CG Oncology, Inc.

CG Oncology, Inc. is a late-stage clinical biopharmaceutical company focused on developing and commercializing cretostimogene grenadenorepvec, an investigational oncolytic immunotherapy for bladder cancer ¹. The company's core business model revolves around the development and potential commercialization of this single product candidate, generating revenue primarily through license and collaboration agreements, and more recently, commercial and development revenue from a contract manufacturing organization. The primary customer segments, if approved, would be patients afflicted with high-risk and intermediate-risk non-muscle invasive bladder cancer (NMIBC), representing up to 150,000 addressable patients ².

The company's sole product candidate, cretostimogene, is an oncolytic immunotherapy designed to selectively replicate in retinoblastoma (Rb)-E2F gene pathway-altered cancer cells, directly eliminating them, and indirectly activating an anti-tumor immune response ³. This dual mechanism of action positions cretostimogene as a potential backbone therapy across a broad range of bladder cancer indications. The administration method is intravesical, similar to standard-of-care BCG therapy, which is expected to facilitate physician adoption due to familiarity with the procedure ⁴.

CG Oncology is evaluating cretostimogene as a monotherapy in BOND-003 Cohort C, a Phase 3 clinical trial for high-risk Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC with carcinoma in situ (CIS), with or without Ta/T1 disease. Enrollment for this cohort is complete, and potentially best-in-disease data was reported in September 2025 ⁵. This trial forms the basis for a Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA), initiated in the fourth quarter of 2025 and expected to be completed in 2026 ⁶. Cretostimogene has received both Fast Track and Breakthrough Therapy designations from the FDA for this indication ⁷. The high-risk BCG-unresponsive NMIBC segment is estimated to represent up to 25,000 addressable patients ⁸.

Another key product development is the Phase 3 PIVOT-006 clinical trial, a randomized registrational trial evaluating adjuvant cretostimogene in intermediate-risk NMIBC following transurethral resection of the bladder tumor (TURBT). Enrollment for this trial was completed in the third quarter of 2025 ⁹. The intermediate-risk NMIBC segment is estimated to represent up to 50,000 addressable patients ¹⁰. Additionally, the company is conducting Phase 2 CORE-008 cohorts in high-risk BCG-exposed and BCG-naïve NMIBC patients, with initial data from Cohort A (BCG-naïve) reported in December 2025 ¹¹. The high-risk BCG-naïve NMIBC segment may represent up to 25,000 addressable patients ¹², and the high-risk BCG-exposed NMIBC segment may represent up to 50,000 addressable patients ¹³.

For the year ended December 31, 2025, total revenues were $4.040 million ¹⁴, an increase from $1.139 million in the prior year ¹⁵. This includes $3.234 million in commercial and development revenue ¹⁶ (zero in 2024 ¹⁷) and $0.806 million in license and collaboration revenue ¹⁸ ($1.139 million in 2024 ¹⁹). Cost of sales was $4.647 million ²⁰ (zero in 2024 ²¹). Research and development expenses increased to $116.641 million ²² from $82.102 million in 2024 ²³. General and administrative expenses rose to $73.526 million ²⁴ from $33.703 million in 2024 ²⁵. The company reported a loss from operations of $190.774 million ²⁶ compared to $114.666 million in 2024 ²⁷. Net loss and comprehensive loss for 2025 was $160.995 million ²⁸, compared to $88.039 million in 2024 ²⁹. As of December 31, 2025, cash, cash equivalents, and marketable securities totaled $742.2 million ³⁰, and the accumulated deficit was $379.0 million ³¹.

Year-over-year, total revenues increased by $2.901 million ³², driven by the new commercial and development revenue stream from Biovire. License and collaboration revenue decreased by $0.333 million ³³. Research and development expenses increased by $34.539 million ³⁴, primarily due to a $17.512 million increase in external clinical trial expenses and a $13.518 million increase in personnel-related expenses ³⁵. General and administrative expenses increased by $39.823 million ³⁶, with personnel-related expenses rising by $17.854 million ³⁷ and professional and consultant fees by $14.344 million ³⁸. The net loss widened by $72.956 million ³⁹.

In July 2025, CG Oncology obtained control of Biovire, a contract manufacturing organization that provides clinical supply of cretostimogene, which was previously a third-party provider ⁴⁰. This acquisition is intended to strengthen manufacturing supply continuity. In January 2024, the company completed its initial public offering, selling 23,000,000 shares of common stock at $19.00 per share, generating net proceeds of approximately $399.6 million ⁴¹. In December 2024, a follow-on offering of 8,500,000 common shares at $28.00 per share generated net proceeds of $223.1 million ⁴². Through December 31, 2025, the company also received net proceeds of $147.1 million from an Open Market Sale Agreement with Jefferies LLC ⁴³.

CG Oncology expects to complete its Biologics License Application (BLA) submission for cretostimogene for high-risk BCG-unresponsive NMIBC with CIS, with or without Ta/T1 disease, in 2026 ⁴⁴. The company anticipates that its existing cash, cash equivalents, and marketable securities of $742.2 million as of December 31, 2025, along with an additional $188.0 million in net cash proceeds received subsequent to December 31, 2025, from the Jefferies Sales Agreement, will be sufficient to fund operations for at least the next twelve months from the date of the Annual Report ⁴⁵. However, this estimate is based on assumptions that may prove incorrect, and capital resources could be utilized sooner than expected ⁴⁶.

