clnn20230602_8k.htm
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 OR 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 14, 2023

CLENE INC.
(Exact name of registrant as specified in its charter)

 
Delaware
001-39834
85-2828339
(State or Other Jurisdiction
(Commission File Number)
(IRS Employer
of Incorporation)
 
Identification No.)
     
6550 South Millrock Drive, Suite G50
Salt Lake City, Utah
 
84121
(Address of Principal Executive Offices)
 
(Zip Code)
(801) 676-9695
(Registrant’s telephone number, including area code)
N/A
(Former Name or Former Address, if Changed Since Last Report.)

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:
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
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.


 

Item 2.02 Results of Operations and Financial Condition.
 
On August 14, 2023, Clene Inc. (the “Company”) issued a press release announcing its second quarter 2023 financial results and operating highlights for its quarter ended June 30, 2023. 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 (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 7.01 Regulation FD Disclosure.
 
In connection with the August 14, 2023 press release announcing the Company’s second quarter 2023 financial results and operating highlights for its quarter ended June 30, 2023, the Company released an updated corporate presentation (the “Corporate Presentation”) on its website, invest.clene.com. A copy of the Corporate Presentation is furnished as Exhibit 99.2 to this Current Report and is incorporated herein by reference. The Company plans to use its website to disseminate future updates to the Corporate Presentation and may not file or furnish a Current Report on Form 8-K alerting investors if the Corporate Presentation is updated.
 
The information furnished in this Item 7.01, including Exhibit 99.2, shall not be deemed to be “filed” for purposes of Section 18 of 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, 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
 
Exhibit
Number
 
Exhibit Description
99.1
 
99.2   Corporate Presentation.
104
 
Cover Page Interactive Data File (formatted as Inline XBRL).
 
1

 
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.
 
     
 
CLENE INC.
   
Date: August 14, 2023
By:
/s/ Robert Etherington
   
Robert Etherington
   
President and Chief Executive Officer
 
2
ex_529186.htm

Exhibit 99.1

 

CLENE REPORTS SECOND QUARTER 2023 FINANCIAL RESULTS AND OPERATING HIGHLIGHTS

 

 

Reported statistically significant reductions in plasma neurofilament light chain (NfL) levels compared to placebo at 24 weeks (p=0.04) in patients treated with CNM-Au8® in the HEALEY ALS Platform trial
  Announced publication of the results of the Phase 2 RESCUE ALS study and its open-label extension in the Lancet journal, eClinicalMedicine
  Received one year grant from the National Multiple Sclerosis Society (NMSS) that will fund Cohort 2 of REPAIR-MS, a Phase 2 clinical study investigating target engagement of CNM-Au8 in patients with non-active progressive MS
  Company expects multiple near-term data announcements that will further support benefit and safety of CNM-Au8 in people living with ALS
  Company is preparing for upcoming ALS regulatory discussions with FDA
  Cash, cash equivalents and marketable securities of $49.2 million as of June 30, 2023, which includes gross proceeds of $40 million from a recent public offering and that may provide additional capital up to $130 million through future warrant exercises

 

SALT LAKE CITY, August 14, 2023 -- 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 its second quarter 2023 financial results and provided recent operating highlights for the clinical programs in ALS and MS.

 

“Our recent financing has strengthened our capital position and provided the runway needed to advance our ALS clinical program with upcoming engagement with regulatory agencies, the initiation of our global Phase 3 in ALS (RESTORE-ALS), and additional clinical trial data read-outs,” said Rob Etherington, President and CEO of Clene. “We look forward to additional long-term clinical data, including survival, time-to-clinical-worsening and additional biomarker data, from the HEALEY ALS Platform trial. We are actively preparing for ALS regulatory discussions with the FDA and EMA, with meetings anticipated later this year. Additionally, we plan to continue advancing our clinical program in MS, while pursuing prospective partnering opportunities in parallel.”

 

Second Quarter 2023 and Recent Operating Highlights

 

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

 

 

Results of the Phase 2 RESCUE ALS study and its open-label extension trial were published in the Lancet journal, eClinicalMedicine. The article can be accessed via the following link:

https://authors.elsevier.com/sd/article/S2589537023002134.

  Clene reported that CNM-Au8 treatment demonstrated significantly reduced plasma NfL levels compared to placebo at 24 weeks (p=0.04). The results are based on an analysis of the plasma NfL biomarker across all Regimen C participants (CNM-Au8 or placebo, n=161) from the HEALEY ALS Platform trial.

