Core Insights - Alumis Inc. reported positive Phase 3 topline results for envudeucitinib, showing significant skin clearance and symptom improvement in moderate-to-severe plaque psoriasis, along with a favorable safety profile [1][2] - The company plans to submit a New Drug Application (NDA) for envudeucitinib in the second half of 2026 [1] - Anticipated pivotal Phase 2b clinical data for envudeucitinib in systemic lupus erythematosus (SLE) is expected in the third quarter of 2026 [1][7] - Alumis completed a public offering, raising approximately $345.1 million in gross proceeds in January 2026 [1][5] Phase 3 Clinical Trials - The Phase 3 ONWARD1 and ONWARD2 trials for envudeucitinib met all primary and secondary endpoints with high statistical significance [5] - Approximately 65% of patients achieved a Psoriasis Area Severity Index (PASI) 90, and over 40% achieved PASI 100 at Week 24 [5] - The drug demonstrated a favorable safety and tolerability profile consistent with earlier Phase 2 results [5] Financial Performance - For the year ended December 31, 2025, Alumis reported total revenue of $24.05 million, primarily from license and collaboration revenue [15] - Research and development expenses increased to $386.0 million from $265.6 million in 2024, driven by clinical trial costs and increased headcount [12][15] - The net loss for 2025 was $243.3 million, an improvement from a net loss of $294.2 million in 2024 [12][15] Pipeline and Future Plans - Alumis is evaluating additional indications for envudeucitinib beyond psoriasis and SLE, as part of a unified TYK2 franchise development strategy [2][5] - An update on the TYK2 franchise strategy, including the timing for commencing A-005's Phase 2 trial, is expected in the second quarter of 2026 [5][8] - The company plans to present additional Phase 3 data at the American Academy of Dermatology (AAD) Annual Meeting in March 2026 [11]
Alumis Reports Year End 2025 Financial Results and Highlights Recent Achievements