Statistik Asas
CIK | 1822791 |
SEC Filings
SEC Filings (Chronological Order)
September 5, 2025 |
Up to $6,280,000 Clene Inc. Common Stock Filed Pursuant to Rule 424(b)(5) PROSPECTUS SUPPLEMENT No. 2 Registration No. 333-286058 (To Prospectus dated April 25, 2025 and Prospectus Supplement dated April 28, 2025 and Prospectus Supplement No. 1 dated July 3, 2025) Up to $6,280,000 Clene Inc. Common Stock This prospectus supplement supplements, modifies and supersedes, only to the extent indicated herein, certain information contained in |
|
September 5, 2025 |
Table 1: Newly Registered Securities Calculation of Filing Fee Tables S-8 Clene Inc. Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee 1 Equity Common Stock, par value $0.0001 per share Other 800,000 $ 5.29 $ 4,232,000.00 0.0001531 $ 647.92 Total Offering Amounts: $ |
|
September 5, 2025 |
As filed with the Securities and Exchange Commission on September 5, 2025 As filed with the Securities and Exchange Commission on September 5, 2025 Registration No. |
|
September 5, 2025 |
As filed with the Securities and Exchange Commission on September 5, 2025 As filed with the Securities and Exchange Commission on September 5, 2025 Registration No. |
|
September 5, 2025 |
Calculation of Filing Fee Tables S-3 Clene Inc. Table 1: Newly Registered and Carry Forward Securities ☐Not Applicable Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Carry Forward Form Type Carry Forward File Number Carry Forward Initial Effectiv |
|
September 5, 2025 |
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): September 5, 2025 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 o |
|
August 14, 2025 |
CLENE REPORTS Second QUARTER 2025 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS Exhibit 99.1 CLENE REPORTS Second QUARTER 2025 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS ● Following constructive FDA feedback on its proposed statistical analysis plan, Clene plans to analyze the neurofilament light data from its large NIH-sponsored Early Access Protocol early in the fourth quarter of 2025 ● A second Type C meeting has been scheduled with the FDA in the third quarter of 2 |
|
August 14, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-39834 CLENE INC. |
|
August 14, 2025 |
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 13, 2025 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 |
|
August 14, 2025 |
Exhibit 10.3 Certain information (as indicated by “[*]”) has been redacted from this Exhibit in accordance with Item 601(a)(6) of Regulation S-K. NOTE PURCHASE AGREEMENT This Note Purchase Agreement (this “Agreement”) is made as of August 13, 2025, by and among Clene Inc., a Delaware corporation (the “Company”), each of the persons and entities listed on Exhibit A attached hereto (the “Schedule of |
|
August 14, 2025 |
Form of Senior Secured Convertible Promissory Note. Exhibit 10.4 THIS NOTE AND THE SHARES OF CAPITAL STOCK ISSUABLE UPON CONVERSION HEREOF HAVE NOT BEEN REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED, OR UNDER THE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION, AND MAY NOT BE SOLD, ASSIGNED, TRANSFERRED, PLEDGED OR OTHERWISE DISPOSED OF EXCEPT IN COMPLIANCE WITH, OR PURSUANT TO AN EXEMPTION FROM, THE REGISTRATION REQUIREM |
|
August 14, 2025 |
Form of Amended and Restated Senior Secured Convertible Promissory Note. Exhibit 10.2 THIS NOTE AND THE SHARES OF CAPITAL STOCK ISSUABLE UPON CONVERSION HEREOF HAVE NOT BEEN REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED, OR UNDER THE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION, AND MAY NOT BE SOLD, ASSIGNED, TRANSFERRED, PLEDGED OR OTHERWISE DISPOSED OF EXCEPT IN COMPLIANCE WITH, OR PURSUANT TO AN EXEMPTION FROM, THE REGISTRATION REQUIREM |
|
August 14, 2025 |
Exhibit 10.1 Certain information (as indicated by “[*]”) has been redacted from this Exhibit in accordance with Item 601(a)(6) of Regulation S-K. FIRST AMENDMENT TO NOTE PURCHASE AGREEMENT This First Amendment to Note Purchase Agreement and Senior Secured Convertible Promissory Notes (this “Amendment”) is made as of August 13, 2025, by and among Clene Inc., a Delaware corporation (the “Company”), |
|
July 3, 2025 |
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): July 3, 2025 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 inc |
|
July 3, 2025 |
Up to $2,015,000 Clene Inc. Common Stock Filed Pursuant to Rule 424(b)(5) PROSPECTUS SUPPLEMENT No. 1 Registration No. 333-286058 (To Prospectus dated April 25, 2025 and Prospectus Supplement dated April 28, 2025) Up to $2,015,000 Clene Inc. Common Stock This prospectus supplement supplements, modifies and supersedes, only to the extent indicated herein, certain information contained in our prospectus supplement dated April 28, 2025 (the |
|
June 30, 2025 |
Exhibit 99.1 CLENE PROVIDES REGULATORY UPDATE FOLLOWING CONSTRUCTIVE FDA TYPE-C MEETING ON NEUROFILAMENT BIOMARKER ANALYSIS PLAN AND CONFIRMS TWO ADDITIONAL FDA MEETINGS ● FDA provides supportive feedback on proposed statistical analysis plan for neurofilament biomarker analysis of Clene’s NIH-sponsored Expanded Access Program ● NfL EAP biomarker analyses to be conducted early in the 4th Quarter o |
|
June 30, 2025 |
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): June 30, 2025 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 in |
|
June 17, 2025 |
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): June 17, 2025 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 in |
|
May 23, 2025 |
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): May 21, 2025 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 inc |
|
May 23, 2025 |
Clene Inc. Amended Board of Directors Compensation Program. Exhibit 10.2 CLENE INC. BOARD OF DIRECTORS COMPENSATION PROGRAM Adopted by action of the Board of Directors on April 16, 2021, as amended May 21, 2025 Annual Board Service Grant of Options Each nonemployee director serving at the time of the adoption of this Program and thereafter that has then served at least six months on the Board of Directors (“Board”) at the time of each Annual Meeting of Sto |
|
May 23, 2025 |
Clene Inc. Amended 2020 Stock Plan. Exhibit 10.1 CLENE INC. AMENDED 2020 STOCK PLAN 1. Purpose. The purpose of this Amended 2020 Stock Plan (the “Plan”) is to enable Clene Inc., a Delaware corporation (the “Company”), to attract and retain the services of (i) selected employees, officers, and directors of the Company or any parent or subsidiary of the Company, and (ii) selected nonemployee agents, consultants, advisers, and independ |
|
May 16, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM SD SPECIALIZED DISCLOSURE REPORT CLENE INC. (Exact name of registrant as specified in its charter) Delaware 001-39834 85-2828339 (State or other jurisdiction of (Commission File Number) (I.R.S. Employer incorporation or organization) Identification No.) 6550 South Millrock Drive, Suite G50 Salt Lake City, Utah 84121 (Addr |
|
May 7, 2025 |
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): May 6, 2025 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 inco |
|
May 7, 2025 |
CLENE REPORTS First QUARTER 2025 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS Exhibit 99.1 CLENE REPORTS First QUARTER 2025 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS ● Clene preparing for upcoming meeting in the second quarter with the U.S. Food and Drug Administration (FDA) to reach agreement on its statistical analysis plan (SAP) regarding analysis of neurofilament light chain (NfL) biomarker data ● Clene collecting NfL biomarker data from its large National Insti |
|
May 7, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-39834 CLENE INC |
|
April 28, 2025 |
Up to $1,950,000 Clene Inc. Common Stock Filed Pursuant to Rule 424(b)(5) PROSPECTUS SUPPLEMENT Registration No. 333-286058 (To Prospectus dated April 25, 2025) Up to $1,950,000 Clene Inc. Common Stock We have entered into an equity distribution agreement dated April 28, 2025 (the “Equity Distribution Agreement”) with Canaccord Genuity LLC (“Canaccord”), relating to the offer and sale of shares of our common stock, par value $0.0001 per |
|
April 28, 2025 |
