Celcuity (CELC) Q2 2025 earnings summary

Executive summary

• Gedatolisib achieved statistically significant and clinically meaningful improvements in progression-free survival in HR-positive, HER2-negative advanced breast cancer, reducing risk of progression or death by 76% in the PIK3CA wild-type cohort, with NDA submission planned for Q4 2025 and patent exclusivity extended to 2042.

• Initiated Phase 3 VIKTORIA-2 trial and reported positive early-phase data in prostate and HER2-positive breast cancer, including a 43% response rate in heavily pretreated HER2-positive patients.

• Completed major capital raises, including $286.5 million from convertible notes, common stock, and pre-funded warrants, bringing proforma cash to $455 million to fund operations through 2027.

• No commercial revenue generated to date; focus remains on clinical development and commercialization preparations.

Financial highlights

• Q2 2025 net loss was $45.3 million ($1.04/share), up from $23.7 million ($0.62/share) in Q2 2024; non-GAAP adjusted net loss was $40.5 million ($0.93/share).

• R&D expenses rose to $40.2 million, mainly due to increased clinical trial activity and a $5 million milestone payment to Pfizer; G&A expenses increased to $3.8 million.

• Cash, cash equivalents, and short-term investments at June 30, 2025, were $168.4 million; proforma including financing, $455 million.

• Net cash used in operations was $36.2 million in Q2 2025, up from $18.1 million year-over-year.

• Interest expense for the quarter was $3.2 million, up 42% year-over-year due to increased debt.

Outlook and guidance

• NDA submission for gedatolisib based on PIK3CA wild-type cohort data is planned for Q4 2025, with topline data from the PIK3CA mutant cohort expected by end of 2025.

• Cash position, including recent financing, is expected to fund operations through 2027, with access to an additional $116 million from financing arrangements.

• Anticipated increases in R&D and G&A expenses as clinical programs expand and commercialization preparations accelerate.