# EDGAR Filing Document

**Accession Number:** 0001822791
**File Stem:** 0001437749-23-005863
**Filing Date:** 2023-3
**Character Count:** 13337
**Document Hash:** 753f611be8cd70fddb8d66788bd22215
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001437749-23-005863.hdr.sgml**: 20230309

**ACCESSION NUMBER**: 0001437749-23-005863

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20230309

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230309

**DATE AS OF CHANGE**: 20230309

**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:** 23718108

**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

clnn20230308_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):**March 9, 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 March 9, 2023, Clene Inc. (the "Company") issued a press release announcing new results for CNM-Au8<sup>®</sup> in the HEALEY ALS Platform Trial. 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 March 9, 2023, announcing CNM-Au8 associated with delayed time to key clinical progression events at six months supporting a survival benefit in the HEALEY ALS Platform Trial.](ex_485881.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: March 9, 2023 | By: | /s/ Robert Etherington |
|  |  | Robert Etherington |
|  |  | President and Chief Executive Officer |

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## Exhibit 99.1

**Exhibit 99.1**

**CNM-Au8<sup>®</sup> ASSOCIATED WITH DELAYED TIME TO KEY CLINICAL PROGRESSION EVENTS AT SIX MONTHS SUPPORTING A SURVIVAL BENEFIT IN THE HEALEY ALS PLATFORM TRIAL**

● ***CNM-Au8 associated with a 74% lower risk (lower hazard ratio) of ALS clinical worsening, which included death, non-invasive ventilation >22 hours per day, tracheostomy, or feeding tube placement (p = 0.035)*** 

● ***CNM-Au8 associated with a 98% lower risk of death or permanent assisted ventilation (p= 0.028)*** 

● ***CNM-Au8 associated with a 74% lower risk of feeding tube placement (p= 0.035)*** 

● ***CNM-Au8 associated with a 63% lower risk of initiation of assisted ventilation (p= 0.058)*** 

● ***CNM-Au8 treatment was well-tolerated without significant safety concerns*** 

**Clene will host a live audio webcast at 7:30 a.m. EST today to review these new clinical results.**

**SALT LAKE CITY, March 9, 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 new results from exploratory analyses including delayed time to key clinical progression events in people living with amyotrophic lateral sclerosis (ALS) who were treated with CNM-Au8<sup>®</sup> in the HEALEY ALS Platform Trial over the 6-months of the double-blind period.

"Analyses of prespecified exploratory endpoints from the HEALEY ALS Platform Trial suggest that treatment with CNM-Au8 delayed time to ALS clinical worsening events across all of the domains, including the need for assisted breathing and placement of stomach feeding tubes. When supported by a confirmatory trial, this would give people living with ALS longer periods of independence, which are precious to them and their families. The consistent nature of the efficacy signal for delayed clinical worsening is highly encouraging and provides new insights supporting the survival benefit seen with the 30mg dose of CNM-Au8. We plan to discuss these findings with the FDA in an end of Phase 2 meeting in order to seek a regulatory pathway towards approval for this significant unmet need," said Rob Etherington, Clene's CEO.

***New Six-Month Findings from HEALEY ALS Platform Trial Regimen C (CNM-Au8):***

Results are based on prespecified risk adjusted Cox proportional hazards analyses within the population for Regimen C, where treatment with CNM-Au8 30mg over 24-weeks was associated with:

● **A 74% decreased risk (lower hazard) of the composite endpoint of time to ALS clinical worsening**, which included the first instance of death, tracheostomy, initiation of permanent assisted ventilation (>22-hours per day of non-invasive ventilatory support), or placement of a feeding tube **(p = 0.035)**. Living longer, being independent of breathing support, and eating and drinking without a stomach feeding tube is important for ALS patients to lead more independent lives.

● **Treatment with CNM-Au8 was also associated with statistically significant and directional trends** across all prespecified time to clinical worsening event analyses:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• 98% decreased risk (lower hazard) of death or permanently assisted ventilation **(p= 0.028)** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• 95% decreased risk of death **(p= 0.053)** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• 74% decreased risk of feeding tube placement **(p= 0.035)** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• 63% decreased risk of assisted ventilation **(p= 0.058)** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• 84% decreased risk of ALS-related hospitalization **(p= 0.107)** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• 69% decreased risk of all-cause hospitalization **(p= 0.065)** 

The reported p-values were not adjusted for multiple comparisons. Supportive sensitivity analyses incorporating baseline neurofilament light chain (NfL) levels were similarly robust and resulted in increased effect sizes and smaller nominal p-values in the same 'within regimen' analyses.

"These meaningful delays in clinical worsening, coupled with the previously suggested benefit in ALS patient survival and favorable tolerability profile of CNM-Au8 could prove to be profoundly beneficial to people living with ALS and their families," stated Merit Cudkowicz, M.D., Chief Neurology Department, Director, Sean M Healey & AMG Center for ALS, and the Principal Investigator of the HEALEY ALS Platform Trial. "We hope to see these results persist and strengthen over an even longer-term follow-up period for patients who have entered the open-label portion of the trial, and for those individuals who will participate in Clene's next ALS clinical trial."

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"The results from the HEALEY Platform Trial suggesting an association of CNM-Au8 with delays in time to clinical decline, particularly at the 30mg dosage, provide ample rationale to continue its development in a Phase 3 ALS trial. We would like to thank the hundreds of people living with ALS and their loved ones and caregivers, who have dedicated themselves to participation in this trial, and we look forward to learning more about the impact of CNM-Au8 on ALS progression in the future," stated James Berry, M.D., the co-lead investigator for Regimen C, which evaluated CNM-Au8.

Robert Glanzman, M.D. FAAN, Clene's Chief Medical Officer, noted, "In addition to these highly encouraging delayed time to clinical worsening results, we will be analyzing disease progression based on validated biomarkers from both the double-blind and open label periods of the HEALEY ALS Platform Trial. We also plan to perform similar analyses of clinical worsening and survival beyond the six-month double-blind period. These data will inform the design of the planned Phase 3 trial with CNM-Au8, RESTORE-ALS. We sincerely thank the people living with ALS, as well as their families, for their willingness to engage in clinical research and participate in the HEALEY ALS Platform Trial."

The HEALEY ALS Platform Trial is a perpetual multi-center, randomized, double-blind, placebo-controlled program designed to evaluate the efficacy and safety of multiple investigational products utilizing a shared placebo group in people living with ALS.

Clene will host a live audio webcast at 7:30 a.m. EST today, Thursday, March 9, to review these new clinical results.

**Webcast Information**

Title: Clene's HEALEY ALS Platform Trial Data Update

Presenters: Clene and Merit Cudkowicz, M.D., Chief Neurology Department, Director, Sean M Healey & AMG Center for ALS

Date: March 9, 2023

Start Time: 7:30 a.m. ET

Webcast link: https://edge.media-server.com/mmc/p/e8xezoye

The archived webcast will be available on the Company's website beginning approximately two hours after the event.

**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 <u>Twitter</u>, <u>LinkedIn</u> and <u>Facebook</u>.

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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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