Cg Oncology, Inc. · NASDAQ:CGON
Cg Oncology — Investor Presentation (September 2025)
31 slides from Cg Oncology's investor presentation, Sep 9, 2025
Slide 1: Attacking Bladder Cancer for a Better Tomorrow
Attacking Bladder Cancer for a Better Tomorrow™
Slide 2: Disclaimer and Forward-Looking Statements
Disclaimer and Forward-Looking Statements We caution you that this presentation contains forward-looking statements about us and our industry. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and
Slide 3: Cretostimogene has the potential to shift the treatment paradigm in NMIBC
CONFIDENTIAL Cretostimogene has the potential to shift the treatment paradigm with best-in-disease durability in a multi-billion dollar opportunity in NMIBC Cretostimogene grenadenorepvec is an oncolytic immunotherapy with a dual mechanism of action designed to drive selective tumor killing and trig
Slide 4: Comprehensive Programs in High-Risk and Intermediate-Risk NMIBC
Comprehensive Programs in High-Risk and Intermediate-Risk NMIBC Addressing a Multi-Billion Dollar Market Opportunity COMPOUND/INDICATION PHASE 1 PHASE 2 PHASE 3 MILESTONES Cretostimogene Monotherapy High-Risk BCG-Unresponsive NMIBC (BOND-003 Cohort C)1 Cretostimogene Monotherapy Intermediate-Risk NM
Slide 5: Cretostimogene's Dual Mechanism of Action
Cretostimogene’s Dual Mechanism of Action: Selective Tumor Killing Triggers Durable Anti-Tumor Immune Response Progeny viruses are released and enter new cancer cells Cretostimogene stimulates cytokine and antigen release 1a 1b Attacking Bladder Cancer for a Better Tomorrow™ Cancer Cell Creto Progen
Slide 6: Significant Need for Innovation and Disruption in Bladder Cancer Treatments
Significant Need for Innovation and Disruption in Bladder Cancer Treatments Highly Recurrent Disease With Few Treatment Options A Very Common Cancer 85,000+ people will be diagnosed with bladder cancer this year1 ~15%-61% of high-risk patients will recur within 1 year7 Complex Disease Journey & Subo
Slide 7: NMIBC Represents a Multi-Billion Dollar Market Opportunity in Bladder Cancer
Bladder wall Lamina Propria Inner Muscle Deep Muscle Inside of the bladder wall Outside of the bladder wall Carcinoma in Situ (CIS) Non-Invasive Papillary Carcinoma Tumor Invades Connective Tissue Tumor Invades Deep Muscle Tumor Invades Perivesical Tissue Tumor Invades Adjacent Tissue and Organs Tum
Slide 8: The Patient Journey
The Patient Journey 2 Testing Work-up may include cystoscopy, urine cytology, and imaging (CT scan, MRI) 1 Symptoms Patient presents to primary care and/or urologist with symptoms (hematuria, urinary frequency) 3 TURBT1 TURBT, followed by tumor staging and grading Ongoing Treatment Require surveilla
Slide 9: Cretostimogene is Intravesically Administered, Similar to BCG Therapy
GAG Layer Tumor Standard Catheter Cretostimogene Cretostimogene is Intravesically Administered into the Bladder, Similar to Standard-of-Care BCG Therapy Which Urology Practices Perform Regularly BCG = Bacillus Calmette Guerin. DDM = n-Dodecyl β-D-maltoside. GAG = glycosaminoglycan. Procedure Can Be
Slide 10: Ease of Delivery and Administration for Patients, Physicians, and Practice Providers
Ease of Delivery and Administration for Patients, Physicians, and Practice Providers Cold chain and stability Commercial product will be shipped via Just-In-Time delivery with multi-day stability in the box; and at least 4 weeks at 2-8oC in a regular fridge until administration Prepared and administ
Slide 11: Programs Address More Than 70% of NMIBC Market Potential
