# EDGAR Filing Document

**Accession Number:** 0001822791
**File Stem:** 0001437749-25-029846
**Filing Date:** 2025-9
**Character Count:** 13355
**Document Hash:** 4ba8599001278bf151abb4ec7a7c54ff
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001437749-25-029846.hdr.sgml**: 20250925

**ACCESSION NUMBER**: 0001437749-25-029846

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 16

**CONFORMED PERIOD OF REPORT**: 20250925

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250925

**DATE AS OF CHANGE**: 20250925

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Clene Inc.
- **CENTRAL INDEX KEY:** 0001822791
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 852828339
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-39834
- **FILM NUMBER:** 251340250

**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

?xml version='1.0' encoding='ASCII'? clnn20250923_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):**September 25, 2025**

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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-fortieth of one share of Common Stock for $230.00 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 7.01 Regulation FD Disclosure.**

In connection with the press release discussed under Item 8.01 in this Current Report on Form 8-K (the "Current Report"), on September 25, 2025, Clene Inc. (the "Company") presented new clinical data at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis ("ECTRIMS 2025") demonstrating CNM-Au8<sup>®</sup> improves brain energy metabolism in multiple sclerosis patients. A copy of the poster is furnished as Exhibit 99.1 to this Current Report and is incorporated herein by reference.

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 Securities 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, as amended, regardless of any general incorporation language in any such filings, except as shall be expressly set forth by specific reference in such a filing.

**Item 8.01 Other Events.**

On September 25, 2025, the Company issued a press release announcing a presentation of new clinical data at ECTRIMS 2025 meeting demonstrating CNM-Au8 improves brain energy metabolism in multiple sclerosis patients. A copy of the press release is filed as Exhibit 99.2 to this Current Report and is incorporated herein by reference.

**Item 9.01 Financial Statements and Exhibits.**

(d) Exhibits

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| | |
|:---|:---|
| **Exhibit Number** | **Exhibit Description** |
| 99.1 | [REPAIR-MS Poster.](ex_863758.htm) |
| 99.2 | [Press release, dated September 25, 2025, announcing Clene presents new clinical data at ECTRIMS 2025 meeting demonstrating CNM-Au8 improves brain energy metabolism in multiple sclerosis patients.](ex_863757.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: September 25, 2025 | By: | /s/ Robert Etherington |
|  |  | Robert Etherington |
|  |  | President and Chief Executive Officer |

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## Exhibit 99.1

**Exhibit 99.1**

![slide1.jpg](slide1.jpg)

## Exhibit 99.2

**Exhibit 99.2**

**CLENE PRESENTS NEW CLINICAL DATA AT ECTRIMS 2025 MEETING**

**DEMONSTRATING CNM-Au8<sup>®</sup> IMPROVES BRAIN ENERGY**

**METABOLISM IN MULTIPLE SCLEROSIS PATIENTS**

● ***Late-breaking clinical data presented at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis*** 

● ***Across non-active progressive MS (primary progressive and secondary progressive MS), relapsing MS, and Parkinson's disease patients, CNM-Au8<sup>®</sup> improved the brain's energy metabolism evidenced by improved NAD+/NADH ratio*** 

● ***At the Type B end-of-Phase 2 MS meeting with the U.S. Food and Drug Administration, FDA aligned with Clene acknowledging the limitations of the Expanded Disability Status Scale and expressed openness to considering other potential primary endpoints, including cognition, to evaluate broader treatment effects*** 

**SALT LAKE CITY, September 25, 2025** – Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurological diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced the presentation of the combined REPAIR-MS results across relapsing MS and non-active progressive MS during the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), held September 24-26, 2025, in Barcelona, Spain.

The REPAIR studies, including REPAIR-MS and REPAIR-PD, were Phase 2, open label, sequential group, investigator blinded studies of magnetic resonance spectroscopy (31P-MRS) to assess the effects of CNM-Au8 on the bioenergetic improvement impaired neuronal redox state. Participants received 12 weeks of CNM-Au8, followed by a 6-week post-therapy safety follow up (REPAIR-MS). The primary endpoint was the change in brain NAD+/NADH ratio—a measure of energetic capacity—from baseline to week 12.

