# EDGAR Filing Document

**Accession Number:** 0001822791
**File Stem:** 0001437749-26-007828
**Filing Date:** 2026-3
**Character Count:** 17877
**Document Hash:** cd998c87df7bb75ba217ec9489977657
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001437749-26-007828.hdr.sgml**: 20260312

**ACCESSION NUMBER**: 0001437749-26-007828

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20260312

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260312

**DATE AS OF CHANGE**: 20260312

**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:** 26745718

**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'? clnn20251022_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 12, 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 2.02 Results of Operations and Financial Condition.**

On March 12, 2026, Clene Inc. (the "Company") issued a press release announcing its full year operating and financial results for its year ended December 31, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information furnished in this Item 2.02, 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 9.01 Financial Statements and Exhibits.**

(d) Exhibits

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| | |
|:---|:---|
| **Exhibit Number** | **Exhibit Description** |
| 99.1 | [Press Release, dated March 12, 2026, announcing the Company's full year 2025 financial results and recent operating highlights.](ex_874803.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 12, 2026 | By: | /s/ Robert Etherington |
|  |  | Robert Etherington |
|  |  | President and Chief Executive Officer |

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## Exhibit 99.1

**Exhibit 99.1**

**CLENE REPORTS FULL YEAR 2025 FINANCIAL RESULTS**

**AND RECENT OPERATING HIGHLIGHTS**

● *In-person Type C FDA meeting scheduled by end of the first quarter of 2026 to discuss the latest CNM-Au8® data submitted; Clene expects formal written meeting minutes early in the second quarter 2026* 

● *Oversubscribed registered direct offering of over $28 million priced above market* 

○ *Initial financing tranche of over $6 million, which will provide cash runway to the end of the third quarter enabling funding through potential NDA acceptance decision by the FDA* 

○ *Completion of this financing through its three tranches is expected to provide the Company with sufficient capital into 2027* 

**SALT LAKE CITY, Mar. 12, 2026** -- 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 neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced its full year 2025 financial results and provided recent updates on its CNM-Au8 programs.

"Our next key milestone is the upcoming Type C face-to-face meeting with the U.S. Food and Drug Administration (FDA) on Clene's biomarker and survival data, which if positive, will facilitate filing of an new drug application (NDA) under an accelerated approval pathway for ALS by the end of the second quarter of 2026," said Rob Etherington, President and CEO of Clene. "In parallel, we continue to advance plans to initiate our confirmatory Phase 3 trial in ALS, which is required to be "underway" by CNM-Au8 approval in ALS, as well as to continue working with the FDA on the initiation of a Phase 3 clinical trial using cognition as an endpoint in MS. Based on our combined findings to date, we continue to believe that patients across multiple neurodegenerative conditions may benefit from the improved mitochondrial function plus energy metabolism associated with CNM-Au8 treatment."

**Fourth Quarter 2025 and Recent Operating Highlights**

***CNM-Au8 for the treatment of ALS***

Clene expects its Type-C meeting with the FDA will occur before the end of this month. Clene will then await formal written meeting minutes from the agency which are expected early in the second quarter of 2026, after which Clene will publicly announce the outcome of the FDA meeting. Clene plans to file an NDA for CNM-Au8 in ALS under an accelerated approval pathway by the end of June 2026.

***Prolonged Survival and Associated Declines in Biomarkers of Neurodegeneration***

In December 2025, the Company announced completion of the FDA-recommended biomarker analyses for CNM-Au8 in people living with ALS. The results demonstrated statistically significant reductions in both neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) and provided compelling evidence linking biomarker decline to improved survival. The analyses followed FDA recommendations to support the persuasiveness of the Company's original NfL findings observed in the HEALEY ALS Platform Trial by extending the analyses to the NIH-sponsored Expanded Access Protocol (NIH-EAP) for CNM-Au8 in ALS. These biomarker findings correlated to survival findings and build on prior constructive FDA interactions in support of a planned NDA submission under an accelerated approval pathway for the treatment of ALS.

***Favorable Safety and Benefit/Risk Profile***

Across over 1,100 patient years of CNM-Au8 exposure data, with long-term treatment of people with ALS over 6 years, CNM-Au8's safety profile has no significant safety concerns nor safety trends identified. No serious adverse events (SAEs) have been identified as related to CNM-Au8 treatment by any investigator to date.

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***Corporate Update***

In January, Clene announced an oversubscribed registered direct offering of over $28 million priced above market. The initial tranche of over $6 million is expected to provide operating runway to the end of the third quarter of 2026, sufficient funding through a potential NDA acceptance decision by the FDA. Two potential additional financing tranches totaling over $22 million are structured to align with NDA acceptance and FDA approval milestones and provide runway into 2027.

**Full Year 2025 Financial Results**

Clene's cash and cash equivalents totaled $5.2 million as of December 31, 2025, compared to $12.2 million as of December 31, 2024. Clene expects that its resources as of December 31, 2025, combined with the proceeds received from its January 2026 registered direct offering, will provide operating runway to the end of the third quarter of 2026 with potential additional tranches of financing from this offering extending its cash runway into 2027.

Research and development expenses were $14.0 million for the year ended December 31, 2025, compared to $20.1 million for the same period in 2024. The year-over-year decrease was primarily due to decreased expenses related to the HEALEY ALS Platform Trial and RESCUE-ALS due to their previous completion of the blinded portion and open-label extensions of each trial, a decrease in expenses for regulatory activities, and a decrease in pre-clinical, non-clinical and other general CNM-Au8 related expenses, partially offset by an increase in expenses related to the NIH-EAP due to higher enrollment in the EAP. Manufacturing-related expenses, as well as expenses related to personnel and stock-based compensation, also decreased. Additionally, grant revenue, which is recorded as a reduction to research and development expense, significantly increased in 2025 as compared to 2024 primarily related to an increase in enrollment and study operations of the NIH-EAP.