NMIBC (75%) (Non-Muscle Invasive Bladder Cancer) Intermediate-Risk (30%) High-Risk (40%) All Bladder Cancer (U.S. Incidence ~85,000 Patients/Year; Prevalence ~730,000 Patients) BCG-Exposed BCG-Unresponsive BOND-003 Phase 3 Monotherapy Cohort C and Cohort P Cretostimogene Programs Across High-Risk &
Slide 12: Cretostimogene Monotherapy for HR BCG-Unresponsive NMIBC (BOND-003)
Phase 3 Cretostimogene Monotherapy for High-Risk (HR) BCG-Unresponsive NMIBC (NCT04452591) Cohort C DoR CR at 12 months PFS Cohort P RFS PFS Additional Endpoints HR BCG-Unresponsive NMIBC Cretostimogene Single-Arm, Open-Label, Intravesical Administration CR at Any Time (CIS) EFS (Ta/T1) Study Design
Slide 13: Patient Demographics & Baseline Characteristics
Patient Demographics & Baseline Characteristics N=112 % Gender Male 83 74.1 Female 29 25.9 Age (Years) Mean (SD) 72.9 (9.2) Median (Range) 74.0 (43-90) Age (Categories) < 65 19 17.0 ≥ 65 and < 75 43 38.4 ≥ 75 50 44.6 BCG History: Number of Prior Instillations Median (Range) 12 (7 – 66) High-Risk NMI
Slide 14: BOND-003 Cohort C Overall Complete Response
BOND-003 Cohort C Overall Complete Response 75.5% (95% CI, 66.3% - 83.2%) CR (n=83) 25 Overall CR Rate (%) (n=110) 50 75 100 0 Efficacy data cutoff as of June 23, 2025. Efficacy analysis are centrally confirmed. All patients have active disease at baseline prior to enrollment. Received adequate BCG
Slide 15: Cretostimogene Demonstrates Sustained Duration of Response
Cretostimogene Demonstrates Sustained Duration of Response in HR BCG-UR NMIBC Efficacy data cutoff as of June 23, 2025. Median DoR is 27.9 months and ongoing (95% CI 14.3-NE) Median follow-up of 25.8 months Suggests innate to adaptive switching with immunogenic memory & long IO tail Duration of Resp
Slide 16: Longest Median Duration of Response Exceeding 28 Months
Note: These data are not based on head-to-head or comparator studies, but have all enrolled FDA guidance defined BCG-Unresponsive High-Risk NMIBC CIS-containing patients according to their inclusion/exclusion criteria. 1 Efficacy data cutoff as of June 23, 2025. 2 Jacobs et al. AUA 2025 TAR-200 mono
Slide 17: High CR Rate Consistent Across Patient Subgroups
High CR Rate Consistent Across Patient Subgroups, Including Patients Treated with Prior Chemotherapy Efficacy data cutoff as of June 23, 2025. Complete Response Rate (95% CI) BOND-003 Cohort C
Slide 18: Favorable and Well Tolerated Safety Profile
Favorable and Well Tolerated Safety Profile 0% Grade ≥ 3 treatment-related AEs or deaths reported Most AEs were Grade 1-2 Median time to treatment-related AE resolution is 1 day No treatment-related discontinuations observed 97.3% completed all protocol-defined treatments 1.8% patients (n=2) had ser
Slide 19: Cross-Study Comparison Notes and References
1 These data are not based on head-to-head or comparator studies. Differences exist between study designs and subject characteristics, and caution should be exercised when comparing data across studies. From published data. 2 All 9 ongoing CRs remained in response at the 24-month assessment, as well
Slide 20: Best-in-Disease Complete Response Rate at 24 Months
Cretostimogene Has Delivered Best-in-Disease Complete Response (CR) Rate at 24 Months Cretostimogene demonstrated best-in-disease long-term DoR compared to approved drugs in NMIBC with 41.8% of patients in CR at 24 months 90% of patients in CR at 12 months maintained in CR at 24 months No grade 3+ T
Slide 21: Intermediate-Risk NMIBC Study Design (PIVOT-006)