Exhibit 99.1 CLENE INC. $25,000,000 EQUITY DISTRIBUTION AGREEMENT April 28, 2025 Canaccord Genuity LLC 1 Post Office Square, Suite 3000 Boston, Massachusetts 02109 Ladies and Gentlemen: Clene Inc., a Delaware corporation (the “Company”), confirms its agreement (this “Agreement”) with Canaccord Genuity LLC (the “Sales Agent”), as of the date first written above, as follows: The Company has prepared |
|
April 28, 2025 |
Entry into a Material Definitive Agreement, Financial Statements and Exhibits 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): April 28, 2025 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 i |
|
April 23, 2025 |
Clene Inc. 6550 South Millrock Drive, Suite G50 Salt Lake City, Utah 84121 Clene Inc. 6550 South Millrock Drive, Suite G50 Salt Lake City, Utah 84121 VIA EDGAR April 23, 2025 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Lauren Hamill Re: Clene Inc. Acceleration Request for Registration Statement on Form S-3 File No. 333-286058 Ladies and Gentlemen: Pursuant to Rule 461 |
|
April 8, 2025 |
Exhibit 99.3 CLENE PRESENTS EVIDENCE OF REMYELINATION AND NEURONAL REPAIR WITH CNM-Au8® TREATMENT AT THE AMERICAN ACADEMY OF NEUROLOGY LATE-BREAKING SCIENCE SESSION ● Analyses of MRI and VEP data confirm anatomical and physiological improvements, indicating remyelination and neuronal repair in the brains of MS patients treated with CNM-Au8 during the long-term extension of VISIONARY-MS ● Over 90% |
|
April 8, 2025 |
Exhibit 99.2 |
|
April 8, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☒ Definitive Proxy State |
|
April 8, 2025 |
VISIONARY-MS LTE Presentation. Exhibit 99.1 |
|
April 8, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Proxy State |
|
April 8, 2025 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events 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): April 8, 2025 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 in |
|
March 28, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Proxy State |
|
March 27, 2025 |
Clene Inc. 35,311 Shares of Common Stock Filed Pursuant to Rule 424(b)(5) Registration No. 333-264299 PROSPECTUS SUPPLEMENT (To Prospectus dated April 26, 2022) Clene Inc. 35,311 Shares of Common Stock We are issuing 35,311 shares (the “Shares”) of our common stock, par value $0.0001 per share (“common stock”), pursuant to this prospectus supplement and the accompanying base prospectus. The Shares are being issued directly to a counterpa |
|
March 27, 2025 |
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): March 26, 2025 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 i |
|
March 24, 2025 |
Up to $3,385,000 Clene Inc. Common Stock Filed Pursuant to Rule 424(b)(5) Registration No. 333-264299 PROSPECTUS SUPPLEMENT No. 1 (To Prospectus dated April 26, 2022 and Prospectus Supplement dated December 10, 2024) Up to $3,385,000 Clene Inc. Common Stock This prospectus supplement, or this supplement, supplements, modifies and supersedes, only to the extent indicated herein, certain information contained in our prospectus supplement d |
|
March 24, 2025 |
Subsidiaries of the Registrant. Exhibit 21.1 Subsidiaries of Clene Inc. Name of Subsidiary Jurisdiction of Organization Clene Nanomedicine, Inc. Delaware Clene Australia Pty Ltd Australia dOrbital, Inc. Delaware Clene Netherlands B.V. Netherlands |
|
March 24, 2025 |
As filed with the Securities and Exchange Commission on March 24, 2025 As filed with the Securities and Exchange Commission on March 24, 2025 Registration No. |
|
March 24, 2025 |
Financial Statements and Exhibits, Results of Operations and Financial Condition 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): March 24, 2025 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 i |
|
March 24, 2025 |
Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) Clene Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Fees to Be P |
|
March 24, 2025 |
Clene Inc. Insider Trading Policy. Exhibit 19.1 Clene Inc. (the “Company”) SECURITIES TRADING POLICY (Adopted by the board of directors of the Company, effective December 30, 2020) This Policy governing trading by directors, officers and employees of the Company in the Company’s securities (or related companies’ securities) (this “Policy”) of the Company consists of three sections: Section I provides an overview; Section II sets fo |
|
March 24, 2025 |
Description of Securities of the Registrant. Exhibit 4.1 DESCRIPTION OF THE REGISTRANT’S SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 The following is a summary of the rights and preferences of the capital stock of Clene Inc. (the “Company,” “we,” “us,” or “our”). While we believe that the following description covers the material terms of our capital stock, the description may not contain all of the in |
|
March 24, 2025 |
CLENE REPORTS FULL YEAR 2024 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS Exhibit 99.1 CLENE REPORTS FULL YEAR 2024 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS ● Clene planning to submit a New Drug Application (NDA) in the second half of 2025 for potential Accelerated Approval of CNM-Au8® in ALS ● Clene planning to initiate the confirmatory Phase 3 RESTORE-ALS trial in subjects with ALS in mid-2025 ● Secured new $10.0 million debt facility at a lower interest rate |
|
March 24, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 01-39834 CLENE INC. (Exact nam |
|
March 12, 2025 |
Exhibit 99.1 CLENE DEMONSTRATES STRENGTHENED ALS SURVIVAL BENEFIT WITH CNM-Au8® TREATMENT New Cross-Regimen Analysis of HEALEY ALS Platform Trial Shows Significant Survival Advantage SALT LAKE CITY, March 12, 2025 – Clene, Inc. (Nasdaq: CLNN) and its subsidiary, Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseas |
|
March 12, 2025 |
Financial Statements and Exhibits, Other Events 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): March 12, 2025 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 i |
|
February 3, 2025 |
Clene Inc. Up to 1,146,789 Shares of Common Stock Filed Pursuant to Rule 424(b)(3) Registration No. 333-284479 PROSPECTUS Clene Inc. Up to 1,146,789 Shares of Common Stock This prospectus relates to the offer and resale, from time to time by the Selling Securityholders, of up to 1,146,789 shares of our common stock, par value $0.0001 per share (“common stock”), that may be issued upon the conversion of senior secured convertible promissory notes |
|
January 31, 2025 |
Clene Inc. 6550 South Millrock Drive, Suite G50 Salt Lake City, Utah 84121 Clene Inc. 6550 South Millrock Drive, Suite G50 Salt Lake City, Utah 84121 VIA EDGAR January 30, 2025 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Tyler Howes Re: Clene Inc. Acceleration Request for Registration Statement on Form S-3 File No. 333-284479 Ladies and Gentlemen: Pursuant to Rule 461 |
|
January 30, 2025 |
Entry into a Material Definitive Agreement, Financial Statements and Exhibits 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): January 28, 2025 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 |
|
January 30, 2025 |
Exhibit 10.1 SAPO: G19458 & G19791 FDP Subaward Amendment Awarding Agency National Institute of Health (NIH) Amendment No 01 PTE/Prime Award No. 5U01NS136023-02 Subaward No 2(GG011355-02) Pass-Through Entity (PTE) Subrecipient The Trustees of Columbia University in the City of New York Entity Name Clene Nanomedicine, Inc. [email protected] Contact Name [email protected] Jinsy An |
|
January 24, 2025 |
Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) Clene Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered(1) Proposed Maximum Aggregate Offering Price Per Unit(2) Maximum Aggregate Offering Price(2) Fee Rate Amount of Registrati |
|
January 24, 2025 |
As filed with the Securities and Exchange Commission on January 24, 2025 As filed with the Securities and Exchange Commission on January 24, 2025 Registration No. |
|
January 2, 2025 |
January 2, 2025 VIA EDGAR & ELECTRONIC MAIL U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Jenn Do and Kevin Vaughn Re: Clene Inc. Form 10-K for the fiscal year ended December 31, 2023 Filed March 13, 2024 File No. 001-39834 Ladies and Gentlemen: This letter sets forth the response of Clene Inc. ( |
|
December 20, 2024 |
