CG Oncology, Inc.: Q2 FY2026 earnings call

What management said about Q2 FY2026, from the documents filed with the SEC on 6 August 2026: press release. Guidance figures: 3 kept. The quarter’s numbers.

Read the filing

Key takeaways

• Net loss widened to $79.1 million: Net loss was $79.1 million, or $(0.90) per share, for the quarter, against $41.4 million, or $(0.54), a year earlier. Six-month net loss was $139.3 million, or $(1.61) per share. Source
• PIVOT-006 readout expected near-term: Topline data from the Phase 3 PIVOT-006 trial, testing monotherapy as adjuvant therapy in intermediate-risk NMIBC, are expected in the near-term. The prior release gave a first half 2026 window. Source
• BLA completion still set for 4Q’26: Completion of the BLA for HR BCG-unresponsive NMIBC with CIS is expected in 4Q’26. The prior release described the CMC module as progressing as planned.
• Court denied ANI’s post-trial motion: In July the Delaware Superior Court denied ANI’s motion for a new trial and judgment as a matter of law, rejecting ANI’s challenges to the verdict and related claims. Source
• R&D expense rose to $54.7 million: R&D expense was $54.7 million in the quarter, against $31.3 million a year earlier. Six-month R&D expense was $98.4 million, against $58.8 million. Source
• Cash position at $1.0 billion: Cash, cash equivalents and marketable securities were $1.0 billion at June 30, 2026, against $1.1 billion at March 31, 2026 and $742.2 million at December 31, 2025. Source
• Cash runway to 2029 maintained: Management anticipates that existing cash, cash equivalents and marketable securities will be sufficient to fund operations through 2029. Source

“This quarter we have made significant progress across our clinical, regulatory, manufacturing and commercial-readiness initiatives, positioning the Company for long-term success.”

Arthur Kuan, Chairman & Chief Executive Officer

Guidance

What changed from last quarter

• New: In July, the Delaware Superior Court denied ANI’s post-trial motion for a new trial and judgment as a matter of law, upholding the jury verdict for CG Oncology. Source
• New: BOND-003 Cohort C results were published in The Lancet Oncology in July. Source
• New: Jim DeTore was appointed Chief Financial Officer in April 2026, as reported in the prior release.

Results, revenue and operating loss

• Net loss widened to $79.1 million: Net loss was $79.1 million, or $(0.90) per share, for the quarter, against $41.4 million, or $(0.54), a year earlier. Six-month net loss was $139.3 million, or $(1.61) per share. Source
• Revenue of $1.2 million reported: Total revenues were $1.2 million in the quarter, mostly commercial and development revenue of $1.1 million, against nil a year earlier. Q1 2026 total revenues were $1.1 million. Source
• Cost of sales rose to $3.9 million: Cost of sales was $3.9 million in the quarter, against $3.0 million in Q1 2026 and no cost in the prior-year quarter. Six-month cost of sales was $6.9 million. Source
• Operating loss widened to $86.4 million: Loss from operations was $86.4 million, against $48.7 million a year earlier, after total operating costs of $87.6 million. Interest income, net, was $7.3 million. Source

Pipeline milestones

• PIVOT-006 readout expected near-term: Topline data from the Phase 3 PIVOT-006 trial, testing monotherapy as adjuvant therapy in intermediate-risk NMIBC, are expected in the near-term. The prior release gave a first half 2026 window. Source
• BLA completion still set for 4Q’26: Completion of the BLA for HR BCG-unresponsive NMIBC with CIS is expected in 4Q’26. The prior release described the CMC module as progressing as planned.
• Further 2026 data readouts still listed: BOND-003 Cohort C and Cohort P, CORE-008 Cohort CX and Cohort A data, and durability data remain on the anticipated 2026 milestone list. Source

“We are confident in the potential of cretostimogene and are committed to delivering what we believe will be a backbone therapy for patients”

Arthur Kuan, Chairman & Chief Executive Officer

Publications and legal matters

• Lancet Oncology publishes BOND-003 Cohort C: The BOND-003 Cohort C study is titled as a single-arm, phase 3 trial in high-risk, BCG-unresponsive NMIBC with carcinoma in situ. It was published in The Lancet Oncology in July. Source
• Court denied ANI’s post-trial motion: In July the Delaware Superior Court denied ANI’s motion for a new trial and judgment as a matter of law, rejecting ANI’s challenges to the verdict and related claims. Source
• Royalty provision severed, agreement intact: The jury verdict in favor of CG Oncology held that the invalidated royalty provision was properly severed and that the rest of the ANI agreement remains in force. Source

Operating costs

• R&D expense rose to $54.7 million: R&D expense was $54.7 million in the quarter, against $31.3 million a year earlier. Six-month R&D expense was $98.4 million, against $58.8 million. Source
• Clinical and CMC spending drove R&D: Management attributed the R&D increase primarily to clinical trial expenses, including CMC costs, and to compensation costs from increased headcount. Source
• G&A rose on personnel costs: G&A expense was $29.0 million in the quarter, against $17.4 million a year earlier. Management attributed the increase primarily to personnel-related expenses from headcount growth. Source

Cash, capital and share count

• Cash position at $1.0 billion: Cash, cash equivalents and marketable securities were $1.0 billion at June 30, 2026, against $1.1 billion at March 31, 2026 and $742.2 million at December 31, 2025. Source
• Cash runway to 2029 maintained: Management anticipates that existing cash, cash equivalents and marketable securities will be sufficient to fund operations through 2029. Source
• Q1 at-the-market sales added cash: The March 31, 2026 balance included about $391.4 million of net proceeds from 6,941,407 shares sold through the at-the-market facility in Q1. The Q2 release does not mention further sales.
• Weighted share count rose to 88.2 million: Weighted average basic and diluted shares were 88.2 million in the quarter, against 76.2 million a year earlier. Source
• Equity rose to $1.03 billion: At June 30, 2026, total assets were $1,085.7 million, total liabilities $56.5 million and stockholders’ equity $1,029.1 million, against $752.6 million of equity at December 31, 2025. Source

Leadership, supply and access

• Manufacturing readiness work continues: The prior release said manufacturing inspection readiness activities continue to progress, including a commitment to sustainable long-term supply.
• BLA execution called top priority: The prior release said the quality and execution of the rolling BLA had been a top priority for management.
• Expanded access program initiated: The company has initiated an Expanded Access Program in North America for patients who are unresponsive to BCG and meet program eligibility requirements. Source

Coming up, as management said on 6 August 2026

• PIVOT-006 topline data near-term: Management expects PIVOT-006 Phase 3 topline data in intermediate-risk NMIBC in the near-term. No date is given. Source
• BLA submission completion in 4Q’26: Completion of the BLA submission in the initial indication is expected in the fourth quarter of 2026. Source
• Remaining 2026 data and durability readouts: BOND-003 Cohort C and Cohort P, CORE-008 Cohort CX and Cohort A data, and durability data are listed as anticipated 2026 milestones. Source

Figures management reported

Earlier plans management reported on

• On track: The prior release said the CMC module was progressing as planned and that the company was on track to finalize the submission in 4Q 2026. The current release keeps the 4Q’26 target.
• Met: The prior release planned presentation of first CORE-008 Cohort CX results at AUA 2026. The current release says the data were presented at the SUO session in May. Source
• Not stated: The prior release gave a first half 2026 window for PIVOT-006 topline data. The current release says near-term with no date, and management did not state a status against the earlier window.

Other quarters

• Q3 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.