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Jun 30, 2025
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
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
Historical Earnings Impact
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Avg. Return Before/After Earnings
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