# EDGAR Filing Document

**Accession Number:** 0001822791
**File Stem:** 0001437749-23-006270
**Filing Date:** 2023-3
**Character Count:** 19580
**Document Hash:** 3312f4200029671c4e406630562aba68
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001437749-23-006270.hdr.sgml**: 20230313

**ACCESSION NUMBER**: 0001437749-23-006270

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20230313

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

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230313

**DATE AS OF CHANGE**: 20230313

**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:** 23725665

**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

clnn20221214_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 13, 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 2.02 Results of Operations and Financial Condition.**

On March 13, 2023, Clene Inc. (the "Company") issued a press release announcing its full year operating and financial results for its year ended December 31, 2022. 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**<br> **Number** | **Exhibit Description** |
| 99.1 | [Press Release, dated March 13, 2023, announcing the Company's operating and financial results for its year ended December 31, 2022.](ex_456562.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 13, 2023 | 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 2022 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS**

● *Amyotrophic lateral sclerosis (ALS): Significant survival benefits demonstrated across two ALS clinical trials, along with clinical improvements as early as six months* 

○ *CNM-Au8<sup>®</sup> associated with 74% lower risk of ALS clinical worsening events at six months supporting a survival benefit in the HEALEY ALS Platform Trial* 

○ *CNM-Au8 significantly preserved physical function (ALSFRS-R) from randomization to 48 weeks in the RESCUE-ALS Trial OLE follow-up* 

● *Multiple sclerosis (MS): Significant improvements in MS clinical outcomes including the visual system and global neurological function on top of immunomodulatory background standard-of-care in the VISIONARY-MS trial; significant paraclinical MRI and visual evoked potential (VEP) improvements reinforce clinical benefits:* 

○ *CNM-Au8 significantly improved information signaling from the eye to the brain's visual cortex as shown by multifocal VEP* 

○ *CNM-Au8 significantly improved brain neuronal structural integrity by MRI diffusion tensor imaging resulting in decreased brain deterioration* 

● *Clinical and quantitative paraclinical outcomes support the potential neuroprotective and remyelinating effects of CNM-Au8 for treatment of multiple neurodegenerative disorders* 

● *Cash, cash equivalents and marketable securities of $23.3 million as of December 31, 2022* 

**SALT LAKE CITY, March 13, 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 its full year 2022 financial results and provided recent operating highlights for the clinical programs in ALS and MS.

"We had an extremely productive year during which we generated consistent positive results from our clinical programs in ALS and MS that have helped advance both programs toward the next regulatory milestones. The initial placebo-controlled double-blinded Phase 2 RESCUE-ALS results were strengthened further with evidence of a survival benefit and preserved function at one year and beyond. The HEALEY ALS Platform Trial demonstrated consistent evidence of delayed time to ALS clinical worsening at six months in addition to a survival benefit," said Rob Etherington, President and CEO of Clene. "Results from our ALS clinical trials taken together along with significant Phase 2 findings of improvements in clinical outcomes, brain structure, and enhanced visual system signaling in stable MS patients from the VISIONARY-MS trial, have taught us of CNM-Au8's efficacy in multiple therapeutic areas. The totality of the clinical and paraclinical data are robust. In 2023, we will work to advance regulatory discussions with FDA on both ALS and MS and pursue partnering opportunities for the MS indication."

**Fourth Quarter 2022 and Recent Operating Highlights**

***CNM-Au8, a gold nanocrystal suspension, for the treatment of ALS***

New clinical improvement data from the HEALEY ALS Platform Trial (n=120 CNM-Au8 treated patients and 164 placebo-treated patients), led by the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital demonstrated a 74% decreased risk (lower hazard) of the composite endpoint of time to ALS clinical worsening (p = 0.035) as well as statistically significant and directional trends across all prespecified time to clinical worsening event analyses:

● 98% decreased risk (lower hazard) of death or permanently assisted ventilation (p= 0.028)

● 74% decreased risk of feeding tube placement (p= 0.035)

● 63% decreased risk of assisted ventilation (p= 0.058)

New clinical results showing preserved ALS patient functional score (ALSFRS-R) and delayed time to clinical worsening from the most recent 12-month data cut of the OLE of the Phase 2 RESCUE ALS trial in people with early ALS, specifically:

● Statistically significant difference in ALSFRS-R slope from day 1 (randomization) to week 48: among participants originally randomized to active compared to participants originally randomized to placebo (p=0.0159)

● Statistically significant difference in ALSFRS-R slope from week 60 to week 120 comparing participants originally randomized to active or placebo (p=0.0057).