Exhibit 99.1 CLENE IMPROVES CASH POSITION AND RUNWAY BY SECURING NEW DEBT FACILITY TO PAY OFF EXISTING SENIOR LOAN ● Secures new $10.0 million debt facility to replace remaining $7.85 million of Avenue Capital debt ● Improves cash position enabling Clene to generate the additional data to support the new drug application of CNM-Au8® for ALS via an accelerated regulatory pathway ● Carries a 12% int |
|
December 20, 2024 |
Exhibit 10.1 NOTE PURCHASE AGREEMENT This Note Purchase Agreement (this “Agreement”) is made as of December 17, 2024, by and among Clene Inc., a Delaware corporation (the “Company”), each of the persons and entities listed on Exhibit A attached hereto (the “Schedule of Purchasers”), as it may be amended as hereinafter provided (each, a “Purchaser” and collectively, the “Purchasers”) and Kensington |
|
December 20, 2024 |
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): December 17, 2024 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 o |
|
December 10, 2024 |
Exhibit 99.1 |
|
December 10, 2024 |
Exhibit 99.2 |
|
December 10, 2024 |
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): December 10, 2024 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 o |
|
December 10, 2024 |
Exhibit 99.4 FDA PROVIDES ROADMAP FOR ACCELERATED APPROVAL PATHWAY THROUGH SUBMISSION OF ADDITIONAL CNM-Au8® BIOMARKER DATA IN ALS ● FDA recommends that Clene leverage additional Neurofilament Light (NfL) data from its three Expanded Access Protocols (EAPs) and the HEALEY ALS Platform Trial to support earlier presented findings ● FDA recommends a follow-up meeting to discuss in more detail the ana |
|
December 10, 2024 |
Up to $7,390,000 Clene Inc. Common Stock Filed Pursuant to Rule 424(b)(5) Registration No. 333-264299 PROSPECTUS SUPPLEMENT (To Prospectus dated April 26, 2022) Up to $7,390,000 Clene Inc. Common Stock We have entered into an equity distribution agreement dated April 14, 2022, as amended on December 19, 2022 (together, the “Equity Distribution Agreement”) with Canaccord Genuity LLC (“Canaccord”), relating to the offer and sale of shares |
|
December 10, 2024 |
Exhibit 99.3 |
|
November 22, 2024 |
Clene Inc. Up to 2,351,202 Shares of Common Stock Filed Pursuant to Rule 424(b)(3) Registration No. 333-283204 PROSPECTUS Clene Inc. Up to 2,351,202 Shares of Common Stock This prospectus relates to the offer and resale, from time to time by the Selling Securityholders, of the following securities: (i) up to an aggregate of 379,930 shares of our common stock, par value $0.0001 per share (“common stock”), originally issued as part of three separat |
|
November 20, 2024 |
Clene Inc. 6550 South Millrock Drive, Suite G50 Salt Lake City, Utah 84121 Clene Inc. 6550 South Millrock Drive, Suite G50 Salt Lake City, Utah 84121 VIA EDGAR November 20, 2024 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Lauren Hamill Re: Clene Inc. Acceleration Request for Registration Statement on Form S-3 File No. 333-283204 Ladies and Gentlemen: Pursuant to Rule |
|
November 14, 2024 |
CLNN / Clene Inc. / ARMISTICE CAPITAL, LLC Passive Investment SC 13G 1 armistice-clnn093024.htm UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* CLENE INC. (Name of Issuer) Common Stock, $0.0001 par value, $0.0001 par value (Title of Class of Securities) 185634201 (CUSIP Number) September 30, 2024 (Date of Event Which Requires Filing of this Statement) Check the app |
|
November 13, 2024 |
Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) Clene Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered(1) Proposed Maximum Aggregate Offering Price Per Unit(2) Maximum Aggregate Offering Price(2) Fee Rate Amount of Registrati |
|
November 13, 2024 |
Exhibit 99.2 |
|
November 13, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 01-39834 CLENE |
|
November 13, 2024 |
CLENE REPORTS Third QUARTER 2024 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS Exhibit 99.1 CLENE REPORTS Third QUARTER 2024 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS ● Clene met with the U.S. Food and Drug Administration (FDA) on November 1, 2024 in a Type C meeting to discuss the potential for an accelerated approval pathway in ALS and are awaiting meeting minutes ● Cash, cash equivalents and marketable securities of $14.6 million as of September 30, 2024 ● Amended |
|
November 13, 2024 |
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): November 13, 2024 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 o |
|
November 13, 2024 |
As filed with the Securities and Exchange Commission on November 13, 2024 As filed with the Securities and Exchange Commission on November 13, 2024 Registration No. |
|
November 12, 2024 |
CLNN / Clene Inc. / Mosca Alison - SC 13G/A Passive Investment SC 13G/A 1 tm2427957d1sc13ga.htm SC 13G/A SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No.2 )* Clene Inc. (Name of Issuer) Common Stock, $0.0001 par value (Title of Class of Securities) 185634201 (CUSIP Number) September 30, 2024 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designat |
|
October 23, 2024 |
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 23, 2024 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 |
|
October 23, 2024 |
Exhibit 99.1 |
|
October 2, 2024 |
CLNN.W / Clene Inc. - Equity Warrant / MATLIN DAVID J Activist Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Fourth Amended and Restated SCHEDULE 13D Under the Securities Exchange Act of 1934 Clene Inc. (Name of Issuer) Common Stock, $0.0001 par value (Title of Class of Securities) 185634102 (CUSIP Number) David J. Matlin 61 Cedar Pt Lane Sag Harbor, NY 11963 (917) 841-2666 (Name, Address and Telephone Number of Person Authorized to |
|
October 2, 2024 |
SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G* (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO RULES 13d-1(b), (c), AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO RULE 13d-2 (AMENDMENT NO. 1)* Clene Inc. (Name of Issuer) Common Stock, $.0001 par value per share (Title of Class of Securities) G8959N130 (CUSIP Number) September 30, 2024 (Date of E |
|
September 30, 2024 |
Filed Pursuant to Rule 424(b)(5) Registration No. 333-264299 PROSPECTUS SUPPLEMENT (To Prospectus dated April 26, 2022) Clene Inc. 725,000 Shares of Common Stock Pre-Funded Warrants to Purchase up to 17,626 Shares of Common Stock We are offering (i) 725,000 shares of our common stock, par value $0.0001 per share (the “Registered Shares”), at an offering price of $4.713 per share, and (ii) pre-fund |
|
September 30, 2024 |
Exhibit 10.1 THIRD AMENDMENT TO SUPPLEMENT TO LOAN AND SECURITY AGREEMENT This Third Amendment to Supplement to Loan and Security Agreement (this “Amendment”) is entered into as of September 30, 2024, by and among AVENUE VENTURE OPPORTUNITIES FUND, L.P., a Delaware limited partnership (“Lender”) and CLENE INC., a Delaware corporation and CLENE NANOMEDICINE, INC., a Delaware corporation (individual |
|
September 30, 2024 |
Form of Affiliate Securities Purchase Agreement, dated September 30, 2024. Exhibit 10.3 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of September 30, 2024, between Clene Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively, the “Purchasers”). WHEREAS, subject to the terms and conditions set for |
|
September 30, 2024 |
Exhibit 4.3 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR |
|
September 30, 2024 |
Entry into a Material Definitive Agreement, Financial Statements and Exhibits 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): September 30, 2024 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 |
|
September 30, 2024 |
Form of Restricted Pre-Funded Warrant. Exhibit 4.2 THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE U.S. SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”) AND ARE “RESTRICTED SECURITIES” AS DEFINED IN RULE 144 PROMULGATED UNDER THE ACT. THE SECURITIES MAY NOT BE OFFERED, SOLD, PLEDGED, OR OTHERWISE DISTRIBUTED OR TRANSFERRED EXCEPT: (i) PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE ACT OR (ii) PURSUANT TO A |
|
September 30, 2024 |
Form of Amended and Restated Warrant to Purchase Shares of Stock of Clene Inc. Exhibit 4.1 THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE BEEN ACQUIRED FOR INVESTMENT AND NOT WITH A VIEW TO, OR IN CONNECTION WITH, THE SALE AND DISTRIBUTION THEREOF, AND HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”) OR ANY STATE SECURITIES LAWS. SUCH SECURITIES MAY NOT BE SOLD OR TRANSFERRED IN THE ABSENCE OF (A) SUCH REGISTRATION, (B) AN OPI |
