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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): May 22, 2026
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 1.01.
Entry into a Material Definitive Agreement
On
May 22, 2026, MoonLake Immunotherapeutics (the “Company”) entered into a Master Commercial Supply Agreement (the “Vetter
MCSA”) with Vetter Pharma International GmbH (“Vetter”). Pursuant to the Vetter MCSA, Vetter, through Vetter Pharma-Fertigung
GmbH & Co. KG, has agreed to manufacture one or more application systems pre-filled with an active pharmaceutical ingredient, placebo
or other material for the Company. The Company and Vetter previously entered into a master development agreement, effective as of October
27, 2021, under which Vetter performed development and manufacturing services related to the Company’s product candidate sonelokimab.
The
Vetter MCSA is structured as a master agreement under which the parties may enter into product-specific schedules (each, a “Product
Schedule”) from time to time, each detailing the specific manufacturing services and pricing applicable to a particular product.
The Company has agreed to pay Vetter the prices set forth in each Product Schedule. For each Product Schedule, Vetter may, subject to
limitations, adjust its prices based upon reasonable and documented information reflecting increases in Vetter’s cost structure,
including wages, insurance, energy costs and other associated costs and expenses, as well as increases in costs of materials supplied
or services provided by any third party.
The
Vetter MCSA shall remain in full force and effect until terminated. Either party may terminate the Vetter MCSA or any Product Schedule
for cause in the event of a material breach by the other party that has not been cured within 60 calendar days of receiving written notice
of such breach. Either party may also terminate the Vetter MCSA without cause upon 12 months’ written notice, with immediate effect
at any time when all existing Product Schedules have been terminated. Vetter may terminate the Vetter MCSA if the Company is the subject
of a “Change of Control” (as defined in the Vetter MCSA) by an acquirer that is not a reputable pharmaceutical company meeting
certain specified criteria, and the Company may terminate the Vetter MCSA if Vetter is taken over by a competitor of the Company that
is active within the sector of development of dermatology and inflammatory diseases, including rheumatology, before the end of 2029.
Either party may terminate the Vetter MCSA with immediate effect due to the other party’s bankruptcy or insolvency. The Vetter
MCSA includes customary provisions relating to, among others, procedures for defective products, delivery, inspection and acceptance
procedures, manufacturing facilities, regulatory matters, intellectual property rights, and confidentiality.
Also
on May 22, 2026, the Company and Vetter entered into a Capacity Agreement (the “Vetter Capacity Agreement”), under which
the Company is required to provide Vetter with its aggregate demand for a product for a certain period, with the annual demands for the
initial term of such forecast constituting a binding capacity reservation commitment (the “MoonLake Commitment”). The MoonLake
Commitment may not be increased without Vetter’s prior written consent (the quantity so specified being the “Maximum Quantity”)
and may not be decreased below specified floors (the “Minimum Quantity”). Vetter has committed to reserve filling capacity
equivalent to the Maximum Quantity per year for the agreed binding period. The Company may be obligated to pay capacity compensation
to Vetter if the Company fails to order the Minimum Quantity commitment or fails to provide purchase orders for the agreed binding period.
Pursuant to the Vetter Capacity Agreement, the Company may, depending on the timing and amount of reduced aggregate demand, if any, be
obligated to pay Vetter for a portion of lost net revenue, subject to certain limitations.
The
above descriptions of the Vetter MCSA and Vetter Capacity Agreement are summaries only and are qualified in their entirety by reference
to the Vetter MCSA and Vetter Capacity Agreement, which will be filed as exhibits to the Company’s Quarterly Report on Form 10-Q
for the quarter ending June 30, 2026.
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 1, 2026 |
By: |
/s/
Matthias Bodenstedt |
| |
Name: |
Matthias
Bodenstedt |
|
Title: |
Chief
Financial Officer |
