Someone involved in this deal must like the number 17: Bladder cancer biotech CG Oncology (CGON Proposed) upsized its IPO to 17 million shares – up from 11.8 million shares originally – and kept the price range at $16.00 to $18.00. If the upsized IPO is priced at the $17.00 mid-point, CG Oncology will raise $289.0 million – up 44.1 percent from its original estimated IPO proceeds of $200.6 million. The increase in the IPO’s size was disclosed in an S-1/A filing early today (Tuesday, Jan. 23, 2024) – a day ahead of the IPO’s pricing date. Bankers expect to price the California biotech’s IPO on Wednesday night, Jan. 24, 2024, to trade Thursday, Jan. 25, on the NASDAQ.
Morgan Stanley, Goldman Sachs and Cantor are the joint book-runners. LifeSci Capital is the co-manager.
CG Oncology is set to be the first biotech IPO of the year. The big increase in the IPO’s size reflects the early enthusiasm for the deal among IPO investors.
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.) CG Oncology, originally known as Cold Genesys, was founded in 2010.
“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, a genetically engineered oncolytic virus, 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.
Most of the IPO’s proceeds will be used to finance clinical trials.
CG Oncology is also evaluating the use of cretostimogene in two other clinical trials:
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A Phase 2 clinical trial of cretostimogene in combination with FDA-approved pembrolizumab (Keytruda from Merck) for this same patient population, and
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A second Phase 3 clinical trial evaluating adjuvant cretostimogene in intermediate-risk NMIBC patients after transurethral resection of the bladder tumor.
Developing and commercializing a new drug is a long and expensive process. CG Oncology has not generated any revenue from product sales yet, the prospectus says. The company reported a net loss of $57.91 million for the 12 months that ended Sept. 30, 2023, according to the prospectus.
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