|
September 30, 2024 |
Exhibit 99.1 CLENE ANNOUNCES $7.3 MILLION REGISTERED DIRECT OFFERING AND CONCURRENT PRIVATE PLACEMENTS PRICED AT MARKET UNDER NASDAQ RULES SALT LAKE CITY, September 30, 2024 – 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 ne |
|
September 30, 2024 |
Exhibit 10.4 PLACEMENT AGENCY AGREEMENT September 30, 2024 Canaccord Genuity LLC 1 Post Office Square 30th Floor Boston, Massachusetts 02109 Ladies and Gentlemen: Introduction. Subject to the terms and conditions herein (this “Agreement”), Clene Inc., a Delaware corporation (the “Company”), hereby agrees to sell up to an aggregate of (i) 725,000 registered shares (the “Registered Shares”) |
|
September 30, 2024 |
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): September 30, 2024 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 |
|
September 30, 2024 |
Filed Pursuant to Rule 424(b)(5) Registration No. 333-264299 PROSPECTUS SUPPLEMENT No. 2 (To Prospectus dated April 26, 2022 and Prospectus Supplement dated November 7, 2023 and Prospectus Supplement No. 1 dated May 8, 2024) Clene Inc. This Supplement No. 2 to the Prospectus Supplement supplements and amends the Prospectus Supplement dated November 7, 2023 (the “Prospectus Supplement”) and Supplem |
|
September 30, 2024 |
Form of Registered Securities Purchase Agreement, dated September 30, 2024. Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of September 30, 2024, between Clene Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”). WHEREAS, subject to the terms and conditions set fort |
|
September 30, 2024 |
Form of Private Securities Purchase Agreement, dated September 30, 2024. Exhibit 10.2 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of September 30, 2024, between Clene Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively, the “Purchasers”). WHEREAS, subject to the terms and conditions set for |
|
September 30, 2024 |
Form of Registered Pre-Funded Warrant. Exhibit 4.1 PREFUNDED COMMON STOCK PURCHASE WARRANT CLENE INC. Warrant Shares: Issue Date: October 1, 2024 Initial Exercise Date: October 1, 2024 THIS PREFUNDED COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on |
|
September 16, 2024 |
Exhibit 99.1 CLENE GRANTED IN-PERSON MEETING WITH FDA SENIOR LEADERSHIP TO DISCUSS CNM-AU8 BIOMARKER AND RELATED CLINICAL AND SURVIVAL DATA SALT LAKE CITY, September 16, 2024 - 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 improving mitochondrial health and protect |
|
September 16, 2024 |
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): September 16, 2024 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 |
|
August 7, 2024 |
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 7, 2024 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 i |
|
August 7, 2024 |
CLENE REPORTS Second QUARTER 2024 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS Exhibit 99.1 CLENE REPORTS Second QUARTER 2024 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS ● Survival analyses with CNM-Au8® 30 mg treatment compared to matched PRO-ACT controls demonstrated improved survival up to 3.5 years post-baseline ● CNM-Au8 treated participants in the HEALEY ALS Platform Trial with substantial neurofilament light (NfL) declines (CNM-Au8 NfL Responders) demonstrated s |
|
August 7, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 01-39834 CLENE INC. |
|
August 6, 2024 |
Exhibit 99.2 CLENE ANNOUNCES NEW CNM-Au8® BIOMARKER AND CLINICAL EFFICACY DATA SUBMITTED TO FDA IN SUPPORT OF TREATMENT FOR ALS ● CNM-Au8 treated participants in the HEALEY ALS Platform Trial with substantial neurofilament light (NfL) declines (CNM-Au8 NfL Responders) demonstrated significant clinical improvements in survival, functional status (slowed ALSFRS-R decline), and combined function and |
|
August 6, 2024 |
Exhibit 99.1 |
|
August 6, 2024 |
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 6, 2024 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 i |
|
July 26, 2024 |
Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing 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): July 25, 2024 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 in |
|
July 11, 2024 |
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): July 11, 2024 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 in |
|
July 11, 2024 |
Exhibit 99.1 Clene Announces Plans to Submit Briefing Book to the U.S. Food and Drug Administration in Connection with Granted Type C Interaction to Obtain FDA Feedback on Potential Pathway to Accelerated Approval for CNM-Au8® in ALS SALT LAKE CITY, July 11, 2024 - Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-s |
|
July 9, 2024 |
Clene Announces 1-for-20 Reverse Stock Split Exhibit 99.1 Clene Announces 1-for-20 Reverse Stock Split SALT LAKE CITY, July 9, 2024 - 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 scle |
|
July 9, 2024 |
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): July 8, 2024 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 inc |
|
July 9, 2024 |
Exhibit 3.1 CERTIFICATE OF AMENDMENT TO THE FOURTH AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF CLENE INC. (Pursuant to Sections 242 of the General Corporation Law of the State of Delaware) Clene Inc., a corporation organized and existing under and by virtue of the provisions of the General Corporation Law of the State of Delaware (the “General Corporation Law”), does hereby certify as fol |
|
June 18, 2024 |
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): June 17, 2024 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 in |
|
June 18, 2024 |
HEALEY ALS Platform Trial OLE Poster. Exhibit 99.1 |
|
June 18, 2024 |
Exhibit 99.2 Clene Presents Extended Survival Data Through 3.5 Years and New NfL Responder Results with CNM-Au8® 30 mg Treatment from the HEALEY ALS Platform Trial Open Label Extension at the 2024 ENCALS Meeting ● Survival analyses with CNM-Au8 30 mg treatment compared to matched PRO-ACT controls demonstrated improved survival up to 3.5 years post-baseline (hazard ratio: 0.431, p=0.0002) ● Average |
|
June 5, 2024 |
As filed with the Securities and Exchange Commission on June 5, 2024 As filed with the Securities and Exchange Commission on June 5, 2024 Registration No. |
|
June 5, 2024 |
Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) Clene Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered(1) Proposed Maximum Offering Price Per Unit(2) Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Fees t |
|
June 3, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM SD SPECIALIZED DISCLOSURE REPORT CLENE INC. (Exact name of registrant as specified in its charter) Delaware 001-39834 (State or other jurisdiction (Commission file number) of incorporation) 6550 South Millrock Drive, Suite G50 Salt Lake City, Utah 84121 (Address of principal executive offices) (Zip code) Jerry Miraglia, ( |
|
May 30, 2024 |
Exhibit 3.1 CERTIFICATE OF AMENDMENT TO THE FOURTH AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF CLENE INC. (Pursuant to Section 242 of the General Corporation Law of the State of Delaware) Clene Inc., a corporation organized and existing under and by virtue of the provisions of the General Corporation Law of the State of Delaware (the “General Corporation Law”), does hereby certify as foll |
|
May 30, 2024 |
UNITED STATES -12-31 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): May 29, 2024 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 |
|
May 30, 2024 |
Clene Inc. Amended 2020 Stock Plan. Exhibit 10.1 CLENE INC. AMENDED 2020 STOCK PLAN 1. Purpose. The purpose of this Amended 2020 Stock Plan (the “Plan”) is to enable Clene Inc., a Delaware corporation (the “Company”), to attract and retain the services of (i) selected employees, officers, and directors of the Company or any parent or subsidiary of the Company, and (ii) selected nonemployee agents, consultants, advisers, and independ |
|
May 8, 2024 |
CLENE REPORTS First QUARTER 2024 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS Exhibit 99.1 CLENE REPORTS First QUARTER 2024 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS ● Data from long-term extension of Phase 2 VISIONARY-MS clinical trial of CNM-Au8® demonstrated significant evidence of repair and remyelination across multiple paraclinical endpoints (change from original baseline, p<0.05) ● Peer-reviewed publication characterized the protein corona of CNM-Au8 ● Compan |
