Moonlake Immunotherapeutics · NASDAQ:MLTX

Moonlake Immunotherapeutics — SHSA 2025 (Symposium on Hidradenitis Suppurativa Advances)

19 slides from Moonlake Immunotherapeutics's conference presentation, October 2025

  1. Slide 1: Sonelokimab in moderate-to-severe HS: Efficacy and safety results from the Phase 3 VELA-1/-2 trials

    Sonelokimab in moderate-to-severe HS: Efficacy and safety results from the Phase 3 VELA-1/-2 trials Martina L. Porter, 1* Alexa B. Kimball, 1* Melinda J. Gooderham,2 Kenneth B. Gordon,3 Alice B. Gottlieb,4 Iltefat H. Hamzavi,5 Jennifer L. Hsiao,6 Brian Kirby,7 James G. Krueger,8 Hadar Lev-Tov,9 Jack

  2. Slide 2: Disclosures

    Disclosures MLP has received consulting fees from AbbVie, Alumis, Arcutis, Avalo Therapeutics, Eli Lilly, FIDE, Incyte, Janssen, Merck, MoonLake Immunotherapeutics AG, Navigator Biosciences, Novartis, Pfizer, Sanofi, Sonoma Biotherapeutics, Trifecta Clinical/WCG, UCB, and ZuraBio; serves as chair fo

  3. Slide 3: Sonelokimab is a novel IL-17A-and-IL-17F-inhibiting Nanobody

    Sonelokimab is a novel IL-17A-and-IL-17F-inhibiting Nanobody1,2 Sonelokimab is a Nanobody, a novel biologic class Sonelokimab inhibits IL-17A and IL-17F Anti-IL-17F Inhibits IL-17A and IL-17F Anti- albumin Conventional mAb Heavy-chain-only Nanobody (typical biologic) antibody (camelids) building blo

  4. Slide 4: VELA-1 and VELA-2 are identically designed Phase 3 trials

    VELA-1 and VELA-2 are identically designed Phase 3 trials Two global, randomized, double-blind, placebo-controlled 52-week trials to evaluate the efficacy and safety of subcutaneous sonelokimab in adults with moderate-to-severe HS Sonelokimab 120mg Q4W Continue Induction doses at Weeks 0, 2, 4, 6, 8

  5. Slide 5: Key endpoints in VELA-1 and VELA-2 include both lesion scores and PROs

    Key endpoints in VELA-1 and VELA-2 include both lesion scores and PROs VELA Hierarchy Sonelokimab vs. placebo at Week 16 Primary endpoint HiSCR 75 Lesion HiSCR 50 counts IHS4-55 Composite Treatment Policy Key strategy for strategy for secondary Pain response intercurrent events ≥3-point improvement

  6. Slide 6: Baseline characteristics were balanced across treatment arms

    Baseline characteristics were balanced across treatment arms VELA-1 VELA-2 Placebo N=138 Sonelokimab N=283 Placebo N=141 Sonelokimab N=276 Age [years], mean 36.1 37.2 38.0 37.2 Female, % 62.3 61.5 49.6 53.6 Race, % White 76.1 77.7 85.1 81.5 Black or African American 15.2 12.0 10.6 9.4 BMI [kg/m2], m

  7. Slide 7: Sonelokimab treatment led to strong and reproducible HiSCR 75 responses

    Sonelokimab treatment led to strong and reproducible HiSCR 75 responses VELA-1 HiSCR 75 VELA-2 HiSCR 75 50 Placebo Sonelokimab 50 Placebo Sonelokimab N=138 N=283 N=141 N=276 ITT, mNRI 40 40 *** % patients achieving HiSCR 75 34.4 *** 34.1 *** 30 *** 30 * Composite strategy 24.9 for intercurrent event

  8. Slide 8: HiSCR responses were similar across both prespecified analysis strategies

    HiSCR 75 responses were similar across both prespecified analysis strategies VELA-1 HiSCR 75 VELA-2 HiSCR 75 50 PBO: Composite PBO: T. P. 50 SLK: Composite SLK: T. P. ITT, MI 40 *** 40 *** * 35.9 % patients achieving HiSCR 75 34.8 *** * 30 *** 30 25.6 Treatment policy (T. P.) strategy for intercurre

  9. Slide 9: HiSCR responses were significant with sonelokimab as early as Week 4

    HiSCR 75 responses were significant with sonelokimab as early as Week 4 VELA-1 HiSCR 75 VELA-2 HiSCR 75 50 PBO: Composite PBO: T. P. 50 SLK: Composite SLK: T. P. 40 40 ITT, mNRI/MI *** % patients achieving HiSCR 75 *** * *** *** * † 30 Week 4 *** 30 Week 4 HiSCR 75 at Week 4 Both prespecified *** 20

