Clene Inc. · NASDAQ:CLNN
Clene — Investor Presentation (December 2021)
19 slides from Clene's investor presentation, Dec 1, 2021
Slide 1: CLNN (NASDAQ) November 30, 2021
CLNN (NASDAQ) November 30, 2021
Slide 2: Forward Looking Statements
2 Forward Looking Statements This presentation contains "forward - looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 . Clene's actual results may differ from its expectations, estimates, and projections and consequently, yo
Slide 3: Neurons With High Energetic Demand Are At Increased Risk For Neurodegenerative Disease
3 Fu, H., et al; Nature Neuroscience (2018) 21: 1350 - 1358. Zhu et al. Proc Natl Acad Sci USA . 2015 Mar 3;112(9):2876 - 81. Rone et al. J Neurosci. 2016 Apr 27;36(17):4698 - 707. Neurons With High Energetic Demand Are At Increased Risk For Neurodegenerative Disease ~0.5% NAD + /NADH unit decline p
Slide 4: Catalytically-Active Nanocrystals: Intersection of Physics and Biology
Vertices, Edges, & Facets Key to Catalytic Activity 4 CNM - Au8 Catalytically Active Nanocrystal Suspension Clean Surfaced, Highly Faceted Shape Enhances Catalytic Activity CNM - Au8 Nanocrystal CNM - Au8® | Catalytically - Active Nanocrystals Intersection of Physics and Biology Electron Sharing Dri
Slide 5: Nanocrystal Mechanistic Effects: Improved Energy Production and Utilization
CNM - Au8 Nanocrystal Mecha ni s tic Effects Improved Energy Production and Utilization Promotes Neuroprotection and Remyelination CNM - Au8 | Improves Energy Production to Promote Neuroprotection and Remyelination 5
Slide 6: Catalysis of NADH to NAD+
Catalysis of NADH to NAD + UV - VIS Spectroscopy Absorbance (OD) Wa v elen gth NAD + & NADH Concentration vs. Time Time (min) Concentration (mM) 6 Data on File, Clene Nanomedicine, Inc. Robinson et al. Sci Rep. 2020 Feb 11;10(1):1936. NA DH CNM - Au8 | Catalysis of NADH to NAD +
Slide 7: Neuroprotection from Excitotoxic Glutamate
7 CNM - Au8 | Neuroprotection from Excitotoxic Glutamate Rat Primary Motor Neurons In Vitro Results
Slide 8: ALS Neuroprotection in Human iPSCs
CNM - Au8 | ALS Neuroprotection in Human iPSCs Concentration (ng/mL) iPSC In Vitro Survival Results – SOD1 A4V Astrocytes with Human Motor Neuron 8 Ho et al.
Slide 9: Survival in Human C9ORF72 iPSC Neurons
CNM - Au8 | Survival in Human C9ORF72 iPSC Neurons iPSC Derived Neurons In Vitro Results – Cortical Neurons (Forebrain) Significant Survival Benefit 9 Data on File, Clene Nanomedicine, Inc. C9ORF72 mutant neurons Vehicle 30 ng/ml CNM - Au8 100 ng/ml CNM - Au8 300 ng/ml CNM - Au8 1000 ng/ml CNM - Au8
Slide 10: Phase 2 Study Design Overview
First Patient First Visit 16 - Jan - 2020; 45 enrolled of 42 planned Phase 2 1 Study was powered for MUNIX primary endpoint based on 50% relative decrease in rate of MUNIX decline Neurophysiology MUNIX 1 10 Pulmonary Function Forced Vital Capacity Function & QoL ALSFRS - R, ALSSQOL - SF Disease Prog
Slide 11: Pioneered Use of MUNIX Biomarker
| Pioneered Use of MUNIX Biomarker Primary Endpoint: Spinal Cord Lower Motor Neuron Protection Muscle Fibers Spinal Cord Motor Neuro n Bulbar Onset ALS (Brainstem) Limb Onset ALS (Spinal Cord) Primary Endpoint: Spinal Cord Lower Motor Neuron Motor Unit Index (MUNIX) Sum Biceps b r a chii + Abduc t o
Slide 12: Evidence for Motor Neuron Protection
| Evidence for Motor Neuron Protection Primary Endpoint (MUNIX %, LS Mean Change) All Randomized All Placebo Limited Rate of MUNIX Decline in Bulbar Onset 12 Data on File, Clene Nanomedicine, Inc. Limb Bulb ar Insufficient Spinal Cord Lower Motor Neuron Progression in Early Bulbar Trial Participants
Slide 13: MUNIX Biomarker Efficacy in Limb Onset
| MUNIX Biomarker Efficacy in Limb Onset 45% 46% Primary Endpoint (MUNIX %, LS Mean Change, Limb Onset Subset) Pre - specified: Limb Onset Spinal Cord Lower Motor Neuron Motor Unit Index (MUNIX) Sum Biceps b r a chii + Abduc t or Pollicis Brevis + Abduc t or Digiti Minimi + Tibialis A nt er ior 13 D
Slide 14: Significant Impact on ALSFRS-R Decline
| Significant Impact on ALSFRS - R Decline Exploratory (ALSFRS - R Responder Analysis, < 6 - point decline) All Randomized All Bu l b a r All Limb Sensitivity 14 Data on File, Clene Nanomedicine, Inc.
Slide 15: Significantly Reduced Disease Progression Risk
| Significantly Reduced Disease Progression Risk Exploratory Endpoint (Disease Progression) ALS Disease Progression defined as: • Death, or • Tracheostomy, or • Non - invasive ventilation, or • Gastrostomy tube All Bu l b a r All Limb Sensitivity 15 Data on File, Clene Nanomedicine, Inc.
Slide 16: Impact on CAFS Progression to Wk36
16 | Impact on CAFS Progression to Wk36 Exploratory (Combined Assessment of Function & Survival) By Average of Summated Scores By Average of Ranks
Slide 17: Potential Survival Signal
| Potential Survival Signal Exploratory Endpoint (Observed Survival vs. Predicted) ENCALS Predicted 17 Data on File, Clene Nanomedicine, Inc. Observed Survival
Slide 18: Well Tolerated & No Safety Signals
| Well Tolerated & No Safety Signals (aspiration 18 Data on File, Clene Nanomedicine, Inc. • Most common TEAEs associated with CNM - Au8 pneumonia, n=3; nausea, n=2; abdominal discomfort, n=2) Safety Summary • No CNM - Au8 related serious adverse events (SAEs) • No CNM - Au8 related drug discontinua
Slide 19: Clene Inc. HQ & Clinical Development
Clene Inc. HQ & Clinical Development 6550 South Millrock Drive, Suite G50 Salt Lake City, UT 84121 R&D and Manufacturing 500 Principio Parkway, Suite 400 North East, MD 21901 © 2021 Clene Inc. Version: 30 - November - 2021