CG Oncology Reports $1.7 Million Revenue and $119.7 Million Net Loss for Nine Months Ended September 30, 2025

CG Oncology, Inc. reported its financial results for the third quarter of 2025, revealing a total revenue of $1.7 million for the nine months ended September 30, 2025, a significant increase from $683,000 in the same period of 2024. The revenue primarily stemmed from commercial and development activities, which generated $1.5 million, while license and collaboration revenue amounted to $210,000. Despite this revenue growth, the company incurred a net loss of $119.7 million for the nine months, compared to a loss of $56.2 million in the prior year, reflecting increased operational costs associated with its ongoing clinical trials and development efforts.

The company's operating expenses surged to $143.8 million for the nine months ended September 30, 2025, up from $77.3 million in the same period of 2024. This increase was largely driven by a rise in research and development (R&D) expenses, which reached $86.7 million, compared to $55.3 million in the previous year. The R&D costs were attributed to higher external clinical trial expenses and increased personnel-related costs due to a growing workforce. General and administrative expenses also rose significantly, totaling $55.5 million, up from $22 million, primarily due to increased professional fees and compensation costs.

In terms of strategic developments, CG Oncology completed the acquisition of Biovire, a contract manufacturer, in July 2025, which is expected to enhance its capabilities in supplying clinical materials for its product candidate, cretostimogene grenadenorepvec. This acquisition was part of a broader strategy to streamline operations and ensure a reliable supply chain for its clinical trials. The company has also been actively preparing for the potential commercialization of cretostimogene, which is currently in late-stage clinical trials for bladder cancer treatment.

As of September 30, 2025, CG Oncology reported cash, cash equivalents, and marketable securities totaling approximately $680.3 million, providing a solid financial foundation to support its ongoing operations. The company anticipates that this capital will be sufficient to fund its activities into the first half of 2028. However, it acknowledged the need for additional funding to support its growth strategy, which includes further clinical development and potential commercialization efforts. The company has entered into an at-the-market offering agreement to raise up to $250 million, which could provide further financial flexibility.

Looking ahead, CG Oncology remains focused on advancing its clinical trials and preparing for regulatory submissions. The company has received Fast Track and Breakthrough Therapy designations from the FDA for cretostimogene, underscoring its commitment to addressing the unmet needs of patients with high-risk bladder cancer. The company is optimistic about the potential for cretostimogene to become a key treatment option, although it recognizes the inherent uncertainties and challenges associated with drug development and commercialization.