EX-99.1 2 clnn-ex99_1.htm EX-99.1

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Evidence for A Survival Benefit with CNM-Au8 Treatment: Interim Results from the RESCUE-ALS Trial Long-Term Open Label Extension Long Term Survival All Randomized | Active vs. Placebo Original Treatment vs. No OLE or OLE Delayed Start All OLE Participants | Survival Observed Survival vs. ENCALS Predicted Median Survival 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 CONCLUSION: CNM-Au8 treatment improved long-term survival with decreased mortality risk >70% vs. original placebo randomization, and compared to ENCALS predicted median survival Long-Term OLE Participant Vital Status by Treatment Group Study Design Scheme Early symptomatic ALS (within 2-years onset or 1-year diagnosis) Randomized (1:1, CNM-Au8 30 mg or placebo) Notes: Time to all-cause mortality amongst participants originally randomized to CNM-Au8 compared to participants originally randomized to placebo through 31-Aug-2022. Vital status and date of death (as applicable) were captured for all subjects withdrawn from the study. Lost-to-follow-up (active, n=1; placebo, n=1) censored as of the date of last study contact (Active: Feb-2021; Placebo: Feb-2022). All OLE ex-placebo CNM-Au8 transitioned participants within the placebo group. All alive subjects are right censored as of 31-Aug-2022.  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. Exhibit 99.1