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Phase 3 VIKTORIA-1 HR+/HER2-/PIK3CA WT Trial Results October 20, 2025 Gedatolisib is an investigational agent and is not approved by any regulatory agency as a treatment for any indication.
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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 limited to our current beliefs, expectations and assumptions regarding the future of our business and our pipeline, including our lead drug candidate gedatolisib and its potential benefits, that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These statements include, but are not limited to, (i) our interpretation of clinical trial data; (ii) our expectation regarding regulatory interpretations and assessments of our clinical data; (iii) our expectations regarding the timing of and our ability to obtain regulatory approvals for gedatolisib within and outside the U.S.; (iv) our beliefs with respect to the clinical utility of gedatolisib, its market acceptance and the size of the market, as well as the cost to commercialize and our ability to serve that market; (v) our expectations regarding governmental laws and regulations affecting our operations; (vi) our beliefs about our ability to capitalize on the exclusive global development and commercialization rights obtained from our license agreement with Pfizer Inc. (“Pfizer”) with respect to gedatolisib, and payments due to Pfizer thereunder; (vii) our product pricing, coverage, reimbursement and revenue expectations; (viii) our expectations as to the availability of capital and use of proceeds from our financing activities as well as cash on hand; and (ix) our expectations regarding our ability to obtain and maintain intellectual property protection for gedatolisib. These statements may be affected by underlying assumptions that may prove inaccurate or incomplete and are subject to change. Certain risks, uncertainties and other factors include, but are not limited to: the uncertainties inherent in research and development, including the cost of clinical trials, and the ability to meet anticipated clinical endpoints and commencement and/or completion dates for our clinical trials involving gedatolisib which include our ongoing VIKTORIA-1 and VIKTORIA-2 phase 3 clinical trials, and our ongoing Phase 1b/2 clinical trial; our limited operating history; our potential inability to develop, obtain FDA approval for and commercialize gedatolisib on a timely basis or at all; the reporting of results based on a preliminary analysis of key efficacy and safety data prior to a more comprehensive review of the data, and such topline data may not accurately reflect the complete results of a clinical trial; the complexity and difficulty of demonstrating the safety and sufficient magnitude of benefit to support regulatory approval of gedatolisib; the uncertainties and costs associated with commercializing pharmaceuticals; challenges we may face in developing and maintaining relationships with our vendors and partners; the uncertainty regarding market acceptance by physicians, patients, third-party payors and others in the medical community, and with the size of the market opportunity available to us; difficulties we may face in managing growth, such as hiring and retaining a qualified sales force and attracting and retaining key