TYK2 Inhibition
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Alumis (ALMS) Earnings Call Presentation
2025-09-03 12:00
Financial Status and Pipeline - Alumis had $486.3 million in cash, cash equivalents, and marketable securities as of June 30, 2025, expected to fund operations into 2027[12] - The company has a portfolio of three clinical molecules against validated targets, including Envudeucitinib, A-005, and Lonigutamab, plus multiple pipeline assets in late-stage research[12] Envudeucitinib (TYK2 Inhibitor) - Phase 3 topline data for Envudeucitinib in Psoriasis is expected in early Q1 2026, and Phase 2b topline data for SLE is expected in Q3 2026[12] - Envudeucitinib targets a market opportunity greater than $4 billion in SLE[27, 75] - In a Phase 2 trial, Envudeucitinib demonstrated high statistical significance at Week 12 (PASI 75: p < 0001)[45] - Approximately 75% of psoriasis patients prefer an oral therapy[25, 33, 40] A-005 (CNS Penetrant TYK2 Inhibitor) - A-005 is a first-in-class brain-penetrant TYK2 inhibitor for neuroinflammation and neurodegeneration, with Phase 2 initiation in MS expected in 1H 2026[14, 16] - A-005 demonstrated full CNS penetration in Phase 1, with doses established to provide high peripheral and CSF exposure[29, 86] Lonigutamab (Anti-IGF-1R Therapy) - Lonigutamab is an anti-IGF-1R therapy with a unique MOA for Thyroid Eye Disease (TED), with development program evaluation ongoing[12, 16] Market Opportunities - Near-term results could unlock interferon and IL-23 pathway-driven diseases with global market opportunities greater than $150 billion[15] - Approximately 16 million people worldwide have moderate-to-severe psoriasis, representing a global market of over $25 billion[40] Kaken Collaboration - Alumis is receiving $40 million near-term for Japan, which is less than 5% of the worldwide psoriasis market (estimated at $600 million in 2024), highlighting significant opportunity for Alumis in ROW[72]
Alumis (ALMS) 2025 Conference Transcript
2025-06-04 20:10
Summary of Illumis (ALMS) Conference Call Company Overview - Illumis recently completed a merger with Accelerin to strengthen its position as a leading immunology company [2][3] - The merger aims to combine their pipelines and financial resources to build a well-capitalized precision immunology company [3] Key Pipeline Developments - Upcoming key readouts include: - Psoriasis readout expected in early 2026 after completing enrollment of over 1,700 patients in a Phase III trial [4][7] - Lupus readout planned for next year, with ongoing Phase II trial expected to complete enrollment by summer [5][8] - The company has a cash runway into 2027, with approximately $600 million in cash and 100 million shares outstanding [6] Psoriasis Program - The psoriasis program is in Phase III, with a six-month readout expected early in 2026 [4][7] - The trial has been completed ahead of schedule, indicating strong patient interest [7] - The company is focused on maximizing target inhibition with its TYK2 inhibitors, which have shown promising results in clinical trials [12][21] Lupus Program - The lupus program is designed as a pivotal trial to demonstrate significant efficacy over placebo [43] - The company aims to reduce the placebo effect by ensuring strict patient selection and monitoring [44] - The ongoing study is expected to read out in 2026, with a focus on genetic validation for TYK2 inhibition in lupus patients [38][40] Competitive Landscape - The psoriasis market is competitive, but injectable biologics account for less than 10% of treatments, indicating a significant opportunity for effective oral therapies [34][35] - The company aims to capture a portion of the market by offering a highly efficacious and safe oral drug [34] Differentiation and Safety Profile - Illumis emphasizes the importance of maximum target inhibition for efficacy and safety, with ongoing studies supporting this hypothesis [20][21] - The safety profile of their drugs has been favorable, with no significant safety findings reported to date [24][25] Future Milestones - The company plans to initiate a Phase II trial for its brain-penetrant TYK2 inhibitor, A5, later this year [52][56] - A once-a-day formulation for ESK001 is also in development, with plans to announce details later this year [57] - Key readouts for psoriasis and lupus are anticipated in 2026, along with potential updates on MS and lanagutamab [58] External Validation - A partnership with Kakken in Japan for the development of ESK001 has provided external validation and a significant financial boost [46] Conclusion - Illumis is strategically positioned in the immunology space with a robust pipeline and a focus on maximizing efficacy and safety through innovative drug development and strategic partnerships [2][3][34]