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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 OR 15(d)

of The Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): December 15, 2021

 

Clene Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-39834   85-2828339
(State or other jurisdiction   (Commission File Number)   (IRS Employer
of incorporation)       Identification No.)

 

6550 South Millrock Drive, Suite G50

Salt Lake City, Utah
  84121
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (801) 676-9695

 

N/A

(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on
which registered
Common Stock, par value US$0.0001 per share   CLNN   The Nasdaq Capital Market
Warrants, to acquire one-half of one share of Common Stock for $11.50 per share   CLNNW   The Nasdaq Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 

 

 

 

Item 7.01 Regulation FD Disclosure.

 

On December 15, 2021, Clene Inc. (the “Company”) released an updated corporate presentation (the “Corporate Presentation”) on its website, www.clene.com. A copy of the Corporate Presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The Company plans to use its website to disseminate future updates to the Corporate Presentation and may not file or furnish a Current Report on Form 8-K alerting investors if the Corporate Presentation is updated.

 

The information furnished in this Item 7.01, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act of 1934 (the “Exchange Act”), as amended, or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing made by the Company under the Exchange Act or the Securities Act of 1933, regardless of any general incorporation language in any such filings, except as shall be expressly set forth by specific reference in such a filing.

 

Forward-Looking Statements

 

This Current Report on Form 8-K and the Corporate Presentation may contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. The forward-looking statements include, but are not limited to, our expectations, hopes, beliefs, intentions, strategies, estimates and assumptions concerning events and financial trends that may affect our future results of operations or financial condition. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. The forward-looking statements are based on information available as of the date of this report and our management’s current expectations, forecasts and assumptions, and involve a number of judgments, risks and uncertainties. As a result of a number of known and unknown risks and uncertainties, our actual results and the timing of events may differ materially from those expressed or implied by these forward-looking statements due to a number of factors. Applicable risks and uncertainties include those related to the possibility that any results of operations and financial condition of the Company are preliminary and subject to final audit, and the risks listed under the heading “Risk Factors” and elsewhere in our Quarterly Report on Form 10-Q filed on November 8, 2021 and our Annual Report on Form 10-K filed on March 29, 2021, and our subsequent filings with the U.S. Securities and Exchange Commission. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. We disclaim any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as specifically required under applicable securities laws.

 

Item 9.01 Financial Statements and Exhibits.

 

(d)Exhibits

 

Exhibit
Number
  Exhibit Description
99.1   Corporate Presentation
104   Cover Page Interactive Data File (formatted as Inline XBRL).

 

1

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  Clene Inc.
   
Date: December 16, 2021 By: /s/ Robert Etherington
    Robert Etherington
    President and Chief Executive Officer

 

 

2

 

Exhibit 99.1

 

CLNN (NASDAQ) December 14, 2021

 

 

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, you should not rely on these forward - looking statements as predictions of future events . Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "might" and "continues," and similar expressions are intended to identify such forward - looking statements . These forward - looking statements involve significant known and unknown risks and uncertainties, many of which are beyond Clene’s control and could cause actual results to differ materially and adversely from expected results . Factors that may cause such differences include Clene’s ability to demonstrate the efficacy and safety of its drug candidates ; the clinical results for its drug candidates, which may not support further development or marketing approval ; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval ; Clene’s ability to achieve commercial success for its marketed products and drug candidates, if approved ; Clene’s ability to obtain and maintain protection of intellectual property for its technology and drugs ; Clene’s reliance on third parties to conduct drug development, manufacturing and other services ; Clene’s limited operating history and its ability to obtain additional funding for operations and to complete the licensing or development and commercialization of its drug candidates ; the impact of the COVID - 19 pandemic on Clene’s clinical development, commercial and other operations, as well as those risks more fully discussed in the section the section entitled “Risk Factors” in Clene’s recently filed Quarterly Report on Form 10 - Q (filed November 8 , 2021 ), as well as discussions of potential risks, uncertainties, and other important factors in Clene’s subsequent filings with the U . S . Securities and Exchange Commission . Clene undertakes no obligation to release publicly any updates or revisions to any forward - looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based, subject to applicable law . All information in this presentation is as of the date of presented or the date made publicly available . The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this presentation .