personnel; changes in government regulations; tightening credit markets and limitations on access to capital on favorable terms or at all; the time and expense associated with defending third-party claims of intellectual property infringement, investigations or litigation threatened or initiated against us; and potential changes to economic and trade policy in the U.S. and globally, including tariffs. Actual results may differ materially from past results, future plans and projected future results. As forward-looking statements involve significant risks and uncertainties, caution should be exercised against placing undue reliance on such statements. Additional information regarding these and other factors can be found in Celcuity’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and its subsequent Quarterly Reports on Form 10-Q, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov. The forward-looking statements in this presentation speak only as of the original date of this presentation and we undertake no obligation to update or revise any of these statements, except as required by law. This presentation is intended for the investor community only and is not intended to promote gedatolisib or otherwise influence healthcare prescribing decisions. Definitive conclusions cannot be drawn from cross-trial comparisons or anticipated data as they may be confounded by various factors and should be interpreted with caution. All trademarks in this presentation are the property of their respective owners. 2
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PAM regulates key metabolic functions Plays a key role in promoting tumor cell proliferation Cross-regulates other oncogenic pathways Affects immune response by regulating tumor microenvironment Unlocking the Potential of Treating Cancers That Involve the PI3K/AKT/mTOR (PAM) Pathway Source: (1) cBioPortal References:Cerami et al., Cancer Discov. 2012, and Gao et al., Sci. Signal, 2013; Proportion of alterations correlates to pathway’s role as a cancer driver Breast and prostate cancers involve PAM pathway >500,000 addressable patient population in US, 5EU, and Japan Nominal penetration of PAM drugs in these markets MOST HIGHLY ALTERED OF ALL SIGNALING PATHWAYS1 PAM 38% RAS 15% HER2 8% EGFR 5% ONE OF THE MOST IMPORTANT ONCOGENIC PATHWAYS LARGEST UNTAPPED DRUG DEVELOPMENT OPPORTUNITY IN SOLID TUMORS 3
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Difficult to Safely and Comprehensively Inhibit the PAM Pathway Optimal efficacy may require inhibition of all Class I PI3K isoforms and mTORC1 and mTORC2 Sources: (1) Juric 2015 Nature. 518:240-244; (2) Castel 2021 Nat Cancer. 2:587-597; (3) Mao 2021 Nat Commun. 12:5053; (4) Schwartz 2015 Cancer Cell. 27:109-122. (5) Chandarlapaty 2011, Cancer Cell. 19:58-71; (6) Bago 2016, EMBO J. 35:1902-1922; (7) Manning 2017, Cell. 169:381-405.; (8) Mukherjee 2021, Mol Cell. 81:708-723 e705 (9) Elkabets 2013, Sci Transl Med; 5(196); (10) Alves 2023, Int. J. Mol. Sci., 24, 4522 If only a single target is inhibited, redundancy ensures pathway function is maintained1-9 Feedforward and feedback loops between PI3K isoforms, AKT, and mTOR cross-activates uninhibited targets 1-9 Explains why 1st generation of PAM inhibitors were pan-PI3K/mTOR inhibitors Difficult to optimize pathway inhibition without inducing undue toxicity