CG Oncology Sets PIVOT-006 Data for November

The Tip Desk · November 6, 2026 · 3 min read

Cash, cash equivalents and marketable securities were $984.5 million as of September 30, 2026, as the company said it expects to fund operations through 2029.

CG Oncology, Inc. (CGON) reported a third-quarter net loss of $56.9 million, or $(0.64) a share, as it moved Phase 3 PIVOT-006 topline data into November 2026 and added December 12-month readouts for two other cretostimogene cohorts.

The late-stage clinical biopharmaceutical company said the PIVOT-006 trial is the first randomized registrational study of cretostimogene monotherapy as an adjuvant therapy in intermediate-risk and high-grade Ta non-muscle invasive bladder cancer. In the second-quarter update, the company had described that data as anticipated in the near term.

Chairman, President and Chief Executive Officer Arthur Kuan said the company is entering an eventful period as it looks forward to sharing PIVOT-006 topline data in November. He also said 12-month data from CORE-008 Cohort CX and BOND-003 Cohort P are expected in December, which he said further strengthens the evidence for cretostimogene across the NMIBC landscape. The company said it remains confident in cretostimogene’s potential to become a backbone therapy.

Research and development expenses were $39.2 million in the three months ended September 30, 2026, down from $54.7 million in the second quarter. The company said the year-over-year increase versus $27.9 million was primarily due to higher clinical trial expenses, including CMC costs, and higher compensation from increased headcount. General and administrative expenses were $23.0 million, compared with $23.3 million a year earlier, which the company attributed to lower professional and consultant fees, partly offset by higher personnel-related costs.

Total revenues were $1.604 million, all commercial and development revenue, with no license and collaboration revenue. Cost of sales was $2.669 million. Loss from operations was $63.2 million. Interest income, net, was $6.4 million. Weighted average shares outstanding, basic and diluted, were 88.9 million.

Cash, cash equivalents and marketable securities were $984.5 million as of September 30, 2026, compared with $1.0 billion as of June 30, 2026. The company said those resources are sufficient to fund operations through 2029.

The company also listed completion of a BLA submission in the initial indication of BCG-unresponsive NMIBC with CIS with or without papillary disease as anticipated in the fourth quarter of 2026. Cretostimogene has FDA Fast Track and Breakthrough Therapy designations for BCG-unresponsive NMIBC. The clinical program includes more than 700 patients with NMIBC, including Phase 3 trials BOND-003 and PIVOT-006.

In October, the company appointed Isabel Kalofonos as Chief Commercial Officer. The company said she brings more than 20 years of experience driving launches including PALSONIFY (paltusotine) and ELAHERE (mirvetuximab soravtansine).

Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy. Its safety and efficacy have not been established by the FDA or any other health authority. The company said it has initiated an Expanded Access Program in North America for patients who are unresponsive to BCG and meet certain eligibility requirements.

Forward-looking statements in the release cover anticipated cash runway, trial timing and results, BLA completion, and the potential for cretostimogene to address a broad range of NMIBC patients. The company said actual results may differ due to risks including incomplete or non-predictive trial data, potential delays in trials and the BLA, and the possibility that the FDA may not approve cretostimogene on the anticipated timeline, indication or label, or at all.