CG Oncology (CGON) Q1 2026 earnings summary

Executive summary

• Focused on developing cretostimogene grenadenorepvec for bladder cancer, with multiple ongoing Phase 2 and 3 trials targeting high- and intermediate-risk NMIBC.

• Completed non-clinical and clinical modules for first BLA submission; CMC module on track for Q4 2026 completion.

• No products approved for sale; revenue is from license, collaboration, and contract manufacturing activities.

• Net loss increased to $60.2 million for Q1 2026, up from $34.5 million in Q1 2025, driven by higher R&D and G&A expenses.

• Strengthened leadership with appointment of new CFO, Jim DeTore, in April 2026.

Financial highlights

• Q1 2026 revenue: $1.1 million (commercial/development), less than $0.1 million (license/collaboration).

• R&D expenses: $43.7 million, up $16.3 million year-over-year, mainly due to increased clinical trial and CMC costs.

• G&A expenses: $20.8 million, up $6.0 million year-over-year, reflecting higher headcount and professional fees.

• Net loss per share: $(0.71) vs. $(0.45) year-over-year.

• Cash, cash equivalents, and marketable securities: $1.1 billion as of March 31, 2026, up from $742.2 million at year-end 2025.

Outlook and guidance

• Cash runway expected to fund operations through 2029.

• Anticipates continued significant operating losses as clinical development and pre-commercial activities expand.

• BLA submission for cretostimogene expected to complete in Q4 2026.

• Phase 3 PIVOT-006 topline data in intermediate-risk NMIBC expected in 1H 2026.

• Additional clinical data presentations and regulatory milestones anticipated in 2026.