 

 

3 CLENE | Management Team

 

 

4 CLENE | Overview September 30, 2021 Cash and restricted cash on hand (unaudited): $60.6M ALS Registration Trial Topline data in 2H 2022 2 >270 patient years of CNM - Au8 clinical exposure CNM - Au8® a gold nanocrystal suspension, in development as the first cellular energetic catalyst to remyelinate 1 & neuroprotect DƵĨĐƚƵƌŝŐ džƉƐŝŝƉƌŐƌƐƐ͕ ƉƌƉƌŝŐĨƌƉƐƐŝď ĐŵŵƌĐŝŝnjƚŝ ŝ Ϭϯ Strong IP: 150+ patents on Clean - Surface - Nanocrystal technology (CSN®) platform Data on File, Clene Nanomedicine, Inc. 1 Robinson et al. Sci Rep. 2020 Feb 11;10(1):1936. 2 https:// clinicaltrials.gov /ct2/show/NCT04414345.

 

 

5 CLENE | Pipeline

 

 

6 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 per decade (~0.13 mV units per year by 31 P - MRS Imaging) WƚƚŝĐŝƐtŝƚŚ EƌŵŐŝŐ Closed squares = averaged data by age group: 21 – 26 yrs , 33 – 36 yrs , and 59 – 68 yrs old; Open squares= individual subject values PARKINSON’S DISEASE Dopaminergic Neurons AMYOTROPHIC LATERAL SCLEROSIS Motor Neurons HUNTINGTON’S DISEASE Medium Spiny Neurons FRONTOTEMPORAL DEMENTIA Spindle Neurons Specific Neuronal Populations Are Vulnerable to Energetic Failure MULTIPLE SCLEROSIS Axonal Degeneration

 

 

ϳ Vertices, Edges, & Facets Key to Catalytic Activity 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 Drives Catalytic Activity 60 mL per bottle (once daily)

 

 

ϴ CNM - Au8 Nanocrystal Mechanistic Effects Improved Energy Production and Utilization Promotes Neuroprotection and Remyelination CNM - Au8 | Improves Energy Production to Promote Neuroprotection and Remyelination

 

 

9 CNM - Au8 | Significant Global Opportunity 707,158 Ϭϯ͕ϵϬϯ 828,703 596,407 256,455 1,407,701 0 400,000 800,000 1,200,000 1,600,000 U.S. Canada W. Europe Central/E. Europe Japan China Est. Diagnosed PD Patients by Region Source: Lancet Neurol. 2018 Nov;17(11):939 - 953 ; ~6.1M patients globally, data as of 2016. . PARKINSON’S DISEASE ~6.1M pts globally; $6B projected by 2026 3 E ŵƐƚĐŵŵƵƌĚŐƌƚŝǀ ĚŝƐƌĚƌ͖LJƐLJŵƉƚŵƚŝĐƚƌƚŵƚƐ 62,531 10,013 71,288 10,946 13,893 54,405 0 20,000 40,000 60,000 80,000 U.S. Canada W. Europe Central/E. Europe Japan China Est. Diagnosed MND Patients by Region ^ƵƌĐ͗>ĐƚEƵƌ͘ Ϭϴ Đ͖ ϳ ; Ϳ͗ Ϭϴϯ Ͳ Ϭϵϳ ͘ DEŝĐƵĚƐŵLJƚƌƉŚŝĐƚƌƐĐƌƐŝƐ͕ƐƉŝŵƵƐĐƵƌƚƌƉŚLJ͕ŚƌĚŝƚƌLJƐƉƐƚŝĐƉƌƉŐŝ͕ƉƌŝŵƌLJ ƚƌƐĐƌƐŝƐ͕ƉƌŐƌƐƐŝǀŵƵƐĐƵƌƚƌƉŚLJ͕ĚƉƐƵĚďƵďƌƉƐLJ MOTOR NEURON DISEASE (ALS, Other Orphan Disorders) ALS sales >$1B globally by 2029 1 . Current drugs are largely ineffective, mostly generic Source: Lancet Neurol. 2019 Mar;18(3):269 - 285 ; ~2.2.M patients globally, data as of 2016 511,855 79,419 543,862 204,591 ϰϲ͕ϰϵ 103,194 0 150,000 300,000 450,000 600,000 U.S. Canada W. Europe Central/E. Europe Japan China Est. Diagnosed MS Patients by Region MULTIPLE SCLEROSIS ~2.2M pts globally; $23B market 2 Only approved treatments are immunomodulators 1 Clarivate, DRG, ALS 2020 . 2 Westad et al. 2017, doi:10.1038/nrd.2017.107;. 3 Parkinson’s Market Data Forecast, April 2021.

