Clene (CLNN) investor relations material

Executive summary

• Focused on developing clean-surfaced nanotechnology therapeutics for neurodegenerative diseases, with lead candidate CNM-Au8 targeting ALS, MS, and PD.

• Plans to submit a New Drug Application (NDA) for CNM-Au8 in ALS under the FDA's accelerated approval pathway in early Q4 2026, supported by new biomarker and clinical data showing improved survival and function.

• No drugs approved for commercial sale; revenue is primarily from dietary supplements and expected to remain minimal until drug approval.

• Engaged with FDA for MS program; planning Phase 3 study focused on cognition improvement.

• Closed a $7.0 million direct stock offering and amended debt facilities to extend maturities and defer payments until August 2027.

Financial highlights

• Revenue for Q2 2026 was $90,000, up from $27,000 in Q2 2025, driven by dietary supplement sales and royalties.

• Net loss for Q2 2026 was $13.4 million ($1.08 per share), compared to $7.4 million ($0.78 per share) in Q2 2025.

• Cash and cash equivalents were $9.7 million as of June 30, 2026, up from $5.2 million at year-end 2025.

• Net cash used in operating activities was $7.1 million for the first half of 2026, down from $9.8 million in the prior year period.

• General and administrative expenses decreased to $1.9 million from $2.4 million year-over-year.

Outlook and guidance

• Plans to submit NDA for CNM-Au8 in ALS in early Q4 2026; Phase 3 confirmatory trial to begin in Q2 2027.

• Current resources expected to provide operating runway through late Q4 2026.

• Expects continued operating losses and negative cash flows as clinical programs advance.

• Additional funding required within 12 months to sustain operations; substantial doubt exists about ability to continue as a going concern.