MoonLake Immunotherapeutics (NASDAQ: MLTX) posts Phase 3 HS trial data

Rhea-AI Filing Summary

MoonLake Immunotherapeutics reported that it has released week 16 results from its Phase 3 VELA-1 and VELA-2 trials, which are part of its registrational global program in patients with moderate-to-severe hidradenitis suppurativa, a chronic inflammatory skin disease. These late-stage studies are important because they test whether the company’s therapy can provide meaningful benefit in a difficult-to-treat population.

The company issued a press release with the data on September 28, 2025 and scheduled a webcast on September 29, 2025 at 8:00 a.m. Eastern Time to review the results. The press release detailing the clinical data has been filed as an exhibit to this report, giving investors and clinicians access to the full outcome of the VELA-1 and VELA-2 trials.

Insights

Biopharma & Clinical Trials Analyst

MoonLake discloses key Phase 3 HS trial results, a pivotal data milestone.

MoonLake Immunotherapeutics has released week 16 results from its Phase 3 VELA-1 and VELA-2 trials in moderate-to-severe hidradenitis suppurativa, framed as a registrational global program. Phase 3 data in a chronic inflammatory skin disease are typically central to eventual approval strategies and commercial prospects.

The details of efficacy and safety are contained in the attached September 28, 2025 press release, and the company is hosting a webcast on September 29, 2025 at 8:00 a.m. Eastern Time to discuss the findings. Without the actual response and adverse event rates, the market impact depends on how these results compare to existing treatment options, which will be interpreted from the press release and webcast materials.

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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): September 29, 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 8.01. Other Events.

On September 28, 2025, MoonLake Immunotherapeutics (the “Company”) issued a press release announcing the week 16 results of the Phase 3 VELA-1 and VELA-2 trials of its registrational global program in patients with moderate-to-severe hidradenitis suppurativa. The Company will host a webcast today, Monday, September 29, 2025 at 8:00 am, Eastern Time, to discuss the data results.

A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

Item 9.01. Financial Statements and Exhibits.

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

Exhibit Number		Exhibit Title or Description
99.1		Press Release, dated September 28, 2025
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: September 29, 2025	By:	/s/ Matthias Bodenstedt
	Name:	Matthias Bodenstedt
	Title:	Chief Financial Officer

2

FAQ

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

MoonLake Immunotherapeutics announced that it has released week 16 results from its Phase 3 VELA-1 and VELA-2 trials in patients with moderate-to-severe hidradenitis suppurativa, part of its registrational global program.

Which clinical trials are covered in MoonLake Immunotherapeutics (MLTX) update?

The update covers the Phase 3 VELA-1 and VELA-2 trials, which are part of MoonLake’s registrational global program in moderate-to-severe hidradenitis suppurativa.

How is MoonLake Immunotherapeutics (MLTX) sharing details of the Phase 3 results?

The company issued a press release dated September 28, 2025 with the week 16 results and filed it as Exhibit 99.1, and it scheduled a webcast on September 29, 2025 at 8:00 a.m. Eastern Time to discuss the data.

What indication are MoonLake Immunotherapeutics (MLTX) VELA-1 and VELA-2 trials targeting?

The VELA-1 and VELA-2 Phase 3 trials target patients with moderate-to-severe hidradenitis suppurativa, a chronic inflammatory skin disease.

Does this MoonLake Immunotherapeutics (MLTX) filing include the full Phase 3 data?

The filing states that the detailed week 16 results are contained in a press release dated September 28, 2025, which is attached as Exhibit 99.1 and incorporated by reference.

Why are the VELA-1 and VELA-2 Phase 3 trials important for MoonLake Immunotherapeutics (MLTX)?

The trials are described as part of a registrational global program in hidradenitis suppurativa, meaning their results may play a central role in potential regulatory and commercialization pathways for MoonLake’s therapy.