Celcuity Q1 FY26 earnings call CELC

Celcuity reported positive top-line results for the PIK3CA mutant cohort of the Phase III VIKTORIA-1 clinical trial. The gedatolisib triplet and doublet demonstrated statistically significant and clinically meaningful improvement in progression-free survival compared to alpelisib and fulvestrant. These results, combined with previously reported wild-type data, suggest gedatolisib's potential as a second-line standard of care regardless of PIK3CA status. Detailed results are scheduled to be presented at the 2026 ASCO meeting on June 2.

The company announced the expansion of its Phase III VIKTORIA-2 trial to include a second study evaluating gedatolisib as first-line treatment in endocrine-sensitive HR-positive, HER2-negative advanced breast cancer. This expansion aims to address nearly all patients in the first-line setting, irrespective of endocrine sensitivity or PIK3CA status, potentially advancing the standard of care for approximately 90,000 women annually in the U.S. The study design was amended following a Type B meeting with the FDA, and the sample size for the endocrine-resistant study (Study 1) was reduced from 638 to 440 patients.

Celcuity is advancing the development of a subcutaneous injection formulation for gedatolisib, with a patent application already submitted to the U.S. Patent and Trademark Office. This formulation is intended to support potential future indications requiring longer treatment durations, with the goal of demonstrating clinical equivalence to the current intravenous formulation. The company aims to have the subcutaneous form available around the same timeline as a potential approval for the endocrine-sensitive population.

An update was provided on the Phase Ib/II trial evaluating gedatolisib in combination with darolutamide in mCRPC. The Phase Ib portion showed the combination was generally well tolerated with mostly low-grade treatment-related adverse events and no dose-limiting toxicities. The 6-month radiographic PFS rate was 67%, and median radiographic PFS was 9.1 months, comparing favorably to historical data of 40% for second-line androgen receptor inhibitors. Enrollment in the dose escalation portion is ongoing, with a data update expected at an upcoming medical conference.

Celcuity has completed building its commercial organization, including hiring and onboarding all oncology sales specialists, who possess extensive experience (average 24 years in pharma, 16 years in oncology) in launching novel oncology therapeutics. Research indicates optimism about establishing gedatolisib as a new standard of care. The estimated total addressable market for gedatolisib in the second-line setting for HR-positive/HER2-negative advanced breast cancer is over $5 billion annually, with a potential for peak revenue of up to $2.5 billion annually.

For Q1 FY26, Celcuity reported a net loss of $52.8 million and a non-GAAP adjusted net loss of $46.8 million. R&D expenses increased by $3.3 million to $33.1 million, primarily due to employee-related and consulting expenses. SG&A expenses rose by $11.1 million to $17.4 million, mainly driven by commercial headcount and launch activities. Net cash used in operating activities was $55.1 million. The company ended the quarter with $387.1 million in cash, cash equivalents, and short-term investments, which are expected to fund operations through 2027.