8-K: Celcuity Reports Q4/FY25 Results, Gedatolisib NDA Priority Review

Celcuity Inc. announced its fourth quarter and full year 2025 financial results, alongside a corporate update highlighting FDA Priority Review for gedatolisib and positive Phase 3 clinical trial data.

Summary

• The U.S. Food and Drug Administration (FDA) accepted Celcuity's New Drug Application (NDA) and granted Priority Review for gedatolisib in HR+/HER2-/PIK3CA wild-type (WT) advanced breast cancer (ABC), with a Prescription Drug User Fee Act (PDUFA) goal date of July 17, 2026.
• Results from the PIK3CA WT cohort of the Phase 3 VIKTORIA-1 study of gedatolisib regimens in HR+/HER2ABC were published in the Journal of Clinical Oncology.
• Topline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 study are expected to be released in the second quarter of 2026.
• For patients in specific regions, median progression-free survival (PFS) was 16.6 months with the gedatolisib triplet versus 1.9 months for fulvestrant (HR=0.14; 95% CI: 0.08-0.28; p<0.0001).
• The gedatolisib triplet delayed time to definitive deterioration in patient well-being measures to 23.7 months versus 4.0 months for fulvestrant (HR=0.39; 95% CI: 0.25-0.67; p = 0.0003).
• Net loss for the fourth quarter of 2025 was $51.0 million, or $0.97 per share, compared to a net loss of $36.7 million, or $0.85 per share, for the fourth quarter of 2024.
• Net loss for the full year 2025 was $177.0 million, or $3.79 per share, compared to a net loss of $111.8 million, or $2.83 per share, in 2024.
• Total operating expenses increased to $49.2 million for Q4 2025 from $36.4 million for Q4 2024, and to $172.2 million for FY 2025 from $113.3 million for FY 2024.
• Cash, cash equivalents, and short-term investments totaled $441.5 million at the end of fiscal year 2025 and are expected to finance operations through 2027.

Sentiment

Score: 8

Explanation: StockSavvy.ai views this as highly positive due to the FDA's Priority Review and exceptionally strong Phase 3 clinical data for gedatolisib, which significantly de-risks the lead asset and points towards potential market approval and commercialization. While financial losses increased, this is typical for a clinical-stage biotech nearing commercialization.

Positives

• The FDA accepted the New Drug Application (NDA) for gedatolisib and granted Priority Review, indicating a faster review timeline and potential for accelerated market entry.
• A PDUFA goal date of July 17, 2026, provides a clear and near-term timeline for potential FDA approval.
• Strong efficacy results from the Phase 3 VIKTORIA-1 PIK3CA WT cohort showed a median Progression Free Survival (PFS) of 16.6 months for the gedatolisib triplet versus 1.9 months for fulvestrant (HR=0.14; p<0.0001).
• Significant improvement in patient-reported outcomes for well-being, with the gedatolisib triplet delaying time to definitive deterioration to 23.7 months versus 4.0 months for fulvestrant.
• The hazard ratio for the gedatolisib triplet is more favorable than any previously reported in Phase 3 trials for patients with HR+/HER2Advanced Breast Cancer (ABC).
• The 7.3-month incremental improvement in median PFS for the gedatolisib triplet over fulvestrant is higher than any previously reported in Phase 3 trials for patients with HR+/HER2ABC receiving at least their second line of endocrine therapy-based regimen.
• Gedatolisib is the first inhibitor targeting the PI3K/AKT/mTOR (PAM) pathway to demonstrate positive Phase 3 results in patients with HR+/HER2-/PIK3CA WT ABC whose disease progressed on or after treatment with a CDK4/6 inhibitor.
• Median duration of response (DOR) of 17.5 months and incremental objective response rate (ORR) improvement of 31% relative to control for the gedatolisib triplet is the highest reported for an endocrine therapy-based regimen in second-line HR+/HER2ABC.
• Cash, cash equivalents, and short-term investments of $441.5 million at year-end 2025 are expected to finance operations through 2027, providing a strong liquidity runway.

Negatives

• Net loss for the fourth quarter of 2025 increased to $51.0 million from $36.7 million in the prior-year quarter.
• Full year 2025 net loss increased to $177.0 million from $111.8 million in 2024.
• Net loss per share for Q4 2025 was $0.97, up from $0.85 in Q4 2024, and for FY 2025 was $3.79, up from $2.83 in FY 2024.
• Total operating expenses significantly increased to $49.2 million in Q4 2025 from $36.4 million in Q4 2024, and to $172.2 million for FY 2025 from $113.3 million for FY 2024.
• Research and development (R&D) expenses increased due to higher employee and consulting expenses, including commercial headcount additions and launch-related activities.
• General and administrative (G&A) expenses substantially increased due to higher employee-related and consulting expenses, including $10.4 million in non-cash stock-based compensation for the full year 2025, and expanding infrastructure costs.
• Net cash used in operating activities increased to $36.4 million in Q4 2025 from $27.8 million in Q4 2024, and to $153.3 million for FY 2025 from $83.5 million for FY 2024, indicating a higher cash burn rate.
• The gedatolisib triplet was associated with higher rates of Grade 3+ treatment-related adverse events (TRAEs) such as neutropenia (62.3%), stomatitis (19.2%), rash (4.6%), and hyperglycemia (2.3%) compared to fulvestrant alone.
• 2.3% of patients in the gedatolisib triplet group discontinued study treatment due to TRAEs.

