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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):
February 18, 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 February 20, 2026 (the “Amendment
Closing Date”), MoonLake Immunotherapeutics (the “Company”), as a guarantor, entered into a first amendment to loan
and security agreement (the loan and security agreement, as so amended, the “Amended Loan and Security Agreement”) with its
subsidiary, MoonLake Immunotherapeutics AG, as borrower, the other guarantors party thereto, the lenders party thereto (the “Lenders”),
and Hercules Capital, Inc., as the administrative agent and collateral agent (the “Agent”) for itself and the Lenders, pursuant
to which the parties agreed to amend the loan and security agreement dated March 31, 2025 to, among other things, modify the available
tranches, milestone dates and financial covenants. As described below, after giving effect to a $25.0 million draw on the Amendment Closing
Date, the remaining tranches under the Amended Loan and Security Agreement provide for an aggregate principal amount of up to $400.0 million
of potential future funding. The Amended Loan and Security Agreement provides for six non-dilutive senior secured term loan tranches in
the aggregate principal amount of $500.0 million (the “Amended Credit Facility”), consisting of (a) a first tranche consisting
of term loans in an aggregate principal amount of $75.0 million, which was fully funded on March 31, 2025, (b) a second tranche in an
aggregate principal amount of $25.0 million, which was fully funded on the Amendment Closing Date, (c) subject to the Company’s
announcement that the IZAR-1 and IZAR-2 Phase 3 studies of sonelokimab (“SLK”) in patients with active psoriatic arthritis
each achieved their protocol-specified primary endpoint and that the efficacy and safety data available to the Company together support
the planned commercialization strategy and outlook of the Company (the “Tranche 3 Milestone”), a third tranche with additional
term loans in an aggregate principal amount of up to $50.0 million, available on the Tranche 3 Milestone achievement date through the
earlier of (i) 60 days following such date and (ii) March 15, 2027, (d) subject to (i) the Company’s announcement that the VELA-1
and VELA-2 Phase 3 studies of SLK in adult patients with moderate to severe hidradenitis suppurativa each demonstrated clinically meaningful
improvements across protocol-specified 52-week endpoints and an acceptable safety profile which together support (x) the planned commercialization
strategy and outlook of the Company and (y) the filing of the biologics license application (“BLA”) for SLK with the U.S.
Food and Drug Administration’s (the “FDA”) for an indication for use generally consistent with the population studied
in VELA-1 and VELA-2 of patients with moderate to severe hidradenitis suppurativa as the next immediate step in development, in each case,
subject to the Agent’s verification (together, the “Tranche 4 HS Milestone”), and (ii) the Company has closed the previous
10 consecutive trading days with a market capitalization of at least $1,500.0 million; provided that, the first trading day tested cannot
be prior to the public announcement of the Tranche 4 HS Milestone (collectively with the Tranche 4 HS Milestone, the “Amended Tranche
4 Milestone”), a fourth tranche with additional term loans in an aggregate principal amount of up to $50.0 million, available on
the Amended Tranche 4 Milestone achievement date through the earlier of (i) 60 days following the achievement of the Tranche 4 HS Milestone
and (ii) December 15, 2026, (e) subject to the Company’s achievement of the Tranche 4 HS Milestone and the FDA’s approval
of the Company’s submission of a BLA for SLK with an indication for use generally consistent with that sought in the Company’s
BLA filing with the FDA and which supports the target product profile for SLK (the “Approval Milestone”) (collectively, the
“Tranche 5 Milestone”), a fifth tranche with additional term loans in an aggregate principal amount of up to $100.0 million,
available on the Tranche 5 Milestone achievement date through the earlier of (i) 60 days following such date and (ii) December 15, 2027,
and (f) subject to approval by the Lenders’ in their discretion, a sixth tranche of additional term loans in an aggregate principal
amount of up to $200.0 million.
The Amended Loan and Security
Agreement adds a conditional performance financial covenant (the “Conditional Performance Covenant”) that if the fifth tranche
is drawn, then beginning with the quarter nine months after the achievement of the Approval Milestone and tested quarterly thereafter,
the Company shall be required to maintain trailing six months net product revenue equal to at least 50% of the forecast delivered under
the Amended Loan and Security Agreement. The Conditional Performance Covenant will not be tested at any time in which the Company either:
(a) has a market capitalization of $1,500.0 million and unrestricted cash of at least 50% of the loan amount outstanding, (b) has unrestricted
cash of at least 85% of the loan amount outstanding, or (c) is reporting a market capitalization of at least $2,000.0 million.
