Celcuity Inc. · NASDAQ:CELC

Celcuity — Investor Presentation (October 2025)

54 slides from Celcuity's investor presentation, October 2025

  1. Slide 1: Unlocking the Potential of Treating Cancers That Involve the PAM Pathway

    Unlocking the Potential of Treating Cancers That Involve the PI3K/AKT/mTOR (PAM) Pathway October 2025 Gedatolisib is an investigational drug and is not approved by any regulatory agency as a treatment for any indication.

  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: Phase 3 VIKTORIA-1 Study with Gedatolisib: PIK3CA Wild-Type Cohort Data

    Phase 3 VIKTORIA-1 Study with Gedatolisib: PIK3CA Wild-Type Cohort Data GEDATOLISIB TRIPLET (gedatolisib + fulvestrant + palbociclib) In patients with  mPFS was 9.3 months vs. 2.0 months for fulvestrant HR+/HER2-/PIK3CA wild-type (WT) advanced breast cancer (ABC),  7.3-month incremental improvemen

  4. Slide 4: Gedatolisib Has the Potential to Establish New SOC in HR+/HER2- ABC

    Gedatolisib Has the Potential to Establish New SOC in HR+/HER2- ABC Uniquely positioned to advance multiple potential blockbuster indications in breast and prostate cancer 1 Gedatolisib’s differentiated MOA and PK profile result in a highly potent, cytotoxic, and well tolerated PAM inhibitor Phase 3

  5. Slide 5: Unlocking the Potential of Treating Cancers That Involve the PAM Pathway

    Unlocking the Potential of Treating Cancers That Involve the PI3K/AKT/mTOR (PAM) Pathway LARGEST ONE OF THE MOST UNTAPPED DRUG MOST IMPORTANT HIGHLY ALTERED DEVELOPMENT ONCOGENIC OF ALL SIGNALING OPPORTUNITY PATHWAYS PATHWAYS1 IN SOLID TUMORS PI3K/AKT/mTOR (PAM) Proportion of alterations Breast and

  6. Slide 6: Difficult to Safely and Comprehensively Inhibit the PAM Pathway

    Difficult to Safely and Comprehensively Inhibit the PAM Pathway Optimal efficacy may require inhibition of all Class I PI3K isoforms and mTORC1 and mTORC2 MULTIPLE PATHWAY TARGETS THERAPEUTIC WINDOW FOR ORAL PROVIDE FUNCTIONAL REDUNDANCY PI3K/mTOR INHIBITORS IS NARROW If only a single target is inhi

  7. Slide 7: Gedatolisib Has a Highly Differentiated Mechanism of Action and Potency

    Gedatolisib Has a Highly Differentiated Mechanism of Action and Potency Potential First-in-Class PAM Inhibitor with superior cytotoxicity vs. single target PAM inhibitors Cell-Free Biochemical Dose Response Analysis Live Cell Proliferation Rate Dose Response Analysis7 IC50 (nM)1 Average values for 1

  8. Slide 8: Safety Data for Gedatolisib vs. Single Target PAM Inhibitors When Combined with ET

    Safety Data for Gedatolisib vs. Single Target PAM Inhibitors When Combined with ET Fewer patients reported AE’s associated with PAM when treated with gedatolisib, compared to other PAM inhibitors gedatolisib alpelisib everolimus capivasertib 100 capivasertib gedatolisib alpelisib GRADE 1-2 (SOLID);

  9. Slide 9: Clinical Development Programs: Current

    Clinical Development Programs: Current 2ND LINE 2ND LINE METASTATIC 1ST LINE HR+/HER2- CASTRATION HR+/HER2- ADVANCED RESISTANT ADVANCED BREAST CANCER PROSTATE BREAST CANCER CANCER Phase 3 clinical trial for Phase 1b/2 clinical trial for Phase 3 clinical trial for gedatolisib with fulvestrant gedatol

