CGON CG Oncology, Inc.

FY2025 10-K
Filed: Feb 27, 2026
Health Care
Biological Products, (No Diagnostic Substances)SEC EDGAR

CG Oncology, Inc. (CGON) filed its fiscal year 2025 10-K annual report with the SEC on Feb 27, 2026. This page provides AI-powered analysis of the filing, including business overview, management discussion, risk factors, and key financial metrics from XBRL data.

AI Filing Analysis
FY2025 10-K

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
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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
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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
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Financial Summary
XBRL

Revenue

$4M

Net Income

-$161M

Operating Margin

-4722.1%

Net Margin

-3985.0%

ROE

-21.4%

Total Assets

$792M

EPS (Diluted)

$-2.08

Operating Cash Flow

-$132M

Source: XBRL data from CG Oncology, Inc. FY2025 10-K filing on SEC EDGAR. All figures in USD.

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