Celcuity Q4 FY25 earnings call CELC

Celcuity achieved a significant regulatory milestone with the FDA's acceptance of its New Drug Application (NDA) for gedatolisib, granting it priority review with a PDUFA goal date of July 17, 2026. This submission was made under the FDA's real-time oncology review program, indicating the drug's potential for substantial improvement over existing therapies. The NDA is supported by groundbreaking data from the PIK3CA wild-type cohort of the Phase III VIKTORIA-1 trial, which demonstrated a median Progression-Free Survival (PFS) of 9.3 months for the gedatolisib triplet (gedatolisib, palbociclib, and fulvestrant) compared to only 2 months for fulvestrant, resulting in an unprecedented^🌐 hazard ratio of 0.24. This represents a 7.3-month incremental improvement in median PFS, the highest reported in this disease setting. Additionally, the gedatolisib triplet achieved a 17.5-month median duration of response and a 31% incremental increase in objective response rate, setting new benchmarks for endocrine therapy-based regimens in second-line HR-positive/HER2-negative advanced breast cancer.

The safety profile of the gedatolisib triplet in the VIKTORIA-1 trial was generally well tolerated, with mostly low-grade adverse events. Treatment discontinuation due to treatment-related adverse events was low at 2.3%. Notably, measures to mitigate stomatitis were effective, with median time to improvement from first onset to a lower grade being 12 and 14 days for Grade 2 and 3 stomatitis, respectively. Unlike other approved PI3K-alpha inhibitors, gedatolisib did not induce clinically relevant hypoglycemia, requiring no dose reductions or withdrawals due to glucose issues. Patient-reported outcomes further supported tolerability, showing a median time to definitive deterioration of 23.7 months for the gedatolisib triplet versus 4 months for fulvestrant (HR 0.39), and stable patient well-being assessments for the first 8 cycles of treatment.

Celcuity is actively preparing for the potential launch of gedatolisib, having largely completed building its commercial organization, including the sales force and internal systems. The company has engaged extensively with payers, strategic accounts, and population health decision-makers, receiving positive feedback. Research indicates strong willingness among oncologists to prescribe gedatolisib upon approval. Based on epidemiological data, an estimated 37,000 patients in the U.S. with HR-positive/HER2-negative advanced breast cancer have progressed after CDK4/6 inhibitor treatment. Using internal duration of treatment estimates (approximately 10 months) and pricing assumptions, the total addressable market for gedatolisib in this second-line setting is estimated to be over $5 billion, with a potential for peak annual revenue of up to $2.5 billion.

Enrollment for the PIK3CA mutant cohort of the Phase III VIKTORIA-1 trial was completed late last year, with top-line results expected to be announced in a press release in Q2 2026, followed by full results presentation at a medical conference later in 2026. The company believes positive results from this cohort would uniquely position the gedatolisib triplet as a second-line therapy regardless of PIK3CA mutation status. Additionally, the VIKTORIA-2 study, a Phase III trial evaluating gedatolisib as first-line treatment, is wrapping up its safety run-in, with an update on the final study design anticipated in Q2 2026. The positive wild-type data augurs well for gedatolisib's potential efficacy in this first-line setting.

Celcuity presented detailed data for the Phase Ib portion of its Phase Ib/II clinical trial evaluating gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer. In this study, patients receiving standard doses of darolutamide and either 120 mg or 180 mg of gedatolisib achieved a 6-month radiographic PFS (rPFS) rate of 67% and a median rPFS of 9.1 months across both arms. These results compare favorably to historical rates of 40% 6-month rPFS for similar patients. The combination was generally well tolerated with mostly low-grade adverse events, and no dose-limiting toxicities were observed. The company is continuing dose escalation to determine the recommended Phase II dose, with an update on this data expected by the end of 2026 or early 2027.

For Q4 FY25, Celcuity reported a net loss of $51 million ($0.97 per share) and a non-GAAP adjusted net loss of $38.4 million ($0.73 per share). Full-year 2025 saw a net loss of $177 million ($3.79 per share) and a non-GAAP adjusted net loss of $150.8 million ($3.22 per share). Research and development expenses increased to $145 million for FY25, driven by increased employee and consulting expenses, including commercial headcount additions and launch-related activities. General and administrative expenses also rose to $27.2 million for FY25, primarily due to increased employee-related and consulting expenses, including non-cash stock-based compensation. Net cash used in operating activities for FY25 was $153.3 million. The company ended FY25 with $441.5 million in cash, cash equivalents, and short-term investments, which is expected to fund operations through 2027.

Celcuity plans to submit a Marketing Authorization Application (MAA) in Europe in Q4 2026, following the potential completion of a supplemental NDA (sNDA) for gedatolisib in the U.S. that would incorporate both wild-type and mutant cohort data. The MAA review process is estimated to take approximately 13 months. This timeline provides a window to explore partnerships for commercialization in Europe and potentially globally. The company is also engaging with regulators in Japan to define the regulatory pathway for submission there, aiming to proceed with regulatory activities in key international markets without delaying launch capabilities.