CG Oncology, a late-stage clinical biopharmaceutical company, is focused on developing and commercializing cretostimogene grenadenorepvec (cretostimogene) as a potential backbone bladder-sparing therapeutic for patients with bladder cancer. The company's goal is to offer an alternative to Bacillus Calmette-Guérin (BCG) in treating a broad range of bladder cancer indications. Cretostimogene is in clinical development for the treatment of patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) who are unresponsive to BCG therapy, the current standard-of-care for high-risk NMIBC.
Financially, CG Oncology reported a net loss of $34.5 million for the three months ended March 31, 2025, compared to $16.9 million for the same period in 2024. As of March 31, 2025, the company had an accumulated deficit of $252.4 million. CG Oncology has primarily funded its operations through the sale of shares of common stock and recognized $26.2 million in license and collaboration revenue. The company's cash, cash equivalents, and marketable securities totaled $688.4 million as of March 31, 2025, with estimated funds sufficient to support operations into the first half of 2028.
CG Oncology has entered into significant license and collaboration agreements, including a development and license agreement with Lepu, which granted an exclusive license to Lepu to develop, manufacture, and commercialize cretostimogene and/or DDM in the Lepu Territory. The company also has a license and collaboration agreement with Kissei, granting Kissei an exclusive license to certain intellectual property rights in various territories for the development and commercialization of cretostimogene in combination with DDM.
The company does not own or operate any manufacturing facilities and relies on third parties for the manufacture, packaging, labeling, storage, and distribution of cretostimogene. CG Oncology plans to focus its resources on the development of cretostimogene and any future product candidates, utilizing third parties for manufacturing to maintain an efficient infrastructure.
Looking ahead, CG Oncology anticipates incurring significant expenses related to the development and potential commercialization of cretostimogene. The company's ability to generate product revenue is contingent upon successful clinical development and regulatory approval for cretostimogene or any future product candidates. CG Oncology may seek additional funding through equity offerings, debt financings, or other capital sources to support its operations and growth strategy.
Following these announcements, the company's shares moved 5.98%, and are now trading at a price of $25.16. If you want to know more, read the company's complete 10-Q report here.
