cretostimogene grenadenorepvec (CG0070) / Kissei, CG Oncology - LARVOL DELTA

TOPLINE RESULTS FROM BOND-003 COHORT P- A MULTI-NATIONAL, SINGLE-ARM STUDY OF INTRAVESICAL CRETOSTIMOGENE GRENADENOREPVEC FOR TREATMENT OF HIGH-RISK, PAPILLARY ONLY, BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER (SUO 2025) - P3 | "Results from the BOND-003 Cohort P clinical trial of cretostimogene monotherapy in patients with BCG-UR papillary-only NMIBC demonstrate encouraging HG-RFS and a consistent, well-tolerated safety profile. Mature data with longer term follow-up will build upon these promising findings and will inform future treatment approaches with cretostimogene in High-Risk papillary-only BCG-UR NMIBC."

IO biomarker • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • CSF2

DESIGN AND IMPLEMENTATION OF A PATIENT-CENTRIC EXPANDED ACCESS PROGRAM WITH CRETOSTIMOGENE GRENADENOREPVEC IN NON-MUSCLE INVASIVE BLADDER CANCER UNRESPONSIVE TO BACILLUS CALMETTE-GUERIN (SUO 2025) - P | "The study is actively enrolling, with initial patients treated. "

Clinical • IO biomarker • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • CSF2

DURABLE 24-MONTH OUTCOMES FROM BOND-003 COHORT C: PHASE 3 STUDY OF INTRAVESICAL CRETOSTIMOGENE GRENADENOREPVEC FOR HIGH-RISK BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER WITH CARCINOMA IN SITU (SUO 2025) - P3 | "Cretostimogene offers distinct advantages with its efficacy, durability and safety profile for the treatment of HR BCG-UR NMIBC. Ongoing and future investigations of this promising therapy, as monotherapy and in rational combinations, may address the considerable unmet need for patients with bladder cancer."

IO biomarker • P3 data • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • CSF2

CORE-008 COHORT B: EVALUATING INTRAVESICAL CRETOSTIMOGENE GRENADENOREPVEC IN PATIENTS WITH HIGH-RISK, BCG-EXPOSED NON-MUSCLE INVASIVE BLADDER CANCER (SUO 2025) - P2 | "Cohort B is now open for enrollment in collaboration with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC). "

Clinical • IO biomarker • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • CSF2

FIRST RESULTS FROM CORE-008 COHORT A- PHASE 2 STUDY OF INTRAVESICAL CRETOSTIMOGENE GRENADENOREPVEC IN PATIENTS WITH HIGH-RISK BCG-NAÏVE NON-MUSCLE INVASIVE BLADDER CANCER (SUO 2025) - P2 | "The first results from CORE-008 Cohort A demonstrate that cretostimogene has promising clinical efficacy and safety in patients with high-risk, BCG-naïve NMIBC. These findings support the further evaluation of cretostimogene in the early, HR NMIBC disease continuum. Additional analyses are planned in patients with high-grade BCG-naïve Ta/T1 papillary-only NMIBC, within CORE-008, Cohort A."

Clinical • IO biomarker • P2 data • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • CSF2

PIVOT-006: A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT (clinicaltrials.gov) - P3 | N=367 | Active, not recruiting | Sponsor: CG Oncology, Inc. | Trial completion date: Jan 2030 ➔ Feb 2029 | Trial primary completion date: Jan 2028 ➔ Jun 2026

Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urethral Cancer • Urothelial Cancer

CG Oncology Provides Updated Timeline for PIVOT-006 Phase 3 Topline Data in Intermediate-Risk NMIBC (GlobeNewswire) - "PIVOT-006 Phase 3 topline data evaluating cretostimogene monotherapy for intermediate-risk NMIBC now expected in 1H 2026, nearly one year ahead of schedule....This expedited timeline is due to the rapid study enrollment across over 90 sites."

P3 data: top line • Bladder Cancer

CORE-008 Cohort B: Evaluating Intravesical Cretostimogene Grenadenorepvec in Patients with High-Risk, BCG-Exposed Non-Muscle Invasive Bladder Cancer (EAU 2026) - No abstract available

Clinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Translational Insights from CORE-008 Cohort A- Phase 2 Study of Intravesical Cretostimogene Grenadenorepvec in Patients with High-Risk BCG-Naïve Non-Muscle Invasive Bladder Cancer (EAU 2026) - No abstract available

Clinical • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Final results of CORE-001: A phase-2, single arm study of cretostimogene grenadenorepvec in combination with pembrolizumab in patients with BCG-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ. (ASCO 2024) - P2 | "The efficacy and safety of cretostimogene plus pembrolizumab for treatment of BCG-UR, HR NMIBC with CIS demonstrates best-in-class CR and DOR compared to current FDA-approved therapies, with an acceptable AE profile. Further investigation of this promising combination therapy is warranted and may serve to address a considerable unmet need."

