CG Oncology Reports Q2 Financials, Announces BOND-003 Durability Data.

• CG Oncology reports Q2 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 on CG Oncology royalties to ANI Pharmaceuticals • Reports progress in bladder cancer treatment development • Focuses on developing bladder-sparing therapeutic for patients with bladder cancer.

CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, reported its second-quarter financial results for the period ended June 30, 2025. The company also announced significant milestones in its clinical trials and business updates.

Financial Highlights

The company reported a net loss of $41.4 million, or ($0.54) per share, for the three months ended June 30, 2025, compared to a net loss of $18.9 million, or ($0.28) per share, for the same period in 2024. Cash and cash equivalents and marketable securities as of June 30, 2025, were $661.1 million, compared to $688.4 million as of March 31, 2025. Research and Development (R&D) expenses for the three months ended June 30, 2025, were $31.3 million, up from $18.5 million for the same period in 2024. General and Administrative (G&A) expenses for the three months ended June 30, 2025, were $17.4 million, compared to $7.5 million for the same period in 2024 [1].

Clinical Trial Updates

CG Oncology presented best-in-disease durability and tolerability data in Cohort C of the Phase 3 BOND-003 clinical trial at the American Urological Association (AUA) Annual Meeting. The trial 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 are 50.7% and 42.3% by K-M estimation respectively. Cohort P, which is in patients with BCG-unresponsive Ta/T1 papillary disease without carcinoma in situ (CIS), showed an estimated 90.5% high-grade recurrence-free survival at 3 and 9 months in 24 treated patients [1].

The company also initiated CORE-008 Cohort CX evaluating the combination of cretostimogene and gemcitabine in high-risk (HR) BCG-exposed Non-Muscle Invasive Bladder Cancer (NMIBC). The trial will evaluate the combination of cretostimogene and gemcitabine, given either concurrently or sequentially, in patients with HR BCG-exposed NMIBC, including patients with CIS and with or without Ta/T1 disease and patients with only Ta/T1 disease [1].

Business Updates

CG Oncology announced a unanimous verdict that it owes no future royalties or other payments to ANI Pharmaceuticals, Inc. (ANI). The jury in the Superior Court of the State of Delaware unanimously found in favor of CG Oncology on all claims in a March 2024 lawsuit brought by ANI. The verdict allows CG Oncology to continue focusing its resources on developing and commercializing its innovative therapy [1].

Upcoming Milestones

The company anticipates the following upcoming milestones: completion of Phase 3 enrollment for PIVOT-006 in the third quarter of 2025, initiation of BLA submission for cretostimogene monotherapy in high-risk BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease in the fourth quarter of 2025, and top-line data from BOND-003 Cohort P and CORE-008 Cohort A in the fourth quarter of 2025 and the first half of 2026, respectively [1].

Conclusion

CG Oncology's Q2 financial results and business updates demonstrate the company's commitment to developing innovative treatments for bladder cancer. The company's clinical trial data and upcoming milestones position it to make significant strides in the treatment of high-risk and intermediate-risk NMIBC.

References

[1] CG Oncology, Inc. (2025). CG Oncology Reports Second-Quarter 2025 Financial Results and Provides Business Updates. Retrieved from https://www.globenewswire.com/news-release/2025/08/08/3130103/0/en/CG-Oncology-Reports-Second-Quarter-2025-Financial-Results-and-Provides-Business-Updates.html