The Amended Loan and Security
Agreement does not provide for scheduled amortization payments during the term. All principal will be due on the maturity date. Under
the Amended Loan and Security Agreement, the Company may prepay all loans in whole at any time subject to (i) a prepayment charge equal
to a range of 2.0% to 0.0% and (ii) an end of term charge equal to a range of 6.95% to 4.25%, each based on when the prepayment occurs.
If the Amended Loan and Security Agreement is repaid in full as a result of a change of control of the Company, the prepayment premium
shall be waived.
All obligations under the Amended
Loan and Security Agreement are secured on a first-priority basis, subject to certain exceptions, by security interests in substantially
all assets of the Company and material subsidiaries of the Company, including its intellectual property, and are guaranteed by material
subsidiaries of the Company, including foreign subsidiaries, subject to certain exceptions.
The above description of the Amended
Loan and Security Agreement and Amended Credit Facility is a summary only and is qualified in its entirety by reference to the Amended
Loan and Security Agreement, which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ending
March 31, 2026.
Item 2.02 Results of Operations
and Financial Condition.
On February 22, 2026, the Company
issued a press release announcing its financial results for the year ended December 31, 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 here to as Exhibit 99.1, insofar as they disclose information regarding the Company’s results of operations and financial
condition for the year ended December 31, 2025, are being furnished to the U.S. Securities and Exchange Commission (“SEC”).
Item 2.03 Creation of
a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.
The disclosure set forth in Item
1.01 above is incorporated by reference into this Item 2.03.
Item 5.02 Departure of Directors or Certain
Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On February 18, 2026, Simon Sturge
notified the Board of Directors (the “Board”) of the Company of his intent to resign as a member of the Board, effective as
of February 28, 2026 (the “Effective Date”). As of the Effective Date, the size of the Board will be reduced from six to five
directors. Mr. Sturge’s decision to resign from the Board was not the result of any dispute or disagreement with the Company on
any matter relating to the Company’s operations, policies or practices. The Company and the Board extend their deepest gratitude
to Mr. Sturge for his contributions to the Company.
In connection with Mr. Sturge’s
resignation, Dr. Jorge Santos da Silva was appointed Interim Chair of the Board, and Spike Loy was appointed as Lead Independent Director,
both effective as of the Effective Date.
Item 7.01 Regulation FD Disclosure.
On February 22, 2026, the Company
issued a press release announcing topline results from the S-OLARIS Phase 2 trial of SLK in patients with radiographic and non-radiographic
axial spondyloarthritis (“axSpA”), as well as its entry into the Amended Loan and Security Agreement. The Company will hold
an Investor Day webcast on February 23, 2026 at 8:00 am, Eastern Time, which will include an open Q&A session.
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 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, regardless of any general incorporation
language in such filing.
Item 8.01 Other Events.
On February 22, 2026, the Company issued a press release
announcing topline results from the S-OLARIS Phase 2 trial of SLK in patients with radiographic and non-radiographic axSpA and its financial
results for the fourth quarter and year ended December 31, 2025.
Topline Phase 2 S-OLARIS clinical trial results of SLK in axSpA
In the Phase 2 S-OLARIS trial
in axSpA, SLK demonstrated clinically meaningful and statistically significant benefit. 81% of patients treated with SLK (n=26, mNRI)
achieved an Assessment of Spondyloarthritis International Society 40 (“ASAS40”) response at week 12. ASAS40 measures an improvement
of at least 40% and an absolute improvement of ≥2 units on a 0-10 numerical rating scale from baseline in at least three of the four
key domains (Patient Global Assessment of disease activity, total back pain, physical function, inflammation) and has been the primary
endpoint for the latest approved therapies. More than 80% of patients also achieved a ‘clinically important improvement’ as
per ASDAS-CRP score by week 12. The clinical improvement, in patients treated with SLK, was confirmed by SPARCC MRI scores in the sacroiliac
joint (“SIJ”), measuring inflammation and injury inside the bone, at week 12. This suggests rapid onset of action for SLK
and IL-17A and F inhibitory activity in deep, difficult-to-access tissues. PET imaging with an 18F-NaF tracer collected as part of the
clinical trial showed reduction of inflammation and osteoblast activity in SIJ affected by axSpA, a key driver of irreversible ossification
in the disease. Objective peripheral blood and tissue biomarker analyses conducted to control for the effect of SLK showed rapid and sustained
effects of the treatment with SLK in inhibiting key immune pathways known to drive inflammation and ossification in affected patients.
