Cg Oncology, Inc. · NASDAQ:CGON
Cg Oncology — SUO Annual Meeting 2023
15 slides from Cg Oncology's conference presentation, Dec 1, 2023
Slide 1: First Results from BOND-003: Phase 3 Study of Cretostimogene Monotherapy
First Results from BOND-003: Phase 3 Study of Cretostimogene Grenadenorepvec Monotherapy for Patients with BCG- Unresponsive High-Risk NMIBC with CIS +/- Papillary (Ta/T1) Tumors https://cgoncology.com/wp- content/uploads/2023/10/SUO_2023_ First_Results_from_BOND-003.pdf For individual reference onl
Slide 2: What is Cretostimogene Grenadenorepvec?
What is Cretostimogene Grenadenorepvec? • Conditionally replicating adenovirus oHighly immunogenic • Oncolytic immunotherapy oEncodes GM-CSF oInsertion of human E2F-1 promoter • Binds to Coxsackie Adenovirus Receptor (CAR) oRobust expression in all stages of bladder cancer • Viral replication result
Slide 3: Oncolytic Immunotherapy: Selective Oncolysis and Potent Anti-Tumor Immune Response
Oncolytic Immunotherapy: Spreads to additional tumor cells Selective Oncolysis and Potent inducing a chain reaction of killing Anti-Tumor Immune Response cancer cells Targeting and Destroying 1 of Cancer Cells Enters target cell Replicates and kills the cell Stimulation of Anti-tumor Virus stimulate
Slide 4: BOND-003 Phase 3 Trial Cretostimogene Monotherapy for BCG-Unresponsive High-Risk NMIBC with CIS
BOND-003 Phase 3 Trial Cretostimogene Monotherapy for BCG-Unresponsive High-Risk NMIBC with CIS1 Enrollment Complete (N=116) Trial Design Dosing Regimen Endpoints • Single-arm, open-label, • CR at any time intravesical administration of Induction Course: cretostimogene monotherapy Weekly x 6 • CR at
Slide 5: BOND-003 Patient Demographics
BOND-003 Patient Demographics Subjects in Efficacy Dataset N=66 % • Majority of patients are male Gender Male 50 75.8 (76%), white (56%), > 65 Female 16 24.2 years (80%) Age (Years) Mean (SD) 72.32 (8.30) • ECOG 0 at baseline (80%) Median (Range) Age (Categories) 73 (49-90) • Qualifying BCG < 65 13
Slide 6: First Results From BOND-003: 76% CR at Any Time
First Results From BOND-003: 76% CR at Any Time CR at Any Time • Efficacy analysis for all patients based on central review 75.7% • All patients have active disease at (95% CI, 63% - 85%) baseline prior to enrollment • Received adequate BCG therapy as per FDA 2018 Guidance on BCG- unresponsive NMIBC
Slide 7: First Results From BOND-003: 76% CR at Any Time
First Results From BOND-003: 76% CR at Any Time 74.4% of Responders Maintained Response ≥ 6 Months CR at Any Time CR Lasting ≥ 6 Mo 75.7% 74.4% Cretostimogene Monotherapy (95% CI, 63% - 85%) (95% CI, 58% - 86%) Response Evaluation %, (n/N) Confidence Interval (CI) Complete Response Complete Response
Slide 8: Cretostimogene Shows Durable Response Over Time
Cretostimogene Shows Durable Response Over Time • 74% of complete responders maintained their response for at least 6 months • 31% of patients salvaged with re-induction 0 3 6 9 Efficacy data cutoff as of October 5, 2023. Complete Response Assessment (Months) ©2022 Mayo Foundation for Medical Educat
Slide 9: Cretostimogene Has Been Generally Well-Tolerated
Cretostimogene Has Been Generally Well-Tolerated Patients with TRAEs, Cretostimogene (n=112) n (%) Any Grade (%) Grade ≥ 3 • Most AEs were Grade 1-2 ≥ 1 TRAE 63 (56.3) 0 (0) • 2 patients (1.8%) had serious ≥ 1 Treatment-Related AE treatment-related AEs (Grade 2)1 Bladder Spasm 23 (20.5) 0 (0) • No g
Slide 10: Cretostimogene Has Potential to Disrupt NMIBC Treatment Landscape
Cretostimogene Has Potential to Disrupt NMIBC Treatment Landscape1 Trial BOND-003 CORE-0012 QUILT 3.032 NCT02773849 KEYNOTE-057 SunRISe-1 Cretostimogene + Intervention Cretostimogene N-803 + BCG Nadofaragene Pembrolizumab TAR-200 Pembrolizumab Oncolytic Local Delivery of Oncolytic IL-15 Superagonist
Slide 11: Next Phase of BOND-003 Trial
Next Phase of BOND-003 Trial Trial Extension & Addition of BCG-UR Papillary Only Cohort Treatment Extension Addition of Papillary Cohort (n=70) Maintenance Extension: Dosing Schedule: Complete Responders eligible for Standard cretostimogene induction maintenance through Year 3 and maintenance schedu
Slide 12: SUO-CTC Trial: PIVOT-006 Phase 3 Adjuvant Cretostimogene Versus TURBT Alone
SUO-CTC Trial: PIVOT-006 Phase 3 Adjuvant Cretostimogene Versus TURBT Alone in Intermediate Risk NMIBC Dr. Robert Svatek as Global Principal Investigator (NCT06111235) • Over 90 North American sites to participate in the study • First Site Open o Carolina Urologic Research Center, Neal Shore, M.D. ©
Slide 13: Acknowledgements
Acknowledgements All BCG-Unresponsive Bladder Cancer Patients and Their Families The Study Coordinators and Nurses Key Collaborators CG Oncology Edward Uchio, UC Irvine, CA Shelly Basye Roger Li, Moffitt Cancer Center, FL James Burke Jong-kil Nam, Pusan University, South Korea Andy Darilek Don Lamm,
Slide 14: Fast Track Designation Granted for Cretostimogene Monotherapy
Fast Track Designation Granted for Cretostimogene Monotherapy in BCG-Unresponsive CIS with or with out Ta/T1 Papillary Disease! ©2022 Mayo Foundation for Medical Education and Research | slide-14
Slide 15: Questions & Answers
QUESTIONS & ANSWERS https://cgoncology.com/wp- content/uploads/2023/10/SUO_2023_ First_Results_from_BOND-003.pdf For individual reference only. The information accessed through this QR code is intended solely for individual reference and should not be altered, modified, or reproduced in any way. ©20