Celcuity Inc. (CELC) Q4 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call highlights significant increases in expenses, particularly in employee and consulting costs, which have substantially widened losses. Despite having sufficient cash reserves to finance operations through 2027, the Q&A session revealed management's vague responses and lack of clarity on key issues, such as mutant data disclosure timelines. This uncertainty, combined with rising costs, suggests a negative sentiment, likely leading to a stock price decline in the range of -2% to -8%.
Key Financial Performance
Net Loss (Q4 2025) $51 million or $0.97 per share, compared to $36.7 million net loss, or $0.85 per share, for Q4 2024. The increase in net loss is attributed to higher R&D and G&A expenses.
Net Loss (Full Year 2025) $177 million or $3.79 per share, compared to $111.8 million or $2.83 per share in 2024. The increase is due to higher R&D and G&A expenses.
Non-GAAP Adjusted Net Loss (Q4 2025) $38.4 million or $0.73 per share, compared to $32.3 million or $0.75 per share in Q4 2024. The increase is attributed to higher R&D and G&A expenses.
Non-GAAP Adjusted Net Loss (Full Year 2025) $150.8 million or $3.22 per share, compared to $101.9 million or $2.58 per share in 2024. The increase is due to higher R&D and G&A expenses.
Research and Development Expenses (Q4 2025) $37.6 million, compared to $33.5 million in Q4 2024. The $4.1 million increase is due to $8.6 million in increased employee and consulting expenses, partially offset by a $4.5 million decrease in costs for the VIKTORIA-1 Phase III trial.
Research and Development Expenses (Full Year 2025) $145 million, compared to $104.2 million in 2024. The $40.8 million increase is due to $26.7 million in increased employee and consulting expenses and $14.1 million for clinical trials, milestone payments, and launch-related activities.
General and Administrative Expenses (Q4 2025) $11.6 million, compared to $3 million in Q4 2024. The $8.6 million increase is due to $6.9 million in employee and consulting expenses, including $5.4 million in noncash stock-based compensation, and $1.7 million in professional fees and infrastructure costs.
General and Administrative Expenses (Full Year 2025) $27.2 million, compared to $9.1 million in 2024. The $18.1 million increase is due to $14.9 million in employee and consulting expenses, including $10.4 million in noncash stock-based compensation, and $3.2 million in professional fees and infrastructure costs.
Net Cash Used in Operating Activities (Q4 2025) $36.4 million, compared to $27.8 million in Q4 2024. The increase is due to higher operating expenses.
Net Cash Used in Operating Activities (Full Year 2025) $153.3 million, compared to $83.5 million in 2024. The increase is due to higher operating expenses.
Cash, Cash Equivalents, and Short-Term Investments (End of 2025) $441.5 million, expected to finance operations through 2027.
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Operating Highlights
Gedatolisib NDA Submission: The FDA accepted the new drug application (NDA) for gedatolisib, granting it priority review with a Prescription Drug User Fee Act (PDUFA) goal date of July 17, 2026. The NDA was submitted under the FDA's real-time oncology review program.
Clinical Trial Results: The Phase III VIKTORIA-1 trial demonstrated unprecedented efficacy data for the gedatolisib triplet in HR-positive/HER2-negative advanced breast cancer. Median progression-free survival (PFS) was 9.3 months compared to 2 months for fulvestrant, with a hazard ratio of 0.24.
Safety and Tolerability: Gedatolisib triplet was generally well tolerated with mostly low-grade adverse events. No clinically relevant hypoglycemia was observed, and patient-reported outcomes indicated stable well-being during treatment.
Market Opportunity: The total addressable market for gedatolisib in the second-line setting for HR-positive/HER2-negative advanced breast cancer is estimated at over $5 billion in the U.S., with potential peak revenue of up to $2.5 billion annually.
Launch Preparations: Celcuity has built the necessary infrastructure, including a sales force and internal systems, to support the potential launch of gedatolisib. Extensive outreach to payers and healthcare decision-makers has been conducted.
Financial Position: Cash, cash equivalents, and short-term investments totaled $441.5 million at the end of 2025, expected to finance operations through 2027.
Increased R&D and G&A Expenses: R&D expenses increased by $40.8 million in 2025, driven by clinical trial activities and launch preparations. G&A expenses rose by $18.1 million, primarily due to employee-related costs and infrastructure expansion.
Strategic Focus on Oncology: Celcuity is focusing on advancing gedatolisib for breast and prostate cancer, aiming to establish it as a new standard of care in oncology.
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Risk or Challenges
Regulatory Approval Uncertainty: The approval of gedatolisib by the FDA is not guaranteed, despite the promising data. The company is awaiting the FDA's decision, which introduces uncertainty and potential delays in commercialization.
Financial Losses: The company reported significant net losses for both the fourth quarter and full year 2025, with increased R&D and G&A expenses contributing to these losses. This financial strain could impact future operations and strategic initiatives.
Clinical Trial Risks: The ongoing clinical trials, including the VIKTORIA-1 and VIKTORIA-2 studies, carry inherent risks such as potential negative outcomes or delays, which could adversely affect the company's strategic plans and market positioning.
Commercialization Challenges: The company is preparing for the potential launch of gedatolisib, but there are risks associated with market acceptance, payer engagement, and competition in the oncology space, which could impact revenue projections.
Supply Chain and Operational Risks: As the company transitions to a commercial stage, there may be challenges in scaling operations, managing supply chains, and ensuring consistent product availability.
