Core Insights - Immunovant, Inc. reported corporate updates and financial results for the fourth quarter and fiscal year ended March 31, 2025, highlighting its focus on autoimmune diseases and the development of IMVT-1402 [1] Recent Highlights and Upcoming Milestones - Leadership changes were announced in April 2025, with Eric Venker appointed as CEO and Tiago Girao as CFO, as Roivant increases operational involvement [2] - IMVT-1402 is being developed for six indications, including registrational trials in Graves' disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and Sjögren's disease, along with a proof-of-concept trial in cutaneous lupus erythematosus [2] - Positive results were reported in March 2025 from batoclimab studies for myasthenia gravis and chronic inflammatory demyelinating polyneuropathy, with significant improvements in clinical outcomes [3][4] Financial Highlights for Fiscal Fourth Quarter - As of March 31, 2025, cash and cash equivalents totaled approximately $714 million, providing sufficient runway for ongoing clinical trials [6] - Research and development expenses increased to $93.7 million for the quarter, up from $66.1 million in the same period the previous year, primarily due to clinical trial activities [7] - General and administrative expenses rose to $20.2 million, compared to $14.8 million in the prior year, driven by higher personnel-related expenses and professional fees [8] Financial Highlights for Fiscal Year - For the fiscal year ended March 31, 2025, research and development expenses were $360.9 million, up from $212.9 million the previous year, reflecting increased clinical trial costs [11] - General and administrative expenses for the fiscal year were $77.2 million, compared to $57.3 million in the prior year, attributed to higher personnel-related and professional fees [13] - The net loss for the fiscal year was $413.8 million ($2.73 per share), compared to a net loss of $259.3 million ($1.88 per share) the previous year [14]

Core Insights - Immunovant, Inc. reported positive topline results from its Phase 3 study of batoclimab in Myasthenia Gravis (MG) and initial results from its Phase 2b study in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) [1][2] Phase 3 Study in MG - The Phase 3 study was a randomized, quadruple-blind, placebo-controlled trial assessing batoclimab's efficacy and safety in adults with moderate to severe MG [3] - Participants receiving 680mg of batoclimab weekly achieved a 5.6 point improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score at Week 12, while those on 340mg achieved a 4.7 point improvement [6][7] - The study met its primary endpoint with a significant mean change from baseline in MG-ADL for acetylcholine receptor antibody positive (AChR+) participants [6] Phase 2b Study in CIDP - The Phase 2b study is also a randomized, quadruple-blind, placebo-controlled trial designed to evaluate batoclimab in adults with active CIDP [4] - Initial results from Period 1 showed a mean improvement of 1.8 points in the adjusted Inflammatory Neuropathy Cause and Treatment (aINCAT) disability score, with an 84% responder rate among patients achieving an IgG reduction of ≥70% [8] - Other scales demonstrated improvements, including a 15.3 point increase in I-RODS, a 5.6 point increase in MRC-SS, and a 15.1 increase in grip strength at Week 12 [8] Efficacy and Safety - Deeper IgG reductions correlated with better clinical outcomes across both studies [6][8] - Safety and tolerability profiles were consistent with previous batoclimab studies [9] Future Plans - Immunovant plans to initiate potentially registrational studies for both MG and CIDP with its lead asset IMVT-1402, having received clearance for Investigational New Drug (IND) applications [10] - The company does not intend to seek regulatory approval for batoclimab in MG or CIDP at this time, focusing instead on leveraging data from these studies to inform its programs with IMVT-1402 [11]