CG Oncology Announces First Patient Dosed in Japan in Phase 3 Monotherapy Study of CG0070 in Non-Muscle-Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin

IRVINE, Calif.–()–CG Oncology, Inc., a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for patients with advanced cancer, announced today it has triggered the first development milestone payment under its licensing agreement with Kissei Pharmaceutical Co., Ltd. for its oncology immunotherapy CG0070 for Japan, South Korea, Taiwan and other Asian countries with the exception of China.

CG Oncology will receive a $10 million cash payment with the dosing of the first patient in Japan in the Phase 3 study (BOND3) for CG0070 as monotherapy for the treatment of patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG).

The goal of BOND3, an ongoing global Phase 3 trial 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).

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.

About Kissei Pharmaceutical Co., Ltd.

Kissei is a Japanese pharmaceutical company based on the management philosophy “contributing to society through high-quality, innovative pharmaceutical products” and “serving society through our employees.” As a strong R&D-oriented corporation, it concentrates on providing innovative pharmaceuticals to patients worldwide. Kissei is engaged in bringing new drugs into the world through drug discovery and licensing activities in the field of urology, nephrology/dialysis, and rare/intractable diseases, which are its focus fields.

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