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

RESCUE-ALS Trial Results: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of CNM-Au8 to Slow Disease Progression in ALS 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 Baseline Value mean (sd) Age (yrs) Sex n, (%) Male | Female Onset Site n, (%) Limb | Bulbar Months from Onset FVC (% pred.) ALSFRS-R Score ENCALS Risk Profile1 MUNIX Sum All (n=45) 59.1 (12.3) M: 26 (58%) F: 19 (42%) L: 33 (73%) B: 12 (27%) 15.8 (9.3) 81.5 (16.7) 38.7 (6.0) -4.4 (1.8) 378.2 (175.3) CNM-Au8 30mg (n=23) 57.0 (13.3) M: 13 (57%) F: 10 (43%) L: 16 (70%) B: 7 (30%) 15.5 (7.6) 84.5 (18.3) 38.6 (6.6) -4.6 (1.7) 380.2 (198.0) Placebo (n=22) 61.3 (10.9) M: 13 (59%) F: 9 (41%) L: 17 (77%) B: 5 (23%) 16.1 (10.9) 78.2 (14.5) 38.8 (5.4) -4.2 (1.8) 376.2 (152.7) 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 Design Scheme Baseline Demographics 1° Endpoint | Summated MUNIX Change at Week 36 No CNM-Au8 related SAEs, drug discontinuations, or adverse event (AE) imbalance by system organ class. AEs predominantly mild-to-moderate & transient. The AEs most commonly associated with CNM-Au8 included aspiration pneumonia, n=3; nausea, n=2; abdominal discomfort, n=2. Early symptomatic ALS Randomized (1:1, CNM-Au8 30 mg or placebo) 36-week treatment period with open label extension 1st EP: MUNIX(4) summed %change of ADM, APB, BB, & TA 2nd EPs: absolute MUNIX change, % FVC Exploratory EPs: disease progression, 6-pt decline in ALSFRS-R, ALSSQOL-SF, & other neurophysiology endpoints Safety Summary Design Summary Clinical Endpoints | Exploratory CONCLUSION: RESCUE-ALS has established safety and suggested efficacy of CNM-Au8, a cellular energetic catalyst, for the treatment of ALS 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. 2° EP | FVC Change at Week 36 +45% Primary endpoint p-value is based on mixed model repeat measures with treatment, visit, treatment by visit interaction as fixed effects, and baseline value and ENCALS score as covariates. An unstructured covariance model was used. Exhibit 99.2