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Jun 30
Celcuity Q2 2025 Earnings Report
Celcuity reported a wider net loss in Q2 2025 due to higher R&D expenses driven by clinical trials and milestone payments, while bolstering its cash position with recent financing.
Key Takeaways
Celcuity significantly increased R&D investments in Q2 2025 to advance gedatolisib clinical programs. The net loss widened, but the company’s strengthened balance sheet is expected to fund operations through 2027.
Net loss widened to $45.3 million due to increased R&D and milestone payments
Operating expenses rose to $44 million, up from $24.3 million YoY
Cash and investments stood at $168.4 million, with a pro forma balance of $455 million post-financing
Non-GAAP EPS was -$0.93, excluding stock-based comp and non-cash items
Celcuity
Celcuity
Forward Guidance
Celcuity plans to submit an NDA for gedatolisib in Q4 2025 and expects pivotal data from ongoing trials, positioning itself for multiple market opportunities.
Positive Outlook
- NDA submission for gedatolisib planned for Q4 2025
- Strong topline data from PIK3CA wild-type cohort of Phase 3 VIKTORIA-1
- Enrollment ongoing in PIK3CA mutant cohort with data expected by year-end
- Phase 3 VIKTORIA-2 trial initiated as first-line treatment
- Patent issuance extends gedatolisib exclusivity to 2042
Challenges Ahead
- Operating expenses nearly doubled YoY due to clinical development costs
- R&D spending driven by $5M milestone payment to Pfizer
- Net loss widened to $45.3 million in Q2
- Free cash flow not disclosed separately
- No revenue generated as company remains pre-commercial