Early generations of orally administrated pan- PI3K or pan-PI3K/mTOR inhibitors induced unacceptable toxicity 10 Led to focus on development of single-node PAM inhibitors (e.g., PI3Kα, AKT, mTORC1) MULTIPLE PATHWAY TARGETS PROVIDE FUNCTIONAL REDUNDANCY THERAPEUTIC WINDOW FOR ORAL PI3K/mTOR INHIBITORS IS NARROW 1st GEN Oral pan-PI3K/mTOR inhibitors Toxicity high, poor PK properties Failed in Phase 1/2 2nd GEN Pan-PI3K inhibitors Significant toxicity Failed in Phase 3 3rd GEN Single-target inhibitors Limited PFS benefit Four drugs approved TODAY Need safe, potent pan-P13K/mTORi 4
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Improved therapeutic options are needed for the 37,000 patients1 with HR+/HER2- advanced breast cancer whose disease progressed on or after treatment with a CDK4/6 inhibitor Gedatolisib’s differentiated MOA and PK profile as a comprehensive PAM inhibitor results in a highly potent, well tolerated therapeutic that has potential to induce efficacy in PIK3CA wild-type and mutant tumors Gedatolisib Has the Potential to Establish New SOC in HR+/HER2- Advanced Breast Cancer 5 Most favorable hazard ratio ever reported by any Phase 3 trial in HR+/HER2- ABC Highest incremental improvement in mPFS ever reported by any Phase 3 trial in 2nd line HR+/HER2- ABC First PAM inhibitor to achieve positive Phase 3 data in PIK3CA WT patients post-CDK4/6 inhibitor 1 2 3 4 Phase 3 VIKTORIA-1 PIK3CA WT results for gedatolisib triplet and doublet: unprecedented 76% & 67% reduction in risk of disease progression or death and unprecedented 7.3- & 5.4-month improvement over fulvestrant, respectively Source: (1) Patient Population based on data from National Cancer Institute, SEER, 2024; Pan, H, NEJM, 2017;377:1836-46. Abbreviations: MOA, mechanism of action; PK, pharmokinetic HR, hormone receptor; ABC, advanced breast cancer, cancer; WT, wild-type, 2L, second line, mPFS, median progression free survival
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Phase 3 VIKTORIA -1 PIK3CA WT Trial Results 6
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VIKTORIA-1: Global Phase 3 Clinical Trial of Gedatolisib 7 Abbreviations: ABC, advanced breast cancer; AKTi, protein kinase B inhibitor; BICR, blinded independent central review; CDK4/6i, cyclin-dependent kinase 4 and 6 inhibitor; ET, endocrine therapy; HbA1c, hemoglobin A1c; HER2-, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; IV, intravenous; MT, mutated; mTORi, mechanistic target of rapamycin inhibitor; NSAI, non-steroidal aromatase inhibitor; OS, overall survival; PFS, progression-free survival; PI3Ki, phosphatidylinositol 3-kinase inhibitor; QoL, quality of life; R, randomization; ROW, rest of world; T1DM, type 1 diabetes mellitus; T2DM, type 2 diabetes mellitus; WT, wild-type STUDY 1 PIK3CA (WT) Gedatolisib + Palbociclib + Fulvestrant Gedatolisib† + Fulvestrant Assign Alpelisib + Fulvestrant R 1:1:1 R 3:3:1 HR+/HER2- ADVANCED BREAST CANCER Eligibility Criteria: Pre- & postmenopausal women & men Progression on/after CDK4/6i + NSAI ≤2 lines of prior ET for ABC Measurable disease, RECIST v1.1 Screening result for PIK3CA status No T2DM with HbA1c >6.4% or T1DM No prior mTORi, PI3Ki, or AKTi No prior chemotherapy for ABC Stratification factors: Lung/liver metastases (yes/no) Time to progression on immediate prior therapy (≤ or >6 months) Region (US/Canada