CG Oncology, Inc. has reported its financial results for the third quarter ended September 30, 2025. The company's cash and cash equivalents and marketable securities stood at $680.3 million, compared with $661.1 million as of June 30, 2025. The increase includes net proceeds of approximately $48.7 million from the sale of 1,515,151 shares through the company’s at-the-market (ATM) facility based on reverse inquiry from an existing, high-quality fund.
In terms of expenses, research and development (R&D) expenses for the three months ended September 30, 2025, were $27.9 million compared with $19.6 million for the three months ended September 30, 2024. The increase was primarily due to an increase in clinical trial expenses and an increase in compensation costs due to increased headcount. General and administrative (G&A) expenses for the three months ended September 30, 2025, were $23.3 million compared with $8.7 million for the three months ended September 30, 2024. The increase was primarily attributed to an increase in legal expenses and other professional fees and an increase in personnel-related expenses, including compensation costs from increased headcount.
The net loss for the third quarter of 2025 was reported as $43.8 million, or ($0.57) per share, compared to a net loss of $20.4 million, or ($0.30) per share, for the same period in 2024.
The company has also provided updates on its business, including the initiation of the rolling biologics license application (BLA) submission to the U.S. FDA for cretostimogene monotherapy in high-risk (HR) BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). CG Oncology has completed enrollment of Pivot-006, one of the largest randomized phase 3 studies in intermediate-risk (IR) NMIBC encompassing the broadest range of patients per AUA/SUO guidelines.
Additionally, the company presented best-in-disease durability and tolerability data from Bond-003 cohort C, demonstrating a robust 24-month complete response (CR) rate of 41.8% observed for cretostimogene monotherapy in patients with HR NMIBC unresponsive to BCG.
CG Oncology also highlighted that it is well-positioned to deliver on key milestones with its cash and cash equivalents and marketable securities sufficient to fund operations into the first half of 2028.
The company mentioned anticipated upcoming milestones, including topline data from the Phase 3 clinical trial of cretostimogene monotherapy in 4Q’25 for HR BCG-unresponsive NMIBC in ta/t1 disease without cis and first results from the Phase 2 clinical trial of cretostimogene monotherapy in 4Q’25 for HR BCG-naïve NMIBC with cis +/* ta/t1.
Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 400 patients with NMIBC. This program includes two Phase 3 clinical trials: Bond-003 for high-risk BCG-unresponsive NMIBC and Pivot-006 for intermediate-risk NMIBC. CG Oncology also has a Phase 2 trial, Core-008, evaluating the safety and efficacy of cretostimogene in high-risk NMIBC. The market has reacted to these announcements by moving the company's shares -4.19% to a price of $37.76. For the full picture, make sure to review CG Oncology's 8-K report.