General and administrative expenses were $9.2 million for the year ended December 31, 2025, compared to $13.3 million for the same period in 2024. The year-over-year decrease was primarily attributable to lower insurance fees, legal fees and public and investor relations fees, as well as decreased personnel and stock-based compensation expenses, partially offset by an increase in finance and accounting fees. Additionally, grant revenue, which is recorded as a reduction to general and administration expense, increased in 2025 as compared to 2024 primarily related to an increase in enrollment and study operations of the NIH-EAP.

Total other expense, net, was $3.1 million for the year ended December 31, 2025, compared to $6.3 million for the same period in 2024. The year-over-year decrease in other expense was primarily attributable to lower interest expense and smaller changes in warrant and derivative liabilities. Additionally, a one-time loss on extinguishment of notes payable and a loss on initial issuance of equity only occurred in 2024.

Clene reported a net loss of $26.2 million, or $2.65 per share, for the year ended December 31, 2025, compared to a net loss of $39.4 million, or $5.67 per share, for the same period in 2024.

**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>.

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**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**

**Investor Contact:** Kevin Gardner, LifeSci Advisors; <u>kgardner@lifesciadvisors.com</u>; 617-283-2856

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**CLENE INC.**

**CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS**

**(In thousands, except share and per share amounts)**

**(Audited)**

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| | | |
|:---|:---|:---|
|  | **Year Ended December 31,** | **Year Ended December 31,** |
|  | **2025** | **2024** |
| Revenue: |  |  |
| Product revenue | $119 | $237 |
| Royalty revenue | 81 | 105 |
| Total revenue | 200 | 342 |
| Operating expenses: |  |  |
| Cost of revenue | 43 | 70 |
| Research and development | 14011 | 20058 |
| General and administrative | 9229 | 13307 |
| Total operating expenses | 23283 | 33435 |
| Loss from operations | (23083) | (33093) |
| Other income (expense), net: |  |  |
| Interest income | 223 | 865 |
| Interest expense | (2682) | (4064) |
| &nbsp;&nbsp;&nbsp; Loss on extinguishment of notes payable |  | (214) |
| Issuance costs for common stock warrant liabilities |  | (157) |
| Loss on initial issuance of equity |  | (2097) |
| Change in fair value of common stock warrant liabilities | (522) | (702) |
| &nbsp;&nbsp;&nbsp; Change in fair value of derivative liabilities | (363) | (379) |
| Change in fair value of Clene Nanomedicine contingent earn-out liability |  | 75 |
| Change in fair value of Initial Stockholders contingent earn-out liability |  | 10 |
| Research and development tax credits and unrestricted grants | 254 | 357 |
| Other expense, net |  | (1) |
| Total other income (expense), net | (3090) | (6307) |
| Net loss before income taxes | (26173) | (39400) |
| Income tax expense |  |  |
| Net loss | $(26173) | $(39400) |
| Other comprehensive income (loss): |  |  |
| Unrealized loss on available-for-sale securities | $— | $(1) |
| Foreign currency translation adjustments | 101 | (127) |
| Total other comprehensive income (loss) | 101 | (128) |
| Comprehensive loss | $(26072) | $(39528) |
| Net loss per share – basic and diluted | $(2.65) | $(5.67) |
| Weighted average common shares used to compute basic and diluted net loss per share | 9858907 | 6954133 |

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**CLENE INC.**

**CONSOLIDATED BALANCE SHEETS**

**(In thousands, except share and per share amounts)**

**(Audited)**

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| | | |
|:---|:---|:---|
|  | **December 31,** | **December 31,** |
|  | **2025** | **2024** |
| **ASSETS** |  |  |
| Current assets: |  |  |
| Cash and cash equivalents | $5189 | $12155 |
| Accounts receivable |  | 64 |
| Inventory | 37 | 68 |
| Prepaid expenses and other current assets | 3751 | 3870 |
| Total current assets | 8977 | 16157 |
| Restricted cash | 58 | 58 |
| Operating lease right-of-use assets | 3073 | 3643 |
| Property and equipment, net | 6023 | 7479 |
| TOTAL ASSETS | $18131 | $27337 |
| **LIABILITIES AND STOCKHOLDERS' DEFICIT** |  |  |
| Current liabilities: |  |  |
| Accounts payable | $892 | $1240 |
| Accrued liabilities | 5002 | 7766 |
| Operating lease obligations, current portion | 808 | 926 |
| Notes payable, current portion | 1696 | 359 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Convertible notes payable, current portion | 2378 |  |
| Total current liabilities | 10776 | 10291 |
| Operating lease obligations, net of current portion | 3250 | 4132 |
| Notes payable, net of current portion | 3741 | 4610 |
| Convertible notes payable | 9800 | 10816 |
| Common stock warrant liabilities | 5063 | 4541 |
| Derivative liabilities | 3093 | 1804 |
| TOTAL LIABILITIES | 35723 | 36194 |
| Commitments and contingencies |  |  |
| Stockholders' deficit: |  |  |
| Common stock, $0.0001 par value: 600,000,000 shares authorized; 10,849,974 and 8,089,565 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively | 1 | 1 |
| Additional paid-in capital | 290531 | 273194 |
| Accumulated deficit | (308296) | (282123) |
| Accumulated other comprehensive income | 172 | 71 |
| TOTAL STOCKHOLDERS' DEFICIT | (17592) | (8857) |
| &nbsp;&nbsp;&nbsp; TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT | $18131 | $27337 |

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