CG Oncology

Name

CG Oncology

Legal name

CG Oncology, Inc.

Website

https://cgoncology.com

Company type

Public

Founded year

2010

Operating status

Operating

Headcount range

101–250 employees

Ownership category

akta.pro rank

Product category

Bladder Cancer Therapeutics

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Medical Oncology (HLAKAFAB)

akta.pro secondary industry

Gastrointestinal Oncology (HLAKAFAK)

Keywords

• Oncolytic immunotherapy
• Bladder cancer therapeutics
• Biopharmaceutical drug development
• Clinical stage oncology
• Investigational urology drugs

Headquarters

HQ city

Irvine

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Out-licensing (Asia ex-China): Exclusive development and commercialization license to Kissei Pharmaceutical Co., Ltd. for cretostimogene in Japan, South Korea, Taiwan and other Asian countries (excluding China). Deal valued up to $140 million: $10M upfront licensing fee, up to $100M in development and commercial milestones, $30M equity investment, plus tiered royalties on sales in licensed territories. First $10M development milestone triggered December 2021 upon first patient dosed in Japan.
2. Pre-revenue commercial product: No approved product yet; minimal revenue ($4.0M in FY2025, $1.08M in Q1 2026) primarily from collaboration activities. Future revenue expected from direct US commercialization of cretostimogene following FDA approval (BLA completion targeted Q4 2026).

Go-to-market motion1 record

Distribution channels4 records

Marketing channels8 records

Core offering

CG Oncology is developing cretostimogene grenadenorepvec (formerly CG0070), an investigational intravesically delivered oncolytic immunotherapy for non-muscle invasive bladder cancer (NMIBC). The drug uses a genetically modified adenovirus type 5 backbone with a cancer-selective E2F promoter driving GM-CSF expression to selectively replicate in tumor cells with defective retinoblastoma (Rb) pathways, causing tumor lysis and stimulating systemic anti-tumor immunity. The company is preparing to file a Biologics License Application (BLA) targeted for Q4 2026 for high-risk BCG-unresponsive NMIBC.

Product overview

CG Oncology is a late-stage clinical biopharmaceutical company singularly focused on developing and commercializing cretostimogene grenadenorepvec (formerly CG0070) as a potential backbone bladder-sparing therapeutic for patients with bladder cancer, particularly non-muscle invasive bladder cancer (NMIBC). Rather than operating as a multi-asset platform, the company's offering centers on a single investigational oncolytic immunotherapy evaluated across an integrated clinical development program of complementary trials: the BOND-003 Phase 3 monotherapy program for high-risk BCG-unresponsive NMIBC, the PIVOT-006 Phase 3 adjuvant program for intermediate-risk NMIBC, and the CORE-008 Phase 2 combination program with gemcitabine in high-risk NMIBC, all of which together form the company's pipeline architecture. The company is preparing for FDA approval and commercialization of cretostimogene, with Biologics License Application (BLA) completion expected in Q4 2026 and has an Expanded Access Program in North America.

Differentiator

Problem solved

Functional benefit

Products and services

• Cretostimogene Grenadenorepvec (formerly CG0070) Lead investigational intravesically delivered oncolytic immunotherapy (OIT) with a dual mechanism of action: selectively replicates inside bladder tumor cells with dysfunctional retinoblastoma (Rb) pathways to cause tumor cell lysis and immunogenic cell death, and encodes GM-CSF to stimulate a systemic anti-tumor immune response. Evaluated in over 600 patients with non-muscle invasive bladder cancer (NMIBC). Safety and efficacy have not been established by the FDA or any other health authority; investigational drug candidate awaiting BLA completion targeted for Q4 2026.
• Expanded Access Program (North America) Pre-approval patient access pathway in North America providing cretostimogene grenadenorepvec to BCG-unresponsive non-muscle invasive bladder cancer patients who meet program eligibility requirements, prior to FDA approval.