 

 

10 CNM - Au8 | Preclinical Evidence for Energetic Improvement Therapeutic Activity Across Remyelination + Neuroprotection Models ƚ&ŝ͕ EŵĚŝĐŝ͕/Đ͘ZďŝƐƚ͘^ĐŝZƉ͘ ϬϬ &ď ͖ Ϭ ; Ϳ͗ ϵϯϲ ͘ MN Neuroprotection ALS SOD1, In Vitro Forebrain Neuroprotection C9ORF72 In Vitro Alzheimer’s Disease Induced Neurons In Vitro

 

 

11 CNM - Au8 | Neuroprotection & Remyelination Data on File, Clene Nanomedicine, Inc. Phase 2 and Phase 3 Clinical Trials ǀŝĚĐĨED Ͳ Ƶ ϴ ƚƌƚŵƚĨĨĐƚ>^ ĚŝƐƐƉƌŐƌƐƐŝ Ongoing Established brain target engagement & safety Planned : Demonstrate Disease Modification Ongoing Established brain target engagement & safety Key Findings Disease ŝŝĐdƌŝƐ Q4 2021 Q3 2021 Q1 2022 Q2 2022 Q3 2022+

 

 

12 CNM - Au8 | Safety Summary Kǀƌ ϳϬ zƌƐĨ^ƵďũĐƚ džƉƐƵƌtŝƚŚƵƚLJ ^ĨƚLJ^ŝŐƐ Patient Exposure Across PD, MS, & ALS • Long - term dosing experience up to 115 weeks All Animal Toxicology Studies Resulted in No - Adverse Effect Level (NOAEL) Findings Clean Toxicology Findings • Multiple species up to 9 - months treatment • Up to maximum feasible dosing without any toxicology findings related to CNM - Au8 Assessed as Predominantly Mild - to - Moderate Severity and Transient Well Tolerated Adverse Event (AE) Profile ‡ EƌƚĚED Ͳ Ƶ ϴ ƐĚŝŐƚ ĚŝƐĐƚŝƵƚŝĨƚƌƚŵƚ ‡ E^ƐƌƚĚƚED Ͳ Ƶ ϴ ĐƐŝĚƌĚ Ɛǀƌ͕ŝĨ Ͳ ƚŚƌƚŝŐ͕ƌƌƐƵƚŝŐŝ ĚƚŚ Data on File, Clene Nanomedicine, Inc.

 

 

