# EDGAR Filing Document

**Accession Number:** 0001822791
**File Stem:** 0001437749-25-021483
**Filing Date:** 2025-6
**Character Count:** 10518
**Document Hash:** 5fe54fc07ebf8a9ba916676b54104835
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001437749-25-021483.hdr.sgml**: 20250630

**ACCESSION NUMBER**: 0001437749-25-021483

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20250630

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250630

**DATE AS OF CHANGE**: 20250630

**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:** 251088804

**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'? clnn20250627_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):**June 30, 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 8.01 Other Events.**

On June 30, 2025, Clene Inc. (the "Company") issued a press release to provide a regulatory update following a constructive Type C meeting with the U.S. Food and Drug Administration ("FDA") on the Company's neurofilament biomarker analysis plan and confirmed two additional FDA meetings. 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.**

(d) Exhibits

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| | |
|:---|:---|
| **Exhibit Number** | **Exhibit Description** |
| 99.1 | [Press release, dated June 30, 2025, providing a regulatory update following constructive FDA Type-C meeting on neurofilament biomarker analysis plan and confirms two additional FDA meetings.](ex_834925.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: June 30, 2025 | By: | /s/ Robert Etherington |
|  |  | Robert Etherington |
|  |  | President and Chief Executive Officer |

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## Exhibit 99.1

**Exhibit 99.1**

**CLENE PROVIDES REGULATORY UPDATE**

**FOLLOWING CONSTRUCTIVE FDA TYPE-C MEETING ON**

**NEUROFILAMENT BIOMARKER ANALYSIS PLAN**

**AND CONFIRMS TWO ADDITIONAL FDA MEETINGS**

● ***FDA provides supportive feedback on proposed statistical analysis plan for neurofilament biomarker analysis of Clene's NIH-sponsored Expanded Access Program*** 

● ***NfL EAP biomarker analyses to be conducted early in the 4th Quarter of 2025*** 

● ***Clene confirms two additional FDA meetings scheduled for 3rd Quarter of 2025, to discuss ALS survival data and MS clinical development program*** 

● ***Submission of new drug application for ALS under the accelerated approval pathway on track for potential submission in the 4th Quarter of 2025*** 

**SALT LAKE CITY, June 30, 2025** – Clene, Inc. (Nasdaq: CLNN) and its subsidiary, Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to advancing therapies for neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today provided a regulatory update following a Type C meeting with the U.S. Food and Drug Administration (FDA), and announced two additional meetings scheduled with the FDA in the 3rd quarter of 2025.

In the recently concluded Type C meeting, Clene discussed its proposed statistical analysis plan (SAP) for comparing neurofilament light (NfL) biomarker data from its ongoing NIH-sponsored Expanded Access Protocol (EAP), supporting nearly 200 people living with ALS treated with compassionate use of CNM-Au8®, to matched ALS controls. The FDA provided constructive feedback on Clene's proposed analysis methodology for assessing NfL change. NfL change will be analyzed following 9 months of treatment (primary NfL analysis) and after 6 months of treatment (supportive NfL analysis). These analyses are planned to provide supportive data of the NfL change demonstrated in the HEALEY ALS Platform Trial double-blind period following 6 months of treatment with CNM-Au8.

The Agency's acceptance of the SAP, expected this summer, will establish an agreed upon framework for analyses of NfL change in EAP participants. Clene has already resubmitted its revised SAP incorporating FDA's requested revisions. The NfL analyses will be conducted early in the 4th quarter of 2025. If the findings demonstrate a clinically meaningful decline in NfL, they may support a new drug application (NDA) submission under the accelerated approval pathway, planned for the end of 2025.

The FDA has also confirmed two additional meetings with Clene scheduled for the 3rd quarter of 2025:

● **ALS Survival Data Type C Meeting:** This meeting will review the long-term survival benefit from CNM-Au8 30 mg treatment compared to concurrently randomized controls from another Healey ALS Platform Trial Regimen, assessing whether these data support filing of an NDA under an accelerated approval pathway.

● **End-of-Phase 2 Type B MS Program Meeting:** This meeting will review results from the Phase 2 VISIONARY-MS trial and discuss the planned Phase 3 study focusing on cognition improvement as an adjunct to standard-of-care MS therapies, addressing a critical unmet medical need for people struggling with MS.

"We are encouraged by the FDA's collaborative approach and their constructive feedback on our NfL biomarker analysis plan from the ongoing NIH-sponsored EAP program," said Benjamin Greenberg, MD, Head of Medical at Clene. "With two additional FDA meetings scheduled to discuss long-term ALS survival results and the End-of-Phase 2 MS results, we are advancing our ALS and MS programs to deliver an innovative therapy for people living with neurodegenerative diseases."

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**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® 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® 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**

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

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