Core Insights - Immunovant reported its financial results for the second quarter ended September 30, 2025, highlighting significant advancements in its clinical programs and financial performance [1] Recent Highlights and Upcoming Milestones - The study of IMVT-1402 in uncontrolled Graves' disease (GD) patients demonstrated the first-ever potentially disease-modifying therapy with six-month off-treatment data [2][9] - IMVT-1402 is being developed for six indications, with ongoing potentially registrational trials in GD, myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), difficult-to-treat rheumatoid arthritis (D2T RA), and Sjögren's disease (SjD) [2][9] - Results from the open-label portion of the potentially registrational trial of IMVT-1402 in D2T RA and topline results from the proof-of-concept trial in cutaneous lupus erythematosus (CLE) are expected in 2026 [3] - Topline results from potentially registrational trials in GD, MG, and D2T RA are anticipated in 2027 [3] Financial Highlights for Fiscal Second Quarter - As of September 30, 2025, Immunovant's cash and cash equivalents totaled approximately $521.9 million, providing sufficient runway for announced indications through the GD readout expected in 2027 [4][9] - Research and development (R&D) expenses for the quarter were $114.2 million, an increase from $97.3 million in the same period of 2024, primarily due to clinical trial activities for IMVT-1402 [5][11] - General and administrative (G&A) expenses decreased to $17.5 million from $18.5 million year-over-year, attributed to streamlined administrative processes [6] Net Loss Analysis - The net loss for the quarter was $126.5 million ($0.73 per common share), compared to a net loss of $109.1 million ($0.74 per common share) in the prior year [8][14] - Non-GAAP net loss was $113.3 million for the quarter, compared to $96.5 million in the same period of 2024 [8] Financial Highlights for Fiscal Six Months - For the six months ended September 30, 2025, R&D expenses totaled $215.4 million, up from $172.7 million in the same period of 2024 [11][14] - G&A expenses for the six months increased to $43.5 million from $37.3 million year-over-year [12] - The net loss for the six months was $247.1 million ($1.43 per common share), compared to $196.3 million ($1.34 per common share) in the previous year [14]

Core Insights - Immunovant, Inc. reported corporate updates and financial results for the quarter ended June 30, 2025, focusing on its clinical-stage immunology developments and financial performance [1][4]. Recent Highlights and Upcoming Milestones - In June 2025, Immunovant initiated two potentially registrational trials for IMVT-1402, one for Graves' disease (GD) and another for Sjögren's disease (SjD) [1][10]. - The company is on track with clinical development timelines for IMVT-1402 across six indications, including GD, difficult-to-treat rheumatoid arthritis (D2T RA), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), SjD, and a proof-of-concept trial in cutaneous lupus erythematosus (CLE) [1][10]. - Remission data from the batoclimab proof-of-concept study in GD is expected to be reported at the American Thyroid Association Annual Meeting in September 2025 [2][10]. - Results from the open-label portion of the potentially registrational trial of IMVT-1402 in D2T RA and top-line results from the proof-of-concept trial in CLE are anticipated in 2026 [3]. Financial Highlights - As of June 30, 2025, Immunovant's cash and cash equivalents totaled approximately $598.9 million, providing a runway for announced indications through the GD readout expected in 2027 [4][10]. - Research and development (R&D) expenses for the three months ended June 30, 2025, were $101.2 million, an increase from $75.5 million for the same period in 2024, primarily due to clinical trial activities for IMVT-1402 [5][6]. - General and administrative (G&A) expenses rose to $26.0 million for the three months ended June 30, 2025, compared to $18.8 million for the same period in 2024, mainly due to higher personnel-related expenses [6][7]. - The net loss for the three months ended June 30, 2025, was $120.6 million ($0.71 per common share), compared to a net loss of $87.2 million ($0.60 per common share) for the same period in 2024 [8][15].

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 Viewpoint - Immunovant, Inc. is entering a new growth phase with leadership changes and expanded development of IMVT-1402 into Sjögren's Disease (SjD) and Cutaneous Lupus Erythematosus (CLE) [1][2] Leadership Changes - Eric Venker, M.D. has been appointed as the new CEO of Immunovant, bringing over 20 years of clinical and operational experience [2][6] - Pete Salzmann, M.D. has retired from his role as CEO and Director, while Tiago Girao has been appointed as the new CFO [2][6] - George Migausky has stepped down from the board, with Robert Susman and Jacob Bauer joining [3] Strategic Transition - The leadership changes are part of a broader strategic transition, with Roivant increasing its operational involvement and oversight of Immunovant [2][6] - Development activities for batoclimab are concluding, while those for IMVT-1402 are ramping up [2][6] Clinical Development Updates - The IND for IMVT-1402 in SjD has been cleared, marking it as the fifth indication for the drug, with a study expected to initiate in summer 2025 [6] - A proof-of-concept study for IMVT-1402 in CLE has been initiated, based on promising efficacy data from previous studies [6] - Current cash balance is sufficient to support the announced indications through the expected readout for Graves' Disease in 2027 [6] Market Need - Sjögren's Disease is characterized by severe dryness and has no approved therapies specifically targeting it, indicating a significant market opportunity [7] - Cutaneous Lupus Erythematosus (CLE) has a high unmet need, with up to 50% of patients not optimally managed by current therapies, and no new therapies approved in over 50 years [8]

Core Insights - Immunovant, Inc. is entering a new growth phase with leadership changes and expanded development of IMVT-1402 into Sjögren's Disease (SjD) and Cutaneous Lupus Erythematosus (CLE) [1][2] Leadership Changes - Eric Venker, M.D. has been appointed as the new CEO of Immunovant, bringing over 20 years of clinical and operational experience [2][6] - Pete Salzmann, M.D. has retired from his role as CEO and Director, while Tiago Girao has been appointed as the new CFO [2][6] - The board of directors has seen changes with George Migausky stepping down and Robert Susman and Jacob Bauer joining [3] Strategic Transition - The leadership changes are part of a broader strategic transition, with Roivant increasing its operational involvement and oversight of Immunovant [2][6] - Development activities for batoclimab are concluding, while those for IMVT-1402 are ramping up [2][6] Clinical Development Updates - The IND for IMVT-1402 in SjD has been cleared, marking it as the fifth indication for the drug, with a study expected to initiate in summer 2025 [6] - A proof-of-concept study for IMVT-1402 in CLE has been initiated, based on promising efficacy data from previous studies [6] - Current cash reserves are sufficient to support the announced indications through the expected readout for Graves' Disease in 2027 [6] Market Needs - Sjögren's Disease is characterized by severe dryness and has no approved therapies specifically targeting it, indicating a significant market opportunity for new treatments [7] - Cutaneous Lupus Erythematosus (CLE) has a high unmet need, with up to 50% of patients not optimally managed by existing therapies, and no new therapies approved in over 50 years [8]

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]