8-K: CG Oncology Accelerates Bladder Cancer Trial Data

CG Oncology announced an expedited timeline for its PIVOT-006 Phase 3 trial data and reported positive early results from BOND-003 Cohort P and CORE-008 Cohort A for bladder cancer treatments.

Summary

• The timeline for PIVOT-006 Phase 3 topline data in intermediate-risk Non-Muscle Invasive Bladder Cancer (NMIBC) has been expedited, now expected in the first half of 2026, nearly one year ahead of schedule.
• PIVOT-006 is the first Phase 3 randomized trial in the intermediate-risk NMIBC patient population, encompassing a broad range of patient types per AUA/SUO Guidelines, including HG Ta solitary lesions less than 3cm.
• The intermediate-risk NMIBC population in the United States is estimated to be greater than 50,000 patients.
• Topline results from the BOND-003 Cohort P clinical trial (cretostimogene monotherapy in BCG-unresponsive papillary-only NMIBC) showed encouraging High-Grade Event-Free Survival (HG-EFS) rates of 95.7% at 3 months, 84.6% at 6 months, and 80.4% at 9 months (as of September 1, 2025, data cut-off in 51 efficacy evaluable patients).
• BOND-003 Cohort P observed a favorable safety and tolerability profile with no Grade 3 or greater treatment-related adverse events (TRAEs) and no deaths reported; no patients underwent radical cystectomy or progressed to MIBC.
• First results from CORE-008 Cohort A (cretostimogene monotherapy in high-risk, BCG-naive NMIBC with Carcinoma in Situ (CIS)) demonstrated promising clinical efficacy with an overall Complete Response (CR) rate of 83.7% (41/49) at any time (as of September 1, 2025, data cut-off).
• The optimized two-step administration in CORE-008 Cohort A resulted in an 88.0% CR rate (22/25) compared to the original five-step administration's 79.2% CR rate (19/24).
• CORE-008 Cohort A's safety and tolerability profile was consistent with prior clinical trials, showing no related serious adverse events, Grade 3+ adverse events, or treatment-related discontinuations; no patients progressed to MIBC or metastatic disease.

Sentiment

Score: 8

Explanation: The filing reports an expedited timeline for a key Phase 3 trial and strong positive early clinical data from two other trials, demonstrating high efficacy and a favorable safety profile for cretostimogene across different NMIBC populations. This significantly de-risks the development program and expands the potential market opportunity.

Positives

• PIVOT-006 Phase 3 topline data is now expected in 1H 2026, nearly one year ahead of schedule, due to rapid study enrollment.
• Rapid enrollment in PIVOT-006 underscores the immense unmet need for intermediate-risk NMIBC patients and broad participation across sites.
• BOND-003 Cohort P demonstrated encouraging HG-EFS (95.7% at 3 months, 80.4% at 9 months) and a well-tolerated safety profile with no Grade 3+ TRAEs or deaths.
• CORE-008 Cohort A showed promising clinical efficacy with an 83.7% overall CR rate, with an even higher 88.0% CR rate achieved with optimized administration.
• Cretostimogene has a favorable safety and tolerability profile across trials, with no Grade 3+ TRAEs or treatment-related discontinuations reported in BOND-003 Cohort P or CORE-008 Cohort A.
• No patients in BOND-003 Cohort P or CORE-008 Cohort A progressed to MIBC or required radical cystectomy.
• The optimized administration process for cretostimogene offers approximately 25% time savings and improved benefit to sites and patients.
• Cretostimogene is positioned as a potential backbone therapy with best-in-disease durability and safety in HR BCG-UR NMIBC (BOND-003 Cohort C data: 41.8% CR at 24 months, 0% Grade 3+ TRAEs).
• The intermediate-risk NMIBC market is estimated to be greater than 50,000 patients in the US alone, representing a significant market opportunity.

