CG Oncology Reports 90% Revenue Decline and 84% Increase in Operating Expenses for Q1 2025

CG Oncology, Inc. reported its financial results for the first quarter of 2025, revealing a significant decline in revenue and an increase in operating expenses compared to the same period in 2024. The company generated $52,000 in license and collaboration revenue, a decrease of approximately 90% from $529,000 in the prior year. This drop is attributed to the absence of revenue from the Lepu License Agreement, which contributed $500,000 in the first quarter of 2024, while the Kissei License Agreement generated $100,000 in the current quarter.

Operating expenses surged to $42.3 million, up from $23.0 million in the same quarter last year, marking an increase of 84%. This rise was primarily driven by a $10.3 million increase in research and development expenses, which totaled $27.5 million, reflecting higher costs associated with clinical trials and increased personnel expenses. General and administrative expenses also rose significantly, reaching $14.8 million, up from $5.8 million, largely due to increased headcount and associated compensation costs.

The company reported a net loss of $34.5 million for the first quarter of 2025, compared to a net loss of $16.9 million in the same period of 2024. The loss per share was $0.45, compared to $0.36 in the previous year. As of March 31, 2025, CG Oncology had an accumulated deficit of $252.4 million and cash, cash equivalents, and marketable securities totaling $688.4 million, which the company believes will be sufficient to fund operations into the first half of 2028.

In terms of strategic developments, CG Oncology is actively preparing for the potential commercialization of its product candidate, cretostimogene grenadenorepvec, which is currently in clinical trials for bladder cancer treatment. The company has initiated several clinical trials, including the BOND-003 and CORE-008 studies, and has received Fast Track and Breakthrough Therapy designations from the FDA. Additionally, the company entered into an Open Market Sale Agreement with Jefferies LLC to potentially raise up to $250 million through the sale of common stock.

Looking ahead, CG Oncology anticipates continued significant expenses as it advances its clinical development and prepares for potential commercialization. The company remains focused on obtaining regulatory approval for cretostimogene and is evaluating additional product candidates. However, it acknowledges the inherent uncertainties in pharmaceutical development and the need for substantial additional funding to support its operations and growth strategy.