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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Item 7.01. Regulation FD Disclosure.
On February 26, 2024, MoonLake Immunotherapeutics (the “Company”) issued a press release announcing the successful outcome of its end-of-Phase 2 interactions with the U.S. Food and Drug Administration, as well as positive feedback from its interactions with the E.U. European Medicines Agency, with both regulatory bodies unanimously supporting the Company’s proposed approach for advancing its Phase 3 program of the Nanobody® sonelokimab in hidradenitis suppurativa.
A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein. The exhibit furnished under Item 7.01 of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act, regardless of any general incorporation language in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits. The following exhibits are being furnished herewith:
| Exhibit Number | Exhibit Title or Description | |
| 99.1 | Press Release, dated February 26, 2024 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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SIGNATURE
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.
| MOONLAKE IMMUNOTHERAPEUTICS | ||
| Date: February 26, 2024 | By: | /s/ Matthias Bodenstedt |
| Name: | Matthias Bodenstedt | |
| Title: | Chief Financial Officer | |
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