CG Oncology, Inc.

• CG Oncology's cretostimogene grenadenorepvec demonstrated a 75.5% complete response rate in high-risk BCG-unresponsive non-muscle invasive bladder cancer patients, with 34% maintaining complete response at 24 months. • The FDA has granted Fast Track and Breakthrough Therapy designations to cretostimogene, potentially expediting its regulatory pathway for a disease with limited treatment options. • The drug's 27.9-month median duration of response may provide a competitive edge over Johnson & Johnson's TAR-200, positioning CG Oncology as a significant player in the bladder cancer treatment landscape.

CG Oncology's cretostimogene demonstrated a positive outcome in its Phase 3 BONDER-002 trial for non-muscle invasive bladder cancer (NMIBC).

• Protara Therapeutics' TARA-002 demonstrated a 72% complete response rate in non-muscle invasive bladder cancer patients, regardless of prior BCG exposure. • In BCG-unresponsive patients, TARA-002 achieved a 100% complete response rate at six months, highlighting its potential in a registrational cohort. • CG Oncology's cretostimogene grenadenorepvec showed a 74.5% complete response rate in BCG-unresponsive patients, with a median duration of response exceeding 27 months. • Both TARA-002 and cretostimogene grenadenorepvec exhibited favorable tolerability profiles, with minimal treatment-related adverse events.

The PIVOT-006 trial is a phase 3 study assessing cretostimogene, an oncolytic immunotherapy, against surveillance in intermediate-risk non-muscle invasive bladder cancer (NMIBC).

• CG Oncology will host a conference call on December 5, 2024, to discuss Phase 3 BOND-003 trial results for cretostimogene in high-risk BCG-unresponsive NMIBC. • The BOND-003 trial evaluates cretostimogene monotherapy as a potential bladder-sparing treatment for non-muscle invasive bladder cancer (NMIBC). • Dr. Mark Tyson, II from Mayo Clinic, the lead investigator, will present the findings at the Society of Urologic Oncology (SUO) annual meeting. • Cretostimogene is an investigational oncolytic immunotherapy being studied across multiple clinical trials for NMIBC, including ongoing Phase 3 studies.

Cretostimogene monotherapy demonstrated a 74.5% complete response rate at any time in patients with high-risk BCG-unresponsive NMIBC.

Cretostimogene monotherapy achieved a 75.2% complete response rate in patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

• Phase 3 trial of cretostimogene grenadenorepvec shows a 75.7% complete response rate in patients with high-risk BCG-unresponsive NMIBC. • The 3- and 6-month landmark complete response rates were 68.2% and 63.6%, respectively, indicating sustained efficacy over time. • The oncolytic immunotherapy was generally well-tolerated, with mostly low-grade genitourinary adverse events and no treatment discontinuations. • CG Oncology plans to discuss advancing cretostimogene grenadenorepvec with the FDA as a potential new therapy for bladder cancer.