Clene 2025 Q3 Earnings Widened Net Loss of $8.8M Amid Revenue Decline

Clene (CLNN) reported fiscal 2025 Q3 earnings on Nov 13, 2025, marked by a significant revenue drop and a widened net loss. The company’s total revenue fell 82.8% to $15,000, missing market expectations, while its net loss expanded to $8.8M, reflecting ongoing operational challenges. Management highlighted progress in advancing CNM-Au8 for neurodegenerative diseases but emphasized the need for additional funding to sustain operations through Q2 2026.

Revenue

Clene’s total revenue plummeted by 82.8% to $15,000, entirely driven by its royalty revenue stream, which also stood at $15,000. This represents a stark decline from $87,000 in the prior-year quarter, underscoring the company’s limited revenue-generating capabilities.

Earnings/Net Income

The company narrowed its per-share loss to $0.85 from $1.22, a 30.3% improvement, but its net loss widened to $8.8M, a 9.9% increase from $7.99M in 2024 Q3. The earnings showed a 30.3% improvement in per-share losses but a 9.9% wider net loss, reflecting ongoing financial challenges.

Price Action

Clene’s stock price has experienced sharp declines, dropping 18.98% in a single trading day, 21.08% over the past week, and 15.02% month-to-date. These movements align with broader market concerns over the company’s financial health and regulatory uncertainties.

Post-Earnings Price Action Review

The stock’s post-earnings performance has been characterized by sustained volatility, with investors reacting to the company’s narrowed per-share losses but widened net loss. While the management’s focus on regulatory milestones and clinical trials offers some optimism, the lack of revenue growth and cash runway constraints have dampened investor sentiment. The stock’s trajectory will likely depend on the outcomes of upcoming FDA meetings and the company’s ability to secure additional funding.

CEO Commentary

Rob Etherington, President and CEO, emphasized Clene’s progress in advancing CNM-Au8 for ALS, MS, and PD, including three FDA-recommended biomarker paths for ALS data analysis. The company plans to submit an NDA under accelerated approval by Q1 2026 and initiate the RESTORE-ALS Phase 3 trial in H1 2026. Despite cash reserves of $7.9M as of September 30, 2025, Etherington acknowledged regulatory dependencies and the need for robust biomarker validation.

Guidance

Clene expects to complete ALS biomarker analyses shortly, request a Type C meeting with the FDA in Q1 2026, and submit an NDA by Q1 2026. The RESTORE-ALS Phase 3 trial is anticipated to begin in H1 2026. Current cash reserves, combined with $1.2M raised post-Q3, are projected to fund operations through Q2 2026. The company reiterated its focus on FDA-mandated pathways for regulatory milestones.

Additional News

Recent developments include Clene’s Type B meeting with the FDA for MS, confirming cognition as a potential primary endpoint, and preclinical PD data supporting CNM-Au8’s efficacy. The company also announced a $1.2M fundraising effort post-Q3 to extend its cash runway. Additionally, Clene’s Zacks Rank was upgraded to #3 (Hold), reflecting mixed earnings estimate revisions and a neutral outlook.