| Metric | Value ($ M) | Q1 FY25 |
|---|---|---|
| Revenue | 1.08 | 2060.0% |
| Total Income | 1.08 | 2060.0% |
| Expenditure | 67.47 | 59.6% |
| PBT | — | |
| Net Profit | -60.20 | 74.8% |
| OPM | — | |
| NPM | — | |
| EPS | -0.71 | 57.8% |
CG Oncology Reports Q1 2026 Financial Results
08 May 2026 · 8 May, 6:16 pm
Summary
CG Oncology reported financial results for the first quarter ended March 31, 2026. The company has approximately $1.1 billion in cash, cash equivalents, and marketable securities, which is expected to fund operations through 2029. R&D expenses increased to $43.7 million, while G&A expenses rose to $20.8 million. The net loss for the quarter was $60.2 million, or $(0.71) per share. The company anticipates completing its BLA submission in the fourth quarter of 2026 and expects topline data from the PIVOT-006 Phase 3 trial in the first half of 2026.
Key Highlights
- 1
CG Oncology anticipates BLA completion for HR BCG-unresponsive NMIBC in the fourth quarter of 2026, following alignment discussions with the FDA.
- 2
Topline data from the PIVOT-006 Phase 3 trial, evaluating cretostimogene monotherapy in intermediate-risk NMIBC, is expected in the first half of 2026.
- 3
First results from the CORE-008 Cohort CX Phase 2 trial, which combines cretostimogene with gemcitabine in high-risk NMIBC, will be presented at AUA 2026.
- 4
The company's cash, cash equivalents, and marketable securities totaled approximately $1.1 billion, sufficient to fund operations through 2029.
- 5
Research and Development expenses increased to $43.7 million for the first quarter of 2026, compared to $27.5 million for the prior year period.
- 6
General and Administrative expenses were $20.8 million for the first quarter of 2026, compared to $14.8 million for the prior year period.
- 7
Net loss for the first quarter of 2026 was $60.2 million, or $(0.71) per share, compared to a net loss of $34.5 million, or $(0.45) per share, for the prior year period.
Management Comments
Arthur Kuan
“We have successfully completed non-clinical and clinical modules for our first BLA submission. The remaining CMC module is progressing as planned, and we are on track to finalize our submission in the fourth quarter 2026. We are pleased to provide this additional guidance on expected BLA completion following focused filing discussions with FDA. Manufacturing inspection readiness activities continue to progress, including our commitment to sustainable long-term supply. The quality and execution of the rolling BLA has been a top priority for us, and we are confident that we are taking all appropriate measures to ensure a successful package. This has been a tremendous undertaking, and I am extremely proud of the team for their unwavering commitment.” We look forward to a number of meaningful near‑term milestones for CG, including anticipated topline data from the Phase 3 PIVOT‑006 trial in intermediate‑risk NMIBC in the coming months, as well as the first results from the Phase 2 CORE‑008 Cohort CX in high‑risk BCG‑exposed and BCG-unresponsive patients, to be presented at AUA.”
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