Alumis (ALMS) Oppenheimer 36th Annual Healthcare Life Sciences Conference summary

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.