0001493152-26-023180
SEC filingPre-revenue biotech Celcuity deepened losses in Q1 FY2026 as it ramped commercial launch preparations for gedatolisib, with operating cash burn widening to $55.1M.
Celcuity expects to use cash on hand, together with funds received or to be received under debt and equity financings, to fund research and development expenses, clinical trial costs, sales and marketing expenses, general corporate expenses, capital expenditures, and working capital. The company's cash position is expected to support operations through key milestones, including the PDUFA target action date of July 17, 2026, for the NDA seeking approval of gedatolisib in HR+/HER2- PIK3CA WT advanced breast cancer.
The most significant near-term catalyst is the PDUFA target action date of July 17, 2026, for the NDA seeking approval of gedatolisib in HR+/HER2- PIK3CA WT advanced breast cancer. On May 1, 2026, the company announced positive topline results from the PIK3CA MT cohort of VIKTORIA-1, with detailed results to be presented at ASCO on June 2. These data are expected to support a supplemental NDA submission. Additionally, the VIKTORIA-2 Phase 3 trial in first-line HR+/HER2- ABC is ongoing, with topline data for the endocrine-resistant cohort expected by end of 2028. The company also submitted its first patent application for a subcutaneous formulation of gedatolisib, which could extend the drug's utility for longer treatment durations.