CG Oncology, Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 6 November 2026: press release. Guidance figures: 3 new, 2 kept. The quarter’s numbers.

Read the filing

Key takeaways

• Net loss widened year on year: Net loss was $56.9 million, or $(0.64) per share, against $43.8 million, or $(0.57) per share, a year earlier. Weighted average shares rose to 88.9 million from 76.7 million. Source
• R&D expense rose to $39.2 million: R&D expense was $39.2 million, against $27.9 million a year earlier. Management attributed the rise mainly to clinical trial costs, including CMC costs, and to compensation from higher headcount. Source
• PIVOT-006 is first randomized registrational trial: Management described PIVOT-006 as the first randomized registrational trial in intermediate-risk and high-grade Ta NMIBC, evaluating cretostimogene as monotherapy in an adjuvant setting. Source
• Evidence base described as growing: Management said the 12-month data from CORE-008 Cohort CX and BOND-003 Cohort P add to the evidence for cretostimogene across NMIBC. Source
• Product remains investigational: The company describes cretostimogene as an investigational candidate. Its safety and efficacy have not been established by the FDA or any other health authority. Source
• Chief Commercial Officer brings launch experience: Isabel Kalofonos joined as Chief Commercial Officer in October. The company says she has more than 20 years of experience driving launches. Source
• Cash fell to $984.5 million: Cash, cash equivalents and marketable securities were $984.5 million at September 30, 2026, against $1.0 billion at June 30, 2026. Source

“We are entering an eventful period for CG Oncology as we look forward to sharing PIVOT-006 topline data this month.”

Arthur Kuan, Chairman, President & Chief Executive Officer

Guidance

What changed from last quarter

• New guidance: PIVOT-006 topline data timing moved from near-term in the Q2 release to November 2026 in the Q3 release. Source
• New guidance: 12-month data for CORE-008 Cohort CX and BOND-003 Cohort P are now dated December 2026. The Q2 release listed durability data for these cohorts without a date. Source
• New: Isabel Kalofonos was appointed Chief Commercial Officer in October 2026. Source

Results and growth drivers

• Net loss widened year on year: Net loss was $56.9 million, or $(0.64) per share, against $43.8 million, or $(0.57) per share, a year earlier. Weighted average shares rose to 88.9 million from 76.7 million. Source
• Revenue stayed near $1.6 million: Total revenues were $1.6 million, against $1.7 million a year earlier. Commercial and development revenue was $1.6 million, and license and collaboration revenue was nil in the quarter. Source
• Nine-month net loss grew: Net loss for the nine months ended September 30, 2026 was $196.1 million, against $119.7 million a year earlier. Source

Operating costs and expenses

• R&D expense rose to $39.2 million: R&D expense was $39.2 million, against $27.9 million a year earlier. Management attributed the rise mainly to clinical trial costs, including CMC costs, and to compensation from higher headcount. Source
• G&A held near $23 million: G&A expense was $23.0 million, against $23.3 million a year earlier. Lower professional and consultant fees were offset by higher personnel costs from increased headcount and other G&A. Source
• Cost of sales rose to $2.7 million: Cost of sales was $2.7 million, against $1.6 million a year earlier. Nine-month cost of sales was $9.6 million. Source
• Loss from operations widened: Loss from operations was $63.2 million, against $51.1 million a year earlier. Total operating costs and expenses were $64.9 million, against $52.8 million. Source

“As a reminder, PIVOT-006 is the first randomized registrational trial in intermediate-risk and high-grade Ta NMIBC.”

Arthur Kuan, Chairman, President & Chief Executive Officer

Clinical and regulatory milestones

• PIVOT-006 is first randomized registrational trial: Management described PIVOT-006 as the first randomized registrational trial in intermediate-risk and high-grade Ta NMIBC, evaluating cretostimogene as monotherapy in an adjuvant setting. Source
• Evidence base described as growing: Management said the 12-month data from CORE-008 Cohort CX and BOND-003 Cohort P add to the evidence for cretostimogene across NMIBC. Source
• BLA indication wording reworded: The Q2 release described the initial BLA indication as HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease. The Q3 release describes it as BCG-unresponsive NMIBC with CIS with or without papillary disease.

Pipeline and product profile

• Fast Track and Breakthrough designations held: Cretostimogene has FDA Fast Track and Breakthrough Therapy designations for BCG-unresponsive NMIBC, according to the company. Source
• Product remains investigational: The company describes cretostimogene as an investigational candidate. Its safety and efficacy have not been established by the FDA or any other health authority. Source
• Expanded access program initiated: An Expanded Access Program in North America is open to patients unresponsive to BCG who meet program eligibility requirements. Source
• Clinical program exceeds 700 patients: The development program includes more than 700 patients with NMIBC, up from more than 600 in the Q2 release. Source

“We remain confident in cretostimogene’s potential to become a backbone therapy for patients and to create long-term value for shareholders,”

Arthur Kuan, Chairman, President & Chief Executive Officer

Commercial readiness and leadership

• Chief Commercial Officer brings launch experience: Isabel Kalofonos joined as Chief Commercial Officer in October. The company says she has more than 20 years of experience driving launches. Source
• Prior launches named in background: The company cites her work on the PALSONIFY and ELAHERE launches as part of her background. Source
• Readouts tied to broad patient access: The chief executive said the readouts support the company's goal of addressing the broadest number of patients with NMIBC. Source

Cash, funding and balance sheet

• Cash fell to $984.5 million: Cash, cash equivalents and marketable securities were $984.5 million at September 30, 2026, against $1.0 billion at June 30, 2026. Source
• Balance sheet totals rose: Total assets were $1,046.7 million and total liabilities were $55.7 million at September 30, 2026. Stockholders' equity was $991.0 million. Source
• Weighted share count increased: Weighted average basic and diluted shares were 88.9 million for the quarter, against 76.7 million a year earlier. Source

Coming up, as management said on 6 November 2026

• PIVOT-006 topline data: Topline Phase 3 data from PIVOT-006 are anticipated in November 2026. Source
• Twelve-month data in December: 12-month data from CORE-008 Cohort CX and BOND-003 Cohort P are expected in December 2026. Source
• BLA submission completion: Completion of the BLA submission for BCG-unresponsive NMIBC is anticipated in Q4 2026. Source

Figures management reported

Earlier plans management reported on

• Not stated: The Q2 release anticipated PIVOT-006 topline data in the near-term. The Q3 release gives November 2026. Management does not state a status.
• Not stated: The Q2 release expected BLA completion in the fourth quarter of 2026. The Q3 release keeps Q4 2026 as the anticipated timing.

Other quarters

• Q2 FY2026 earnings call
• Q1 FY2026 earnings call
• Q4 FY2025 earnings call
• Q3 FY2025 results

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.