Participants analyzed for the primary efficacy outcome (all evaluable with post-baseline scans at the Week 12 visit) included REPAIR-MS Cohort 1 (relapsing MS, n=11), REPAIR-MS Cohort 2 (non-active progressive MS, n=15), and REPAIR-PD (n=13) in prespecified analyses across the overall population (total n=39).

Key findings from CNM-Au8 treatment include:

● The mean NAD+/NADH ratio in the brain was significantly increased following 12 weeks of treatment with CNM-Au8 in the full REPAIR population (+0.449 units, 95% CI: 0.093 to 0.805, p=0.0148; percent change: 8.65%, 95% CI: 2.6% to 14.7%, p=0.0006).

● The change in REPAIR-MS participants alone demonstrated consistent increases in the NAD+/NADH ratio to Week 12 (+0.480 units, 95% CI: -0.018 to 0.979, p=0.058; percent change: +9.49%, 95% CI: 1.14% to 17.85%, p=0.0275), a measure of how efficiently the brain makes energy.

● Secondary endpoints: the change in the % fraction of brain NAD+ and NADH similarly demonstrated statistically significant increases in NAD+ and decreases in NADH for both the full REPAIR population (p=0.0058) and REPAIR-MS (p=0.0232), respectively.

Striking relationships between MS disease activity and brain energy metabolic indices were present at the pre-treatment baseline visit.

● The Expanded Disability Status Scale (EDSS), a global measure of MS disease severity, was significantly associated with the baseline deficits in the NAD+/NADH ratio (Pearson Correlation: ρ= 0.429, p=0.0127).

● Baseline measures of working memory and cognitive processing speed, measured by the Symbol Digit Modalities Test, were significantly associated with average brain ATP levels (peak signal area average for α-ATP, β-ATP, γ-ATP; Pearson Correlation: ρ=0.542, p=0.0009).

● Baseline measures of upper extremity function, measured by the 9-Hole Peg Test time (total time across hands), was also significantly associated with average brain ATP levels (peak signal area average for α-ATP, β-ATP, γ-ATP; Pearson Correlation: ρ=-0.513, p=0.0032).

Collectively, these data reinforce the insight that bioenergetic failure in the brain is a key contributor to neurodegeneration and disease progression in MS. By improving brain energy metabolism, CNM-Au8 may help slow progression of disability.

CNM-Au8 treatment was safe and well tolerated with treatment emergent adverse events characterized as transient and predominantly mild-to-moderate in severity.

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"CNM-Au8 was able to demonstrate an improvement in metabolic profiles in the brain over 12 weeks, highlighting the potential of CNM-Au8 to address key energy deficits in the brain," said Benjamin Greenberg, MD, Head of Medical at Clene. "These results not only demonstrate a direct correlation of brain bioenergetics with disability, but they also demonstrate the ability of CNM-Au8 to 'rescue' this deficit. Further analysis is ongoing to tell us more about progressive MS and may show how targeting brain bioenergetics can treat MS as well as other neurodegenerative disorders."

"We are grateful to the patients with MS and Parkinson's disease who participated in this clinical research," said Rob Etherington, CEO of Clene. "These promising clinical results strengthen the body of evidence supporting further clinical development of CNM-Au8 for the treatment of MS. Additionally, the openness from the FDA to discuss disability outcome measures beyond the EDSS, such as cognition and other broader treatment effects, marks a new milestone for MS clinical trials."

**About Clene**

Clene Inc., (Nasdaq: CLNN) (along with its subsidiaries, "Clene" and its wholly owned subsidiary Clene Nanomedicine, Inc.), is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson's disease, and multiple sclerosis. CNM-Au8<sup>®</sup> is an investigational first-in-class therapy that improves central nervous system cells' survival and function via a mechanism that targets mitochondrial function and the NAD pathway while reducing oxidative stress. CNM-Au8<sup>®</sup> is a federally registered trademark of Clene Nanomedicine, Inc. 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>X</u> (formerly <u>Twitter</u>) and <u>LinkedIn</u>.

**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<sup>®</sup> is a federally registered trademark of Clene Nanomedicine, Inc.

**Forward-Looking Statements**

<u>**Investor Contact:**</u> Kevin Gardner, LifeSci Advisors, <u>kgardner@lifesciadvisors.com</u>

(617) 283-2856