CG Oncology Reports First Quarter 2024 Financial Results and Provides Business Updates

• Cretostimogene Monotherapy Demonstrated 75.2% Complete Response (CR) Rate at Any Time in Bacillus Calmette Guerin (BCG)-Unresponsive, High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC)
  
• First Patient Dosed in PIVOT-006 Phase 3 Clinical Trial of Cretostimogene in Intermediate-Risk NMIBC (IR-NMIBC)
• Final Results from CORE-001 Phase 2 Clinical Trial of Cretostimogene in Combination with Pembrolizumab in BCG-Unresponsive HR-NMIBC will be presented at ASCO 2024
  • Completed Oversubscribed and Upsized $437 Million Initial Public Offering that Extends Expected Runway Through 2027

IRVINE, Calif., May 09, 2024 (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 reported financial results for the first quarter ended March 31, 2024, and provided business updates.

“2024 is a transformative year for CG Oncology, with our oversubscribed and upsized $437 million IPO on NASDAQ and our recent presentation at AUA of interim data showing a 75.2% CR rate at any time in BCG-Unresponsive HR-NMIBC from our BOND-003 Phase 3 clinical trial, which potentially supports cretostimogene monotherapy as backbone therapy in this disease with significant unmet need,” said Arthur Kuan, Chairman & Chief Executive Officer of CG Oncology. “In the coming months we look forward to sharing final results from our CORE-001 Phase 2 clinical trial of crestostimogene in combination with pembrolizumab and final results from our BOND-003 Phase 3 registrational clinical trial of cretostimogene monotherapy by the end of the year.”

Corporate Highlights

• Completed Oversubscribed and Upsized Initial Public Offering that extends expected runway through 2027.
• Cretostimogene Monotherapy Demonstrated 75.2% CR Rate at Any Time in BCG-Unresponsive HR-NMIBC. On May 3^rd at AUA in the paradigm-shifting, practice-changing clinical trials in urology session, the Company announced data from the BOND-003 Phase 3, single arm, open label, registrational study evaluating the efficacy and safety of cretostimogene monotherapy in patients with HR-NMIBC unresponsive to BCG, showed that 75.2% of patients (79 out of 105 [95% confidence interval (CI), 65-83]) achieved a CR at any time, as of the cutoff date of April 1, 2024.
• First Patient Dosed in PIVOT-006 Phase 3 Clinical Trial of Cretostimogene in IR-NMIBC. In February, the Company announced the first patient was dosed in PIVOT-006, a Phase 3, open-label, two-arm trial enrolling up to 364 IR-NMIBC patients, one arm to be administered cretostimogene following the standard of care TURBT with the second arm receiving the standard of care TURBT only. The primary endpoint of this trial is overall recurrence-free survival (RFS), with secondary endpoints including RFS at 12 and 24 months and progression-free survival.
• Final Results from CORE-001 Phase 2 Clinical Trial of Cretostimogene in Combination with Pembrolizumab in BCG-Unresponsive HR-NMIBC to be presented at ASCO 2024.

Anticipated Next Milestones