13 • D ifference in brain NAD + and NADH fraction at Week 12 (End of Treatment) • Difference in bioenergetic metabolites (e.g., ATP, NAD ) concentration at Week 12 – 16 • D ifference in brain membrane markers ( PE , PC , etc.) at Week 12 – 16 Change in Brain Bioenergetic Potential (NAD + /NADH) vs. Baseline 1 ι 2 ι CNM - Au8 Effects on Br ain Energetic Metabolites WŚƐ ͕KƉ>ď͕^ƋƵƚŝ'ƌƵƉ͕/ǀƐƚŝŐƚƌŝĚĚ^ƚƵĚLJĨDŐƚŝĐ Z ƐĐ ^ƉĐƚƌƐĐƉLJ; ϯ W Ͳ DZ^Ϳƚ ƐƐƐƐƚŚĨĨĐƚƐĨED Ͳ Ƶ ϴ ĨƌƚŚŝƌŐƚŝĐ / ŵƉƌǀŵƚ Ĩ/ŵƉŝƌĚEƵƌ Z Ědž^ƚƚ ;ZW/ZͿ N = Up to 15 per dosing cohort (7.5, 15, 30, or 60 mg) Phase 2 Exploratory Stable Relapsing MS Early Parkinson’s Disease Visit Safety Assessment Dispense Drug Visit Safety Assessment Dispense Drug sŝƐŝƚ ĚĨdƌƚŵƚ ϯ W Ͳ DZ^^Đ Visit Follow - up 31 P - MRS Scan (REPAIR - MS) Baseline Visit Assessments 31 P - MRS Scan Dispense Drug + 4 - 6 weeks Data on File, Clene Nanomedicine, Inc.

 

 

14 CNM - Au8 Improves Brain Energy Metabolism Increases NAD+/NADH Ratio in MS & PD WŚƐ ZƐƵƚƐ 1 ° Endpoint 2 ° Endpoint NAD is an essential molecule responsible for cellular energy production Exploratory (ATP Normalization) Glanzman et al. 2021. International Parkinson and Movement Disorder Society (MDS) Virtual Congress 2021. September 17 – 22, 2021 . Data on File, Clene Nanomedicine, Inc.

 

 

15 (January 2020); FPFV 16 - Jan - 2020; 45 of 42 enrolled (Nov - 2020) WŚƐ 1 Study was powered for MUNIX primary endpoint Neurophysiology MUNIX 1 Pulmonary Function Forced Vital Capacity Function & QoL ALSFRS - R, ALSSQOL - SF Disease Progression & Survival Vucic et al. BMJ Open. 2021 Jan 11;11(1):e041479. Data on File, Clene Nanomedicine, Inc.

 

 

16 ͮ WŝƌĚhƐĨDhE/yŝŵƌŬƌ Primary Endpoint: Spinal Cord Lower Motor Neuron Protection Muscle Fibers Spinal Cord Motor Neuron Bulbar Onset ALS (Brainstem) Limb Onset ALS (Spinal Cord) Primary Endpoint: Spinal Cord Lower Motor Neuron Motor Unit Index (MUNIX) Sum ŝĐƉƐ ďƌĐŚŝŝ Tibialis Anterior Abductor Pollicis Brevis Abductor Digiti Minimi + + + Motor Units DhE/yďŝŵƌŬƌƐƚŝŵƚƐƚŚƵŵďƌ ĨĨƵĐƚŝŝŐǁƌŵƚƌƵƌƐ ƐƌǀŝŐƐƉĐŝĨŝĐŵƵƐĐƐ Vucic et al. BMJ Open. 2021 Jan 11;11(1):e041479.

 

 

17 | Evidence for Motor Neuron Protection Primary Endpoint (MUNIX %, LS Mean Change) All Randomized All Placebo Limited Rate of MUNIX Decline in Bulbar Onset Limb Ƶďƌ Insufficient Spinal Cord Lower Motor Neuron Progression in Early Bulbar Trial Participants RESCUE - ALS: A Phase 2, randomized, double - blind, placebo - controlled study of CNM - Au8 to slow disease progression in ALS. MNDA Vi rtual Symposium, 2021 Data on File, Clene Nanomedicine, Inc.

 

 

18 | MUNIX Biomarker Efficacy in Limb Onset Primary Endpoint (MUNIX %, LS Mean Change, Limb Onset Subset) Pre - specified: Limb Onset 45% Biceps brachii Tibialis Anterior Abductor Pollicis Brevis Abductor Digiti Minimi Spinal Cord Lower Motor Neuron Motor Unit Index (MUNIX) Sum + + н RESCUE - ALS: A Phase 2, randomized, double - blind, placebo - controlled study of CNM - Au8 to slow disease progression in ALS. MNDA Vi rtual Symposium, 2021 Data on File, Clene Nanomedicine, Inc.

