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): October 31, 2022
Clene Inc.
(Exact name of registrant as specified in its charter)
Delaware |
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001-39834 |
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85-2828339 |
(State or Other Jurisdiction |
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(Commission File Number) |
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(IRS Employer |
of Incorporation) |
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Identification No.) |
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6550 South Millrock Drive, Suite G50 Salt Lake City, Utah |
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84121 |
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(Address of Principal Executive Offices) |
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(Zip Code) |
Registrant’s telephone number, including area code: (801) 676-9695
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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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 |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common Stock, $0.0001 par value |
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CLNN |
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The Nasdaq Capital Market |
Warrants, to acquire one-half of one share of Common Stock for $11.50 per share |
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CLNNW |
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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 1.01 Entry into a Material Definitive Agreement.
On October 31, 2022, Clene Inc. (the “Company”) entered into securities purchase agreement (the “Securities Purchase Agreement”) with certain of the Company’s existing stockholders, including stockholders affiliated with directors of the Company (the “Purchasers”), pursuant to which the Company agreed to issue and sell, in a registered direct offering (the “Offering”), 10,723,926 shares of common stock, par value $0.0001 per share, at a sale price of $1.01 per share. The Offering is being made without a placement agent, underwriter, broker or dealer and the Company is not paying underwriting discounts or commissions.
The aggregate gross proceeds to the Company, before expenses, will be approximately $10.8 million. The estimated total expenses of the Offering will be approximately $20,000. The closing of the Offering is expected to occur on November 2, 2022, subject to the satisfaction of customary closing conditions.
The Offering is being made pursuant to the Company’s registration statement on Form S-3 (file number 333-264299) (the “Registration Statement”), filed with the Securities and Exchange Commission (the “SEC”) on April 14, 2022 and declared effective on April 26, 2022, and the Company’s prospectus supplement relating to the Offering, filed with the SEC on October 31, 2022, that forms part of the Registration Statement.
The Securities Purchase Agreement contain customary representations, warranties, covenants and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Purchasers, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions.
The foregoing description of the Securities Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the text of the form of Securities Purchase Agreement, which is filed herewith as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.
A copy of the legal opinion of Holland & Knight LLP, relating to the validity of the shares issued in the Offering, is filed as Exhibit 5.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 8.01 Other Events.
On October 31, 2022, the Company issued a press release announcing the Offering. 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 8.01, 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 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit |
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Exhibit Description |
5.1 |
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10.1 |
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23.1 |
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99.1 |
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104 |
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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. |
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Date: October 31, 2022 |
By: |
/s/ Robert Etherington |
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Robert Etherington |
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President and Chief Executive Officer |
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Exhibit 5.1
200 South Orange Avenue, Suite 2600 | Orlando, FL 32801 | T 407.425.8500 | F 407.244.5288
Holland & Knight LLP | www.hklaw.com
October 31, 2022
Clene Inc.
6550 South Millrock Drive, Suite G50
Salt Lake City, Utah 84121
Re: Clene Inc. – 10,723,926 Shares of Common Stock
Ladies and Gentlemen:
We have acted as special counsel to Clene Inc., a Delaware corporation (the “Company”), in connection with the issuance and sale of 10,723,926 shares (the “Shares”) of common stock, $0.0001 par value per share (the “Common Stock”). This opinion letter is being issued pursuant to the requirements of the Securities Act.
The Shares are to be sold by the Company pursuant to a securities purchase agreement (the “Securities Purchase Agreement”) proposed to be entered into by and among the Company and the investors signatory thereto. Capitalized terms in this opinion letter that are not otherwise defined herein have the meanings ascribed to them in the Securities Purchase Agreement.
In connection with the foregoing, we have examined certain records of the Company, certificates of public officials and officers of the Company, and such other documents as we have deemed relevant for purposes of the opinion expressed below.
With respect to various factual matters material to the opinion expressed below, we have relied upon certificates and information furnished by public officials and representatives of the Company.
We have assumed without inquiry or other investigation: (i) the legal capacity of each natural person executing the agreements described herein; (ii) the full power and authority of each entity other than the Company to execute, deliver and perform such agreements and each document executed and delivered or to be executed and delivered in connection therewith; (iii) the due authorization, execution and delivery by each entity other than the Company of each such agreement and each document executed and delivered or to be executed and delivered by such entity; (iv) that there have been no undisclosed modifications of any provision of any document reviewed by us in connection with the rendering of this opinion letter and no undisclosed prior waiver of any right or remedy contained in any of the documents; (v) the genuineness of each signature; (vi) the completeness of each document submitted to us; (vii) the authenticity of each document reviewed by us as an original; (viii) the conformity to the original of each document reviewed by us as a copy and the authenticity of the original of each document received by us as a copy; (ix) that each certificate or copy of a public record furnished by public officials is accurate, complete and authentic; and (x) the valid, legal, binding and enforceable nature of the obligations of all parties under the transaction documents other than the Company.