Quantifiable outcome

• 75.5% (83/110) complete response rate at any time in BOND-003 Phase 3 Cohort C (cretostimogene monotherapy, HR BCG-unresponsive NMIBC)
• +6 more outcomes

Named customers4 records

Segments5 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Nine partnerships are on record, tiered core, minor and flagship.

• Pegasus Park (Tower)coreOthers · 19 May 2026CG Oncology expanded its footprint at Pegasus Park in Dallas in May 2026, leasing space on the tower's 16th floor alongside Highlander Health and LH Capital. Pegasus Park is positioned as a premier innovation hub where biotech, venture capital, and philanthropic leaders collaborate.
• Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC)coreStrategic or Co-development Partner · 18 December 2025Co-sponsored NMIBC Research Fellowship program with CG Oncology, awarding annual grants of up to $50,000 each to early-career investigators. First annual program launched May 2025; second annual awarded May 2026 to Patrick Hensley, MD (University of Kentucky) and Daniel Joyce, MD, MS (Vanderbilt University Medical Center). SUO-CTC is a clinical research investigator network of 750+ members from 350+ clinical sites.
• American Biotech Innovation Alliance (ABIA)minorGTM or Marketing Partner · 1 May 2025CG Oncology is a member company of the American Biotech Innovation Alliance (ABIA), a national coalition of approximately 50 biotech companies (including Moderna and Gamida Cell) formed in early May 2025 by Patroski Lawson of KPM Group. ABIA aims to develop a national policy strategy to strengthen American biotech innovation amid rising competition from China.
• University of Pennsylvania (Trinity Bivalacqua, M.D. — Phase 3 BOND-003)flagshipStrategic or Co-development Partner · 20 December 2021Lead investigator site partnership with University of Pennsylvania (Trinity J. Bivalacqua, M.D., Ph.D., Professor of Urology and Oncology at the Perelman Center for Advanced Medicine) for Phase 3 BOND-003 study of cretostimogene in HR BCG-unresponsive NMIBC. Dr. Bivalacqua also serves as lead investigator for CORE-008 Cohort CX.
• RochecoreStrategic or Co-development Partner · 22 September 2021Clinical trial collaboration to evaluate CG0070 (cretostimogene) in combination with Roche's anti-PD-L1 therapy atezolizumab in a Phase 1/2 study for various advanced solid tumors. CG Oncology sponsors the study; Roche provides atezolizumab.
• Bristol Myers Squibb (BMS)coreStrategic or Co-development Partner · 9 September 2021Clinical trial collaboration to evaluate CG0070 (cretostimogene) in combination with Bristol Myers Squibb's anti-PD-1 therapy OPDIVO (nivolumab) in a Phase 1/2 study for metastatic urothelial cancer. CG Oncology sponsors the study; BMS provides nivolumab.
• Moffitt Cancer Center (Roger Li, M.D.)flagshipStrategic or Co-development Partner · 12 November 2020Investigator-initiated Phase 1b study led by Dr. Roger Li at Moffitt Cancer Center evaluating CG0070 + nivolumab combination as neoadjuvant immunotherapy for Muscle-Invasive Bladder Cancer (MIBC) in cisplatin-ineligible patients. Multi-center trial with up to 30 patients. CORE-2 study (NCT04610671).
• Kissei Pharmaceutical Co., Ltd.flagshipOEM/ Whitelabel/ Licensing Partner · 26 March 2020Exclusive development and commercialization license for cretostimogene grenadenorepvec in Japan, South Korea, Taiwan and other Asian countries (excluding China). Deal valued at up to $140 million plus royalties, including a $10M upfront licensing fee and $30M equity investment. CG Oncology retains rights for US and rest of world. First $10M development milestone triggered December 2021 upon first patient dosed in Japan in Phase 3 BOND-003 study.
• Merck (MSD)flagshipStrategic or Co-development Partner · 28 November 2018Clinical trial collaboration to evaluate CG0070 (cretostimogene) in combination with Merck's anti-PD-1 therapy KEYTRUDA (pembrolizumab) in Phase 2 CORE1 study for BCG-unresponsive NMIBC. CG Oncology sponsors the study; Merck provides pembrolizumab. Additional details of the collaboration not disclosed. Multiple data readouts presented at AUA, ASCO, AACR, SITC (2018–2022); fully enrolled with 35 patients; long-term data published in Nature Medicine June 2024.

