CELC — Celcuity Inc.

Celcuity Q4 2025 Earnings Call Summary

1. Key Financial Results and Metrics

• Q4 2025 Net Loss: $51 million ($0.97 per share), compared to a net loss of $36.7 million ($0.85 per share) in Q4 2024.
• Full-Year 2025 Net Loss: $177 million ($3.79 per share), up from $111.8 million ($2.83 per share) in 2024.
• Non-GAAP Adjusted Net Loss: $38.4 million ($0.73 per share) for Q4 2025, compared to $32.3 million ($0.75 per share) in Q4 2024. Full-year adjusted net loss was $150.8 million ($3.22 per share) versus $101.9 million ($2.58 per share) in 2024.
• R&D Expenses: Increased to $37.6 million in Q4 2025 from $33.5 million in Q4 2024; full-year R&D expenses were $145 million, up from $104.2 million in 2024.
• G&A Expenses: Rose to $11.6 million in Q4 2025 from $3 million in Q4 2024; full-year G&A expenses were $27.2 million compared to $9.1 million in 2024.
• Cash Position: $441.5 million at year-end 2025, expected to fund operations through 2027.

2. Strategic Updates and Business Highlights

• Gedatolisib NDA: The FDA accepted the new drug application (NDA) for gedatolisib with a priority review and a PDUFA goal date of July 17, 2026.
• Clinical Milestones:
  • Positive results from the PIK3CA wild-type cohort of the Phase III VIKTORIA-1 trial, showing a median progression-free survival (PFS) of 9.3 months for the gedatolisib triplet compared to 2 months for fulvestrant.
  • Enrollment completion for the PIK3CA mutant cohort of VIKTORIA-1, with results expected in Q2 2026.
• Commercial Preparation: Significant progress in building the sales force and engaging with payers and oncologists to prepare for the potential launch of gedatolisib.
• Market Opportunity: Estimated total addressable market for gedatolisib in the second-line setting for HR-positive/HER2-negative advanced breast cancer is over $5 billion, with potential peak revenue of $2.5 billion annually.

3. Forward Guidance and Outlook

• Upcoming Data Releases: Top-line results from the PIK3CA mutant cohort are anticipated in Q2 2026, with full results to be presented at a medical conference.
• Launch Strategy: Ongoing preparations for a potential launch of gedatolisib, with a focus on broad engagement with oncologists and healthcare systems.

4. Bad News, Challenges, or Points of Concern

• Increased Losses: The company reported higher net losses and expenses compared to the previous year, raising concerns about financial sustainability.
• Market Competition: Potential competition from other PI3K inhibitors and the complexity of the oncology landscape could impact market penetration.
• Regulatory Risks: The success of the NDA and subsequent approvals are contingent on clinical trial outcomes, which carry inherent risks.

5. Notable Q&A Insights

• Data Disclosure: Management confirmed that top-line data from the mutant cohort will focus on statistical significance rather than detailed PFS numbers due to embargo requirements.
• Physician Feedback: Discussions with oncologists indicate a willingness to prescribe gedatolisib broadly, with efficacy being the primary concern over administration routes.
• Commercial Strategy: The company plans to position gedatolisib as a biomarker-agnostic treatment option, simplifying decision-making for physicians.
• European Strategy: Plans for a supplemental NDA following the mutant cohort results, with ongoing discussions for potential partnerships in Europe.

This summary encapsulates the key points from Celcuity's Q4 2025 earnings call, highlighting both the company's progress and the challenges it faces as it approaches a critical phase in its product development and commercialization efforts.