  10. Slide 10: Sonelokimab led to strong, rapid and reproducible HiSCR 50 responses

    Sonelokimab led to strong, rapid and reproducible HiSCR 50 responses VELA-1 HiSCR 50 VELA-2 HiSCR 50 70 Placebo Sonelokimab 70 Placebo Sonelokimab N=138 N=283 N=141 N=276 60 60 * *** 55.6 ITT, mNRI 51.0 *** % patients achieving HiSCR 50 50 *** 50 *** Composite *** 42.2 strategy 40 *** 40 *** HiSCR 5

  11. Slide 11: Patients reported meaningful improvements in skin pain as early as Week 1

    Patients reported meaningful improvements in skin pain as early as Week 1 VELA-1 Skin pain response VELA-2 Skin pain response 40 Placebo N=99 Sonelokimab N=206 40 Placebo N=110 Sonelokimab N=201 Baseline: 6.2 Baseline: 5.9 Baseline 6.0 Baseline 6.0 % patients achieving skin pain response *** ITT, mN

  12. Slide 12: Sonelokimab substantially improved the impact of HS on quality of life

    Sonelokimab substantially improved the impact of HS on quality of life HiSQOL HS-specific QOL score VELA-1 HiSQOL improvement VELA-2 HiSQOL improvement 17 items, including those specific to HS Week Week such as drainage, and odor 0 4 8 12 16 0 4 8 12 16 0 0 LSM change from baseline in HiSQOL Total s

  13. Slide 13: Patients reported meaningful improvements in quality of life with sonelokimab

    Patients reported meaningful improvements in quality of life with sonelokimab VELA-1 DLQI MCID VELA-2 DLQI MCID 80 Placebo N=127 Sonelokimab N=254 80 Placebo N=124 Sonelokimab N=262 Baseline: 12.7 Baseline: 12.9 Baseline: 12.6 Baseline: 13.2 ITT, mNRI *** ** % patients achieving DLQI MCID 60 56.8 60

  14. Slide 14: Efficacy with sonelokimab was consistent across trials and analysis strategies

    Efficacy with sonelokimab was consistent across trials and analysis strategies VELA-1 VELA-2 VELA-1 and VELA-2 Combined Placebo SLK 120mg Placebo SLK 120mg Placebo SLK 120mg N=138 N=283 Delta P value N=141 N=276 Delta P value N=279 N=559 Delta P value Composite Strategy (Primary Estimand) HiSCR 75 (

  15. Slide 15: Interim analysis shows continued HiSCR improvement to Week 36

    Interim analysis shows continued HiSCR 75 / 50 improvement to Week 36 VELA-1 and VELA-2 Combined As observed VELA-1 and VELA-2 Combined As observed Placebo> Sonelokimab Sonelokimab Placebo> Sonelokimab Sonelokimab 80 80 75 HiSCR 75 HiSCR 50 % patients achieving HiSCR 75 % patients achieving HiSCR 50

  16. Slide 16: Interim analysis shows rapid responses after crossover from placebo

    Interim analysis shows rapid responses after crossover from placebo VELA-1 and VELA-2 Combined As observed VELA-1 and VELA-2 Combined As observed Placebo> Sonelokimab Sonelokimab Placebo> Sonelokimab Sonelokimab 80 80 75 HiSCR 75 HiSCR 50 % patients achieving HiSCR 75 % patients achieving HiSCR 50 6

  17. Slide 17: Sonelokimab was well tolerated to Week 16, with no new safety signals

    Sonelokimab was well tolerated to Week 16, with no new safety signals VELA-1 and VELA-2 Combined to Week 16 Treatment-emergent adverse events (TEAE), n (%) Placebo N=279 Sonelokimab N=559 Any TEAE 155 (55.6) 376 (67.3) Any Serious TEAE 5 (1.8) 14 (2.5) Any TEAE leading to discontinuation 4 (1.4) 16

  18. Slide 18: Conclusions

    Conclusions Sonelokimab: Key Findings from VELA-1 and VELA-2 • Efficacy: High and sustained HiSCR 75 (primary endpoint) and other clinical responses across both trials, including after switching from placebo • Symptoms and quality of life: Meaningful, consistent improvements in pain, HiSQOL, and DLQ

  19. Slide 19: Acknowledgements

    Acknowledgements The authors and MoonLake Immunotherapeutics AG would like to thank all patients who participated in the trials and their families, and the staff at each site who assisted with the trials. We would also like to acknowledge Mark Hopton (MoonLake Immunotherapeutics) for support with da

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