) 90 Adjusted HR (95% CI) 0.47 (0.25-0.86);

  20. Slide 20: Safety and Tolerability

    Safety and Tolerability Gedatolisib + palbociclib + fulvestrant Gedatolisib + fulvestrant Alpelisib + fulvestrant Exposure (n=153) (n=52) (n=152) Median RDI, Geda (IQR) 93.3 (80.6-100) 100 (97.8-100) -- Median RDI, Alpe (IQR) -- -- 81.7 (64.8-96.2) TRAE and TR-SAE. % Pts with ≥1 TRAE 98.0 96.2 96.7

  21. Slide 21: Summary

    Summary  Gedatolisib + fulvestrant +/- palbociclib significantly improved PFS compared with alpelisib + fulvestrant in patients with PIK3CA-mutant, HR+/HER2- ABC in VIKTORIA-1 Study 2 − Gedatolisib triplet: mPFS 11.1 months (HR, 0.50; 95% CI, 0.37-0.68; P < 0.0001) − Gedatolisib doublet: mPFS 11.3

  22. Slide 22: Igor Gorbatchevsky, MD

    Igor Gorbatchevsky, MD Chief Medical Officer 22

  23. Slide 23: How Does Gedatolisib Potentially Fit in the 2L PIK3CA MT Landscape?

    How Does Gedatolisib Potentially Fit in the 2L PIK3CA MT Landscape? Gedatolisib regimens induced the highest mPFS ever reported in 2L HR+/HER2- ABC PATIENT MEDIAN PFS AND ORR POPULATION 2ND LINE ER+/HER2-/PIK3CA MUTANT ABC PIK3CA mPFS 11.3 months MT Gedatolisib + Fulvestrant 1 ORR 36% PIK3CA mPFS 11

  24. Slide 24: VIKTORIA-1 PIK3CA WT Cohort: Both Co-Primary Endpoints Met

    VIKTORIA-1 PIK3CA WT Cohort: Both Co-Primary Endpoints Met Gedatolisib triplet and gedatolisib doublet vs. fulvestrant, BICR assessment 100 100 Geda + Palbo + Geda + fulvestrant Fulvestrant Fulvestrant fulvestrant (n=130) (n=131) 90 (n=131) 90 (n=131) 80 Median PFS, 9.3 2.0 80 Median PFS, 7.4 2.0 Pr

  25. Slide 25: How Does the Gedatolisib Regimen Potentially Fit in the 2L Landscape?

    How Does the Gedatolisib Regimen Potentially Fit in the 2L Landscape? Gedatolisib regimens showed highest multiple of mPFS improvement versus endocrine therapy PATIENT MULTIPLE OF mPFS IMPROVEMENT IN MONTHS RELATIVE TO ENDOCRINE MONOTHERAPY POPULATION PIK3CA WT Gedatolisib + Fulvestrant + Palbocicli

  26. Slide 26: How Does the Gedatolisib Regimen Potentially Fit in the 2L Landscape?

    How Does the Gedatolisib Regimen Potentially Fit in the 2L Landscape? Hazard ratios for regimens compared to endocrine monotherapy as primary endpoint in a Phase 3 trial PATIENT HAZARD RATIO (LOWER IS BETTER) POPULATION 2ND LINE HR+/HER2-/PIK3CA WILD-TYPE ABC Geda + Fulv + PIK3CA WT 0.24 Palbo1 PIK3

  27. Slide 27: Igor Gorbatchevsky, MD and Sara M. Tolaney, MD, MPH

    Igor Gorbatchevsky, MD Chief Medical Officer Celcuity Inc. Sara M. Tolaney, MD, MPH Chief of the Division of Breast Oncology Dana-Farber Cancer Institute Associate Professor of Medicine Harvard Medical School 27

