CRETOSTIMOGENE GRENADENOREPVEC PIPELINE AND CLINICAL PROGRAM

CG Oncology has a robust clinical trials program with a pipeline in place to study the safety and efficacy of cretostimogene. It is purposefully designed to address the full spectrum of NMIBC disease stages and tumor types. Cretostimogene has received FDA Fast Track and Breakthrough Therapy designations.

Monotherapy
Combination
COMPOUND/INDICATION
PHASE 1
PHASE 2
PHASE 3

COMPOUND/INDICATION

Cretostimogene Monotherapy

High-Risk BCG-Unresponsive NMIBC (BOND-003 Cohort C)1
Enrollment complete
Milestone
BOND-003 Cohort C data presented at AUA 2025
PHASE 1
PHASE 2
PHASE 3

COMPOUND/INDICATION

Cretostimogene Monotherapy

High-Risk BCG-Unresponsive NMIBC (BOND-003 Cohort P)2
Enrollment complete
BOND-003 Cohort P topline data in 4Q’25
Milestone
Topline Results from BOND-003 Cohort P SUO 2025
PHASE 1
PHASE 2
PHASE 3

COMPOUND/INDICATION

Cretostimogene Monotherapy

Intermediate-Risk NMIBC (PIVOT-006)
Enrollment complete
Trial in Progress PIVOT-006
Milestone
PIVOT-006 enrollment completed in 3Q'25
PHASE 1
PHASE 2
PHASE 3

COMPOUND/INDICATION

Cretostimogene Monotherapy

First Results from CORE-008 Cohort A
Trial in Progress CORE-008
Milestone
First Results from CORE-008 Cohort A SUO 2025
PHASE 1
PHASE 2
PHASE 3

COMPOUND/INDICATION

Cretostimogene Monotherapy

High-Risk BCG-Exposed NMIBC (CORE-008 Cohort B)
Trial in Progress CORE-008
Milestone
CORE-008 Cohort B initiated in 1H’25, expected data in 2026
PHASE 1
PHASE 2
PHASE 3

COMPOUND/INDICATION

Cretostimogene + Gemcitabine

High-Risk BCG-Exposed NMIBC (CORE-008 Cohort CX)
Trial in Progress CORE-008
Milestone
CORE-008 Cohort CX initiated in 2Q’25
PHASE 1
PHASE 2
PHASE 3

COMPOUND/INDICATION

Cretostimogene + Pembrolizumab

High-Risk BCG-Unresponsive NMIBC (CORE-001)
Nature Medicine Final Results Manuscript
Milestone
CORE-001 24-month data presented at ASCO 2024
PHASE 1
PHASE 2
PHASE 3

1Patients with carcinoma in situ, with or without high-grade Ta/T1 disease.

2Patients with high-grade Ta/T1. Cohort P is a Phase 2 cohort of BOND-003 and currently not intended for regulatory approval.

Additionally, we’ve initiated an Expanded Access Program for cretostimogene in the US for patients with NMIBC who are unresponsive to BCG and meet certain program eligibility criteria.


A potential backbone bladder-sparing therapeutic

We remain steadfast in our mission to transform treatment across the NMIBC landscape. Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority.

NMIBC (75%) (Non-Muscle Invasive Bladder Cancer)

Intermediate-Risk (30%)
TURBT (Transurethral Resection of the Bladder Tumor)
PIVOT-006
Phase 3 Monotherapy
High-Risk (40%)
CORE-008
Multi-Cohort Study Mono/Combo
BCG-Naïve
CORE-008
Multi-Cohort Study Mono/Combo
BCG-Exposed

CORE-008

Multi-Cohort Study Mono/Combo

BCG-Unresponsive

BOND-003

Phase 3 Multi-Cohort Study Monotherapy

CORE-001

Phase 2 Cretostimogene + Checkpoint Combo

CORE-008

Multi-Cohort Study Mono/Combo

EXPANDED PATIENT ACCESS

How Patients can Access the on-going Studies

CG Oncology is currently focused on conducting clinical research that evaluates the safety and effectiveness of investigational cretostimogene grenadenorepvec in Non-Muscle Invasive Bladder Cancer (NMIBC). Our clinical trials program is the primary way for interested patients to access cretostimogene grenadenorepvec. We encourage patients to speak with their healthcare providers about participating in a clinical trial and may also find information on our current clinical studies site.

In circumstances where patients are not eligible for our clinical trials and may not have options for alternative therapies, including investigational therapies in trials being conducted by other sponsors, CG Oncology will consider providing a requesting physician with pre-approval access to cretostimogene grenadenorepvec, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met. These conditions include the following:

  • The patient has a serious or life-threatening illness or condition and is either no longer responsive to or no longer able to tolerate any available treatment option;
  • The investigational drug is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient's specific condition;
  • A benefit-risk analysis, based on both the available clinical data as well as the requesting physician's assessment of the individual patient's condition and history, supports making the investigational drug available;
  • Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access; and
  • Adequate supply of the investigational drug is available

Requests will be considered on a case-by-case basis. CG Oncology is committed to evaluating all requests in a fair and equitable manner. All requests must be submitted by the patient's treating physician; CG Oncology may require more detailed information in order to fully evaluate a request. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals and comply with regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting. Each request will be given careful consideration. Physicians seeking pre-approval access for patients with no alternative treatment options should submit their requests to creto.eap@cgoncology.com. We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request.

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