Slide 1: Visionary-MS Webinar
Visionary-MS Webinar 15 August 2022 Exhibit 99.4
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, which are intended to be covered by the “safe harbor” provisions created
Slide 3: Phase 2 Results: Treatment of Visual Pathway Deficits in Chronic Optic Neuropathy
Phase 2 Results Treatment of Visual Pathway Deficits In Chronic Optic Neuropathy for Assessment of Remyelination in Non-Active Relapsing MS
Slide 4: Core Design Elements
Core Design Elements Change in Low Contrast Letter Acuity (LCLA) 1 2 https://clinicaltrials.gov/ct2/show/NCT03536559, Data on File, Clene Nanomedicne, Inc. Change in modified MS Functional Composite (mMSFC) Enrolled stable relapsing remitting MS participants with chronic optic neuropathy on backgrou
Slide 5: Baseline Demographics Showed Balanced Randomization and Clinical Profile
Baseline Demographics Showed Balanced Randomization and Clinical Profile Baseline Value mean (sd) Age (yrs) Sex n, (%) Female Race n, (%) White Weight (kg) EDSS Score Years from Dx Months Since Relapse CNM-Au8 15 mg (n=24) 38.4 (10.2) 15 (63%) 23 (96%) 78.0 (17.1) 1.83 (1.3) 6.5 (5.0) 53 (57) CNM-Au
Slide 6: Pandemic Significantly Impacted Study Conduct
Pandemic Significantly Impacted Study Conduct Study was ended prematurely due to COVID enrollment challenges (as announced February 2022) Enrolled 73 of 150 planned Underpowered due to limited enrollment Pre-specified statistical threshold set at p=0.10 COVID restrictions precluded direct Sponsor mo
Slide 7: Modified ITT (mITT) Analysis Population
modified ITT (mITT) Analysis Population Censored observations included Change in mobility assist device (cane to walker) for T25FW (n=1) Invalid data from 1 of 11 sites (n=9) with LCLA testing execution errors Multiple testing locations with different light boxes and varying ambient lighting conditi
Slide 8: Treatment Significantly Improved Vision
CNM-Au8 treatment significantly improved vision Primary outcome - low contrast letter acuity (LCLA) LCLA in the Affected Eye Data on File, Clene Nanomedicine, Inc. mITT excludes one site where data inconsistencies were observed in both active and placebo participants LCLA 2.5% Contrast
Slide 9: CNM-Au8 Demonstrated Global Neurological Improvement by mMSFC
Lead 2nd EP | (m)MFSC Composite Mean Standardized Change (6-domain) CNM-Au8 demonstrated global neurological improvement by the modified MS functional composite LCLA SDMT 9HPT T25FWT Data on File, Clene Nanomedicine, Inc. mITT excludes one site where data inconsistencies were observed in both active
Slide 10: Neurological Improvement Driven by Cognition, Manual Dexterity, and Low Contrast Vision
CNM-Au8 neurological improvement was driven by cognition, manual dexterity, and low contrast vision LCLA SDMT 9HPT T25FWT Data on File, Clene Nanomedicine, Inc. mITT excludes one site where data inconsistencies were observed in both active and placebo participants
Slide 11: mMFSC Averaged Rank Sum Score
2nd EP | mMFSC Averaged Rank Sum Score CNM-Au8 treatment improved functional outcomes Improvement relative to placebo decline Score all subjects versus all other subjects by each mMSFC domain Better function than comparison Same function as comparison Worse function than comparison Data on File, Cle
Slide 12: Time to Repeated Clinical Improvement Was Not Significant
Time to repeated clinical improvement was not significant 2nd EP | Time to Repeated Clinical Improvement (Last 2nd EP) Data on File, Clene Nanomedicine, Inc. mITT excludes one site where data inconsistencies were observed in both active and placebo participants
Slide 13: The Visual System is a Window into the MS Brain
The Visual System is a Window into the MS Brain Quantitative physiological biomarkers of Improved axonal and myelin integrity Balcer et la. Mult Scler. 2017 Apr;23(5):734-747. Visual Evoked Potentials (VEP) Advanced MRI Techniques Optical Coherence Tomography Diffusion Tensor Imaging Magnetization T
Slide 14: Improved Visual Information Processing
CNM-Au8 improved visual information processing Multi-focal VEP amplitude – marker of axonal integrity Increased Amplitude (Signal Strength) Data on File, Clene Nanomedicine, Inc.
Slide 15: Improved Myelin Integrity
CNM-Au8 improved myelin integrity Multi-focal VEP latency – marker of remyelination Increased Conduction Velocity (Signal Speed) Supports Remyelination or Enhanced Functional Myelin Integrity Data on File, Clene Nanomedicine, Inc.
Slide 16: Improved Axonal Integrity
CNM-Au8 improved axonal integrity Structural MRI marker of fractional anisotropy Data on File, Clene Nanomedicine, Inc. DTI Diffusion Patterns
Slide 17: Improved Magnetization Transfer Ratio
CNM-Au8 improved magnetization transfer ratio Increased myelin integrity throughout the brain Data on File, Clene Nanomedicine, Inc.
Slide 18: Preserved Retinal Structure
CNM-Au8 preserved retinal structure Protection of retinal nerve fiber & ganglion cell layers Data on File, Clene Nanomedicine, Inc.
Slide 19: Safety Summary
Safety Summary Treatment Emergent Adverse Events (TEAEs) CNM-Au8 15 mg number (%) CNM-Au8 30 mg number (%) Placebo number (%) Subjects with any TEAE 21 (88%) 25 (100%) 22 (92%) Subjects with SAE 1 (4%) 2 (8%) 2 (8%) Subjects with Related TEAEs 2 (8%) 5 (20%) 2 (8%) Subjects Discontinued due to TEAE
Slide 20: Efficacy Summary
CNM-Au8 Efficacy Summary First therapy to demonstrate global neurological improvement in MS patients on top of background DMT standard of care Independent quantitative biomarkers of myelin and axonal integrity Clinical and functional improvements LCLA vision improvement mMFSC global neurological imp
Slide 21: Conclusions and Next Steps
Conclusions and Next Steps First proof of neuroprotective and remyelinating treatment for MS Multiple signals of clinical and biomarker improvement Clinical neurological function Axonal integrity and neuroprotection Remyelination and myelin integrity Results support advancement into Phase 3 MS clini
Slide 22: Clene Nanomedicine, Inc.
©2022 Clene Nanomedicine, Inc. Clene Nanomedicine, Inc. HQ & Clinical Development 6550 S. Millrock Drive, Suite G50 Salt Lake City, UT 84121 R&D and Manufacturing 500 Principio Parkway, Suite 400 North East, MD 21901