CGON at a glance
CG Oncology, Inc. (CGON, SEC CIK 1991792) filed its latest 10-K annual report on February 27, 2026, a 10-Q quarterly report on August 6, 2026, an 8-K current report on August 6, 2026 and Form 4 insider filings as recently as September 17, 2026. SignalX summarizes each filing with AI and tracks the company's insider trades and institutional holders.
- For the fiscal year ended December 31, 2025 (FY2025), CG Oncology, Inc. (CGON) reported revenue of $4.0 million (up 254.7% from FY2024) and a net loss of $161.0 million. Diluted EPS was -$2.08.
- As of June 30, 2026, 28 institutional investment managers tracked by SignalX reported holding CG Oncology, Inc. (CGON) shares worth $2.2 billion in 13F-HR filings.
- The most recent insider open-market sale reported on Form 4 was by POST LEONARD E on September 15, 2026 of 1,000 shares at $72.98 per share.
- In the last 90 days, CGON insiders reported 0 open-market purchases ($0) and 4 open-market sales ($2.0M) on Form 4, a net sale of $2.0M.
Source: SEC EDGAR (XBRL financial data, 13F-HR and Form 4 filings).
- Revenue · FY2025
- $4.0M
- +254.7% vs prior year
- Insiders · 90 days
- 0 buys · 4 sells
- Net −$2.0M
- 13F holders
- 28 funds
- $2.2B · −1 vs prior quarter
- Latest 8-K
- Aug 6, 2026
- Item 2.02 · Item 8.01
AI 10-K Annual Report Analysis
Latest 10-K, fiscal year ended Dec 31, 2025
Business Overview
- Core business: Late-stage clinical biopharma developing cretostimogene, an oncolytic immunotherapy targeting non-muscle invasive bladder cancer (NMIBC)
- New emphasis: BLA submission initiated Q4 2025 for high-risk BCG-unresponsive NMIBC; expanded Phase 2/3 trials including combination with gemcitabine and pembrolizumab
- Strategic shift: Positioning cretostimogene as potential first-in-class backbone bladder-sparing therapy across multiple NMIBC risk segments amid ongoing BCG shortages
- Key metric: Over 740 patients treated with cretostimogene in clinical trials as of Jan 30, 2026; 75.5% complete response rate in Phase 3 high-risk cohort
- Noteworthy fact: FDA granted Fast Track and Breakthrough Therapy designations for cretostimogene in high-risk BCG-unresponsive NMIBC, accelerating regulatory pathway
Risk Factors
- Regulatory risk from FDA on novel gene-modified virus cretostimogene may delay BLA approval; FDA may issue Complete Response Letter requiring more trials
- Macroeconomic risk from global clinical trial delays due to geopolitical issues in foreign countries impacting patient enrollment and regulatory approvals
- Supply chain risk from inability to demonstrate comparability between cretostimogene lots from different third-party manufacturers, possibly delaying regulatory submissions
- Competitive risk from other pharmaceutical companies recruiting bladder cancer patients for clinical trials, limiting CG Oncology’s patient enrollment pool
- Financial risk from high dependence on a single product candidate cretostimogene in Phase 3, increasing business risk if trials fail or are delayed
Management Discussion & Analysis
- Revenue $4.0M in 2025 vs $1.1M in 2024; $3.2M commercial/development revenue in 2025 (vs $0 in 2024)
- Net loss $161.0M in 2025 vs $88.0M in 2024; operating costs $194.8M (2025) vs $115.8M (2024) with general & admin $73.5M vs $33.7M
- Best performing segment: commercial/development revenue $3.2M in 2025 (new from integration of Biovire); worst: license & collaboration revenue down $0.3M to $0.8M
- Cash, cash equivalents & marketable securities $742.2M at 12/31/25; net proceeds from public offerings and ATM sales approx. $1.1B through 2025; no buybacks/dividends; capex not detailed
