Clene (CLNN) Q1 2026 earnings summary

Executive summary

• Focused on developing clean-surfaced nanotechnology therapeutics for neurodegenerative diseases, with lead programs in ALS and MS.

• Completed a successful FDA Type C meeting, planning NDA submission for CNM-Au8 in ALS under accelerated approval in Q3 2026.

• No drugs approved or significant revenue from drug sales; revenue is mainly from dietary supplements.

• Cost-saving initiatives implemented, including reduced R&D and staff reductions.

• Raised over $35 million through direct offerings and amended a $10 million convertible debt facility, extending maturity and eliminating payments until August 2027.

Financial highlights

• Net loss was $8.1 million ($0.69 per share) for Q1 2026, compared to $0.8 million ($0.09 per share) in Q1 2025.

• Revenue was $15,000 in Q1 2026, down from $81,000 in Q1 2025, primarily from dietary supplements and royalties.

• Operating expenses decreased 41% year-over-year to $2.1 million, driven by lower R&D and G&A costs.

• Cash and cash equivalents were $5.9 million as of March 31, 2026, up from $5.2 million at year-end 2025.

• Total other expense, net, was $6.0 million in Q1 2026, due to warrant liability costs, a one-time loss on equity issuance, and higher interest expense.

Outlook and guidance

• NDA submission for CNM-Au8 in ALS planned for Q3 2026, with a confirmatory Phase 3 trial to begin in Q1 2027.

• Cash resources, including recent financings and potential warrant exercises, expected to fund operations into 2027.

• Expects continued losses and negative cash flows; additional financing required within 12 months to sustain operations.

• Cost-saving measures in place, but substantial doubt remains about ability to continue as a going concern beyond one year.