MoonLake Immunotherapeutics Files 8-K

TL;DR

MoonLake Immunotherapeutics filed an 8-K on June 10, 2024, detailing corporate events and regulatory disclosures.

AI Summary

MoonLake Immunotherapeutics filed an 8-K on June 10, 2024, reporting on various corporate events. The filing includes information related to Regulation FD disclosures, other events, and financial statements and exhibits. MoonLake Immunotherapeutics was formerly known as Helix Acquisition Corp and changed its name on August 18, 2020.

Why It Matters

This 8-K filing provides an update on MoonLake Immunotherapeutics' corporate activities and regulatory disclosures, which is important for investors to stay informed about the company's status.

Risk Assessment

Risk Level: low — The filing is a routine corporate disclosure and does not appear to contain significant new risks.

Key Players & Entities

• MoonLake Immunotherapeutics (company) — Registrant
• Helix Acquisition Corp (company) — Former company name
• June 10, 2024 (date) — Date of report
• August 18, 2020 (date) — Date of name change

FAQ

Key Financial Figures

• $0.0001 — red Class A ordinary share, par value $0.0001 per share MLTX The Nasdaq Capital M

Filing Documents

• ea0207582-8k_moonlake.htm (8-K) — 30KB
• ea020758201ex99-1_moonlake.htm (EX-99.1) — 35KB
• image_001.jpg (GRAPHIC) — 3KB
• ex99-1_001.jpg (GRAPHIC) — 10KB
• 0001213900-24-051263.txt ( ) — 267KB
• mltx-20240610.xsd (EX-101.SCH) — 3KB
• mltx-20240610_lab.xml (EX-101.LAB) — 33KB
• mltx-20240610_pre.xml (EX-101.PRE) — 22KB
• ea0207582-8k_moonlake_htm.xml (XML) — 3KB

01. Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure. On June 10, 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 (the "FDA"), as well as positive feedback from its interactions with the E.U. European Medicines Agency (the "EMA"), with both regulatory bodies unanimously supporting the Company's proposed approach for advancing its Phase 3 program of the Nanobody sonelokimab ("SLK") in psoriatic arthritis ("PsA"). 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 of 1934 (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 of 1933, regardless of any general incorporation language in such filing.

01. Other Events

Item 8.01. Other Events. On June 10, 2024, the Company announced the successful outcome of its end-of-Phase 2 interactions with the FDA, as well as positive feedback from its interactions with the EMA, with both regulatory bodies unanimously supporting the Company's proposed approach for advancing its Phase 3 program of SLK in PsA. The Phase 3 program, named IZAR, is expected to enroll around 1,500 patients and, in combination with data from the Phase 2 ARGO trial, is designed to support a Biologics License Application and E.U. Marketing Authorization Application.

Forward-Looking Statements

Forward-Looking Statements This Current Report on Form 8-K and the press release furnished as Exhibit 99.1 contain certain "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding the Company's expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: plans for and timing of clinical trials, including the topline primary endpoint readout for the Phase 3 IZAR program, the trial design and patient enrollment across the IZAR-1 and IZAR-2 trials, the initiation of the Phase 3 program in PsA, the efficacy and safety of SLK for the treatment of hidradenitis suppurativa and PsA, including in comparison to existing standards or care or other competing therapies, clinical trials and research and development programs and the anticipated timing of the results from those studies and trials. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward looking statements. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "would" and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. These statements reflect our plans, estimates, and expectations, as of the date of this Current Report on Form 8-K. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this Current Report on Form 8-K. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a resu

01. Financial Statements and Exhibits

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 June 10, 2024 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) 1 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: June 10, 2024 By: /s/ Matthias Bodenstedt Name: Matthias Bodenstedt Title: Chief Financial Officer 2

View Full Filing

View this 8-K filing on SEC EDGAR