- Management expects cash sufficiency >12 months; key risks include regulatory approval timing uncertainty and ongoing R&D and commercialization expenses
AI summary of the CGON 10-K filed . Generated from the filing text; verify against the original.View on SEC EDGARHow to read a 10-K
AI 10-Q Quarterly Report Analysis
Latest 10-Q, quarter ended Jun 30, 2026
Risk Factors
- No material changes to risk factors disclosed in the 2025 Annual Report filed February 27, 2026
- Carried-forward clinical-development risk for cretostimogene and related research programs
- Carried-forward manufacturing risk involving contract supply of cretostimogene
- IPO proceeds fully used by June 30, 2026 for corporate, development, manufacturing, and pre-commercial activities
AI summary of the CGON 10-Q filed . Generated from the filing text; verify against the original.View on SEC EDGAR10-K vs 10-Q vs 8-K
AI 8-K Current Report Analysis
The most recent material events, by 8-K item
Item 2.02: Results of Operations and Financial Condition
- CG Oncology announced financial results for the quarter ended June 30, 2026
- Detailed results are provided in Exhibit 99.1, the accompanying earnings press release
Item 8.01: Other Events
- $500.0M increase in shares available under CG Oncology’s Jefferies at-the-market offering
- Cumulative shares registered and sold under the agreement now approximately $1.05B
Item EX-99.1: Item EX-99.1
- Q2 net loss $79.1M, or $0.90 per share, versus $41.4M and $0.54 year over year
- R&D expense rose to $54.7M from $31.3M, reflecting increased clinical-trial, CMC, and headcount investment
Item 5.07: Submission of Matters to a Vote of Security Holders
- Stockholders reelected Christina Rossi and Victor Tong, Jr. as Class II directors through the 2029 annual meeting
- Ernst & Young LLP ratified as independent auditor for fiscal year ending December 31, 2026
Item 5.02: Departure/Appointment of Directors or Principal Officers
- President & COO Ambaw Bellete departing effective June 30, 2026 under planned separation agreement
- Severance governed by Section 4(b) of Bellete’s January 9, 2025 employment agreement
AI summaries of CGON 8-K current reports filed with the SEC. What 8-K item codes mean
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Recent Insider Transactions (Form 4)
Latest reported trades by officers, directors and 10% owners
| Insider | Type | Date | Shares | Price |
|---|---|---|---|---|
| POST LEONARD E | Sell | Sep 15, 2026 | 1,000 | $72.98 |
| POST LEONARD E | M | Sep 15, 2026 | 1,000 | $0.60 |
| POST LEONARD E | M | Sep 15, 2026 | 1,000 | - |
| POST LEONARD E | M | Aug 14, 2026 | 1,000 | - |
| POST LEONARD E | Sell | Aug 14, 2026 | 1,000 | $74.54 |
| POST LEONARD E | M | Aug 14, 2026 | 1,000 | $0.60 |
| POST LEONARD E | Sell | Jul 15, 2026 | 1,000 | $71.17 |
| POST LEONARD E | M | Jul 15, 2026 | 1,000 | - |
Financial SummaryXBRL
| Metric | FY2023 | FY2024 | FY2025 |
|---|---|---|---|
| Profitability | |||
| Revenue | $204K | $1.1M | $4.0M |
| Operating Income | - | -$114.7M | -$190.8M |
| Net Income | - | -$88.0M | -$161.0M |
| Op. Margin | - | -10067.3% | -4722.1% |
| Net Margin | - | -7729.5% | -3985.0% |
| Balance Sheet | |||
| Total Assets | $199.3M | $754.8M | $791.6M |
| Equity | -$123.1M | $733.4M | $752.6M |
| ROE | - | -12.0% | -21.4% |
| Per Share | |||
| EPS | $-15.65 | $-1.41 | $-2.08 |
| Cash Flow | |||
| Operating CF | - | -$78.7M | -$132.3M |
| CapEx | - | $234K | $134K |
Source: XBRL data in CG Oncology, Inc. (CGON)'s 10-K filings on SEC EDGAR, in USD. Compare across companies →
13F Fund Holdings: Quarterly Trend
Latest: Q2 2026Aggregate CGON share value held by 13F filers tracked by SignalX, by quarter.