|
May 8, 2024 |
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): May 8, 2024 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 inco |
|
May 8, 2024 |
Up to $12,300,000 Clene Inc. Common Stock Filed Pursuant to Rule 424(b)(5) Registration No. 333-264299 PROSPECTUS SUPPLEMENT No. 1 (To Prospectus dated April 26, 2022 and Prospectus Supplement dated November 7, 2023) Up to $12,300,000 Clene Inc. Common Stock This prospectus supplement, or this supplement, supplements, modifies and supersedes, only to the extent indicated herein, certain information contained in our prospectus supplement d |
|
May 8, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 01-39834 CLENE INC. |
|
April 26, 2024 |
Exhibit 10.2 AMENDED AND RESTATED LICENSE AGREEMENT THIS AMENDED AND RESTATED LICENSE AGREEMENT (“Agreement”) and the Amended and Restated Supply Agreement are being entered between CLENE NANOMEDICINE, INC., a Delaware corporation (“Clene”) and 4LIFE RESEARCH, LLC, a Utah limited liability company (“4Life”) effective as of April 25, 2024 (the “Effective Date”). Clene and 4Life are sometimes collec |
|
April 26, 2024 |
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): April 25, 2024 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 i |
|
April 26, 2024 |
Exhibit 10.1 AMENDED AND RESTATED EXCLUSIVE SUPPLY AGREEMENT THIS AMENDED AND RESTATED EXCLUSIVE SUPPLY AGREEMENT (this “Agreement”), dated as of April 25, 2024 (the “Effective Date”), is entered into by and between CLENE NANOMEDICINE, INC., a Delaware corporation having its principal place of business at 3615 Millrock Dr., Salt Lake City, Utah 84121 (“Seller”), and 4LIFE RESEARCH, LLC, a Utah lim |
|
April 16, 2024 |
Exhibit 99.3 EVIDENCE FOR CLENE’S CNM-Au8® AS A TREATMENT FOR REPAIR AND REMYELINATION IN MULTIPLE SCLEROSIS PRESENTED IN THE EMERGING SCIENCE SESSION AT THE 2024 AMERICAN ACADEMY OF NEUROLOGY ANNUAL MEETING ● Long term extension of the Phase 2 VISIONARY-MS clinical trial of CNM-Au8 demonstrated significant evidence of repair and remyelination across multiple paraclinical endpoints (change from or |
|
April 16, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events 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): April 16, 2024 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 i |
|
April 16, 2024 |
VISIONARY-MS LTE Presentation. Exhibit 99.1 |
|
April 16, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Proxy State |
|
April 16, 2024 |
Exhibit 99.2 |
|
April 16, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☒ Definitive Proxy State |
|
April 9, 2024 |
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): April 3, 2024 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 in |
|
April 9, 2024 |
Exhibit 10.1 SAPO: G18548 & G18549 FDP Cost Reimbursement Subaward Federal Awarding Agency: National Institute of Health (NIH) Pass-Through Entity (PTE): The Trustees of Colombia University in the City of New York Subrecipient: Clene Nanomedicine Inc PTE PI: Jinsy Andrews Sub PI: Benjamin Greenberg PTE Federal Award No: 1U01NS136023-01 Subaward No: 2(GG011355-01) Project Title: Intermediate-sized |
|
April 5, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Proxy State |
|
March 13, 2024 |
CLENE REPORTS FULL YEAR 2023 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS Exhibit 99.1 CLENE REPORTS FULL YEAR 2023 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS ● Initiated discussions with FDA regarding accelerated approval pathway for CNM-Au8® for the treatment of ALS with the objective of submitting an NDA in 2024 ● Released long-term data from the open-label extension of the HEALEY ALS Platform Trial in which CNM-Au8 demonstrated statistically significant reduc |
|
March 13, 2024 |
Description of Securities of the Registrant. Exhibit 4.1 DESCRIPTION OF THE REGISTRANT’S SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 The following is a summary of the rights and preferences of the capital stock of Clene Inc. (the “Company,” “we,” “us,” or “our”). While we believe that the following description covers the material terms of our capital stock, the description may not contain all of the in |
|
March 13, 2024 |
Financial Statements and Exhibits, Results of Operations and Financial Condition 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): March 13, 2024 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 i |
|
March 13, 2024 |
Exhibit 97.1 CLENE INC. CLAWBACK POLICY November 28, 2023 1. Purpose. The purpose of this Clene Inc. (the “Company”) Clawback Policy (the “Policy”) is to provide for the recovery of certain incentive-based compensation in the event that the Company is required to prepare an Accounting Restatement (as defined below). This Policy is designed to comply with, and shall be interpreted to be consistent |
|
March 13, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 01-39834 CLENE INC. (Exact nam |
|
March 13, 2024 |
Subsidiaries of the Registrant. Exhibit 21.1 Subsidiaries of Clene Inc. Name of Subsidiary Jurisdiction of Organization Clene Nanomedicine, Inc. Delaware Clene Australia Pty Ltd Australia dOrbital, Inc. Delaware Clene Netherlands B.V. Netherlands |
|
February 29, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events 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): February 29, 2024 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 o |
|
February 29, 2024 |
VISIONARY-MS LTE Presentation. Exhibit 99.1 |
|
February 29, 2024 |
Exhibit 99.2 CLENE PRESENTS CLINICAL RESULTS OF CNM-Au8® 30MG TREATMENT FROM VISIONARY-MS TRIAL LONG-TERM EXTENSION AT ANNUAL ACTRIMS FORUM 2024 ● Long-term CNM-Au8 treatment demonstrated significant and clinically meaningful improvement of vision as measured by low contrast letter acuity (LCLA), an assessment of visual function in people living with multiple sclerosis (MS), through 35 months from |
|
February 22, 2024 |
Exhibit 99.1 |
|
February 22, 2024 |
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): February 22, 2024 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 o |
|
February 22, 2024 |
Exhibit 99.2 CLENE REPORTS SIGNIFICANT SURVIVAL BENEFIT WITH CNM-Au8® TREATMENT IN ALS EAP COMPASSIONATE USE PROGRAMS ● Two “Compassionate Use” Expanded Access Programs (EAPs) provided access to treatment with CNM-Au8 to more than 250 people living with amyotrophic lateral sclerosis (ALS). ● A significant survival benefit (p=0.0001) was observed in EAP participants treated with CNM-Au8 compared to |
|
February 14, 2024 |
VGG8959N1069 / Tottenham Acquisition I Limited / Mosca Alison - SC 13G/A Passive Investment SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. |
|
February 14, 2024 |
CLNN / Clene Inc. / CITADEL ADVISORS LLC - SC 13G/A Passive Investment SC 13G/A 1 tm245287d8sc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G* (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO § 240.13d-1(b), (c), AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO § 240.13d-2 (Amendment No. 1)* Clene Inc. (Name of Issuer) Common Stock, $0.0001 par value per share (the “Shares”) (Title of Cla |
|
February 13, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G/A UNDER THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. 1)* Clene, Inc. (Name of Issuer) Common Stock, $0.0001 par value per share (Title of Class of Securities) 185634102 (CUSIP Number) December 31, 2023 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pur |
|
January 31, 2024 |
Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing 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): January 30, 2024 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 |
|
January 8, 2024 |
Exhibit 99.2 CLENE REPORTS SIGNIFICANT IMPROVEMENT IN VISION AND COGNITION WITH CNM-Au8® TREATMENT IN VISIONARY-MS TRIAL LONG-TERM OPEN LABEL EXTENSION ● Long-term CNM-Au8 treatment demonstrated improvement of vision as measured by low contrast visual acuity (LCLA), an assessment of visual function in people living with multiple sclerosis (MS), through 35 months from randomization, p<0.0001 ● Long |
|
