Summary of Alumis FY Conference Call - September 08, 2025 Company Overview - Alumis is a precision immunology company based in the Bay Area, established four years ago, with a focus on TIK2 inhibitors [3][4] - The lead asset, Envuducitinib (ESK-021), is in Phase 3 for psoriasis and Phase 2 for lupus, with readouts expected in early Q1 2026 and Q3 2026, respectively [3][4][16] Pipeline and Strategic Priorities - The company has four key assets, including a second TIK2 inhibitor that is brain-penetrant and shows a 1:1 ratio between blood and brain [3][4] - A preclinical asset, lenaludomab, is expected to enter the clinic soon, with Phase 1 data anticipated next year [4][5] - The company emphasizes genomic analysis and has identified biomarkers related to TIK2, which may help predict responses in lupus and CNS indications [4][5] TIK2 Inhibition and Clinical Insights - TIK2 is considered a promising target due to its genomic richness and specific mutations that may downregulate its kinase function, potentially leading to safer drugs [7][8] - The protective effect of the P1104A mutation against autoimmune diseases is highlighted, with a 50% average protective rate in lupus and psoriasis [8][9] - The company aims to achieve maximum inhibition of TIK2 without significant side effects, which has been a differentiating factor in their clinical trials [10][24] Competitive Landscape - The oral drug market for psoriasis is growing, with oral drugs currently holding a higher patient share than injectables, despite the latter's higher dollar share [14][15] - Alumis aims to develop a high-efficacy oral drug, with Phase 2 data showing promising results that could change treatment paradigms [15][16] - The company is aware of competitors like Sotyktu and Johnson & Johnson's oral IL-23, and believes that their drug's efficacy and safety profile will differentiate it in the market [27][28] Upcoming Trials and Data Expectations - The Phase 3 trial for psoriasis (Onward) is designed with a placebo-controlled portion and an active control section, with data expected in early Q1 2026 [17][18] - The primary endpoint for the trial is PASI 75, with expectations to exceed 50-60% efficacy at week 16 [20][21] - The company is also preparing for a Phase 2 trial for their CNS-penetrant TIK2 inhibitor, which has been delayed to the first half of 2026 due to resource allocation [56][58] Financial Position and Strategic Partnerships - Alumis ended Q2 2025 with $486 million in cash, projecting a runway into 2027, allowing them to navigate key inflection points [53][55] - The company is considering strategic partnerships for global launches, with a focus on maximizing asset value [37][38] Future Opportunities - High conviction in lupus treatment due to successful trials with interferon inhibition, and ongoing analysis to minimize placebo effects in trials [49][50] - Interest in IBD as a potential indication for TIK2, with ongoing research into the genomic data supporting this [52] - Plans to introduce a new molecule targeting a different mechanism, with Phase 1 expected next year [61][62] Conclusion - Alumis is positioned to make significant advancements in the immunology space with its TIK2 inhibitors, focusing on both efficacy and safety, while navigating a competitive landscape and preparing for upcoming clinical data releases. The strategic financial position allows for flexibility in partnerships and future developments.
Alumis (NasdaqGS:ALMS) FY Conference Transcript