CG Oncology (CGON) Q3 2026 earnings summary

Executive summary

• Q3 2026 net loss was $56.9M; 9M net loss was $196.1M as development and operating costs rose. September 30 cash, cash equivalents and marketable securities totaled $984.5M.

• Cretostimogene’s BLA submission for the initial BCG-unresponsive NMIBC indication is expected in Q4 2026; PIVOT-006 topline data and two 12-month cohort updates are expected by year-end.

Financial highlights

• Q3 revenue was $1.666M versus $1.508M; 9M revenue was $3.844M versus $1.718M, primarily reflecting a full nine months of Biovire activity in 2026.

• Q3 operating loss was $63.2M versus $51.1M YoY; 9M operating loss was $216.0M versus $142.1M.

• Q3 net loss was $56.9M, or $0.64 per share, versus $43.8M, or $0.57 per share; 9M net loss was $196.1M, or $2.25 per share, versus $119.7M, or $1.57 per share.

• Q3 R&D expense was $39.2M versus $27.9M, driven by clinical-trial and CMC costs and headcount growth; G&A was $23.0M versus $23.3M.

• 9M operating expenses rose to $219.9M from $143.8M, including R&D of $137.6M and G&A of $72.7M.

Outlook and guidance

• BLA submission for cretostimogene in BCG-unresponsive NMIBC with CIS, with or without papillary disease, is expected in Q4 2026.

• PIVOT-006 Phase 3 topline data are anticipated in November 2026; CORE-008 Cohort CX and BOND-003 Cohort P 12-month data are anticipated in December 2026.

• $984.5M in cash, cash equivalents and marketable securities is expected to fund operations through 2029; a separate filing states resources are expected to fund operations for at least 12 months from its report date, subject to assumptions and spending levels.

• R&D and G&A expenses are expected to increase substantially as clinical development, regulatory work, hiring and potential commercialization preparations continue.