Cg Oncology, Inc. · NASDAQ:CGON
Cg Oncology — NCSAUA 2025
12 slides from Cg Oncology's conference presentation, Oct 16, 2025
Slide 1: PIVOT-006: Phase 3 Adjuvant Cretostimogene vs Surveillance in IR-NMIBC
Trial in Progress: PIVOT-006- A Phase-3, Randomized Study of Adjuvant Intravesical Cretostimogene Grenadenorepvec Versus Surveillance for the Treatment of Intermediate-Risk Non- Muscle Invasive Bladder Cancer Piyush Agarwal, MD Director, Bladder Cancer Program UChicago Medicine Presented at NCSAUA 2
Slide 2: Disclosures
Disclosures • CG Oncology – No conflict of interest 2
Slide 3: Cretostimogene Selectively Targets Rb-E2F Pathway Altered Cancers
Cretostimogene Selectively Targets Rb-E2F Pathway Altered Cancers • Oncolytic immunotherapy with dual MOA o Viral replication results in tumor lysis o Stimulation of immune response • Conditionally replicating, highly immunogenic adenovirus o Under regulation of the human E2F-1 promoter o Encodes GM
Slide 4: Significant Unmet Need with High Prevalence of Intermediate-Risk NMIBC in the U.S.
Significant Unmet Need with High Prevalence of Intermediate-Risk NMIBC in the U.S. NMIBC Prevalence NMIBC in U.S. 1 Risk Stratification Intermediate-Risk NMIBC • High Recurrence; 50-70%2 • Low Progression; < 5%2 Low -Risk High -Risk • Common 2 ~30% ~40% • Costly3 • Chronic4 • Risk of Anesthesia, Sur
Slide 5: Management of Intermediate-Risk NMIBC
Management of Intermediate-Risk NMIBC 5
Slide 6: Experience with TURBT with Surveillance in NMIBC
Experience with TURBT with Surveillance in NMIBC 63% Freedom from Subsequent TURBT at 1 Year Contieri R., et al. Eur Urol Suppl 2024;85 (S1): S1717 6
Slide 7: Intermediate-Risk NMIBC Study Considerations
Intermediate-Risk NMIBC Study Considerations • IR-NMIBC is a challenging disease state o Disease is heterogenous o Guidelines recommendations are mixed; Limited adjuvant options • PIVOT-006 is one of the first adjuvant, RCTs in IR-NMIBC • Surveillance as a comparator offers advantages o Reflects tru
Slide 8: Phase 3 Adjuvant Cretostimogene vs Surveillance for Intermediate-Risk NMIBC
Phase 3 Adjuvant Cretostimogene vs Surveillance for Intermediate-Risk NMIBC N = 367 Regimen*: IVE cretostimogene Induction (Weekly x 6) & Trial Type: Phase 3 1- yr Maintenance following TURBT Exploratory: Biomarkers, PROs, Design: Open-label, RCT Endpoints: RFS (primary), RFS at 12-month and 24-mont
Slide 9: Exclusion Criteria
Exclusion Criteria • Current or prior evidence of HR-NMIBC defined as: o HG T1 o HG Ta > 3 cm that is recurrent or multifocal o Any carcinoma in situ (CIS) o Any variant histology o Any HG prostatic urethral involvement o Any LVI o Any BCG treatment failure in HG patient • LR-NMIBC o A LG solitary,
Slide 10: Efficacy Assessments
Efficacy Assessments • Efficacy Assessments • Recurrence Free Assessment - Visit, cystoscopy, biopsy for cause, cytology - Without recurrence or o Q3mo, first 2 years progression in the bladder o Q6mo, 3rd year - Imaging - Upper tract or prostatic urethra o Q12mo - Mapping biopsy/imaging for isolate
Slide 11: Strong Enrollment Momentum on PIVOT-006
Strong Enrollment Momentum on PIVOT-006 • SUO-CTC trial • Diverse representation across LUGPA & Academic sites • First enrollments January 2024 • Enrollment Completed ahead of schedule 11
Slide 12: Acknowledgements
Acknowledgements All Bladder Cancer Patients and Their Families The Study Coordinators and Nurses Key Collaborators CG Oncology Andy Darilek Robert Svatek, UTHSA, TX Jalees Farhan Trinity Bivalacqua, UPenn, PA Pradnya Gunjotikar Neal Shore, CURC, SC Jee-Hyun Kim Gautam Jayram, Urology Associates, TN