CG Oncology reports Q2 2026 results, flags near-term PIVOT-006 data

CG Oncology, Inc. reported second quarter 2026 financial results on August 6, 2026, along with business updates on its bladder cancer program. The company said PIVOT-006 Phase 3 topline data evaluating cretostimogene monotherapy as an adjuvant therapy in intermediate-risk NMIBC is anticipated in the near term, and BLA completion for HR BCG-unresponsive NMIBC is expected in the fourth quarter of 2026.¹

In July, the Phase 3 BOND-003 Cohort C study results were published in The Lancet Oncology, titled "Intravesical cretostimogene grenadenorepvec oncolytic immunotherapy in high-risk, BCG-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ (BOND-003 Cohort C): a single-arm, phase 3 trial."¹ Also in July, the Superior Court of the State of Delaware denied ANI's post-trial motion for a new trial and judgment as a matter of law, upholding the jury's verdict in favor of CG Oncology regarding the invalidated royalty provision and the remainder of the agreement with ANI.¹

On the financial side, 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, and the company said this is expected to fund operations through 2029.¹ R&D expenses rose to $54.7 million from $31.3 million a year earlier, G&A expenses rose to $29.0 million from $17.4 million, and net loss was $79.1 million, or $(0.90) per share, versus $41.4 million, or $(0.54) per share, in the prior year period.¹

Separately, on August 6, 2026 the company filed Amendment No. 2 to Prospectus with the SEC to increase shares available for sale under its Open Market Sale Agreement with Jefferies LLC by an additional $500.0 million.¹