First Tracks Biotherapeutics Inc "Lots of catalysts starting with..."

Research evidence excerpt

First Tracks Biotherapeutics Inc "Lots of catalysts starting with..."

challenge. In Cohort B (Vh:Cd < 2.0), we will look to see mucosal healing in these

"sicker" patients over 12 weeks although we think positive trends and not stat sig are

the bar here and would de-risk a larger Phase IIB similar in design to the study run by

SNY for their OX40L (which has since been deprioritized) which looked at mucosal

healing in a large Phase IIB which included symptomatic patients with Vh:Cd <2.5 - this

would be instead of running Phase IIA gluten challenge studies in higher Vh:Cd non-

symptomatic patients like TEVA and FBRX as the commercially relevant population are

those patients not adequately controlled on gluten-free diet thus these gluten challenge

studies are not necessarily approvable.

Note the Phase I healthy volunteer study for second candidate ANB101 (BDCA2

modulator) is nearing completion. This is a pot'l more potent and longer half-life

BDCA2 modulator vs. Biogen's litifilimab which is currently in Phase III trials for systemic

lupus SLE and cutaneous lupus CLE which are due to read out in Q4 and mid'27

respectively. If positive we think ANAB could be up 10-20%. Recall litifilimab has positive

Phase II data in both SLE and CLE and a pot'l better safety profile than other SLE

competitors and 2 positive Phase II datasets in CLE where there are no approved drugs

thus well-positioned in an under-penetrated multi-billion-dollar lupus market.

TRAX reported Q1 EPS which is inclusive of both ANAB + TRAX as the separation of

businesses occurred on April 20. TRAX is launching with $180M of cash inclusive of the

recent financing which contemplates beginning 4 Phase II trials for lead program

ANB033 and represents two-year cash runway.