On November 6, 2026 CG Oncology, Inc. (NASDAQ: CGON) reported financial results for the third quarter ended September 30, 2026, and provided business updates.

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"We are entering an eventful period for CG Oncology as we look forward to sharing PIVOT-006 topline data this month. As a reminder, PIVOT-006 is the first randomized registrational trial in intermediate-risk and high-grade Ta NMIBC. Additionally, we expect to have 12-month data from both CORE-008 Cohort CX and BOND-003 Cohort P in December, which further strengthens the growing body of evidence for cretostimogene across the NMIBC landscape and supports our goal to address the broadest number of patients. We remain confident in cretostimogene’s potential to become a backbone therapy for patients and to create long-term value for shareholders," stated Arthur Kuan, Chairman, President & Chief Executive Officer at CG Oncology.

Corporate Highlights

Strengthened Executive Leadership Team with the addition of life-science executive Isabel Kalofonos as Chief Commercial Officer
In October, the Company appointed Isabel Kalofonos as Chief Commercial Officer. Ms. Kalofonos brings more than 20 years of experience driving successful launches including PALSONIFYTM (paltusotine) and ELAHERE (mirvetuximab soravtansine) through strong commercial execution, helping bring innovative therapies to patients at scale across the biotechnology and pharmaceutical industries.
Anticipated 2026 Milestones

PIVOT-006 (intermediate-risk and high-grade Ta ≤ 3cm NMIBC): Phase 3 topline data November 2026
CORE-008 Cohort CX (BCG-exposed HR and BCG-unresponsive NMIBC) 12-month data December 2026
BOND-003 Cohort P (BCG-unresponsive papillary only NMIBC) 12-month data December 2026
Completion of BLA submission in initial indication of BCG-unresponsive NMIBC with CIS with or without papillary disease Q4 2026

Third Quarter Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2026 were $984.5 million, compared with $1.0 billion as of June 30, 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 $39.2 million for the third quarter of 2026, as compared to $27.9 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 $23.0 million for the third quarter of 2026, as compared to $23.3 million for the prior year period. The decrease was primarily due to a decrease in professional and consultant fees, partially offset by an increase in personnel-related expenses, including compensation costs from increased headcount, and an increase in other general G&A expenses.
Net Loss: Net loss was $56.9 million, or $(0.64) per share, for the third quarter of 2026, as compared to a net loss of $43.8 million, or $(0.57) 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 700 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical trials: BOND-003 for BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk and high-grade Ta ≤ 3cm NMIBC. Cretostimogene has received FDA Fast Track and Breakthrough Therapy designations for BCG-unresponsive NMIBC. CG Oncology also has a multi-cohort trial, CORE-008, evaluating the safety and efficacy of cretostimogene in BCG-exposed HR and BCG-unresponsive 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, NOV 6, 2026, View Source [SID1234674426])