The safety profile of SLK in the S-OLARIS trial was consistent with previous trials with no new safety signals detected. Data from this
clinical trial further represents the fifth indication with positive data, in Phase 2 and Phase 3 clinical trials, for the IL-17A and
F Nanobody®.
Financial results for the fourth quarter and year ended December 31,
2025
As of December 31, 2025, the Company
held cash, cash equivalents and short-term marketable debt securities of $394.0 million.
Cautionary Statement Regarding Forward Looking Statements
This Current Report on Form 8-K
contains 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: the efficacy and safety of SLK for the treatment
of axSpA; potential market opportunities for SLK; and the anticipated usage of cash and the expected timing of when the Company’s
operating cash would be fully spent. 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.
Forward-looking statements are
based on current expectations and assumptions that, while considered reasonable by the Company and its management, as the case may be,
are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties.
Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties,
which include, without limitation, risks and uncertainties associated with the Company’s business in general and limited operating
history; difficulty enrolling patients in clinical trials; state and federal healthcare reform measures that could result in reduced demand
for the Company’s product candidates; reliance on third parties to conduct and support its preclinical studies and clinical trials;
and the other risks described in or incorporated by reference into the Company’s Annual Report on Form 10-K for the year ended December
31, 2024 and subsequent filings with the SEC.
Nothing in this Current Report
on Form 8-K should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved
or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking
statements in this Current Report on Form 8-K, which speak only as of the date they are made and are qualified in their entirety by reference
to the cautionary statements herein. The Company does not undertake or accept any duty to release publicly any updates or revisions to
any forward-looking statements to reflect any change in its expectations or in the events, conditions or circumstances on which any such
statement is based.
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 22, 2026 |
| 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: February 23, 2026 |
By: |
/s/ Matthias Bodenstedt |
| |
Name: |
Matthias Bodenstedt |
| |
Title: |
Chief Financial Officer |
Exhibit 99.1
MoonLake Announces Positive Topline
Results from its Phase 2 Clinical Trial of Sonelokimab in Axial Spondyloarthritis and Reports 2025 Financial Results
| |
● | In the Phase 2 S-OLARIS clinical trial in axial spondyloarthritis (axSpA), sonelokimab (SLK) demonstrated
clinically meaningful benefit with 80+% of patients achieving ASAS40 by Week 12 |
| |
● | Consistently, other clinical and imaging scores also showed improvements of 80+% by week 12 for patients
treated with SLK, including ASDAS-CRP and SPARCC MRI |
| |
● | axSpA is a disease driven by inflammation leading to irreversible ossification (via osteoblast activity)
and ultimately to irreversible restriction of mobility – objective PET/MRI imaging data further showed a significant reduction in
inflammation and osteoblast activity deep in affected joints, already by week 12, suggesting potential for disease modification in axSpA
for SLK |
| |
● | As a biomarker-controlled trial, S-OLARIS data showed SLK reduced the levels of key inflammatory mediators
in axSpA, in peripheral blood and biopsy samples from patients – the safety profile of SLK was similar to other trials and no new
signals were detected |
| |
● | MoonLake ended the fourth quarter with $394 million in cash, cash equivalents and short-term marketable
debt securities which, together with funds from its latest equity raise (gross proceeds of $75 million), are expected to provide a cash
runway into the second half of 2027 |
| |
● | The Company also announced the amendment of its debt facility with Hercules Capital, with a concurrent
drawdown of $25 million, and up to $400 million in non-dilutive funds remaining available to support future funding needs |
| |
● | An Investor Day webcast has been confirmed for February 23, 2026, 8.00 – 9.30 am EST (2:00 –
3.30pm CET), including an open Q&A session |
ZUG, Switzerland, February 22, 2026 –
MoonLake Immunotherapeutics (NASDAQ:MLTX) (“MoonLake” or the “Company”), a clinical-stage biotechnology company
focused on creating next-level therapies for inflammatory diseases, today announces topline results from the S-OLARIS Phase 2 trial of
SLK in patients with radiographic and non-radiographic axSpA and announces its financial results for the fourth quarter and year ended
December 31, 2025. An Investor Day webcast has been confirmed for February 23, 2026, 8.00 – 9.30 am EST (2:00 – 3.30pm
CET), including an open Q&A session.
