Clene (CLNN) Q4 2025 earnings summary

Executive summary

• Scheduled in-person FDA Type C meeting for CNM-Au8 data by end of Q1 2026, with minutes expected early Q2 2026.

• Plans to file NDA for CNM-Au8 in ALS under accelerated approval by end of June 2026.

• Oversubscribed $28M direct offering, with initial $6M tranche extending cash runway to Q3 2026 and full financing expected to last into 2027.

• Statistically significant biomarker reductions (NfL, GFAP) linked to improved survival in ALS, supporting NDA submission.

• Over 1,100 patient-years of CNM-Au8 exposure show no significant safety concerns or trends.

Financial highlights

• Cash and cash equivalents were $5.2M as of Dec 31, 2025, down from $12.2M at end of 2024.

• Research and development expenses decreased to $14.0M in 2025 from $20.1M in 2024, mainly due to lower trial and regulatory costs.

• General and administrative expenses fell to $9.2M in 2025 from $13.3M in 2024, driven by lower insurance, legal, and personnel costs.

• Net loss for 2025 was $26.2M ($2.65/share), improved from $39.4M ($5.67/share) in 2024.

• Total other expense, net, was $3.1M in 2025, down from $6.3M in 2024, reflecting lower interest and one-time charges.

Outlook and guidance

• Cash runway expected through Q3 2026 with current resources and initial financing; additional tranches could extend runway into 2027.

• NDA submission for CNM-Au8 in ALS targeted for end of Q2 2026, pending positive FDA meeting outcome.

• Plans to initiate confirmatory Phase 3 ALS trial and Phase 3 MS trial using cognition as endpoint.