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Alumis (ALMS) investor relations material
Alumis Oppenheimer 36th Annual Healthcare Life Sciences Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Key clinical data and competitive positioning
Positive top-line Phase 3 data for envudeucitinib in psoriasis showed PASI 75 of 74% and sPGA 0/1 of 59% at week 16, with rapid onset and deepening response through week 24.
PASI 90 at week 24 reached 65% and PASI 100 just over 40%, with quality of life and itch improvements; safety profile consistent with Phase 2, with no malignancy signal or concerning blood chemistry changes.
Competitive landscape includes J&J's IL-23 blocker, Takeda's TYK2 inhibitor, and others; differentiation may come from patient-reported outcomes and quality of life benefits.
Twice-daily dosing preferred by two-thirds of surveyed patients over once-daily with fasting, though a once-daily formulation is in development as a lifecycle extension.
Orals have higher patient share than injectables in systemic therapy for psoriasis, and the oral market is expected to grow significantly.
Regulatory and commercial plans
NDA submission planned for the second half of the year, pending 48-week data including randomized withdrawal for durability and maintenance.
Commercial strategy includes a small, experienced team with potential for partnership to support up to 20 indications globally.
Decision on internal vs. external commercial ramp-up expected by year-end, depending on broader TYK2 franchise strategy.
SLE program and future opportunities
Phase 2b pivotal trial in SLE (lupus) completed enrollment, with data readout expected in Q3; trial designed with agency alignment and robust patient selection.
Primary endpoint is BICLA at 48 weeks, with SRI-4 as secondary; strong validation for TYK2 in lupus from genomics and prior clinical data.
Potential for improved efficacy and safety over deucravacitinib; FDA guidance may allow for single pivotal trial approval, but safety database requirements remain a key consideration.
Base case assumes a second Phase 3 trial may be needed, with upside for conditional approval if data are strong.
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