August 8, 2025 — CG Oncology, Inc. (NASDAQ: CGON) reported its second quarter financial results for the period ended June 30, 2025, alongside business updates. The company highlighted best-in-disease durability data from the BOND-003 Cohort C and promising early signals from Cohort P for cretostimogene grenadenorepvec, presented at the American Urological Association Annual Meeting. Additionally, CG Oncology initiated the CORE-008 Cohort CX to evaluate the combination of cretostimogene and gemcitabine in patients with high-risk BCG-exposed NMIBC and announced a unanimous verdict in its favor, stating that it owes no future royalties or other payments to ANI Pharmaceuticals.
According to Arthur Kuan, Chairman & Chief Executive Officer at CG Oncology, the company remains focused on advancing cretostimogene, a potential backbone treatment for patients. The positive outcome of the ANI litigation enables CG Oncology to concentrate resources on delivering this innovative therapy, with plans to initiate a BLA submission for cretostimogene in the fourth quarter of the year for treating patients with HR NMIBC unresponsive to BCG.
The company presented data at the AUA Annual Meeting on April 26th, showcasing a 75.5% complete response (CR) rate at any time from Cohort C of the Phase 3 BOND-003 clinical trial. The 12- and 24-month CR rates are 50.7% and 42.3% by K-M estimation, respectively, with a median duration of response of 28 months and ongoing. Furthermore, 97.3% of patients were free from progression to muscle invasive disease at 24 months. Cohort P showed an estimated 90.5% high-grade recurrence-free survival at 3 and 9 months in 24 treated patients.
In April, CG Oncology began the CORE-008 Cohort CX clinical trial to assess the combination of cretostimogene and gemcitabine in patients with HR BCG-exposed NMIBC.
On July 29th, a jury ruled in favor of CG Oncology in a lawsuit brought by ANI Pharmaceuticals, Inc. (ANI), determining that CG Oncology owes no future royalties. The company will continue to defend any post-trial motions and appeals brought by ANI.
Upcoming milestones include Phase 3 enrollment completion for PIVOT-006 in 3Q’25, initiation of a BLA submission in 4Q’25 for cretostimogene monotherapy, and topline data readouts for BOND-003 Cohort P and CORE-008 Cohort A in 4Q’25, and CORE-008 Cohort CX in 1H’26.
CG Oncology reported a cash position of $661.1 million as of June 30, 2025, sufficient to fund operations into the first half of 2028. R&D expenses were $31.3 million for the quarter, and G&A expenses were $17.4 million. The net loss for the quarter was $41.4 million, or ($0.54) per share.
Cretostimogene grenadenorepvec is an investigational oncolytic immunotherapy being studied in NMIBC, with ongoing Phase 3 clinical trials (BOND-003 and PIVOT-006) and a Phase 2 trial (CORE-008).
Contacts:
Media: Sarah Connors, Vice President, Communications and Patient Advocacy, CG Oncology, (508) 654-2277, sarah.connors@cgoncology.com
Investor Relations: Megan Knight, Vice President, Investor Relations, CG Oncology, (619) 990-3447, megan.knight@cgoncology.com
