CG Oncology, Inc.
CGON evidence brief
What we can confirm
What it means
What to watch
Prepared research question
What matters most for CGON—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · CGON
CG Oncology, Inc. is a clinical-stage biopharmaceutical company focused on developing cretostimogene, an investigational oncolytic immunotherapy for bladder cancer, with no approved products and no product revenue to date.
Key risk: No approved products or revenue
BioSniper Score
Based on 6 of 6 signals
Market Cap
$6.59B
Cash Runway
63.6 moLead Asset
cretostimogene (Phase 3)
Next Catalyst
Phase3_Topline · Nov 11, 2026Financial data as of Jun 30, 2026.
Tracking 2 pipeline candidates · 130 clinical trials · 61 catalysts for CG Oncology, Inc..
CG Oncology, Inc. is a clinical-stage biopharmaceutical company focused on developing cretostimogene, an investigational oncolytic immunotherapy for bladder cancer, with no approved products and no product revenue to date.
- CG Oncology has no products approved for sale and has not generated any product revenue [sec_mda · as of 2024-11-12].
- As of June 30, 2025, the company reported cash, cash equivalents and marketable securities of $661.1 million [sec_mda · as of 2025-08-08].
- The company has recognized $26.2 million in license and collaboration revenue through its agreements [sec_mda · as of 2025-08-08].
- CG Oncology is conducting a Phase 3 clinical trial, PIVOT-006, evaluating adjuvant cretostimogene in intermediate-risk NMIBC [sec_mda · as of 2025-03-28].
- The company estimates its existing cash will fund operations into the first half of 2028 [sec_mda · as of 2025-08-08].
What works
- Cretostimogene has potential as a backbone therapy for intermediate-risk NMIBC, which could address the BCG shortage [sec_mda · as of 2025-03-28].
- The company has a strong cash position of $661.1 million as of June 30, 2025, providing a runway into the first half of 2028 [sec_mda · as of 2025-08-08].
- License and collaboration revenue of $26.2 million demonstrates existing partnership value [sec_mda · as of 2025-08-08].
What to weigh
- CG Oncology has no approved products and no product revenue, with profitability dependent on successful development and commercialization of cretostimogene [sec_mda · as of 2025-08-08].
- The company will need substantial additional capital to complete clinical development and obtain regulatory approval, which may take years and may never occur [sec_mda · as of 2026-08-06].
- The company's operating plan and cash runway estimates are based on assumptions that may prove incorrect [sec_mda · as of 2026-08-06].
From the filings
Quoted directly from source documents.
The company has no approved products and no product revenue.
“We do not have any products approved for sale and have not generated any revenue from product sales.”
SEC MD&A · November 12, 2024
Cash position as of June 30, 2025 was $661.1 million.
“As of June 30, 2025, we had cash, cash equivalents and marketable securities of $661.1 million.”
SEC MD&A · August 8, 2025
License and collaboration revenue recognized through June 30, 2025 was $26.2 million.
“we have recognized $26.2 million in license and collaboration revenue pursuant to our license and collaboration agreements.”
SEC MD&A · August 8, 2025
The company is conducting a Phase 3 trial for cretostimogene in intermediate-risk NMIBC.
“we have launched our second Phase 3 clinical trial, PIVOT-006, evaluating adjuvant cretostimogene in intermediate-risk NMIBC following transurethral resection of the bladder tumor (TURBT).”
SEC MD&A · March 28, 2025
Catalyst timeline
- 2026-11-11 · Phase3_Topline — Phase 3 Topline: Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prosta — Topline data from a Phase 3 trial in prostate cancer; results may inform the company's pipeline or competitive positioning.
- 2027-02-04 · Phase3_Topline — Phase 3 Topline: A Phase III Randomized Trial of Protons Versus Photons for Hepatocellular Carcinoma — Topline data from a Phase 3 trial in hepatocellular carcinoma; results may affect the company's strategic focus.
- 2027-02-09 · Phase3_Topline — Phase 3 Topline: Randomized Phase II/III Trial of Radiation With Cisplatin at 100 mg/m2 Every Three Weeks Versus Radi — Topline data from a Phase 2/3 trial in an undisclosed indication; results could impact the company's clinical development plans.
- 2027-04-01 · Phase3_Topline — Phase 3 Topline: ALTernate Approaches for Clinical Stage II or III Estrogen Receptor Positive Breast Cancer Neoadjuva — Topline data from a Phase 3 trial in breast cancer; results may influence the company's pipeline decisions.