January 8, 2024 |
Exhibit 99.1 |
|
January 8, 2024 |
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): January 8, 2024 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 |
|
December 21, 2023 |
Exhibit 99.1 |
|
December 21, 2023 |
Exhibit 99.2 CLENE REPORTS REDUCTION IN BIOMARKER PLASMA NEUROFILAMENT LIGHT (NfL) LEVELS AND IMPROVED SURVIVAL WITH CNM-Au8® TREATMENT FROM HEALEY ALS PLATFORM TRIAL LONG-TERM OPEN LABEL EXTENSION ● CNM-Au8 30mg treatment demonstrated significantly reduced plasma neurofilament light chain (NfL) levels at 76 weeks relative to placebo (18 months from randomization, p=0.023) ● 60% decreased risk of |
|
December 21, 2023 |
CLENE PROVIDES UPDATE ON ALS CLINICAL DEVELOPMENT MEETING WITH FDA Exhibit 99.3 CLENE PROVIDES UPDATE ON ALS CLINICAL DEVELOPMENT MEETING WITH FDA SALT LAKE CITY, Dec. 21, 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 improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including a |
|
December 21, 2023 |
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): December 21, 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 o |
|
November 7, 2023 |
Exhibit 99.2 |
|
November 7, 2023 |
Up to $15,000,000 Clene Inc. Common Stock Filed Pursuant to Rule 424(b)(5) Registration No. 333-264299 PROSPECTUS SUPPLEMENT (To Prospectus dated April 26, 2022) Up to $15,000,000 Clene Inc. Common Stock We have entered into an equity distribution agreement (the “Equity Distribution Agreement”) with Canaccord Genuity LLC (“Canaccord”), relating to the offer and sale of shares of our common stock, par value $0.0001 per share. Under this pr |
|
November 7, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 01-39834 CLENE |
|
November 7, 2023 |
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): November 7, 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 |
|
November 7, 2023 |
CLENE REPORTS THIRD QUARTER 2023 FINANCIAL RESULTS AND OPERATING HIGHLIGHTS Exhibit 99.1 CLENE REPORTS THIRD QUARTER 2023 FINANCIAL RESULTS AND OPERATING HIGHLIGHTS ● Reported statistically significant improved survival benefit of 19.3 months and significantly delayed clinical worsening in patients treated with CNM-Au8® in the RESCUE ALS open-label extension trial ● Reported statistically significant long-term survival benefit of 70% decreased risk of death associated wit |
|
October 6, 2023 |
Clene Inc. Up to 3,000,000 Shares of Common Stock Filed Pursuant to Rule 424(b)(3) Registration No. 333-274651 PROSPECTUS Clene Inc. Up to 3,000,000 Shares of Common Stock This prospectus relates to the offer and resale from time to time by the Selling Securityholder, of up to an aggregate of 3,000,000 shares of Clene Inc. common stock, par value $0.0001 per share, that may be issued upon the exercise of a warrant to purchase common stock at an e |
|
October 4, 2023 |
Clene Inc. 6550 South Millrock Drive, Suite G50 Salt Lake City, Utah 84121 Clene Inc. 6550 South Millrock Drive, Suite G50 Salt Lake City, Utah 84121 VIA EDGAR October 4, 2023 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Lauren Hamill and Laura Crotty Re: Clene Inc. Acceleration Request for Registration Statement on Form S-3 File No. 333-274651 Ladies and Gentlemen: Pu |
|
September 29, 2023 |
Clene Inc. 6550 South Millrock Drive, Suite G50 Salt Lake City, Utah 84121 Clene Inc. 6550 South Millrock Drive, Suite G50 Salt Lake City, Utah 84121 September 29, 2023 VIA EDGAR & ELECTRONIC MAIL U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Lauren Hamill and Laura Crotty Re: Clene Inc. Registration Statement on Form S-3 Filed September 22, 2023 File No. 333-274651 Lad |
|
September 29, 2023 |
As filed with the Securities and Exchange Commission on September 29, 2023 As filed with the Securities and Exchange Commission on September 29, 2023 Registration No. |
|
September 25, 2023 |
Exhibit 99.1 |
|
September 25, 2023 |
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): September 25, 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 |
|
September 25, 2023 |
Exhibit 99.2 CLENE REPORTS SIGNIFICANT LONG-TERM SURVIVAL IMPROVEMENT FROM CNM-Au8 TREATMENT IN HEALEY ALS PLATFORM TRIAL COMPARED TO PRO-ACT HISTORICAL CONTROLS ● Prolonged life with 49% decreased risk of death for participants in the HEALEY ALS Platform Trial treated with CNM-Au8® 30mg compared to PRO-ACT matched placebo over long-term follow-up, p=0.046 ● Prolonged life with 59% decreased risk |
|
September 22, 2023 |
As filed with the Securities and Exchange Commission on September 22, 2023 As filed with the Securities and Exchange Commission on September 22, 2023 Registration No. |
|
September 22, 2023 |
Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) Clene Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered(1) Proposed Maximum Offering Price Per Unit(2) Maximum Aggregate Offering Price(2) Fee Rate Amount of Registration Fee Fee |
|
September 19, 2023 |
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): September 18, 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 |
|
September 11, 2023 |
VGG8959N1069 / Tottenham Acquisition I Limited / Ugwumba Chidozie - SCHEDULE 13G Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO RULES 13d-1(b), (c), AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO RULE 13d-2 Under the Securities Exchange Act of 1934 Clene Inc. (Name of Issuer) Common Stock, $.0001 par value per share (Title of Class of Securities) G8959N130 (CUSIP N |
|
August 29, 2023 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events 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 29, 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 |
|
August 29, 2023 |
Exhibit 99.2 CLENE REPORTS SIGNIFICANTLY IMPROVED SURVIVAL BENEFIT OF 19.3 MONTHS AND SIGNIFICANTLY DELAYED CLINICAL WORSENING IN RESCUE-ALS OPEN-LABEL EXTENSION TWO YEAR FOLLOW-UP ● 19.3 month significant survival difference for CNM-Au8® treated participants versus placebo ● 52% significant decreased risk of ALS clinical worsening events ● Over 475 years of CNM-Au8 treatment exposure without any |
|
August 29, 2023 |
Exhibit 99.1 |
|
August 14, 2023 |
CLENE REPORTS SECOND QUARTER 2023 FINANCIAL RESULTS AND OPERATING HIGHLIGHTS 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 th |
|
August 14, 2023 |
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 |
|
August 14, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 01-39834 CLENE INC. |
|
August 14, 2023 |
Exhibit 99.2 |
|
August 4, 2023 |
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 1, 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 I |
|
July 3, 2023 |
EXHIBIT 99.1 JOINT FILING AGREEMENT The undersigned hereby agree that the Statement on Schedule 13G filed herewith (and any amendments thereto), relating to the Shares of Clene Inc., a Delaware corporation, is being filed jointly with the Securities and Exchange Commission pursuant to Rule 13d-1(c) under the Securities Exchange Act of 1934, as amended, on behalf of each of the undersigned. This Ag |
|
July 3, 2023 |
CLNN / Clene Inc / CITADEL ADVISORS LLC - SC 13G Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G* (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO § 240.13d-1(b), (c), AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO § 240.13d-2 (Amendment No. )* Clene Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (the “Shares”) (Title of Class of Securities) 185634102 (CUSIP Number) |
|
June 30, 2023 |
Exhibit 4.1 THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE BEEN ACQUIRED FOR INVESTMENT AND NOT WITH A VIEW TO, OR IN CONNECTION WITH, THE SALE AND DISTRIBUTION THEREOF, AND HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”) OR ANY STATE SECURITIES LAWS. SUCH SECURITIES MAY NOT BE SOLD OR TRANSFERRED IN THE ABSENCE OF (A) SUCH REGISTRATION, (B) AN OPI |
|
June 30, 2023 |
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): June 27, 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 In |
|
June 30, 2023 |
Exhibit 99.1 |
|
June 30, 2023 |
Exhibit 10.1 SECOND AMENDMENT TO SUPPLEMENT TO LOAN AND SECURITY AGREEMENT This Second Amendment to Supplement to Loan and Security Agreement (this “Amendment”) is entered into as of June 27, 2023, by and among AVENUE VENTURE OPPORTUNITIES FUND, L.P., a Delaware limited partnership (“Lender”) and CLENE INC., a Delaware corporation and CLENE NANOMEDICINE, INC., a Delaware corporation (individually |
