Bladder cancer biotech CG Oncology (CGON Proposed) unveiled the terms and launched its $200.6 million IPO shortly before sunrise on Wall Street today – Thursday, Jan. 18, 2024. CG Oncology is offering 11.8 million shares at $16.00 to $18.00 to raise $200.6 million. The California biotech plans to price its IPO next week – on Wednesday night, Jan. 24, 2024, to trade Thursday, Jan. 25, 2024, on the NASDAQ.
Morgan Stanley, Goldman Sachs and Cantor are the joint book-runners. LifeSci Capital is the co-manager.
CG Oncology, based in Irvine, California, is a Phase 3 clinical biotech focused on developing and commercializing its leading product candidate, cretostimogene, to treat patients with high-risk non-muscle invasive bladder cancer (NMIBC) who are unresponsive to BCG therapy, the standard treatment. (BCG stands for Bacillus Calmette Guerin, a treatment that is in such short supply that it must be rationed.)
“There is significant unmet need for treatments in these patients, given the limitations of currently approved therapies and patient reluctance to undergo radical cystectomy, or the complete removal of the bladder,” the prospectus says.
CG Oncology has completed enrollment for its Phase 3 clinical trial of cretostimogene as monotherapy for high-risk NMIBC patients who are unresponsive to BCG therapy, according to the prospectus. The company reported interim data in November 2023. It expects to report topline data by the end of 2024.
“If successful, we believe that this trial could serve as the basis for a Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA),” the prospectus says.
CG Oncology is also evaluating the use of cretostimogene in two other clinical trials:
A Phase 2 clinical trial of cretostimogene in combination with FDA-approved pembrolizumab for this same patient population, and
A second Phase 3 clinical trial evaluating adjuvant cretostimogene in intermediate-risk NMIBC patients after transurethral resection of the bladder tumor.
Like most biotechs, CG Oncology has no revenue from product sales. The company reported a net loss of nearly $58 million for the 12 months that ended on Sept. 30, 2023, according to financial statements in the prospectus.
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