Celcuity Inc. Q3 FY2025 earnings call

• Celcuity achieved clinical and regulatory milestones: released top-line data from VICTORIA-one study's PIK3CA wild-type cohort, presented at ESMO, completed VICTORIA-two study enrollment, FDA accepted NDA submission under real-time oncology review, and strengthened balance sheet via financial offerings. - VICTORIA-one trial PIK3CA wild-type cohort: gadetelicib triplet had median PFS of 9.3 months vs. 2 months for fulvestrant (7.3-month improvement); gadetelicib doublet had median PFS of 7.4 months vs. 2.0 months for fulvestrant (5.4-month improvement). - Progress in commercial launch preparation: hiring sales and medical teams, engaging with payers, positive feedback on oncologist willingness. - VICTORIA-two study enrollment ongoing; Phase I/III prostate cancer trial showed favorable results.

Celcuity's third-quarter net loss was $43.8 million or $0.92 per share compared to $29.8 million net loss or $0.70 per share in 2024. Non-GAAP adjusted net loss was $37.2 million or $0.78 per share in 2025 vs. $27.6 million or $0.65 per share in 2024. Research and development expenses were $34.9 million in 2025 vs. $27.6 million in 2024. General and administrative expenses were $7.9 million in 2025 vs. $2.5 million in 2024. Net cash used in operating activities was $44.8 million in 2025 vs. $20.6 million in 2024. The company ended the quarter with approximately $455 million in cash, cash equivalents, and short-term investments.

• Expect to complete NDA submission for wild-type cohort by end of Q4 2025. - Optimistic about establishing gadetelicib as new standard of care in second-line HR-positive HER2-negative advanced breast cancer. - Plan to commercialize in US and seek partners for ex-US commercialization, with MAA filing to European authorities in line with regulatory submissions.

• Risks associated with forward-looking statements, including uncertainties in regulatory approval, market adoption, and clinical trial outcomes.

Q: Talk about data presentation at San Antonio Breast Cancer Symposium and subpopulation data on ESR1.

A: Presentations will include additional subgroup analyses; expect to share more detailed subpopulation data in future.

Q: Impact of Victoria two enrollment from second-line data.

A: Enrollment on track, positive impact expected; long-term development plan ongoing.

Q: Real-time oncology review for mutant submission.

A: On track for wild-type submission, mutant submission may seek real-time review depending on data.

Q: Duration of therapy and pricing strategy.

A: Duration of therapy under analysis; pricing assumptions based on novel therapeutics in HR-positive space, considering discounts.

Q: Plan to bring gedotolitinib outside US.

A: Plan to commercialize in US and find partners for ex-US, waiting for mutant data and regulatory submissions.

Q: Impact of OS trend in second/third-line.

A: Interim OS analysis shows favorable hazard ratios, supportive of regulatory submission; high bar for OS advantage in second-line.

Q: Data manufacturing location.

A: Multiple manufacturing sites, working on supply chain flexibility.