Short answer
CG Oncology, Inc. (CGON) filed its fiscal 2025 10-K annual report with the SEC on Feb 27, 2026. It reported revenue of $4M (+254.7% year over year) and net income of −$161M.
- Top risk flagged: Regulatory risk from FDA on novel gene-modified virus cretostimogene may delay BLA approval; FDA may issue Complete Response Letter requiring more trials
FY2025 key financial metrics · XBRL
- Revenue
- $4M
- +254.7% YoY
- Net income
- −$161M
- −82.9% YoY
- Operating margin
- -4722.1%
- +5345.1 pp YoY
- EPS (diluted)
- −$2.08
- −47.5% YoY
- ROE
- -21.4%
- −9.4 pp YoY
- Operating cash flow
- −$132M
- −68.1% YoY
Source: XBRL data from the CG Oncology, Inc. (CGON) FY2025 10-K on SEC EDGAR. USD.
CG Oncology, Inc. FY2025 10-K analysis
AI summary of each section, grounded in the filing text
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
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
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
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