CG Oncology, Inc. recently released its 10-K report, providing a detailed look into the company's financial condition and operations. The late-stage clinical biopharmaceutical company is focused on developing and commercializing cretostimogene grenadenorepvec (cretostimogene), an investigational oncolytic immunotherapy for patients with bladder cancer. Cretostimogene is currently in clinical development for the treatment of high-risk and intermediate-risk non-muscle invasive bladder cancer (NMIBC), potentially representing up to 150,000 addressable patients.
In the 10-K report, the company reported net losses of $161.0 million and $88.0 million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, CG Oncology had an accumulated deficit of $379.0 million. The company has primarily funded its operations through public offerings, redeemable convertible preferred stock, and term debt, raising approximately $1.1 billion in aggregate gross proceeds. Additionally, CG Oncology had cash, cash equivalents, and marketable securities of $742.2 million as of December 31, 2025.
The report also highlighted the company's ongoing clinical trials, including the completion of enrollment for BOND-003 Cohort C, a Phase 3 clinical trial for high-risk BCG-unresponsive NMIBC with potentially best-in-disease data reported. CG Oncology also initiated PIVOT-006, the first randomized registrational trial to evaluate an investigational therapy in intermediate-risk NMIBC, with enrollment completed in the third quarter of 2025.
Furthermore, the 10-K report discussed the company's financial projections, stating that CG Oncology believes its existing cash, cash equivalents, and marketable securities will be sufficient to fund operations for at least the next twelve months from the date of the report. However, the company may need substantial additional funding to support its continuing operations and pursue its growth strategy.
CG Oncology also highlighted its reliance on third-party manufacturers for the production of cretostimogene for clinical testing and potential commercial manufacture if marketing approval is obtained. The company does not own or operate any manufacturing facilities and has no current plans to establish any.
The market has reacted to these announcements by moving the company's shares 3.13% to a price of $54.73. For more information, read the company's full 10-K submission here.
