CG Oncology Announces Best-in-Disease Durability Data in BOND-003 Cohort C and Promising Early Signal in Cohort P for Cretostimogene Grenadenorepvec at the American Urological Association Annual Meeting

- Robust 24-month complete response rate of 42.3% by K-M for cretostimogene monotherapy in BOND-003 Cohort C –

- 58.3% of patients showed durable complete responses by K-M at 24 months –

- 97.3% of all treated patients remained free from progression to MIBC at 24 months–

- 91.6% of responders remained cystectomy-free at 24 months –

- No Grade 3 or greater treatment-related adverse events or deaths reported –

- Strong initial Cohort P data reported 90.5% high-grade recurrence-free survival at 3 and 9 months by K-M –

- Company will host a conference call and webcast at 8 a.m. EDT on Monday, April 28, 2025 -

IRVINE, Calif., April 26, 2025 (GLOBE NEWSWIRE) -- 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, today announced that cretostimogene grenadenorepvec monotherapy data was presented at the Practice-Changing, Paradigm-Shifting Clinical Trials in Urology Plenary Session at the 2025 American Urological Association (AUA) Annual Meeting, in Las Vegas, Nevada.

The Phase 3 BOND-003 Cohort C study is in patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) treatment with carcinoma in situ (CIS) with or without Ta or T1 disease. The study reported 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. Median duration of response (DOR) is 28 months and is ongoing. Notably, 97.3% of patients were free from progression to muscle invasive disease at 24 months.

BOND-003 Cohort C	CR Rate, % (95% CI)	CR by K-M estimate, % (95% CI)	DOR by K-M estimate, % (95% CI)
12-month	46.4% (36.9, 56.1)1	50.7% (40.9, 59.8)	64.1% (52.4, 73.7)
24-month	33.7% (24.8, 43.8)2	42.3% (32.7, 51.6)	58.3% (46.3, 68.5)

_{¹ CR rate observed in 51 out of 110 patients
² CR rate observed in 34 out of 101 evaluable patients, pending 9 ongoing CRs yet to reach 24-month assessment}

Additionally, Cohort P, which is in patients with BCG-unresponsive Ta/T1 disease without CIS, showed an estimated 90.5% (95% CI: 77.9, 100.0) high-grade recurrence-free survival at 3 and 9 months in 24 treated patients. A well-tolerated safety profile was observed, consistent with the data in Cohort C.