-- Phase 3 IZAR-1 trial in bio-naïve patients met all clinical
endpoints at Week 16 for 60 mg sonelokimab
-- The primary endpoint of ACR50 was met with a high response of 42.1% for
sonelokimab's 60 mg with induction, and significant responses were
observed across key secondary endpoints, including ACR20 (66.5%), MDA
(41.2%) and PASI90 (61%), supporting the broad multidomain efficacy
profile of sonelokimab in psoriatic arthritis
-- Meaningful and statistically significant improvements were seen across
patient-reported outcomes and physical function measures, including
HAQ-DI and SF-36 PCS
-- Blinded safety analysis suggests a profile consistent with previous
studies and no new safety signals were identified, reinforcing
sonelokimab's potential to become a leading treatment option for patients
living with psoriatic arthritis, and enabling MoonLake's entry into
another multi-billion dollar indication
-- The IZAR-1 trial remains blinded and will continue until Week 52 with
MoonLake expecting the full readout in H1 2027 whereas the IZAR-2 trial
(a trial in TNF-refractory patients) is expected to complete enrollment
in Q3 2026
-- MoonLake ended the second quarter with $537.0 million in cash, cash
equivalents and short-term marketable debt securities and expects to have
a cash runway to mid-2028; additionally, up to $400 million in
non-dilutive funds remain available through its debt facility with
Hercules Capital
ZUG, Switzerland, August 10, 2026 -- MoonLake Immunotherapeutics (NASDAQ: MLTX) ("MoonLake" or the "Company"), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced positive topline results from the Phase 3 IZAR-1 trial evaluating sonelokimab in biologic-naïve adults with active psoriatic arthritis (PsA) and reported second quarter 2026 financial results.
IZAR-1 Phase 3 trial Week 16 positive topline results
The IZAR Phase 3 program consists of two registrational global randomized, double-blind trials, IZAR-1 and IZAR-2, designed to evaluate the efficacy and safety of sonelokimab in adults with active psoriatic arthritis (PsA). IZAR-1 is being conducted in biologic-naïve adults with active PsA. Following the Week 16 primary endpoint analysis, patients will continue participating in their respective studies through Week 52 to evaluate the durability of efficacy and safety of sonelokimab.
The primary endpoint of IZAR-1 is the percentage of patients achieving an American College of Rheumatology 50 (ACR50) response at Week 16. Key secondary clinical endpoints evaluate the broad multidomain efficacy of sonelokimab across musculoskeletal, skin, patient-reported and physical outcomes and include the percentage of patients achieving an ACR20 response, Minimal Disease Activity $(MDA)$, and Psoriasis Area and Severity Index 90 (PASI90) response, as well as changes from baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) and SF-36 Physical Component Summary $(PCS)$ score.
The Phase 3 IZAR-1 trial met all clinical endpoints at Week 16 for 60 mg sonelokimab. Consistent with the unblinding protocol defined with the FDA, topline disclosure at Week 16 includes absolute response levels and endpoint outcomes for the sonelokimab 60 mg with induction arm. Comparative analyses versus placebo and detailed treatment arm data remain blinded until completion of the Phase 3 program.
A total of 42.1% of biologic-naïve patients treated with sonelokimab 60 mg with induction achieved an ACR50 response. In addition, sonelokimab demonstrated strong efficacy across multiple disease domains characteristic of PsA. Across key secondary clinical endpoints, 66.5% of patients achieved ACR20, and 41.2% achieved MDA at Week 16. In patients with concomitant skin involvement, 61% achieved PASI90 at Week 16. Patients treated with sonelokimab also demonstrated clinically meaningful improvements in patient-reported and physical outcomes. Mean change from baseline in HAQ-DI was -0.427, while improvements were observed in SF-36 Physical Component Summary (PCS) with a score of 6.54. IZAR-1 does not include a Standard of Care arm as ARGO had provided data in such context for the Bio-Naïve population (adalimumab arm). IZAR-2 will provide data in comparison with a Standard of Care (risankizumab) in TNF-refractory patients.
The blinded safety analysis of IZAR-1 suggests a profile consistent with previous clinical studies and no new safety signals were observed. In addition, the drop-out rate of IZAR-1 until Week 16 is low and in line with other trials in PsA.
These results further support the potential of sonelokimab to address, not just single symptoms of PsA, but rather the diverse manifestations of psoriatic arthritis through meaningful improvements across musculoskeletal symptoms, skin disease, patient quality of life and physical function. After the lead indication of hidradenitis suppurativa (HS) these results set the path for sonelokimab to compete in another multi-billion dollar indication.
Dr. Jorge Santos da Silva, Founder and Chief Executive Officer of MoonLake Immunotherapeutics, said: "The positive topline results from IZAR-1 represent an important milestone for MoonLake and, more importantly, for patients living with psoriatic arthritis. We are particularly encouraged by the strong efficacy observed across multiple clinically relevant endpoints simultaneously, which has been our focus. These data are also encouraging as they are consistent with what was previously observed in other IL-17A/F programs. This reinforces our conviction that sonelokimab has the potential to become a leading treatment option in PsA and further validate the broad potential of our Nanobody$(R)$ platform in inflammatory disease."
Prof. Kristian Reich, Founder and Chief Scientific Officer of MoonLake Immunotherapeutics, added: "Psoriatic arthritis is a complex and heterogeneous disease, requiring therapies that can effectively address multiple manifestations simultaneously. The breadth of response observed in IZAR-1 across clinical, functional and patient-reported outcomes is highly encouraging. Taken together, these findings support the potential of sonelokimab to deliver meaningful benefits for patients across the diverse domains that define PsA."
Second Quarter 2026 Financial Results
Today, MoonLake also reported its financial results for the second quarter of 2026. As of June 30, 2026, MoonLake held cash, cash equivalents and short-term marketable debt securities of $537.0 million. The Company expects to have sufficient capital to fund its operating expenses and capital expenditure requirements to mid-2028. MoonLake's debt facility with Hercules Capital provides up to $400 million in additional non-dilutive funds to support potential future funding needs. Research and development expenses were $50.2 million for the three months ended June 30, 2026, compared to $54.5 million for the three months ended March 31, 2026. General and administrative expenses were $11.4 million for the three months ended June 30, 2026, compared to $15.5 million for the three months ended March 31, 2026. The decrease of $4.1 million was primarily related to $4.8 million in accelerated expense recognition in the prior quarter due to a voluntary cancellation of unvested stock option awards for no consideration.
Important upcoming anticipated milestones for MoonLake:
-- HS:
-- End Sep. 2026: Expected submission of Biologics License
Application (BLA)
-- End Nov. 2026: Expected to receive Prescription Drug User Fee Act
(PDUFA) date allocation and decision on Priority Review
-- Palmoplantar Pustulosis (PPP): Expected to commence enrollment in H2 2026
-- PsA -- IZAR-2: Expected to complete enrollment in Q3 2026
-- PsA/axial spondyloarthritis (axSpA): Expected to report results from the
P-OLARIS trial at the end of 2026 or early 2027
-Ends-
MoonLake Immunotherapeutics
MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody(R) 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 https://moonlaketx.com/.
About Nanobodies(R)
Nanobodies(R) 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(R) 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(R) and Nanobodies(R) are trademarks of Ablynx, a Sanofi company.
About Sonelokimab
Sonelokimab (M1095) is an investigational 40 kDa humanized Nanobody(R) 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.
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