Clene 2025 Q3 Earnings Net Loss Widens 9.9% Despite Improved EPS

Clene (CLNN) reported fiscal 2025 Q3 earnings on Nov 13, 2025, with results undershooting revenue expectations and highlighting prolonged financial challenges. The company narrowed its per-share loss but saw a wider net loss, while cash reserves now fund operations until mid-2026.

Revenue

Clene's total revenue for Q3 2025 fell to $15,000, driven entirely by royalty revenue, reflecting an 82.8% decline from $87,000 in the prior-year period. The absence of other revenue streams underscores the company’s reliance on licensing income amid ongoing development of its nanotechnology-based therapeutics.

Earnings/Net Income

The company reduced its per-share loss to $0.85 in Q3 2025 from $1.22 in Q3 2024, marking a 30.3% improvement. However, the net loss expanded to $8.78 million compared to $7.99 million, reflecting persistent operational inefficiencies. The EPS improvement contrasts with a deteriorating net loss, signaling mixed performance.

Post-Earnings Price Action Review

Clene’s stock experienced sharp declines post-earnings, with an 18.98% drop in a single trading day, 21.08% over the week, and 15.02% month-to-date. The sell-off aligns with the company’s continued losses and lack of revenue growth, despite regulatory progress in ALS and MS programs. While the narrower EPS loss may offer short-term relief, investors remain skeptical about the sustainability of cash reserves and the feasibility of accelerated NDA submissions without additional funding.

CEO Commentary

Rob Etherington emphasized regulatory milestones, including FDA-endorsed biomarker pathways and a Q1 2026 Type C meeting, aiming to accelerate CNM-Au8’s NDA filing. The CEO also highlighted preclinical advancements in Parkinson’s disease and optimism around cognition-focused endpoints for MS, though financial constraints remain a critical risk.

Guidance

Clene reported $7.9 million in cash as of Sept 30, 2025, with an additional $1.2 million raised post-Q3 extending liquidity into Q2 2026. The company plans to file an NDA for CNM-Au8 in Q1 2026 and initiate the Phase 3 RESTORE-ALS trial in H1 2026, contingent on biomarker analysis outcomes and regulatory alignment.

Additional News

Recent updates include a Zacks Rank #3 (Hold) rating due to mixed earnings estimate revisions, a $7.9 million cash position as of September 2025, and a $1.2 million post-Q3 fundraising round. Clene also announced new preclinical data for CNM-Au8 in Parkinson’s disease, showing mitochondrial and metabolic improvements. Regulatory discussions with the FDA on cognition-based endpoints for MS trials and ongoing NIH-sponsored Expanded Access Programs further shape its pipeline.

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