  10. Slide 10: The PAM Pathway is the Most Underdeveloped Target in Solid Tumors

    The PAM Pathway is the Most Underdeveloped Target in Solid Tumors PAM is the most frequently altered PAM revenue potential comparable pathway in solid tumors to CDK4/6 & AR therapies $10.1B $8.8B altered pathways1 38% % Tumors w / Peak Global Revenues2 8% 5% 4% $0.8B Target PAM HER2 EGFR ALK Target

  11. Slide 11: Multiple potential blockbuster indications in both tumor types

    Multiple potential blockbuster indications in both tumor types HR+/HER2- Breast Cancer Advanced Prostate Cancer US 156,880 EU5+J 115,080 116,600 101,760 82,880 Patient Population 93,280 Addressable 78,440 66,080 69,960 61,600 53,760 49,280 53,000 41,440 36,960 28,000 74,000 59,000 55,000 48,000 37,0

  12. Slide 12: Key Gedatolisib Patents

    Key Gedatolisib Patents Loss of exclusivity now expected to occur in 2042; expect new formulations to extend this period further Subject Matter Patent Expiration Date Note Composition of matter (API)  Includes 209 days of patent term adjustment (PTA), and expected 5 Dec 2034 (generic and species) y

  13. Slide 13: Gedatolisib for Advanced Breast Cancer (ABC)

    Gedatolisib for Advanced Breast Cancer (ABC) 13

  14. Slide 14: HR+/HER2- Breast Cancer Treatment Landscape

    HR+/HER2- Breast Cancer Treatment Landscape1 ~30,000 women in US and ~33,000 women in 5EU and Japan die from breast cancer annually2 DISEASE STAGE ADVANCED AND METASTATIC STAGE LOCALIZED AND REGIONAL STAGE I-III III (INOPERABLE) OR STAGE IV Low Higher ~32% 1st line 2nd line 3rd line 4th line recurre

  15. Slide 15: Phase 3 VIKTORIA-1 2nd Line HR+, HER2- ABC

    Phase 3 VIKTORIA-1 2nd Line HR+, HER2- ABC 15

  16. Slide 16: Clinical Strategy: Simultaneous Blockade of PAM, ER, & CDK4/6 Pathways

    Clinical Strategy: Simultaneous Blockade of PAM, ER, & CDK4/6 Pathways CLINICAL HYPOTHESIS Blockade of interdependent ER, PI3K, mTOR & CDK signaling pathways is required to optimize anti-tumor control PAM inhibition:1-4  Blockades PAM pathway and limits cross- activation when ER or CDK4/6 is inhibi

  17. Slide 17: VIKTORIA-1 Study (PIK3CA WT): Phase 3 Clinical Trial of Gedatolisib

    VIKTORIA-1 Study 1 (PIK3CA WT): Phase 3 Clinical Trial of Gedatolisib Arm A† HR+/HER2- ADVANCED Gedatolisib | 180mg IV once weekly, 3 weeks on, PRIMARY ENDPOINTS BREAST CANCER 1 week off  PFS (BICR) STUDY 1 Palbociclib | 125mg daily, 21 days on, 7 days off  Arm A vs. Arm C PIK3CA R 1:1:1 Fulvestra

  18. Slide 18: Patient Disposition

    Patient Disposition Randomized (N=392) Gedatolisib + palbociclib+ Gedatolisib + fulvestrant Fulvestrant fulvestrant (n=130) (n=131) (n=131) Received allocated treatment n=130 Received allocated treatment n=130 Received allocated treatment n=123 Discontinued study treatment n=97 Discontinued study tr

  19. Slide 19: Patient Population Includes Significant Proportion with Aggressive Disease

    Patient Population Includes Significant Proportion with Aggressive Disease 80% with liver or lung metastases and included endocrine therapy resistant patients Gedatolisib + Gedatolisib + palbociclib+ Gedatolisib + palbociclib+ Gedatolisib + fulvestrant fulvestrant fulvestrant fulvestrant fulvestrant

