Celcuity Inc. Q2 FY2025 earnings call

• Achieved positive top line data from PIK3CA wild-type cohort of Phase III VIKTORIA-1 clinical trial, with gedatolisib triplet showing median PFS of 9.3 months and doublet showing 7.4 months vs fulvestrant, both meeting primary endpoints.
• Dosed first patient in Phase III VIKTORIA-2 clinical trial for first-line treatment of HR-positive, HER2-negative advanced breast cancer.
• Announced favorable preliminary top line results from early-phase trials: gedatolisib with darolutamide in metastatic castration-resistant prostate cancer (6-month radiographic PFS rate 66%) and gedatolisib with trastuzumab biosimilar in HER2-positive, PIK3CA-mutated metastatic breast cancer (43% overall response rate).
• Extended patent exclusivity for gedatolisib into 2042 with a new dosing regimen patent.
• Raised ~$287 million through public offerings to fund preparation for FDA approval.
• Market potential for second-line therapy in HR-positive, HER2-negative advanced breast cancer is estimated at ~$5 billion.

No traditional product segment breakdown as Celcuity is focused on a single drug candidate, gedatolisib. Financials discussed but no product segment revenue contribution details provided.

• On track to submit NDA to FDA in Q4 2025 based on VIKTORIA-1 PIK3CA wild-type cohort data.
• Expect to release top line data for VIKTORIA-1 PIK3CA mutation cohort by end of 2025.
• Believe they have resources and financing in place to fund operations through 2027, with ~$455 million in cash pro forma and access to incremental $160 million over next few quarters.

• Uncertainties related to forward-looking statements and potential differences between actual results and projections.
• Risks associated with clinical trial outcomes, regulatory approvals, and market acceptance of gedatolisib.

Q: Can you elaborate on the upcoming full data presentation for the PIK3CA wild-type portion of the Phase III study, including subgroup analysis?

A: We'll focus on primary analyses initially, with subsequent meetings expected for additional subgroup analyses like ESR1 wild type and mutant cohorts.

Q: How are you thinking about benchmarks for success in the PIK3CA mutant population?

A: Compare to alpelisib (historical ~7-8 months median PFS) and capivasertib (~5.5 months median PFS), looking for statistically and clinically meaningful results.

Q: What are the practical ramifications for physicians regarding the doublet vs triplet options?

A: Triplet offers extended PFS but may have myelosuppression concerns; doublet provides benefit for patients where triplet may not be suitable, allowing broader patient access.

Q: Is there consideration of a commercial partnering strategy for launch?

A: Planning to launch themselves, with sufficient capital and infrastructure in place to support the launch.

Q: Can you discuss the competitive landscape in the mutant population?

A: Inavolisib (Itovebi) is for PIK3CA mutation first-line, geda targets wild-type and aims for broader applicability regardless of PIK3CA status or metabolic factors.

Q: Any specifics on the CMC portion of the NDA filing?

A: Confident in CMC package, modules are complete, and engaged with FDA to ensure compliance with requirements.