CG Oncology Reports $161M Net Loss and $4M Revenue in Annual 10-K Filing

CG Oncology Reports Financial Results and Business Updates in Annual 10-K Filing

CG Oncology, Inc., a late-stage clinical biopharmaceutical company, released its financial results and provided business updates in its annual report on Form 10-K. The company, focused on developing cretostimogene for bladder cancer, reported a net loss of $161.0 million for the year ended December 31, 2025, compared to a net loss of $88.0 million for the previous year. This increase in net loss is primarily attributed to increased research and development expenses, as well as higher general and administrative costs associated with expanding operations and supporting ongoing clinical trials. The company's accumulated deficit as of December 31, 2025, stood at $379.0 million.

Despite the losses, CG Oncology reported total revenues of $4.0 million for 2025, a significant increase from $1.1 million in 2024. This revenue includes $3.2 million in commercial and development revenue from Biovire, a contract manufacturing organization acquired in July 2025, and $0.8 million in license and collaboration revenue, primarily related to the Kissei License Agreement. Research and development expenses increased to $116.6 million in 2025 from $82.1 million in 2024, driven by higher clinical trial expenses and increased personnel costs. General and administrative expenses also rose to $73.5 million from $33.7 million, reflecting increased headcount and professional fees.

Operationally, CG Oncology has made significant progress with its lead product candidate, cretostimogene. The company initiated its Biologics License Application (BLA) submission to the FDA in the fourth quarter of 2025, based on data from its Phase 3 BOND-003 Cohort C trial. Enrollment was completed in the Phase 3 PIVOT-006 trial for intermediate-risk NMIBC, and initial data from the Phase 2 CORE-008 Cohort A trial in high-risk BCG-naïve NMIBC patients were reported. The company also expanded the CORE-008 trial to include cohorts evaluating cretostimogene in BCG-exposed patients and in combination with gemcitabine. As of December 31, 2025, CG Oncology had 142 full-time employees, with 85 engaged in research and development and 22 in commercial readiness activities.

Looking ahead, CG Oncology anticipates continued investment in its clinical development programs and commercial infrastructure. The company believes its existing cash, cash equivalents, and marketable securities of $742.2 million as of December 31, 2025, will be sufficient to fund operations for at least the next twelve months. However, the company acknowledges the need for substantial additional funding to support its long-term goals and may seek to raise capital through equity offerings, debt financings, or strategic collaborations. The company's strategy includes pursuing FDA approval for cretostimogene, expanding its development across various bladder cancer indications, and building its operational capabilities to successfully commercialize its product candidate.