CG Oncology, Inc.

CG Oncology announced the publication of positive results from its pivotal Phase 3 BOND-003 Cohort C trial in The Lancet Oncology. The trial evaluated cretostimogene grenadenorepvec monotherapy for high-risk, BCG-unresponsive non-muscle invasive bladder cancer, demonstrating a 75.5% complete response rate and a median duration of response of at least 27.9 months. The therapy also showed favorable safety, high rates of bladder preservation, and meaningful progression-free survival, positioning it as a potential bladder-sparing treatment.

CG Oncology, Inc. announced that its Chairman, President, and CEO, Arthur Kuan, will participate in fireside chat presentations at two upcoming healthcare conferences. He is scheduled to speak at the Jefferies Global Healthcare Conference on June 3, 2026, and the Goldman Sachs 47th Annual Global Healthcare Conference on June 9, 2026. Live audio webcasts and replays will be accessible via the company's investor relations website.

CG Oncology announced the separation of Ambaw Bellete, its President & Chief Operating Officer, effective June 30, 2026. Concurrently, the Board of Directors appointed Arthur Kuan as President, in addition to his other positions, effective May 20, 2026. The company expects to enter into a separation agreement with Mr. Bellete, providing severance benefits as per his employment agreement, and has initiated a search for a Chief Commercial Officer.

CG Oncology announced positive first results from CORE‑008 Cohort CX, a Phase 2 study evaluating cretostimogene grenadenorepvec in combination with gemcitabine for high‑risk non‑muscle invasive bladder cancer. The study showed encouraging high-grade event-free survival (HG-EFS) of 96.0% at 3 months and 89.5% at 6 months. High complete response rates of 85.7% (ITT) and 92.3% (Efficacy Evaluable) were observed, along with a favorable safety profile with no Grade 3 or greater treatment-related adverse events.

CG Oncology, Inc. announced its participation in the American Urological Association (AUA) 2026 Annual Meeting, where it will present the first results from its CORE-008 Cohort CX Phase 2 Trial. This trial evaluates an intravesical combination therapy for High-Risk BCG-Exposed and BCG-Unresponsive non-muscle invasive bladder cancer (NMIBC) patients. The company will have both poster and podium presentations on May 15 and 16, respectively. Additionally, grant recipients of the CG-SUO-CTC NMIBC Research Fellowship will present their research at the SUO 2026 Annual Meeting at the AUA.

CG Oncology reported a net loss of $60.2 million for Q1 2026, widening from $34.5 million in Q1 2025, as total revenues increased significantly to $1.08 million from $52 thousand. The company substantially strengthened its liquidity, raising $391.4 million in net proceeds from a public offering, bringing its cash, cash equivalents, and marketable securities to $1.08 billion. Additionally, the company successfully defended against a lawsuit from ANI Pharmaceuticals, Inc. regarding royalty payments for its product candidate, cretostimogene.

CG Oncology reported a net loss of $60.2 million, or $(0.71) per share, for the first quarter of 2026, compared to a net loss of $34.5 million, or $(0.45) per share, in the prior year. The company announced that BLA completion for HR BCG-unresponsive NMIBC is now expected in the fourth quarter of 2026, following discussions with the FDA. CG Oncology also strengthened its executive team with the appointment of Jim DeTore as Chief Financial Officer in April 2026 and holds approximately $1.1 billion in cash, sufficient to fund operations through 2029.

CG Oncology reported Q1 2026 financial results and provided key business updates. The company expects to complete its Biologics License Application (BLA) submission for high-risk BCG-unresponsive NMIBC in the fourth quarter of 2026, following alignment with the FDA. Additionally, topline data from the Phase 3 PIVOT-006 trial and first results from the Phase 2 CORE-008 Cohort CX are anticipated in the first half of 2026. The company maintains a strong financial position with approximately $1.1 billion in cash, cash equivalents, and marketable securities, projected to fund operations through 2029, and appointed Jim DeTore as its new CFO.

CG Oncology, Inc. will hold its 2026 Annual Meeting of Stockholders virtually on Thursday, June 4, 2026, at 10:00 a.m. Pacific Time. Stockholders of record as of April 7, 2026, will vote on the election of two Class II directors, the ratification of Ernst & Young LLP as the independent registered public accounting firm for 2026, and advisory votes on executive compensation and its preferred frequency.

CG Oncology, Inc. announced its 2026 Annual Meeting of Stockholders will be held virtually on June 4, 2026. Stockholders will vote on the election of two Class II directors, the ratification of Ernst & Young LLP as the independent registered public accounting firm, and advisory votes on executive compensation and the frequency of such votes. The record date for voting is April 7, 2026.