A major growth area for the company is the expansion of cretostimogene monotherapy across NMIBC indications. This includes patients diagnosed with intermediate-risk NMIBC, assessed in the Phase 3 PIVOT-006 clinical trial, and patients with high-risk BCG-exposed and BCG-naïve NMIBC in the Phase 2 CORE-008 clinical trial ⁴⁷. The company aims to develop cretostimogene as a bladder-sparing backbone therapeutic, addressing a significant unmet need in bladder cancer, with approximately 85,000 new U.S. diagnoses per year and over 730,000 patients living with the disease ⁴⁸. Topline data for the PIVOT-006 trial is now expected in the first half of 2026, an expedited timeline ⁴⁹.

Another growth vector is the continued evaluation of cretostimogene in combination with other therapies, such as checkpoint inhibitors, to potentially enhance its clinical utility across various stages of bladder cancer ⁵⁰. The Phase 2 CORE-008 multi-cohort trial is assessing cretostimogene in combination with gemcitabine in high-risk BCG-exposed and BCG-unresponsive populations, with first results expected in the first half of 2026 ⁵¹. This approach aims to expand the product candidate's utility beyond monotherapy in intermediate- and high-risk NMIBC ⁵².

Operationally, the company is building a capital-efficient, in-house commercial organization, including field sales, marketing, and market access capabilities, in preparation for potential FDA regulatory approval of cretostimogene in the United States ⁵³. The concentration of bladder cancer patients in a small number of high-value targets and large urology practices is expected to enable efficient market reach with a relatively small commercial footprint ⁵⁴. The intravesical administration of cretostimogene, similar to BCG, is anticipated to drive increased physician adoption and improve patient experience compared to alternative treatments requiring new procedures or transfers to medical oncologists ⁵⁵.

The company is leveraging its chemistry, manufacturing, and controls (CMC) expertise and relationships to scale commercialization efforts, aiming for a high-yield manufacturing process capable of rapidly meeting demand if cretostimogene receives FDA approval ⁵⁶. The acquisition of Biovire in July 2025 is intended to strengthen manufacturing supply continuity ⁵⁷. The company has established an in-house CMC team and an advisory board with deep experience in manufacturing at scale and former FDA leadership, which is expected to enable attractive cost of goods and rapid commercial scalability ⁵⁸.

CG Oncology expects its research and development expenses to increase substantially in the near term and future due to ongoing and planned clinical and preclinical development activities ⁵⁹. General and administrative expenses are also anticipated to increase substantially as operations expand, including increased headcount and costs associated with operating as a public company ⁶⁰. Interest income is expected to increase due to investments of cash proceeds from public offerings ⁶¹.

The company expects to finance its cash needs through public or private equity or debt financings or other capital sources, including potential collaborations, licenses, and other similar arrangements ⁶². The development of biopharmaceutical product candidates is a time-consuming, capital-intensive, and uncertain process, and substantial additional capital will be required to advance cretostimogene and any future product candidates through clinical trials, regulatory approval, and commercialization ⁶³.

CG Oncology faces significant risks, including its sole dependence on cretostimogene, a novel oncolytic immunotherapy, making development timelines and regulatory approval uncertain. Clinical trials are lengthy and expensive, with results from preclinical studies and early trials not always predictive of future outcomes, and adverse side effects could delay or preclude approval. The company relies heavily on third parties for clinical trials and manufacturing, increasing risks of delays, non-compliance, or insufficient supply. Commercialization faces challenges from significant competition, the need to build an internal marketing and sales organization from early stages, and the potential for market aversion to new treatments or inadequate market acceptance by physicians, patients, and payors. Regulatory approval is subject to ongoing obligations and review, with potential for limitations on use or post-approval requirements. The company has a limited operating history, has incurred significant operating losses of $161.0 million for the year ended December 31, 2025 ⁶⁴, and expects to incur substantial losses for the foreseeable future, requiring additional capital that may not be available on acceptable terms. Intellectual property protection is uncertain, with risks of challenges to patents, inability to protect trade secrets, and claims of infringement. The company is also exposed to risks from unstable market and economic conditions, including potential liquidity shortages, and is subject to various U.S. federal, state, and foreign healthcare laws and regulations, including anti-kickback, fraud and abuse, and data privacy laws, with potential for significant penalties for non-compliance. Litigation, such as the ongoing dispute with ANI Pharmaceuticals, Inc., which resulted in a jury verdict in the company's favor on July 29, 2025 ⁶⁵, could incur substantial costs and divert management attention. The acquisition of Biovire introduces risks related to operating a highly regulated contract manufacturing organization without prior experience.

Management's overall tone emphasizes the potential of cretostimogene as a category-defining, bladder-sparing therapeutic for a broad range of bladder cancer indications, highlighting its favorable monotherapy data, strong safety and tolerability profile, simple intravesical administration, and potential for combination therapies. They are focused on pursuing FDA approval for cretostimogene monotherapy in high-risk BCG-unresponsive NMIBC, with a BLA submission initiated in the fourth quarter of 2025 and expected to be completed in 2026 ⁶⁶. Strategic priorities include expanding cretostimogene development across NMIBC indications, continuing to evaluate combination therapies, building operational capabilities for successful commercialization, and leveraging chemistry, manufacturing, and controls expertise to scale production. Management also noted the expedited timeline for topline data readout from the Phase 3 PIVOT-006 trial, now expected in the first half of 2026 ⁶⁷.