MoonLake Immunotherapeutics : ARGO Week 12 Results

MoonLake Immunotherapeutics

R&D Day Webcast

Presentation Document - Results ARGO trial November 2023

Welcome to our R&D Day

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Introduction

PsA: IL-17F dependent multi-domain disease in difficult-to-reach tissues

Plaques

producing cells in

associated plaques3 and

IL-17FPsAaxial disease4-6, and with 80% of patients suffering

from nail psoriasis7)

The key messages

MLTX's ARGO trial is a SUCCESS

• Joints: ACR50 primary endpoint met at wk 12 for 60mg and 120mg induction doses - up to 47% ACR50 (p<0.01 vs placebo)
• Skin: PASI90 secondary endpoint met at wk 12 also for 60mg and 120mg induction doses - up to 77% PASI90 (p<0.001 vs placebo)
• Other secondary end points met at wk 12, wk16 data indicated continued improvement- impact of SLK for PsA patients is clear (e.g., PASI100, ACR70, MDA)
• No new safety signals - continues to indicate favorable safety profile

MLTX's SLK Nanobody® continues to open a new era in therapy

• Differentiating on multi-domain responses - consistency across skin & joint scores
• Potential to use both doses (60mg and 120mg), advantageous for label
• Highest numbers on higher level outcomes (e.g., ACR70, PASI100) at week 12
• Impact in important disease activity scores as early as week 12
• Differentiating with favorable safety profile

MLTX positioned to become a leader in I&I

• Our view: SLK now a leading potential asset in HS, PsA & PsO (all multi-bn markets)
• A wealth of potential indications to further pursue ($30bn+)
• Soon Ph3-readyin 3+ TAs - expected to start Ph3s in 2024

ARGO Trial

Results

ARGO: Phase 2 trial design

Notes: 1 Randomization stratified by sex and prior exposure to biologics; 2 At Week 0/Day 1, all eligible participants were randomized 1:1:1:1:1; 3 In the cross-over period, starting at Week 12, participants on sonelokimab 120 mg who did not achieve an adequate response switched to adalimumab 40 mg Q2W until Week 24; participants on sonelokimab 60 mg (started at baseline Q2W or Q4W) who did not achieve an adequate response switched to sonelokimab 120 mg Q4W until week 24; participants on adalimumab who did not achieve an adequate response switched to sonelokimab 120 mg Q4W until Week 24; an adequate response is defined as a reduction of the tender and swollen joint count of ≥20%. Participants on placebo at Week 12 were switched to sonelokimab Q4W until Week 24

Baseline: All arms of the ARGO trial are well balanced