● The risk of ALS progression was less than half for those originally receiving CNM-Au8 compared to those originally receiving placebo (p=0.0494).

Clene continues to support two expanded access programs providing CNM-Au8 treatment at four clinical sites to more than 50 participants with ALS and is presently expanding one EAP to include multiple centers across the U.S. and enroll up to 200 additional participants. The company plans to meet with the U.S. Food and Drug Administration (FDA) in an end of Phase 2 meeting during the third quarter of 2023 to discuss the regulatory path forward for CNM-Au8 in ALS.

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

New data from the VISIONARY MS trial from MRI and VEP provide evidence of improved information signaling from the eye to the brain's visual cortex and improved brain neuronal structural integrity and decreased brain deterioration further supporting primary and secondary results shared in August 2022, including:

● Multi-focal Visual Evoked Potential (mf-VEP) findings provide evidence of improved information transmission in the visual system (from the eye to the visual cortex) with increased amplitude signal suggesting previously impaired neurons subsequently increase information transmission following CNM-Au8 treatment, supporting improved axonal integrity:

○ mf-VEP amplitude percent change in the least affected eye at baseline – Week 48 least squares [LS] mean difference: 9.7%, 95% CI: 3.1% to 16.3%, p=0.0047

○ mf-VEP amplitude percent change across both eyes – Week 48 LS mean difference: 7.9%, 95% CI: 1.4% to 14.4%, p=0.0184

● MRI findings provide evidence of brain neuronal structural integrity assessed by diffusion tensor imaging (DTI) that demonstrated statistically significant results for key metrics of axonal integrity and white matter integrity, independent of an immunomodulatory effect, with:

○ Fractional Anisotropy change within the whole brain (Cerebrum) – Week 48 Least-Squares (LS) Mean Difference: 0.0029, 95% CI: 0.0048 to 0.0054, p = 0.0199

Clene plans to meet with the FDA in an end of Phase 2 meeting during the third quarter of 2023 to discuss the regulatory path forward for CNM-Au8 in MS.

***Corporate Updates***

● In November 2022, Clene closed a registered direct offering of $10.8 million with certain existing stockholders, including existing stockholders affiliated with Clene's board of directors, for the purchase and sale of 10,723,926 shares of the Company's common stock at a purchase price per share of $1.01, priced at-the-market based on the October 28, 2022, closing stock price.

● In December 2022, Clene closed a debt facility with the Maryland Department of Housing and Community Development to borrow $5.0 million.

● On March 3, 2023, Clene entered into common stock purchase agreement for up to $25.0 million with Lincoln Park Capital Fund, LLC.

**Full Year 2022 Financial Results**

Clene's cash, cash equivalents and marketable securities totaled $23.3 million as of December 31, 2022, compared to $50.3 million as of December 31, 2021. Clene expects that its resources as of December 31, 2022, will be sufficient to fund its operations into the third quarter of 2023.

Research and development expenses were $31.9 million for the year ended December 31, 2022, compared to $28.4 million for the same period in 2021. The year-over-year increase was primarily related to the development of CNM-Au8 and CNM-ZnAg, rent expense for the newly-leased facility in Elkton, Maryland, and personnel, partially offset by decreased stock-based compensation and depreciation expense.

General and administrative expenses were $16.9 million for the year ended December 31, 2022, compared to $22.0 million for the same period in 2021. The year-over-year decrease was primarily attributable to lower finance and accounting fees, legal expenses and stock-based compensation, offset by increased personnel expenses.

Total other income (expense) was $18.5 million for the year ended December 31, 2022, compared to $39.8 million for the same period in 2021. The year-over-year decrease was primarily attributable to a decrease in the change in the fair value of the Clene and initial shareholder contingent earn-out liability, an increase in interest expense due to increasing interest rates during 2022, and a decrease in the change in the fair value of the common stock warrant liability; offset by an increase in research and development credits received in 2022.

