MLTX - 1Q26; Positive Pre-BLA Meeting Outcome Aligns With Best-Case Outcome for Competitive Labeling in HS; VELA-TEEN to Expand Label Further; PsA Readouts Remain On-Track

研报英文原文证据摘录

MLTX - 1Q26; Positive Pre-BLA Meeting Outcome Aligns With Best-Case Outcome for Competitive Labeling in HS; VELA-TEEN to Expand Label Further; PsA Readouts Remain On-Track

May 11, 2026

Yatin Suneja yatin.suneja@guggenheimpartners.com MLTX - 1Q26; Positive Pre-BLA Meeting Outcome

212 518 9565 Aligns With Best-Case Outcome for Competitive

Min Lee, Ph.D.

min.lee@guggenheimpartners.com Labeling in HS; VELA-TEEN to Expand Label Further;

212 823 6744 PsA Readouts Remain On-Track Iris Gao, Ph.D.

iris.gao@guggenheimpartners.com

212 518 9013 Key Message: Yesterday, MLTX reported 1Q26 earnings and provided key new

Eddie Hickman, Ph.D. corporate updates: (1) HS & BLA updates: On Apr 1st, MLTX held a pre-BLA meeting

eddie.hickman@guggenheimpartners.com with the FDA. As expected, the FDA confirmed acceptability of MIRA trial to establish

212 518 9904 substantial evidence of effectiveness (SEE), as well as inclusion of VELA-TEEN

Delma Caiati, M.D., Ph.D. data for the final label that covers adolescent HS patients ages 12 & above (see note

delma.caiati@guggenheimpartners.com HERE; broadest HS label to-date). Per mgmt, these adolescent HS patients represent

617 859 4606 ~10% of the total HS market, effectively enabling sonelokimab (SLK; dual IL-17A/

F targeting nanobody) to capture a broader HS population that is not included in

UCB's Bimzelx's label. These outcomes support the company's upside case, potentially

including a blended HiSCR-75 of pbo-adj. ~Δ23% (Recall that VELA-1 & MIRA showed

MLTX BUY ~Δ17%option. BLA& ~Δ29%,submissionrespectively),is expectedwhichforcouldend supportof Sept, sonelokimabwith potentialasBLAa BICacceptancetreatment

MoonLake Immunotherapeutics as early as end of Nov 2026 (contingent upon decision of Priority Review designation,