MoonLake Immunotherapeutics, a clinical-stage biopharmaceutical company, engages in developing therapies. It is developing Sonelokimab, a novel investigational Nanobody therapy for the treatment of inflammation. The company is involved in conducting Phase II trials for hidradenitis suppurativa, psoriatic arthritis, ankylosing spondylitis, or radiographic axial spondyloarthritis. MoonLake Immunotherapeutics was founded in 2021 and is headquartered in Zug, Switzerland.
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- The Eli Lilly or AbbVie of highly specialized inflammatory disease drugs.
- A Moderna for autoimmune and inflammatory disease therapies, pioneering a new drug class.
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- Sonelokimab: An investigational anti-IL-17A/F nanobody currently in clinical development for inflammatory diseases such as Hidradenitis Suppurativa (HS), Psoriatic Arthritis (PsA), and Axial Spondyloarthritis (AxSpA).
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MoonLake Immunotherapeutics (MLTX) is a clinical-stage biotechnology company focused on developing novel nanobody treatments for inflammatory diseases. As a company in the research and development phase, its primary product candidate, sonelokimab, is still undergoing clinical trials and has not yet received regulatory approval for commercial sale.
Therefore, MoonLake Immunotherapeutics does not currently have major customers in the traditional sense of selling products or services to other companies or individuals. The company's focus is on clinical development, and its revenue sources typically come from:
- Investments from venture capital firms and public market investors.
- Potential upfront payments from licensing or collaboration agreements with larger pharmaceutical companies, should it choose to partner for further development or commercialization upon approval.
Currently, there are no commercial sales to specific customer companies or categories of individual customers to report.
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MoonLake Immunotherapeutics (MLTX) has identified the following major supplier:
- Lonza Group AG (SWX: LONN)
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Jorge Santos da Silva – Chief Executive Officer
Jorge Santos da Silva is the co-founder and Chief Executive Officer of MoonLake Immunotherapeutics. He co-founded MoonLake AG in 2021 and served as its CEO before its merger with MLTX in April 2022, when he assumed the CEO role for the combined entity. He successfully guided MoonLake through its public listing on NASDAQ in 2022. Prior to MoonLake, Dr. Santos da Silva spent nearly 15 years as a Senior Partner at McKinsey & Company, where he led the Pharmaceutical & Medical Products Practice and the Biotech and Biosimilars groups. His consulting work involved advising numerous pharmaceutical and biotechnology companies on corporate strategy, business development, mergers and acquisitions, and commercialization. He holds a Ph.D. in Neuroscience and has a decade of experience in academic research.
Matthias Bodenstedt – Chief Financial Officer
Matthias Bodenstedt has served as the Chief Financial Officer of MoonLake Immunotherapeutics since July 2021. Before joining MoonLake, he was a Partner at McKinsey & Company from September 2015 to June 2021. At McKinsey, Mr. Bodenstedt provided extensive advisory services to a diverse range of biopharmaceutical clients, from early-stage biotechs to large global pharmaceutical companies, focusing on finance, commercial strategy, financing, mergers and acquisitions (M&A), and business development. MoonLake Immunotherapeutics was founded in 2021 with Series A financing led by BVF Partners LP, indicating his involvement with a company backed by a private equity firm from its early stages.
Kristian Reich – Chief Scientific Officer
Dr. Kristian Reich is a co-founder and the Chief Scientific Officer of MoonLake Immunotherapeutics. He is recognized globally as a key opinion leader and clinical expert in dermatology and immunology, with over 25 years of experience in the field. Dr. Reich has served as a principal investigator for numerous major biologic development programs, including for Merck's psoriasis program. His previous roles include Managing Partner at Dermatologikum Hamburg GmbH and Professor & Vice Director of the Dermatology Department at the University of Gottingen. He also serves on the Board of Directors for derma2go AG, Dermagnostix GmbH, and Proderma Foundation.
Arnout Ploos van Amstel – Chief Operating Officer
Arnout Ploos van Amstel is a co-founder and the Chief Operating Officer of MoonLake Immunotherapeutics. He brings over 25 years of experience as a global executive leader within the biopharma industry, including a tenure at Novartis.
Oliver Daltrop – Chief Technical Officer
Oliver Daltrop serves as the Chief Technical Officer at MoonLake Immunotherapeutics.
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Key Risks to MoonLake Immunotherapeutics (MLTX)
The key risks to MoonLake Immunotherapeutics' business are primarily centered around clinical development, regulatory hurdles, shareholder litigation, and intense market competition.
1. Clinical Trial Setbacks and Regulatory Uncertainty
The most significant risk stems from the disappointing Phase 3 results for sonelokimab (SLK), the company's lead drug candidate, in hidradenitis suppurativa (HS). One of its two pivotal Phase 3 trials (VELA-2) narrowly missed its primary endpoint due to a higher-than-expected placebo response. This outcome has led to analyst skepticism regarding a swift regulatory clearance and has significantly reduced sales projections for the drug in HS. The company faces an upcoming FDA Type B meeting to discuss the adequacy of its current clinical package, which represents a critical regulatory milestone and a source of uncertainty.
