Celcuity Inc. Reports Financial Developments, Increases Research and Development Expenses, and Raises $138.3 Million in Funding

Celcuity Inc., a clinical-stage biotechnology company focused on targeted therapies for solid tumors, reported significant financial developments in its 10-Q filing for the quarter ending September 30, 2024. The company continues to operate without generating any revenue, as it invests heavily in research and development, particularly for its lead therapeutic candidate, gedatolisib.

As of September 30, 2024, Celcuity's cash and cash equivalents stood at $12.6 million, a decrease from $30.7 million at the end of 2023. However, the company’s investments increased substantially to $251.5 million from $149.9 million during the same period. Total current assets rose to $272.4 million, while total liabilities surged to $123.3 million, up from $51.5 million at the end of the previous fiscal year. This increase in liabilities is primarily attributed to the company’s new debt financing arrangements.

Operating expenses for the three months ended September 30, 2024, reached $30.1 million, a 59% increase from $18.9 million in the same period of 2023. Research and development expenses accounted for a significant portion of this, totaling $27.6 million, up from $17.5 million year-over-year. The net loss for the quarter was approximately $29.8 million, compared to $18.4 million in the prior year, marking a 62% increase in losses.

For the nine months ended September 30, 2024, Celcuity reported a net loss of $75.1 million, a 67% increase from $44.9 million in the same period of 2023. The company’s total operating expenses for this nine-month period were $76.8 million, up from $46.5 million in 2023. The increase in expenses is largely due to heightened research and development activities as the company advances its clinical trials.

In terms of financing, Celcuity raised approximately $138.3 million through various activities, including a significant equity offering that generated net proceeds of about $56.3 million. The company also entered into an Amended and Restated Loan and Security Agreement, securing up to $180 million in term loans, with the first tranche of $100 million funded in May 2024.

Celcuity is currently conducting several clinical trials, including the Phase 3 VIKTORIA-1 trial for gedatolisib in advanced breast cancer, which is actively enrolling patients. The company anticipates further clinical developments, including the initiation of the VIKTORIA-2 trial in 2025. As of September 30, 2024, the accumulated deficit stood at approximately $235.2 million, reflecting the ongoing investment in its clinical programs.