 

CNM-Au8 for the treatment of MS

 

Clene received a one-year grant from NMSS that will fund Cohort 2 of REPAIR-MS, a Phase 2 clinical study investigating target engagement of CNM-Au8 in patients with non-active progressive MS. Using non-invasive brain imaging, the study will enroll up to 15 individuals with primary progressive or non-active secondary progressive MS and determine the effects of 12 weeks of daily oral dosing with CNM-Au8 on critical brain energy metabolites that have been shown to be compromised in individuals with MS.

 

Corporate Updates

 

On June 21, 2023, Clene announced the closing of its underwritten public offering. This financing raised gross proceeds of $40 million with potentially up to an additional $130 million in proceeds through future warrant exercises with expiration dates accelerated following the satisfaction of regulatory milestones. The investment was led by Vivo Capital with participation from SymBiosis, Acuta Capital Partners, AIGH Capital, Serrado Capital LLC and other new biotech investors, with support from existing investors.

 

Second Quarter 2023 Financial Results

 

Clene’s cash, cash equivalents and marketable securities totaled $49.2 million as of June 30, 2023, compared to $23.3 million as of December 31, 2022. Clene expects that its resources as of June 30, 2023, will be sufficient to fund its operations through mid-2024.

 

 

 

Research and development expenses were $6.6 million for the quarter ended June 30, 2023, compared to $9.2 million for the same period in 2022. The year-over-year decrease was primarily related to a decrease in expenses related to our lead drug candidate, CNM-Au8, due to a decrease in clinical trial expenses in our HEALEY ALS Platform Trial, RESCUE-ALS, REPAIR-MS, REPAIR-PD, and VISIONARY-MS clinical trials.

 

General and administrative expenses were $3.9 million for the quarter ended June 30, 2023, compared to $4.5 million for the same period in 2022. The year-over-year decrease was primarily attributable to decreases in directors’ and officers’ insurance fees and personnel expenses. These decreases were offset by an increase in finance and accounting fees, primarily due to increased fees from auditors, consultants, advisors and other financial vendors.

 

Total other expense was $14.8 million for the quarter ended June 30, 2023, compared to total other income of $9.1 million for the same period in 2022. The year-over-year increase in other expense was primarily attributable to an increase in interest expense, primarily due to increasing interest rates and increased amortization of debt discount and debt issuance costs on notes payable, changes in the fair value of contingent earn-out liabilities and changes in the fair value of common stock warrant liabilities offset by increased interest income. Additionally, in 2023 there was a loss on initial issuance of equity and charges for issuance costs related to the closing of the $40 million underwritten public offering in June 2023 that did not occur in 2022.

 

Clene reported a net loss of $25.1 million, or $0.29 per share, for the quarter ended June 30, 2023, compared to a net loss of $4.5 million, or $0.07 per share, for the same period in 2022.

 

About Clene

Clene is a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including ALS and MS, 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 Twitter, LinkedIn and Facebook.

 

About CNM-Au8®

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

This press release contains “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, which are intended to be covered by the “safe harbor” provisions created by those laws. Clene’s forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding our future operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements represent our views as of the date of this press release and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include our ability to demonstrate the efficacy and safety of our drug candidates; the clinical results for our drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; our ability to achieve commercial success for our drug candidates, if approved; our limited operating history and our ability to obtain additional funding for operations and to complete the development and commercialization of our drug candidates; and other risks and uncertainties set forth in “Risk Factors” in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to rely unduly upon these statements. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.

 

 

 

Media Contact

Investor Contact

Ignacio Guerrero-Ros, Ph.D., or David Schull

Kevin Gardner

Russo Partners, LLC

LifeSci Advisors
Ignacio.guerrero-ros@russopartnersllc.com

kgardner@lifesciadvisors.com

David.schull@russopartnersllc.com

617-283-2856
(858) 717-2310  

 

 

CLENE INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share amounts)

(Unaudited)

 

   

Three Months Ended June 30,

   

Six Months Ended June 30,

 
   

2023

   

2022

   

2023

   

2022

 

Revenue:

                               

Product revenue

  $ 226     $ 2     $ 290     $ 9  

Royalty revenue

    43       33       86       56  

Total revenue

    269       35       376       65  

Operating expenses:

