CG Oncology Announces Presentation of the First Phase 3 Monotherapy Data for Cretostimogene Grenadenorepvec in BCG-Unresponsive NMIBC Patients at SUO 2023

CG Oncology, Inc. announced today that interim Phase 3 monotherapy data from the BOND-003 study will be presented as a late-breaking abstract at the upcoming 24^th Annual Meeting of the Society of Urologic Oncology (SUO), held November 28-December 1, 2023, at the Omni Shoreham Hotel in Washington, DC.

BOND-003 (NCT04452591) is a single-arm, open-label, Phase 3 clinical trial evaluating cretostimogene grenadenorepvec as monotherapy in patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG). The study enrolled 116 patients with BCG-unresponsive NMIBC across North America and the Asia-Pacific region. The primary endpoint of the study is complete response (CR) at any time, with duration of response measured as a secondary endpoint.

Details of the oral presentation are as follows:

First results from BOND-003, a Phase 3 study of intravesical Cretostimogene grenadenorepvec monotherapy for patients with high-risk Bacillus Calmette-Guerin (BCG)-unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

Abstract Number: 3396

Session: Urothelial Cancer Session I

Presenter: Mark D. Tyson, M.D., Urologic Oncologist at Mayo Clinic, Scottsdale, AZ

Date & Time: Thursday, November 30, 2023, from 11:59am-12:04pm Eastern Standard Time

About Cretostimogene Grenadenorepvec

Cretostimogene grenadenorepvec is an investigational, intravesically delivered oncolytic immunotherapy being evaluated in BOND-003, a Phase 3 clinical trial for the treatment of BCG-unresponsive Non-Muscle Invasive Bladder Cancer. Cretostimogene grenadenorepvec is also being evaluated in a Phase 2 clinical trial (CORE-001) in combination with pembrolizumab in the same indication. In addition, cretostimogene grenadenorepvec is being evaluated in an investigator-sponsored clinical trial in combination with nivolumab for the treatment of muscle invasive bladder cancer.

About Bladder Cancer

More than 82,000 people are estimated to be diagnosed with bladder cancer in 2023. NMIBC is the most common form of bladder cancer, representing approximately 75% of newly diagnosed cases. Bladder cancer is the sixth most common form of cancer in the United States, and men account for three quarters of newly diagnosed cases.

About CG Oncology

CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. To learn more, please visit: www.cgoncology.com.

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