# EDGAR Filing Document

**Accession Number:** 0001822791
**File Stem:** 0001437749-23-004629
**Filing Date:** 2023-2
**Character Count:** 13486
**Document Hash:** 6b1f2e02fd53cd5196833fb4f8b049f3
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001437749-23-004629.hdr.sgml**: 20230227

**ACCESSION NUMBER**: 0001437749-23-004629

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20230227

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230227

**DATE AS OF CHANGE**: 20230227

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Clene Inc.
- **CENTRAL INDEX KEY:** 0001822791
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 852828339
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-39834
- **FILM NUMBER:** 23670018

**BUSINESS ADDRESS:**
- **STREET 1:** 6550 SOUTH MILLROCK DRIVE, SUITE G50
- **CITY:** SALT LAKE CITY
- **STATE:** UT
- **ZIP:** 84121
- **BUSINESS PHONE:** 801-676-9695

**MAIL ADDRESS:**
- **STREET 1:** 6550 SOUTH MILLROCK DRIVE, SUITE G50
- **CITY:** SALT LAKE CITY
- **STATE:** UT
- **ZIP:** 84121

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Chelsea Worldwide Inc.
- **DATE OF NAME CHANGE:** 20200827

clnn20230222b_8k.htm

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**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**WASHINGTON, D.C. 20549**

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**FORM**8-K**

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**CURRENT REPORT**

**Pursuant to Section 13 OR 15(d)** 

**of The Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported):**February 27, 2023**

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**CLENE INC.**

(Exact name of registrant as specified in its charter)

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| | | |
|:---|:---|:---|
| **Delaware** | **001-39834** | **85-2828339** |
| (State or Other Jurisdiction | (Commission File Number) | (IRS Employer |
| of Incorporation) |  | Identification No.) |
| **6550 South Millrock Drive, **Suite G50**<br> **Salt Lake City,**Utah** |  | **84121** |
| (Address of Principal Executive Offices) |  | (Zip Code) |

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**(**801**)**676-9695**

(Registrant's telephone number, including area code)

**N/A**

(Former Name or Former Address, if Changed Since Last Report.)

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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:

☐ 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:**

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| | | |
|:---|:---|:---|
| **Title of each class** | **Trading Symbol(s)** | **Name of each exchange on which registered** |
| Common Stock, $0.0001 par value | 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 |

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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. ☐

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**Item 8.01 Other Events.**

On February 27, 2023, Clene Inc. (the "Company") issued a press release announcing updated data presented at the 2023 ACTRIMS Forum from the Phase 2 VISIONARY-MS clinical trial in multiple sclerosis. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

**Item 9.01 Financial Statements and Exhibits.**

&nbsp;&nbsp;&nbsp;&nbsp;(d) Exhibits

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| | |
|:---|:---|
| **Exhibit**<br> **Number** | **Exhibit Description** |
| 99.1 | [Press release, dated February 27, 2022, announcing updated VISIONARY-MS Phase 2 trial data presented at 2023 ACTRIMS Forum show CNM-Au8 demonstrated significant improvements in clinical outcomes, brain structure, and visual system.](ex_479455.htm) |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL). |

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**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.

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| | | |
|:---|:---|:---|
|  | CLENE INC. | CLENE INC. |
| Date: February 27, 2023 | By: | /s/ Robert Etherington |
|  |  | Robert Etherington |
|  |  | President and Chief Executive Officer |

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## Exhibit 99.1

**Exhibit 99.1**

**Clene Announces Updated VISIONARY-MS Phase 2 Trial Data Presented at 2023 ACTRIMS Forum Show CNM-Au8<sup>®</sup> Demonstrated Significant Improvements in Clinical Outcomes, Brain Structure, and Visual System**

● ***Positive clinical results demonstrated in stable relapsing multiple sclerosis patients adjunctive to immunomodulatory disease modifying therapy was previously reported*** 

● ***Updated Visual Evoked Potential (VEP) findings provide evidence of improved information signaling from the eye to the brain's visual cortex*** 

● ***These significant VEP results alongside the previously reported significant MRI results add to the totality of evidence supporting the clinical benefits of CNM-Au8*** 

● ***CNM-Au8 treatment was well-tolerated, and no significant safety findings were observed*** 

**SALT LAKE CITY, Feb. 27, 2023** -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, today announced updated results from the VISIONARY-MS Phase 2 trial were presented this weekend at the 8th annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2023.

The poster titled, "CNM-Au8 Phase 2 VISIONARY-MS Updated Trial Results," contributes to the growing body of evidence supporting improvements in clinical neurologic function and significant paraclinical MRI and VEP findings. The VEP and MRI analyses presented were prespecified exploratory endpoints.

VISIONARY-MS investigated the efficacy and safety of CNM-Au8 (15 mg or 30 mg daily) versus placebo over 48 weeks in stable relapsing remitting multiple sclerosis (MS) patients with chronic optic neuropathy. The study was designed to investigate the hypothesis that supporting neuronal energy metabolism protects neurologic function in patients with MS. Nearly all participants (92%) were treated with highly effective disease modifying therapies (DMT) as background standard of care. Due to limited enrollment, 73 of 150, attributed to the COVID pandemic, the threshold for significance was pre-specified at p=0.10 prior to database lock and submitted to the FDA in the statistical analysis plan. Clene announced the topline results of the study in August 2022.

