VELA program

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MoonLake Immunotherapeutics (NasdaqCM:MLTX) 2025 Earnings Call Presentation
2025-09-29 12:00
VELA Program Results - The combined VELA program demonstrated statistically significant improvement across primary and key secondary endpoints at week 16 (p<0.001)[9] - In VELA-1 and VELA-2, the sonelokimab arm showed HiSCR75 response rates of 35% and 36% respectively[9] - VELA-1 achieved statistical significance for all primary and key secondary endpoints[10] - In VELA-2, using the treatment policy strategy, statistically significant HiSCR75 response rates were demonstrated at week 16[10] - Approximately 30% of patients in VELA-1 and VELA-2 experienced a marked reduction in pain[32] Efficacy and Safety Profile - Sonelokimab continues to show a differentiated profile, including leading Patient Reported Outcomes (PROs) and a favorable safety profile[10] - VELA-1 showed a HiSQOL response with a change from baseline of -9.4 for Sonelokimab vs -3.8 for Placebo[34] - VELA-2 showed a HiSQOL response with a change from baseline of -9.0 for Sonelokimab vs -3.5 for Placebo[34] - VELA-1 showed a DLQI-MCID response of 58% for Sonelokimab vs 39% for Placebo[37] - VELA-2 showed a DLQI-MCID response of 59% for Sonelokimab vs 38% for Placebo[37] Future Plans - MoonLake will seek to confirm the registration path with regulatory authorities and is seeking guidance from the FDA[10, 55]