Clene Inc.
October 31, 2022
Page 2
Based upon the foregoing and subject to the assumptions, limitations, qualifications and exceptions set forth herein, we are of the opinion that when the Shares are issued and delivered against payment of the consideration thereof in accordance with the terms and conditions of the Securities Purchase Agreement, the Shares will be validly issued, fully paid and nonassessable.
Our opinion is limited to matters governed by the General Corporation Law of the State of Delaware, and we are expressing no opinion as to the effect of the laws of any other jurisdiction or, in the case of Delaware, any other laws, or as to any matters of municipal law or the laws of any local agencies within any state. This opinion letter is rendered as of the date hereof, and we undertake no, and hereby disclaim any, obligation to advise you of any change in any matter set forth herein. Our opinion is limited to the matters stated herein, and no opinion is to be implied or inferred beyond the matters stated herein.
We hereby consent to the filing of this opinion letter as an exhibit to the Company’s Current Report on Form 8-K, and further consent to the reference to our name under the caption “Legal Matters” in the Prospectus Supplement. In giving this consent, we do not admit that we are in the category of persons whose consent is required under Section 7 of the Securities Act or the rules and regulations of the Commission.
Very truly yours,
HOLLAND & KNIGHT LLP
/s/ Holland & Knight LLP
Exhibit 10.1
SECURITIES PURCHASE AGREEMENT
Clene Inc.
6550 South Millrock Drive, Suite G50
Salt Lake City, Utah 84121
Ladies and Gentlemen:
This Securities Purchase Agreement (this “Agreement”) is being entered into as of the last date set forth on the signature pages hereto, by and between Clene Inc., a Delaware corporation (the “Company”), and the undersigned investors identified on the signature pages hereto (each, including its successors and assigns, an “Investor” and collectively the “Investors”).
The Company and the Investors are entering into this Agreement for the purchase of 10,723,926 shares of the Company’s Common Stock in the aggregate (the “Shares”) in a registered direct offering for a purchase price of $1.01 per Share (the “Per Share Purchase Price”). The aggregate purchase price to be paid by each Investor for the purchased Shares (as set forth on the signature pages hereto) is referred to herein as the “Purchase Amount.”
In connection therewith, and in consideration of the foregoing and the mutual representations, warranties and covenants, and subject to the conditions, set forth herein, and intending to be legally bound hereby, each of the Investor and the Company acknowledges and agrees as follows:
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“Closing” means the closing of the purchase and sale of the Shares pursuant to Section 2.
“Closing Date” means the Trading Day on which all of the Transaction Documents have been executed and delivered by the applicable parties thereto, and all conditions precedent to (i) the Investors’ obligations to pay the Purchase Amount and (ii) the Company’s obligations to deliver the Shares, in each case, have been satisfied or waived, but in no event later than the second (2nd) Trading Day following the date hereof.
“Common Stock” means the common stock of the Company, par value $0.0001 per share, and any other class of securities into which such securities may hereafter be reclassified or changed.
“Disclosure Time” means, (i) if this Agreement is signed on a day that is not a Trading Day or after 9:00 a.m. (New York City time) and before midnight (New York City time) on any Trading Day, 9:01 a.m. (New York City time) on the Trading Day immediately following the date hereof, and (ii) if this Agreement is signed between midnight (New York City time) and 9:00 a.m. (New York City time) on any Trading Day, no later than 9:01 a.m. (New York City time) on the date hereof.
“Prospectus” means the final base prospectus filed for the Registration Statement.
“Prospectus Supplement” means the supplement to the Prospectus complying with Rule 424(b) of the Securities Act that is filed with the Commission and delivered by the Company to each Investor at the Closing.
“Registration Statement” means the effective registration statement with Commission (File No. 333-264299), including all information, documents and exhibits filed with or incorporated by reference into such registration statement, which registers the sale of the Shares to the Investors.
“Trading Day” means a day on which the principal Trading Market is open for trading.
“Trading Market” means the Nasdaq Capital Market (or any successors thereto).
“Transaction Documents” means this Agreement, all exhibits and schedules thereto and hereto and any other documents or agreements executed in connection with the transactions contemplated hereunder.