  20. Slide 20: Both Co-Primary Endpoints Met: 7.3- & 5.4-month improvement in mPFS

    Both Co-Primary Endpoints Met: 7.3- & 5.4-month improvement in mPFS 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

  21. Slide 21: Gedatolisib Triplet vs. Fulvestrant

    Gedatolisib Triplet vs. Fulvestrant Consistent PFS consistent across pre-specified sub-groups Gedatolisib + Palbociclib + Fulvestrant Fulvestrant Subgroup n/N mPFS, mo. n/N mPFS, mo. Hazard Ratio (90% CI) Age <65 years 39/93 9.3 74/108 1.9 0.23 (0.17-0.35) ≥65 years 20/38 9.7 15/23 2.1 0.28 (0.16-0.

  22. Slide 22: Gedatolisib Doublet vs. Fulvestrant

    Gedatolisib Doublet vs. Fulvestrant Consistent PFS consistent across pre-specified sub-groups Gedatolisib + Fulvestrant Fulvestrant Subgroup n/N mPFS, mo. n/N mPFS, mo. Hazard Ratio (90% CI) Age <65 years 52/96 5.6 74/108 1.9 0.31 (0.25-0.46) ≥65 years 17/34 7.7 15/23 2.1 0.53 (0.29-1.10) Menopause

  23. Slide 23: PFS in Key Subgroups: Gedatolisib Triplet vs. Doublet

    PFS in Key Subgroups: Gedatolisib Triplet vs. Doublet Gedatolisib + Palbociclib + Fulvestrant Gedatolisib + Fulvestrant Subgroup n/N mPFS, mo. n/N mPFS, mo. Age <65 years 39/93 9.3 52/96 5.6 ≥65 years 20/38 9.7 17/34 7.7 Menopause status Pre/perimenopause 9/28 11.1 19/37 5.6 Postmenopause 50/101 8.9

  24. Slide 24: Interim Overall Survival Analysis Shows Favorable Trend for Gedatolisib

    Interim Overall Survival Analysis Shows Favorable Trend for Gedatolisib Triplet and Doublet; Encouraging Given High Number of Patient Crossover Geda + Palbo + fulvestrant Fulvestrant Geda + fulvestrant Fulvestrant (n=131) (n=131) (n=130) (n=131) Median OS, 23.7 18.5 Median OS, NR 18.5 months (95% CI

  25. Slide 25: Interim OS Sensitivity Analysis - Cross-Over Patients Censored

    Interim OS Sensitivity Analysis - Cross-Over Patients Censored Geda + Palbo + fulvestrant Fulvestrant Geda + fulvestrant Fulvestrant (n=131) (n=131) (n=130) (n=131) Median OS, 23.7 15.8 Median OS, NR 15.8 months (95% CI) (21.4-NE) (11.7-NE) months (95% CI) (NE-NE) (11.7-NE) Adjusted HR (95% CI) 0.56

  26. Slide 26: Duration of Response and Incremental ORR Improvement

    Duration of Response and Incremental ORR Improvement for Triplet and Doublet is the Highest Reported for an ET-Based Regimen Relative to Control in 2L HR+/HER2- ABC Patients with evaluable disease, BICR assessment DURATION OF RESPONSE 100 Geda + Palbo + Gedatolisib + Duration of Response (%) 90 Fulv

  27. Slide 27: Gedatolisib Regimens Were Generally Well-Tolerated, With Low Discontinuation Rates

    Gedatolisib Regimens Were Generally Well-Tolerated, With Low Discontinuation Rates; Majority of TRAE’s Grade 1/2; Low Hyperglycemia and Diarrhea Rates SAE and Gedatolisib + palbociclib + fulvestrant Gedatolisib + fulvestrant Fulvestrant discontinuation, % (n=130) (n=130) (n=123) Pts with ≥1 SAE 11 9

