CG Oncology 2025 Q1 Earnings Misses Targets as Net Loss Widens 103%

CG Oncology (CGON) reported its fiscal 2025 Q1 earnings on May 13th, 2025. Despite promising clinical developments, CG Oncology’s financial performance fell short of expectations, with net losses significantly larger than anticipated. The company did not adjust its guidance, maintaining plans for a Biologics License Application (BLA) submission for cretostimogene monotherapy in the second half of 2025. The expected continuation of clinical progress aims to address unmet needs in the bladder cancer market, despite current financial headwinds.

Revenue
CG Oncology reported a dramatic decline in total revenue, falling by 90.2% to $52,000 in Q1 2025 compared to $529,000 in Q1 2024. License and collaboration revenue entirely accounted for this total, reflecting the complete shift in the company's revenue generation focus for the quarter.

Earnings/Net Income
CG Oncology's earnings report for Q1 2025 revealed a deepening loss, with net income per share dropping from $0.36 to $0.45, marking a 25% wider loss. The net loss surged to $34.45 million from $16.93 million in Q1 2024, a 103.4% increase. The earnings per share data indicates an unfavorable trend for the company's financial health.

Price Action
The stock price of CG Oncology edged down by 0.12% during the latest trading day, jumped 11.43% over the most recent full trading week, and surged 37.15% month-to-date.

Post-Earnings Price Action Review
The strategy of buying CG Oncology stock when revenue exceeds expectations and holding for 30 days has consistently delivered favorable outcomes, yielding a robust 25.8% return. This approach significantly outperforms the broader market, demonstrating its effectiveness in harnessing positive momentum following earnings beats. Investors employing this strategy have seen substantial gains, indicating strong market confidence during periods of revenue outperformance. This approach highlights the potential for tactical investment strategies tailored to post-earnings scenarios, allowing investors to capitalize on favorable market conditions and company performance metrics.

CEO Commentary
"In 2025, we made further progress advancing cretostimogene monotherapy as a bladder-sparing backbone therapy for patients with NMIBC," said Arthur Kuan, Chairman & Chief Executive Officer at CG Oncology. Kuan highlighted the best-in-disease durability and tolerability data from the BOND-003 Cohort C registrational trial, positioning the company to initiate a Biologics License Application (BLA) submission in the second half of the year. He expressed confidence that, upon approval, cretostimogene could become the backbone therapy in NMIBC, potentially addressing over 70% of the market in need of innovative treatment options.

Guidance
CG Oncology anticipates initiating the BLA submission for cretostimogene monotherapy in HR BCG-unresponsive NMIBC with CIS in the second half of 2025. The company expects the completion of enrollment for the PIVOT-006 Phase 3 trial and the release of topline data from both the BOND-003 Cohort P and CORE-008 Cohort A trials in the same timeframe. Based on current operating plans, CG Oncology expects its existing cash reserves will fund operations into the first half of 2028.

Additional News
CG Oncology recently showcased promising results for cretostimogene grenadenorepvec at the American Urological Association Annual Meeting, revealing a 42.3% complete response rate at 24 months for Cohort C. The company also initiated the CORE-008 Cohort CX trial, combining cretostimogene with gemcitabine for high-risk NMIBC patients. In addition, CG Oncology announced the recipients of the 2025 Non-Muscle Invasive Bladder Cancer Research Fellowship Award, emphasizing its commitment to advancing bladder cancer research and fostering innovation in therapeutic development.