CG Oncology Says PIVOT-006 Topline Data Near-Term

The Tip Desk · August 7, 2026 · 3 min read

The company said the Phase 3 trial had accrued the vast majority of target events, with cash of $1.0 billion still expected to fund operations through 2029.

CG Oncology, Inc. (CGON) said Phase 3 topline data from PIVOT-006, which evaluates cretostimogene monotherapy as an adjuvant therapy in intermediate-risk non-muscle-invasive bladder cancer, are anticipated in the near term after the trial accrued the vast majority of target events.

That language tightened the company’s prior calendar. In the first-quarter update, it had said those data were expected in the first half of 2026. Chairman and Chief Executive Officer Arthur Kuan said the company looks forward to sharing topline results soon and is committed to delivering what it believes will be a backbone therapy for patients.

BLA completion for high-risk BCG-unresponsive NMIBC remained expected in the fourth quarter of 2026, matching the outlook given after FDA alignment discussions in the first-quarter release.

In July, BOND-003 Cohort C Phase 3 results were published in The Lancet Oncology, a disclosure not present in the first-quarter update. The company said the publication further validated the strength of the clinical evidence supporting cretostimogene. In May, CORE-008 Cohort CX data were presented at the Society of Urologic Oncology session at the American Urological Association 2026 Annual Meeting.

The late-stage clinical biopharmaceutical company also said the Superior Court of the State of Delaware in July denied ANI’s post-trial motion for a new trial and judgment as a matter of law, upholding the jury’s verdict that an invalidated royalty provision was properly severed and that the remainder of the agreement with ANI remains in force.

Cash, cash equivalents and marketable securities were $1.0 billion as of June 30, 2026, compared with $1.1 billion as of March 31, 2026. The balance is sufficient to fund operations through 2029.

Research and development expenses were $54.7 million for the second quarter of 2026, compared with $31.3 million for the prior-year period. The increase was primarily due to higher clinical trial expenses, including CMC costs, and higher compensation from increased headcount. General and administrative expenses were $29.0 million, compared with $17.4 million a year earlier, primarily due to higher personnel-related expenses, including compensation from increased headcount.

Net loss was $79.1 million, or $(0.90) a share, for the second quarter of 2026, compared with a net loss of $41.4 million, or $(0.54) a share, for the prior-year period. Weighted average shares outstanding were 88.2 million.

Total revenues were $1.16 million in the second quarter of 2026, including $1.15 million of commercial and development revenue and $10 thousand of license and collaboration revenue, versus zero total revenues in the year-ago quarter. Cost of sales was $3.93 million. Loss from operations was $86.4 million. Interest income, net, was $7.33 million.

Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy studied in a program that includes more than 600 patients with NMIBC. The program includes two Phase 3 trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC. CG Oncology also has a multi-cohort Phase 2 trial, CORE-008, evaluating the candidate in high-risk NMIBC. The company initiated an Expanded Access Program in North America for patients who are unresponsive to BCG and meet certain eligibility requirements. Cretostimogene’s safety and efficacy have not been established by the FDA or any other health authority.

Anticipated 2026 milestones still include PIVOT-006 Phase 3 topline data, completion of the BLA submission in the initial indication of HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease in the fourth quarter, and durability data from BOND-003 Cohort C, BOND-003 Cohort P, CORE-008 Cohort CX and CORE-008 Cohort A.