Clene (CLNN) Registration Filing summary

Company overview and business model

• Clinical-stage pharmaceutical company developing clean-surfaced nanotechnology (CSN®) therapeutics targeting central nervous system disorders such as ALS, MS, and Parkinson's disease.

• Proprietary electro-crystal-chemistry platform enables production of highly catalytic, nontoxic nanocrystals for therapeutic use.

• No approved drugs or significant drug sales revenue to date; minor revenue from dietary supplements via subsidiary and licensing.

• Recent clinical focus includes a planned Phase 3 ALS trial and ongoing Phase 2 MS trial, with regulatory engagement in the US and EU.

Financial performance and metrics

• Loss from operations was $7.8M for Q3 2024 and $24.4M for the first nine months of 2024; accumulated deficit reached $268.6M as of September 30, 2024.

• Cash, cash equivalents, and marketable securities totaled $14.6M as of September 30, 2024, down from $35.0M at year-end 2023.

• Net cash used in operating activities was $16.5M for the first nine months of 2024.

• Raised $2.1M from equity distribution in Q3 2024 and $7.3M from equity offerings and private placements after September 30, 2024.

• Substantial doubt exists about ability to continue as a going concern beyond one year without additional funding.

Use of proceeds and capital allocation

• Will not receive proceeds from resale of shares by selling securityholders, except for cash received upon warrant exercises.

• If all warrants are exercised for cash, could receive up to $7.5M, intended for general working capital.

• Ongoing cost-saving initiatives include delaying R&D and commercialization and reducing staff.