or ROW) STUDY 2 PIK3CA (MT) Arm A† Gedatolisib | 180mg IV once weekly, 3 weeks on, 1 week off Palbociclib | 125mg daily, 21 days on, 7 days off Fulvestrant | 500mg; cycle 1, days 1 & 15, then every 4 weeks Arm B† Gedatolisib | 180mg IV once weekly, 3 weeks on, 1 week off Fulvestrant | 500mg; cycle 1, days 1 & 15, then every 4 weeks Arm C Fulvestrant | 500mg; cycle 1, days 1 & 15, then every 4 weeks PRIMARY ENDPOINTS PFS (BICR) Arm A vs. Arm C Arm B vs. Arm C SECONDARY ENDPOINTS OS Response Safety QoL †Prophylactic use of a steroid-containing “swish and spit” regimen was protocol- mandated; oral non-sedating antihistamine therapy was recommendedOptional cross-over to Arm A or B at progression
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Patient Disposition 8 Randomized (N=392) Gedatolisib + palbociclib+ fulvestrant (n=131) Received allocated treatment n=130 Discontinued study treatment n=97 Disease progression n=70 Patient decision n=9 Physician decision n=8 Adverse event (AE) n=4 Treatment-related AE n=3 Death n=6 Gedatolisib + fulvestrant (n=130) Received allocated treatment n=130 Discontinued study treatment n=95 Disease progression n=79 Patient decision n=4 Physician decision n=3 Adverse event (AE) n=5 Treatment-related AE n=4 Death n=3 Fulvestrant (n=131) Received allocated treatment n=123 Discontinued study treatment n=117 Disease progression n=108 Patient decision n=2 Physician decision n=4 Adverse event (AE) n=0 Death n=3 Data cut-off: 30 May 2025; median follow-up: 10.1 months (interquartile range, 6.6-15.1)
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Patient Population Includes Significant Proportion with Aggressive Disease 80% with liver or lung metastases and included endocrine therapy resistant patients 9 1) Totals add up to >100% due to some patients receiving multiple CDK4/6i. Abbreviations: ABC, advanced breast cancer; CDK4/6i, cyclin-dependent kinase 4 and 6 inhibitor; ECOG PS, Eastern Cooperative Oncology Group Performance Status; ET, endocrine therapy; IQR, interquartile range; mets, metastases; mo., months; Palbo, palbociclib; TTP, time to disease progression; tx, therapy; yr, years CHARACTERISTIC Gedatolisib + palbociclib+ fulvestrant (n=131) Gedatolisib + fulvestrant (n=130) fulvestrant (n=131) Age, yr, median (range) 57 (33-83) 57 (32-81) 54 (28-83) Female, % 99 100 98 Postmenopausal, % 77 72 70 Race/ethnic group, % White 65 73 72 Asian 14 15 19 Black/African American 4 2 1 Other/Unknown 17 10 8 Geographic region, % United States/Canada 16 16 17 Asia Pacific 14 14 20 Latin America 27 28 27 Europe 44 42 37 ABC at diagnosis, % 48 39 34 ECOG PS score, % 0 53 65 59 1 47 35 41 CHARACTERISTIC Gedatolisib + palbociclib+ fulvestrant (n=131) Gedatolisib + fulvestrant (n=130) fulvestrant (n=131) Liver or lung mets, % 78 80 83 Prior (neo)adjuvant tx, % Chemotherapy 25 30 29 Endocrine therapy 35 44 49 Prior lines, ET for ABC, % 0 2 2 3 1 86 87 88 2 12 12 9 TTP on immediate prior tx, % ≤6 months 16 15 15 >6 months 84 85 85 Prior adjuvant CDK4/6i, % 2 5 3 Prior CDK4/6i for ABC, %1 Palbociclib 43 36 40 Ribociclib 45 48 53 Abemaciclib 18 20 12 Prior CDK4/6i for ABC, mo., median duration (IQR) 21.7 (13.7-35.0) 18.1 (10.8-30.0) 20.0 (12.0-34.2)
