Quarterly ResultMay 8, 2026, 08:32 AM
CG Oncology BLA for NMIBC Expected Q4 2026; $1.1B Cash
AI Summary
CG Oncology reported Q1 2026 financial results and provided key business updates. The company expects to complete its Biologics License Application (BLA) submission for high-risk BCG-unresponsive NMIBC in the fourth quarter of 2026, following alignment with the FDA. Additionally, topline data from the Phase 3 PIVOT-006 trial and first results from the Phase 2 CORE-008 Cohort CX are anticipated in the first half of 2026. The company maintains a strong financial position with approximately $1.1 billion in cash, cash equivalents, and marketable securities, projected to fund operations through 2029, and appointed Jim DeTore as its new CFO.
Key Highlights
- BLA completion for HR BCG-unresponsive NMIBC expected in Q4 2026 following FDA discussions.
- PIVOT-006 Phase 3 topline data anticipated in 1H 2026 for intermediate-risk NMIBC.
- CORE-008 Cohort CX Phase 2 first results to be presented at AUA 2026.
- Cash, cash equivalents, and marketable securities totaled $1.1 billion as of March 31, 2026.
- Cash position is sufficient to fund operations through 2029.
- Q1 2026 R&D expenses increased to $43.7 million from $27.5 million YoY.
- Q1 2026 G&A expenses increased to $20.8 million from $14.8 million YoY.
- Net loss for Q1 2026 was $60.2 million, or $(0.71) per share.
- Jim DeTore appointed Chief Financial Officer in April 2026.