Risks

• Additional patient data related to cretostimogene that continues to become available may be inconsistent with the data produced as of the data cutoffs.
• Further analysis of existing data and analysis of new data may lead to conclusions different from those established as of the date hereof.
• Results from earlier clinical trials and preclinical studies are not necessarily predictive of future results.
• Unexpected adverse side effects or inadequate efficacy of cretostimogene may limit its development, regulatory approval, and/or commercialization.
• Potential delays in the commencement, enrollment, and completion of clinical trials.
• Competitive developments with respect to current and other investigational NMIBC treatments may adversely affect the commercial opportunity of cretostimogene.
• The company currently depends entirely on the success of cretostimogene, which is its only product candidate.
• Preliminary or interim data results are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data becomes available.
• The company may use its capital resources sooner than expected and they may be insufficient to allow it to achieve anticipated milestones.
• Dependence on third parties in connection with manufacturing, shipping, and clinical and preclinical testing.
• Regulatory developments in the United States and foreign countries.
• Ability to obtain, maintain, and enforce intellectual property protection for cretostimogene.
• Significant competition in the market.

Future Outlook

The company anticipates the PIVOT-006 study's topline data in the first half of 2026, nearly a year ahead of schedule, aiming for a potential indication in adjuvant intermediate-risk NMIBC where no U.S. FDA-approved options currently exist. They believe cretostimogene has the potential for best-in-disease durability and tolerability, meaningfully improving patient outcomes across high-risk and intermediate-risk NMIBC. The optimized two-step administration process is also expected to deliver equivalent or better results compared to the five-step administration.

Management Comments

• "We are thrilled to announce that we now expect PIVOT-006 topline Phase 3 data in the first half of 2026, which is nearly one year ahead of schedule thanks to the unprecedented early completion of enrollment." Arthur Kuan, Chairman & Chief Executive Officer, CG Oncology.
• "Our goal is to bring forward a potential indication in adjuvant IR NMIBC, for which there are currently no U.S. FDA approved options." Arthur Kuan, Chairman & Chief Executive Officer, CG Oncology.
• "Broad participation across academic and community sites supports the realworld relevance of this trial, and the rapid enrollment underscores the immense unmet need that exists for intermediate-risk NMIBC patients." Arthur Kuan, Chairman & Chief Executive Officer, CG Oncology.
• "The IR population is estimated to be greater than fifty thousand patients in the US alone, and we look forward to broadening our potential reach to individuals living with IR NMIBC." Arthur Kuan, Chairman & Chief Executive Officer, CG Oncology.

Industry Context

CG Oncology is developing cretostimogene as an oncolytic immunotherapy for Non-Muscle Invasive Bladder Cancer (NMIBC), a significant market representing approximately 75% of newly diagnosed bladder cancer cases. The company is targeting both high-risk (BCG-unresponsive, BCG-naive, BCG-exposed) and intermediate-risk NMIBC populations. The expedited timeline for PIVOT-006 in intermediate-risk NMIBC is particularly notable as there are currently no U.S. FDA approved options for this patient group, positioning cretostimogene as a potential first-in-class adjuvant therapy. The positive early data from BOND-003 Cohort P and CORE-008 Cohort A suggest cretostimogene could offer best-in-disease durability and safety compared to existing treatments, addressing a substantial unmet medical need.