  28. Slide 28: Additional Observations

    Additional Observations EXCEEDED PFS benefit for both triplet and doublet were more favorable than statistical assumptions STATISTICAL  Assumed HR = 0.56 for triplet analysis endpoint and HR = 1.0 for doublet analysis ASSUMPTIONS  Assumed 13.0, 7.3, 7.3 months mPFS for geda-triplet, geda-doublet,

  29. Slide 29: Eldon Mayer

    Eldon Mayer Chief Commercial Officer 29

  30. Slide 30: Commercial and Medical Affairs Leadership Team: Track Record of Launching New Therapies

    Commercial and Medical Affairs Leadership Team: Track Record of Launching New Therapies Eldon Mayer Steve Vickers Samir Garg Chief Commercial Officer VP Sales VP Marketing Nancy Ruscio-Bell Laura Gunn, PhD Carly Loeb VP Market Access VP, Medical Affairs VP Commercial Operations 30

  31. Slide 31: Commercial Strategy– PIK3CA Wild-Type & Mutant

    Commercial Strategy– PIK3CA Wild-Type & Mutant Positioning Gedatolisib for strong market adoption in breast cancer LARGE SIGNIFICANT UNMET WELL COMPELLING VALUE POPULATION NEED IN HR+/HER2- DIFFERENTIATED PROPOSITION ADVANCED BREAST 37,000 patients with Gedatolisib MOA, Best-in-class efficacy + safe

  32. Slide 32: Wild-Type Launch Readiness and Key Preparations

    Wild-Type Launch Readiness and Key Preparations Wild-Type Launch Readiness and Key Preparations Experienced teams actively preparing for potential launch 1 2 3 4 Marketing – Sales force, field Supply Chain, Market access & PAM pathway & marketing & Distribution & Reimbursement Gedatolisib medical af

  33. Slide 33: Wild-Type Launch Readiness and Key Preparations

    Wild-Type Launch Readiness and Key Preparations Wild-Type Launch Readiness and Key Preparations Experienced teams actively preparing for potential launch 1 2 3 4 Marketing – Sales force, Field Supply Chain, Market Access & PAM pathway & Marketing & Distribution & Reimbursement Gedatolisib Medical Af

  34. Slide 34: Wild-Type Launch Readiness and Key Preparations

    Wild-Type Launch Readiness and Key Preparations Wild-Type Launch Readiness and Key Preparations Experienced teams actively preparing for potential launch 1 2 3 4 Marketing – Sales force, Field Supply Chain, Market Access & PAM pathway & Marketing & Distribution & Reimbursement Gedatolisib Medical Af

  35. Slide 35: Wild-Type Launch Readiness and Key Preparations

    Wild-Type Launch Readiness and Key Preparations Wild-Type Launch Readiness and Key Preparations Experienced teams actively preparing for potential launch 1 2 3 4 Marketing – Sales force, Field Market access & PAM pathway & Distribution & Marketing & Reimbursement Gedatolisib Patient Advocacy Medical

  36. Slide 36: Brian Sullivan

    Brian Sullivan Chief Executive Officer and Co-Founder 36

  37. Slide 37: Long-Term Plans Supported by Extended Exclusivity Period for Gedatolisib

    Long-Term Plans Supported by Extended Exclusivity Period for Gedatolisib Loss of exclusivity now expected to occur in 2042; anticipate new formulations to extend this period further Subject Matter Patent Expiration Date Note Composition of matter (API)  Includes 209 days of patent term adjustment (

  38. Slide 38: Upcoming Milestones

    Upcoming Milestones NDA The FDA granted a priority review with a PDUFA date of July 17, 2026 for DECISION the VIKTORIA-1 PIK3CA wild-type cohort NDA DATA Phase 1b mCRPC study data update in Q4 2026 UPDATES VIKTORIA-1 PIK3CA wild-type and mutant cohort data updates in Q4 2026 SUBMIT Submit supplement

  39. Slide 39: Unlocking the Potential of Treating Cancers That Involve the PI3K/AKT/mTOR Pathway

    Unlocking the Potential of Treating Cancers That Involve the PI3K/AKT/mTOR Pathway

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