ESK-001 - (LUMUS)

August 13, 2026: Alumis (NASDAQ: ALMS) reported catalyst updates led by envudeucitinib, its oral TYK2 inhibitor. In moderate-to-severe plaque psoriasis, topline data from the ongoing ONWARD3 long-term extension showed 75% of patients achieved PASI 90 and 54% achieved PASI 100 after up to 48 weeks of continuous treatment (n=773); the drug was described as well tolerated with a safety profile consistent with ONWARD1/2. Alumis said it remains on track to submit an NDA to the FDA for envudeucitinib in plaque psoriasis in Q4 2026, with additional long-term data planned for future medical meetings and Phase 2 two-year safety data expected in 2H 2026.

For systemic lupus erythematosus, Alumis expects potentially pivotal Phase 2b LUMUS topline data for envudeucitinib in Q3 2026.

Pipeline updates: Alumis is prioritizing Sjögren’s disease and cutaneous lupus erythematosus as possible future indications for envudeucitinib, subject to LUMUS results. A-005, a CNS-penetrant TYK2 inhibitor, is planned to enter a Phase 2 biomarker trial in Parkinson’s disease in 1H 2027 after Phase 1 healthy volunteer data showing tolerability, maximal peripheral target inhibition, and CNS penetration. Alumis also said it is exploring strategic alternatives for lonigutamab.