EX-99.2 3 clnn-ex99_2.htm EX-99.2

Steve Vucic PhD, DSc, FRACP, FAHMS1, Parvathi Menon PhD, FRACP1, William Huynh PhD, FRACP2, Colin Mahoney, PhD, MB, MRCPI2, Karen S. Ho, PhD MSc3, Austin Rynders, RN3, Jacob Evan3, Jeremy Evan, PA-C3, Robert Glanzman, MD FAAN3, Michael T. Hotchkin3, Matthew C. Kiernan PhD, DSc, MBBS, FRACP, FAHMS 1Concord Repatriation General Hospital, University of Sydney, Australia; 2Brain and Mind Centre, University of Sydney, Australia; 3Clene Nanomedicine, Salt Lake City, UT, USA Evidence for Continuing Quality of Life Benefit Following CNM-Au8 ALS Treatment Preliminary Analyses of the RESCUE-ALS Long Term OLE Design Scheme Early symptomatic ALS (within 2-years onset or 1-year diagnosis) Randomized (1:1, CNM-Au8 30 mg or placebo) 36-week treatment period with long-term open label extension 1st EP: MUNIX(4) summed %change of 4-spinal cord innervated muscles 2nd EPs: absolute MUNIX change, % FVC Exploratory EPs: disease progression, 6-pt decline in ALSFRS-R, ALSSQOL-SF, & other neurophysiology endpoints CONCLUSION: In RESCUE-ALS, CNM-Au8 treatment stabilised ALS-Specific QoL decline during the double-blind period, which was maintained for up to 84 weeks post-randomisation 36-Week Blinded Treatment Period with Long-Term Open-Label Extension Screening (4-weeks) Baseline Wk12 Wk36 Wk24 Wk48 Wk60 Wk72 Wk84 Wk96 Wk108+ Double-Blind Period Long-Term Open Label Extension Long-Term OLE Notes: Interim data cut as of 15-March-2022. Data include all reported values without imputation for missing data. Acknowledgements: We thank the ALS study patients and their families for their support and willingness to engage in clinical research. We thank the site investigators for their research excellence and dedication to patients. We thank FightMND of Australia for substantially funding the RESCUE-ALS trial. Original Placebo to OLE CNM-Au8 Treatment Original Placebo | 36-Week Randomized Period Original Active to OLE CNM-Au8 Treatment Original Active | 36-Week Randomized Period Week 36 Unblinded ALSSQOL Results Ex-Placebo OLE CNM-Au8 treated participants stabilized ALS Specific QOL decline during OLE Original CNM-Au8 treated participants maintained ALS Specific QOL values during OLE treatment Average slope decline/week, mean (sd) = -0.008 (0.03) Average slope decline/week, mean (sd) = -0.004 (0.02) n=22 n=16 n=23 n=20 Average slope decline/week, mean (sd) = -0.05 (0.07) Average slope decline/week, mean (sd) = -0.005 (0.03) Exhibit 99.2