- 2027-04-30 · Phase3_Topline · futibatinib — Phase 3 Topline: An Open-label, Rollover Study of Futibatinib in Patients Previously Enrolled in an Antecedent Futiba — Topline data from a rollover study of futibatinib; results may affect the company's partnered programs.
- 2027-05-27 · Phase3_Topline — Phase 3 Topline: Randomized, Controlled, Open-label, Phase 3, Global Multi - Center Trial to Assess the Efficacy and — Topline data from a Phase 3 trial in an undisclosed indication; results could be a key value driver.
- 2027-06-30 · Phase3_Topline — Phase 3 Topline: A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cispla — Topline data from a Phase 3 trial in low-risk cancer; results may inform the company's clinical strategy.
- 2027-08-01 · Phase3_Topline — Phase 3 Topline: A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated An — Topline data from a Phase 3 trial evaluating inotuzumab ozogamicin; results could impact the company's pipeline or partnerships.
Risks & what to watch (4)›
Key risks
- No approved products or revenue — CG Oncology has no products approved for sale and no product revenue; profitability depends on successful development and commercialization [sec_mda · as of 2025-08-08].
- Clinical and regulatory uncertainty — Completion of clinical development and regulatory approval may take years and may never occur [sec_mda · as of 2026-08-06].
- Capital needs and dilution risk — The company will need substantial additional capital; existing cash may be consumed sooner than expected [sec_mda · as of 2026-08-06].
- Dependence on cretostimogene — The company's future is heavily reliant on the success of a single product candidate, cretostimogene [sec_mda · as of 2025-03-28].
What to watch
- Phase 3 topline data for cretostimogene in intermediate-risk NMIBC (PIVOT-006) [sec_mda · as of 2025-03-28].
- Regulatory submissions and potential approval decisions for cretostimogene [sec_mda · as of 2026-08-06].
- Cash burn rate and any additional financing activities, including the at-the-market offering [sec_mda · as of 2025-08-08].
- Updates on the BCG shortage and its impact on cretostimogene's market opportunity [sec_mda · as of 2025-03-28].
Sources: SEC MD&A · Generated August 28, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 6 of 6 signals · derived from public data
63.6 months
D/E 0.05 · 0% dilution
Lead: Phase 3
2 candidates
61 upcoming, next in ~73d
1 buy · 11 sells (180d)
Runway
Catalysts
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
235
Total value held
$5.05B
| Holder | Shares | Value |
|---|---|---|
| rtw investments, lp | 6,984,808 | $472.7M |
| vanguard capital management llc | 6,067,250 | $410.6M |
| wellington management group llp | 5,371,232 | $363.5M |
| blackrock, inc. | 5,064,180 | $342.7M |
| fmr llc | 3,764,844 | $254.8M |
| vanguard portfolio management llc | 3,095,098 | $209.5M |
| caption management, llc | 2,758,880 | $186.7M |
| state street corp | 2,647,054 | $179.2M |
| foresite capital management vi llc | 2,221,474 | $150.3M |
| geode capital management, llc | 1,596,864 | $108.1M |
Showing top 10 of 235 institutional holders of CG Oncology, Inc.. Open the full 13F history after sign-in.
Short Interest
as of May 20, 2026- % of float
- 10.7%
- Days to cover
- 8.2
- Shares short
- 9,222,491
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
CGON short interestGovernance
Frequently asked questions
What is the AI investment thesis for CG Oncology, Inc.?
CG Oncology, Inc. is a clinical-stage biopharmaceutical company focused on developing cretostimogene, an investigational oncolytic immunotherapy for bladder cancer, with no approved products and no product revenue to date.
What is CG Oncology, Inc.'s lead drug candidate?
CG Oncology, Inc.'s most advanced tracked candidate is cretostimogene (Phase 3) for Non-Muscle Invasive Bladder Cancer; Non Muscle Invasive Bladder Cancer; High-Risk Non-Muscle-Invasive Bladder Cancer.
What is CG Oncology, Inc.'s next catalyst?
CG Oncology, Inc.'s next tracked catalyst is a Phase3_Topline event — "Phase 3 Topline: Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prosta" — expected November 11, 2026.
Who is the CEO of CG Oncology, Inc.?
Mr. Arthur Kuan is the chief executive officer of CG Oncology, Inc. (CGON).
Where is CG Oncology, Inc. headquartered?
CG Oncology, Inc. (CGON) is headquartered in Dallas, TX, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.