Celcuity Inc. Q4 FY2024 earnings call

Brian Sullivan discussed significant progress in clinical development in 2024, including completing enrollment in VIKTORIA-1 Phase III study, selecting sites for VIKTORIA-2 Phase III study, ongoing Phase Ib prostate cancer study, and reporting preliminary overall survival data from Phase Ib breast cancer study. Vicky Hahne reviewed financial results, noting net losses for Q4 2024 and full year 2024, increased R&D and G&A expenses, and cash position as of year-end 2024.

• Anticipates reporting top line data for VIKTORIA-1 PIK3CA wild-type cohort in Q2 2025 and mutant type cohort in Q4 2025. • Hopes to initiate TOR request soon after top line data and expects priority review or TOR to shorten FDA review time. • Views 2025 as transformational with important clinical data readouts. • Prostate cancer Phase Ib study data expected in end of Q2 2024.

Q: Update on event rate for VIKTORIA-1?

A: Brian Sullivan said not commenting on specifics related to achieving event rate to trigger readout, but provided guidance on when top line data will be available.

Q: Plans following Q2 readout for NDA filing and priority review?

A: Hopes to initiate TOR request soon after top line data, expects FDA approval of TOR request or priority review to shorten review time, and thinks breakthrough status will help.

Q: Feedback from investigators on Roche's inavolisib and impact on mutant population?

A: Brian Sullivan said Roche's drug overlaps with VIKTORIA-2 first-line population, and feedback from investigators is that inavolisib imposes burden on patients and doctors, while Celcuity's drug has potential advantage in treating patients independent of PIK3CA and metabolic status.

Q: Assumptions behind $2 billion second-line opportunity?

A: Estimates based on third-party data on number of women in second-line setting, pricing, and penetration rate.

Q: Whether to enter quiet period ahead of Q2 top line data?

A: Brian Sullivan said it would be determined but they would enter a quiet period.

Q: Powering of VIKTORIA study for ESR1 mutant population?

A: Brian Sullivan said preliminary Phase Ib data did not show differences in activity associated with ESR1 status, but hopes to report results isolating activity between ESR1 mutant and wild-type patients.

Q: Prostate study moving pieces and bar for later-stage studies?

A: Brian Sullivan said population is second-line after prior androgen receptor inhibitor, primary endpoint is landmark PFS at 6 months compared to historical controls, and decisions will be based on safety and data review.