CG Oncology — Third Quarter 2026 Earnings Summary

Financial Performance

• Total revenues were $1.604 million for the three months ended September 30, 2026, 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, compared to $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 costs.
• 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 totaled $984.5 million as of September 30, 2026, down from $1.0 billion as of June 30, 2026.
• The company anticipates its existing cash resources will be sufficient to fund operations through 2029.

Guidance and Future Outlook

• Topline data from the PIVOT-006 Phase 3 trial evaluating cretostimogene monotherapy as an adjuvant therapy in intermediate-risk and high-grade Ta NMIBC is anticipated in November 2026.
• 12-month data from BOND-003 Cohort P and CORE-008 Cohort CX are anticipated in December 2026.
• Completion of the Biologics License Application (BLA) for BCG-unresponsive NMIBC is anticipated in the fourth quarter of 2026.
• Management expressed confidence in cretostimogene's potential to become a backbone therapy for patients and create long-term value for shareholders.

Business Segments and Product Lines

• Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy currently in a clinical development program involving over 700 patients with Non-Muscle Invasive Bladder Cancer (NMIBC).
• The development program includes two Phase 3 trials: BOND-003 for BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk and high-grade Ta ≤ 3cm NMIBC.
• Cretostimogene has received FDA Fast Track and Breakthrough Therapy designations for BCG-unresponsive NMIBC.
• The company has initiated an Expanded Access Program for cretostimogene in North America for patients unresponsive to BCG who meet specific 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

• PIVOT-006 is the first randomized registrational trial in intermediate-risk and high-grade Ta NMIBC.
• The company is positioned to address the broadest number of patients with cretostimogene across the NMIBC landscape.
• Total assets increased to $1.047 billion as of September 30, 2026, from $791.6 million as of December 31, 2025.
• Total stockholders' equity increased to $991.0 million as of September 30, 2026, from $752.6 million as of December 31, 2025.