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MoonLake Immunotherapeutics (MLTX) investor relations material

MoonLake Immunotherapeutics R&D Day 2025 summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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R&D Day 2025 summary29 Sep, 2025

Pipeline overview and program updates

  • VELA-1 and VELA-2 phase 3 trials evaluated sonelokimab in adults with moderate to severe hidradenitis suppurativa (HS), enrolling over 800 patients with identical designs and endpoints, and over 90% completion at week 16.

  • Sonelokimab demonstrated a differentiated profile with strong efficacy, favorable safety, and convenient dosing.

  • All patients receive sonelokimab from week 16 onward in the VELA trials.

  • The program includes additional ongoing studies in PPP, PsA, axSpA, and adolescent HS, with key readouts expected from late 2025 through 2026.

Clinical trial data and development milestones

  • VELA-1 met all primary and secondary endpoints, while VELA-2's primary endpoint was not met under the composite strategy due to a high placebo response, but was significant under the treatment policy strategy.

  • HiSCR75 response rates at week 16 were 35% (VELA-1) and 36% (VELA-2) for sonelokimab, with a 17% delta to placebo and robust statistical significance.

  • Statistically significant improvements were observed in all key secondary endpoints, including HiSCR50, IHS4-55, pain reduction, HiSQOL, and DLQI, with benefits seen as early as week 4.

  • Sonelokimab's safety profile remained favorable, with no new safety signals and low rates of serious adverse events.

  • Efficacy continued to build beyond week 16, with strong cross-over responses and a week 52 readout planned.

R&D strategy and innovation priorities

  • Two pre-specified statistical strategies (composite and treatment policy) were used in accordance with regulatory advice to ensure robustness.

  • The development strategy leverages a robust pipeline in multiple inflammatory indications, with innovative trial designs and biomarker integration.

  • Nanobody® technology is highlighted for its potential advantages in tissue penetration, stability, and multivalent design.

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Frequently asked questions

MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company, focusing on the development of innovative therapies for inflammatory diseases. The company is advancing Sonelokimab, a novel investigational Nanobody, to address conditions such as hidradenitis suppurativa, psoriatic arthritis, ankylosing spondylitis, and axial spondyloarthritis. MoonLake Immunotherapeutics aims to leverage the therapeutic potential of Sonelokimab to meet significant unmet medical needs in the treatment of these diseases. MoonLake Immunotherapeutics is headquartered in Zug, Switzerland, and its shares are listed on the NASDAQ.

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