{"url_path":"/sec/mltx/8-k/2026-06-22/item-8-01","section_key":"item-8-01","section_title":"Item 8.01 Other Events.**","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-06-22","source_url":"https://www.sec.gov/Archives/edgar/data/1821586/0001213900-26-070362-index.html","accession_number":"0001213900-26-070362","cik":"0001821586","ticker":"MLTX","issuer_name":"MoonLake Immunotherapeutics","edgar_url":"https://www.sec.gov/Archives/edgar/data/1821586/0001213900-26-070362-index.html","primary_entity_key":"0001821586","primary_entity_name":"MoonLake Immunotherapeutics"},"word_count":648,"has_tables":true,"body_markdown":"**Item 8.01. Other Events.**\n\n** **\n\n**Results from the Phase 3 VELA clinical trials at Week 52**\n\n \n\nWeek 52 data for SLK showed consistent and further\nimprovement in all clinical scores, compared to Week 16 data. Across both VELA-1 and VELA-2, 67.2% of patients treated with SLK achieved\nHidradenitis Suppurativa Clinical Response (“HiSCR”) 75 and 33.1% of patients achieved HiSCR100 at Week 52 (n=396). The results\nwere consistent across both trials (VELA-1: 68.3% HiSCR75, 31.2% HiSCR100; VELA-2: 66.0% HiSCR75, 35.1% HiSCR100). At Week 52, 26.0% of\npatients (n=396) achieved an International Hidradenitis Suppurativa Severity Score System (“IHS4”)-100 response (VELA-1: 24.4%,\nVELA-2: 27.7%), reflecting inflammatory remission, defined as a 100% reduction in abscesses (A100), nodules (N100) and draining tunnels\n(DT100). The long-term results of the VELA program are higher than in previous Phase 3 HS programs with competing agents (using the same\npooled, as observed, end of parental trial data analysis). Relative to the competitor IL-17-A & F inhibitor monoclonal antibody, the\nSLK Nanobody®, for example, showed responses with over ~10% more responding patients for HiSCR75, HiSCR100 or IHS4-100.\n\n \n\nThe strong long-term clinical responses observed\nwith SLK were accompanied by sustained improvements in Patient-Reported Outcomes, which are considered to matter most to patients living\nwith HS and their treating physicians. Patients treated with SLK consistently showed the largest reductions in the HS-specific Quality\nof Life score (“HiSQOL”) at Week 52, with a -15.3 mean score difference between end of trial and baseline in VELA-1, and -14.8\nin VELA-2 (as observed, n=395). The broader skin Dermatology Life Quality Index (“DLQI”) score confirmed the HiSQOL results\nand showed clinically meaningful response (≥4-point improvement from baseline) in 75.0% (VELA-1) and 69.4% (VELA-2) of patients (as\nobserved, in patients with baseline DLQI ≥4, n=363). Responses for both these quality of life metrics were higher than previously demonstrated\nin competitor pivotal HS studies. In line with these data, 46.5% of patients experienced a marked reduction in pain, measured as at least\na 3-point reduction from baseline in the worst skin pain Numerical Rating Scale (VELA-1: 48.4%, VELA-2: 44.3%; as observed, in patients\nwith baseline worst skin pain score of ≥3, n=241).\n\n \n\nThese findings demonstrate leading and durable improvements\nacross outcomes of key relevance for patients, including quality of life, pain and long-term disease control.\n\n \n\nResponses seen in patients crossing over from placebo\n(switch to SLK at Week 16) confirm and validate these findings. After 4 Weeks of SLK treatment, HiSCR75 rates increased by ~20 percentage\npoints across both studies. At the end of the VELA program (i.e., after 36 weeks of SLK treatment), cross-over patients (“Placebo-to-SLK”)\nshowed HiSCR75 rates similar to those observed after 36 weeks of treatment in the “SLK-to-SLK” arms (~60%, as observed).\n\n \n\n 1\n\n \n\n \n\nThe high acceptance rate and good tolerability of\nSLK across the VELA program was confirmed by the rate of patients rolling over into the VELA-OLE (two-year open-label extension) following\nthe parental trials (~90% across all arms) further validating the convenience of the 120mg Q4W (once every four weeks) dosing regimen.\n\n** **\n\n**Interim Week 24 data from the Phase 3 VELA-TEEN trial**\n\n \n\nFurthermore, data from the VELA-TEEN clinical trial\nshowed rapid onset and high response rates in adolescent patients with HS. Interim analysis of Week 24 data show that ~68% of patients\ntreated with SLK achieved HiSCR75, alongside ~86% achieving HiSCR50 and ~45% achieving HiSCR100 (as observed, n=22). HiSCR75 rates in\nVELA-TEEN were higher than those observed in the adult VELA program at comparable timepoints, indicating a pronounced clinical response\nin adolescent patients with earlier stage disease. SLK was generally well tolerated in this vulnerable patient population, and no new\nsafety signals were observed. These promising results highlight the relevance and opportunity of an early treatment of HS with the goal\nto slow down the progression to irreversible tissue damage.\n\n \n\nThe safety profile of SLK in the VELA clinical\nprograms including VELA-TEEN remains consistent over time, with no new safety signals detected."}