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CG Oncology (CGON) investor relations material
CG Oncology Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary14 Nov, 2025
Executive summary
Focused on developing cretostimogene grenadenorepvec for bladder cancer, with no approved products or product sales to date.
Reported topline Phase 3 data for cretostimogene showing a 41.8% complete response rate at 24 months in high-risk NMIBC, supporting a BLA submission to the FDA.
Initiated rolling BLA submission to the FDA for cretostimogene monotherapy in high-risk BCG-unresponsive NMIBC, with full submission expected in 2026.
Completed enrollment of PIVOT-006, a large Phase 3 trial in intermediate-risk NMIBC, 10 months ahead of schedule.
Building commercial infrastructure in anticipation of potential FDA approval.
Financial highlights
Net loss for Q3 2025 was $43.8 million ($0.57 per share), compared to $20.4 million ($0.30 per share) in Q3 2024; net loss for the nine months ended September 30, 2025 was $119.7 million, up from $56.2 million year-over-year.
Total revenues for Q3 2025 were $1.7 million, up from $43,000 in Q3 2024, driven by commercial and development revenue from the Biovire acquisition.
Research and development expenses rose to $27.9 million in Q3 2025 (from $19.6 million in Q3 2024) and $86.7 million for the nine months (from $55.3 million year-over-year).
General and administrative expenses increased to $23.3 million in Q3 2025 (from $8.7 million in Q3 2024) and $55.5 million for the nine months (from $22.0 million year-over-year).
Cash, cash equivalents, and marketable securities totaled $680.3 million as of September 30, 2025, up from $661.1 million at June 30, 2025.
Outlook and guidance
Current cash position expected to fund operations into the first half of 2028, but additional funding will be needed for commercialization and further development.
Anticipates continued significant operating losses as clinical development and commercialization efforts expand.
Topline data from BOND-003 Cohort P and first results from CORE-008 Cohort A expected in Q4 2025.
Topline data from CORE-008 Cohort CX anticipated in 1H 2026.
Completion of BLA submission for cretostimogene in initial indication targeted for 2026.
Cretostimogene label optimization strategy
Cretostimogene's competitive differentiation
Cash runway beyond H1 2028 assumptions
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Next CG Oncology earnings date
Q4 202527 Mar, 2026
Next CG Oncology earnings date
Q4 202527 Mar, 2026
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Frequently asked questions
CG Oncology Inc. is a late-stage clinical biopharmaceutical company primarily engaged in the development and commercialization of innovative treatments for bladder cancer. The company's main focus is on creating a bladder-sparing therapeutic option for patients suffering from this disease. CG Oncology's leading product candidate, cretostimogene, is currently in clinical development targeting high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) patients who have not responded to Bacillus Calmette Guerin (BCG) therapy, the current standard-of-care. The company is headquartered in Irving, California, and its shares are listed on the Nasdaq.
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