CG Oncology, Inc. Q2 FY26 Results

Summary

CG Oncology reported its financial results for the second quarter ended June 30, 2026, highlighting significant progress across clinical, regulatory, manufacturing, and commercial-readiness initiatives. The company anticipates near-term topline data for the PIVOT-006 Phase 3 trial and expects BLA completion for HR BCG-unresponsive NMIBC in the fourth quarter of 2026. Despite an increase in net loss to $79.1 million ($0.90 per share) from $41.4 million ($0.54 per share) in the prior year, driven by higher R&D and G&A expenses, the company maintains a strong cash position of approximately $1.0 billion, sufficient to fund operations through 2029.

Key Highlights

1. 1

   CG Oncology anticipates PIVOT-006 Phase 3 topline data evaluating cretostimogene monotherapy in intermediate-risk NMIBC in the near-term.

2. 2

   The company expects BLA completion for HR BCG-unresponsive NMIBC in the fourth quarter of 2026.

3. 3

   Phase 3 BOND-003 Cohort C Study Results were published in The Lancet Oncology, further validating the clinical evidence for cretostimogene.

4. 4

   CG Oncology is well-positioned to deliver on key milestones with approximately $1.0 billion in cash, cash equivalents, and marketable securities, sufficient to fund operations through 2029.

5. 5

   Net loss for the second quarter of 2026 was $79.1 million, or $(0.90) per share, compared to a net loss of $41.4 million, or $(0.54) per share, in the prior year period.

6. 6

   Research and Development expenses increased to $54.7 million for the second quarter of 2026 from $31.3 million in the prior year period, primarily due to increased clinical trial and CMC costs.

7. 7

   General and Administrative expenses rose to $29.0 million for the second quarter of 2026 from $17.4 million in the prior year period, mainly due to increased personnel-related expenses.