CG Oncology (CGON) investor relations material

Executive summary

• Advanced cretostimogene grenadenorepvec for bladder cancer with multiple late-stage clinical trials, including PIVOT-006 and BOND-003, and a BLA submission for high-risk NMIBC expected in Q4 2026.

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

• Significant progress in clinical, regulatory, manufacturing, and commercial-readiness initiatives during Q2 2026.

• Net loss for the quarter was $79.1 million, and $139.3 million for the six months ended June 30, 2026.

• BOND-003 Cohort C Phase 3 results published, further validating cretostimogene's clinical evidence.

Financial highlights

• Cash, cash equivalents, and marketable securities totaled $1,028.3 million as of June 30, 2026.

• Revenue for the quarter was $1.2 million, primarily from contract manufacturing (Biovire); license and collaboration revenue was less than $0.1 million.

• R&D expenses rose to $54.7 million for the quarter, up $23.3 million year-over-year, driven by higher clinical trial and CMC costs.

• General and administrative expenses increased to $29.0 million, up $11.6 million year-over-year, mainly due to higher headcount and stock-based compensation.

• Net loss per share was $(0.90) for the quarter and $(1.61) for the six months ended June 30, 2026.

Outlook and guidance

• Management expects continued significant operating losses as clinical development and pre-commercial activities accelerate.

• Cash position expected to fund operations through 2029.

• Additional capital may be raised through equity offerings, including up to $500 million under the Jefferies Sales Agreement.

• Anticipated milestones include PIVOT-006 Phase 3 topline data and BLA completion for HR BCG-unresponsive NMIBC in Q4 2026.