MoonLake Immunotherapeutics (MLTX) investor relations material

Strategic focus and clinical development

• Sonelokimab (SLK), a nanobody targeting IL-17A and IL-17F, is being advanced for dermatology and rheumatology, with hidradenitis suppurativa (HS) as the lead indication now completing phase III and moving to registration.

• Multiple pivotal phase III trials are completed or ongoing in HS, psoriatic arthritis (PsA), palmoplantar pustulosis (PPP), axial spondyloarthritis (axSpA), and psoriasis (PsO), with key data readouts anticipated through 2027.

• HS phase III program includes MIRA, VELA-1, VELA-2, and VELA-TEEN (adolescents), supporting a broad label and BLA submission.

• Sonelokimab demonstrates high efficacy (67% HiSCR75 at one year, 33% HiSCR100, 25% inflammatory remission), rapid onset, and favorable safety, with adolescent data supporting pediatric labeling and priority review.

• Ongoing phase III in psoriatic arthritis (IZAR-1) with readout expected soon, aiming to expand indications.

Regulatory and label strategy

• BLA submission for HS is planned by end of Q3 or in 2026, targeting approval and launch between late 2025 and Q4 2026, with potential for priority review due to adolescent data.

• Label strategy aims for inclusion of HiSCR50 and HiSCR75 (with HiSCR75 as primary), pain, IHS4, and patient-reported outcomes, with FDA confirming MIRA and VELA-1 as pivotal for efficacy.

• Proposed FDA label expected to show highest response among approved HS drugs, with differentiation in efficacy, safety (no SIB, IBD, or hepatic signals), and convenience.

• Safety profile may allow avoidance of certain class warnings, supporting a more comprehensive and differentiated label.

Commercialization and market opportunity

• HS market is projected to exceed $10–15 billion by 2035, with only 3% biologics penetration and ~2.9 million diagnosed U.S. patients, indicating significant growth potential.

• High pricing in HS (net >$100,000/year), limited competition, and high unmet need create favorable launch conditions.

• Commercial infrastructure in the US is established, with supply chain readiness, partnerships, and expansion plans to support launch and access.

• Prescriber research shows high willingness to prescribe sonelokimab, with label claims on quality of life and pain reduction seen as key differentiators; expected to be prescribed in 20–30%+ of HS patients.

• Financial position is strong, with runway through 2027 and access to $400 million in additional non-dilutive funding.