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Both Co-Primary Endpoints Met: 7.3- & 5.4-month improvement in mPFS Gedatolisib triplet and gedatolisib doublet vs. fulvestrant, BICR assessment 10Abbreviations: BICR, blinded independent central review; HR, hazard ratio; mPFS, median progression-free survival No. at Risk: Geda + Palbo + Fulv 131 127 103 94 69 68 50 49 35 34 24 22 19 16 10 10 9 6 6 6 4 4 4 1 0 Fulv 131 114 45 35 20 20 11 11 7 5 3 2 2 2 1 1 1 0 Geda + Palbo + fulvestrant (n=131) Fulvestrant (n=131) Median PFS, months (95% CI) 9.3 (7.2-16.6) 2.0 (1.8-2.3) Adjusted HR (95% CI) 0.24 (0.17-0.35); P < 0.0001 100 90 80 70 60 50 40 30 20 10 0 Progression-free Survival (%) 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Months Progression-free Survival (%) Months 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 23 25 262422 90 80 70 60 50 40 30 20 10 0 100 Geda + fulvestrant (n=130) Fulvestrant (n=131) Median PFS, months (95% CI) 7.4 (5.5-9.9) 2.0 (1.8-2.3) Adjusted HR (95% CI) 0.33 (0.24-0.48); P < 0.0001 No. at Risk: Geda + Fulv 130 126 93 89 64 63 45 44 33 33 22 22 17 16 11 8 6 5 5 3 1 1 1 1 1 1 0 Fulv 131 114 45 35 20 20 11 11 7 5 3 2 2 2 1 1 1 0
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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 (0.16-0.55) Menopause status Pre/perimenopause 9/28 11.1 26/36 1.8 0.13 (0.07-0.29) Postmenopause 50/101 8.9 62/92 2.0 0.27 (0.19-0.38) Geographic area US/Canada 6/21 19.3 14/22 2.0 0.13 (0.05-0.36) Europe 29/57 9.3 32/48 2.0 0.17 (0.12-0.31) Latin America 16/35 5.6 20/35 3.7 0.53 (0.29-0.90) Asia Pacific 8/18 16.6 23/26 1.8 0.18 (0.09-0.37) Presence of visceral metastasis Yes 44/102 10.7 71/100 1.8 0.21 (0.16-0.30) No 15/29 8.9 18/31 5.6 0.35 (0.20-0.71) Liver metastasis Yes 37/74 9.2 60/72 1.8 0.21 (0.14-0.30) No 22/57 9.9 29/59 5.4 0.31 (0.19-0.53) Lines of prior tx for ABC <2 52/115 9.7 82/118 2.0 0.23 (0.17-0.33) ≥2 7/16 5.4 7/13 1.8 0.31 (0.09-0.99) TTP on immediate prior tx ≤6 months 13/26 7.4 13/25 2.1 0.47 (0.24-0.93) >6 months 46/105 9.9 76/106 1.9 0.20 (0.14-0.28) Prior CDK4/6i for ABC Ribociclib 29/59 8.9 48/70 1.9 0.22 (0.14-0.34) Palbociclib 21/56 16.6 37/52 1.9 0.21 (0.13-0.35) Abemaciclib 13/23 5.4 10/16 3.1 0.31 (0.23-0.97) Gedatolisib Triplet vs. Fulvestrant Consistent PFS consistent across pre-specified sub-groups PFS assessed by blinded independent central review Abbreviations: ABC, advanced breast cancer; CDK4/6i, cyclin-dependent kinase 4 and 6 inhibitor; CI, confidence interval; mo., months; mPFS, median progression-free survival; TTP, time to disease progression; tx, therapy Gedatolisib plus palbociclib and fulvestrant better Fulvestrant better 0.01 0.1 1.0 10.0 11
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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 status Pre/perimenopause 19/37 5.6 26/36 1.8 0.33 (0.19-0.55) Postmenopause 50/93 7.6 62/92 2.0 0.33 (0.24-0.47) Geographic area US/Canada 9/21 14.9 14/22 2.0 0.35 (0.17-0.76) Europe 31/55 7.6 32/48 2.0 0.31 (0.22-0.53) Latin America 20/36 5.6 20/35 3.7 0.42 (0.26-0.78) Asia Pacific 9/18 7.3 23/26 1.8 0.21 (0.10-0.42) Presence of visceral metastasis Yes 57/102 7.3 71/100 1.8 0.30 (0.23-0.42) No 12/28 9.3 18/31 5.6 0.51 (0.27-1.00) Liver metastasis Yes 46/82 7.3 60/72 1.8 0.29 (0.20-0.40) No 23/48 10.0 29/59 5.4 0.43 (0.26-0.73) Lines of prior tx for ABC <2 62/114 7.3 82/118 2.0 0.35 (0.27-0.48) ≥2 7/16 10.0 7/13 1.8 0.32 (0.07-0.69) TTP on immediate prior tx ≤6 months 14/26 5.6 13/25 2.1 