  28. Slide 28: How Does the Gedatolisib Regimen Potentially Fit in the 2L Landscape?

    How Does the Gedatolisib Regimen Potentially Fit in the 2L Landscape? Gedatolisib and approved regimens with Phase 3 data for 2L HR+/HER2-/PIK3CA WT post-CDK4/6i PATIENT MEDIAN PROGRESSION-FREE SURVIVAL POPULATION 2L Gedatolisib + Fulvestrant + Palbociclib1 9.3 months All 2L Gedatolisib + Fulvestran

  29. Slide 29: 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 incremental mPFS improvement versus endocrine therapy PATIENT INCREMENTAL mPFS IMPROVEMENT RELATIVE TO ENDOCRINE THERAPY POPULATION 2L Gedatolisib + Fulvestrant + Palbociclib1 Δ 7.3 months 2L Ge

  30. Slide 30: 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 gedatolisib regimens are unprecedented PATIENT HAZARD RATIO (LOWER IS BETTER) POPULATION Geda + Fulv+ 2L 0.24 Palbo 2L Gedatolisib + Fulvestrant 0.33 2L Giredestrant + Everolimus 1 0.38 Not FDA approved 0.55 ESR1

  31. Slide 31: Phase 1B Data: Geda-Triplet & SOC for 2L HR+/HER2-/PIK3CA MT ABC

    Phase 1B Data: Geda-Triplet & SOC for 2L HR+/HER2-/PIK3CA MT ABC Data from PIK3CA MT Cohort of VIKTORIA-1 expected in 1H 2026 PATIENT 2ND LINE ER+/HER2-/PIK3CA MUTANT ABC POPULATION 2L mPFS 14.6 months PIK3CA Gedatolisib + Fulvestrant + Palbociclib 1 WT/MT ORR 48% 2L PIK3CA mPFS 8.0 months MT Alpeli

  32. Slide 32: Phase 3 VIKTORIA-2 1st Line HR+, HER2- ABC

    Phase 3 VIKTORIA-2 1st Line HR+, HER2- ABC 32

  33. Slide 33: VIKTORIA-2: Phase 3 Study Features for 1L HR+/HER2- ABC

    VIKTORIA-2: Phase 3 Study Features for 1L HR+/HER2- ABC Global open-label randomized study (~200 sites) Key eligibility criteria: KEY CONSIDERATIONS  ER+/HER2- advanced or metastatic breast cancer  No prior treatment for advanced or metastatic breast cancer  1L endocrine treatment resistant  Pro

  34. Slide 34: VIKTORIA-2: Phase 3 Trial Design Overview for 1L HR+/HER2- ABC

    VIKTORIA-2: Phase 3 Trial Design Overview for 1L HR+/HER2- ABC Will conduct small safety run-in with gedatolisib plus ribociclib plus fulvestrant prior to Phase 3 Arm 1 Gedatolisib + CDK4/6i + fulvestrant Patients with N = 319 HR+/HER2- ABC Patients randomized 1:1 PRIMARY ENDPOINTS in two cohorts ba

  35. Slide 35: Phase 1b 1st Line HR+, HER2- Endocrine Therapy Sensitive ABC

    Phase 1b 1st Line HR+, HER2- Endocrine Therapy Sensitive ABC 35

  36. Slide 36: Phase 1B: Gedatolisib + Palbociclib + Letrozole in 1L HR+/HER2- ABC (N=41)

    Phase 1B: Gedatolisib + Palbociclib + Letrozole in 1L HR+/HER2- ABC (N=41)1 mPFS of 48.6 months, mDOR of 46.9 months, and ORR of 79% Treatment-Naïve Patients who are Endocrine Treatment Sensitive (ETS) (N=41) Escalation Arm A Expansion Arm A Total Treatment Naïve Progression-Free Survival n = 11 n =

