Cg Oncology, Inc. · NASDAQ:CGON
Cg Oncology — AUA Annual Meeting 2025
14 slides from Cg Oncology's conference presentation, Apr 26, 2025
Slide 1: Paradigm-Shifting, Practice-Changing Clinical Trials in Urology: BOND-003 Cohort C
P2: Paradigm-Shifting, Practice-Changing Clinical Trials in Urology BOND-003 Cohort C- A Phase-3, Single-Arm For https://cgoncology.com/wp- individual reference only. content/uploads/2024/10/WSAUA Study of Intravesical Cretostimogene 2024The information accessed Tyson_BOND-003 through Final.pdf inte
Slide 2: Disclosures
Disclosures • CG Oncology - No Conflicts of Interest ©2024 Mayo Foundation for Medical Education and Research | slide-2
Slide 3: Cretostimogene Selectively Targets Rb-E2F Pathway Altered Cancers
Cretostimogene Grenadenorepvec Selectively Targets Rb-E2F Pathway Altered Cancers • Conditionally replicating, highly immunogenic adenovirus oUnder regulation of the human E2F-1 promoter - Selective for RB-E2F pathway alterations oEncodes GM-CSF transgene • Oncolytic immunotherapy with dual MOA oVir
Slide 4: Phase 3 Cretostimogene Monotherapy for High-Risk BCG-Unresponsive NMIBC with CIS
Phase 3 Cretostimogene Monotherapy for High-Risk BCG-Unresponsive NMIBC with CIS HR BCG-Unresponsive NMIBC Cretostimogene Grenadenorepvec Primary Endpoint: Single-Arm, Open-Label, IVE Administration CR at Any Time Population Study Design / Regimen Additional Endpoints • Enrollment complete (n=112) •
Slide 5: Patient Demographics & Baseline Characteristics
Patient Demographics & Baseline Characteristics Subjects in Safety Dataset N=112 % Gender Male 83 74.1 Female 29 25.9 Age (Years) • Majority of patients are: Mean (SD) 72.9 (9.19) 74.0 (43-90) o Male (74%) Median (Range) Age (Categories) o White (62%) < 65 19 17.0 o > 65 years (83%) ≥ 65 and < 75 43
Slide 6: Consistent and Compelling CR & Durability Data
Consistent and Compelling CR & Durability Data Overall Complete Response 100 CR CR Rate, % CR by K-M Est, % 75.5% Landmark (95% CI) (95% CI) (95% CI, 66.3 % - 83.2 %) 12-month 46.4% (36.9, 56.1) 50.7% (40.9, 59.8) Overall CR Rate (%) 75 51 out of 110 patients 33.7% (24.8, 43.8) 34 out of 101 evaluab
Slide 7: Cretostimogene Demonstrates Best in Class Duration of Response
Cretostimogene Demonstrates Best in Class Duration of Response in HR BCG-UR NMIBC Estimated DOR Probability at 12 Months Estimated DOR Probability at 24 Months 64.1% Duration of Response Probability (%) (95% CI: 52.4-73.7) 58.3% (95% CI: 46.3-68.5) • Median DoR is 27.9 months and ongoing (95% CI 14.
Slide 8: Sustained Responses Observed Over 45 Months
Sustained Responses Observed Over 45 Months • 50.0% of patients reinduced with oncolytic immunotherapy converted to CR o 64.3% remain in durable response after conversion to CR • Patients remain in response after treatment completion Efficacy data cutoff as of 14MAR2025. 1 Per 2018 FDA Guidance Docu
Slide 9: High CR Rate Consistent Across Patient Subgroups
High CR Rate Consistent Across Patient Subgroups, Including Patients Treated with Prior Chemotherapy ©2024 Mayo Foundation for Medical Education and Research | slide-9
Slide 10: Favorable and Well-Tolerated Safety Profile
Favorable and Well-Tolerated Safety Profile Cretostimogene (n=112) Preferred Term (MedDRA v.26.1) Any Grade (%) Grade ≥ 3 • Most AEs were Grade 1-2 Patients with ≥ 1 TRAE 71 (63.4%) 0 (0) • 0% Grade ≥ 3 TRAEs or deaths Treatment-Related AE reported in > 10% patients • Median time to TRAE resolution:
Slide 11: Viral Replication and Transgene Expression
Viral Replication and Transgene Expression Pre-Dose Creto Titer Post-Dose Creto Titer Pre-Dose GM-CSF Post-Dose GM-CSF • Cretostimogene replication 1000 108 and GM-CSF expression are 107 linked • Urine levels peak Cretostimogene Titer in Urine (Genome Copy Number/mL) GM-CSF in Urine (pg/mL) 100 106
Slide 12: Key Takeaways
Key Takeaways • Highly effective and very well-tolerated regimen • Best in class durability and tolerability • Robust and stable anti-tumor response • Heavily pre-treated BCG-UR CIS containing cohort • Scalable within existing clinic workflow; administered by MAs & RNs • Future and ongoing clinical
Slide 13: First Results: BOND-003 Cohort P HR NMIBC BCG-Unresponsive HG Ta/T1
First Results: BOND-003 Cohort P HR NMIBC BCG- Unresponsive HG Ta/T1 Kaplan-Meier Estimate for High Grade Recurrence-Free Survival • Data from first 24 treated patients HG Recurrence-Free Survival (%) • Strong early responses with 90.5% HG-RFS (95% CI: 77.9-100%) at 3 and 9 Months • Very well-tolera
Slide 14: Thank you
Thank you All Bladder Cancer Patients and Their Families Key Investigators, Study Coordinators, Nurses Mark Tyson Mayo Clinic, AZ, USA Hong Koo Ha Pusan National University Hospital, S. Korea Roger Li Moffitt Cancer Center, FL, USA Kiyohide Fujimoto Nara Medical University Hospital, Japan Jong-Kil N