MLTX files 8-K on Q3 results; LEDA & VELA-TEEN updates

Rhea-AI Filing Summary

MoonLake Immunotherapeutics furnished an 8-K announcing a press release with its financial results for the quarter ended September 30, 2025 and clinical program updates. Under Item 2.02, the company reported Q3 2025 results via Exhibit 99.1. Under Item 7.01, it highlighted results from the Phase 2 LEDA trial of Sonelokimab (SLK) in adult palmoplantar pustulosis and an interim analysis from the Phase 3 VELA-TEEN trial in adolescents with hidradenitis suppurativa. The Item 7.01 information is being furnished and is not deemed filed under Section 18.

8-K Event Classification

3 items: 2.02, 7.01, 9.01

3 items

Item 2.02 Results of Operations and Financial Condition Financial

Disclosure of earnings results, typically an earnings press release or preliminary financials.

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

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Accepted by SEC EDGAR 11/05/2025 - 07:00 AM Learn about SEC filing dates

0001821586FALSE00018215862025-11-052025-11-05

 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 5, 2025

MOONLAKE IMMUNOTHERAPEUTICS

(Exact Name of Registrant as Specified in Its Charter)

Cayman Islands

001-39630

98-1711963

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

Dorfstrasse 29

6300 Zug

Switzerland

(Address of Principal Executive Offices and Zip Code)

41 415108022

(Registrant’s Telephone Number, Including Area Code)

N/A

(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:

☐ 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:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Class A ordinary share, par value $0.0001 per share

MLTX

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 2.02.     Results of Operations and Financial Condition.

On November 5, 2025, MoonLake Immunotherapeutics (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

This Item 2.02 and the press release attached hereto as Exhibit 99.1, insofar as they disclose information regarding the Company’s results of operation and financial condition for the quarter ended September 30, 2025, are being furnished to the U.S. Securities and Exchange Commission (“SEC”).

Item 7.01. Regulation FD Disclosure.

On November 5, 2025, the Company issued a press release announcing results from its Phase 2 clinical trial of Sonelokimab (“SLK”) in adult patients with palmoplantar pustulosis (the “LEDA” trial), as well as an interim analysis of its Phase 3 clinical trial of SLK in adolescents with hidradenitis suppurativa (the “VELA-TEEN” trial). A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

This Item 7.01 and the press release attached hereto as Exhibit 99.1, are being furnished to the SEC and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (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, as amended.

Item 9.01.     Financial Statements and Exhibits.

(d) Exhibits. The following exhibit is being furnished herewith:

 

Exhibit Number			Exhibit Title or Description
99.1			Press Release, dated November 5, 2025
104			Cover Page Interactive Data File (embedded within the Inline XBRL document)

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:			November 5, 2025			By:			/s/ Matthias Bodenstedt
						Name:			Matthias Bodenstedt
						Title:			Chief Financial Officer

FAQ

What did MoonLake Immunotherapeutics (MLTX) disclose in this 8-K?

It furnished a press release covering Q3 2025 financial results and updates on Sonelokimab trials LEDA (PPP) and VELA-TEEN (adolescent HS).

Which period do the MLTX financial results cover?

The quarter ended September 30, 2025, as noted in the furnished press release (Exhibit 99.1).

Which clinical trials of Sonelokimab (SLK) were mentioned by MLTX?

Phase 2 LEDA in adult palmoplantar pustulosis and a Phase 3 VELA-TEEN interim analysis in adolescents with hidradenitis suppurativa.

Where can investors find the detailed results referenced by MLTX?

In Exhibit 99.1, the press release dated November 5, 2025.

Is the Item 7.01 information considered filed with the SEC?

No. It is furnished and shall not be deemed filed for purposes of Section 18 of the Exchange Act.

What is MoonLake Immunotherapeutics’ trading symbol and exchange?

MLTX on The Nasdaq Capital Market.