 

 

19 | Significant Impact on ALSFRS - R Decline Exploratory (ALSFRS - R Responder Analysis, < 6 - point decline) All Randomized All Bulbar All Limb ^ƐŝƚŝǀŝƚLJ RESCUE - ALS: A Phase 2, randomized, double - blind, placebo - controlled study of CNM - Au8 to slow disease progression in ALS. MNDA Vi rtual Symposium, 2021 Data on File, Clene Nanomedicine, Inc.

 

 

20 | Significant Quality of Life Improvement Exploratory (ALS Specific QOL - SF) All Randomized RESCUE - ALS: A Phase 2, randomized, double - blind, placebo - controlled study of CNM - Au8 to slow disease progression in ALS. MNDA Vi rtual Symposium, 2021 Data on File, Clene Nanomedicine, Inc.

 

 

21 | Significant Impact on ALS Disease Progression džƉƌƚƌLJĚƉŝƚ;ŝƐƐWƌŐƌƐƐŝͿ 1 ALS Disease Progression defined as : • Death, or • Tracheostomy, or • Non - invasive ventilation, or • Gastrostomy tube All Bulbar All Limb Sensitivity RESCUE - ALS: A Phase 2, randomized, double - blind, placebo - controlled study of CNM - Au8 to slow disease progression in ALS. MNDA Vi rtual Symposium, 2021 Data on File, Clene Nanomedicine, Inc.

 

 

22 Joint Rank | Survival & Disease Progression ^ƵŵŵƚĚ^ĐƌŝŐdžŵƉ Berry et al. Amyotroph Lateral Scler Frontotemporal Degener . 2013 Apr;14(3):162 - 8.

 

 

23 | Impact on Joint Rank Score to Wk36 Post Hoc (Combined Assessment of ( i ) Survival, (ii) King’s Clinical Stage 4, (iii) ALSFRS - R) Data on File, Clene Nanomedicine, Inc. ALSFRS - R Decline Survival E Ͳ /ǀƐŝǀ sƚŝƚŝ Gastrostomy Tube King’s Clinical Stage 4 By Average of Summated Scores

 

 

24 | Potential Impact on Survival Exploratory Endpoint (Observed Survival vs. Median Predicted) ENCALS Predicted Median Survival KďƐƌǀĚ^Ƶƌǀŝǀ Data on File, Clene Nanomedicine, Inc.

 

 

25 | Well Tolerated & No Safety Signals Data on File, Clene Nanomedicine, Inc. • No CNM - Au8 related serious adverse events (SAEs) • No CNM - Au8 related drug discontinuations • No imbalances in treatment emergent adverse event (TEAEs) by system organ class • TEAEs were predominantly mild - to - moderate and transient • Most common TEAEs associated with CNM - Au8 (aspiration pneumonia, n=3; nausea, n=2; abdominal discomfort, n=2) Safety Summary

 

 

26 Exploratory Endpoints ‡ ŵďŝĚ:ŝƚZŬ ;^Ƶƌǀŝǀн>^&Z^ Ͳ ZͿ ‡ sŝĐƉƚŚŐLJ ‡ WZK ;>^YͿ ‡ WŚƌŵĐĚLJŵŝĐŵƌŬƌƐ Slow Vital Capacity Hand - Held Dynamometry Survival Change in ALSFRS - R Registration Study: 24 - Week Treatment Period (3:1 randomization, 120 active [30mg, 60mg]: 40 placebo) 1 ι 2 ι Phase 3 Anticipated full unblinded data readout: 2H 2022

 

 