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Guidance & Outlook
FDA Approval and Commercialization of Gedatolisib: Celcuity is preparing for the potential FDA approval and commercialization of gedatolisib in 2026. The FDA has accepted the New Drug Application (NDA) for gedatolisib, granted it priority review, and set a Prescription Drug User Fee Act (PDUFA) goal date of July 17, 2026.
Clinical Trial Results and Future Data Announcements: Celcuity expects to announce results from the PIK3CA mutant cohort of the Phase III VIKTORIA-1 trial in the second quarter of 2026 and present full results at a medical conference later in the year. The company is also finalizing the Phase III VIKTORIA-2 study design and will provide updates in the second quarter of 2026.
Market Potential and Revenue Projections for Gedatolisib: Celcuity estimates the total addressable market for gedatolisib in the second-line setting for HR-positive/HER2-negative advanced breast cancer to exceed $5 billion. The company projects potential peak annual revenue of up to $2.5 billion for this indication.
Strategic Launch Preparations: Celcuity has been preparing for the potential launch of gedatolisib for nearly two years, building the necessary organizational infrastructure, including a sales force and internal systems. The company has engaged extensively with payers, strategic accounts, and oncologists to ensure market readiness.
Expansion into Prostate Cancer: Celcuity is conducting a Phase Ib/II clinical trial evaluating gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer. The company is continuing dose escalation to determine the recommended Phase II dose.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:Can you comment on the status of the database lock for the mutant data?
A:No, I can't comment on that.
Q:How will the disclosure of the mutant data take place and what will be shared in the readout?
A:Top line data will be provided in a press release, and details will be shared at an upcoming medical conference.
Q:When can we expect more details at a medical conference?
A:No specific timeline was provided; the response was vague.
Q:What feedback are you hearing from physicians regarding segments that may be treated immediately upon wild-type approval?
A:The company will not target specific segments but will generally reach out to doctors to help them understand the benefits of gedatolisib regimens.
Q:Will physicians potentially use gedatolisib off-label in mutants ahead of a potential mutant approval if the data are positive?
A:The company is not having any conversations with doctors about off-label use.
Q:Will the top-line release of the mean data include details like headline PFS numbers and risk reduction?
A:No, it will only include a statement regarding the achievement of statistical significance.
Q:How high can the dose be pushed in prostate trials, and what metrics will be prioritized for dose nomination?
A:The company is evaluating higher doses stepwise and will balance safety and tolerability. Metrics like radiographic PFS, PSA response, and RECIST response will be considered.
Q:What is the duration of therapy estimate being used to inform peak revenue numbers for second-line breast cancer?
A:A round number of 10 months is being used as an assumption for modeling purposes.
Q:What is the key gating factor for getting the frontline endocrine-sensitive trial up and running?
A:Completing the safety run-in and evaluating gedatolisib in combination with ribociclib.
Q:How does the company plan to address potential challenges in getting patients to come in for infusions?
A:The company believes efficacy and tolerability will outweigh concerns about IV administration, which is seen as a minor issue for less than 10% of patients.
Q:What are the commercial advantages of having gedatolisib labeled across metastatic breast cancer subtypes?
A:It simplifies decision-making for physicians by offering a biomarker-agnostic alternative with a strong risk/benefit profile.
Q:What learnings from the launch of inavolisib are supportive of gedatolisib's positioning in the VIKTORIA-2 trial?
A:Gedatolisib's unique safety profile, particularly its lack of glycemic system disruption, is a key differentiator.
Q:What is the company's level of interest in a frontline endocrine-sensitive study?
A:The company sees strong potential based on favorable Phase Ib data and is considering conducting a study in this space.
Q:What are the updated thoughts on the European commercial strategy for gedatolisib?
A:The company plans to submit an MAA in Q4 of this year and use the time to find partners for launching in Europe and globally.
Q:Do you need to hit both the doublet and triplet arms to file later in the year?
A:The primary endpoint is the comparison of the triplet to alpelisib, which would form the basis for regulatory submission.
Q:What feedback has the company received from payers regarding the profile of gedatolisib in wild type?
A:The feedback has been very positive, with payers collaborating to ensure early access for patients.
Q:What are the thoughts on potential future competition from mutant-selective PI3K alpha inhibitors?
A:The company believes its comprehensive inhibition approach with gedatolisib offers superior efficacy compared to selective inhibitors.
Q:Review of Unclear Management Responses
A:Management avoided providing a direct answer to the timeline for when more details on the mutant data would be shared at a medical conference.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
CDK inhibitor
Celcuity
Chief
FDA
GA
HR breast
III trial
Jodi
NDA
Officer
PFS
Phase III
Phase Ib
VIKTORIA
afternoon
assessment
breast cancer
cohort
effort
employee consulting
fulvestrant hazard
grade
hazard ratio
launch activity
loss share
milestone
month fulvestrant
oncology
patient HR
portion
press release
result PIKCA
share loss
triplet
CELC Transcript
Celcuity Inc. (CELC) Q4 2025 Earnings Call Transcript
Unknown3-25
The earnings call highlights significant increases in expenses, particularly in employee and consulting costs, which have substantially widened losses. Despite having sufficient cash reserves to finance operations through 2027, the Q&A session revealed management's vague responses and lack of clarity on key issues, such as mutant data disclosure timelines. This uncertainty, combined with rising costs, suggests a negative sentiment, likely leading to a stock price decline in the range of -2% to -8%.
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CELC Report
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