On 18 January 2024, US-based biotech CG Oncology announced it was looking to raise $200m in an upcoming initial public offering (IPO), which will be the first for the biotech sector in 2024.

The bladder cancer-focused biotech will sell 11.8 million shares at $16-$18 per share.

CG’s lead asset, cretostimogene grendenorepevec, an oncolytic virus immunotherapy, is under development for the treatment of high-grade non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer.

Recently, the US Food and Drug Administration (FDA) granted cretostimogene breakthrough therapy and fast-track designation for the treatment of high-risk Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC patients.

Currently, the therapy has a 16% likelihood of approval (LoA) while the indication’s benchmark is at 40%, according to GlobalData’s Pharmaceutical Intelligence Center; however, the LoA is likely to increase with the upcoming completion of the Phase III BOND-003 study.

BCG vaccine induction is an effective therapy for NMIBC patients, but those at high risk commonly experience reoccurrence following their course.

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By GlobalData

Cretostimogene is a potential therapy for patients unwilling to undergo cystectomy (bladder removal).

The adenovirus is engineered to replicate in retinoblastoma gene pathway-defective cells and trigger an anti-tumour immune response.

In addition, the virus contains the gene for granulocyte-macrophage colony stimulation factor, which can prime the immune system and induce an anti-tumour immune response.

The FDA designations were granted due to preliminary data from the Phase III single-arm trial, which showed that 75.7% of the patients (50/66) evaluable for efficacy at a three-month follow-up achieved a complete response (CR), the trial’s primary endpoint.

CR rates were consistent at three and six-month follow-ups, 68.2% (n=45/66) and 63.6% (n=42/66), respectively.

Treatment was well-tolerated with no Grade 3 or higher adverse events or treatment discontinuations reported.

Separately, cretostimogene is being evaluated in a Phase III study for intermediate-risk NMIBC and a Phase II study in combination with Merck’s Keytruda in the same indication.

CG will use the cash generated from the IPO to fund the completion of these trials and precommercial activities.

For 2024, GlobalData analysts forecast 1,940 BCG-unresponsive NMIBC patients in the US; if the cancer vaccine captures 15% of the market, that would be 291 patients treated with cretostimogene.