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

Clene (CLNN) reported its fiscal 2025 Q3 earnings on November 13, 2025, with results undershooting expectations. The company posted a net loss of $8.8 million (-9.9% YoY) and revenue of $15,000 (-82.8% YoY), while cash reserves stood at $7.9 million. Guidance highlighted an NDA filing for CNM-Au8 in Q1 2026 and Phase 3 trial initiation in H1 2026, contingent on biomarker analyses and funding.

Revenue

Clene’s total revenue for Q3 2025 plummeted by 82.8% year-over-year to $15,000, driven by a sharp decline in royalty revenue, which accounted for the entire $15,000 in revenue. The absence of other revenue streams underscored the company’s reliance on limited monetization channels, compounding its financial challenges.

Earnings/Net Income

The company narrowed its per-share loss to $0.85 from $1.22 in Q3 2024, reflecting a 30.3% improvement. However, the net loss expanded to $8.8 million, a 9.9% increase from $7.99 million in the prior year. This discrepancy highlights the risks of relying on per-share metrics while ignoring absolute losses. The EPS improvement, though positive, failed to offset the broader financial deterioration.

Price Action

Clene’s stock price experienced steep declines in the latest trading day (-18.98%), week (-21.08%), and month (-15.02%), reflecting investor pessimism. The stock’s beta of 1.16 indicated heightened volatility compared to the broader market, amplifying exposure to market swings.

Post-Earnings Price Action Review

The strategy of purchasing Clene shares immediately after its earnings announcement and holding for 30 days yielded a 3-year average return of -40.7%, with a maximum drawdown of -82.78%. This underperformance was driven by the company’s declining revenue, widened net losses, and urgent need for additional funding. The stock’s volatility and poor returns underscored the risks of short-term trading strategies in the biotech sector.

CEO Commentary

Rob Etherington, President and CEO, emphasized progress in ALS biomarker analyses, including NfL data from NIH and HEALEY trials, as part of the FDA’s accelerated approval pathway. The company aims to submit an NDA for CNM-Au8 by Q1 2026 and initiate the Phase 3 RESTORE-ALS trial by H1 2026. Despite a cash runway extending to Q2 2026, financial constraints remain a critical concern.

Guidance

Clene plans to submit an NDA for CNM-Au8 in Q1 2026, contingent on positive biomarker data, and expects to begin the Phase 3 RESTORE-ALS trial in H1 2026. A Type C meeting with the FDA is scheduled for Q1 2026 to review further data. The company’s cash runway is projected to last until Q2 2026, including $1.2 million raised post-Q3.

Additional News

Clene’s SEC 10-Q filing on November 13, 2025, detailed a net loss of $8.8 million and $15,000 in revenue, with cash reserves at $7.9 million. The company emphasized the need for additional funding to sustain operations. In a Type C meeting, the FDA outlined three biomarker analysis paths to strengthen ALS data, including NfL analysis from NIH and HEALEY trials. Clene also announced new preclinical data showing CNM-Au8’s efficacy in Parkinson’s disease models, supporting its pipeline expansion.

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