Clene (CLNN) investor relations material

Executive summary

• October NDA submission seeks accelerated approval of CNM-Au8 for ALS, supported by biomarker and clinical data from HEALEY ALS, RESCUE-ALS and the NIH-sponsored Expanded Access Protocol.

• Q3 net income was $3.9M, primarily reflecting warrant and derivative fair-value gains rather than operating profitability.

• Cash was $9.9M at September 30; the September offering is expected to fund operations through mid-Q1 2027, but management says additional financing is needed and substantial doubt about going concern remains.

Financial highlights

• Q3 revenue was $56K vs. $15K YoY; 9M revenue rose 31% to $161K from $123K, all from dietary supplements and royalties.

• Q3 operating loss widened to $6.3M from $5.6M; operating expenses were $6.4M vs. $5.7M.

• Q3 net income was $3.9M, or $0.30 basic and $0.05 diluted EPS, vs. an $8.8M net loss and $0.85 loss per share; 9M net loss was $17.6M vs. $16.9M.

• 9M operating cash use was $11.7M vs. $13.7M; cash, cash equivalents and restricted cash were $9.9M at September 30, up from $5.2M at year-end 2025.

Outlook and guidance

• FDA response on whether it will accept the ALS NDA for review is expected before year-end 2026; first RESTORE-ALS Phase 3 participants are planned for Q2 2027, contingent on funding.

• RESTORE-ALS is planned to assess survival as its primary endpoint and time to ALS clinical worsening events as a secondary efficacy endpoint.

• R&D and regulatory costs could rise with Phase 3 advancement or NDA review; G&A could rise for commercialization preparation if the NDA is accepted, or decline with cost-saving measures if it is not.

• Additional financing is needed to sustain operations; potential sources include equity, debt, licensing or collaboration, ATM sales and warrant or option exercises, with no assurance of sufficient proceeds.

• Next-12-month commitments include $15.4M of debt principal and interest, $1.1M of lease payments and $1.6M of manufacturing-facility capital expenditures.