|
June 28, 2023 |
CLNN / Clene Inc / Vivo Opportunity Fund Holdings, L.P. - SCHEDULE 13G Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G UNDER THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. )* Clene, Inc. (Name of Issuer) Common Stock, $0.0001 par value per share (Title of Class of Securities) 185634102 (CUSIP Number) June 21, 2023 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant t |
|
June 28, 2023 |
EXHIBIT 99.1 Joint Filing Agreement The undersigned acknowledge and agree that the foregoing statement on Schedule 13G is filed on behalf of each of the undersigned and that all subsequent amendments to this statement on Schedule 13G shall be filed on behalf of each of the undersigned without the necessity of filing additional joint filing statements. The undersigned acknowledge that each shall be |
|
June 20, 2023 |
CLNN / Clene Inc / MATLIN DAVID J - SCHEDULE 13D/A Activist Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Third Amended and Restated SCHEDULE 13D Under the Securities Exchange Act of 1934 Clene Inc. (Name of Issuer) Common Stock, $0.0001 par value (Title of Class of Securities) 185634102 (CUSIP Number) David J. Matlin 61 Cedar Pt Lane Sag Harbor, NY 11963 (917) 841-2666 (Name, Address and Telephone Number of Person Authorized to R |
|
June 16, 2023 |
CLENE ANNOUNCES LAUNCH OF PROPOSED PUBLIC OFFERING Exhibit 99.1 CLENE ANNOUNCES LAUNCH OF PROPOSED PUBLIC OFFERING SALT LAKE CITY, June 15, 2023 (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 a proposed underwritten public offer |
|
June 16, 2023 |
Exhibit 4.1 CLENE INC. TRANCHE A WARRANT TO PURCHASE COMMON STOCK Warrant No.: [] Number of Warrant Shares: [] [CUSIP: [●]] Date of Issuance: June [], 2023 (“Issuance Date”) Expiration Date: The earlier of (i) sixty (60) days following the date of the Company’s public announcement of NDA Acceptance of its NDA for CNM-Au8, which announcement shall be made promptly after receipt of such NDA Acceptan |
|
June 16, 2023 |
Clene Announces Pricing of $40 Million Public Offering Exhibit 99.2 Clene Announces Pricing of $40 Million Public Offering SALT LAKE CITY, June 16, 2023 (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 the pricing of an underwritten p |
|
June 16, 2023 |
Underwriting Agreement, dated June 16, 2023, by and between Clene Inc. and Canaccord Genuity LLC. Exhibit 1.1 Clene Inc. 50,000,000 Shares of Common Stock Tranche A Warrants to Purchase 50,000,000 Shares of Common Stock Tranche B Warrants to Purchase 50,000,000 Shares of Common Stock Underwriting Agreement New York, New York June 16, 2023 Canaccord Genuity LLC As Representative of the Several Underwriters 99 High Street, Suite 1200 Boston, Massachusetts 02110 Ladies and Gentlemen: Clene Inc., |
|
June 16, 2023 |
Filed Pursuant to Rule 424(b)(5) Registration No. 333-264299 SUPPLEMENT NO. 1 TO PROSPECTUS SUPPLEMENT DATED MARCH 7, 2023 (To Prospectus dated April 26, 2022) Clene Inc. This Supplement No. 1 to the Prospectus Supplement supplements and amends the Prospectus Supplement dated March 7, 2023 (the “Prospectus Supplement”) filed by Clene Inc. (“we,” “us,” and “our”). This Supplement No. 1 to the Prosp |
|
June 16, 2023 |
Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) Clene Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered(1) Proposed Maximum Offering Price Per Unit(2) Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Fees t |
|
June 16, 2023 |
Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) Clene Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered(1) Proposed Maximum Offering Price Per Unit(2) Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Fees t |
|
June 16, 2023 |
Filed Pursuant to Rule 424(b)(5) Registration No. 333-264299 Registration No. 333-272692 PROSPECTUS SUPPLEMENT (To Prospectus dated April 26, 2022) Clene Inc. 50,000,000 Shares of Common Stock Tranche A Warrants to Purchase 50,000,000 Shares of Common Stock Tranche B Warrants to Purchase 50,000,000 Shares of Common Stock We are offering 50,000,000 shares of our common stock, par value $0.0001 per |
|
June 16, 2023 |
As filed with the Securities and Exchange Commission on June 16, 2023 As filed with the Securities and Exchange Commission on June 16, 2023 Registration No. |
|
June 16, 2023 |
As filed with the Securities and Exchange Commission on June 16, 2023 As filed with the Securities and Exchange Commission on June 16, 2023 Registration No. |
|
June 16, 2023 |
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): June 15, 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 In |
|
June 16, 2023 |
Entry into a Material Definitive Agreement, Financial Statements and Exhibits, Other Events 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): June 16, 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 In |
|
June 16, 2023 |
Exhibit 4.2 CLENE INC. TRANCHE B WARRANT TO PURCHASE COMMON STOCK Warrant No.: [] Number of Warrant Shares: [] [CUSIP: [●]] Date of Issuance: June [], 2023 (“Issuance Date”) Expiration Date: The earlier of (i) sixty (60) days following the date of the Company’s public announcement of its receipt of written approval from the FDA of its NDA for CNM-Au8, which announcement shall be made promptly afte |
|
June 15, 2023 |
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): June 15, 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 In |
|
June 15, 2023 |
SUBJECT TO COMPLETION, DATED JUNE 15, 2023 Filed Pursuant to Rule 424(b)(5) Registration No. 333-264299 The information in this preliminary prospectus supplement is not complete and may be changed. A Registration Statement relating to these securities has been filed with the Securities and Exchange Commission and is effective. This preliminary prospectus supplement and the accompanying prospectus are not an offer to sell these securities a |
|
June 15, 2023 |
Exhibit 99.1 |
|
June 15, 2023 |
Exhibit 99.2 CLENE’S CNM-Au8® SHOWS STATISTICALLY SIGNIFICANT DIFFERENCE IN PLASMA NEUROFILAMENT LIGHT (NfL) LEVELS IN THE HEALEY ALS PLATFORM TRIAL ● CNM-Au8® treatment demonstrated significantly reduced plasma neurofilament light chain (NfL) levels compared to placebo at 24 weeks (p=0.04) ● Clene plans to discuss the totality of the survival and time-to-event results from the full CNM-Au8 clinic |
|
June 2, 2023 |
Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing 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): May 31, 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 Inc |
|
May 19, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM SD SPECIALIZED DISCLOSURE REPORT CLENE INC. (Exact name of registrant as specified in its charter) Delaware 001-39834 (State or other jurisdiction (Commission file number) of incorporation) 6550 South Millrock Drive, Suite G50 Salt Lake City, Utah 84121 (Address of principal executive offices) (Zip code) Jerry Miraglia, ( |
|
May 12, 2023 |
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): May 12, 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 Inc |
|
May 12, 2023 |
CLENE REPORTS FIRST QUARTER 2023 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS Exhibit 99.1 CLENE REPORTS FIRST QUARTER 2023 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS ● ALS biomarker and long-term clinical data expected mid-year ● Neurology expert Ben Greenberg, M.D., M.H.S., joined as Head of Medical SALT LAKE CITY, May 12, 2023 - Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stag |
|
May 12, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 01-39834 CLENE INC. |
|
May 12, 2023 |
Exhibit 99.2 |
|
May 11, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION -12-31 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): May 9, 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 |
|
May 11, 2023 |
Exhibit 3.1 CLENE INC. FOURTH AMENDED AND RESTATED CERTIFICATE OF INCORPORATION (Pursuant to Sections 242 and 245 of the General Corporation Law of the State of Delaware) Clene Inc., a corporation organized and existing under and by virtue of the provisions of the General Corporation Law of the State of Delaware (the “General Corporation Law”), does hereby certify as follows: 1. The name of this c |
|
May 11, 2023 |