Clinical • Combination therapy • IO biomarker • P2 data • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Solid Tumor • CSF2 • PD-L1

Mk3475 Keynote 935: Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin (clinicaltrials.gov) - P2 | N=37 | Recruiting | Sponsor: CG Oncology, Inc. | Trial completion date: Jun 2022 ➔ Jun 2023 | Trial primary completion date: Dec 2021 ➔ Jun 2023

Combination therapy • Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Phase 2, Single Arm Study of CG0070 Combined with Pembrolizumab in Patients with Non Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) (SITC 2022) - P2 | "Data on efficacy and safety for all enrolled patients, N=35, as well as biomarker (CAR, E2F, and PDL1) assessment will be presented at the time of the conference. Trial Registration NCT04387461 Ethics Approval CENTRAL IRB Castle: Protocol Number: CORE-001 (CG2003C) Sponsor CG Oncology, Inc Study Title A Phase 2, Single Arm Study of CG0070 Combined with Pembrolizumab in Patients with Non- Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Study Materials Reviewed and Approved by Castle IRB: • Clinical Study Protocol CORE-001 (CG2003C) Summary of Changes, Version: Amendment 4, 24JAN 2022 • Clinical Study Protocol CORE-001 (CG2003C), Version: Amendment 4, 24 JAN 2022 • Investigator’s Brochure Pembrolizumab Risk Language, Version: Edition 03 SEP 2021 • Investigator’s Brochure Pembrolizumab, Version: Edition 21, 02 SEP 2021 • Master Informed Consent Form Template, Version: 5, 04 FEB 2022 • Patient Educational Slide Deck Sites Approved..."

Clinical • IO biomarker • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • CSF2 • PD-L1

CORE1: Phase 2 Single Arm Study of CG0070 Combined with Pembrolizumab in Patients with Non Muscle Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin (BCG) (AUA 2023) - "This initial data on the efficacy and safety of CG0070 plus pembrolizumab for the treatment of BCG unresponsive NMIBC is encouraging. Data on efficacy and safety for all enrolled patients, N=35, as well as biomarker (CAR, E2F, and PDL1) assessment will be presented at the time of the conference."

Clinical • IO biomarker • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • CSF2 • PD-L1

PIVOT-006: A phase 3, randomized study of cretostimogene grenadenorepvec versus observation for the treatment of intermediate risk non-muscle invasive bladder cancer (IR-NMIBC) following transurethral resection of bladder tumor (TURBT). (ASCO-GU 2024) - "Exploratory outcome measures include patient-reported quality of life, biomarker analyses, coxsackie adenovirus receptor and E2F promoter expression, neutralizing antibodies, and markers of immunogenicity. Clinical trial information: Pending."

Clinical • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • CSF2

P2s: Paradigm-shifting, Practice-changing Clinical Trials in Urology: Pivotal Results from BOND-003: A Phase 3, Single-arm Study of Intravesical Cretostimogene Grenadenorepvec for the Treatment of High Risk, BCG-Unresponsive Non-Muscle Invasive Bladder C (AUA 2024) - No abstract available

Clinical • P3 data • Urology

BOND-003- Cohort P: A Multi-national, Single-arm Study of Intravesical Cretostimogene Grenadenorepvec for the Treatment of High-Risk, Papillary Only, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (SUO 2024) - "Screening and patient selection have been initiated. NCT044552591 "

IO biomarker • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • Urology • CSF2

P2s: Practice-changing, Paradigm-shifting Clinical Trials in Urology (P2): FINAL RESULTS: BOND-003 COHORT C- PHASE 3, SINGLE-ARM STUDY OF INTRAVESICAL CRETOSTIMOGENE GRENADENOREPVEC FOR HIGH-RISK BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER WITH CARCINOMA IN SITU (AUA 2025) - "The compelling efficacy, durability, freedom from progression, and tolerability of cretostimogene offer distinct advantages over existing therapies for the treatment of HR BCG-UR NMIBC. Ongoing investigations of this promising monotherapy, as well as future combinations, have the potential to address a considerable unmet need for bladder cancer patients."

Clinical • IO biomarker • P3 data • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • Urology • CSF2

TRIAL IN PROGRESS: BOND-003 COHORT P- A MULTI-NATIONAL, SINGLE-ARM STUDY OF INTRAVESICAL CRETOSTIMOGENE GRENADENOREPVEC FOR THE TREATMENT OF HIGH-RISK, PAPILLARY ONLY, BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER (AUA 2025) - "35+ clinical sites have been selected in the United States and Japan. The study has surpassed 50% enrollment, with interim results expected at the end of 2025."