Clene reported a net loss of $29.9 million, or $0.46 per share, for the year ended December 31, 2022, compared to a net loss of $9.7 million, or $0.16 per share, for the same period in 2021.

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**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>.

**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.

**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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**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,** |
|  | **2022** | **2021** |
| Revenue: |  |  |
| Product revenue | $329 | $570 |
| Royalty revenue | 144 | 153 |
| Total revenue | 473 | 723 |
| Operating expenses: |  |  |
| Cost of revenue | 26 | 289 |
| Research and development | 31920 | 28416 |
| General and administrative | 16936 | 21996 |
| Total operating expenses | 48882 | 50701 |
| Loss from operations | (48409) | (49978) |
| Other income (expense), net: |  |  |
| Interest expense | (3296) | (870) |
| Gain on extinguishment of notes payable |  | 648 |
| Gain on termination of lease | 420 |  |
| Change in fair value of common stock warrant liability | 169 | 983 |
| Change in fair value of Clene Nanomedicine contingent earn-out liability | 15836 | 33953 |
| Change in fair value of Initial Stockholders contingent earn-out liability | 2026 | 3589 |
| Research and development tax credits and unrestricted grants | 3079 | 1519 |
| Other income (expense), net | 257 | (12) |
| Total other income (expense), net | 18491 | 39810 |
| Net loss before income taxes | (29918) | (10168) |
| Income tax benefit |  | 428 |
| Net loss | (29918) | (9740) |
| Other comprehensive loss: |  |  |
| Unrealized loss on available-for-sale securities | (14) |  |
| Foreign currency translation adjustments | (16) | (92) |
| Total other comprehensive loss | (30) | (92) |
| Comprehensive loss | $(29948) | $(9832) |
| Net loss per share – basic and diluted | $(0.46) | $(0.16) |
| Weighted average common shares used to compute basic and diluted net loss per share | 65204663 | 61558455 |

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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,** |
|  | **2022** | **2021** |
| **ASSETS** |  |  |
| Current assets: |  |  |
| Cash and cash equivalents | $18332 | $50288 |
| Marketable securities | 4983 |  |
| Accounts receivable | 189 | 49 |
| Inventory | 43 | 41 |
| Prepaid expenses and other current assets | 5648 | 4205 |
| Total current assets | 29195 | 54583 |
| Restricted cash | 58 | 58 |
| Right-of-use assets | 4602 | 3250 |
| Property and equipment, net | 10638 | 5172 |
| TOTAL ASSETS | $44493 | $63063 |
| **LIABILITIES AND STOCKHOLDERS' EQUITY** |  |  |
| Current liabilities: |  |  |
| Accounts payable | $3014 | $1923 |
| Accrued liabilities | 3863 | 3610 |
| Operating lease obligations, current portion | 488 | 347 |
| Finance lease obligations, current portion | 74 | 146 |
| Notes payable, current portion | 6418 |  |
| Total current liabilities | 13857 | 6026 |
| Operating lease obligations, net of current portion | 5557 | 4370 |
| Finance lease obligations, net of current portion | 34 | 97 |
| Notes payable, net of current portion | 9483 | 14484 |
| Convertible notes payable | 9770 | 4598 |
| Common stock warrant liability |  | 474 |
| Clene Nanomedicine contingent earn-out liability | 2264 | 18100 |
| Initial Stockholders contingent earn-out liability | 291 | 2317 |
| TOTAL LIABILITIES | 41256 | 50466 |
| Commitments and contingencies |  |  |
| Stockholders' equity: |  |  |
| Common stock, $0.0001 par value: 150,000,000 shares authorized; 74,759,591 and 62,312,097 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively | 7 | 6 |
| Additional paid-in capital | 196246 | 175659 |
| Accumulated deficit | (193219) | (163301) |
| Accumulated other comprehensive income | 203 | 233 |
| TOTAL STOCKHOLDERS' EQUITY | 3237 | 12597 |
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $44493 | $63063 |

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