  37. Slide 37: Phase 1B: Gedatolisib + Palbociclib + Letrozole in 1L HR+/HER2- ABC (N=41)

    Phase 1B: Gedatolisib + Palbociclib + Letrozole in 1L HR+/HER2- ABC (N=41)1 mPFS and ORR for treatment-naïve ETS patients compares favorably to published data for SOC palbociclib + letrozole2 Median Progression Free Survival Tumor Size Change 48.6 Months ORR = 79% (26/33) 100 90 80 Progression Free

  38. Slide 38: Phase 1B: Gedatolisib + Palbociclib + Letrozole in 1L HR+/HER2- ABC (N=41)

    Phase 1B: Gedatolisib + Palbociclib + Letrozole in 1L HR+/HER2- ABC (N=41)1 mOS data for treatment-naïve patients ETS compares favorably to published data for current SOC Median Overall Survival 77.3 Months Overall survival (%) RELEVANT OS DATA IN 1L SETTING  Palbociclib + letrozole: 53.8 months2 

  39. Slide 39: Gedatolisib Combo vs. SOC for 1L HR+ / HER2- ABC (Endocrine Sensitive)

    Gedatolisib Combo vs. SOC for 1L HR+ / HER2- ABC (Endocrine Sensitive) Gedatolisib Combo Offers Potential for Superior mPFS Compared to 1L SOC 1ST LINE HR+/HER2- ABC mPFS 48.6 months Gedatolisib + Palbociclib + Letrozole1 ORR 79% mPFS 27.6 Months Palbociclib + Letrozole2 ORR 55% mPFS 14.5 mos Letroz

  40. Slide 40: Relevant Comparisons to VIKTORIA-2 Control

    Relevant Comparisons to VIKTORIA-2 Control B2151009 study results for 1L patients compares favorably to published data for 1L ETS patients Gedatolisib + Palbociclib + Letrozole Palbociclib + Letrozole Palbociclib + Fulvestrant 1 2 N=41 N=441 N=164 3 WT / MT MT PIK3CA Status NR (76% / 22%) (100%) End

  41. Slide 41: Gedatolisib for Prostate Cancer

    Gedatolisib for Prostate Cancer 41

  42. Slide 42: Androgen Signaling is the Key Driver of Prostate Cancer

    Androgen Signaling is the Key Driver of Prostate Cancer The PI3K/AKT/mTOR (PAM) pathway helps promote excessive cell proliferation and resistance to apoptosis THE AR PATHWAY IS THE THE PAM PATHWAY PLAYS A KEY PRIMARY THERAPEUTIC TARGET ROLE IN mCRPC  The androgen receptor (AR) drives the  AR and P

  43. Slide 43: Prostate Cancer Disease and Treatment Landscape

    Prostate Cancer Disease and Treatment Landscape1,2 34,700 men in US and 62,400 men in 5EU and Japan die from prostate cancer annually3,4 DISEASE STAGE nmCRPC Non-metastatic castration resistant Localized Systemic Rising PSA mCRPC mCRPC Biochemical or tumor prostate cancer progression 1L 2L recurrenc

  44. Slide 44: Limited Benefit from Current Therapeutic Options for 2L mCRPC Patients After Treatment with AR Inhibitor

    Limited Benefit from Current Therapeutic Options for 2L mCRPC Patients After Treatment with AR Inhibitor Significant need for better therapeutic options 1st Line Treatment Outcomes 2nd Line Treatment Outcomes (post AR inhibitor treatment) 20.0 16.5 mPFS (mo) 6.7 5.6 5.6 5.5 Drugs Xtandi1 Zytiga2 Doc

  45. Slide 45: Combining a PAM Inhibitor with an AR Inhibitor has Strong Scientific Rationale

    Combining a PAM Inhibitor with an AR Inhibitor has Strong Scientific Rationale Biological parallels between mCRPC and HR+ ABC – PAM and hormonal pathway drive progression 1 PI3K/MTOR + AR INHIBITION TREATMENT RATIONALE  Favorable clinical data in mCRPC with PAM inhibitors provides “proof-of-concept

