EX-99.4 5 clnn-ex99_4.htm EX-99.4

Evidence for Brain Energy Metabolic Support with CNM-Au8 Treatment: Results from the REPAIR Phase 2 Clinical Trials Robert Glanzman1, MD FAAN, Chief Medical Officer, Jimin Ren2, PhD, Richard B. Dewey, III MD2, Austin Rynders1, RN, Senior Director, Clinical Operations, Karen S. Ho1 PhD MSc, Head, Translational Medicine Michael T. Hotchkin1, Chief Development Officer, Richard B. Dewey, Jr.2 MD, Benjamin Greenberg2 MD 1Clene Nanomedicine, Inc., 2University of Texas, Southwestern Design Scheme CONCLUSION: The REPAIR clinical trials demonstrate brain target engagement with CNM-Au8 treatment impacting brain energy metabolic support Clinic Visit Safety Clinic Visit Safety Clinic Visit Primary Endpoint 31P-MRS Scan Clinic Visit Follow-up 31P-MRS Scan Baseline Visit 31P-MRS Scan 4-6 weeks 1° Endpoint | NAD+/NADH Change at Week 121 2° Endpoint | NAD+ & NADH Fraction Objective Demonstration of CNS target engagement with 31P-magnetic resonance spectroscopy (31P-MRS) Design Open-label, dose blinded 12-week treatment (Enrolled: REPAIR-PD n=13, REPAIR-MS, n=13) Endpoints Primary: change of NAD+/NADH ratio based on pre-specified integrated analyses of PD & MS cohorts Secondary: change of NAD+ and NADH fractions of NAD pool Safety Well tolerated; 97% treatment compliance TEAEs were all mild-to-moderate severity and transient No SAEs Exploratory | Equilibration of Energetic Metabolites Acknowledgements: We are honored by the PD and MS 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 Jimin Ren, PhD and colleagues at the UTSW Advanced Imaging Research Center for development of the 31P-MRS imaging methodology. 1 NAD+/NADH ratio declines approximately 0.5% per decade in cross-sectional observational studies Exhibit 99.4