- Oral Presentation Providing Update on the Phase 2 Clinical Trial of CG0070, an Oncolytic Immunotherapy, in Combination with KEYTRUDA® (pembrolizumab) for NMIBC Unresponsive to BCG -

- Poster Presentation Providing Overview of the Global Phase 3 Clinical Trial of CG0070 as a Monotherapy for NMIBC Unresponsive to BCG -

CG Oncology, Inc., a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for patients with advanced cancer, announced today acceptance of an oral presentation and a poster presentation at The Society for Immunotherapy of Cancer (SITC) Annual Meeting, held virtually and in-person in Washington, DC, November 10-14, 2021.

CG Oncology will present preliminary safety and efficacy data from CORE1, an ongoing Phase 2 clinical trial of CG0070 in combination with KEYTRUDA® (pembrolizumab), for the treatment of patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG).

Under a previously announced clinical collaboration with Merck relating to the investigation of CG0070 used in combination with pembrolizumab, the goal of CORE1, which will enroll up to 35 patients, is to evaluate the safety and efficacy of CG0070 plus KEYTRUDA for the treatment of NMIBC unresponsive to BCG.

More information about the study can be found at www.clinicaltrials.gov (NCT04387461).

Details of the oral presentation are as follows:

CORE1: Phase 2, Single Arm Study of CG0070 Combined with Pembrolizumab in Patients with Non Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)

Abstract Number: 955

Presenter: Roger Li, M.D., Moffitt Cancer Center

Session Date & Time: Saturday, November 13, 2021 from 12:15-12:30pm EST

Category: Late-Breaking Oral Abstract Session

In addition, CG Oncology will present an overview of trial design and methodology of BOND3, an ongoing global Phase 3 trial with CG0070 as a monotherapy for the treatment of patients with NMIBC unresponsive to BCG. The goal of BOND3, which will enroll 110 patients, is to evaluate the safety and efficacy of CG0070 as a monotherapy for the treatment of NMIBC unresponsive to BCG.

More information about the study can be found at www.clinicaltrials.gov (NCT04452591).

Details of the poster presentation are as follows:

A phase 3, single-arm study of CG0070 in subjects with non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG)

Abstract Number: 426

Presenter: Edward Uchio, M.D., UC Irvine Health, Department of Urology

Session Date & Time: Friday, November 12, 2021 and Saturday, November 13, 2021 from 7:00am-8:30pm EST

Category: Poster Abstract Session

Full abstracts of both presentations will be available on the SITC website on November 10, 2021.

About CG Oncology

CG Oncology is a clinical-stage biotechnology company focused on developing the next evolution of oncolytic immunotherapy for patients with advanced cancer. Our lead candidate, CG0070, is a selective oncolytic immunotherapy in a Phase 3 trial with CG0070 as a monotherapy for the treatment of BCG-unresponsive NMIBC, and a combination Phase 2 study of CG0070 with KEYTRUDA® (pembrolizumab) in the same indication. Other types of bladder cancer are being evaluated with CG0070 in combination with OPDIVO® (nivolumab), and additional indications in other solid tumors are being pursued with CG0070 in combination with other immune checkpoint inhibitors. At CG Oncology, we aim to take the next evolutionary step in delivering innovative cancer care to millions of patients in need worldwide. Learn more at www.cgoncology.com.

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