On August 6, 2026 CG Oncology, Inc. (NASDAQ: CGON) reported financial results for the second quarter ended June 30, 2026, and provided business updates.
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"This quarter we have made significant progress across our clinical, regulatory, manufacturing and commercial-readiness initiatives, positioning the Company for long-term success. PIVOT-006 has accrued the vast majority of the target events, and we look forward to sharing topline results soon. We are confident in the potential of cretostimogene and are committed to delivering what we believe will be a backbone therapy for patients," stated Arthur Kuan, Chairman & Chief Executive Officer at CG Oncology.
Corporate Highlights
In July, BOND-003 Cohort C Study Results were published in The Lancet Oncology validating the strength of the clinical evidence supporting cretostimogene
Title: 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
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 that the invalidated royalty provision was properly severed and that the remainder of the agreement with ANI remains in force, while rejecting ANI’s challenges to the verdict and related claims
In May, CORE-008 Cohort CX data were presented at the Society of Urologic Oncology (SUO) session at the American Urological Association (AUA) 2026 Annual Meeting
Anticipated 2026 Milestones
PIVOT-006 (intermediate-risk NMIBC): Phase 3 topline data
Completion of BLA submission in initial indication of HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease in 4Q’26
BOND-003 Cohort C (HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease), BOND-003 Cohort P (HR BCG-unresponsive NMIBC in Ta/T1 disease without CIS), CORE-008 Cohort CX (HR BCG-exposed and BCG-unresponsive NMIBC) and CORE-008 Cohort A (HR BCG-naïve NMIBC with CIS +/- Ta/T1), durability data
Second Quarter Financial Highlights
Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2026 were $1.0 billion, compared with $1.1 billion as of March 31, 2026. The Company anticipates its existing cash, cash equivalents and marketable securities as of this date will be sufficient to fund operations through 2029.
Research and Development (R&D) Expenses: R&D expenses were $54.7 million for the second quarter of 2026, as compared to $31.3 million for the prior year period. The increase was primarily due to an increase in clinical trial expenses, including CMC costs, and an increase in compensation costs due to increased headcount.
General and Administrative (G&A) Expenses: G&A expenses were $29.0 million for the second quarter of 2026, as compared to $17.4 million for the prior year period. The increase was primarily attributed to an increase in personnel-related expenses, including compensation costs from increased headcount.
Net Loss: Net loss was $79.1 million, or $(0.90) per share, for the second quarter of 2026, as compared to a net loss of $41.4 million, or $(0.54) per share, for the prior year period.
About Cretostimogene Grenadenorepvec
Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 600 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical 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 safety and efficacy of cretostimogene in high-risk NMIBC. Additionally, we have initiated an Expanded Access Program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements. Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority.
(Press release, CG Oncology, AUG 6, 2026, View Source [SID1234669843])