On May 8, 2026 CG Oncology, Inc. (NASDAQ: CGON) reported financial results for the first quarter ended March 31, 2026, and provided business updates.

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"We have successfully completed non-clinical and clinical modules for our first BLA submission. The remaining CMC module is progressing as planned, and we are on track to finalize our submission in the fourth quarter 2026. We are pleased to provide this additional guidance on expected BLA completion following focused filing discussions with FDA. Manufacturing inspection readiness activities continue to progress, including our commitment to sustainable long-term supply. The quality and execution of the rolling BLA has been a top priority for us, and we are confident that we are taking all appropriate measures to ensure a successful package. This has been a tremendous undertaking, and I am extremely proud of the team for their unwavering commitment," stated Arthur Kuan, Chairman & Chief Executive Officer at CG Oncology.

"We look forward to a number of meaningful near-term milestones for CG, including anticipated topline data from the Phase 3 PIVOT-006 trial in intermediate-risk NMIBC in the coming months, as well as the first results from the Phase 2 CORE-008 Cohort CX in high-risk BCG-exposed and BCG-unresponsive patients, to be presented at AUA."

Corporate Highlights

CORE-008 Cohort CX data podium and poster presentation at the Society of Urologic Oncology (SUO) session at the American Urological Association (AUA) 2026 Annual Meeting on May 16.
Title: First Results from CORE-008 Cohort CX- Phase 2 Study of Intravesical Cretostimogene Grenadenorepvec with Gemcitabine in Patients with High-Risk BCG-Exposed or BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Strengthened Executive Leadership Team with the addition of life-science executive Jim DeTore.
In April 2026, the Company appointed Jim DeTore to Chief Financial Officer. Jim brings over 30 years of life sciences expertise including executive leadership roles at Neurogastrx, Inc., Bluebird Bio, and Proteostasis Therapeutics, in each case leading the company’s financing and investor relations strategies, helping to raise over a billion dollars in equity capital. He also served as vice president of corporate finance at Ironwood Pharmaceuticals where he worked directly on several debt and equity transactions, including the company’s initial public offering. Jim received his M.B.A. and bachelor’s degree in finance from Northeastern University in Boston.

Anticipated 2026 Milestones

CORE-008 Cohort CX (HR BCG-exposed and BCG-unresponsive NMIBC): First results from the Phase 2 clinical trial of the combination of cretostimogene with gemcitabine in 1H’26
PIVOT-006 (intermediate-risk NMIBC): Phase 3 topline data in 1H’26
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 in Ta/T1 disease without CIS), BOND-003 Cohort P (HR BCG-unresponsive NMIBC in Ta/T1 disease without CIS), and CORE-008 Cohort A (HR BCG-naïve NMIBC with CIS +/- Ta/T1), durability data in 2026
First Quarter Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2026 were $1.1 billion, compared with $742.2 million as of December 31, 2025. The March 31, 2026, cash includes net proceeds of approximately $391.4 million from a total of 6,941,407 shares sold through the Company’s at-the-market (ATM) facility in Q1 based on reverse inquiries from existing and new, high-quality funds. 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 $43.7 million for the first quarter of 2026, as compared to $27.5 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 $20.8 million for the first quarter of 2026, as compared to $14.8 million for the prior year period. The increase was primarily attributed to an increase in personnel-related expenses, including compensation costs from increased headcount, and an increase in professional and consulting fees.
Net Loss: Net loss was $60.2 million, or $(0.71) per share, for the first quarter of 2026, as compared to a net loss of $34.5 million, or $(0.45) 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, MAY 8, 2026, View Source [SID1234665401])