Celcuity Reports $111.8 Million Net Loss and Advances Clinical Trials for Gedatolisib

Celcuity Inc., a clinical-stage biotechnology company, reported significant financial developments in its recent 10-K filing for the fiscal year ending December 31, 2024. The company recorded a net loss of approximately $111.8 million, a 75% increase from the $63.8 million loss reported in 2023. This increase in losses was primarily driven by a 72% rise in research and development expenses, which totaled $104.2 million, largely due to ongoing clinical trials for its lead product candidate, gedatolisib. General and administrative expenses also rose by 61% to $9.1 million, reflecting the company's expansion efforts and increased operational costs.

Celcuity's cash and cash equivalents decreased to approximately $22.5 million as of December 31, 2024, down from $30.7 million the previous year. However, the company reported a substantial increase in short-term investments, which rose to $212.6 million from $149.9 million in 2023. The company has funded its operations primarily through equity and debt offerings, raising approximately $369 million since its inception. Notably, Celcuity entered into an Amended and Restated Loan and Security Agreement in May 2024, allowing for term loans of up to $180 million, which will support ongoing clinical trials and operational needs.

In terms of strategic developments, Celcuity is advancing its clinical programs for gedatolisib, which targets multiple solid tumor indications. The company is currently enrolling patients in its Phase 3 clinical trial, VIKTORIA-1, which evaluates gedatolisib in combination with fulvestrant and palbociclib for patients with HR+/HER2- advanced breast cancer. The trial has achieved its enrollment target for the PIK3CA wild-type cohort, with topline data expected in the second quarter of 2025. Additionally, the company has initiated a Phase 1b/2 trial, CELC-G-201, for metastatic castration-resistant prostate cancer, with the first patient dosed in February 2024.

Operationally, Celcuity reported a total of 87 full-time employees as of December 31, 2024, with a voluntary turnover rate of approximately 5%. The company is focused on expanding its workforce in preparation for the anticipated commercialization of gedatolisib. The filing also highlighted the company's reliance on third-party manufacturers and clinical trial partners, which poses risks related to compliance and operational efficiency. Celcuity's management expressed confidence that its current cash and investments will be sufficient to fund operations through at least 2026, although they may seek additional capital to support future growth and development initiatives.

Looking ahead, Celcuity remains optimistic about the potential of gedatolisib, particularly following its receipt of Fast Track and Breakthrough Therapy designations from the FDA. These designations are intended to expedite the development and regulatory review processes for drugs that address unmet medical needs. However, the company acknowledged the inherent uncertainties in clinical development and regulatory approval, emphasizing that its future success is contingent upon the successful completion of ongoing trials and the ability to secure necessary funding.