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Key Takeaway: Clene Inc. presented the preliminary design for its RESTORE-ALS Phase 3 clinical trial of CNM-Au8 at the 2024 Annual NEALS Meeting. The trial aims to explore potential treatment avenues for Amyotrophic Lateral Sclerosis. This presentation signifies an important step in the company's clinical development strategy and impacts its standing as an emerging growth company.

Market Sentiment Analysis

POSITIVE FACTORS

  • Clene Inc. presented a preliminary design for an international Phase 3 clinical trial of CNM-Au8.
  • The presentation occurred at a recognized conference, enhancing visibility.
  • The company is categorized as an emerging growth company, indicating potential for growth.

Full Press Release Details

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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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
(Exact name of registrant as specified in its charter)
Delaware 001-39834 85-2828339
(State or other jurisdiction (Commission File Number) (IRS Employer
of incorporation) Identification No.)
6550 South Millrock Drive , Suite G50 Salt Lake City , Utah 84121
(Address of principal executive offices) (Zip Code)
(Registrant's telephone number, including area code)
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
Title of each class Trading Symbol(s) Name of each exchange on which registered
Common Stock, $0.0001 par value CLNN The Nasdaq Capital Market
Warrants, to acquire one-fortieth of one share of Common Stock for $230.00 per share CLNNW The Nasdaq Capital Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 ( 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 ( 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 7.01 Regulation FD Disclosure.
On October 23, 2024, Clene Inc. (the "Company") presented the preliminary design for RESTORE-ALS, an international Phase 3 clinical trial of CNM-Au8 30 mg, at the 2024 Annual Northeast Amyotrophic Lateral Sclerosis Consortium
("NEALS") Meeting. A copy of the presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K (the "Current Report") 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.
Exhibit Number Exhibit Description
99.1 RESTORE-ALS Presentation.
104 Cover Page Interactive Data File (formatted as Inline XBRL).
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
CLENE INC.
Date: October 23, 2024 By: /s/ Robert Etherington
Robert Etherington
President and Chief Executive Officer

Frequently Asked Questions

What is the purpose of the SEC filing by Clene Inc.?

The SEC filing by Clene Inc. reports the preliminary design of a Phase 3 trial.

What clinical trial was presented by Clene Inc.?

Clene Inc. presented the preliminary design for the RESTORE-ALS clinical trial.

What is the active ingredient in the RESTORE-ALS trial?

The RESTORE-ALS trial is using CNM-Au8 at a dosage of 30 mg.

When was the SEC filing date for Clene Inc.?

The SEC filing date for Clene Inc. was October 23, 2024.

What type of securities are mentioned in the filing?

The filing mentions common stock and warrants to acquire shares.

Last updated: Oct 23, 2024