MLTX - Investor Day Updates: Robust 52-Week Results Support BIC Potential; BLA Submission End of Sept; Priority Review Is Possible w/ VELA-TEEN; IZAR-1 Data Expected in 3Q26

研报英文原文证据摘录

MLTX - Investor Day Updates: Robust 52-Week Results Support BIC Potential; BLA Submission End of Sept; Priority Review Is Possible w/ VELA-TEEN; IZAR-1 Data Expected in 3Q26

June 22, 2026

Yatin Suneja yatin.suneja@guggenheimpartners.com MLTX - Investor Day Updates: Robust 52-Week

212 518 9565 Results Support BIC Potential; BLA Submission End

Min Lee, Ph.D.

min.lee@guggenheimpartners.com of Sept; Priority Review Is Possible w/ VELA-TEEN;

212 823 6744 IZAR-1 Data Expected in 3Q26 Eddie Hickman, Ph.D.

eddie.hickman@guggenheimpartners.com

212 518 9904 Key Message: This morning, MLTX hosted an Investor Day, highlighting key updates

Delma Caiati, M.D., Ph.D. throughout the company's ongoing pipeline: (1) 52-week results from VELA studies

delma.caiati@guggenheimpartners.com revealed ~67% HiSCR-75 & ~33.1% HiSCR-100 (~10 ppts up from ~62% HiSCR-75 &

617 859 4606 ~30% HiSCR-100 at 40-weeks disclosed at AAD, exceeding Bimzelx's 62% HiSCR75

& 30% HiSCR100 at 48-weeks; Figure 1). These absolute HiSCR efficacies are highest Iris Gao, Ph.D.

iris.gao@guggenheimpartners.com observed to-date, and we believe SLK has realistic potential to emerge as BIC therapy

212 518 9013 for HS, as the safety profile is significantly differentiated as well; (2) BLA Updates

in HS: Recall that the FDA has confirmed acceptability of MIRA trial to establish

substantial evidence of effectiveness (SEE), as well as inclusion of VELA-TEEN data.

BLA submission is expected for end of Sept, with granting of PDUFA data &

MLTX BUY decisionin the U.S.onisPriorityexpectedReviewfor 3Q27-4Q27expected at(Withend Priorityof Nov Review,2026. SLK'sas earlycommercialas 2Q27);launch(3)

MoonLake Immunotherapeutics Commercialization: Continued growth in real-world data validates HS market potential