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- **Wild-Type Cohort Success**: VIKTORIA-1 trial showed 9.3-month PFS for the gedatolisib triplet (HR 0.24), setting new benchmarks in HR-positive, HER2-negative breast cancer. FDA NDA submission under RTOR expected by end-2025.
- **Market Potential**: $2.5-$3 billion peak revenue estimate for the second-line wild-type indication, targeting 37,000 U.S. patients.
- **Financial Strength**: $287 million raised in Q3, with $500 million term loan facility to support launch. Q3 net loss of $43.8 million reflects increased R&D and G&A expenses.
- **Global Strategy**: U.S. launch in 2026, with ex-U.S. partnerships pending mutant data. Pricing benchmarked at $25,000/month, with discounts for oral/injectable formulations.

**【CEO Opening Remarks】**
- **Clinical Milestones**: Released top-line data from the PIK3CA wild-type cohort of the Phase III VIKTORIA-1 trial, showing median PFS of 9.3 months for the gedatolisib triplet vs. 2.0 months for fulvestrant (HR 0.24). Presented detailed efficacy and safety results at ESMO, including 32% ORR for the triplet and 28% for the doublet.
- **Regulatory Progress**: FDA accepted the New Drug Application (NDA) under the real-time oncology review (RTOR) program for the wild-type cohort, with submission expected by end-Q4 2025. Enrollment completed for the PIK3CA mutant cohort, with top-line data expected in Q1/Q2 2026.
- **Financial Strength**: Raised $287 million through convertible notes, common stock, and prefunded warrants. Increased term loan facility to $500 million, providing flexibility for commercial launch preparation.
- **Market Potential**: Estimated addressable market of $2.5-$3 billion for the second-line wild-type indication, with 37,000 eligible patients in the U.S.

**【CFO Financial Commentary】**
- **Q3 2025 Results**: Net loss of $43.8 million ($0.92 per share), up 47% YoY. Non-GAAP adjusted net loss of $37.2 million ($0.78 per share), up 35% YoY.
- **Expense Growth**: R&D expenses rose 26% YoY to $34.9 million, driven by commercial headcount additions ($5.6 million) and clinical trial costs. G&A expenses surged 128% YoY to $7.9 million, due to headcount expansion and infrastructure build-out.
- **Cash Position**: Ended Q3 with $455 million in cash, including $27.8 million from a term loan draw triggered by VIKTORIA-1 data. Expects cash to fund operations through 2027.

**【Q&A Highlights】**
- **San Antonio Breast Cancer Symposium (SABCS) Presentation**: Will share subgroup analyses from the wild-type cohort, including ESR1 wild-type/mutant data. No plans to expand to endocrine-sensitive frontline patients yet.
- **FDA Submission Strategy**: Wild-type NDA under RTOR; mutant cohort data will determine if RTOR is requested. Targeting U.S. launch in 2026, with ex-U.S. partnerships to follow.
- **Pricing Strategy**: Wholesale acquisition cost benchmarked at $25,000/month, with potential discounts for oral vs. injectable formulations. Estimated 70% gross-to-net for oral, 20% for injectable.
- **International Plans**: Planning MAA submissions for Europe and Japan, with commercialization in the U.S. first. Manufacturing sites diversified to ensure supply chain resilience.

Celcuity Inc. (CELC) Q3 2025 Earnings Call Transcript

- **Breakthrough Clinical Data**: Geda demonstrates 7.3-month PFS improvement in wild-type cohort (HR 0.24) and 5.4-month improvement in doublet (HR 0.33), outperforming all competitors in HR-positive, HER2-negative breast cancer.
- **$5B Market Potential**: Addressable market of 34,000 annual second-line patients with wild-type PIK3CA, with no effective therapies beyond 4 months of PFS.
- **Funding Secured**: $287M raised in Q3 2025 to support FDA filing and launch, with $160M in additional funding commitments.
- **Launch Readiness**: Internal commercial team hired and infrastructure building underway, targeting Q4 2025 FDA submission.

**【CEO Summary Section】**
- **Clinical Milestones**: Reported positive top-line data from the PIK3CA wild-type cohort of the Phase III VIKTORIA-1 trial, showing median PFS of 9.3 months for the triplet regimen and 7.4 months for the doublet, both significantly outperforming fulvestrant (2 months). The hazard ratios of 0.24 (triplet) and 0.33 (doublet) are unprecedented in HR-positive, HER2-negative breast cancer. Additionally, dosed first patient in Phase III VIKTORIA-2 trial for first-line treatment and announced favorable early results from prostate and breast cancer trials.
- **Market Opportunity**: Estimated addressable market of $5 billion for second-line therapy in 34,000 PIK3CA wild-type patients annually. Geda's IV administration and medical benefit category positioning may streamline reimbursement and adoption in community practices.
- **Launch Readiness**: Raised $287 million in Q3 2025 to fund commercial preparation. Hired leadership team for sales, market access, and operations, with plans to expand infrastructure ahead of potential FDA approval in Q4 2025.

**【CFO Financial Commentary】**
- **Q2 2025 Financials**: Net loss of $45.3 million (GAAP) and $40.5 million (non-GAAP), driven by $40.2 million in R&D expenses (up 73% YoY) and $3.8 million in G&A expenses (up 111% YoY). Cash position of $455 million post-Q3 financing, with $160 million in additional funding commitments through 2027.
- **Funding Update**: Secured $286.5 million from convertible notes, common stock, and prefunded warrants, supporting development and commercial readiness.

