Celcuity (NASDAQ:CELC) executives used the company’s fourth-quarter and full-year 2025 earnings call to highlight progress toward a potential 2026 U.S. launch of gedatolisib, review data from its lead breast cancer program, and outline its commercial and regulatory preparations. Management also reported higher operating expenses and a larger net loss in 2025 as the company expanded headcount and ramped launch-related activities.
Gedatolisib NDA accepted with priority review
Chief Executive Officer and co-founder Brian Sullivan said the company is preparing for what it expects could be a “transformative year” as it moves toward a potential approval and commercialization of gedatolisib. Sullivan said the FDA has accepted Celcuity’s new drug application (NDA) and granted priority review, with a Prescription Drug User Fee Act (PDUFA) goal date of July 17, 2026. He added that the submission was made under the FDA’s Real-Time Oncology Review Program, which he described as being used for drugs offering substantial improvements over available therapies.
VIKTORIA-1 wild-type efficacy and safety recap
Management reiterated previously disclosed efficacy results from the PIK3CA wild-type cohort of VIKTORIA-1 evaluating the gedatolisib triplet (gedatolisib, abemaciclib, and fulvestrant) in HR-positive, HER2-negative advanced breast cancer after progression on or after CDK4/6 inhibitor therapy. Sullivan said median progression-free survival (PFS) was 9.3 months for the triplet compared with 2 months for fulvestrant, with a hazard ratio of 0.24.
He emphasized additional metrics and subgroup analyses, including:
- Median duration of response of 17.5 months for the gedatolisib triplet and a 31% incremental increase in objective response rate versus control.
- Consistent benefit across subgroups, including a median PFS of 19.3 months versus 2 months in patients enrolled in the U.S. or Canada (hazard ratio 0.13).
- In an expanded regional analysis covering the U.S., Canada, Western Europe, and Asia-Pacific (nearly 60% of enrolled patients), median PFS of 16.6 months versus 1.9 months (hazard ratio 0.14).
On safety, Sullivan said the triplet regimen was “generally well-tolerated” with mostly low-grade adverse events and a 2.3% discontinuation rate due to treatment-related adverse events. He highlighted additional analyses presented at SABCS on stomatitis mitigation, reporting a median time to improvement to a lower grade of 12 days for grade 2 and 14 days for grade 3 stomatitis. He also said gedatolisib “did not induce meaningful changes” in glucose levels and required no dose reductions or withdrawals due to hyperglycemia.
Celcuity also discussed patient-reported outcomes. Sullivan said median time to definitive deterioration was 23.7 months for the triplet versus 4 months for fulvestrant (hazard ratio 0.39), and that patients’ self-assessments of well-being were stable over the first eight cycles compared with baseline.
Upcoming catalysts: PIK3CA mutant readout, VIKTORIA-2 design update
Sullivan said Celcuity completed enrollment of the PIK3CA mutant cohort of VIKTORIA-1 late in 2025 and expects to announce results in a top-line press release in the second quarter, with full results presented at a medical conference in 2026 alongside an investor call. He repeatedly emphasized that the company would not provide additional details on trial progress, database status, or expectations for the mutant cohort during Q&A. In response to an analyst question about the scope of the top-line disclosure, Sullivan said it would be limited and mindful of embargo requirements, characterizing it as a statement about whether statistical significance was achieved.
Celcuity also provided an update on VIKTORIA-2, a Phase III study evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment in endocrine therapy-resistant HR-positive, HER2-negative advanced breast cancer. Sullivan said the company is “wrapping up” the safety run-in and expects to provide an update on the final Phase III study design in the second quarter. In Q&A, he said completion of the safety run-in—particularly assessing the combination with ribociclib—was the key gating factor before proceeding with Phase III enrollment.
Commercial and regulatory preparations, plus 2025 financial results
Chief Commercial Officer Eldon Mayer and other executives were available for Q&A, while Sullivan described launch readiness activities. He said Celcuity has “largely completed” building its commercial organization, including sales force and internal systems, and has been conducting outreach to payers, strategic accounts, and population health decision-makers across health systems, integrated delivery networks, and community practices.
On physician and patient receptivity to an IV-administered therapy, Sullivan said Celcuity’s market research indicates efficacy is the most important decision factor, while IV administration appeared as a negative factor in “meaningfully less than 10%” of physician responses. He said patient research suggested limited pushback except in cases of geographic or mobility constraints.
Management also discussed the potential advantage of a biomarker-agnostic label, arguing it could simplify decision-making for physicians. Sullivan said that if the mutant cohort also reads out positively, gedatolisib could be positioned as a second-line option regardless of PIK3CA mutation status.
On market sizing, Sullivan said Celcuity estimates about 37,000 U.S. patients with HR-positive, HER2-negative advanced breast cancer have progressed after CDK4/6 inhibitor therapy. Using internal duration-of-treatment estimates and pricing assumptions consistent with available therapies, he estimated a total addressable market of more than $5 billion in the second-line setting and suggested peak revenue could reach up to $2.5 billion annually. In response to an analyst question, he cited a “round number” assumption of 10 months duration of therapy for modeling purposes, noting it was not a projection.
In Europe and Japan, Sullivan said Celcuity’s plan—assuming positive mutant data and an initial U.S. approval—would be to submit a supplemental NDA in the U.S., then leverage documentation from both datasets for a European submission targeted for the fourth quarter of the current year. He said the company would use the review window to explore partnering for Europe and potentially global markets, while continuing regulatory engagement in Japan.
Chief Financial Officer Vicky Hahne reported a fourth-quarter net loss of $51.0 million, or $0.97 per share, compared with a net loss of $36.7 million, or $0.85 per share, in the fourth quarter of 2024. For the full year, net loss was $177.0 million, or $3.79 per share, compared with $111.8 million, or $2.83 per share, in 2024.
On a non-GAAP basis, Celcuity posted an adjusted net loss of $38.4 million (or $0.73 per share) in the fourth quarter and $150.8 million (or $3.22 per share) for the full year.
R&D expense rose to $37.6 million in the fourth quarter from $33.5 million a year earlier, and to $145.0 million for the full year from $104.2 million. Hahne attributed the increases primarily to higher employee and consulting expenses, including commercial headcount additions and launch-related activities, along with costs supporting ongoing clinical trials and a development milestone payment under Celcuity’s license agreement with Pfizer.
G&A expense increased to $11.6 million in the fourth quarter from $3.0 million in the prior-year quarter, and to $27.2 million for the year from $9.1 million, driven largely by employee-related and consulting expenses, including non-cash stock-based compensation, plus professional fees and infrastructure expansion.
Net cash used in operating activities was $36.4 million for the fourth quarter and $153.3 million for the full year. Celcuity ended 2025 with $441.5 million in cash, cash equivalents, and short-term investments, which Hahne said is expected to fund operations through 2027.
About Celcuity (NASDAQ:CELC)
Celcuity, Inc is a clinical-stage biotechnology company specializing in precision oncology diagnostics. The company develops and commercializes predictive biomarker assays designed to identify which patients are most likely to benefit from targeted cancer therapies. By integrating functional profiling of tumor cells with molecular analyses, Celcuity seeks to optimize treatment selection and improve outcomes for patients with solid tumors.
Celcuity’s proprietary platform evaluates tumor cell sensitivity to various therapeutic agents using ex vivo assays that measure DNA damage response and other critical pathways.