  46. Slide 46: CELC-G-201: Phase 1b/2 Trial Design Overview

    CELC-G-201: Phase 1b/2 Trial Design Overview Evaluating gedatolisib plus darolutamide to determine preliminary safety and efficacyRP2D DOSE ESCALATION DOSE EXPANSION Determine RP2D, assess safety and tolerability Primary endpoint: rPFS6 Arm 1 Cohort A Gedatolisib + 120mg + darolutamide Gedatolisib +

  47. Slide 47: CELC-G-201: Gedatolisib + Darolutamide for Arms 1 and 2

    CELC-G-201: Gedatolisib + Darolutamide for Arms 1 and 2 rPFS6 for G + ARi (darolutamide) compares favorably to historical data for ARi monotherapy TREATMENT CELC-G-201 6-MONTH rPFS PROBABILITY Arms 1 & 2 (N=38) REGIMEN (TRIAL) rPFS6 67% Gedatolisib + ARi 67% (CELC-G-201) Discontinuation rate 0% due

  48. Slide 48: Additional Early Phase Clinical Data

    Additional Early Phase Clinical Data 48

  49. Slide 49: Gedatolisib + Trastuzumab Biosimilar in 3L+ HER2+ ABC Patients (N=44)

    Gedatolisib + Trastuzumab Biosimilar in 3L+ HER2+ ABC Patients (N=44) 43% objective response rate Best Response Duration of Response  2 of 44 best response was a complete response (CR)  17 of 44 best response was a partial response (PR) Source: Kim ASCO 2025. Note: Data presented is as of a cutoff

  50. Slide 50: Gedatolisib + Paclitaxel + Carboplatin in Patients with Solid Tumors (N=17)

    Gedatolisib + Paclitaxel + Carboplatin in Patients with Solid Tumors (N=17)1 65% ORR in all patients, 82% ORR in patients with ovarian cancer Ovarian Cancer (N=11) | ORR: 82%  Clear cell ovarian cancer (CCOC) (N = 10) ‒ ORR: 80% - 5/10 PR, 3/10 CR  Low grade serous ovarian (N=1) ‒ 1/1 PR Other sol

  51. Slide 51: Leadership Team: Track Record of Developing Approved Therapies and Building Companies

    Leadership Team: Track Record of Developing Approved Therapies and Building Companies Brian Sullivan Lance Laing, PhD Chief Executive Officer Chief Scientific Officer Vicky Hahne Co-Founder Co-Founder Chief Financial Officer Igor Gorbatchevsky, MD Eldon Mayer Brent Eilefson Chief Medical Officer Chi

  52. Slide 52: Upcoming Milestones

    Upcoming Milestones SUBMIT Complete the submission of a New Drug Application via FDA’s RTOR NDA program for VIKTORIA-1 PIK3CA wild-type cohort indication in Q4 2025 PRESENT DATA Present additional data updates for VIKTORIA-1 PIK3CA wild-type UPDATES cohort at a major medical conference later this ye

  53. Slide 53: Gedatolisib Has the Potential to Establish New SOC in HR+/HER2- ABC

    Gedatolisib Has the Potential to Establish New SOC in HR+/HER2- ABC Uniquely positioned to advance multiple potential blockbuster indications in breast and prostate cancer 1 Gedatolisib’s differentiated MOA and PK profile result in a highly potent, cytotoxic, and well tolerated PAM inhibitor Phase 3

  54. Slide 54: Celcuity is Focused on Unlocking the Potential of Treating Cancers that Involve the PAM Pathway

    Celcuity is Focused on Unlocking the Potential of Treating Cancers that Involve the PI3K/AKT/mTOR (PAM) Pathway Our third-generation We harvest these insights cellular analysis platform to develop new unravels complex targeted therapies oncogenic activity molecular tests can’t detect. for cancer pat

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