CGON CG Oncology, Inc.

company

SEC Filings & Insider Trading Activity 2026

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

What are the latest CGON SEC filings in 2026?

CG Oncology, Inc. (CGON) has filed a 10-K annual report on February 27, 2026, a 10-Q quarterly report on May 8, 2026, an 8-K current report on August 6, 2026 with the SEC. SignalX tracks every new SEC EDGAR filing daily, including 10-K, 10-Q, 8-K, and Form 4 insider transactions, with AI-powered summaries of key sections.

When did CGON file its most recent 10-K annual report?

CG Oncology, Inc. (CGON) filed its most recent 10-K annual report on February 27, 2026. The 10-K includes audited financial statements, business overview, risk factors, and management discussion, all available on SignalX with AI-generated summaries and XBRL financial data.

How do I view CGON 10-Q quarterly reports?

CG Oncology, Inc. (CGON)'s most recent 10-Q quarterly report was filed on May 8, 2026. SignalX displays every CGON 10-Q with AI-generated summaries of the MD&A (Management Discussion & Analysis) and Risk Factors sections, plus links to the original SEC EDGAR document.

What 8-K current reports has CGON filed recently?

CG Oncology, Inc. (CGON)'s most recent 8-K was filed on August 6, 2026. 8-K filings disclose material corporate events such as earnings releases, executive changes, mergers, and other significant developments. SignalX surfaces each 8-K with item-level summaries so you can quickly see what happened.

Where can I find CGON insider trading activity (Form 4)?

SignalX aggregates every CGON Form 4 insider transaction from SEC EDGAR. Form 4 reports show when officers, directors, and 10% shareholders buy or sell company stock, with transaction code, share count, and price per share.

How often does CGON file with the SEC?

CG Oncology, Inc. (CGON) files a 10-K annual report once per year (typically within 60 days of fiscal year-end) and 10-Q quarterly reports three times per year. 8-K current reports are filed as needed when material events occur, and Form 4 insider transaction reports are due within two business days of a trade. SignalX monitors SEC EDGAR daily to surface every new CGON filing with AI-powered analysis.

What is the difference between 10-K, 10-Q, and 8-K SEC filings?

A 10-K is a comprehensive annual report with audited financials, business overview, and risk factors. A 10-Q is a shorter quarterly report with unaudited financials and management discussion. An 8-K is a current report filed when a material event occurs, such as earnings releases, executive changes, acquisitions, or other significant developments. SignalX provides AI-generated summaries for all three filing types for CG Oncology, Inc. (CGON).

What is CGON's SEC CIK number?

CG Oncology, Inc. (CGON)'s SEC CIK (Central Index Key) number is 1991792. The CIK is a unique identifier assigned by the SEC to every filing entity. You can use CIK 1991792 to look up all CGON filings on SEC EDGAR, or browse them here on SignalX with AI-powered analysis.

Where can I find CGON return on equity (ROE) and financial data?

SignalX extracts XBRL financial data from CG Oncology, Inc. (CGON) 10-K annual filings, including revenue, net income, gross profit, operating income, EPS, total assets, stockholders' equity, and operating cash flow. Return on equity (ROE) can be derived from net income divided by stockholders' equity. Multi-year financial trends are displayed in the Financial Summary table above.