0.96 (0.51-0.83) >6 months 55/104 7.6 76/106 1.9 0.25 (0.18-0.35) Prior CDK4/6i for ABC Ribociclib 31/62 5.6 48/70 1.9 0.27 (0.19-0.42) Palbociclib 26/47 7.7 37/52 1.9 0.39 (0.24-0.59) Abemaciclib 15/26 5.6 10/16 3.1 0.66 (0.29-1.21) PFS assessed by blinded independent central review Abbreviations: ABC, advanced breast cancer; CDK4/6i, cyclin-dependent kinase 4 and 6 inhibitor; CI, confidence interval; mo., months; mPFS, median progression-free survival; TTP, time to disease progression; tx, therapy Gedatolisib + fulvestrant better Fulvestrant better 0.01 0.1 1.0 10.0 Gedatolisib Doublet vs. Fulvestrant Consistent PFS consistent across pre-specified sub-groups 12
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PFS in Key Subgroups: Gedatolisib Triplet vs. Doublet 6/21 PFS assessed by blinded independent central review Abbreviations: ABC, advanced breast cancer; CDK4/6i, cyclin-dependent kinase 4 and 6 inhibitor; CI, confidence interval; mo., months; mPFS, median progression-free survival; TTP, time to disease progression; tx, therapy Gedatolisib + Palbociclib + Fulvestrant Gedatolisib + Fulvestrant Subgroup n/N mPFS, mo. n/N mPFS, mo. Age <65 years 39/93 9.3 ≥65 years 20/38 9.7 Menopause status Pre/perimenopause 9/28 11.1 Postmenopause 50/101 8.9 Geographic area US/Canada 19.3 Europe 29/57 9.3 Latin America 16/35 5.6 Asia Pacific 8/18 16.6 Presence of visceral metastasis Yes 44/102 10.7 No 15/29 8.9 Liver metastasis Yes 37/74 9.2 No 22/57 9.9 Lines of prior tx for ABC <2 52/115 9.7 ≥2 7/16 5.4 TTP on immediate prior tx ≤6 months 13/26 7.4 >6 months 46/105 9.9 Prior CDK4/6i for ABC Ribociclib 29/59 8.9 Palbociclib 21/56 16.6 Abemaciclib 13/23 5.4 17/34 19/37 50/93 9/21 31/55 20/36 57/102 12/28 46/82 23/48 62/114 7/16 14/26 55/104 31/62 26/47 15/26 5.6 5.6 7.6 14.9 7.6 5.6 7.3 9.3 7.3 10.0 7.3 10.0 5.6 7.6 5.6 7.7 5.6 52/96 7.7 9/18 7.3 13
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Interim Overall Survival Analysis Shows Favorable Trend for Gedatolisib Triplet and Doublet; Encouraging Given High Number of Patient Crossover 14 Overall Survival (%) Months 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 No. at Risk: Geda + Palbo + Fulv 131 130 129 128 125 119 100 97 86 79 70 61 54 51 43 38 31 27 22 15 11 8 6 5 2 1 0 Fulv 131 124 118 112 108 100 88 81 70 59 53 42 38 36 32 25 23 17 9 7 5 5 3 2 1 1 1 1 1 0 No. at Risk: Geda + Fulv 130 130 130 126 120 115 108 96 84 80 72 64 51 44 37 31 28 23 18 12 9 6 5 5 4 3 1 1 0 Fulv 131 124 118 112 108 100 88 81 70 59 53 42 38 36 32 25 23 17 9 7 5 5 3 2 1 1 1 1 1 0 Overall Survival (%) Months 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 100 90 80 70 60 50 40 30 20 10 0 100 90 80 70 60 50 40 30 20 10 0 At data cutoff (30 May 2025): 99 patients (25.3%) across all arms died: gedatolisib triplet, n=30 (22.9%); gedatolisib doublet, n=32 (24.6%); fulvestrant, n=37 (28.2%) Of 108 patients with disease progression on fulvestrant, 63 (58.3%) crossed over: geda triplet, n=52 (48.1%); geda doublet, n=11 (10.2%) Geda + Palbo + fulvestrant (n=131) Fulvestrant (n=131) Median OS, months (95% CI) 23.7 (21.4-NE) 18.5 (15.8-NE) Adjusted HR (95% CI) 0.69 (0.43-1.12); P = 0.1328 Geda + fulvestrant (n=130) Fulvestrant (n=131) Median OS, months (95% CI) NR (NE-NE) 18.5 (15.8-NE) Adjusted HR (95% CI) 0.74 (0.46-1.19); P = 0.2122