Topline Phase 2 S-OLARIS clinical trial results
of SLK in axSpA
In the Phase 2 S-OLARIS trial in axSpA, SLK demonstrated
clinically meaningful and statistically significant benefit. 81% of patients treated with SLK (n=26, mNRI), achieved an Assessment of
Spondyloarthritis International Society 40 (ASAS40) response at Week 12. ASAS40 measures an improvement of at least 40% and an absolute
improvement of ≥2 units on a 0-10 numerical rating scale from baseline in at least three of the four key domains (Patient Global Assessment
of disease activity, total back pain, physical function, inflammation), with no worsening in the remaining domain and has been the primary
endpoint for the latest approved therapies. More than 80% of patients also achieved a ‘clinically important improvement’
as per ASDAS-CRP score by Week 12 (mNRI). The clinical improvement, in patients treated with SLK, was confirmed by SPARCC MRI scores
in the sacroiliac joint (SIJ), measuring inflammation and injury inside the bone, at week 12. This suggests rapid onset of action for
SLK and IL-17A and F inhibitory activity in deep, difficult-to-access tissues. Importantly, PET imaging with an 18F-NaF tracer collected
as part of the clinical trial showed significant reduction of inflammation and osteoblast activity in sacroiliac joints affected by axSpA,
a key driver of irreversible ossification in the disease. Objective peripheral blood and tissue biomarker analyses conducted to control
for the effect of SLK, showed rapid and sustained effects of the treatment with SLK in inhibiting key immune pathways known to drive
inflammation and ossification in affected patients. The safety profile of SLK in the S-OLARIS trial was consistent with previous trials
with no new safety signals detected.
Data from this clinical trial further strengthens
the potential of SLK in treating a wide array of inflammatory diseases and represents the fifth indication with positive data, in Phase
2 and Phase 3 clinical trials, for the IL-17A and F Nanobody®.
Prof. Kristian Reich, Founder and Chief Scientific
Officer at MoonLake Immunotherapeutics, said:
“The data from our S-OLARIS trial marks a critical step in providing an effective
treatment for patients with this devastating disease. The complementary data from clinical outcomes, MRI and PET imaging as well as peripheral
blood and tissue biomarkers confirm our hypothesis of SLKs ability to access deeper tissue, which is essential to optimally control this
chronic rheumatological condition and prevent irreversible mobility restriction. In our view, the impact of SLK on clinical parameters
and key disease pathways observed in S-OLARIS already within the first 12 weeks of treatment highlight the potential of the drug to elevate
clinical outcomes and to achieve disease modification in axSpA. With millions of patients affected by this devastating condition and limited
impact of current therapies in improving relevant disease mechanisms, SLK has the potential to change the treatment paradigm in axSpA.”
Prof. Xenofon Baraliakos, Head of Rheumatology
at the Rheumazentrum Ruhrgebiet Herne & President of the European Alliance of Associations for Rheumatology (EULAR) said:
“Completing the S-OLARIS trial has been
a remarkable milestone for the axSpA and broader Rheumatology community. The combination of clinical, imaging, and biomarker data presents
one of the clearest demonstrations to date of how targeting IL-17A and IL-17F with a Nanobody® can meaningfully reduce
inflammation in the axial structures. The consistency and speed of response we observed in patients underline the significant potential
of sonelokimab to address the unmet needs in this burdensome disease. It has been an honour for our team to contribute to advancing a
therapy that could profoundly impact patient lives.”
Financial results for the fourth quarter and
year ended December 31, 2025
As of December 31, 2025, MoonLake held cash, cash
equivalents and short-term marketable debt securities of $394.0 million. Research and development expenses for the quarter ended December 31,
2025, were $56.0 million, compared to $60.6 million in the previous quarter. General and administrative expenses for the quarter ended
December 31, 2025 were $9.2 million, compared to the $10.8 million incurred in the previous quarter. The Company expects its cash, cash
equivalents and short-term marketable debt securities to be sufficient to fund its operating expenses and capital expenditure requirements
into the second half of 2027. In addition, the Company announced the amendment of its debt facility with Hercules Capital, with a concurrent
drawdown of $25 million, and up to $400 million in non-dilutive funds remaining available to support future funding needs. The Company
expects to file its full annual report on Form 10-K with the U.S. Securities and Exchange Commission on February 25, 2026.
Investor Day, February 23, 2026
The Company will hold an Investor Day for investors
and analysts on February 23, 2026. The webcast will start at 8.00 – 9.30 am EST (2:00 – 3.30pm CET), including
an open Q&A session. A recording will be made available post event. Webcast Access: https://edge.media-server.com/mmc/p/ke4wbinp
In this session, MoonLake’s CEO, Jorge Santos
da Silva, CSO, Kristian Reich, and CFO, Matthias Bodenstedt, will present the axSpA S-OLARIS data. In addition, the team will discuss
the outcomes of the recent Type B FDA Meeting for hidradenitis suppurativa (HS) and next steps regarding label strategy and BLA submission.
