CG Oncology
- Company typePublic
- Founded2010
- HeadquartersIrvine, United States
- Headcount101–250
- GTM typeB2B
- OfferingHardware or Manufacturing
CG Oncology firmographics
Firmographics- 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
CG Oncology industry classification
Industry- 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
Where CG Oncology is headquartered
LocationHeadquarters
- HQ city
- Irvine
- HQ country
- United States
- HQ region
- North America
Markets served
CG Oncology business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales
Revenue model
- 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.
- 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
CG Oncology product offering
Product offeringCore 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
Companies that use CG Oncology
Customer profileNamed customers4 records
Segments5 records
Ideal customer profiles3 records
CG Oncology technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature6 records
CG Oncology partnerships and signals
Strategic signalPartnerships
Nine partnerships are on record, tiered core, minor and flagship.
- Pegasus Park (Tower)coreCG 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)coreCo-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)minorCG 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)flagshipLead 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.
- RochecoreClinical 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)coreClinical 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.)flagshipInvestigator-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.flagshipExclusive 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)flagshipClinical 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
CG Oncology competitors and assessment
Company assessmentDirect 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
CG Oncology social profiles
Digital presenceCG Oncology financial estimates
Financial estimateRevenue estimate
Valuation estimate
CG Oncology leadership team
Management profileNumber of profiles
Profiles12 records
CG Oncology subsidiaries and ownership
Company hierarchySubsidiaries1 record
CG Oncology funding detail
Funding detailFunding overview
Funding rounds8 records
Investors20 records
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CG Oncology M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about CG Oncology
What does CG Oncology do?
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.
Is CG Oncology a public or private company?
CG Oncology is a public company. It is classified as public and is currently operating.
When was CG Oncology founded?
CG Oncology was founded in 2010. It employs 101 to 250 people.
Where is CG Oncology based?
CG Oncology is headquartered in Irvine, United States, in the North America region.
How does CG Oncology make money?
Two revenue lines are on record. Out-licensing (Asia ex-China) is the primary driver. The others are pre-revenue commercial product.
Who are CG Oncology's main competitors?
Direct peers on record are Ferring Pharmaceuticals and ImmunityBio. Emerging players are Replimune Group, Targovax and Aprea Therapeutics. Broad incumbents are AstraZeneca, Merck & Co. (MSD), Bristol Myers Squibb and Roche. Kissei Pharmaceutical is listed as a regional player.
Does CG Oncology have an API?
No public API is recorded for CG Oncology.
What industry is CG Oncology in?
CG Oncology's product category is Bladder Cancer Therapeutics. Its primary akta.pro industry code is HLAKAFAB, Medical Oncology, with a secondary code of HLAKAFAK, Gastrointestinal Oncology. Its NAICS code is 325414 and its SIC code is 2836.