CG Oncology (CGON) Investor Presentation summary

Clinical development and efficacy highlights

• Cretostimogene, an investigational oncolytic immunotherapy, demonstrated a 75.5% overall complete response (CR) rate in high-risk BCG-unresponsive NMIBC, with 46.4% CR at 12 months and 41.8% at 24 months, showing best-in-disease durability and safety with no grade 3+ treatment-related adverse events reported.

• In high-risk papillary-only BCG-unresponsive NMIBC, cretostimogene achieved 95.7% high-grade event-free survival (HG-EFS) at 3 months, 84.6% at 6 months, and 80.4% at 9 months, with no treatment-related progression or cystectomy.

• For high-risk BCG-naïve NMIBC, an 88% CR rate was observed, with no grade ≥3 adverse events or treatment-related discontinuations.

• Cretostimogene is being evaluated in multiple ongoing and planned Phase 2 and 3 trials across high-risk and intermediate-risk NMIBC, including monotherapy and combination regimens.

• Optimized administration protocol reduces procedure time by ~25%, streamlining integration into clinical workflows and supporting high-volume treatment centers.

Market opportunity and commercial readiness

• NMIBC represents about 75% of newly diagnosed bladder cancer cases, with a multi-billion dollar market opportunity and over 150,000 addressable patients in the U.S.

• Cretostimogene programs target more than 70% of the NMIBC market potential, spanning BCG-unresponsive, BCG-exposed, BCG-naïve, and intermediate-risk populations.

• Annualized wholesale acquisition cost (WAC) of approved therapies in high-risk NMIBC ranges from $200,000 to $690,000.

• Commercial strategy focuses on a capital-efficient, high-touch approach, targeting a concentrated prescriber network where top decile urology centers account for ~10% of national volume.

• Pre-launch activities include field force deployment, site and payor engagement, and integration into established urology practice workflows.

Mechanism of action and patient journey

• Cretostimogene's dual mechanism involves selective tumor cell killing and stimulation of a durable anti-tumor immune response.

• Administered intravesically, similar to standard BCG therapy, allowing seamless adoption by urology practices without additional training.

• Patient journey for NMIBC includes regular surveillance, TURBT, and intravesical therapies, with cretostimogene positioned as a bladder-sparing alternative.