Celcuity Inc. Q3 FY2024 earnings call

Brian Sullivan discussed the clinical development of gedatolisib, noting robust enrollment in VIKTORIA-1 Phase III trial with PIK3CA wild-type cohort 100% enrolled and VIKTORIA-2 on track to enroll first patient in Q2 2025. The Phase Ib/II trial for metastatic castration-resistant prostate cancer is ongoing with preliminary data expected in Q2 2025. He highlighted gedatolisib's safety profile with low treatment-related discontinuation rate, favorable vs other therapies. Vicky Hahne provided financials: third quarter 2024 net loss $29.8M, R&D expenses $27.6M, G&A expenses $2.5M, and cash position $264.1M as of quarter end.

Expect to report top line data for PIK3CA wild-type cohort in late Q1 2025 or Q2 2025, and PIK3CA mutant cohort in H2 2025; potential NDA filing if wild-type results positive, sNDA if mutant also positive. Peak revenue potential for second line and delayed indication alone could exceed $2 billion. VIKTORIA-2 to enroll first patient in Q2 2025.

Forward-looking statements involve risks and uncertainties; actual results may differ from projections. Clinical trial outcomes dependent on event rates, which are out of control.

Q: Maury Raycroft asked about timeline updates and event rate, Brian responded about event rate not related to enrollment change.

A: Brian Sullivan stated the event rate is out of control and not related to enrollment change, as higher proportion of mutated patients affected wild-type enrollment rate but event projection factored that in.

Q: Maury Raycroft asked about Roche's inavolisib approval impact, Brian discussed impact on gedatolisib's second-line use.

A: Brian said Roche's approval doesn't compromise gedatolisib's second-line population, and VIKTORIA-2 addresses a different population than Roche's study.

Q: Brad Canino asked about San Antonio Conference focus and competition, Brian talked about posters and data analysis.

A: Brian mentioned presenting posters at the conference and tracking data from other studies, noting relevance to gedatolisib's population but need to normalize data for comparison.

Q: Tara Bancroft asked about mPFS expectations and control arm, Brian discussed Phase 1b data and population differences.

A: Brian referenced Phase 1b data and population characteristics, noting fulvestrant's average MPFS in relevant population is ~3 months, and VIKTORIA-2's population is distinct.

Q: Chase Knickerbocker asked about VIKTORIA-2 enrollment, Brian discussed site enthusiasm and enrollment expectations.

A: Brian said sites from VIKTORIA-1 are enthusiastic about VIKTORIA-2, and first-line studies are easier to enroll, expecting good enrollment for VIKTORIA-2