CG Oncology (CGON) investor relations material

Industry trends and macro environment

• U.S. proximity to providers and patients remains a key differentiator for innovation despite rising China-originated biotech competition.

• AI is being integrated across all business functions to drive productivity and efficiency, with a focus on workflow analysis and optimization.

• The Most Favored Nation (MFN) policy is closely monitored due to its potential impact on EU pricing and broader economics.

Regulatory and manufacturing updates

• The BLA for cretostimogene grenadenorepvec was completed in Q4, with robust, reproducible manufacturing processes validated and ready for commercial launch.

• All process characterization and validation experiments are complete, with ongoing data compilation for Module 3 submission.

• Inspection readiness is a priority, with ex-FDA inspectors engaged to prepare facilities for thorough FDA review.

• Lessons from ADCETRIS and ANKTIVA have led to increased resourcing and rigorous pressure testing at manufacturing sites.

Commercial strategy and launch preparation

• Current manufacturing can produce up to 50,000 vials, supporting approximately 2,500 patients in early years, with storage at -60°C for up to four years.

• A scaled-up process is in development for future demand, expected to be ready in a couple of years.

• Launch readiness centers on account profiling, targeting key accounts responsible for 80% of BCG volume, and gathering direct customer feedback.

• Operational simplicity and improved storage (2–8°C for up to eight weeks) are highlighted as major advantages for community urologists.