An interim analysis of the continued response to SLK beyond week 16 from the HS VELA Phase 3 clinical trials in adult patients with HS
will also be shared, as will interim data from the VELA-TEEN clinical trial in adolescent HS. Finally, management will share an update
on its financial position and outline key 2026 catalysts, including upcoming data releases from the Phase 3 IZAR trials in Psoriatic Arthritis
(PsA), the market opportunity and planned Phase 3 program in palmo-plantar pustulosis (PPP), among other expected milestones.
Important upcoming anticipated milestones for
MoonLake:
| ● | Q2 2026: 52-week data of the VELA-1 and VELA-2 trials in HS |
| ● | Mid 2026: Primary endpoint readout of the Phase 3 IZAR-1 trial in PsA |
| ● | Mid 2026: Primary endpoint readout of Phase 3 VELA-TEEN trial in adolescent HS |
| ● | H2 2026: Submission of a BLA for HS |
| ● | H2 2026: Primary endpoint readout of the Phase 3 IZAR-2 trial in PsA |
-Ends-
MoonLake Immunotherapeutics
MoonLake Immunotherapeutics is a clinical-stage
biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of
inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F,
and IL-17F/F dimers that drive inflammation. The Company’s focus is on inflammatory diseases with a major unmet need, including
hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis and palmoplantar pustulosis – conditions affecting millions
of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland.
Further information is available at www.moonlaketx.com.
About Nanobodies®
Nanobodies® represent a new generation
of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only
antibodies (VHH). Nanobodies® have a number of potential advantages over traditional antibodies, including their small
size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and their ability to be designed into multivalent
therapeutic molecules with bespoke target combinations.
The terms Nanobody® and Nanobodies®
are trademarks of Ablynx, a Sanofi company.
About Sonelokimab
Sonelokimab (M1095) is an investigational ~40
kDa humanized Nanobody® consisting of three VHHs covalently linked by flexible glycine-serine spacers. With two domains,
sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers.
A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema.
Sonelokimab is being assessed in two lead indications,
hidradenitis suppurativa (HS) and psoriatic arthritis (PsA), and the Company is pursuing other indications in dermatology and rheumatology,
including adolescent HS, palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA).
For adults with HS, sonelokimab is being assessed
in two identical Phase 3 trials, the VELA-1 and VELA-2 trials, using the higher clinical response level of HS Clinical Response (HiSCR)
75 as the primary endpoint, which defines a response as an at least 75% reduction in abscess and inflammatory nodule count, with no increase
from baseline in abscess or draining tunnel count. In September 2025, the primary endpoint data from the VELA-1 and VELA-2 clinical trials
were announced. In the combined VELA program, patients treated with SLK experienced a clinically meaningful and statistically significant
improvement across all primary and key secondary endpoints using both pre-specified strategies (p<0.001). In VELA-1, SLK achieved statistical
significance for all primary and key secondary endpoints using both pre-specified strategies (HiSCR75, delta to placebo of 17%, p<0.001).
In VELA-2, intercurrent events in the higher-than-expected placebo arm precluded the study from achieving statistical significance in
the week 16 primary endpoint using the composite strategy (HiSCR75, delta to placebo of 9%, p=0.053). From week 16, all patients are expected
to continue to receive the 120mg dose of SLK through to 48 weeks, with a last assessment planned at week 52, followed by an open-label
extension for up to two years. The safety profile of sonelokimab in the VELA trials was consistent with previous trials with no new safety
signals detected.
Sonelokimab is currently undergoing evaluation
in the VELA-TEEN Phase 3 trial, which is the first clinical study specifically focused on adolescent patients with moderate-to-severe
HS.
For PsA, sonelokimab is being assessed in the
Phase 3 trials, IZAR-1 and IZAR-2, following the announcement in March 2024 of the full dataset from the global Phase 2 ARGO trial (M1095-PSA-201)
evaluating the efficacy and safety of the Nanobody® sonelokimab over 24 weeks in patients with active PsA. Significant
improvements were observed across all key outcomes, including approximately 60% of patients treated with sonelokimab achieving an American
College of Rheumatology (ACR) 50 response and Minimal Disease Activity (MDA) at week 24. This followed the positive top-line results in
November 2023, where the trial met its primary endpoint with a statistically significant greater proportion of patients treated with either
sonelokimab 60mg or 120mg (with induction) achieving an ACR50 response compared to those on placebo at week 12. All key secondary endpoints
in the trial were met for the 60mg and 120mg doses with induction. The safety profile of sonelokimab in the ARGO trial was consistent
with previous trials with no new safety signals detected.