**【Q&A Highlights】**
- **Data Presentation**: Full VIKTORIA-1 data to be presented at an upcoming medical conference, including subgroup analyses (e.g., ESR1 wild-type/mutant). Safety data, including grade 3 stomatitis rates, will be detailed post-top-line release.
- **Competitive Landscape**: Geda's potential to address both PIK3CA wild-type and mutant populations contrasts with competitors like inavolisib, which is limited to PIK3CA-mutant patients and has metabolic safety concerns.
- **Launch Strategy**: No commercial partnerships planned; internal team will manage launch with a focus on oncologist education and reimbursement support.

Celcuity Inc. (CELC) Q2 2025 Earnings Call Transcript

- **Clinical Milestones**: Q3 2025 topline data for wild-type breast cancer cohort; $2B peak revenue potential. 
- **Financial Health**: $205.7M cash runway; R&D expenses up 56% YoY to support trials. 
- **Strategic Differentiation**: Multi-node PAM inhibitor outperforms single-node competitors in non-clinical models. 
- **Pipeline Expansion**: New endometrial cancer trial with Dana Farber; prostate cancer Phase 1b/2 data expected Q2 2025.

**【CEO Business Update】**
- **Clinical Trial Progress**: 
  - **VIKTORIA-1 Trial**: 
    - PIK3CA wild-type cohort topline data expected in Q3 2025; mutant cohort in Q4 2025. 
    - Potential peak revenue of $2B with 40% market penetration if approved. 
  - **VIKTORIA-2 Trial**: 
    - Phase 3 first-line breast cancer trial with 638 subjects; first patient dosing in Q2 2025. 
  - **Prostate Cancer Trial**: 
    - Phase 1b/2 trial with 36 patients; topline data expected late Q2 2025. 
  - **Endometrial Cancer Collaboration**: 
    - Partnering with Dana Farber for Phase 2 trial evaluating gedatolisib in endometrial cancer. 

**【CFO Financial Overview】**
- **Q1 2025 Financials**: 
  - Net loss: $37M ($0.86/share) vs. $21.6M ($0.64/share) in Q1 2024. 
  - R&D expenses: $32.2M (+56% YoY) driven by clinical trial activities. 
  - Cash balance: $205.7M, sufficient to fund operations through 2026. 

**【Q&A Key Takeaways】**
- **VIKTORIA-1 Timeline**: 
  - Data lock by June 2025; topline results in Q3 2025. 
  - No plans to share OS trends at initial readout. 
- **Competitive Landscape**: 
  - Geda’s multi-node inhibition mechanism differentiates from single-node inhibitors like capivasertib. 
  - No expected impact from SERENA-6 on geda’s wild-type or mutant patient cohorts. 
- **Endometrial Cancer Collaboration**: 
  - No incremental financial impact; Celcuity provides drug supply and clinical support.

Celcuity Inc. (CELC) Q1 2025 Earnings Call Transcript

- **Clinical Milestones**: Q2 2025 top-line data for VIKTORIA-1 wild-type cohort; $2B+ peak revenue potential for breast cancer drug.
- **Financial Health**: $235M cash reserve; R&D expenses up 77% YoY to $104M, driven by late-stage trials.
- **Strategic Advantage**: IV-administered gedatolisib offers superior tolerability vs. oral PAM inhibitors; 40% market penetration targets $2B in second-line breast cancer.

**【CEO Summary Section】**
- **Clinical Trial Progress**: Completed enrollment for the PIK3CA wild-type cohort in VIKTORIA-1 Phase III trial and selected 200 sites for VIKTORIA-2 Phase III trial. Phase Ib prostate cancer trial on track for Q2 2025 data.
- **Revenue Potential**: Estimates $2 billion peak revenue for second-line breast cancer indication with 40% market penetration. First-line breast cancer program could add $3 billion in U.S. market potential.
- **2025 Milestones**: Top-line data for VIKTORIA-1 wild-type cohort in Q2 and mutant cohort in Q4. VIKTORIA-2 first patient enrollment expected in Q2.
- **Competitive Advantage**: Gedatolisib's IV administration, tolerability (4% discontinuation rate), and comprehensive PAM pathway inhibition differentiate it from oral PAM inhibitors.

**【CFO Financial Commentary】**
- **Q4 2024 Results**: Net loss of $36.7 million (GAAP) / $32.3 million (non-GAAP). Full year net loss: $111.8 million (GAAP) / $101.9 million (non-GAAP).
- **R&D Expenses**: $33.5 million (Q4) / $104.2 million (FY), driven by VIKTORIA-1, prostate trial, and VIKTORIA-2启动.
- **Cash Position**: $235.1 million at year-end, up $54.5 million from 2023, supported by $138.4 million in financing.

**【Q&A Key Highlights】**
- **Regulatory Strategy**: Planning RTOR request post-VIKTORIA-1 data; priority review likely if RTOR denied. NDA filing expected within 1-1.5 quarters of top-line data.
- **Market Competition**: Gedatolisib's IV route and safety profile (no ketoacidosis risk) contrast with Roche's inavolisib, which requires glucose monitoring.
- **Prostate Cancer Trial**: Phase Ib prostate data expected Q2 2025. Dosing optimization and safety will guide next steps.
- **Financial Outlook**: 2025 R&D spend similar to Q4 2024 levels, with potential increase for prelaunch activities if trials succeed.

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