UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 OR 15(d)
of The Securities Exchange Act of 1934
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(Exact name of registrant as specified in its charter)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 7.01 Regulation FD Disclosure.
On April 5, 2022, Clene Inc. (the “Company”) presented updated interim data from the RESCUE-ALS open-label extension study in the Emerging Science Program at 2022 AAN Annual Meeting. A copy of the presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information furnished in this Item 7.01, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), as amended, or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing made by the Company under the Exchange Act or the Securities Act of 1933, as amended, regardless of any general incorporation language in any such filings, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Exhibit Description |
99.1 |
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104 |
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Cover Page Interactive Data File (formatted as Inline XBRL). |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
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CLENE INC. |
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Date: April 5, 2022 |
By: |
/s/ Robert Etherington |
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Robert Etherington |
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President and Chief Executive Officer |
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Matthew Kiernan matthew.kiernan@sydney.edu.au matthew.kiernan@sydney.edu.au Exhibit 99.1
Disclosures & Acknowledgements MCK and the University of Sydney have received research funding from Clene to undertake Rescue-ALS RE PWe thank FightMND for its philanthropic support of the TRESCUE-ALS study We thank the study participants and their families for their willingness to support clinical research
CNM-Au8® Nanocrystal Clean Surfaced, Highly Faceted Shape Enhances Catalytic Activity Mechanistic Effects Increased Energy Production & Utilization Vertices, Edges, & Facets Key to Catalytic Activity CNM-Au8® | Catalytically Active Au Nanocrystals Improve Cellular Energy Production
Significant slowing in disease progression & ALSFRS-R 6-point decline
Significant improvement in quality of life
Long-Term Survival in OLE Participants: 70% Improvement vs. Predicted Survival • All OLE participants. Data censored as of 10-March-2022. Vital status and date of death (as applicable) captured for all subjects withdrawn from the study. ENCALS median survival estimate from baseline characteristics.
Consistent Survival Effect in ex-Placebo Participants • All OLE participants. Data censored as of 10-March-2022. Vital status and date of death (as applicable) captured for all subjects withdrawn from the study. ENCALS median survival estimate from baseline characteristics.
9 Conclusions Well tolerated and safe in ALS Evidence of CNM-Au8 therapeutic activity: Evidence for improved survival Significant reduction in functional decline Significant slowing in disease progression Improvement in quality of life