Overview of CG Oncology’s Financial Performance

CG Oncology, a late-stage clinical biopharmaceutical company, has been focused on developing and commercializing a potential bladder cancer treatment called cretostimogene grenadenorepvec (cretostimogene). The company has made significant progress in its clinical trials and is preparing for a potential FDA approval and commercial launch of cretostimogene.

In the first quarter of 2025, CG Oncology reported a net loss of $34.5 million, compared to a net loss of $16.9 million in the same period in 2024. This increase in net loss was primarily driven by higher research and development (R&D) expenses and general and administrative (G&A) expenses as the company advanced its clinical programs and built out its commercial capabilities.

Revenue and Profit Trends

CG Oncology has not yet generated any revenue from product sales, as cretostimogene is still in clinical development. However, the company has recognized $26.2 million in license and collaboration revenue since its inception through various licensing agreements with partners like Lepu and Kissei.

In the first quarter of 2025, CG Oncology recorded $0.1 million in license and collaboration revenue, down from $0.5 million in the same period in 2024. This decrease was due to lower revenue recognized from the Lepu License Agreement, partially offset by revenue from the Kissei License Agreement.

The company’s net losses have increased over time as it has ramped up its R&D activities and prepared for the potential commercialization of cretostimogene. CG Oncology expects these losses to continue to grow in the near-term as it advances its clinical trials and builds out its commercial infrastructure.

Analysis of Strengths and Weaknesses

Strengths:

• Promising lead product candidate, cretostimogene, which has received Fast Track and Breakthrough Therapy designations from the FDA for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC)
• Robust clinical development pipeline, with several ongoing and planned trials evaluating cretostimogene in different bladder cancer patient populations
• Strong financial position, with $688.4 million in cash, cash equivalents, and marketable securities as of March 31, 2025, which the company estimates will be sufficient to fund operations into the first half of 2028
• Experienced management team and board of directors with expertise in drug development and commercialization

Weaknesses:

• Reliance on a single product candidate, cretostimogene, which increases the company’s risk profile
• No approved products or revenue from product sales, which means the company is entirely dependent on its ability to successfully develop and commercialize cretostimogene
• Significant operating losses and negative cash flows from operations, which are expected to continue in the foreseeable future as the company advances its clinical programs and prepares for commercialization

Outlook and Future Prospects

CG Oncology is well-positioned to potentially bring cretostimogene to market, as the company has made significant progress in its clinical development program. The company is currently evaluating cretostimogene in several late-stage trials, including a Phase 3 trial in high-risk BCG-unresponsive NMIBC patients, which could serve as the basis for a Biologics License Application (BLA) submission to the FDA in the second half of 2025.

If approved, cretostimogene could address a significant unmet need in the treatment of bladder cancer, as the current standard of care, Bacillus Calmette-Guérin (BCG) therapy, has limitations and many patients become unresponsive to it. CG Oncology is also exploring the potential of cretostimogene in earlier-stage NMIBC patients, which could further expand the product’s market opportunity.

However, the company faces several challenges, including the need to continue investing heavily in R&D and commercial preparations, which will likely result in ongoing operating losses in the near-term. Additionally, the company’s reliance on a single product candidate increases its risk profile, as any setbacks in the development or commercialization of cretostimogene could have a significant impact on the company’s future prospects.

To mitigate these risks, CG Oncology will need to continue to execute on its clinical development strategy, secure regulatory approvals, and successfully launch and commercialize cretostimogene, if approved. The company will also need to carefully manage its financial resources and explore additional funding sources, such as potential collaborations or licensing agreements, to support its long-term growth and development.

Overall, CG Oncology appears to be making solid progress in its efforts to bring cretostimogene to market, but the company will need to navigate several challenges and risks to achieve long-term success.