ϳ Exploratory Endpoints Treatment of Vis ual Pathway Deficits I n Chronic O ptic N europathy for A ssessment of R em y elination in Non - Active R elapsing MS Change in Low Contrast Letter Acuity (LCLA) At Week 24 Up to 48 - Week Placebo - Control 2:1 Randomization (Active: Placebo ) 15mg, 30mg , Placebo (n=150) • Optical Coherence Tomography (OCT) • Multi - focal VEP Amplitude & Latency • Full field - VEP Amplitude & Latency • MRI Endpoints • Visual Function (High Contrast) • QOL / EDSS 1 ι 2 ι ŚŐ ŵƉƐŝƚŝŝĐ ZƐƉƐ ϵ ,Wdͬ^Ddͬd ϱ &tͬ>>ͬ^^ Phase 2 - 42 to - 1 24 - Week Blinded Fixed Treatment Period Up to 24 - Week Blinded Extension Period (Until LPLV 24Wk Visit) LPLV Anticipated top - line unblinded data: 1H 2023* *Subject to ongoing COVID - 19 related site research restrictions generally implemented to protect MS patients taking standard - of - care immunosuppressive therapies

 

 

ϴ LC L A Phase 2 Primary: Functional Visual Improvement LC LA Correlates with clinically meaningful deficits in QOL, EDSS and MSFC, MRI, and OCT 1 MS Functional Endpoints Phase 2 Exploratory: Neuroprotection/Remyelination Endpoints The Visual System is a Window into the Brain 9 - Hole Peg Test Symbol Digit Modalities Timed 25 - Ft Walk DƐƵƌŝŐD^ &ƵĐƚŝ/ŵƉƌǀŵƚ 1 Balcer et la. Mult Scler . 2017 Apr;23(5):734 - 747. doi : 10.1177/1352458517690822.

 

 

29 Significant Clinical Improvement Across Study Population Over 48 - Weeks Primary Endpoint: LCLA (Best - Corrected) & Secondary Endpoint: (m)MSFC Phase 2 2 ° - (m)MSFC 1 ° - LCLA Glanzman et al. VISIONARY - MS: Update to a Phase 2 clinical trial of catalytic gold nanocrystals, CNM - Au8; ECTRIMS 2021 – Late Breaking N ews ePoster , October 12, 2021

 

 

30 dƌĚ^ĐƌƚƐ Patent Status b Patent Description Issued & Allowed Patents 150+ Pending Applicat ions ~20 Total Patents / Applications > 170 Process And Method/Device (Clean Surface; Gold CSN) State of Matter (CNM - Au8) DƚŚĚĨhƐ ;WƌǀƚŵLJŝƚŝΘ D Ϳ Method of Use (Bi - Metallic Au/Pt; Antimicrobial) Plasma Conditioning Electrode Design & Cycling Trough Flow, Temp, Pressure Concentration & Filtration Strong Intellectual Property Extensive Patent Portfolio With Protection Through 2035 a & Proprietary Trade Secrets; Plus 7 - year Orphan Drug Designation a With Patent Restoration Term (assuming 5 - year extension). b As of 30 - Sepbember - 2021. ^E Π ƐƵƌĨĐ ĐƌLJƐƚ;^EͿ ƚŚƌƉƵƚŝĐƐ

 

 

31 Clene | Proprietary Nanocrystal Manufacturing In - House ISO8 Clean Room Clinical Production in Maryland Designed to be Scalable to Commercialization Validated CMC Processes Patented Hydro - electro - Crystallization Proprietary Trade Secrets

 

 

32 Anticipated Timeline & Upcoming Milestones 2020 - 2023

 

 

33 EƚŚƌƉƵƚŝĐƐWƚĨƌŵ • Potential first - in - class nanotherapeutic with high catalytic activity to drive energy production and utilization in stressed CNS cells • Applications across neurology, infectious disease, and oncology Lead Asset: CNM - Au8 for Neurorepair • CNM - Au8 improves cellular energy production and utilization to promote neuroprotection and remyelination • Phase 2 ALS proof - of - concept evidence of efficacy across clinical endpoints • Phase 3 Healey ALS platform trial results expected in 2H 2022 • Phase 2 VISIONARY - MS in multiple sclerosis underway Strong Execution Capabilities • Proprietary electrochemical manufacturing process produces nanotherapeutics, scalable to commercialization • Strong IP, including 150+ granted patents, and trade secrets CLENE | Company Highlights

 

 

 

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