CG Oncology, a Phase 3 biotech developing an oncolytic immunotherapy for bladder cancer, filed on Tuesday with the SEC to raise up to $100 million in an initial public offering.
CG Oncology's candidate cretostimogene is initially in development for the treatment of patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) who are unresponsive to Bacillus Calmette Guerin (BCG) therapy, the current standard-of-care for high-risk NMIBC. The company is evaluating cretostimogene as a monotherapy in BOND-003, its ongoing Phase 3 trial in high-risk BCG-unresponsive NMIBC patients, and expects to report topline data by the end of 2024. If successful, CG Oncology believes that this trial could serve as the basis for a Biologics License Application submission to the FDA.
The Irvine, CA-based company was founded in 2010 and plans to list on the Nasdaq under the symbol CGON. CG Oncology filed confidentially on October 27, 2023. Morgan Stanley, Goldman Sachs, and Cantor Fitzgerald are the joint bookrunners on the deal. No pricing terms were disclosed.