Summary of Alumis Conference Call Company Overview - **Company**: Alumis - **Event**: Oppenheimer's Annual Healthcare Conference - **Key Speakers**: Martin Babler (CEO), John Schroer (CFO) Core Industry and Product Insights Psoriasis Treatment - **Product**: Envudeucitinib - **Phase 3 Data**: Positive top-line results announced in January - **Primary Endpoint Results**: - PASI 75: Average of 74% - sPGA 0/1: Average of 59% at week 16 [3][4] - **Secondary Results**: - PASI 90: Approximately 65% at week 24 - PASI 100: Just over 40% on average [5] - **Safety Profile**: Consistent with Phase II results; common side effects include headaches, upper respiratory infections, and acne. No malignancy signals observed [6][15][19]. Competitive Landscape - **Competitors**: J&J's IL-23 blocker and Takeda's TYK2 inhibitors - **Market Positioning**: Emphasis on the unique benefits of the TYK2 pathway, including improved patient-reported outcomes and quality of life [7][9]. - **Dosing Preference**: Market research indicates a preference for a twice-daily dosing regimen without food effects over a once-daily regimen with fasting requirements [11][12]. Regulatory and Commercial Plans - **NDA Submission**: Planned for the second half of the year, contingent on 48-week data [25]. - **Commercial Strategy**: Strong plan in place, with considerations for potential partnerships due to the broad indication landscape [26]. Future Opportunities Systemic Lupus Erythematosus (SLE) - **Unmet Need**: High demand for effective oral treatments; current approved drugs have low efficacy [27]. - **Ongoing Trial**: Phase 2b trial with over 400 patients, primary endpoint BICLA, results expected in Q3 [28]. - **Execution Strategy**: Focus on patient selection and managing co-medications to minimize placebo rates [30]. Pipeline Developments - **Lonigutamab**: Ongoing evaluation of its mechanism and competitive landscape; potential for CNS indications [39][41]. - **CNS Penetrant TYK2**: Consideration of broader applications beyond CNS [39]. Additional Considerations - **Malignancy Concerns**: No significant malignancy signals observed; background rates of cancer in trials acknowledged [18][21]. - **FDA Guidance**: Recent communications suggest potential for single trial approvals, which could impact SLE trial strategy [35][36]. This summary encapsulates the key points discussed during the conference call, highlighting Alumis's strategic positioning, product developments, and future opportunities in the healthcare market.

Pipeline and Milestones - Alumis expects topline data from Phase 3 ONWARD trials for envudeucitinib in moderate-to-severe plaque psoriasis in early 1Q 2026[11] - Alumis anticipates topline data from Phase 2b LUMUS trial in systemic lupus erythematosus in 3Q 2026[11] - Alumis plans to initiate a Phase 2 clinical trial for A-005 in multiple sclerosis in 1H 2026[11] - Alumis is evaluating the development program for lonigutamab in thyroid eye disease[12] - Alumis expects Phase 1 data for its next program in 2026[12] Financial Position - Alumis had $486.3 million in cash as of June 30, 2025, providing runway into 2027[11] Envudeucitinib (TYK2 Inhibitor) - Envudeucitinib demonstrated a 15-20% increase in clinical response (PASI) with maximal target inhibition[23] - In the STRIDE trial, Envudeucitinib 40 mg BID showed a 64.1% PASI-75 response at Week 12[39] - Approximately 92% of diagnosed psoriasis patients are not treated with a biologic therapy, representing a market opportunity for Envudeucitinib[35] - Alumis is receiving $40 million near-term for Japan, <5% of Worldwide Psoriasis Market (estimated at $600M in 2024)[69] A-005 (CNS-Penetrant TYK2 Inhibitor) - A-005 achieves a CSF:Plasma (free drug) ratio of approximately 1:1, indicating full CNS penetration[75]