Celcuity Inc. Q1 FY2025 earnings call

• Upcoming clinical data readouts: Topline data from PIK3CA wild-type cohort of Phase 3 VIKTORIA-1 trial in Q3 2025, PIK3CA mutated patient cohort in Q4 2025, preliminary topline data for Phase 1b of Phase Ib/2 prostate cancer trial in late second quarter. - VIKTORIA-1 trial: Evaluates gedatolisib in combination with fulvestrant with and without palbociclib. Primary completion of PIK3CA wild-type cohort anticipated in June, with topline data in Q3. PIK3CA mutant cohort topline data expected in Q4 2025. - First-line breast cancer program: VIKTORIA-2 trial site activation ongoing, with first patient dosing expected in second quarter. - Phase 1b/2 prostate cancer trial: Completed enrollment of Phase 1b dose escalation, with topline data expected in late second quarter. - Collaboration: With Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gedatolisib in combination with abemaciclib and letrozole in endometrial cancer.

In the first quarter of 2025, Celcuity's net loss was $37 million or $0.86 per share compared to $21.6 million net loss or $0.64 per share in the first quarter of 2024. The non-GAAP adjusted net loss was $34.7 million or $0.81 per share in Q1 2025 versus $19.9 million or $0.59 per share in Q1 2024. Research and development expenses were $32.2 million in Q1 2025 compared to $20.6 million in Q1 2024. General and administrative expenses were $3.9 million in Q1 2025 compared to $1.8 million in Q1 2024. Net cash used in operating activities for Q1 2025 was $35.9 million compared to $17.1 million in Q1 2024. The company ended the quarter with approximately $205.7 million of cash, cash equivalents, and short-term investments.

• Anticipate reporting topline data from PIK3CA wild-type cohort of VIKTORIA-1 trial in Q3 2025 and PIK3CA mutated patient cohort in Q4 2025. - Preliminary topline data for Phase 1b of Phase Ib/2 prostate cancer trial expected in late second quarter. - Progress in activating trial sites for Phase 3 first-line VIKTORIA-2 trial. - Potential peak revenue of over $2 billion for second-line breast cancer indication if approved for both PIK3CA wild-type and mutant populations with 40% market penetration.

• Forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results or performance to differ materially from projections. - Non-GAAP financial measures used have limitations, and actual results may differ from non-GAAP measures as reported.

Q: Maury Raycroft asked about the timeline for locking data and reporting results for VIKTORIA-1.

A: Brian Sullivan stated that the primary completion date is when the data cut-off date is achieved upon reaching the prescribed event threshold, expecting data to be available in Q3 with no further risk of delay.

Q: Andrew Berens inquired about the potential impact of SERENA-6 on geda in wild-type and mutant patient populations.

A: Brian Sullivan responded that SERENA-6 wouldn't affect them as patients in their trial are consistent with those evaluated in SERENA-6, and physicians would likely seek to continue treatment with CDK4/6 inhibitor plus gedatolisib.

Q: Tara Bancroft asked about the minimum HR considered good data for the wild-type update.

A: Brian Sullivan said they wouldn't comment specifically on projections at this time but noted an incremental three months PFS would be clinically meaningful and a statistically significant hazard ratio consistent with that would also be meaningful.

Q: Gil Blum asked about the timing change for wild-type readout and the investment for the endometrial cancer collaboration.

A: Brian Sullivan explained the wild-type readout timing is due to event threshold tracking, confident in Q4 for PIK3CA mutant, and the company is supplying drug product and providing clinical support for the endometrial study with no incremental financial effect.

Q: Oliver McCammon asked about prior proof of concept data in prostate cancer and the PSC data update.

A: Brian Sullivan discussed non-clinical data showing gedatolisib is more active than single-node inhibitors like capivasertib, and the update will focus on primary analysis and safety data with rest reported at a medical meeting in 2025.