2. Shareholder Litigation and Management Credibility
Following the Phase 3 setbacks, MoonLake Immunotherapeutics is facing multiple securities class action lawsuits. These lawsuits allege that the company misled investors about the efficacy of SLK and the purported advantages of its Nanobody structure compared to existing treatments, specifically the FDA-approved drug BIMZELX, which targets the same molecules. This litigation introduces risks related to potential settlement obligations and could undermine management credibility.
3. Intense Competition
Even if sonelokimab were to receive regulatory approval, it would enter a highly competitive landscape. The drug faces "intense competition" from "well-established IL-17 inhibitors" such as Cosentyx and the directly competing BIMZELX in large markets like hidradenitis suppurativa and psoriasis. Analysts have described sonelokimab's clinical data as "undifferentiated" compared to existing treatments, potentially limiting its market share and commercial success.
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The most clear emerging threat to MoonLake Immunotherapeutics (MLTX) is the recent approval and market launch of UCB's bimekizumab (Bimzelx) for Hidradenitis Suppurativa (HS). Both MLTX's lead asset, sonelokimab, and UCB's bimekizumab are potent and selective inhibitors of both IL-17A and IL-17F. HS is the lead indication for sonelokimab, currently in Phase 3 trials. UCB's bimekizumab, with its very similar mechanism of action, received FDA approval for HS in October 2023. This provides a significant first-mover advantage to UCB and establishes a direct competitor with an analogous drug profile in MLTX's primary target market before sonelokimab has completed its pivotal studies and can seek regulatory approval.
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MoonLake Immunotherapeutics (MLTX) is focused on developing sonelokimab, a Nanobody® therapy, for several inflammatory diseases. The addressable markets for their main products are as follows:
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Hidradenitis Suppurativa (HS): The global addressable market for Hidradenitis Suppurativa is projected to reach approximately $15 billion by 2035.
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Psoriatic Arthritis (PsA): The global addressable market for Psoriatic Arthritis treatment is projected to reach approximately $25.89 billion by 2034.
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Axial Spondyloarthritis (axSpA): The global addressable market for Axial Spondyloarthritis is expected to reach approximately $10.8 billion by 2033.
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Here are 3-5 expected drivers of future revenue growth for MoonLake Immunotherapeutics (MLTX) over the next 2-3 years:
- Commercial Launch of Sonelokimab for Adult Hidradenitis Suppurativa (HS): MoonLake's lead product candidate, sonelokimab, is a novel Nanobody® therapy being developed for inflammatory diseases. The company is on track for a Biologic License Application (BLA) submission in mid-2026 for sonelokimab in adult Hidradenitis Suppurativa (HS), with potential FDA approval expected in 2026. This would mark MoonLake's first commercial product and is anticipated to be a significant driver of initial revenue growth.
- Expansion of Sonelokimab to Additional Indications: Beyond adult HS, MoonLake is actively pursuing clinical trials for sonelokimab across multiple other high-value inflammatory and dermatological conditions. These include psoriatic arthritis (PsA), adolescent HS, palmoplantar pustulosis (PPP), and axial spondyloarthritis (axSpA). Successful progression and eventual regulatory approvals for these additional indications are expected to significantly broaden the addressable market for sonelokimab and fuel sustained revenue growth within the 2-3 year timeframe and beyond.
- Potential "Best-in-Class" Profile of Sonelokimab: Sonelokimab's Nanobody® technology offers potential advantages over traditional antibodies, such as enhanced tissue penetration and optimized inhibition of the IL-17A/A, IL-17A/F, and IL-17F/F dimers, which are central drivers of inflammatory disease. Positive clinical trial results have suggested sonelokimab's potential to be a "best-in-class" treatment for certain indications like HS. If this perception translates into strong clinical adoption upon commercialization, it could lead to rapid market penetration and a substantial share in its target markets, driving significant revenue.
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Share Issuance
- MoonLake Immunotherapeutics priced an underwritten offering of 7,142,857 Class A ordinary shares at $10.50 per share on November 5, 2025, expecting to generate gross proceeds of approximately $75 million.
- The offering, which was anticipated to close around November 6, 2025, is being made by MoonLake itself under a shelf registration statement that became effective on September 11, 2023.
- The net proceeds from this offering are intended to fund the research and development of sonelokimab, the company's lead candidate, and for general corporate purposes.
Inbound Investments
- MoonLake Immunotherapeutics drew an initial $75 million under a $500 million credit facility, which is reflected as long-term debt on its balance sheet.
Capital Expenditures
- MoonLake Immunotherapeutics reported quarterly capital expenditures of $35,000 for March 2025.