IO biomarker • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • CSF2

UPDATES TO THE CORE-008 TRIAL PROTOCOL: A PHASE 2 MULTI-ARM, MULTI-COHORT STUDY TO EVALUATE INTRAVESICAL CRETOSTIMOGENE GRENADENOREPVEC IN PATIENTS WITH HIGH-RISK NON-MUSCLE INVASIVE BLADDER CANCER (AUA 2025) - P2 | "Cohort CX, recently added to the study, will evaluate safety and HG-EFS of cretostimogene in combination with intravesical gemcitabine, either concurrent (Arm 1) or sequential (Arm 2) in BCG-exposed and BCG-unresponsive patients. All cohorts in the CORE-008 study are currently open for recruitment, with approximately one-third of patients already enrolled in Cohort A at the time of abstract submission. Cohort B has received collaborative support from the Society of Urologic Oncology-Clinical Trials Consortium (SUO-CTC)."

Clinical • IO biomarker • P2 data • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • Urology • CSF2

Evolving frontiers in bladder cancer immunotherapy: integrating BCG, immune checkpoints, viral vectors, nanotechnology, and CAR-based therapies. (PubMed, Front Cell Dev Biol) - "Viral vector-based approaches, including nadofaragene firadenovec and CG0070, provide localized immune activation, while cellular platforms such as CAR-T and CAR-NK therapies offer precision targeting of tumor antigens. Collectively, these strategies signify a paradigm shift from traditional intravesical therapy toward personalized and durable immunotherapeutic interventions. Identification of predictive biomarkers and rational combination strategies will be critical to improving outcomes and guiding the future management of BC."

IO biomarker • Journal • Review • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Urothelial Carcinoma In Situ: Advances in Diagnosis and Management. (PubMed, Clin Genitourin Cancer) - "Recent advances in diagnostic techniques, such as narrow band imaging and photodynamic diagnosis, have improved detection accuracy, while novel therapeutic strategies, such as immune checkpoint inhibitors, thermo-chemotherapy, intravescical gene therapy (nadofaragene firadenovec), IL-15 superagonists (eg, ALT-803), and oncolytic viral therapies (eg, CG0070), are expanding the treatment landscape. Furthermore, emerging molecular and immune-related biomarkers may help predict response to therapy and guide personalized management. This review summarizes current evidence on the biology, diagnosis, and treatment of CIS, highlighting key challenges and future directions in the effort to improve patient outcomes and reduce the need for radical cystectomy."

IO biomarker • Journal • Review • Bladder Cancer • Gene Therapies • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Study of CG0070 Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin (clinicaltrials.gov) - P2 | N=16 | Recruiting | Sponsor: Lepu Biopharma Co., Ltd.

New P2 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A systematic review of gene-mediated therapy in BCG-unresponsive NMIBC: emerging evidence and future perspectives. (PubMed, World J Urol) - "Gene therapies represent a novel and promising therapeutic approach for BCG-unresponsive NMIBC, with significant oncological efficacy and a favorable safety profile."

Journal • Review • Bladder Cancer • Gene Therapies • Genito-urinary Cancer • Oncology • Solid Tumor

CORE-008 Cohort A Results (GlobeNewswire) - "As of the September 1, 2025, data cut off, the overall CR rate at any time in evaluable patients is 83.7% (41/49) (95% CI 70.3-92.7%) with the original administration achieving a 79.2% CR rate (57.8, 92.9) in 19 out of 24 patients as compared with the optimized administration which resulted in an 88.0% CR rate (68.8, 97.5) in 22 out of 25 patients....These data will be presented today as Late-Breaking Abstracts at the Society of Urologic Oncology (SUO) 26th Annual Meeting."

P2 data • Bladder Cancer

Topline BOND-003 Cohort P Results (GlobeNewswire) - "Results from the BOND-003 Cohort P clinical trial of cretostimogene monotherapy in patients with BCG-UR papillary-only NMIBC demonstrate encouraging HG-EFS and a consistent, well-tolerated safety profile. The study’s primary endpoint is High-Grade Event-Free Survival (HG-EFS). As of the September 1, 2025, data cut-off, in 51 efficacy evaluable patients, Kaplan-Meier estimates of HG-EFS at 3- 6- and 9-months are 95.7% (95% CI 83.8 – 98.9), 84.6% (95% CI 68.6 – 92.9%) and 80.4% (95% CI 62.3-90.4%), respectively....The study has completed enrollment with 56 patients receiving cretostimogene across 35 clinical sites....These data will be presented today as Late-Breaking Abstracts at the Society of Urologic Oncology (SUO) 26th Annual Meeting."

Enrollment status • Late-breaking abstract • P3 data: top line • Bladder Cancer