Scale indicators13 records

Recent moves10 records

Expansion highlights8 records

Direct peers

• Ferring Pharmaceuticals: Ferring markets ADSTILADRIN (nadofaragene firadenovec), an FDA-approved intravesical gene therapy for high-risk BCG-unresponsive NMIBC. Directly competes with cretostimogene in the same lead indication and prescriber base (urologists), and represents the most direct competitive threat in the BCG-unresponsive setting.
• ImmunityBio: ImmunityBio received FDA approval for ANKTIVA (N-803/ nogapendekin alfa inbakicept-pmln) plus BCG for BCG-unresponsive NMIBC with CIS. Directly competes with CG Oncology for the same HR BCG-unresponsive NMIBC patient population and is now an established alternative in urology practices.

Emerging players

• Replimune Group: Replimune develops oncolytic immunotherapies (RP1, RP2, RP3) based on a modified herpes simplex virus platform. While focused on skin cancers rather than bladder, it is one of the few clinical-stage competitors in the broader oncolytic virus modality that CG Oncology's cretostimogene belongs to.
• Targovax: Targovax develops oncolytic virus-based immunotherapies (ONCOS-102) for solid tumors. While focused on different indications, it is a clinical-stage peer in the same oncolytic immunotherapy modality that cretostimogene belongs to.
• Aprea Therapeutics: Aprea Therapeutics is a clinical-stage oncology biopharmaceutical company developing small molecule and biologic therapies. Comparable as a similarly sized late clinical-stage oncology peer with comparable development-stage profile and biopharma industry positioning.

Broad incumbents

• AstraZeneca: AstraZeneca markets IMFINZI (durvalumab), an FDA-approved checkpoint inhibitor studied in NMIBC, and operates broadly in oncology including bladder cancer. Comparable as a checkpoint inhibitor developer for urologic cancers and a potential combination or competitive partner to cretostimogene.
• Merck & Co. (MSD): Merck is the maker of KEYTRUDA (pembrolizumab), which CG Oncology has combined with cretostimogene in the CORE-001 Phase 2 trial. Merck is a leading immuno-oncology incumbent whose checkpoint inhibitor is both a collaboration partner and a competitive threat in advanced bladder cancer.
• Bristol Myers Squibb: BMS markets OPDIVO (nivolumab), an anti-PD-1 checkpoint inhibitor combined with cretostimogene in the CORE-2 study in MIBC. Comparable as a large immuno-oncology incumbent with overlapping bladder cancer indications and a clinical combination partner for cretostimogene.
• Roche: Roche markets TECENTRIQ (atezolizumab), an anti-PD-L1 checkpoint inhibitor combined with cretostimogene in an investigator-sponsored Phase 1/2 study. Comparable as a global oncology incumbent and combination partner whose checkpoint inhibitors compete in advanced urologic cancers.

Regional players

• Kissei Pharmaceutical: Kissei holds exclusive Asia ex-China development and commercialization rights for cretostimogene under a deal valued at up to $140M plus royalties. Comparable as the regional licensee and validated urology commercial partner in Japan, South Korea, Taiwan and other Asian markets.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key highlights7 records

Customer concentration

• Xx.com/cgoncology
• LinkedInlinkedin.com/company/cgoncology

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Subsidiaries1 record

Funding overview

Funding rounds8 records

Investors20 records

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M&A

Investments

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Frequently asked questions about CG Oncology