Celcuity Inc. (CELC) Q3 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
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.
Key Financial Performance
Net Loss $43.8 million for Q3 2025, compared to $29.8 million for Q3 2024. This represents an increase of $14 million year-over-year. The increase is attributed to higher research and development expenses and general and administrative expenses.
Non-GAAP Adjusted Net Loss $37.2 million for Q3 2025, compared to $27.6 million for Q3 2024. This represents an increase of $9.6 million year-over-year. The increase is due to higher operational costs, including employee and consulting expenses.
Research and Development Expenses $34.9 million for Q3 2025, compared to $27.6 million for Q3 2024. This represents an increase of $7.3 million year-over-year. The increase is primarily due to $5.6 million in higher employee and consulting expenses, with $3.2 million related to commercial headcount additions and launch activities, and $1.7 million for clinical trial support.
General and Administrative Expenses $7.9 million for Q3 2025, compared to $2.5 million for Q3 2024. This represents an increase of $5.4 million year-over-year. The increase is mainly due to $4.9 million in higher employee and consulting expenses, including $4 million in non-cash stock-based compensation, and $0.5 million in professional fees and administrative costs.
Net Cash Used in Operating Activities $44.8 million for Q3 2025, compared to $20.6 million for Q3 2024. This represents an increase of $24.2 million year-over-year. The increase is attributed to higher operational and clinical trial expenses.
Cash, Cash Equivalents, and Short-term Investments $455 million as of the end of Q3 2025. This includes $287 million raised from public offerings and $27.8 million from a term loan facility.
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Operating Highlights
Gedatolisib as a new standard of care: Significant progress in clinical and regulatory milestones for gedatolisib, including positive Phase III trial results for HR-positive, HER2-negative advanced breast cancer. FDA accepted NDA submission under real-time oncology review program.
Clinical trial results: Phase III VIKTORIA-1 trial showed gedatolisib triplet improved median progression-free survival (PFS) by 7.3 months compared to fulvestrant. Gedatolisib doublet improved PFS by 5.4 months. Results set new benchmarks in HR-positive, HER2-negative advanced breast cancer.
Prostate cancer trial: Phase I/II trial of gedatolisib with darolutamide in metastatic castration-resistant prostate cancer showed favorable results with median radiographic PFS of 9.1 months.
Market potential for gedatolisib: Estimated total addressable market for gedatolisib in second-line HR-positive, HER2-negative advanced breast cancer is $5-6 billion. Potential peak revenues estimated at $2.5-3 billion.
Commercial launch preparation: Significant progress in preparing for gedatolisib launch, including hiring key personnel, defining sales territories, and engaging with payers and oncologists.
Financial position: Raised $287 million through convertible notes, common stock, and warrants. Amended term loan facility to $500 million, with $350 million committed capital. Cash reserves expected to fund operations through 2027.
Increased R&D and G&A expenses: R&D expenses increased by $7.3 million, primarily due to employee and consulting costs. G&A expenses rose by $5.4 million, driven by stock-based compensation and professional fees.
Strategic focus on oncology: Focused on advancing gedatolisib for breast and prostate cancer indications. Preparing for potential FDA approval and commercial launch in 2026.
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Risk or Challenges
Regulatory Risks: The company is preparing for FDA approval of gedatolisib in 2026. Any delays or issues in the approval process could adversely impact the company's strategic plans and financial performance.
Clinical Trial Risks: The success of the company's future operations heavily depends on the outcomes of ongoing clinical trials, such as the VIKTORIA-2 study and the Phase I/II trial for prostate cancer. Any unfavorable results or delays in these trials could hinder the company's progress.
Financial Risks: The company reported a net loss of $43.8 million for Q3 2025, an increase from the previous year. High R&D and G&A expenses, coupled with reliance on convertible notes and term loans, could strain financial resources if revenue generation is delayed.
Market Penetration Risks: While optimistic about market share for gedatolisib, there is a risk that the company may not achieve the projected penetration or revenue targets due to competition or unforeseen market dynamics.
Operational Risks: The company is ramping up for a commercial launch, including hiring and infrastructure expansion. Any missteps in execution or delays in launch preparations could impact operational efficiency and market readiness.
Supply Chain Risks: Potential disruptions in the supply chain for gedatolisib or other products could delay production and distribution, affecting the company's ability to meet market demand.
