CG Oncology, Inc.: Q1 FY2026 earnings call

What management said about Q1 FY2026, from the documents filed with the SEC on 8 May 2026: press release. Guidance figures: 1 raised, 4 kept. The quarter’s numbers.

Read the filing

Key takeaways

• Net loss widened to $60.2 million: The net loss was $60.2 million, or $(0.71) per share, against $34.5 million, or $(0.45) per share, in the prior year period. Source
• BLA completion set for Q4 2026: Management said the remaining CMC module is progressing as planned and the company is on track to finalize the BLA in the fourth quarter of 2026. Source
• PIVOT-006 topline due first half: Phase 3 topline data for PIVOT-006 in intermediate-risk NMIBC are anticipated in the first half of 2026, which the company described as coming in the coming months. Source
• CORE-008 Cohort CX data at AUA: First results from CORE-008 Cohort CX, a Phase 2 study of cretostimogene with gemcitabine in high-risk BCG-exposed or BCG-unresponsive NMIBC, will be presented at AUA on May 16. Source
• R&D rose on trials and CMC: R&D expenses were $43.7 million, up from $27.5 million, driven by clinical trial expenses including CMC costs and higher compensation from increased headcount. Source
• Cash reached $1.1 billion: Cash, cash equivalents and marketable securities were $1.1 billion at March 31, 2026, against $742.2 million at December 31, 2025. Source
• Runway extended through 2029: Management anticipates existing cash will fund operations through 2029, a later end point than the into the first half of 2029 given in the prior release. Source

“We have successfully completed non-clinical and clinical modules for our first BLA submission.”

Arthur Kuan, Chairman & Chief Executive Officer

Guidance

What changed from last quarter

• Guidance raised: Cash runway was extended from into the first half of 2029 to through 2029. Source
• New: Jim DeTore was appointed Chief Financial Officer in April 2026. Source

Results and per-share loss

• Net loss widened to $60.2 million: The net loss was $60.2 million, or $(0.71) per share, against $34.5 million, or $(0.45) per share, in the prior year period. Source
• Interest income declined year on year: Interest income, net was $6.3 million, against $7.7 million a year earlier. Total other income, net was $6.2 million. Source
• Weighted share count rose: Weighted average shares outstanding were 84.5 million, against 76.2 million in the prior year period, which is the base for the per-share loss. Source

Pipeline, clinical data and filings

• BLA completion set for Q4 2026: Management said the remaining CMC module is progressing as planned and the company is on track to finalize the BLA in the fourth quarter of 2026. Source
• PIVOT-006 topline due first half: Phase 3 topline data for PIVOT-006 in intermediate-risk NMIBC are anticipated in the first half of 2026, which the company described as coming in the coming months. Source
• FDA filing discussions shaped timing: The company said the BLA completion guidance followed focused filing discussions with FDA, and it was given as an additional update. Source
• CORE-008 Cohort CX data at AUA: First results from CORE-008 Cohort CX, a Phase 2 study of cretostimogene with gemcitabine in high-risk BCG-exposed or BCG-unresponsive NMIBC, will be presented at AUA on May 16. Source
• Durability data planned for 2026: Durability data are planned in 2026 for BOND-003 Cohort C, BOND-003 Cohort P and CORE-008 Cohort A, as listed in the milestones. Source

“The quality and execution of the rolling BLA has been a top priority for us, and we are confident that we are taking all appropriate measures to ensure a successful package.”

Arthur Kuan, Chairman & Chief Executive Officer

Costs and operating expenses

• R&D rose on trials and CMC: R&D expenses were $43.7 million, up from $27.5 million, driven by clinical trial expenses including CMC costs and higher compensation from increased headcount. Source
• G&A rose on personnel and fees: G&A expenses were $20.8 million, up from $14.8 million, mainly from personnel-related costs tied to headcount and higher professional and consulting fees. Source
• Total operating costs reached $67.5 million: Total operating costs and expenses were $67.5 million, against $42.3 million a year earlier, which produced a loss from operations of $66.4 million. Source

Cash, financing and runway

• Cash reached $1.1 billion: Cash, cash equivalents and marketable securities were $1.1 billion at March 31, 2026, against $742.2 million at December 31, 2025. Source
• At-the-market sales added $391.4 million: The March 31 cash includes net proceeds of about $391.4 million from 6,941,407 shares sold through the at-the-market facility in the first quarter, based on reverse inquiries. Source
• Runway extended through 2029: Management anticipates existing cash will fund operations through 2029, a later end point than the into the first half of 2029 given in the prior release. Source

“This has been a tremendous undertaking, and I am extremely proud of the team for their unwavering commitment,”

Arthur Kuan, Chairman & Chief Executive Officer

Products and commercial activity

• Commercial and development revenue reported: Commercial and development revenue was $1,069 thousand, against nil in the prior year period. License and collaboration revenue was $14 thousand, against $52 thousand. Source
• Cost of sales recorded this quarter: Cost of sales was $2,962 thousand, against no cost of sales in the prior year period. Source
• Cretostimogene remains investigational: Cretostimogene is an investigational candidate, and the release states that its safety and efficacy have not been established by the FDA or any other health authority. Source

Leadership, strategy and programs

• CFO Jim DeTore appointed in April: Jim DeTore was appointed Chief Financial Officer in April 2026. The release says he previously led financing and investor relations strategies at several life-science companies. Source
• Backbone bladder-sparing strategy: The company describes itself as focused on developing and commercializing a potential backbone bladder-sparing therapeutic for bladder cancer patients. Source

Coming up, as management said on 8 May 2026

• CORE-008 Cohort CX presentation at AUA: Podium and poster presentations of the first CORE-008 Cohort CX results are scheduled for May 16 at the AUA 2026 Annual Meeting. Source
• PIVOT-006 topline data in coming months: Management said it anticipates topline data from the Phase 3 PIVOT-006 trial in intermediate-risk NMIBC in the coming months. Source

Figures management reported

Risks management discussed

• Operational: Management named manufacturing inspection readiness and sustainable long-term supply as ongoing activities tied to the BLA. Source

Earlier plans management reported on

• On track: The remaining CMC module is described as progressing as planned, with the company on track to finalize the submission in the fourth quarter of 2026. Source
• Ahead: In January 2026 the company announced an expedited PIVOT-006 timeline, described as nearly a year ahead of schedule.

Other quarters

• Q3 FY2026 earnings call
• Q2 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.