# EDGAR Filing Document

**Accession Number:** 0001822791
**File Stem:** 0001437749-26-014542
**Filing Date:** 2026-5
**Character Count:** 13231
**Document Hash:** 96842613e92fec145bda6f40d51ee191
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001437749-26-014542.hdr.sgml**: 20260504

**ACCESSION NUMBER**: 0001437749-26-014542

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 13

**CONFORMED PERIOD OF REPORT**: 20260504

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260504

**DATE AS OF CHANGE**: 20260504

**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:** 26934696

**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'? clnn20260503_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): May 4, 2026**

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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** | **Name of each exchange on which registered** |
| Common Stock, $0.0001 par value<br> CLNN | 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.**

On May 4, 2026, Clene Inc. (the "Company") issued a press release announcing that after a successful meeting with the U.S. Food and Drug Administration ("FDA"), the Company plans to file an accelerated approval New Drug Application ("NDA") in amyotrophic lateral sclerosis ("ALS"). A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K (the "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 (the "Securities Act"), 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.**

As previously reported, the FDA granted to the Company a Type C in-person meeting to, among other things, discuss the ability of the Company to file an NDA for ALS under an accelerated approval pathway. The Company today announced receipt of final meeting minutes following its recent Type C meeting with the FDA.

During the meeting and confirmed in the final meeting minutes, the FDA stated that Clene's "*proposed data may be capable of supporting the submission and review of an [New Drug Application (NDA)] under the accelerated approval pathway for the treatment of ALS*." The FDA reminded the Company that the submission should demonstrate the effectiveness of an effect of CNM-Au8 on neurofilament light ("NfL") and show that the magnitude of change in NfL is reasonably likely to predict clinical benefits in patients with ALS. The Company intends to submit its NDA in the third quarter of 2026, which will remain a matter of FDA review.

The Agency also noted that "*NfL could potentially serve as a reasonably likely surrogate endpoint to support (an) accelerated approval*." This submission would occur under the Subpart H accelerated approval pathway (21 CFR 314.510) in ALS. The Agency has also requested that the Company provide additional information in its NDA, including to support a connection between the reported magnitude of reduction in NfL and clinical benefit, which the Company has prepared and will include in the submission.

The Company is conducting the Phase 3 confirmatory study for CNM-Au8, which it intends to commence in the first quarter of 2027. The planned NDA submission will be supported by NfL biomarker and clinical data from the Phase 2 HEALEY ALS Platform Trial and its open-label extension, as well as the Phase 2 RESCUE-ALS Trial, and the National Institute of Health-sponsored Expanded Access Protocol for CNM-Au8. Supporting data include reductions in plasma NfL associated with longer survival in the open-label extension and additional clinical outcomes. CNM-Au8 has previously received Orphan Drug Designation from the FDA for the treatment of ALS.

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***Forward-Looking Statements***

**Item 9.01 Financial Statements and Exhibits.**

(d) Exhibits

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| | |
|:---|:---|
| **Exhibit Number** | **Exhibit Description** |
| 99.1 | [Press release, dated May 4, 2026, announcing after successful FDA meeting, Clene filing accelerated approval NDA for ALS.](ex_955500.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: May 4, 2026 | By: | /s/ Robert Etherington |
|  |  | Robert Etherington |
|  |  | President and Chief Executive Officer |

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## Exhibit 99.1

**Exhibit 99.1**

**AFTER SUCCESSFUL FDA MEETING, CLENE FILING ACCELERATED APPROVAL NDA FOR ALS**

● *FDA stated that the "proposed data may be capable of supporting the submission and review of an [NDA] under the accelerated approval pathway" for CNM-Au8 based on neurofilament light (NfL) biomarker data* 

● *FDA acknowledged NfL could potentially serve as a reasonably likely surrogate endpoint* 

● *Clene expects to submit an NDA for CNM-Au8 to the FDA in the third quarter of 2026* 

● *CNM-Au8 represents a potential first-in-class therapeutic approach for ALS, a disease area with significant unmet medical need* 

**SALT LAKE CITY, May 4, 2026** -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced receipt of final meeting minutes following its recent Type C meeting with the U.S. Food and Drug Administration (FDA).

During the meeting and confirmed in the final meeting minutes, the FDA stated that Clene's "*proposed data may be capable of supporting the submission and review of an [New Drug Application (NDA)] under the accelerated approval pathway for the treatment of ALS*." The FDA reminded the Company that the submission should demonstrate the effectiveness of an effect of CNM-Au8 on NfL and show that the magnitude of change in NfL is reasonably likely to predict clinical benefits in patients with ALS. Clene intends to submit its NDA in the third quarter of 2026, which will remain a matter of FDA review.

The Agency also noted that "*NfL could potentially serve as a reasonably likely surrogate endpoint to support (an) accelerated approval*." This submission would occur under the Subpart H accelerated approval pathway (21 CFR 314.510) in ALS. The Agency has also requested that the Company provide additional information in its NDA, including to support a connection between the reported magnitude of reduction in NfL and clinical benefit, which Clene has prepared and will include in the submission.

Clene's journey with the FDA has been constructive. Today, we express our great appreciation for the FDA's clear display of regulatory flexibility and its recent communications of a willingness to consider receipt of an NDA submission. That the Agency has now agreed to review our extensive data dossier is a critical moment in our company's history.

"We are encouraged by the FDA's careful evaluation of the benefits and risks associated with Clene's ALS drug candidate, CNM-Au8, including the biomarker data the Company provided. The filing of an NDA submission represents an important milestone for CNM-Au8 and for the ALS community," said Rob Etherington, President and CEO of Clene. "We are committed to working with the Agency on this filing and are conducting the Phase 3 confirmatory study for CNM-Au8, which we intend to commence in the first quarter of 2027."

"People living with ALS cannot afford to wait," said Sandra Abrevaya, I AM ALS Co-Founder and Board Member. "Flexible, science-driven regulatory approaches such as this can play a critical role in accelerating access to new therapies for a fast-progressing, fatal disease. We're grateful for the Agency's recognition of the urgency and unmet need in ALS."

The planned NDA submission will be supported by NfL biomarker and clinical data from the Phase 2 HEALEY ALS Platform Trial and its open-label extension, as well as the Phase 2 RESCUE-ALS Trial, and the NIH-sponsored Expanded Access Protocol for CNM-Au8. Supporting data include reductions in plasma NfL associated with longer survival in the open-label extension and additional clinical outcomes. CNM-Au8 has previously received Orphan Drug Designation from the FDA for the treatment of ALS.

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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<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 <u>www.clene.com</u> 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

<u>**Media Contact**</u>: Caroline Wagner, Forbes Tate Partners; <u>CWagner@forbes-tate.com</u>; (267) 294-6563