Reports Q1: Pre-BLA Meeting Outcome Is Best-Case Scenario For SLK Label In HS

研报英文原文证据摘录

Reports Q1: Pre-BLA Meeting Outcome Is Best-Case Scenario For SLK Label In HS

TD Cowen MoonLake Immunotherapeutics

Global Research May 11, 2026

Investment Thesis

MoonLake Therapeutics is a clinical stage biotechnology company with the

mission to create therapies for inflammatory skin and joint diseases. MoonLake

was established around sonelokimab, a trivalent bispecific anti-IL-17A/F

nanobody that was in-licensed from Merck KGaA. Sonelokimab is differentiated

by virtue of its small size, two IL-17 binding domains, and asymmetric IL-17

dimer binding. A Phase II trial of sonelokimab in patients with moderate-to-

severe hidradenitis suppurativa (HS) produced impressive results. The HS Phase

II trial met its primary endpoint with a statistically significant HiSCR75 score at

week 12 observed in both sonelokimab arms (120mg and 240mg) vs placebo,

including a placebo subtracted HiSCR75 rate of 29% at sonelokimab's 120mg

dose. Unfortunately, results from the Phase III VELA program were disappointing.

On the primary endpoint of placebo-controlled week 16 HiSCR75, rates of 17%

and 9% were well below investor expectations (23%). Moreover, only VELA-1

reached statistical significance suggesting its path to approval will require some

regulatory flexibility. Nonetheless, we believe the totality of the data suggest

that sonelokimab is a safe and effective IL-17A/F as the pooled data produced a

stat. sig. benefit on HiSCR 75 (P<0.001) and all key secondary endpoints were

hit. Moreover, the FDA provided MoonLake with clear and specific guidance on

sonelokimab's regulatory filing at Type B and pre-BLA meetings, advising MLTX

to use data from MIRA and VELA-1 to establish efficacy with VELA-2 contributing

to the safety database. With additional trials not required, we think this is the