Celcuity Inc. Q4 FY2025 earnings call

Brian Sullivan discussed the company's progress in 2025, including clinical and regulatory milestones such as the FDA accepting the NDA for getafilicib with priority review, data from the Victoria 1 clinical trial presented at medical conferences and published, completion of enrollment in the PIK3CA mutant cohort of the Victoria 1 trial. Also mentioned the Victoria 2 study, Phase 1B2 clinical trial with darolutamide in prostate cancer, and preparations for potential launch of Get Up to Listen, including building the organization, engaging with payers and oncologists. Vicki Hahn reviewed financial results.

Fourth quarter net loss was $51 million, or $0.97 per share, compared to $36.7 million net loss, or $0.85 per share, for the fourth quarter of 2024. Net loss for the full year was $177 million or $3.79 per share compared to $111.8 million or $2.83 per share for the same period in 2024. Non-GAAP adjusted net loss was $38.4 million or $0.73 per share for the fourth quarter of 2025 compared to $32.3 million or $0.75 per share for the fourth quarter of 2024. Non-GAAP adjusted net loss for the full year of 2025 was $150.8 million or $3.22 per share, compared to $101.9 million or $2.58 per share for 2024. Research and development expenses were $37.6 million for the fourth quarter of 2025, compared to $33.5 million for the prior year period. R&D expenses for the full year 2025 were $145 million compared to $104.2 million for the prior year. General and administrative expenses were $11.6 million for the fourth quarter of 2025, compared to $3 million for the prior year period. G&A expenses for the full year 2025 were $27.2 million compared to $9.1 million for the prior year. Net cash used in operating activities for the fourth quarter of 2025 was $36.4 million, compared to $27.8 million for the fourth quarter of 2024. Net cash used in operating activities for the full year 2025 was $153.3 million, compared to $83.5 million for the full year 2024. Cash, cash equivalents, and in short-term investments were $441.5 million at the end of fiscal year 2025.

Management mentioned expecting to announce results from the PIK3CA mutant cohort of the Phase 3 Victoria 1 trial in a top line press release in the second quarter and present full results at a medical conference in 2026. Also discussed preparations for potential launch of Get Up to Listen and estimated total addressable market for Geta-Telicib in the second-line setting.

Forward-looking statements involve risks and uncertainties outlined in press release and SEC filings. Actual events or results may differ materially from projections. Non-GAAP measures used, but actual results could be affected by various factors.

Q: On mutant data, could comment on database lock, disclosure, and medical conference details.

A: Can't comment on database lock, will provide top line in press release and details at medical conference, can't say when exactly.

Q: Feedback on launch and physicians' treatment segments.

A: Won't narrowcast approach, sales force will help doctors understand benefits.

Q: Top-line release of meeting data, prostate dose, breast revenue duration.

A: Top-line will be statement of statsig, in prostate evaluating higher doses with balance of safety, in breast using 10-month duration estimate.

Q: Key gating factor for frontline endocrine-sensitive trial.

A: Completing safety run, expect update on study design in second quarter.

Q: Commercial challenges with infusions, commercial advantages of label across subtypes.

A: Efficacy most important, IV administration not major issue, label simplifies decision making.

Q: Learnings from PIK3C mutant launch for Victoria 2 trial.

A: Highlighted unique safety profile of Geta.

Q: European commercial strategy, frontline thoughts.

A: Plan to submit MEA in fourth quarter, exploring partners, engaged in Japan.

Q: Mutant update filing.

A: Primary endpoint is triplet vs apalypsib.