Sonelokimab is also being assessed in PPP, a debilitating
inflammatory skin condition affecting a significant number of patients, including in the completed Phase 2 LEDA program. In the Phase
2 LEDA clinical trial in PPP, SLK demonstrated clinically meaningful and statistically significant benefit. Patients treated with SLK
achieved a mean percent change from baseline in the Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI) of 64% at week 16,
and 39% of patients achieved a ≥75% reduction in the PPPASI (PPPASI75), suggesting that SLK could provide clinically meaningful improvements
in this disease for which there are currently no approved therapies. The safety profile of SLK in the LEDA trial was consistent with previous
trials with no new safety signals detected.
Additionally, Sonelokimab is being assessed in
the ongoing Phase 2 S-OLARIS and P-OLARIS trials for active axSpA and PsA, respectively. Both trials feature an innovative design complementing
traditional clinical outcomes with cellular imaging techniques.
Sonelokimab has also been assessed in a randomized,
placebo-controlled third-party Phase 2b trial (NCT03384745) in 313 patients with moderate-to-severe plaque-type psoriasis. High threshold
clinical responses (Investigator’s Global Assessment Score 0 or 1, and Psoriasis Area and Severity Index 90/100) were observed in
patients with moderate-to-severe plaque-type psoriasis. Sonelokimab generally presented a safety profile similar to the active control,
secukinumab (Papp KA, et al. Lancet. 2021; 397:1564-1575).
In an earlier third-party Phase 1 trial in patients
with moderate-to-severe plaque-type psoriasis, sonelokimab decreased (to normal skin levels) the cutaneous gene expression of pro-inflammatory
cytokines and chemokines (Svecova D. J Am Acad Dermatol. 2019;81:196–203).
About the VELA program
The Phase 3 VELA program has enrolled over 800
patients across VELA-1 and VELA-2. Both global, randomized, double-blind, and placebo-controlled trials are identical in design evaluating
the efficacy and safety of the Nanobody® sonelokimab, administered subcutaneously, in adult patients with active moderate-to-severe
hidradenitis suppurativa. Similar to the design of the landmark Phase 2 MIRA trial, the primary endpoint is the percentage of participants
achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75, defined as a ≥75% reduction in total abscess and inflammatory nodule
(AN) count with no increase in abscess or draining tunnel count relative to baseline. The trials also evaluate a number of secondary endpoints,
including the proportion of patients achieving HiSCR50, the change from baseline in International Hidradenitis Suppurativa Severity Score
System (IHS4), the proportion of patients achieving a Dermatology Life Quality Index (DLQI) total reduction of ≥4, the proportion of
patients achieving at least 50% reduction from baseline in Numerical Rating Scale (NRS50) in the Patient’s Global Assessment of
Skin Pain (PGA Skin Pain) and complete resolution of Draining Tunnels (DT100). The VELA protocols and statistical analysis plans were
prepared in accordance with regulatory agency advice and include two analysis strategies. The composite strategy for the VELA trials (also
referred to as the primary estimand) is the primary statistical analysis. The protocol specifies the treatment policy strategy as the
alternative method of handling intercurrent events to test the robustness of the VELA data. The trials compare a single 120mg dose of
sonelokimab to placebo with HiSCR75 reading out at week 16. Results of the week 16 data were announced in September 2025. Further details
are available under NCT06411899 and NCT06411379 at www.clinicaltrials.gov.
About the MIRA trial
The MIRA trial (M1095-HS-201) is a global, randomized,
double-blind, placebo-controlled Phase 2 trial to evaluate the efficacy and safety of the Nanobody® sonelokimab, administered
subcutaneously, in the treatment of adult patients with active moderate-to-severe hidradenitis suppurativa. The trial recruited 234 patients,
with the aim to evaluate two different doses of sonelokimab (120mg and 240mg) with placebo control and adalimumab as an active reference
arm. The primary endpoint of the trial is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75),
defined as a ≥75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count
relative to baseline. The trial also evaluated a number of secondary endpoints, including the proportion of patients achieving HiSCR50,
the change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), the proportion of patients achieving
a Dermatology Life Quality Index (DLQI) total score of ≤5, and the proportion of patients achieving at least 30% reduction from baseline in
Numerical Rating Scale (NRS30) in the Patient’s Global Assessment of Skin Pain (PGA Skin Pain). Further details are available under
NCT05322473 at www.clinicaltrials.gov.
