CG Oncology Reports Q3 Financial Results and Key Milestones

DALLAS, Nov. 06, 2026 /CourierPR/ -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, reported financial results for the third quarter ended September 30, 2026, and provided business updates. The company is well-positioned to deliver on key milestones, with approximately $984.5 million in cash, cash equivalents, and marketable securities sufficient to fund operations through 2029.

The company's executive leadership team has been bolstered with the addition of Isabel Kalofonos as Chief Commercial Officer. Kalofonos brings more than 20 years of experience driving successful launches, including PALSONIFYTM (paltusotine) and ELAHERE® (mirvetuximab soravtansine), through strong commercial execution across the biotechnology and pharmaceutical industries.

CG Oncology is set to share pivotal data from its PIVOT-006 Phase 3 trial evaluating cretostimogene monotherapy as an adjuvant therapy in intermediate-risk and high-grade Ta NMIBC (non-muscle invasive bladder cancer) by November 2026. This trial is the first randomized registrational study in this patient population, and the data is expected to further strengthen the growing body of evidence for cretostimogene in the NMIBC landscape.

Additionally, the company anticipates 12-month data from both BOND-003 Cohort P and CORE-008 Cohort CX by December 2026. The BOND-003 trial focuses on BCG-unresponsive NMIBC, while the CORE-008 trial evaluates the safety and efficacy of cretostimogene in BCG-exposed high-risk and BCG-unresponsive NMIBC.

CG Oncology is also on track to complete the Biologics License Application (BLA) submission for cretostimogene in the initial indication of BCG-unresponsive NMIBC with CIS (carcinoma in situ) with or without papillary disease by the fourth quarter of 2026. The company's financials for the third quarter of 2026 show R&D expenses of $39.2 million, up from $27.9 million in the prior year period, primarily due to increased clinical trial expenses and compensation costs. G&A expenses were $23.0 million, down from $23.3 million, mainly due to a decrease in professional and consultant fees, offset by an increase in personnel-related expenses and other general G&A expenses.

The net loss for the third quarter of 2026 was $56.9 million, or $(0.64) per share, compared to a net loss of $43.8 million, or $(0.57) per share, in the prior year period. The company's cash position as of September 30, 2026, was $984.5 million, down from $1.0 billion as of June 30, 2026.

Cretostimogene, an investigational, intravesically delivered oncolytic immunotherapy, has been studied in a clinical development program involving over 700 patients with non-muscle invasive bladder cancer. This program includes two Phase 3 clinical trials: BOND-003 for BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk and high-grade Ta ≤ 3cm NMIBC. Cretostimogene has received FDA Fast Track and Breakthrough Therapy designations for BCG-unresponsive NMIBC. The company also has a multi-cohort trial, CORE-008, evaluating the safety and efficacy of cretostimogene in BCG-exposed high-risk and BCG-unresponsive NMIBC.