52wk VELA-1/2 Data Confirm Progressive Efficacy, Boding Well for BLA Submission in Late September 2026. IZAR-1 Topline Results in ~1 Month Likely Next Catalyst.

研报英文原文证据摘录

52wk VELA-1/2 Data Confirm Progressive Efficacy, Boding Well for BLA Submission in Late September 2026. IZAR-1 Topline Results in ~1 Month Likely Next Catalyst.

Investment Thesis

A Type B meeting with the FDA confirmed that MLTX could establish substantial evidence of effectiveness of SLK in hidradenitis

suppurativa (HS) without conducting additional clinical studies, supported by a holistic view of data from the VELA and MIRA trials.

With this feedback, MLTX intends to continue its current plans for SLK's BLA submission in HS at the end of September 2026. We

believe this positive update clears a significant overhang for MLTX's clinical development and could position SLK to receive FDA

approval. We also see this update having positive readthroughs to Avalo (AVTX, Buy, $58 PT) and Oruka (ORKA, Buy, $151 PT),

as earlier-stage development programs in HS could likely benefit from similar optionality if regulatory flexibility is proven to be

needed. HS is a large underpenetrated market with high-growth potential (US market size is expected to grow from ~$2B/ yr in 2024BIOTECHNOLOGY to >$10B/yr by the mid-2030s), where there is likely adequate room for multiple advanced therapies to be commercially successful;

a seat at the table would support significant upside in MLTX shares, in our view. MLTX reported the highest 12wk ASAS40 result

from any clinical trial in axSpA, and we believe SLK's potential in high-need rheumatology remains significantly underappreciated.

Our view is SLK's efficacy in axSpA is likely owed to construct-specific advantages and could position SLK as a contender for best-

in-disease Tx option. Other information shared from mgmt. included details for the Phase 3 PPP program, with the first patient inEQUITY

expected in 3Q26.