Loading...
01/11 07:37
Loading...
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
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.
Net Loss $45.3 million for Q2 2025, compared to $23.7 million for Q2 2024. This represents an increase of $21.6 million year-over-year. The increase was attributed to higher research and development expenses and general and administrative expenses.
Non-GAAP Adjusted Net Loss $40.5 million for Q2 2025, compared to $22.2 million for Q2 2024. This represents an increase of $18.3 million year-over-year. The increase was due to similar factors as the net loss, including higher R&D and administrative costs.
Research and Development Expenses $40.2 million for Q2 2025, compared to $22.5 million for Q2 2024. This represents an increase of $17.7 million year-over-year. The increase was driven by $6.6 million in higher employee and consulting expenses, $6.1 million in increased R&D costs for clinical trials, and $5 million for a milestone payment under a license agreement with Pfizer.
General and Administrative Expenses $3.8 million for Q2 2025, compared to $1.8 million for Q2 2024. This represents an increase of $2 million year-over-year. The increase was primarily due to $1.6 million in higher employee and consulting expenses and $0.4 million in professional fees and other administrative costs.
Net Cash Used in Operating Activities $36.2 million for Q2 2025, compared to $18.1 million for Q2 2024. This represents an increase of $18.1 million year-over-year, driven by higher operational expenses.
Cash, Cash Equivalents, and Short-term Investments $168.4 million as of the end of Q2 2025. On a pro forma basis, including financing activities in Q3, this figure was approximately $455 million. The increase was due to proceeds from financing activities.
Phase III VIKTORIA-1 trial results: Gedatolisib demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS) for HR-positive, HER2-negative advanced breast cancer patients. The triplet therapy showed a median PFS of 9.3 months compared to 2 months for fulvestrant, while the doublet therapy showed 7.4 months. Both regimens had favorable safety profiles.
Phase III VIKTORIA-2 trial initiation: First patient dosed to evaluate gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR-positive, HER2-negative advanced breast cancer.
Early-phase clinical trials: Preliminary results showed gedatolisib's efficacy in combination with darolutamide for metastatic castration-resistant prostate cancer and with trastuzumab biosimilar for HER2-positive, PIK3CA-mutated metastatic breast cancer.
Market opportunity for gedatolisib: Estimated 34,000 patients moving to second-line treatment after CDK4/6 inhibitor progression, with 60% being PIK3CA wild type. Addressable market potential estimated at $5 billion.
Patent extension: Gedatolisib's patent exclusivity extended to 2042 with a new dosing regimen patent.
Funding raised: $287 million raised through public offerings, ensuring resources for FDA approval preparation and potential launch.
FDA submission plans: New drug application for gedatolisib to be submitted in Q4 2025 based on VIKTORIA-1 trial data.
Regulatory Approval Uncertainty: The company is preparing for FDA approval of gedatolisib, but there is inherent uncertainty in obtaining regulatory approval, which could delay or prevent the product launch.
Financial Losses: The company reported a net loss of $45.3 million for Q2 2025, significantly higher than the $23.7 million loss in Q2 2024, indicating increasing financial strain.
R&D Cost Increases: Research and development expenses increased by $17.7 million year-over-year, driven by clinical trial activities and milestone payments, which could strain financial resources.
Market Competition: The company faces competition from other therapies in the HR-positive, HER2-negative advanced breast cancer space, which could impact market share and revenue potential.
Clinical Trial Risks: Ongoing clinical trials, including VIKTORIA-2 and others, carry risks of unfavorable outcomes, which could impact the company's strategic objectives and financial performance.
Supply Chain and Manufacturing Risks: As the company prepares for potential product launch, supply chain disruptions or manufacturing challenges could delay commercialization.
Dependence on Key Product: The company's future success heavily depends on the approval and market adoption of gedatolisib, making it vulnerable to setbacks related to this single product.
Economic and Reimbursement Challenges: Reimbursement processes for IV-administered therapies, while smoother than oral drugs, still pose potential economic challenges in terms of payer acceptance and pricing pressures.
FDA Approval and Drug Launch: Celcuity plans to submit a new drug application to the FDA in Q4 2025 for gedatolisib based on data from the PIK3CA wild-type cohort. The company is preparing for a potential launch of gedatolisib in 2026, contingent on FDA approval.
Market Opportunity for Gedatolisib: The addressable market potential for gedatolisib as a second-line therapy for HR-positive, HER2-negative advanced breast cancer is estimated at $5 billion. Approximately 34,000 patients move to second-line treatment annually, with 60% being PIK3CA wild type.
Clinical Trials and Data Releases: Top-line data for the VIKTORIA-1 PIK3CA mutation cohort is expected by the end of 2025. The VIKTORIA-2 trial is ongoing, evaluating gedatolisib as a first-line treatment for HR-positive, HER2-negative advanced breast cancer. Additional dose exploration is planned for the Phase Ib prostate cancer trial.
Patent Exclusivity: Gedatolisib's patent exclusivity has been extended to 2042, providing a long runway for development and commercialization.
Financial Position: Celcuity has raised $287 million through public offerings and expects to have resources to fund operations through 2027, including advancing multiple indications and preparing for gedatolisib's commercial launch.
The selected topic was not discussed during the call.
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%.
All transcripts are sourced directly from the official live webcast or the company’s official investor relations website. We use the exact words spoken during the call with no paraphrasing of the core discussion.
Full verbatim transcripts are typically published within 4–12 hours after the call ends. Same-day availability is guaranteed for all S&P 500 and most mid-cap companies.
No material content is ever changed or summarized in the “Full Transcript” section. We only correct obvious spoken typos (e.g., “um”, “ah”, repeated 10 times”, or clear misspoken ticker symbols) and add speaker names/titles for readability. Every substantive sentence remains 100% as spoken.
When audio quality is poor or multiple speakers talk over each other, we mark the section instead of guessing. This ensures complete accuracy rather than introducing potential errors.
They are generated by a specialized financial-language model trained exclusively on 15+ years of earnings transcripts. The model extracts financial figures, guidance, and tone with 97%+ accuracy and is regularly validated against human analysts. The full raw transcript always remains available for verification.
