| Metric | Value ($ M) | Q3 FY24 |
|---|---|---|
| Revenue | 1.67 | 4075.0% |
| Total Income | 1.67 | 4075.0% |
| Expenditure | 52.80 | 86.3% |
| PBT | — | |
| Net Profit | -43.81 | 114.7% |
| OPM | — | |
| NPM | — | |
| EPS | -0.57 | 90.0% |
CG Oncology Reports Q3 2025 Financial Results
04 May 2026 · 4 May, 7:07 am
Summary
CG Oncology reported financial results for the third quarter ended September 30, 2025. The company initiated its BLA submission for cretostimogene monotherapy in HR BCG-unresponsive NMIBC. They completed enrollment of the PIVOT-006 clinical trial in IR NMIBC. The company's cash and cash equivalents and marketable securities were $680.3 million as of September 30, 2025, which is expected to fund operations into the first half of 2028. Net loss for the quarter was $43.8 million, or ($0.57) per share.
Key Highlights
- 1
CG Oncology initiated a rolling Biologics License Application (BLA) submission to the U.S. FDA for cretostimogene monotherapy in high-risk (HR) BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
- 2
The company demonstrated a 24-month complete response (CR) rate of 41.8% for cretostimogene monotherapy in patients with HR NMIBC unresponsive to Bacillus Calmette Guerin (BCG) in BOND-003 Cohort C.
- 3
Enrollment was completed for PIVOT-006, a Phase 3 study in intermediate risk (IR) NMIBC.
- 4
Cash and cash equivalents and marketable securities totaled $680.3 million as of September 30, 2025, sufficient to fund operations into the first half of 2028.
- 5
Research and Development (R&D) expenses for the three months ended September 30, 2025 were $27.9 million, compared to $19.6 million for the three months ended September 30, 2024.
- 6
Net loss was $43.8 million, or ($0.57) per share, for the three months ended September 30, 2025, compared to a net loss of $20.4 million, or ($0.30) per share, for the three months ended September 30, 2024.
- 7
Total revenues were $1.666 million for the three months ended September 30, 2025, compared to $43 thousand for the three months ended September 30, 2024.
Management Comments
Arthur Kuan
I am proud of the meaningful progress we have made over the last few months, most notably, the initiation of our BLA submission of cretostimogene for our lead indication of HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease. With cretostimogene’s unique profile, we remain committed to advancing a robust clinical, regulatory, and technical strategy designed to support an optimized label and expansion into additional indications—positioning cretostimogene as a potential backbone therapy for a broad range of NMIBC patients. We look forward to sharing additional data from BOND-003 Cohort P and CORE-008 Cohort A before year-end.
Informational and educational content only. Not investment advice.