MLTX: With Updated HS Data In Hand, MLTX Reiterates Case For SLK Competitiveness, Aims To Keep PsA Disclosure Expectations In Check

Research evidence excerpt

MLTX: With Updated HS Data In Hand, MLTX Reiterates Case For SLK Competitiveness, Aims To Keep PsA Disclosure Expectations In Check

s to see potential for this to drive Priority Review, though this is not their base

case.

Mgmt reiterated the previously-conveyed potential label scenarios, where they continue to expect VELA-1 and the ph.II MIRA study

data to be core to the efficacy table without necessarily showing placebo-adjusted deltas, and they still see an upside scenario

where additional important endpoints like pain, HiSQOL, and IHS4-55 scores are included in Sec. 14, as opposed to being included

as narrative points, differentiating vs. competitors. Mgmt also emphasized differentiation in terms of safety as well, with no signal

for hepatic events, IBD, or TB reactivation across trials; although our KOLs have not indicated these warnings on other labels to be

a barrier to use, this could be a detailing point that helps commercial uptake.

Our dermatologist KOL checks have indicated that there does remain an appetite for more options in HS, suggesting a potential

role for SLK in the indication even with bime's increasing use; that said, their experiences with bime have been favorable and so

we do believe this entrenchment is likely to cap SLK's market opportunity.

Mgmt also reiterated guidance for TNF-naive PsA data from IZAR-1 to be announced in 3Q26, including "met" vs "not met"

disclosure regarding endpoints, as is consistent with prior disclosures in PsA. Key endpoints will be reported as absolute responses,

in line with FDA guidance to maintain data integrity and blinding; mgmt is defining comparable responses as seen in ARGO trial

as the bar for success in PsA. Notably, they will provide only the absolute data for the induction arm, which recall in the ph.II