If bladder cancer does not respond to current standard therapy, the next treatment option is surgery to completely remove the bladder. CG Oncology wants to give patients another choice. The biotech company has reached late-stage development with an oncolytic virus and is now seeking public markets to fund clinical trials.
Irvine, Calif.-based CG has not specified financial terms for the proposed offering, according to documents filed with the Securities and Exchange Commission last week. IPO research firm Renaissance Capital estimates the stock offering could raise up to $100 million.
CG is developing treatments for non-muscle invasive bladder cancer (NMIBC). The company's sole drug candidate is cretostimogen, which is made by modifying adenoviruses so that they are more selective for tumor cells. Replication of this virus in cancer cells is thought to have cancer-killing effects. The development of the virus also includes the introduction of a gene that encodes a protein that stimulates longer-term antitumor activity. In the IPO filing, CG said this protein can both boost the immune system and induce tumor-specific immunity.
The first-line treatment for NMIBC is an immunotherapy called Bacillus Calmette-Guérin (BCG). CG has two Phase 3 tests underway. The more advanced study is evaluating cretostimogen in patients whose high-risk bladder cancer has not responded to BCG therapy. The primary objective of this open-label clinical trial is to assess complete response to therapy. During the Society of Urologic Oncology annual meeting in November, CG reported interim efficacy data showing a complete response rate of 75.7%, or 50 of 66 evaluable patients. Therapy was generally well tolerated, with side effects classified as grade 1 or 2. Topline results from the trial are expected later this year and the company hopes to support an FDA application for regulatory approval.
“We believe that cretostimogen, if approved, has the potential to serve as a first-line therapy, eliminating the current need to prioritize treatment recipients and ration administration of BCG given significant market shortages,” the company said in the filing.
The second Phase 3 trial, which began last November, includes patients with intermediate-risk NMIBC and compares oncolytic virus treatment as monotherapy with patients who only received surgery to remove the tumor. The main objective is to measure recurrence-free survival. The targeted recruitment of this study is 426 patients; CG expects to complete enrollment in the second half of 2026.
CG was founded in 2010 as Cold Genesys. Ten years later, the company changed its name to CG Oncology. The company has raised $307.9 million since its inception, most recently a $105 million crossover funding round in August. ORI Capital holds an 11.3% stake in CG before the IPO, followed by 10.4% stake in Deching Capital, the filing said.
At the end of the third quarter of 2023, CG reported that its cash balance was $203.7 million. This capital, along with proceeds from the IPO, will go toward Cretostimogen's Phase 3 testing, including manufacturing the therapy.
CG also plans a Phase 2 clinical trial testing cretostimogen in patients with high-risk bladder cancer. This open-label study will enroll both patients who have received BCG and those who are BCG-naïve. The company said in the filing that it expects to begin this study in the second half of 2024.
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