CG Oncology Reports 2025 Year End Financial Results and Provides Business Updates

Core Insights - CG Oncology, Inc. reported financial results for Q4 and the full year 2025, highlighting a net loss of $161.0 million for the year, compared to a loss of $88.0 million in 2024, indicating increased operational costs and investments in R&D [12][14]. Financial Highlights - Cash and cash equivalents as of December 31, 2025, were $742.2 million, up from $680.3 million as of September 30, 2025, bolstered by net proceeds of approximately $98.4 million from shares sold in Q4 [5][8]. - R&D expenses for Q4 2025 were $30.0 million, an increase from $26.8 million in Q4 2024, with full-year R&D expenses totaling $116.6 million compared to $82.1 million in 2024 [12]. - G&A expenses for Q4 2025 were $18.0 million, up from $11.7 million in the prior year, with full-year G&A expenses reaching $73.5 million compared to $33.7 million in 2024 [12]. Clinical Development Updates - The company anticipates topline data from the PIVOT-006 Phase 3 trial evaluating cretostimogene in intermediate-risk NMIBC in the first half of 2026, which is nearly a year ahead of schedule [6][7]. - Results from the CORE-008 Cohort CX trial, assessing the combination of cretostimogene with gemcitabine in high-risk NMIBC, are also expected in the first half of 2026 [6][7]. - Cretostimogene has shown promising efficacy in previous trials, with high-grade event-free survival rates of 95.7%, 84.6%, and 80.4% at 3, 6, and 9 months, respectively, in high-risk BCG unresponsive NMIBC [7]. Corporate Developments - The company strengthened its Board of Directors by adding Christina Rossi, a life-science executive with extensive experience in commercial organizations and new medicine launches [7]. - CG Oncology has initiated an Expanded Access Program for cretostimogene in North America for patients unresponsive to BCG [9].