Comparison to Industry Standards

• **BOND-003 Cohort C (HR BCG-UR CIS only)**: Cretostimogene demonstrated a 75.5% Complete Response (CR) at any time and 41.8% CR at 24 months, with 0% Grade 3+ Treatment-Related Adverse Events (TRAEs). This compares favorably to approved drugs such as TAR-200 (82.4% CR at any time, 24-month CR not reported, 13% Grade 3+ TRAE), N-803 + BCG (62.3% CR at any time, 24.7% CR at 24 months, 16% SAEs), Nadofaragene (51.0% CR at any time, 19.4% CR at 24 months, 4% Grade 3+ TRAE), and Pembrolizumab (40.6% CR at any time, 9.4% CR at 24 months, 13% Grade 3+ TRAE).
• **BOND-003 Cohort P (HR BCG-UR Ta/T1 Disease)**: Cretostimogene showed 95.7% High-Grade Event-Free Survival (HG-EFS) at 3 months, 84.6% at 6 months, and 80.4% at 9 months, with 0% Grade 3+ TRAEs. This compares favorably to TAR-200 (85.3% EFS at 6 months, 81.1% at 9 months, 74.3% at 12 months, 13.5% Grade 3+ TRAE), N-803 + BCG (92.8% EFS at 3 months, 75.9% at 6 months, 55.4% at 12 months, 48.3% at 24 months), Nadofaragene (72.9% EFS at 3 months, 62.5% at 6 months, 58.3% at 9 months, 43.8% at 12 months, 33.3% at 24 months), and Pembrolizumab (87.7% EFS at 3 months, 53.1% at 6 months, 43.5% at 12 months, 34.9% at 24 months).
• **CORE-008 Cohort A (HR BCG-Nave CIS)**: Cretostimogene demonstrated an 83.7% overall CR rate, with an optimized administration achieving 88.0% CR, and 0% Grade 3+ TRAEs. These results are promising when compared with outcomes observed in historical BCG-naive trials.

Stakeholder Impact

• **Shareholders**: Positive impact due to expedited trial timeline, strong clinical data, and expanded market potential, which could lead to increased share price and future revenue.
• **Patients (NMIBC)**: Significant positive impact as cretostimogene shows promising efficacy and safety, potentially offering a new, bladder-sparing treatment option, especially for intermediate-risk NMIBC where no U.S. FDA-approved options currently exist.
• **Healthcare Providers**: The optimized two-step administration process offers time savings and seamless integration into existing clinical workflows, making it easier to administer.
• **Regulators (FDA)**: The positive data and expedited timeline could facilitate faster review and potential approval, especially given the unmet medical need.

Next Steps

• Share topline data from PIVOT-006 Phase 3 study in 1H 2026.
• Initiation of cretostimogene Biologics License Application (BLA) Submission (anticipated 2026).
• Completion of BLA Submission (1st Indication) (anticipated 2027).
• Completion of supplemental BLA (sBLA) Submission (2nd Indication) (anticipated 2027).
• Long-term durability data for BOND-003 Cohort C (expected 2026).
• Updated results for CORE-008 Cohort A (expected 2H 2026).
• Topline data for CORE-008 Cohort CX (Cretostimogene + Gemcitabine) (expected 2026).
• Durability data for BOND-003 Cohort P (expected 2027).
• Durability data for CORE-008 Cohort A (expected 2027).
• Data for CORE-008 Cohort B (expected 2026).
• Durability data for CORE-008 Cohort B (expected 2027).

Key Dates

Recommendation

The company has announced an expedited timeline for its pivotal PIVOT-006 Phase 3 trial, bringing potential market entry for intermediate-risk NMIBC nearly a year closer. This population currently lacks FDA-approved options, representing a significant first-in-class opportunity. Concurrently, the reported topline data from BOND-003 Cohort P and CORE-008 Cohort A demonstrate compelling efficacy (high HG-EFS and CR rates) and an excellent safety profile for cretostimogene across different high-risk NMIBC settings. The comparative data presented against approved therapies positions cretostimogene as potentially best-in-disease in terms of durability and tolerability. These developments significantly de-risk the company's lead asset and expand its addressable market, making it a highly attractive investment.

Keywords

CG Oncology, CGON, Bladder Cancer, NMIBC, Non-Muscle Invasive Bladder Cancer, Cretostimogene, PIVOT-006, BOND-003, CORE-008, Clinical Trial, Phase 3, Phase 2, Oncolytic Immunotherapy, Biotechnology, Oncology, Drug Development, FDA, Intermediate-Risk NMIBC, High-Risk NMIBC, BCG-unresponsive, BCG-naive, Topline Data, Clinical Efficacy, Safety Profile, Complete Response Rate, Event-Free Survival