                               

Cost of revenue

    66             71        

Research and development

    6,615       9,166       14,010       17,746  

General and administrative

    3,924       4,464       7,363       9,250  

Total operating expenses

    10,605       13,630       21,444       26,996  

Loss from operations

    (10,336 )     (13,595 )     (21,068 )     (26,931 )

Other income (expense), net:

                               

Interest income

    213       61       385       85  

Interest expense

    (1,104 )     (751 )     (2,170 )     (1,533 )

Gain on termination of lease

                      420  

Commitment share expense

    (3 )           (402 )      

Issuance costs for common stock warrant liability

    (333 )           (333 )      

Loss on initial issuance of equity

    (14,840 )           (14,840 )      

Change in fair value of common stock warrant liabilities

    (383 )     20       (383 )     2  

Change in fair value of Clene Nanomedicine contingent earn-out liability

    1,165       8,310       1,110       8,253  

Change in fair value of Initial Stockholders contingent earn-out liability

    150       1,066       143       1,054  

Research and development tax credits and unrestricted grants

    341       356       655       655  

Other income (expense), net

    (13 )     (1 )     (10 )     107  

Total other income (expense), net

    (14,807 )     9,061       (15,845 )     9,043  

Net loss before income taxes

    (25,143 )     (4,534 )     (36,913 )     (17,888 )

Income tax benefit

                       

Net loss

    (25,143 )     (4,534 )     (36,913 )     (17,888 )
                                 

Other comprehensive loss:

                               

Unrealized gain (loss) on available-for-sale securities

    6       (37 )     20       (87 )

Foreign currency translation adjustments

    (53 )     (110 )     (49 )     (60 )

Total other comprehensive loss

    (47 )     (147 )     (29 )     (147 )

Comprehensive loss

  $ (25,190 )   $ (4,681 )   $ (36,942 )   $ (18,035 )
                                 

Net loss per share – basic and diluted

  $ (0.29 )   $ (0.07 )   $ (0.46 )   $ (0.28 )

Weighted average common shares used to compute basic and diluted net loss per share

    86,050,405       63,335,271       81,077,661       63,095,400  

 

 

CLENE INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share amounts)

(Unaudited)

 

   

June 30,

   

December 31,

 
   

2023

   

2022

 

ASSETS

               

Current assets:

               

Cash and cash equivalents

  $ 49,243     $ 18,332  

Marketable securities

          4,983  

Accounts receivable

    161       189  

Inventory

    52       43  

Prepaid expenses and other current assets

    3,915       5,648  

Total current assets

    53,371       29,195  

Restricted cash

    58       58  

Operating lease right-of-use assets

    4,383       4,602  

Property and equipment, net

    10,033       10,638  

TOTAL ASSETS

  $ 67,845     $ 44,493  
                 

LIABILITIES AND STOCKHOLDERS’ EQUITY

               

Current liabilities:

               

Accounts payable

  $ 846     $ 3,014  

Accrued liabilities

    4,298       3,863  

Operating lease obligations, current portion

    529       488  

Finance lease obligations, current portion

    62       74  

Notes payable, current portion

          6,418  

Total current liabilities

    5,735       13,857  

Operating lease obligations, net of current portion

    5,235       5,557  

Finance lease obligations, net of current portion

          34  

Notes payable, net of current portion

    16,017       9,483  

Convertible notes payable

    9,822       9,770  

Common stock warrant liabilities

    8,201        

Clene Nanomedicine contingent earn-out liability

    1,154       2,264  

Initial Stockholders contingent earn-out liability

    148       291  

TOTAL LIABILITIES

    46,312       41,256  

Commitments and contingencies

               

Stockholders’ equity:

               

Common stock, $0.0001 par value: 300,000,000 and 150,000,000 shares authorized at June 30, 2023 and December 31, 2022, respectively; 128,401,112 and 74,759,591 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively

    13       7  

Additional paid-in capital

    251,478       196,246  

Accumulated deficit

    (230,132 )     (193,219 )

Accumulated other comprehensive income

    174       203  

TOTAL STOCKHOLDERS’ EQUITY

    21,533       3,237  

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

  $ 67,845     $ 44,493  

 

 
Image Exhibit

Exhibit 99.2

 

https://cdn.kscope.io/5afdc377a8cc73d7caff7690bd1abf21-a01.jpg

 

 

 

 
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