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Geda + fulvestrant (n=130) Fulvestrant (n=131) Median OS, months (95% CI) NR (NE-NE) 15.8 (11.7-NE) Adjusted HR (95% CI) 0.56 (0.33-0.097); P = 0.0393 Geda + Palbo + fulvestrant (n=131) Fulvestrant (n=131) Median OS, months (95% CI) 23.7 (21.4-NE) 15.8 (11.7-NE) Adjusted HR (95% CI) 0.60 (0.35-1.04); P = 0.0698 Interim OS Sensitivity Analysis - Cross-Over Patients Censored 15 No. at Risk: No. at Risk:Geda + Palbo + Fulv 131 130 129 128 125 119 111 97 86 79 70 61 54 51 43 38 31 27 22 15 11 8 6 5 2 1 0 Fulvestrant 131 124 103 75 64 57 52 43 40 33 26 22 18 17 16 13 9 8 6 4 3 2 2 1 1 1 1 1 1 1 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 Months Overall Survival (%) Overall Survival (%) 100 90 80 70 60 50 40 30 20 10 0 100 90 80 70 60 50 40 30 20 10 0 Geda + Fulv 130 130 130 126 120 115 108 96 84 80 72 64 51 44 37 31 28 23 18 12 9 6 5 5 4 3 1 1 0 Fulvestrant 131 124 103 75 64 57 52 43 40 33 26 22 18 17 16 13 9 8 6 4 3 2 2 1 1 1 1 1 1 1 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 Months 63 patients in the fulvestrant arm who crossed over to one of the gedatolisib regimens were censored in this sensitivity analysis
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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 16 *Defined as CR+PR †Defined as CR+PR+SD >24 weeks as assessed by BICR ‡Defined as CR+PR+SD Abbreviations: BICR, blinded independent central review; CI, confidence interval; CR, complete response; DOR, duration of response; Fulv, fulvestrant; Geda, gedatolisib; NE, not estimable; no., number; NR, not reached; Palbo, palbociclib; PR, partial response; SD, stable disease; ET, endocrine therapy Endpoint, n (%) Geda + Palbo + Fulvestrant (n=124) Gedatolisib + Fulvestrant (n=113) Fulvestrant (n=105) Best Overall Response Complete response 1 (0.8) 0 0 Partial response 38 (30.6) 32 (28.3) 1 (1.0) Stable disease 67 (54.0) 55 (48.7) 40 (38.1) Progressive disease 17 (13.7) 26 (23.0) 62 (59.0) Not evaluable 1 (0.8) 0 2 (1.9) Objective Response Rate* 39 (31.5) 32 (28.3) 1 (1.0) Clinical Benefit Rate† 62 (50.0) 55 (48.7) 12 (11.4) Disease Control Rate‡ 106 (85.5) 87 (77.0) 41 (39.0) Median DOR, months [95% CI] 17.5 [8.8-NE] 12.0 [8.1-NE] NR [NE] 432 32 28 28 23 21 16 16 12 11 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Months Duration of Response (%) No. at Risk: Geda + Fulv 9 7 4 3 2 2 1 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 Months 39 39 36 36 28 25 19 19 13 11 10 8 6 5 5 4 3 3 2 2 1 0 Duration of Response (%) No. at Risk: Geda + Palbo + Fulv DURATION OF RESPONSE 100 90 80 70 60 50 40 30 20 10 0 100 90 80 70 60 50 40 30 20 10 0 Geda + fulv (n=113) Median DOR, months (95% CI) 12.0 (8,1-NE) Geda + palbo +fulv (n=124) Median DOR, months (95% CI) 17.5 (8.8-NE) DURATION OF RESPONSE Data shown for gedatolisib arm only; curve cannot be generated for fulvestrant group with only 1 event Data shown for gedatolisib arm only; curve cannot be generated for fulvestrant group with only 1 event
