CG Oncology, Inc. announced the publication in Nature Medicine of final results from the Company's CORE-001 Phase 2 trial of cretostimogene plus pembrolizumab in BCG-unresponsive Non-Muscle Invasive Bladder Cancer (NIMBC). The article, titled "Oncolytic adenoviral therapy plus pembrolizumib in BCG-unresponsive non-muscle-invasive bladder cancer: the phase 2 CORE-001 trial" is now available online and will be published in a future print issue of Nature Medicine. The combination of cretostimogene and pembrolizumab received FDA Breakthrough Therapy Designation in May 2023.

Cretostimogene monotherapy received FDA Fast Track and Breakthrough Therapy Designations in BCG-Unresponsive, HR-NMIBC with CIS in December 2023. CretostIMogene is an investigational, intravesically delivered oncolytic immunotherapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. CORE-001 was a Phase 2 single-arm, open-label clinical trial of cretostimogen administered in 35 patients with high-risk, BCG-unresponsive NMIBC that have carcinoma in situ-containing tumors, in combination with pembrolizumab, following disease resection.

Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in business, including, without limitation: additional patient data related to Cretostimogene in combination with pembrolIZumab that continues to become available may be inconsistent with the data produced as of the data cutoff, and further analysis of new data may lead to conclusions different from those established as of the date hereof; 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; potential delays in the commencement, enrollment and completion of clinical trials; and other risks described in the Phase 3 monotherapy clinical trial. Cretostimogene is also being evaluated in a Phase 3 monotherapy clinical trial (PIVOT-006) in intermediate-risk NMIBC patients. In addition, Cretostimogene is being evaluated in an investigator-sponsored clinical trial in combination with nivolumab for the treatment of muscle invasive bladder cancer.

Cretostimogene are an investigational, intravesics delivered oncolytic immun therapy candidate, and its safety and safety and efficacy have not been establish by the FDA or any other Health authority. CORE-001 were a Phase 2 single-arm. CORE-001 was an investigational, intravesally delivered oncolytic immun chemotherapy candidate, and its safety and effectiveness have not been established by theF FDA or any other health authority".

CORE-001 was a phase 2 single-arm, open the open-label clinical trial of Cretostimogene administered in 35 patients with high -risk, BCG-un responsive NMIBC that have carcinomas in situ-containing tumors, In combination with pembrolizUMab, following disease resections. Actual results may differ to those set forth in this release due to the risks and uncertainty inherent in business, including, with, without limitation: additional patient Data related to CORE-001 in combination with p Embrolizumab that continues to become known may be inconsistent with the data generated as of the date hereof, and further analysis of existing data and analysis of new data will lead to conclusions different from those establish as of the date hereof. results from earlier clinical trials andpreclinical studies not necessarily being predictive the future results; unexpected adverse side effect or in excess side effects or inadequate efficacy of Cretostimogene that may limits its development, and/or commercialization.