MoonLake Immunotherapeutics (NASDAQ:MLTX) used its Investor Day presentation to outline updates across its clinical portfolio for sonelokimab (SLK), a tri-specific nanobody designed to inhibit IL-17A and IL-17F while also binding human albumin. Company leadership emphasized a development strategy spanning multiple large inflammatory indications in dermatology and rheumatology, and reiterated expectations for a U.S. biologics license application (BLA) submission in the second half of the year.
Chief Financial Officer Matthias Bodenstedt said MoonLake was founded in 2021 in Switzerland and went public in April 2022. He said the company’s balance sheet supports ongoing studies with cash runway into the second half of 2027, and that MoonLake also has access to additional non-dilutive funding through a debt facility.
Axial spondyloarthritis: S-OLARIS Phase 2 readout and imaging focus
Reich highlighted that more than 80% of patients achieved an ASAS40 response by week eight, maintained through week 12, and that approximately 80% reached inactive or low disease status by week four as measured by ASDAS-CRP. He also reported large reductions in MRI-measured inflammation in the sacroiliac joints, citing an absolute SPARCC MRI score reduction he described as exceeding levels typically considered best-in-class, with 90% of patients showing a reduction.
A key element of the presentation was the use of 18F-NaF PET imaging to assess osteoblast activity associated with ossification. Reich said PET imaging showed a more than 40% reduction in osteoblast activity across evaluated sacroiliac joint quadrants within 12 weeks, and he characterized the findings as potentially supportive of “disease modification” by reducing processes linked to structural damage.
On biomarkers, Reich said MoonLake conducted an unsupervised analysis to identify peripheral blood markers correlated with individual clinical response. He stated the identified markers relate to osteoblast activity and pathways linking inflammation, angiogenesis, mesenchymal activity, and ossification, and that correlations between biomarker reductions and clinical response were high.
During Q&A, Reich said baseline characteristics were generally comparable to other studies and included a roughly even mix of radiographic and non-radiographic axSpA patients. Chief Executive Officer Jorge Santos da Silva said the company intends to advance axSpA development, but did not provide a Phase 3 start date or design specifics, noting ongoing preparations for regulatory discussions.
Hidradenitis suppurativa: FDA feedback, BLA path, and label strategy
Santos da Silva focused on hidradenitis suppurativa (HS), emphasizing regulatory interactions with the FDA following the VELA program readouts. He said FDA guidance indicates MoonLake has sufficient material to submit a BLA and that no additional clinical trials are required to establish “substantial evidence of effectiveness” (SEE). He stated the FDA’s guidance was that VELA-1 and MIRA would be used to establish efficacy (SEE) and support safety, while VELA-2 would be submitted to support safety, with the role of VELA-2 in establishing efficacy to be discussed with the agency.
Management discussed how these trial components could translate into U.S. labeling, focusing on three label sections: efficacy (Section 14), warnings and precautions (Section 5), and dosing (Section 2). Santos da Silva said the company’s “base scenario” for Section 14 would include two HS trials—VELA-1 and MIRA—with HiSCR75 presented as the primary endpoint and HiSCR50 as a secondary endpoint. He described potential upside cases where additional endpoints such as pain, HiSCR, and IHS4 could be included more prominently, and he suggested VELA-2 could potentially be referenced depending on discussions with the FDA.
On safety differentiation, Santos da Silva said MoonLake did not detect signals during controlled phases of VELA that are sometimes associated with IL-17 pathway therapies, listing suicidal ideation, infections, tuberculosis, liver-related signals, and inflammatory bowel disease among examples. In response to an analyst question on 52-week HS safety, Reich said the company’s earlier statements remained unchanged, including that it had not seen signals for liver or “SIB,” while also noting the dataset was still under evaluation.
Santos da Silva said the company intends to submit the HS BLA toward the end of the third quarter and expects an acceptance decision within 60 days of submission, adding that multiple pre-BLA meetings were planned in April and May.
Long-term HS data and VELA-TEEN interim results
In discussing interim long-term results, Santos da Silva said HiSCR75 response at the one-year mark in both VELA-1 and VELA-2 appeared high relative to other commercialized drugs’ performance at the end of their respective parent trials. He also highlighted patient-reported outcomes, stating that pain and quality-of-life measures continued to improve over time and that quality-of-life improvements appeared to increase through the one-year mark.
For VELA-TEEN, an open-label study in adolescent HS patients, Santos da Silva said responses remained “extremely promising,” including HiSCR75 and HiSCR100. He stated that HiSCR100 was approximately at the one-third mark at six months and suggested responses appeared strong compared with prior adult studies. He also said safety remained “clean” in VELA-TEEN, based on available data.
PPP, psoriatic arthritis program status, and financial update
Reich provided a brief update on palmoplantar pustulosis (PPP), emphasizing that it is distinct from palmoplantar psoriasis and that no drugs are approved for PPP in the U.S. or Europe. He said MoonLake observed clinical responses alongside biomarker normalization in a Phase 2 program and noted the company applied AI-based assessment to patient photos to validate investigator scoring. Reich said more than 40% of patients achieved clear or almost clear disease on palmoplantar PGA (0/1) and that this aligned with more than 40% achieving at least a 75% reduction on palmoplantar PASI. He said MoonLake has received Fast Track designation and is planning a Phase 3 program with a 12-week induction period and dosing strategies intended to optimize maintenance response.
Santos da Silva reviewed the psoriatic arthritis (PsA) Phase 3 IZAR program, stating IZAR-1 (biologic-naïve) has completed recruitment while IZAR-2 (biologic-experienced) is recruiting and includes a standard-of-care reference arm with risankizumab. He said IZAR-1 is expected to read out between the second and third quarters of 2026, with IZAR-2 later in 2026.
On financials, Bodenstedt said MoonLake ended 2025 with $394 million in cash, cash equivalents, and short-term marketable debt securities, including proceeds from a $75 million offering in November. He reiterated cash runway into the second half of 2027. He also said the company amended its Hercules Capital facility and drew an additional $25 million in non-dilutive debt, retaining access to up to $400 million in additional funding. He reported fourth-quarter operating expenses of $65 million, including $56 million in R&D and $9.2 million in G&A, and said the company expects no material changes in operating expenses overall, though pre-commercial activity is expected to increase in 2026.
Management also addressed manufacturing and commercialization planning in Q&A. Santos da Silva said drug substance and product manufacturing are with FDA-approved partners and that commercial capacity extends into years four or five post-launch. He said the company expects to make key U.S. commercial leadership hires in the second half of the year, and stated the auto-injector has undergone required studies and is being used in HS open-label extension studies with positive feedback.
About MoonLake Immunotherapeutics (NASDAQ:MLTX)
MoonLake Immunotherapeutics, a clinical-stage biopharmaceutical company, engages in developing therapies. It develops Sonelokimab, a novel investigational Nanobody for the treatment of inflammation diseases; and hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis, and psoriasis. MoonLake Immunotherapeutics was incorporated in 2020 and is headquartered in Zug, Switzerland.
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