About the VELA-TEEN trial
The Phase 3 VELA-TEEN trial is an open-label,
single-arm trial designed to evaluate sonelokimab 120mg administered subcutaneously once every two weeks (Q2W) until week six and once
every four weeks (Q4W) from week eight onwards. The trial aims to enroll 30-35 adolescents, aged 12-17, with moderate-to-severe hidradenitis
suppurativa, from U.S. sites experienced in clinical trials and pediatric dermatology. The primary trial phase will be 24 weeks with a
primary endpoint evaluating the pharmacokinetics, safety, and tolerability of sonelokimab. VELA-TEEN will also evaluate several secondary
endpoints, including the proportion of patients achieving the higher clinical response measure of the Hidradenitis Suppurativa Clinical
Response Score (HiSCR) 75, in addition to HiSCR50. Other outcomes are the change from baseline in the International Hidradenitis Suppurativa
Severity Score System (IHS4), which includes the quantitative measure of draining tunnels, and the proportion of patients achieving a
meaningful reduction of the Children’s Dermatology Life Quality Index (CDLQI) and the Patients Global Assessment of Skin Pain (PGA
Skin Pain). Further details are available under NCT06768671 at www.clinicaltrials.gov.
About Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) is a severely debilitating
chronic skin condition resulting in irreversible tissue destruction. HS manifests as painful inflammatory skin lesions, typically around
the armpits, groin, and buttocks. Over time, uncontrolled and inadequately treated inflammation can result in irreversible tissue destruction
and scarring. The disease affects an estimated 2% of the population, with three times more females affected than males. Real-world data
in the United States indicates that at least 2 million unique patients have been diagnosed with and treated for HS between 2016 and 2023
alone, highlighting a significant unmet need and impact on healthcare systems, and a market opportunity projected to reach $15bn by 2035.
Onset typically occurs in early adulthood and HS has a profound negative impact on quality of life, with a higher morbidity than other
dermatologic conditions. There is increasing scientific evidence to support IL-17A- and IL-17F-mediated inflammation as a key driver of
the pathogenesis of HS, with other identified risk factors including genetics, cigarette smoking, and obesity.
About the IZAR Program
IZAR-1 (NCT06641076) and IZAR-2 (NCT06641089)
are global, randomized, double-blind, placebo-controlled Phase 3 trials designed to evaluate the efficacy and safety of sonelokimab compared
with placebo in a total of approximately 1,500 adults with active psoriatic arthritis (PsA), with a primary endpoint of superiority to
placebo in American College of Rheumatology (ACR) 50 response at Week 16. IZAR-1 is expected to enroll biologic-naïve patients and
include an evaluation of radiographic progression, while IZAR-2 is expected to enroll patients with an inadequate response to tumor necrosis
factor-α inhibitors (TNF-IR) — reflecting patients commonly seen in clinical practice — and is the first PsA trial to
include a risankizumab active reference arm. Both trials will also assess a range of secondary endpoints reflecting the multiple disease
manifestations characteristic of PsA. These include skin and nail outcomes, multidomain outcomes, and patient-reported outcome measures
such as pain and quality of life assessments. Further details are available under NCT06641076 and NCT06641089 at www.clinicaltrials.gov.
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic, progressive
and complex inflammatory disease that manifests across multiple domains, leading to substantial functional impairment and decreased quality
of life. The clinical features of PsA are diverse, comprising both musculoskeletal (peripheral arthritis, spondylitis, dactylitis, and
enthesitis) and non-musculoskeletal (skin and nail disease) domains. PsA occurs in up to 30% of patients with psoriasis, most commonly
those aged between 30 and 60 years. Although the exact mechanism of disease is not fully understood, evidence suggests that activation
of the IL-17 pathway plays an important role in the disease pathophysiology.
About the S-OLARIS trial
The S-OLARIS trial (M1095-axSpA-201) is a Phase
2 trial designed to evaluate the efficacy and safety of sonelokimab 60mg administered subcutaneously in adult patients with active axial
spondyloarthritis (axSpA). The trial recruited 26 patients. The primary endpoint is the change from baseline (CfB) in 18F-NaF SUVmax signals
at week 12 in the sacroiliac joints and spine as detected by PET. Throughout the trial, several other endpoints will be assessed including
established clinical disease activity outcomes (e.g., ASAS), scores related to physical function, spinal mobility, and enthesitis as well
as patient reported outcomes. The trial also features an innovative exploratory peripheral blood and tissue biomarker program.
