Celcuity (CELC) Q3 2025 earnings summary

Executive summary

• Achieved major clinical and regulatory milestones, including positive Phase 3 VIKTORIA-1 results for gedatolisib in HR+/HER2- advanced breast cancer, FDA acceptance for NDA submission under RTOR for the wild-type cohort, and completion of PIK3CA mutant cohort enrollment, with topline data expected in late Q1 or Q2 2026.

• NDA pre-submission for gedatolisib made in September 2025; final submission targeted for Q4 2025.

• Strengthened balance sheet with $287 million in net proceeds from offerings, expanded term loan facility to $500 million, and warrant exercises, providing funding through 2027.

• Accelerated commercial launch preparations for gedatolisib, with most hiring completed except for field salesforce.

• Phase 1b/2 trial in metastatic castration-resistant prostate cancer ongoing, with promising early efficacy and safety data.

Financial highlights

• Q3 2025 net loss was $43.8 million ($0.92/share), up from $29.8 million ($0.70/share) in Q3 2024; non-GAAP adjusted net loss was $37.2 million ($0.78/share) vs. $27.6 million ($0.65/share) year-over-year.

• Operating expenses for Q3 2025 rose to $42.8 million from $30.1 million, driven by higher R&D and G&A costs.

• R&D expenses were $34.9 million, up 27% year-over-year; G&A expenses were $7.9 million, up 221%, including $4 million in non-cash stock-based compensation.

• Cash, cash equivalents, and short-term investments totaled $455 million as of September 30, 2025.

• No revenue generated to date; company remains pre-commercial.

Outlook and guidance

• NDA submission for gedatolisib wild-type cohort expected in Q4 2025; topline data for PIK3CA mutant cohort anticipated in late Q1 or Q2 2026.

• Cash runway expected to fund operations through 2027.

• Anticipates increased R&D and G&A expenses as clinical programs advance and commercialization preparations continue.

• Commercial launch preparations for gedatolisib are well underway, with optimistic market feedback and potential for majority market share in the second-line setting.

• Plans to seek additional capital as needed for future growth and commercialization.