Clene (CLNN) Registration Filing summary

Company overview and business model

• Clinical-stage pharmaceutical company focused on developing clean-surfaced nanotechnology (CSN®) therapeutics targeting neurodegenerative diseases 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; limited revenue from dietary supplements via subsidiary and licensing.

• Recent clinical progress includes FDA guidance for accelerated approval pathway for lead candidate CNM-Au8 in ALS and ongoing Phase 2/3 trials in ALS and MS.

Financial performance and metrics

• Loss from operations was $33.1 million in 2024 and $40.5 million in 2023; accumulated deficit reached $282.1 million as of December 31, 2024.

• Cash, cash equivalents, and marketable securities totaled $12.2 million at year-end 2024, down from $35.0 million in 2023.

• Net cash used in operating activities was $21.3 million in 2024.

• Substantial doubt exists about ability to continue as a going concern without additional financing within the next twelve months.

Use of proceeds and capital allocation

• Net proceeds will fund clinical development of CNM-Au8, commercialization efforts, regulatory filings, early-stage R&D, business development, working capital, and general corporate purposes.

• Allocation of proceeds will be determined at the time of each offering and described in the related prospectus supplement.

• Proceeds not immediately used will be invested in capital preservation instruments.