Quarterly totals table
| Quarter | Funds | Total value |
|---|---|---|
| Q2 2026 | 28 | $2.22B |
| Q1 2026 | 29 | $1.92B |
| Q4 2025 | 23 | $1.18B |
| Q3 2025 | 26 | $1.05B |
| Q2 2025 | 26 | $722.3M |
| Q1 2025 | 19 | $400.8M |
| Q4 2024 | 14 | $390.9M |
| Q3 2024 | 11 | $145.6M |
- BlackRock+1.19M (+24%)
- State Street Corp+790.5K (+30%)
- Morgan Stanley+656.9K (+126%)
- FMR LLC (Fidelity)+396.6K (+11%)
- Vanguard Portfolio Management LLC+370.1K (+12%)
- Bank of America Corp−464.4K (-32%)
- Goldman Sachs Group−301.5K (-26%)
- Franklin Resources−194.1K (-13%)
- JPMorgan Chase & Co−141.9K (-25%)
- Ameriprise Financial−102.0K (-33%)
- Citadel Advisors LLC−172.8K
Source: 13F-HR filings on SEC EDGAR (aggregated from 176 fund-quarter rows). Reflects only 13F filers tracked by SignalX, not the full institutional ownership universe. How 13F filings work
CGON filing archive
AI analysis pages for each 10-K, 10-Q and 8-K
10-K annual reports
10-Q quarterly reports
Latest 2026 SEC Filings: 10-K, 10-Q, 8-K & Form 4
| Form | Filing date | Period | Analysis | SEC |
|---|---|---|---|---|
| 4 | Sep 17, 2026 | - | - | - |
| 4 | Aug 18, 2026 | - | - | - |
| 8-K | Aug 6, 2026 | - | Analysis | - |
| 10-Q | Aug 6, 2026 | Jun 30, 2026 | Analysis | |
| 4 | Jul 17, 2026 | - | - | - |
| 4 | Jul 14, 2026 | - | - | - |
| 4 | Jun 29, 2026 | - | - | - |
| 4 | Jun 25, 2026 | - | - | - |
| 4 | Jun 23, 2026 | - | - | - |
| 4 | Jun 16, 2026 | - | - | - |
| 8-K | Jun 8, 2026 | - | Analysis | |
| 4 | Jun 5, 2026 | - | - | |
| 4 | Jun 5, 2026 | - | - | |
| 4 | Jun 5, 2026 | - | - | |
| 4 | Jun 5, 2026 | - | - | |
| 4 | Jun 5, 2026 | - | - | |
| 4 | Jun 5, 2026 | - | - | |
| 8-K | May 26, 2026 | - | Analysis | |
| SC 13G | May 15, 2026 | - | - | |
| SC 13G | May 15, 2026 | - | - | |
| 10-Q | May 8, 2026 | Mar 31, 2026 | Analysis | |
| 8-K | May 8, 2026 | - | Analysis | |
| 4 | Apr 20, 2026 | - | - | - |
| 4 | Apr 16, 2026 | - | - | - |
| 4 | Apr 16, 2026 | - | - | - |
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CGON SEC filings: frequently asked questions
Are CGON insiders buying or selling?
In the last 90 days, CG Oncology, Inc. (CGON) officers, directors and 10% owners reported no open-market purchases and 4 open-market sales worth $2.0 million by 2 insiders on Form 4. Many insider sales are pre-planned or for taxes, so purchases usually carry more information.
Which institutions hold CGON stock?
As of June 30, 2026, the largest CG Oncology, Inc. (CGON) holders among the 13F filers tracked by SignalX were BlackRock ($444.5 million), FMR LLC (Fidelity) ($295.7 million), T. Rowe Price Group ($270.3 million), Vanguard Portfolio Management LLC ($246.2 million), State Street Corp ($244.2 million). 13F-HR reports are filed up to 45 days after each quarter ends.
What was CGON's revenue in fiscal year 2025?
For the fiscal year ended December 31, 2025 (FY2025), CG Oncology, Inc. (CGON) reported revenue of $4.0 million (up 254.7% from FY2024) and a net loss of $161.0 million. Diluted EPS was -$2.08. The figures come from the XBRL data in the 10-K.
What are the main risks in CGON's latest 10-K?
In the 10-K filed February 27, 2026, CG Oncology, Inc. (CGON) flagged: Regulatory risk from FDA on novel gene-modified virus cretostimogene may delay BLA approval; FDA may issue Complete Response Letter requiring more trials. Macroeconomic risk from global clinical trial delays due to geopolitical issues in foreign countries impacting patient enrollment and regulatory approvals. (AI summary of the Risk Factors section.)
What did CGON report in its latest 8-K?
CG Oncology, Inc. (CGON) filed an 8-K on August 6, 2026 reporting Item 2.02 (Results of Operations and Financial Condition) and Item 8.01 (Other Events). CG Oncology announced financial results for the quarter ended June 30, 2026.
What are the latest CGON SEC filings?
CG Oncology, Inc. (CGON) filed its latest 10-K annual report on February 27, 2026, a 10-Q quarterly report on August 6, 2026, an 8-K current report on August 6, 2026 and a Form 4 insider filing on September 17, 2026.
What is CGON's SEC CIK number?
CG Oncology, Inc. (CGON)'s SEC Central Index Key (CIK) is 1991792. EDGAR lists every CGON filing under that number.
Ask anything about CGON
The research agent reads CGON's filings, financials, insider trades and 13F holders, then answers with sources.