Company: MLTX
Filing Date: 2025-11-05
Form Type: 10-Q
Source: 0001821586-25-000022
Chunk: 43

Company: MoonLake Immunotherapeutics
Filing Date: 2025-11-05
Form: 10-Q
Item: Part I, Item 1
Chunk 43
---
 trials. In the combined VELA program, patients treated with SLK experienced a clinically meaningful and statistically significant improvement across all primary and key secondary endpoints using both pre-specified strategies (p<0.001). In VELA-1, SLK achieved statistical significance for all primary and key secondary endpoints using both pre-specified strategies (HiSCR75, delta to placebo of 17%, p<0.001). In VELA-2, intercurrent events in the higher-than-expected placebo arm precluded the study from achieving statistical significance in the week 16 primary endpoint using the composite strategy (HiSCR75, delta to placebo of 9%, p=0.053). From week 16, all patients are expected to continue to receive the 120mg dose of SLK through to 48 weeks, with a last assessment planned at week 52, followed by an open-label extension for up to two years. We are currently seeking FDA input on the adequacy of the current clinical evidence package to support a Biologics License Application (“BLA”) submission for SLK in HS and expect to receive such input around the end of this year. We expect the 1-year data of VELA-1 and VELA-2 to become available in the second quarter of 2026.

PsA Trials

In December 2022, we initiated a Phase 2b trial in patients with active PsA (the ARGO trial (M1095-PSA-201)) and in November 2023, we announced positive top-line results from this trial, which met its primary endpoint of American College of Rheumatology (“ACR”) 50. In March 2024, we announced positive 24-week data from the ARGO trial in PsA showing that continued treatment with SLK led to significant improvements across all key outcomes. In June 2024, we announced the successful outcome of our end-of-Phase 2 interactions with the FDA, as well as positive feedback from our interactions with the EMA, with both regulatory bodies supporting our proposed approach for advancing our Phase 3 program of SLK in PsA. In November 2024, we announced the screening of the first patients in the IZAR-1 trial (M1095-PSA-301) and IZAR-2 trial (M1095-PSA-302). We expect a readout of the primary and key secondary endpoints of the IZAR-1 clinical trial in the second