CG Oncology Reports Significant Revenue Decline and Increased Losses in Latest Financial Filing

CG Oncology, Inc. reported significant financial challenges in its latest 10-Q filing for the quarter ending June 30, 2025. The company recorded no revenue from license and collaboration agreements during the quarter, a stark decline from $111,000 in the same period last year. For the first half of 2025, total revenue amounted to $52,000, down from $640,000 in the first half of 2024. The company continues to operate at a loss, with a net loss of $41.4 million for the second quarter and $75.9 million for the first half of the year, compared to losses of $18.9 million and $35.8 million, respectively, in the prior year.

Operating expenses surged to $90.997 million for the first half of 2025, a 85% increase from $48.962 million in the same period of 2024. This increase was primarily driven by a rise in research and development (R&D) expenses, which totaled $58.8 million, up from $35.7 million a year earlier. The company attributed this rise to higher external clinical trial costs and increased personnel-related expenses, including stock-based compensation. General and administrative expenses also rose significantly, reaching $32.2 million compared to $13.3 million in the previous year, largely due to increased headcount and professional fees.

In terms of operational developments, CG Oncology is focused on advancing its lead product candidate, cretostimogene grenadenorepvec, which is currently in clinical trials for bladder cancer. The company has initiated several studies, including the BOND-003 and CORE-008 trials, and is preparing for a potential Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) in late 2025. The company has received Fast Track and Breakthrough Therapy designations from the FDA, indicating a favorable regulatory outlook for its product candidate.

As of June 30, 2025, CG Oncology reported cash, cash equivalents, and marketable securities totaling approximately $661.1 million, down from $754.8 million at the end of 2024. The company has sufficient liquidity to fund its operations into the first half of 2028, although it anticipates needing additional funding to support ongoing clinical trials and potential commercialization efforts. The company has entered into an Open Market Sale Agreement with Jefferies LLC to offer up to $250 million in common stock, although no sales have been made under this agreement as of the reporting date.

Looking ahead, CG Oncology expects to continue incurring significant expenses as it advances its clinical programs and prepares for potential product commercialization. The company remains focused on its strategic initiatives to build operational capabilities and ensure readiness for market entry, should regulatory approval be granted for cretostimogene. However, the path to profitability remains uncertain, contingent on successful clinical outcomes and market acceptance of its product candidate.