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Alumis Inc.(ALMS) - 2025 FY - Earnings Call Transcript
2025-09-05 14:30
Financial Data and Key Metrics Changes - The company ended the second quarter with $486 million in cash and cash equivalents, providing a runway into 2027 [53] Business Line Data and Key Metrics Changes - The company is focused on Tyk2 inhibitors, with two lead molecules in development: a Phase 3 readout in psoriasis expected in early Q1 next year and a Phase 2b readout in systemic lupus erythematosus (SLE) anticipated in Q3 next year [4][5] Market Data and Key Metrics Changes - The company aims to position its oral Tyk2 inhibitors as a first-line treatment for lupus, targeting patients who currently receive methotrexate or steroids [34] Company Strategy and Development Direction - The company is preparing for commercialization but is considering partnerships for global commercialization due to the potential of the molecule [17] - The strategy includes a robust trial design for lupus, potentially allowing the Phase 2b trial to serve as a pivotal trial, which could streamline the path to registration [27][29] Management's Comments on Operating Environment and Future Outlook - Management believes that the Tyk2 target has significant potential, despite previous disappointments with other molecules in the space, emphasizing the need for maximum target inhibition to achieve efficacy [54][55] - The unmet need in lupus is significant, and the company is optimistic about the potential of its oral therapies to provide safe and effective treatment options [20][26] Other Important Information - The company has a research organization in place to support its pipeline development, including the recently acquired lonigutamab, which is being evaluated for its safety profile [48] - The company is also exploring the potential of its Tyk2 inhibitors in other interferon-driven diseases, which could expand its market opportunities [36] Q&A Session Summary Question: What are the next steps for commercialization? - The company is preparing for commercialization but is unlikely to do so independently on a global scale, considering partnerships based on the data from psoriasis and lupus trials [17] Question: What are the expectations for the lupus trial? - Management believes that achieving a placebo-adjusted benefit of 8% to 15% would position the oral therapy favorably in the market [25] Question: How does the company view the competitive landscape? - The company believes its oral Tyk2 inhibitor has advantages in safety and convenience compared to other therapies, which could make it competitive in the market [16] Question: What is the market opportunity for Tyk2 in lupus? - The company sees the Tyk2 inhibitor as likely being used as a first-line treatment due to its favorable safety profile and ease of administration [34] Question: How does the company plan to address the challenges in lupus trials? - The company has implemented measures to ensure that only patients with active disease are enrolled and has controlled for co-medications to minimize placebo effects [22][24] Question: What is the funding strategy moving forward? - The company aims to maintain sufficient cash reserves to support strategic decisions based on the outcomes of the psoriasis and lupus trials [52]
Alumis (ALMS) Earnings Call Presentation
2025-09-03 12:00
Corporate Presentation September 2025 This presentation contains trademarks, service marks, trade names and copyrights of Alumis and other companies which are the property of their respective owners. This presentation discusses product candidates that are under clinical study and which have not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of these product candidates for the uses for which they are being studied. This pr ...
ACELYRIN (SLRN) Earnings Call Presentation
2025-08-13 20:00
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]