RFS at 12-month and 24-month PFS Safety Additional Endpoints Intermediate-Risk (IR) NMIBC (Enrollment Completed) Cretostimogene vs Surveillance/TURBT Randomized (1:1), Two Arms, Open-Label (n=364) Primary Endpoint: RFS Rate Study Design / Regimen Arm A = Cretostimogene following TURBT Induction cour
Slide 22: Cretostimogene Monotherapy for HR BCG-Naïve and BCG-Exposed NMIBC (CORE-008)
Phase 2 Cretostimogene Monotherapy for High-Risk (HR) BCG-Naïve and BCG-Exposed NMIBC (Cohort A and B) CORE-008 Cohort A DoR (in CIS) EFS, LG RFS, CFS Cohort B DoR (in CIS) EFS, LG RFS, CFS Additional Endpoints HR BCG-Naïve & BCG-Exposed (Actively Enrolling) Cretostimogene Two Cohorts (A and B), Two
Slide 23: Potential Synergy Between Cretostimogene & Gemcitabine
Potential Synergy Between Cretostimogene & Gemcitabine Mechanism of Action Cretostimogene and gemcitabine potentially have complementary, non-overlapping MoA as an intravesical combination Oncolysis – Cretostimogene selectively replicates and lyses cancer cells, triggering an immunogenic cell death
Slide 24: Cretostimogene in Combination for HR NMIBC (Cohort CX)
Phase 2 Cretostimogene in Combination for High-Risk (HR) BCG-Exposed & BCG-Unresponsive NMIBC (Cohort CX) CORE-008 CX CR at any time CR at 12 months DoR PFS CFS Additional Endpoints HR BCG-Exposed & BCG Unresponsive NMIBC Cretostimogene + Gemcitabine 1:1 Randomized, Two Arm, Open-Label Primary Endpo
Slide 25: Scalable Manufacturing Process Positioned for Launch
CG’s high yielding and scalable process is positioned to address BCG-Unresponsive HR NMIBC market at launch Single-use bioreactors allow for optimized manufacturing campaigns that support multiple production runs and results in higher efficiency and throughput Highly stable product enables inventory
Slide 26: Goal: Establish Cretostimogene as a Backbone Therapeutic Option for NMIBC
Our Goal is to Establish Cretostimogene as a Backbone Therapeutic Option for NMIBC Establish Motivating Differentiation Cretostimogene has demonstrated durable efficacy and tolerability, key for elderly patients with multiple recurrences Change Therapy, Not Behavior Cretostimogene is administered li
Slide 27: Catalyst Rich Calendar with Potential for Frontline Indication Expansion
Catalyst Rich Calendar with Potential for Frontline Indication Expansion HR = High-Risk, IR = Intermediate-Risk 1. IR Frontline adjuvant NMIBC 2. HR BCG-UR NMIBC 3. HR BCG-naïve NMIBC 4. HR BCG-exposed NMIBC 5. CX is in combination with gemcitabine * Note: Timing and achievement of milestone events
Slide 28: Cretostimogene Positioned as Backbone Therapy in NMIBC
Cretostimogene Positioned as Backbone Therapy in NMIBC Across High-Risk & Intermediate-Risk Populations Promising early efficacy signal observed in HG Ta/T1 with consistent safety and tolerability profile 90.5% HG RFS at 3-month and 9-month Compares favorably against other therapies in High-Risk, BC
Slide 29: Contact Us
www.CGOncology.com CONTACT US CG Oncology, Inc. 400 Spectrum Center Dr Suite #2040 Irvine, CA 92618 GENERAL INQUIRIES Information@cgoncology.com MEDIA MediaRelations@cgoncology.com
Slide 30: Executive Leadership Team
b b b Arthur Kuan Chairman & CEO Business Insider’s 30 People Under 40 Who Are Transforming Healthcare 2020 Forbes 30 Under 30 featured honoree in healthcare b Ambaw Bellete President & COO Vijay Kasturi, M.D. Chief Medical Officer 30+ Years in Biotech & Life Sciences with multiple BLA approvals & l
Slide 31: Our Vision and Mission
Our Vision We see a world where urologic cancer patients can benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. Our Mission We are focused on developing bladder-sparing therapeutics for patients afflicted with bladder cancer. Attacking Bladder Canc