The trial design has been informed by previous
successful studies of sonelokimab, including the landmark Phase 2 ARGO trial in psoriatic arthritis, which identified the optimal dosing
and demonstrated the potential of sonelokimab to target deep tissue inflammation effectively. Further details are available under EUCT
number 2024-513498-36-00 at https://euclinicaltrials.eu.
About Axial Spondyloarthritis
Axial Spondyloarthritis (axSpA) typically impacts
young people, with diagnosis based on chronic inflammatory back pain lasting more than three months with onset under 45 years of age.
Advanced disease can lead to progressive and pathologic bone formation and joint fusion, severely limiting spinal mobility. Global reported
prevalence of axSpA ranges from 0.5% to 1.5%. AxSpA can be categorized by disease progression into two subtypes: non-radiographic axSpA
and ankylosing spondylitis (AS), also known as radiographic axSpA, which is diagnosed based on radiographic evidence of structural changes
to the sacroiliac joints. Patients with axSpA experience fatigue, persistent morning stiffness, and pain that worsens at night and can
disrupt sleep. Many patients also face the burden of comorbidities such as psoriatic arthritis and psoriasis. Studies have found elevated
IL-17 levels in the blood and synovial fluid of patients with axSpA, and IL-17A and IL-17F are both thought to be key contributors to
pathogenesis across the spondyloarthropathies.
About the LEDA Trial
The LEDA trial (M1095-PPP-201) is a Phase 2 trial
designed to evaluate the efficacy and safety of sonelokimab 120mg administered subcutaneously in adult patients with palmoplantar pustulosis
(PPP). The trial recruited 32 patients. The primary endpoint of the trial is percent change from baseline in Palmoplantar Psoriasis Area
and Severity Index (ppPASI) with important secondary endpoints including ppPASI75 (at least 75% improvement in the ppPASI). The LEDA trial
features an innovative translational research program using peripheral blood and tissue biomarkers as trial controls.
The trial design has been informed by previous
successful studies of sonelokimab, including the landmark Phase 2 MIRA trial in hidradenitis suppurativa, which identified the optimal
dosing and demonstrated the potential of sonelokimab to target deep tissue inflammation effectively. Further details are available under
EUCT number 2024-513305-32-00 at https://euclinicaltrials.eu.
About Palmoplantar Pustulosis
Palmoplantar Pustulosis (PPP) is characterized
by the development of blister-like pustules within erythematous, scaly plaques on the palms and the soles of the feet. PPP typically develops
in adulthood, more frequently impacts females. Patients frequently experience significant pain, burning, and itching sensations on the
palms and soles of the feet which can be debilitating and impair their ability to work, sleep, or perform other activities of daily living.
Currently, the treatment of PPP is challenging with a significant unmet need for novel therapies to reduce the symptom burden for patients.
Evidence suggests that activation of the IL-17 pathway has an important role in disease pathophysiology.
Cautionary Statement Regarding Forward Looking
Statements
This press release contains 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 MoonLake’s expectations, hopes, beliefs, intentions or strategies regarding the future including, without
limitation, statements regarding: the efficacy and safety of sonelokimab for the treatment of axSpA; potential market opportunities for
sonelokimab; the anticipated usage of cash and the expected timing of when MoonLake’s operating cash would be fully spent; and upcoming
anticipated corporate milestones. 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.
Forward-looking statements are based on current expectations and assumptions
that, while considered reasonable by MoonLake and its management, as the case may be, are inherently uncertain. New risks and uncertainties
may emerge from time to time, and it is not possible to predict all risks and uncertainties. Actual results could differ materially from
those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation,
risks and uncertainties associated with MoonLake’s business in general and limited operating history; difficulty enrolling patients
in clinical trials; state and federal healthcare reform measures that could result in reduced demand for MoonLake’s product candidates;
reliance on third parties to conduct and support its preclinical studies and clinical trials; and the other risks described in or incorporated
by reference into MoonLake’s Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent filings with the Securities
and Exchange Commission.
Nothing in this press release should be regarded as a representation
by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking
statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only
as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. MoonLake does not undertake
or accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations
or in the events, conditions or circumstances on which any such statement is based.
Contacts:
MoonLake Immunotherapeutics Media & Investors
Relations
ir@moonlaketx.com
ICR Healthcare
Mary-Jane Elliott, Sarah Elton-Farr, Ashley Tapp
Tel: +44 (0) 20 3709 5700
MoonLake@ICRHealthcare.com
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