Cg Oncology (CGON) Q2 Loss Widens 93%

Cg Oncology (CGON 2.05%), a clinical-stage biotechnology company focused on developing therapies for bladder cancer, reported its second quarter fiscal 2025 earnings on August 8, 2025. The company disclosed a net loss that was more than double that of the same quarter in 2024. Revenue came in at zero, missing the $0.12 million revenue estimated by analysts and reflecting the absence of product sales ahead of commercialization. Quarterly operating costs rose sharply as the company increased investment in clinical trials and prepared for regulatory filings. Overall, the period was defined by accelerating expenses, no near-term revenue, but positive advances in both clinical and regulatory milestones.

Source: Analyst estimates for the quarter provided by FactSet.

Overview of Cg Oncology’s business and focus areas

Cg Oncology is a biotechnology company developing targeted gene therapies for the treatment of bladder cancer, including high-risk, non-muscle invasive bladder cancer (NMIBC). Its lead experimental product is cretostimogene grenadenorepvec, a gene therapy delivered directly into the bladder to trigger cancer cell death while stimulating anti-tumor immune responses.

The company’s major business focus is advancing cretostimogene through late-stage clinical trials and preparing for its commercial launch. The most important factors to success are clinical trial outcomes, especially in populations unresponsive to the standard BCG (Bacillus Calmette-Guérin) therapy, as well as achieving regulatory approval. The current alternative, radical cystectomy -- complete removal of the bladder -- is a drastic option that few patients select, which makes new therapies a substantial unmet need. Building a scalable commercial infrastructure is also a priority as regulatory milestones approach.

Quarter highlights: Clinical progress, financial developments, and key events

During the quarter, clinical development remained the central activity. The company reported updated results from its pivotal BOND-003 Phase 3 trial of cretostimogene for high-risk NMIBC patients who do not respond to BCG therapy. According to the company, 75.5% of patients achieved a complete response at any time in the Phase 3 BOND-003 trial as of January 20, 2025; at 12- and 24-month marks, the estimated response rates were 50.7% and 42.3%, respectively, by Kaplan-Meier estimation at 12 and 24 months as of March 14, 2025. The median duration of response reached 28 months and was ongoing as of the March 14, 2025, data cutoff in the BOND-003 Cohort C Phase 3 trial. Critically, 97.3% of patients were free from progression to more severe, muscle-invasive disease at 24 months in Cohort C of the Phase 3 BOND-003 clinical trial for cretostimogene -- a key measure of clinical benefit.

Another patient group within the same trial, BOND-003 Cohort P, saw an estimated 90.5% high-grade recurrence-free survival at both three and nine months, albeit in a smaller cohort of 24 treated patients. These product-specific results with cretostimogene support its durability and efficacy in the reported patient cohorts. Regulatory progress followed, as the company confirmed plans to begin its Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) in Q4 2025 for BCG-unresponsive high-risk NMIBC. Several other late-stage studies -- such as the Phase 3 PIVOT-006 trial in intermediate-risk NMIBC and the Phase 2 CORE-008 cohort -- also continue to progress, with additional topline data expected in late 2025 into 2026.

Financially, the absence of new revenues highlighted the company’s pre-commercial stage. Research and development costs surged 69.2% for the three months ended June 30, 2025 compared to the same period in 2024, driven by expanding trial activity and growing headcount. General and administrative spending more than doubled, up 132.0%, primarily due to increased personnel-related expenses, including compensation costs from higher headcount and increased legal expenses. The net loss was $41.4 million, up from $18.9 million in the same quarter last year. Interest income provided some offset but was modest relative to operating expenses.

A notable, one-time legal event occurred: a jury delivered a unanimous verdict that Cg Oncology owes no future royalties to ANI Pharmaceuticals (NASDAQ:ANIP) regarding potential commercial sales of cretostimogene. This ruling eliminated a prospective 5% royalty burden and closed obligations from a decade-old agreement. The company ended the quarter with $661.1 million in cash and investments, which it states should be sufficient to fund operations into the first half of 2028, even as its operating expenses and net loss continued to increase.

Looking ahead: Guidance and key items to watch

As it has yet to launch a commercial product, management did not provide formal financial guidance for revenue or earnings for the coming quarter or fiscal 2025. The company stated its cash position should fund operations into the first half of 2028 based on current operating plans.

In the coming quarters, investors and stakeholders should watch for several key developments: the planned start of the BLA submission for cretostimogene, continued progress and data releases from ongoing late-stage trials, and any updates related to commercialization plans. The pace of research spending and headcount growth, in the context of regulatory timelines and evolving competitive dynamics in bladder cancer therapies, will also be important trends to track.

CGON does not currently pay a dividend.

Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.