CG Oncology — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenues for the three months ended September 30, 2026, were $1.604 million, compared to $1.666 million in the prior year period.
• Commercial and development revenue was $1.604 million for the quarter, up from $1.508 million in the prior year period.
• License and collaboration revenue was $0 for the quarter, down from $158,000 in the prior year period.
• Research and development expenses were $39.2 million for the quarter, an increase from $27.9 million in the prior year period, driven by higher clinical trial expenses (including CMC costs) and increased compensation due to headcount growth.
• General and administrative expenses were $23.0 million for the quarter, a decrease from $23.3 million in the prior year period, primarily due to lower professional and consultant fees, partially offset by higher personnel-related expenses.
• Net loss was $56.9 million, or $(0.64) per share, for the quarter, compared to a net loss of $43.8 million, or $(0.57) per share, in the prior year period.
• Cash, cash equivalents, and marketable securities were $984.5 million as of September 30, 2026, compared to $1.0 billion as of June 30, 2026, and $742.2 million as of December 31, 2025.

Guidance and Future Outlook:

• The Company anticipates its existing cash resources will be sufficient to fund operations through 2029.
• PIVOT-006 Phase 3 topline data for cretostimogene monotherapy in intermediate-risk and high-grade Ta NMIBC is anticipated in November 2026.
• 12-month data for BOND-003 Cohort P and CORE-008 Cohort CX is anticipated in December 2026.
• Completion of the Biologics License Application (BLA) for BCG-unresponsive NMIBC is anticipated in the fourth quarter of 2026.

Business Segments and Product Lines:

• Cretostimogene is an investigational oncolytic immunotherapy currently in development for Non-Muscle Invasive Bladder Cancer (NMIBC), having been studied in over 700 patients.
• The clinical program includes two Phase 3 trials: BOND-003 (BCG-unresponsive NMIBC) and PIVOT-006 (intermediate-risk and high-grade Ta ≤ 3cm NMIBC).
• Cretostimogene holds FDA Fast Track and Breakthrough Therapy designations for BCG-unresponsive NMIBC.
• An Expanded Access Program for cretostimogene has been initiated in North America for patients unresponsive to BCG who meet eligibility requirements.
• The Company appointed Isabel Kalofonos as Chief Commercial Officer in October, bringing over 20 years of experience in commercial launches.

Other Key Points:

• The Company is positioned to deliver on key milestones with a cash runway extending through 2029.
• Management expressed confidence in cretostimogene's potential to become a backbone therapy and create long-term shareholder value.
• The Company operates as a late-stage clinical biopharmaceutical company focused on bladder-sparing therapies for urologic cancer.