**<u>Updated VEP Results</u>**

The updated multi-focal Visual Evoked Potential (mf-VEP) findings provide evidence of improved information transmission in the visual system (from the eye to the visual cortex) supported by statistically significant increases in amplitude. The VEP least affected eye was defined as the eye with the shortest latency delay at baseline. Results included all participants with recorded VEP data (n=64):

● mf-VEP amplitude percent change in the least affected eye at baseline – Week 48 least squares [LS] mean difference: 9.7%, 95% CI: 3.1% to 16.3%, p=0.0047

● mf-VEP amplitude percent change in the most affected eye at baseline – Week 48 LS mean difference: 6.1%, 95% CI: -0.6% to 12.7%, p=0.0730

● mf-VEP amplitude percent change across both eyes – Week 48 LS mean difference: 7.9%, 95% CI: 1.4% to 14.4%, p=0.0184

The increased amplitude signal suggests previously impaired neurons subsequently increase information transmission following CNM-Au8 treatment, supporting improved axonal integrity.

**<u>Previously Reported Clinical and MRI Results</u>**

The primary and secondary endpoints demonstrated improved clinical outcomes in the mITT population, independent of an immunomodulatory effect:

● The primary endpoint of LCLA change demonstrated significant improvement – Week 48 LS Mean Difference: 3.13; 95% CI: -0.08 to 6.33, p = 0.056

● The secondary endpoint of global neurological improvement, mMSFC mean standardized change demonstrated significant improvement – Week 48 LS Mean Difference: 0.28; 95% CI: 0.05 to 0.51, p = 0.0197

● CNM-Au8 was well-tolerated, and no significant safety findings were observed.

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The exploratory MRI findings provide evidence of brain neuronal structural integrity assessed by diffusion tensor imaging (DTI) that demonstrated statistically significant results for key metrics of axonal integrity and white matter integrity. Preservation of white matter integrity is associated with decreased cognitive and functional decline in MS patients. Results included all participants with advanced MRI data collection (n=68):

● Fractional Anisotropy change within the whole brain (Cerebrum): 0.0029, 95% CI: 0.0048 to 0.0054, p = 0.0199

● Fractional Anisotropy change within total Cerebral White Matter – Week 48 LS Mean Difference: 0.0026, 95% CI: -0.0003 to 0.0055, p = 0.0805

● Fractional Anisotropy change within total Cerebral Normal Appearing White Matter – Week 48 LS Mean Difference: 0.0025, 95% CI: -0.00025 to 0.0053, p = 0.0737

Since many non-relapsing MS patients continue to clinically deteriorate even while receiving immunomodulatory DMTs, a therapy which improves clinical outcomes, brain structure, and visual system remains a significant unmet medical need in MS.

MS expert and clinical investigator Benjamin Greenberg, MD, MHS, noted, "The totality of the clinical and paraclinical data from the VISIONARY-MS trial are robust. Alongside the previously released MRI findings, the newly released mf-VEP data provide further evidence of neuronal preservation. There is a critical unmet need in multiple sclerosis therapeutics for interventions that protect neuronal function and myelin health independent of immunomodulation or suppression. Years have been spent seeking a truly neuroprotective therapy for multiple sclerosis and other neurodegenerative diseases. These data help build a strong case in favor of pursuing CNM-Au8 in further Phase 3 studies."

**About VISIONARY-MS**

VISIONARY-MS investigated the efficacy and safety of CNM-Au8 (15 mg or 30 mg daily) versus placebo over 48 weeks in stable relapsing remitting multiple sclerosis (MS) patients with chronic optic neuropathy. The study was designed to investigate the hypothesis that supporting neuronal energy metabolism protects neurologic function in patients with MS. Nearly all participants (92%) were treated with highly effective disease modifying therapies (DMT) as background standard of care. Due to limited enrollment (73 of 150) attributed to the COVID pandemic, the threshold for significance was pre-specified at p=0.10 prior to database lock and submitted to the FDA in the statistical analysis plan.

The primary outcome was change in low contrast letter acuity in the most clinically affected eye at baseline. The secondary outcome was global neurological improvement assessed by the modified Multiple Sclerosis Functional Composite (mMSFC), evaluating low contrast vision, cognition, upper extremity function, and walking speed with CNM-Au8 as adjunct to approved background immunomodulatory DMTs in stable MS patients. The mITT population included all study participants with valid clinical data. Censored observations included a subject with a change in mobility assist device (cane to walker) for timed 25-foot walk test (T25FWT, n=1), and invalid data from 1 of 11 sites (n=9) with low contrast letter acuity (LCLA) testing issues.

**About CNM-Au8**<sup>®</sup>

CNM-Au8 is an oral suspension of gold nanocrystals developed to restore neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc.

**About Clene**

Clene is a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease by targeting energetic failure, an underlying cause of many neurological diseases. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com or follow us on Twitter, LinkedIn and Facebook.

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**Forward-Looking Statements**

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|:---|:---|
| **<u>Media Contact</u>** <br> Ignacio Guerrero-Ros, Ph.D., or David Schull<br> Russo Partners, LLC<br> <u>Ignacio.guerrero-ros@russopartnersllc.com</u><br> <u>David.schull@russopartnersllc.com</u><br> (858) 717-2310 | **<u>Investor Contact</u>**<br> Kevin Gardner<br> LifeSci Advisors<br> <u>kgardner@lifesciadvisors.com</u><br> 617-283-2856 |

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