Alumis (ALMS) Guggenheim's Inaugural Healthcare Innovation Conference summary

Company overview and strategy

• Focuses on precision immunology, targeting immune-mediated diseases with selective inhibition strategies.

• Lead program ESK001 is a unique TYK2 inhibitor in phase III for psoriasis and pivotal phase II for lupus.

• Pipeline includes a brain-penetrant TYK2 inhibitor (A-005) and other mechanisms beyond TYK2.

• Genomic data guided the selection of TYK2, leveraging a mutation that reduces autoimmune risk by 50%.

• Aims to move from broad to precise inhibition for better safety and efficacy.

Clinical development and data

• ESK001 shows high selectivity and minimal off-target effects, enabling maximum inhibition with favorable safety.

• STRIDE phase II study demonstrated a 20% efficacy jump at maximum dose, with PASI 75 rates above 90%.

• Consistent efficacy observed across dose escalation and open-label extension studies.

• Phase III program designed for rapid submission, with FDA agreement to file with six-month data.

• Global phase III trials are enrolling, with readout expected by the first half of 2026.

Competitive landscape and market opportunity

• Oral therapies address a large unmet need, as less than 10% of psoriasis patients use injectables.

• Market opportunity includes patients preferring oral over injectable, early and aggressive treatment, and maintenance after biologics.

• ESK001 expected to outperform current oral competitors in efficacy, with PASI 75 rates of 80–90% and PASI 90 of 60–75%.

• Plans for head-to-head trials against other oral competitors, with Otezla as the current active comparator.

• Once-daily formulation in development to enhance convenience and competitiveness.