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Guidance & Outlook
FDA Approval and Launch of Gedatolisib: Celcuity expects to complete the submission of the New Drug Application (NDA) for gedatolisib under the FDA's real-time oncology review program this quarter, with potential FDA approval anticipated in 2026. Preparations for the commercial launch of gedatolisib are underway, with significant progress in building the organization and internal systems required for a commercial-stage company.
Market Potential and Revenue Projections for Gedatolisib: The company estimates the total addressable market for gedatolisib in the second-line setting for HR-positive, HER2-negative advanced breast cancer to be $5 billion to $6 billion. Based on anticipated market penetration, Celcuity projects potential peak revenues of $2.5 billion to $3 billion for this indication.
Clinical Trials and Data Timelines: Top-line data from the PIK3CA mutant cohort of the Phase III VIKTORIA-1 trial is expected in late Q1 2026 or during Q2 2026. Enrollment for the VIKTORIA-2 Phase III trial, evaluating gedatolisib as a first-line treatment, is ongoing. The company is also advancing a Phase I/II trial for gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer.
Financial Outlook and Funding: Celcuity has raised $287 million through offerings and increased its term loan facility to $500 million, providing financial flexibility to support operations through 2027. This funding will be used for clinical trials, commercial launch preparations, and other strategic initiatives.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:What is the main focus of the presentation at the San Antonio Breast Cancer Symposium Conference?
A:The presentation will include additional subgroup analyses for efficacy, safety, and quality of life aspects of the study, following the detailed initial presentation.
Q:Has enrollment in VIKTORIA-2 been positively impacted by the second-line data?
A:Enrollment is on track, and investigators are excited about the results, which may positively impact visibility and credibility of the study.
Q:Will there be additional Phase III studies or expansion to first-line endocrine-sensitive patients?
A:There is a long-term life cycle development plan, but no decisions or announcements are ready yet.
Q:Will the wild-type submission to the FDA be separate from the mutant submission, and will the mutant submission also be a real-time oncology review?
A:The wild-type cohort submission will be completed by the end of the quarter and is separate from the mutant submission. A real-time oncology review for the mutant data will depend on the clarity and potential of the data.
Q:What is the expected duration of therapy for the triplet in the commercial setting?
A:The duration of therapy varies by region, with U.S. PFS reported at 19.3 months. Further analysis is needed before sharing external estimates.
Q:What assumptions go into the pricing strategy for the triplet?
A:Pricing benchmarks include recent drugs targeting the PI3K pathway, with wholesale acquisition costs around $25,000. Discounts for oral drugs are typically 30%, while medical benefit drugs like geda may have a 20% discount. Final pricing decisions are still under research.
Q:What is the plan to bring gedatolisib to patients outside the U.S.?
A:The company plans to commercialize in the U.S. and find partners for ex-U.S. commercialization after mutant data is available and regulatory submissions are made. They are also working with European and Japanese health authorities for regulatory alignment.
Q:Has the thinking around the type of frontline population to be enrolled changed after the VIKTORIA-1 readout?
A:The company sees an opportunity to help patients delay progression longer than current regimens. They are considering how to design a study for treatment-naive endocrine-sensitive patients based on Phase Ib data and other feedback.
Q:What is the potential impact of a favorable overall survival trend in the second- and third-line setting?
A:The interim OS analysis showed a favorable trend with a hazard ratio of 0.69, supporting drug approval. A positive OS readout would be impactful but is a high bar to achieve in the second-line setting.
Q:Where is gedatolisib manufactured?
A:The company has multiple manufacturing sites and a flexible approach to ensure a robust supply chain. Specific locations have not been disclosed.
Q:Review of Unclear Management Responses
A:Management avoided providing specific details on the timing and approach for additional Phase III studies, the final pricing strategy for the triplet, and the exact manufacturing locations for gedatolisib.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
Arm
CDK inhibitor
Capital Partners
Celcuity lender
ESMO Congress
Grade
HR breast
III trial
Innovatus Capital
ORR response
Oxford Finance
Phase III
amendment term
capital
cohort VIKTORIA
doublet
duration response
effort
feedback
launch
loan facility
milestone
month improvement
offering
oncology
patient HR
proceeds
rPFS
release line
response rate
result PIKCA
sale
subgroup
term loan
treatment event
trial patient
triplet
warrant
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