Company: MLTX
Filing Date: 2025-11-05
Form Type: 10-Q
Source: 0001821586-25-000022
Chunk: 44

Company: MoonLake Immunotherapeutics
Filing Date: 2025-11-05
Form: 10-Q
Item: Part I, Item 1
Chunk 44
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 quarter of 2026 and of the IZAR-2 clinical trial in the second half of 2026.

Additional Trials for Other Indications

In March 2024, we announced plans to initiate clinical studies of SLK in additional indications, including a Phase 3 trial in adolescent patients with HS (the VELA-TEEN trial (M1095-HS-304)), a Phase 2 trial in patients with PPP (the LEDA trial (M1095-PPP-201)), a Phase 2 trial in patients with axSpA (the S-OLARIS trial (M1095-axSpA-202)) and another Phase 2 trial applying novel imaging techniques in patients with PsA (the P-OLARIS trial (M1095-

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snSpA-202)). In January 2025, we announced that first patients have been screened in the VELA-TEEN, the LEDA, and the S-OLARIS clinical trials. In November 2025, we presented the results of the LEDA clinical trial, as well as an interim analysis of the VELA-TEEN clinical trial. In the LEDA clinical trial, patients treated with SLK achieved a mean percent change from baseline in the Palmoplantar Pustular Psoriasis Area and Severity Index (“PPPASI”) of 64% at week 16, and 39% of patients achieved a ≥75% reduction in the PPPASI (“PPPASI75”), suggesting that SLK could provide clinically meaningful improvements in patients with PPP. We expect to commence a Phase 3 clinical trial in PPP in the third quarter of 2026. The interim analysis of the VELA-TEEN clinical trial showed that 46% of patients achieved a HiSCR75 response at week 16 (n=11). The trial is expected to enroll a total of 30-35 patients and we expect topline results in the second quarter of 2026. Results of the S-OLARIS trial are expected to become available in the first quarter of 2026.

SLK was also studied in a Phase 2b trial in PsO patients where it showed a significant improvement in the primary end point as compared with placebo and for which results were presented in peer-reviewed scientific publications and conferences. In addition to the three Phase 2b trials, Phase 1 single ascending and multiple ascending dosing trials were previously completed, bringing the total number of patients in completed SLK-related