CG Oncology to Present Results on Cretostimogene Grenadenorepvec at the Society of Urologic Oncology (SUO) 26th Annual Meeting

Two late-breaking podium presentations and three posters continue to demonstrate cretostimogene as a potential backbone therapy for a broad range of NMIBC patients

November 25, 2025 16:05 ET | Source: CG Oncology Inc.

IRVINE, Calif., Nov. 25, 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 t wo late breaking podium presentations on the topline results from BOND-003 Cohort P (BCG-Unresponsive in papillary-only) and first results from CORE-008 Cohort A (BCG-Naïve with carcinoma in situ) as well as three additional posters, will be presented at the Society of Urologic Oncology (SUO) 26th Annual Meeting taking place at the Sheraton Phoenix Downtown, Phoenix, AZ, from December 2 – 5, 2025.

"At SUO this year, we will present important new data from across our clinical program in High-Risk BCG-Naïve NMIBC and High-Risk BCG-Unresponsive Ta/T1 disease, including results from BOND-003 Cohort P and CORE-008 Cohort A. These updates further reinforce cretostimogene’s potential as a backbone immunotherapy across the NMIBC spectrum. We are grateful to the SUO for providing a leading global forum where meaningful scientific advances can be shared on behalf of patients and their families,” said Ambaw Bellete, President & Chief Operating Officer at CG Oncology.

Details on the late-breaking podium presentations and posters are as follows: Late-Breaking Podium Presentations Topline Results From BOND-003 Cohort P- a Multi-National, Single-Arm Study of Intravesical Cretostimogene Grenadenorepvec for Treatment of High-Risk, Papillary Only, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Presenter: Mark D. Tyson, M.D., Urologic Oncologist at Mayo Clinic, Scottsdale, AZ Presentation Date & Time: December 5, 2025, from 2:30-2:35 PM Mountain Standard Time Location: Sheraton Phoenix Downtown, Phoenix, AZ

First Results from CORE-008 Cohort A- Phase 2 Study of Intravesical Cretostimogene Grenadenorepvec in Patients with High-Risk BCG-Naïve Non-Muscle Invasive Bladder Cancer Presenter: Trinity J. Bivalacqua, M.D., Ph.D., Urologic Oncologist at University of Pennsylvania, Philadelphia, PA Presentation Date & Time: December 5, 2025, from 2:35-2:40 PM Mountain Standard Time Location: Sheraton Phoenix Downtown, Phoenix, AZ

Posters Durable 24-month outcomes from BOND-003 Cohort C: Phase 3 Study of Intravesical Cretostimogene Grenadenorepvec for High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer with Carcinoma in Situ Presenter: Mark D. Tyson, M.D., Urologic Oncologist at Mayo Clinic, Scottsdale, AZ Poster Number: 53 Presentation Date & Time: December 3, 2025, from 5-6 PM Mountain Standard Time Location: Sheraton Phoenix Downtown, Phoenix, AZ

Core-008 Cohort B: Evaluating Intravesical Cretostimogene Grenadenorepvec in Patients with High-Risk, BCG-Exposed Non-Muscle Invasive Bladder Cancer Trials in Progress Presenter: Trinity J. Bivalacqua, M.D., Ph.D., Urologic Oncologist at University of Pennsylvania, Philadelphia, PA Poster Number: 54 Presentation Date & Time: December 3, 2025, from 5-6 PM Mountain Standard Time Location: Sheraton Phoenix Downtown, Phoenix, AZ

Design and Implementation of Patient-Centric Expanded Access Program with Cretostimogene Grenadenorepvec in Non-Muscle Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin Trials in Progress Presenter: Sarah P. Psutka, M.D. M.Sc., Urologic Oncologist at University of Washington, Seattle, WA Poster Number: 137 Presentation Date & Time: December 4, 2025, from 2:30 – 3:30 PM Mountain Standard Time Location: Sheraton Phoenix Downtown, Phoenix, AZ

About Cretostimogene Grenadenorepvec Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 400 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC. CG Oncology also has a Phase 2 trial, CORE-008, evaluating the safety and efficacy of cretostimogene in high-risk NMIBC. Additionally, we have initiated an Expanded Access Program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements. Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority.

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 .

Forward-Looking Statements CG Oncology cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, the potential therapeutic benefits of cretostimogene for high-risk and intermediate-risk NMIBC patients, and cretostimogene’s potential as a foundational immunotherapy across the NMIBC spectrum. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data becomes available; potential delays in the commencement, enrollment and completion of clinical trials, including the BOND-003 and PIVOT-006 trials; we may use our capital resources sooner than expected and they may be insufficient to allow us to achieve our anticipated milestones; our dependence on third parties in connection with manufacturing, shipping and clinical and preclinical testing; results from earlier clinical trials and preclinical studies not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of cretostimogene that may limit its development, regulatory approval, and/or commercialization; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K and other filings that we make with the SEC from time to time (which are available at http://www.sec.gov ). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contacts:

Media Sarah Connors Vice President, Communications and Patient Advocacy, CG Oncology sarah.connors@cgoncology.com

Investor Relations Megan Knight Vice President, Investor Relations, CG Oncology megan.knight@cgoncology.com