Clene 2025 Q3 Earnings Net Loss Widens to $8.8M Amid Revenue Decline

Clene (CLNN) reported fiscal 2025 Q3 earnings on Nov 14, 2025, with results falling short of expectations. The company’s revenue plummeted 82.8% to $15,000, while its net loss expanded to $8.8 million, or $0.85 per share, reflecting ongoing financial strain. Despite a 30.3% improvement in per-share losses compared to 2024 Q3, the widening net loss and declining revenue underscore persistent operational challenges.

Revenue

Royalty revenue accounted for the entirety of the $15,000 total revenue, with no other segments contributing to the figure. This represents an 82.8% year-over-year decline from $87,000 in 2024 Q3, driven by a lack of diversified revenue streams and reduced product sales.

Earnings/Net Income

Clene’s net loss widened to $8.8 million in Q3 2025, a 9.9% increase from $7.99 million in the prior-year period. While per-share losses improved slightly to $0.85 from $1.22, the overall net loss reflects ongoing operational inefficiencies. Despite a 30.3% reduction in per-share losses, the company’s financial performance remains under pressure.

Post-Earnings Price Action Review

The strategy of buying Clene shares immediately after quarterly reports and holding for 30 days has historically underperformed. In 75% of quarters, the 30-day holding period returned shares to pre-release levels, but the average return across all quarters was -14.6%. This approach failed to capture positive momentum in any reporting period, highlighting investor skepticism about the stock’s post-earnings trajectory.

CEO Commentary

Rob Etherington, CEO of Clene, emphasized the company’s focus on advancing its ALS, MS, and PD programs despite financial constraints. He highlighted plans to complete FDA-recommended biomarker analyses to support an NDA filing in Q1 2026 and initiate the confirmatory RESTORE-ALS trial by H1 2026. The CEO acknowledged the need for additional funding to sustain operations beyond Q2 2026 but expressed confidence in the therapeutic potential of CNM-Au8.

Guidance

Clene expects to fund operations into Q2 2026 with current cash reserves and recent $1.2 million in financing. Forward-looking statements include plans to request a Type C FDA meeting in Q1 2026 to review biomarker data, anticipate first patient dosing in the RESTORE-ALS trial by H1 2026, and submit an NDA under an accelerated approval pathway. The company also aims to reduce operating expenses through cost-saving initiatives while advancing clinical programs.

Additional News

Clene announced key regulatory milestones, including a planned Type C FDA meeting in Q1 2026 to review ALS biomarker analyses and a target NDA submission for Q1 2026. The company expects to initiate the confirmatory RESTORE-ALS trial in H1 2026, pending biomarker analysis results. Additionally, Clene raised $1.2 million post-Q3 to extend its cash runway into Q2 2026, though further fundraising remains critical. Leadership reiterated confidence in CNM-Au8’s therapeutic potential for neurodegenerative diseases despite ongoing financial challenges.