BioPharma, Pharma

With Phase 3 Studies Ongoing in Bladder Cancer, CG Oncology Plots Course for IPO

CG Oncology’s main asset is cretostimogene, an oncolytic virus in late-stage development as a treatment for advanced bladder cancer. The IPO filing follows the report of interim efficacy data showing a 75% complete response rate.

Urinary system, bladder, kidney

When bladder cancer does not respond to the current standard of care therapy, the next treatment option is surgery to completely remove the bladder. CG Oncology aims to give patients another choice. The biotech has reached late-stage development with an oncolytic virus and it’s now looking to the public markets to finance clinical testing.

Irvine, California-based CG has not yet set financial terms for the planned offering, outlined in paperwork filed with the Securities and Exchange Commission this past week. IPO research firm Renaissance Capital estimates the stock offering could raise up to $100 million. CG has applied for a Nasdaq listing under the stock symbol “CGON.”

CG is developing treatments for non-muscle invasive bladder cancer (NMIBC). The company’s sole drug candidate is cretostimogene, which is made by modifying adenovirus to be more selective to tumor cells. Replication of this virus in cancer cells is intended to offer cancer-killing effects. Engineering of the virus also includes insertion of a gene that codes for a protein that stimulates longer-term anti-tumor activity. In the IPO filing, CG said this protein may both prime 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 cretostimogene in patients whose high-risk bladder cancer has not responded to BCG therapy. The main goal of this open-label clinical trial is to assess a complete response to the therapy. During the annual meeting of the Society of Urologic Oncology in November, CG reported interim efficacy data showing a complete response rate of 75.7%, or 50 of the 66 evaluable patients. The therapy was generally well tolerated with adverse effects classified as Grade 1 or 2. Topline results from the study are expected by the end of this year, and the company hopes they could support an FDA submission seeking regulatory approval.

“We believe cretostimogene, if approved, has the potential to serve as first-line therapy, thereby alleviating the current need to prioritize treatment recipients and ration administration of BCG given its significant market shortage,” the company said in the filing.

The second Phase 3 test, started this past November, is enrolling patients with intermediate-risk NMIBC who have had their tumors surgically removed. These patients are administered cretostimogene as a monotherapy. The study is comparing those treated with the CG oncolytic virus to patients who only received surgery. The main goal is to measure recurrence-free survival. The targeted enrollment of this study is 426 patients; CG expects to complete enrollment in the second half of 2026.

CG was founded as Cold Genesys in 2010. Ten years later, the company changed its name to CG Oncology. The company has raised $307.9 million since its founding, most recently a $105 million crossover financing round in August. ORI Capital holds an 11.3% pre-IPO stake in CG, followed by Decheng Capital’s 10.4% stake, according to the filing.

As of the end of the third quarter of 2023, CG reported its cash position was $203.7 million. That capital, combined with the IPO proceeds, will go toward the Phase 3 tests of cretostimogene, including manufacturing of the therapy.

CG also plans a Phase 2 clinical trial testing cretostimogene in patients with high-risk bladder cancer. This open-label study will enroll patients who have received BCG as well as those who have are naïve to BCG. The company said in the filing that it expects to begin this study in the second half of 2024.

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