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01/11 07:32
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call reveals significant financial challenges, including increased net loss and operational expenses, without any share repurchase program to boost shareholder confidence. Despite optimistic market potential, regulatory and market adoption risks remain high. The Q&A section highlights management's reluctance to provide specific projections, which can increase investor uncertainty. No new partnerships or positive catalysts were announced. Overall, the financial outlook and management's evasive responses contribute to a negative sentiment, likely leading to a stock price decline in the range of -2% to -8%.
Net Loss $37 million (up from $21.6 million), year-over-year increase of $15.4 million due to higher R&D and G&A expenses.
Non-GAAP Adjusted Net Loss $34.7 million (up from $19.9 million), year-over-year increase of $14.8 million attributed to increased operational costs.
Research and Development Expenses $32.2 million (up from $20.6 million), year-over-year increase of $11.6 million due to $5.9 million in employee and consulting expenses and $5.7 million for ongoing clinical trial activities.
General and Administrative Expenses $3.9 million (up from $1.8 million), year-over-year increase of $2.1 million primarily due to $1.6 million in employee and consulting expenses and $0.5 million in professional fees and infrastructure expansion.
Net Cash Used in Operating Activities $35.9 million (up from $17.1 million), year-over-year increase of $18.8 million reflecting higher operational expenditures.
Cash, Cash Equivalents and Short-term Investments $205.7 million at the end of Q1 2025, no year-over-year change mentioned.
New Drug Application: If positive, we expect the data from the VIKTORIA-1 trial will support our first new drug application and if approved, our transition to a commercial-stage company.
Peak Revenue Potential: If gedatolisib ultimately does receive FDA approval for both the PIK3CA wild-type and mutant populations, we estimate the peak revenue potential for this second-line indication could exceed $2 billion with just 40% market penetration.
Collaboration Announcement: We announced today to collaborate with the Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gedatolisib in combination with abemaciclib and letrozole in patients with endometrial cancer.
Market Adoption: Both recently approved drugs for advanced breast cancer have experienced rapid market adoption and penetration, reaching revenue run rates within the first 12 months of launch estimated to be nearly $0.5 billion.
Clinical Trial Progress: We made great progress activating trial sites for our Phase 3 first-line VIKTORIA-2 trial over the past few months, with nearly 200 sites qualified across North America, Europe, Latin America, and Asia Pacific.
Patient Screening: We’ve also begun screening patients and expect to dose our first patient during the second quarter.
Strategic Shift to Commercial Stage: If approved, our transition to a commercial-stage company will be supported by the data from the VIKTORIA-1 trial.
Regulatory Risks: The success of Celcuity's clinical trials and subsequent regulatory approvals for gedatolisib is uncertain, as it depends on meeting specific endpoints and demonstrating clinical efficacy compared to existing treatments.
Market Adoption Risks: Despite potential efficacy, the market adoption of gedatolisib may be limited if it does not demonstrate a clinically meaningful improvement in progression-free survival (PFS) compared to current therapies.
Competitive Pressures: Celcuity faces significant competition from existing therapies in the market, particularly those that have already achieved rapid adoption and revenue generation despite modest efficacy improvements.
Financial Risks: The company reported a net loss of $37 million for Q1 2025, indicating ongoing financial challenges that could impact future operations and development activities.
Supply Chain Challenges: The activation of trial sites and patient recruitment for clinical trials may face delays or challenges, impacting timelines for data readouts and regulatory submissions.
Economic Factors: Broader economic conditions could affect funding availability and investor sentiment, which may impact Celcuity's ability to finance its clinical development programs.
Clinical Data Readouts: Expect topline data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial in Q3 2025 and from the PIK3CA mutated patient cohort in Q4 2025.
Revenue Potential: If regulatory approvals are obtained, nearly 200,000 late-stage cancer patients globally could be treated with gedatolisib, with peak revenue potential exceeding $2 billion at 40% market penetration.
VIKTORIA-2 Trial: Activated nearly 200 trial sites globally and expect to dose the first patient in the second quarter.
Collaboration: Announced collaboration with Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gedatolisib in combination with abemaciclib and letrozole in endometrial cancer patients.
Financial Outlook: Expect cash, cash equivalents, and short-term investments to fund clinical development programs through 2026.
Net Loss: First quarter net loss was $37 million, compared to $21.6 million in Q1 2024.
R&D Expenses: R&D expenses were $32.2 million for Q1 2025, up from $20.6 million in Q1 2024.
Cash Position: Ended the quarter with approximately $205.7 million in cash, cash equivalents, and short-term investments.
Share Repurchase Program: None
The earnings call highlights strong potential for gedatolisib with a $5 billion market opportunity and extended patent exclusivity. Despite increased losses due to higher R&D and operational costs, the company has a solid cash position to support future growth. The Q&A section indicates positive analyst sentiment and excitement around clinical trial progress and market strategy. While some details remain unclear, the overall outlook is promising, suggesting a positive stock price movement.
The earnings call presents mixed signals: collaboration with renowned institutions and a solid cash position are positives, but increased losses and R&D expenses raise concerns. The Q&A revealed management's evasiveness on critical safety and competitive landscape details, which may dampen investor confidence. Despite potential in new drug trials, the lack of clear guidance and increased expenses suggest a neutral sentiment. Without market cap data, we assume a moderate reaction.
The earnings call reveals significant financial challenges, including increased net loss and operational expenses, without any share repurchase program to boost shareholder confidence. Despite optimistic market potential, regulatory and market adoption risks remain high. The Q&A section highlights management's reluctance to provide specific projections, which can increase investor uncertainty. No new partnerships or positive catalysts were announced. Overall, the financial outlook and management's evasive responses contribute to a negative sentiment, likely leading to a stock price decline in the range of -2% to -8%.
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