CG Oncology Reports $88M Net Loss for 2024, Revenue Increases to $1.1M

CG Oncology, Inc. reported a net loss of $88.0 million for the year ended December 31, 2024, compared to a net loss of $48.6 million in 2023. Revenue for 2024 totaled $1.1 million, primarily from license and collaboration agreements, a significant increase from the $0.2 million recorded in 2023. The increase in net loss is attributable to a rise in research and development expenses from $45.8 million to $82.1 million, and general and administrative expenses from $9.9 million to $33.7 million. The company attributes the increased R&D expenses to higher clinical trial costs and increased headcount, while the rise in general and administrative expenses reflects increased compensation costs, professional fees, and marketing expenses.

Significant developments during the year included the completion of enrollment in BOND-003 Cohort C, a Phase 3 clinical trial for cretostimogene grenadenorepvec (cretostimogene) in high-risk BCG-unresponsive NMIBC. Interim data was reported in May 2024, with topline data updated in December 2024 and March 2025. The company also initiated BOND-003 Cohort P, an exploratory study in high-risk BCG-unresponsive NMIBC with only Ta/T1 disease, and CORE-008 Cohort A, a Phase 2 trial in high-risk BCG-naïve NMIBC. In March 2025, CORE-008 was expanded to include the BCG-exposed population (Cohort B). Final results from the Phase 2 CORE-001 trial, evaluating cretostimogene in combination with pembrolizumab, were published. A second Phase 3 clinical trial, PIVOT-006, evaluating cretostimogene in intermediate-risk NMIBC, was also launched.

As of December 31, 2024, CG Oncology employed 113 full-time employees, 42 of whom were involved in research and development. The company's complete response (CR) rate at any time in BOND-003 Cohort C improved to 75.5% as of January 20, 2025, with a median duration of response exceeding 28 months. No Grade 3 or higher treatment-related adverse events were reported. The company expects to initiate a Biologics License Application (BLA) submission to the FDA in the second half of 2025, based on the BOND-003 data. Topline data from Cohort P and Cohort A of CORE-008 are expected in the second half of 2025 and 2026, respectively.

The company's financial position as of December 31, 2024, showed $742.0 million in cash, cash equivalents, and marketable securities. The company anticipates that its current cash resources will fund operations into the first half of 2028, based on its current operating plan. However, this projection is subject to various uncertainties and may require additional funding through equity offerings, debt financings, or collaborations. The company does not currently have any products approved for sale and has not generated any revenue from product sales. The company's strategy involves leveraging third-party manufacturers for cretostimogene production, both for clinical trials and potential commercialization. The company also highlighted ongoing license and collaboration agreements with Lepu Biotech Co., Ltd. and Kissei Pharmaceutical Co., Ltd.

CG Oncology acknowledges several risk factors, including reliance on cretostimogene's success, dependence on third-party manufacturers and clinical trial partners, competition in the oncology market, and the need for substantial additional capital to fund operations. The company also notes risks associated with regulatory approvals, intellectual property protection, product liability, and healthcare reform legislation. The company's future success hinges on the successful development, regulatory approval, and commercialization of cretostimogene and any future product candidates.