“Transfer Agent” means American Stock Transfer & Trust Company, LLC., the current transfer agent of the Company, with a mailing address of 6201 15th Avenue, Brooklyn, New York 11219, and any successor transfer agent of the Company.
[SIGNATURE PAGES FOLLOW]
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly executed by their respective authorized signatories as of the date indicated below.
CLENE Inc.
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Address for Notice: |
By:__________________________________________ Name: Title:
Date: October 31, 2022 |
Fax: E-mail: |
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[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK
SIGNATURE PAGE FOR INVESTOR FOLLOWS]
[INVESTOR SIGNATURE PAGES TO CLENE INC. SECURITIES PURCHASE AGREEMENT]
IN WITNESS WHEREOF, the undersigned have caused this Agreement to be duly executed by their respective authorized signatories as of the date indicated below.
Name of Investor: _______________________________________________________
Signature of Authorized Signatory of Investor:_________________________________
Name of Authorized Signatory:_____________________________________________
Title of Authorized Signatory:______________________________________________
Email Address of Authorized Signatory:______________________________________
Facsimile Number of Authorized Signatory:___________________________________
Address for Notice to Investor:
_____________________________________
_____________________________________
_____________________________________
Address for Delivery of Shares to Investor (if not same as address for notice):
_____________________________________
_____________________________________
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Purchase Amount: $ ____________________
Shares:_______________________________
EIN Number:__________________________
Date: ________________________________
[SIGNATURE PAGES CONTINUE]
Exhibit 99.1
Clene Announces
$10.8 Million Registered Direct Offering
and
$5 Million Debt Facility from the State of Maryland
SALT LAKE CITY, Oct. 31, 2022 (GLOBE NEWSWIRE) -- 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 disease, today announced that it has entered into a securities purchase agreement 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 a registered direct offering.
The closing of the registered direct offering is expected to occur on or about November 2, 2022, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $10.8 million. The registered direct offering is being made without a placement agent, underwriter, broker or dealer and, as a result, Clene is not paying any underwriter commission or discount. Clene intends to use the proceeds from this offering together with its existing cash for expenses primarily related to general corporate purposes, including to fund the clinical development of its lead drug candidate, CNM-Au8®.
The shares were offered pursuant to an effective shelf registration statement on Form S-3 (No. 333-264299) previously filed with the U.S. Securities and Exchange Commission (the “SEC”) and declared effective by the SEC on April 26, 2022. A final prospectus supplement and accompanying prospectus (collectively, the “Prospectus”) containing additional information relating to the offering will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sales of the securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Clene also announced that it has executed a Commitment Letter with the Maryland Department of Housing and Community Development (“DHCD”) to borrow $5 million (the “Loan Facility”). The State Small Business Credit Initiative (“SSBCI”) program within DHCD was provided the source funds for the Loan Facility by the U.S. Department of Treasury. The Loan Facility is conditioned on Clene matching the $5 million loan with at least $5 million of new equity capital. The closing of the registered direct offering referenced above will satisfy that condition of the Loan Facility. Clene is targeting December 1, 2022, as the tentative closing date for the Loan Facility.
Mark Mortenson, Founder & Chief Science Officer of Clene Nanomedicine, added, “We greatly appreciate the continued financial support from the State of Maryland and DHCD. This offered Loan Facility is another great example of effective public-private partnerships that support continued investment in activities that create high-value pharmaceutical manufacturing jobs, specifically producing nanotherapeutics at Clene that have the potential to improve the lives of people living with neurodegenerative diseases.”
Rob Etherington, CEO and President of Clene commented, “These funds, along with existing cash-on-hand, enable Clene to advance its pipeline in difficult-to-treat neurodegenerative diseases, focusing immediately on ALS. The proceeds from these two financings, once closed, one of which is non-dilutive, will further strengthen our balance sheet, enable sufficient capital to fund our operations into the third quarter 2023, and support the regulatory path to potential marketing authorization for CNM-Au8 in the treatment of ALS.”
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 Twitter, LinkedIn and Facebook.
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; uncertainty regarding whether potential strategic partnerships will result in any agreements or transactions, or, if completed, any agreements or transactions will be successful or on attractive terms; 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 filings with the SEC, including 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 |
David Schull |
Kevin Gardner |
Russo Partners, LLC |
LifeSci Advisors |
David.schull@russopartnersllc.com |
kgardner@lifesciadvisors.com |
(858) 717-2310 |
617-283-2856 |
Source: Clene Inc.