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Gedatolisib Regimens Were Generally Well-Tolerated, With Low Discontinuation Rates; Majority of TRAE’s Grade 1/2; Low Hyperglycemia and Diarrhea Rates 17 Abbreviations: D/C, discontinued; Pts, patients; SAE, serious adverse event; TRAE, treatment-related adverse event (per investigator) Shown are adverse events of any grade from safety population that occurred in at least 20% of the patients in any trial group unless otherwise noted †For stomatitis, neutropenia, rash, and hyperglycemia, combined preferred terms shown; if a patient experienced multiple terms, it was counted once for the highest grade. ‡Additional events of clinical importance SAE and discontinuation, % Gedatolisib + palbociclib + fulvestrant (n=130) Gedatolisib + fulvestrant (n=130) Fulvestrant (n=123) Pts with ≥1 SAE 11 9 1 Study treatment D/C due to TRAE 2 3 0 Deaths due to TRAE 2 0 0 Treatment-Related Adverse events, n (%) Gedatolisib + palbociclib + fulvestrant (n=130) Gedatolisib + fulvestrant (n=130) Fulvestrant (n=123) Any Grade Grade 3 Grade 4 Any Grade Grade 3 Grade 4 Any Grade Grade 3 Grade 4 Stomatitis† 69 19 0 57 12 0 0 0 0 Neutropenia† 65 52 10 2 0 1 1 1 0 Nausea 44 4 0 43 1 0 3 0 0 Rash† 28 5 0 32 5 0 0 0 0 Vomiting 28 2 0 23 0 0 1 0 0 Fatigue 22 2 0 21 1 0 4 0 0 Diarrhea‡ 17 2 0 12 1 0 0 0 0 Hyperglycemia†, ‡ 9 2 0 12 2 0 0 0 0
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Data Support for Gedatolisib to Become the Potential SOC Option for 2L HR+, HER2 -, PIK3CA- WT ABC 18
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POSITIVE MARKET DYNAMICS WELL DIFFERENTIATED UNMET NEED Gedatolisib May Address a Significant Unmet Need for the Large 2nd Line HR+/HER2- ABC Patient Population 19 (1) Internal estimates National Cancer Institute, SEER, 2023; Pan, H, NEJM, 2017;377:1836-46; Abbreviations: HR, hormone receptor; ABC, advanced breast cancer, cancer; WT, wild-type, 2L, second line, PFS, progression free survival; Gedatolisib is an investigational agent and is not approved by any regulatory agency as a treatment for any indication. PFS benefit is limited with current 2L standards of care Clearly differentiated efficacy relative to currently available therapies Streamlined reimbursement for infused oncology drugs Can build rapid awareness and adoption ~37,000 patients1 with HR+/HER2- ABC receive 2L Rx post- CDK4/6i 60% are PIK3CA WT LARGE POPULATION $5 billion served market revenue potential1
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Complete the submission of a New Drug Application via FDA’s RTOR program for VIKTORIA-1 PIK3CA wild-type cohort indication in Q4 2025 Upcoming Milestones Present additional data updates for VIKTORIA-1 PIK3CA wild-type cohort at a major medical conference later this year Report topline data for VIKTORIA-1 PIK3CA mutation cohort by late Q1 or in Q2 2026 SUBMIT NDA PRESENT DATA UPDATES REPORT TOPLINE DATA 20 (RTOR, Real-Time Oncology Review
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Phase 1b: Geda + Palbo + Fulvestrant in 2L+ HR+/HER2- ABC Patients Source: Layman R. Lancet Oncol. 2024;25:474-8, Data on file, Celcuity Inc. Gedatolisib is an investigational agent and is not approved by any regulatory agency as a treatment for any indication. mPFS for PIK3CA MT patients compares favorably to currently available therapies PIK3CA-Mutated Sub-Group PIK3CA-Wild-Type Sub-Group All Intermittent Dose All Intermittent Dose N 30 11 60 15 Key Characteristics Prior CDK4/6 71% 100% 73% 100% Weekly Dose 63% 0% 75% 0% Efficacy Median PFS (mos) 14.6 19.7 9.0 9.1 ORR 48% 64% 41% 53% 21
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Unlocking the Potential of Treating Cancers That Involve the PI3K/AKT/mTOR Pathway