Exhibit 10.1 CLENE INC. AMENDED 2020 STOCK PLAN 1. Purpose. The purpose of this Amended 2020 Stock Plan (the “Plan”) is to enable Clene Inc., a Delaware corporation (the “Company”), to attract and retain the services of (i) selected employees, officers, and directors of the Company or any parent or subsidiary of the Company, and (ii) selected nonemployee agents, consultants, advisers, and independ |
|
April 17, 2023 |
Regulation FD Disclosure, Financial Statements and Exhibits 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): April 17, 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 I |
|
April 17, 2023 |
Exhibit 99.1 |
|
March 28, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Proxy State |
|
March 28, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☒ Definitive Proxy State |
|
March 22, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. 1) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Defi |
|
March 17, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Proxy State |
|
March 17, 2023 |
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): March 15, 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 I |
|
March 13, 2023 |
Description of Securities of the Registrant. Exhibit 4.1 DESCRIPTION OF THE REGISTRANT’S SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 The following is a summary of the rights and preferences of the capital stock of Clene Inc. (the “Company,” “we,” “us,” or “our”). While we believe that the following description covers the material terms of our capital stock, the description may not contain all of the in |
|
March 13, 2023 |
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): March 13, 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 I |
|
March 13, 2023 |
CLENE REPORTS FULL YEAR 2022 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS 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® associated with 74% lower risk of ALS clinical worsening events at six months supporting a survival benefit in the HEALEY ALS P |
|
March 13, 2023 |
Subsidiaries of the Registrant. Exhibit 21.1 Subsidiaries of Clene Inc. Name of Subsidiary Jurisdiction of Organization Clene Nanomedicine, Inc. Delaware Clene Australia Pty Ltd Australia dOrbital, Inc. Delaware Clene Netherlands B.V. Netherlands |
|
March 13, 2023 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 01-39834 CLE |
|
March 9, 2023 |
Exhibit 99.1 CNM-Au8® ASSOCIATED WITH DELAYED TIME TO KEY CLINICAL PROGRESSION EVENTS AT SIX MONTHS SUPPORTING A SURVIVAL BENEFIT IN THE HEALEY ALS PLATFORM TRIAL ● CNM-Au8 associated with a 74% lower risk (lower hazard ratio) of ALS clinical worsening, which included death, non-invasive ventilation >22 hours per day, tracheostomy, or feeding tube placement (p = 0.035) ● CNM-Au8 associated with a |
|
March 9, 2023 |
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): March 9, 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 In |
|
March 7, 2023 |
Clene Inc. Up to $25,000,000 and 499,002 Shares of Common Stock Filed Pursuant to Rule 424(b)(5) Registration No. 333-264299 PROSPECTUS SUPPLEMENT (To Prospectus dated April 26, 2022) Clene Inc. Up to $25,000,000 and 499,002 Shares of Common Stock This prospectus supplement relates to the offer and sale of shares of our common stock that we may issue and sell to Lincoln Park Capital Fund, LLC (“Lincoln Park”) from time to time, in our sole discretion, from and |
|
March 6, 2023 |
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): March 6, 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 In |
|
March 6, 2023 |
Exhibit 99.1 |
|
March 6, 2023 |
Exhibit 99.1 NEW DATA SHOW CNM-AU8® PRESERVED ALS PATIENT FUNCTION AND SLOWED DISEASE PROGRESSION IN THE OPEN-LABEL EXTENSION OF THE PHASE 2 RESCUE-ALS TRIAL ● Significant preservation of function (ALSFRS-R) from randomization to 48 weeks (p=0.0159) ● Significant preservation of function (ALSFRS-R) during the long-term open-label extension (OLE) week 24 to 120 weeks from randomization (p=0.0057) ● |
|
March 6, 2023 |
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): March 6, 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 In |
|
March 3, 2023 |
Exhibit 10.2 REGISTRATION RIGHTS AGREEMENT REGISTRATION RIGHTS AGREEMENT (this “Agreement”), dated as of March 3, 2023, by and between CLENE INC., a Delaware corporation (the “Company”), and LINCOLN PARK CAPITAL FUND, LLC, an Illinois limited liability company (together with its permitted assigns, the “Investor”). Capitalized terms used herein and not otherwise defined herein shall have the respec |
|
March 3, 2023 |
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): March 3, 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 In |
|
March 3, 2023 |
Exhibit 10.1 PURCHASE AGREEMENT PURCHASE AGREEMENT (the “Agreement”), dated as of March 3, 2023, by and between CLENE INC., a Delaware corporation (the “Company”), and LINCOLN PARK CAPITAL FUND, LLC, an Illinois limited liability company (the “Investor”). WHEREAS: Subject to the terms and conditions set forth in this Agreement, the Company wishes to sell to the Investor, and the Investor wishes to |
|
February 27, 2023 | ||
February 27, 2023 |
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): February 27, 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 o |
|
February 27, 2023 |
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): February 27, 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 o |
|
February 27, 2023 |
Exhibit 99.1 Clene Announces Updated VISIONARY-MS Phase 2 Trial Data Presented at 2023 ACTRIMS Forum Show CNM-Au8® Demonstrated Significant Improvements in Clinical Outcomes, Brain Structure, and Visual System ● Positive clinical results demonstrated in stable relapsing multiple sclerosis patients adjunctive to immunomodulatory disease modifying therapy was previously reported ● Updated Visual Evo |
|
February 23, 2023 |
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): February 23, 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 o |
|
February 23, 2023 | ||
February 21, 2023 |
CLNN / Clene Inc / MATLIN DAVID J Activist Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Second Amended and Restated SCHEDULE 13D Under the Securities Exchange Act of 1934 Clene Inc. (Name of Issuer) Common Stock, $0.0001 par value (Title of Class of Securities) 185634102 (CUSIP Number) David J. Matlin 61 Cedar Pt Lane Sag Harbor, NY 11963 (917) 841-2666 (Name, Address and Telephone Number of Person Authorized to |
|
February 17, 2023 |
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): February 15, 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 o |
|
February 17, 2023 |
CLNN / Clene Inc. / FOLEY & LARDNER/ FA Activist Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amended and Restated SCHEDULE 13D Under the Securities Exchange Act of 1934 Clene Inc. (Name of Issuer) Common Stock, $0.0001 par value (Title of Class of Securities) 185634102 (CUSIP Number) David J. Matlin 61 Cedar Pt Lane Sag Harbor, NY 11963 (917) 841-2666 (Name, Address and Telephone Number of Person Authorized to Receive |
|
February 13, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 1)* Clene Inc. (Name of Issuer) Common Stock, par value $.0001 per share (Title of Class of Securities) (CUSIP Number) G8959N130 (Name, Address and Telephone Number of Person Authorized to Receive Notices and Communications) December 31, 2022 (Date of Event |
|
February 6, 2023 |
CLNN / Clene Inc. / FOLEY & LARDNER/ FA Activist Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 Clene Inc. (Name of Issuer) Common Stock, $0.0001 par value (Title of Class of Securities) 185634102 (CUSIP Number) David J. Matlin 61 Cedar Pt Lane Sag Harbor, NY 11963 (917) 841-2666 (Name, Address and Telephone Number of Person Authorized to Receive Notices and Communic |
|
February 2, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G (Rule 13d-102) Information to be Included in Statements Filed Pursuant to § 240. |
|
January 17, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G (Rule 13d-102) Information to be Included in Statements Filed Pursuant to § 240. |
|
December 20, 2022 |
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): December 19, 2022 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 o |