CG Oncology reports Q2 FY25 financial results, initiates new clinical trial.

• CG Oncology reports Q2 2025 financial results • Announces best-in-disease durability data in BOND-003 Cohort C • Promising early signal in Cohort P for cretostimogene grenadenorepvec • Initiates CORE-008 Cohort CX evaluating cretostimogene and gemcitabine combo • Announces unanimous verdict against future royalties or payments to ANI Pharmaceuticals • Focuses on bladder cancer treatment and backbone bladder-sparing therapeutic development

CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company, recently reported its second-quarter 2025 financial results and announced significant milestones in its ongoing clinical trials for bladder cancer treatment. The company's stock price has been volatile in recent quarters, but the latest developments offer a glimpse into the potential future of its pipeline.

Financial Highlights

CG Oncology reported a cash position of $661.1 million as of June 30, 2025, compared to $688.4 million at the end of March 2025. The decrease was primarily due to increased research and development (R&D) and general and administrative (G&A) expenses. R&D expenses for the quarter were $31.3 million, up from $18.5 million in the same period last year, driven by higher clinical trial expenses and increased headcount. G&A expenses rose to $17.4 million from $7.5 million, mainly due to increased personnel-related expenses and legal costs.

The company reported a net loss of $41.4 million for the quarter, compared to $18.9 million in the same period last year. This increase was primarily attributed to higher R&D and G&A expenses.

Clinical Trial Updates

CG Oncology announced several key milestones in its clinical trials. At the American Urological Association (AUA) Annual Meeting, the company presented best-in-disease durability and tolerability data from Cohort C of the Phase 3 BOND-003 clinical trial. The data showed a 75.5% complete response (CR) at any time, with 34 confirmed CRs at 24 months and 9 patients pending their 24-month assessment as of the cutoff date of March 14, 2025. The 12- and 24-month CR rates were 50.7% and 42.3%, respectively, with a median duration of response of 28 months.

In Cohort P, which includes patients with BCG-unresponsive Ta/T1 papillary disease without carcinoma in situ (CIS), the estimated 90.5% high-grade recurrence-free survival at 3 and 9 months was promising. The company also initiated CORE-008 Cohort CX, a Phase 2 trial evaluating the combination of cretostimogene and gemcitabine in high-risk (HR) BCG-exposed non-muscle invasive bladder cancer (NMIBC).

Legal Update

CG Oncology announced a unanimous verdict in its favor against future royalties or payments to ANI Pharmaceuticals. The jury in the Superior Court of the State of Delaware unanimously found that CG Oncology did not owe any future royalties to ANI, following a lawsuit brought by ANI in March 2024. This verdict allows CG Oncology to continue focusing its resources on developing cretostimogene, its investigational bladder-sparing therapy.

Upcoming Milestones

CG Oncology anticipates several upcoming milestones, including the completion of Phase 3 enrollment for PIVOT-006 in the third quarter of 2025 and the initiation of its BLA submission for cretostimogene monotherapy in high-risk BCG-unresponsive NMIBC in the fourth quarter of 2025. The company also expects to receive topline data from CORE-008 Cohort A and BOND-003 Cohort P in the fourth quarter of 2025 and from CORE-008 Cohort CX in the first half of 2026.

Conclusion

CG Oncology's second-quarter 2025 financial results and clinical trial updates provide a mixed picture. While the company's financial position remains strong, the increase in expenses highlights the significant costs associated with clinical trial development. The announcements of best-in-disease durability data, promising early signals in Cohort P, and the initiation of new trials are encouraging signs for the company's pipeline. However, the success of these trials and the company's ability to meet its upcoming milestones will be crucial in determining its future prospects.

References

[1] CG Oncology Reports Second Quarter 2025 Financial Results and Provides Business Updates. (2025, July 08). Retrieved from https://www.morningstar.com/news/globe-newswire/9508779/cg-oncology-reports-second-quarter-2025-financial-results-and-provides-business-updates