Risks

• Clinical results are based on an ongoing analysis of key efficacy and safety data, and such data may change following a more comprehensive review.
• Unforeseen delays in clinical trials or the FDA's review of the NDA for gedatolisib.
• The ability to obtain and maintain regulatory approvals to commercialize gedatolisib.
• Market acceptance of gedatolisib if approved.
• The development of therapies and tools competitive with gedatolisib.
• The ability to access capital upon favorable terms.
• Other risks detailed in the Annual Report on Form 10-K for the year ended December 31, 2025, and subsequent filings with the Securities and Exchange Commission.

Future Outlook

Management expects 2026 to be a transformative year for Celcuity, with the anticipated release of topline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 study in the second quarter of 2026. The company's efforts remain on track to commercially launch gedatolisib in anticipation of its potential FDA approval in the third quarter of 2026. Current cash, cash equivalents, and short-term investments are projected to finance operations through 2027.

Management Comments

• "We expect this year to be a transformative one for Celcuity. We plan to release topline results from the PIK3CA mutant cohort of our Phase 3 VIKTORIA-1 study in the second quarter of 2026, which, if positive, could potentially advance the standard-of-care second line therapy for a significant number of patients with HR+/HER2advanced breast cancer."
• "Additionally, our efforts remain on track to launch gedatolisib commercially in anticipation of its potential FDA approval in the third quarter of 2026."

Industry Context

StockSavvy.ai notes that the FDA's Priority Review for gedatolisib in HR+/HER2-/PIK3CA WT advanced breast cancer positions Celcuity as a potential leader in a challenging oncology segment. The strong Phase 3 VIKTORIA-1 data, particularly the unprecedented hazard ratio and incremental PFS, suggest gedatolisib could significantly improve outcomes for patients whose disease has progressed on existing CDK4/6 inhibitors, addressing a critical unmet need in the second-line endocrine therapy setting. This development could disrupt the current treatment landscape, which has seen limited innovation for this specific patient population.

Comparison to Industry Standards

• The hazard ratio for the gedatolisib triplet is more favorable than has ever been reported by any Phase 3 trial for patients with HR+/HER2ABC.
• The 7.3-months incremental improvement in median PFS for the gedatolisib triplet over fulvestrant is higher than has ever been reported by any Phase 3 trial for patients with HR+/HER2ABC receiving at least their second line of endocrine therapy-based regimen.
• Gedatolisib is the first inhibitor targeting the PI3K/AKT/mTOR (PAM) pathway to demonstrate positive Phase 3 results in patients with HR+/HER2-/PIK3CA WT ABC whose disease progressed on or after treatment with a CDK4/6 inhibitor, differentiating it from other PI3K/AKT/mTOR inhibitors.
• Median duration of response (DOR) of 17.5 months and incremental objective response rate (ORR) improvement of 31% relative to control for the gedatolisib triplet is the highest reported for an endocrine therapy-based regimen in second line HR+/HER2ABC.

Stakeholder Impact

• Shareholders: Potential for significant value creation if gedatolisib receives FDA approval and achieves commercial success, driven by strong clinical data and market opportunity. Increased operating expenses and net losses represent ongoing investment in pipeline and commercialization efforts.
• Patients (HR+/HER2ABC): Gedatolisib offers a potentially highly effective new treatment option with significantly improved progression-free survival and quality of life benefits, especially for those whose disease has progressed on prior therapies.
• Employees: Increased headcount for commercial launch activities indicates growth and potential for new roles.
• Regulatory Authorities (FDA): The Priority Review status reflects the FDA's recognition of gedatolisib's potential to address an unmet medical need.

Next Steps

• Release of topline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 study in the second quarter of 2026.
• FDA decision on gedatolisib NDA by the PDUFA goal date of July 17, 2026.
• Commercial launch of gedatolisib in anticipation of potential FDA approval in the third quarter of 2026.
• Ongoing Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for endocrine treatment resistant HR+/HER2ABC.
• Ongoing Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer.

Key Dates

Recommendation

The FDA's acceptance of the NDA with Priority Review and the PDUFA goal date of July 17, 2026, for gedatolisib, combined with exceptionally strong Phase 3 VIKTORIA-1 data showing unprecedented efficacy metrics in a difficult-to-treat breast cancer population, significantly de-risks the company's lead asset. While financial losses are increasing, this is a necessary investment for a clinical-stage biotech on the cusp of commercialization. The substantial cash runway through 2027 further supports the company's ability to execute its launch plans. The potential for gedatolisib to become a new standard of care in second-line HR+/HER2ABC presents a significant market opportunity, making Celcuity a compelling "Strong Buy" for investors seeking exposure to high-growth oncology therapeutics.

Keywords

Celcuity, CELC, biotechnology, oncology, targeted therapies, breast cancer, gedatolisib, PI3K/AKT/mTOR, PAM pathway, VIKTORIA-1, clinical trial, Phase 3, FDA, NDA, Priority Review, PDUFA, HR+/HER2-, PIK3CA WT, advanced breast cancer, financial results, Q4 2025, FY 2025, net loss, operating expenses, R&D, G&A, cash, liquidity