CELC — Celcuity Inc.

Summary of Celcuity Q4 2025 Earnings Call

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: Q4 2025 was $38.4 million ($0.73 per share) vs. $32.3 million ($0.75 per share) in Q4 2024. Full year adjusted loss was $150.8 million ($3.22 per share) vs. $101.9 million ($2.58 per share) in 2024.
• Research and Development (R&D) Expenses: $37.6 million in Q4 2025, up from $33.5 million in Q4 2024. Full year R&D expenses were $145 million, compared to $104.2 million in 2024.
• General and Administrative (G&A) Expenses: $11.6 million in Q4 2025, significantly higher than $3 million in Q4 2024. Full year G&A expenses totaled $27.2 million, up from $9.1 million in 2024.
• Cash Position: $441.5 million at year-end, expected to fund operations through 2027.

2. Strategic Updates and Business Highlights

• FDA NDA Acceptance: The FDA accepted the New Drug Application (NDA) for gedatolisib with a priority review, targeting a PDUFA date of July 17, 2026.
• Clinical Milestones:
  • Positive results from the Phase III VIKTORIA-1 trial for the PIK3CA wild-type cohort were presented at major conferences and published in peer-reviewed journals.
  • Enrollment for the PIK3CA mutant cohort of VIKTORIA-1 was completed, with results expected in Q2 2026.
• Commercial Readiness: Preparations for the potential launch of gedatolisib are underway, including building a sales force and engaging with payers and oncologists.
• Market Opportunity: The estimated total addressable market for gedatolisib in the second-line setting is over $5 billion, with potential peak revenue of up to $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 follow at a medical conference.
• Commercial Strategy: The company is focused on broad access and engagement with oncologists to establish gedatolisib as a new standard of care for HR-positive/HER2-negative advanced breast cancer.

4. Bad News, Challenges, or Points of Concern

• Increased Losses: The company reported significant increases in both net losses and operating expenses, raising concerns about financial sustainability without revenue from gedatolisib.
• Market Competition: The competitive landscape includes other PI3K inhibitors, which may pose challenges, particularly if they demonstrate improved safety profiles.
• Regulatory Risks: The success of gedatolisib's approval and market acceptance hinges on upcoming clinical data and regulatory outcomes.

5. Notable Q&A Insights

• Clinical Data Disclosure: The company will provide top-line data for the mutant cohort without additional details due to embargo requirements.
• Physician Feedback: There is optimism about physician willingness to prescribe gedatolisib, with the efficacy being the primary concern over administration routes.
• Commercial Launch Challenges: Concerns about patient access to infusions were addressed, with feedback suggesting that efficacy will outweigh logistical issues for most patients.
• European Strategy: Plans for a supplemental NDA and MAA submission in Europe are in place, with ongoing discussions for potential partnerships.

Overall, Celcuity is positioned for a pivotal year with the potential approval of gedatolisib, but faces challenges related to financial losses and competitive pressures in the oncology market.