MoonLake To Tap Into Komodo’s Technology and Real-World Data To Unlock

the Full Potential of Its Next-Gen Nanobody^® Therapy

MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, and Komodo Health today announce a new technology partnership to help improve treatment for people living with inflammatory skin and joint diseases. The two companies will collaborate to maximize the impact of MoonLake’s nanobody-based therapy in hidradenitis suppurativa (HS) and active psoriatic arthritis (PsA), two underdiagnosed diseases that have significant unmet patient needs.

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Through this multiyear technology partnership, MoonLake will utilize Komodo’s Healthcare Map and platform technologies to enable data-driven decision-making across its clinical operations, medical, marketing, and market access teams. Komodo’s data and technology applications will support MoonLake’s in-depth market research, clinical trial site selection, go-to-market strategies, and patient journey mapping — all aimed at accelerating the development of new treatment options and improving outcomes for patients with inflammatory skin and joint diseases.

Tino Anthamatten, VP, Marketing & Market Access & Pricing, MoonLake Immunotherapeutics, commented: “We need an experienced technology partner that can help accelerate our disease insights for our clinical, medical, and commercial endeavors. Komodo’s data-driven intelligence is expected to be a critical tool as we work toward commercialization and delivering transformative therapies to patients.”

Recent research underscores the challenges that Life Sciences companies face in generating data-driven intelligence that can support decision-making across the product life cycle. On average, it takes seven months to identify and integrate data sources before teams can even begin to generate insights.

Using Komodo’s software applications and Healthcare Map, MoonLake was able to identify important findings, presented at its R&D day last month, related to the HS market. The real-world analysis of the U.S. patient population revealed that between 2016 and 2023, 2 million unique patients were diagnosed and treated for HS, not including undiagnosed and untreated patients. The data also revealed that, on average, 240,000 net new patients are diagnosed and treated each year. This data helps substantiate the prevalence of HS as ~2%, as stated in the literature. The real-world insights from Komodo helped validate a future HS market size projected to exceed $10B by 2035. Today there is a notably low penetration of current biologics (around 3%) and a high dropout rate from these interventions within the first year (median treatment duration of 11 months in a real-world setting). Furthermore, these insights shed light on the challenges of care and that individuals living with HS are being lost in their treatment journey. Over 50-60% of patients take long-term antibiotics, and many are also prescribed steroids and/or opioids. This real-world perspective substantiates MoonLake’s market size estimates and highlights the need for more effective therapies.

“We are thrilled to support MoonLake’s efforts to advance scientific innovation and gain a deeper understanding of patient journeys and unmet needs for people living with inflammatory diseases,” said Web Sun, President and Co-Founder, Komodo Health. “As MoonLake expects to commence phase 3 trials, we look forward to helping their teams utilize data and analytics to evaluate the market, develop their go-to-market and commercialization strategy, and, most important, help quickly bring its Nanobody^® therapy to market, once approved, for patients who need it most.”

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About 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 and psoriatic arthritis – 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. The terms Nanobody^® and Nanobodies^® are trademarks of Ablynx, a Sanofi company.

About Komodo Health

Komodo Health is a technology platform company creating the new standard for real-world data and analytics by pairing the industry’s most complete view of patient encounters with enterprise software and machine learning that connects the dots between individual patient journeys and large-scale health outcomes. Across Life Sciences, payers, providers, and developers, Komodo helps its customers unearth patient-centric insights at scale — marrying clinical data with advanced algorithms and AI-powered software solutions to inform decision-making, close gaps in care, address disease burden, and help enterprises create a more cost-effective, value-driven healthcare system. For more information, visit Komodohealth.com.

About Psoriatic Arthritis

Psoriatic arthritis (PsA) is a chronic and progressive inflammatory arthritis associated with psoriasis primarily affecting the peripheral joints. The clinical features of PsA are diverse, involving pain, swelling, and stiffness of the joints, which can result in restricted mobility and fatigue. PsA occurs in up to 30% of patients with psoriasis, most commonly those aged between 30 and 60 years. The symptom burden of PsA can have a substantial negative impact on patient quality of life. 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 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 ~2% of the global population, with three times more females affected than males. 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 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.

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: plans for clinical trials and research and development programs; including the initiation of clinical programs in new indications; anticipated support from regulatory agencies with respect to MoonLake’s development plans, anticipated size and timing of enrollment for the VELA trial, the sufficiency of data from the VELA trial to support regulatory filings in the US and EU, the anticipated trial design for the VELA trial and the timing of expected readouts; MoonLake’s expectations regarding the potential market size for HS; the Company’s plans with respect to the commencement of a Phase 3 trial in PsA; and the efficacy of MoonLake’s products, if approved, including in relation to other products. 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, and reliance on third parties to conduct and support its 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, 2023 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.

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