Nanobody (sonelokimab) - (VELA-2)

June 21, 2026: MoonLake Immunotherapeutics (NASDAQ: MLTX) reported Week 52 results from the Phase 3 VELA-1 and VELA-2 registrational trials of sonelokimab (SLK) in adults with moderate-to-severe hidradenitis suppurativa (HS). Across both trials at Week 52 (as observed; n=396), 67.2% achieved HiSCR75 and 33.1% achieved HiSCR100; 26.0% achieved IHS4-100 (inflammatory remission). Quality-of-life improved with HiSQOL mean change from baseline of -15.3 (VELA-1) and -14.8 (VELA-2) (n=395); DLQI clinically meaningful response (≥4-point improvement) occurred in 75.0% (VELA-1) and 69.4% (VELA-2) among those with baseline DLQI ≥4 (n=363). Marked pain reduction (≥3-point improvement in worst skin pain NRS) was seen in 46.5% (n=241). No new safety signals were reported; ~90% rolled into the VELA-OLE extension.

MoonLake also provided interim Week 24 data from the Phase 3 VELA-TEEN trial (adolescent HS): ~68% HiSCR75, ~86% HiSCR50, and ~45% HiSCR100 (as observed; n=22), with no new safety signals.

Regulatory catalyst: BLA submission for SLK in HS (including adolescent data) is expected end of September 2026; PDUFA date allocation is expected by end of November 2026 upon BLA acceptance, with a planned Priority Review request.

Upcoming events: Investor Day webcast June 22, 2026; PsA program milestones include IZAR-1 Phase 3 primary endpoint readout mid-2026, IZAR-2 readout H2 2026, and interim Phase 2 P-OLARIS readout H2 2026.