Batoclimab

Study in uncontrolled Graves’ disease (GD) patients treated for 24 weeks showed first-ever potentially disease-modifying outcome with six-month off-treatment dataIMVT-1402 development is progressing with potentially registrational studies in GD, myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), difficult-to-treat rheumatoid arthritis (D2T RA) and Sjögren’s disease (SjD) remains on trackImmunovant remains on track for the first of the two batoclimab Phase 3 thyroid eye disease (TED) studies to read out before the end of calendar year 2025. However, due to evolving competitive dynamics, the Company anticipates sharing topline results from both TED studies concurrently in the first half of calendar year 2026Current cash balance provides runway for announced indications through GD readout expected in 2027 NEW YORK, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Immunovant (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported its financial results for the second quarter ended September 30, 2025. Recent Highlights and Upcoming Milestones The Immunovant study in uncontrolled GD patients treated for 24 weeks showed first-ever potentially disease-modifying therapy with six-month off-treatment data. IMVT-1402 is being developed in six indications, including ongoing potentially registrational trials in GD, MG, CIDP, D2T RA and SjD, and a proof-of-concept trial in cutaneous lupus erythematosus (CLE). Immunovant expects to report 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 of IMVT-1402 in CLE in calendar year 2026. In calendar year 2027, topline results are expected across three indications from the potentially registrational trials of IMVT-1402 in GD, MG and D2T RA. Immunovant remains on track for the first of the two batoclimab Phase 3 TED studies to read out before the end of calendar year 2025. However, due to evolving competitive dynamics, the Company anticipates sharing topline results from both TED studies concurrently in the first half of calendar year 2026. Financial Highlights for Fiscal Second Quarter Ended September 30, 2025: Cash Position: As of September 30, 2025, Immunovant’s cash and cash equivalents totaled approximately $521.9 million, providing runway for announced indications through GD readout expected in 2027. Research and Development Expenses: Research and development (R&D) expenses were $114.2 million for the three months ended September 30, 2025, compared to $97.3 million for the three months ended September 30, 2024. The increase was primarily due to activities related to our clinical trials of IMVT-1402, including contract manufacturing costs, and elevated personnel-related expenses. The increase was partially offset by lower overall costs related to our batoclimab pivotal clinical trials and nonclinical studies. Non-GAAP R&D expenses were $106.5 million for the three months ended September 30, 2025, compared to $90.5 million for the three months ended September 30, 2024. General and Administrative Expenses: General and administrative (G&A) expenses were $17.5 million for the three months ended September 30, 2025, compared to $18.5 million for the three months ended September 30, 2024. The decrease was primarily due to the streamlining of administrative processes to drive effective cost management strategies. Non-GAAP G&A expenses were $11.9 million for the three months ended September 30, 2025, compared to $12.5 million for the three months ended September 30, 2024. Net Loss: Net loss was $126.5 million ($0.73 per common share) for the three months ended September 30, 2025, compared to $109.1 million ($0.74 per common share) for the three months ended September 30, 2024. Net loss for the three months ended September 30, 2025 and September 30, 2024 included $13.4 million and $12.7 million, respectively, related to non-cash stock-based compensation expense. Non-GAAP net loss was $113.3 million for the three months ended September 30, 2025, compared to $96.5 million for the three months ended September 30, 2024. Common Stock: As of September 30, 2025, there were 174,532,710 shares of common stock issued and outstanding. Financial Highlights for Fiscal Six Months Ended September 30, 2025: Research and Development Expenses: Research and development expenses were $215.4 million for the six months ended September 30, 2025, compared to $172.7 million for the six months ended September 30, 2024. The increase was primarily due to activities related to our clinical trials of IMVT-1402, including contract manufacturing costs, and elevated personnel-related expenses. The increase was partially offset by lower overall costs related to our batoclimab pivotal clinical trials and nonclinical studies. Non-GAAP R&D expenses were $199.9 million for the six months ended September 30, 2025, compared to $158.8 million for the six months ended September 30, 2024. General and Administrative Expenses: General and administrative expenses were $43.5 million for the six months ended September 30, 2025, compared to $37.3 million for the six months ended September 30, 2024. The increase was primarily due to higher personnel-related expenses. Non-GAAP G&A expenses were $27.2 million for the six months ended September 30, 2025, compared to $25.1 million for the six months ended September 30, 2024. Net Loss: Net loss was $247.1 million ($1.43 per common share) for the six months ended September 30, 2025, compared to $196.3 million ($1.34 per common share) for the six months ended September 30, 2024. Net loss for the six months ended September 30, 2025 and September 30, 2024 included $31.9 million and $26.1 million, respectively, related to non-cash stock-based compensation expense. Non-GAAP net loss was $215.4 million for the six months ended September 30, 2025, compared to $170.3 million for the six months ended September 30, 2024. Non-GAAP Financial Measures: In addition to reporting the financial results in accordance with accounting principles generally accepted in the United States of America (GAAP), Immunovant reports certain financial results that differ from what is reported under GAAP. Immunovant believes these non-GAAP financial measures are useful to investors and others because they allow for additional information with respect to financial measures used by management in its financial and operational decision-making and they may be used by institutional investors and the analyst community to help them analyze the health of Immunovant’s business. However, there are a number of limitations related to the use of non-GAAP financial measures, and these non-GAAP measures should be considered in addition to, not as a substitute for or in isolation from, Immunovant’s financial results prepared in accordance with GAAP. Other companies, including companies in Immunovant’s industry, may calculate these non-GAAP financial measures differently or not at all, which reduces their usefulness as comparative measures. About Immunovant, Inc. Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit immunovant.com. Forward-Looking Statements This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “can,” “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” “design,” “plan,” "intend," and other similar expressions are intended to identify forward-looking statements. Such forward-looking statements include statements regarding Immunovant’s expectations regarding the timing, design, and results of clinical trials of IMVT-1402 and batoclimab; Immunovant’s plan to develop IMVT-1402 across a broad range of indications; the number and timing of potentially registrational programs and clinical trials Immunovant plans to initiate for IMVT-1402; and potential benefits of IMVT-1402’s unique product attributes and potential best-in-class and first-in-class profile. All forward-looking statements are based on estimates and assumptions by Immunovant’s management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others: Immunovant may not be able to protect or enforce its intellectual property rights; initial results or other preliminary analyses or results of early clinical trials may not be predictive final trial results or of the results of later clinical trials; the timing and availability of data from clinical trials; the timing of discussions with regulatory agencies, as well as regulatory submissions and potential approvals; the continued development of Immunovant’s product candidates, including the number and timing of the commencement of additional clinical trials; Immunovant’s scientific approach, clinical trial design, indication selection, and general development progress; future clinical trials may not confirm any safety, potency, or other product characteristics described or assumed in this press release; any product candidate that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; Immunovant’s product candidates may not be beneficial to patients, or even if approved by regulatory authorities, successfully commercialized; the potential impact of global factors, such as international trade tariffs, geopolitical tensions, and adverse macroeconomic conditions on Immunovant’s business operations and supply chain, including its clinical development plans and timelines; Immunovant’s business is heavily dependent on the successful development, regulatory approval, and commercialization of IMVT-1402; Immunovant is at various stages of clinical development for IMVT-1402 and batoclimab; and Immunovant will require additional capital to fund its operations and advance IMVT-1402 and batoclimab through clinical development. These and other risks and uncertainties are more fully described in Immunovant’s periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section titled “Risk Factors” in Immunovant’s Annual Report on Form 10-K filed with the SEC on May 29, 2025, and Immunovant’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. IMMUNOVANT, INC.Condensed Consolidated Statements of Operations(Unaudited, in thousands, except share and per share data) Three Months EndedSeptember 30, Six Months EndedSeptember 30, 2025 2024 2025 2024Operating expenses: Research and development$114,249 $97,272 $215,449 $172,745 General and administrative 17,513 18,471 43,537 37,279 Total operating expenses 131,762 115,743 258,986 210,024 Interest income, net (5,604) (6,073) (11,941) (13,254)Other income, net (250) (629) (1,437) (657)Loss before provision for income taxes (125,908) (109,041) (245,608) (196,113)Provision for income taxes 594 78 1,507 156 Net loss$(126,502) $(109,119) $(247,115) $(196,269)Net loss per common share – basic and diluted$(0.73) $(0.74) $(1.43) $(1.34)Weighted-average common shares outstanding – basic and diluted 173,643,829 146,468,991 172,295,320 146,313,696 IMMUNOVANT, INC.Condensed Consolidated Balance Sheets(Unaudited, in thousands, except share and per share data) September 30, 2025 March 31, 2025Assets Current assets: Cash and cash equivalents$521,870 $713,971 Accounts receivable 1,970 2,084 Prepaid expenses and other current assets 49,706 51,705 Total current assets 573,546 767,760 Property and equipment, net 632 844 Other assets 8,781 7,618 Total assets$582,959 $776,222 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable$6,916 $17,656 Accrued expenses and other current liabilities 56,338 51,119 Total current liabilities 63,254 68,775 Total liabilities 63,254 68,775 Commitments and contingencies Stockholders’ equity: Series A preferred stock, par value $0.0001 per share, 10,000 shares authorized, issued and outstanding at September 30, 2025 and March 31, 2025 — — Preferred stock, par value $0.0001 per share, 10,000,000 shares authorized, no shares issued and outstanding at September 30, 2025 and March 31, 2025 — — Common stock, par value $0.0001 per share, 500,000,000 shares authorized, 174,532,710 shares issued and outstanding at September 30, 2025 and 500,000,000 shares authorized, 170,111,593 shares issued and outstanding at March 31, 2025 17 16 Additional paid-in capital 2,004,876 1,945,495 Accumulated other comprehensive income 1,450 1,459 Accumulated deficit (1,486,638) (1,239,523)Total stockholders’ equity 519,705 707,447 Total liabilities and stockholders’ equity$582,959 $776,222 IMMUNOVANT, INC.Reconciliation of GAAP to Non-GAAP Financial Measures(Unaudited, in thousands) Three Months EndedSeptember 30, Note 2025 2024 Net loss: $(126,502) $(109,119)Adjustments Research and development: Stock-based compensation (1) 7,706 6,756 General and administrative: Stock-based compensation (1) 5,652 5,937 Estimated income tax impact from adjustments (164) (85)Adjusted net loss (Non-GAAP) $(113,308) $(96,511) Three Months EndedSeptember 30, Note 2025 2024 Research and Development Expenses $114,249 $97,272Adjustments: Stock-based compensation (1) 7,706 6,756Adjusted research and development expenses (Non-GAAP) $106,543 $90,516 Three Months EndedSeptember 30, Note 2025 2024 General and Administrative Expenses $17,513 $18,471Adjustments: Stock-based compensation (1) 5,652 5,937Adjusted general and administrative expenses (Non-GAAP) $11,861 $12,534 (1) Represents non-cash stock-based compensation expense Six Months EndedSeptember 30, Note 2025 2024 Net loss: $(247,115) $(196,269)Adjustments Research and development: Stock-based compensation (1) 15,571 13,941 General and administrative: Stock-based compensation (1) 16,297 12,207 Estimated income tax impact from adjustments (122) (198)Adjusted net loss (Non-GAAP) $(215,369) $(170,319) Six Months EndedSeptember 30, Note 2025 2024 Research and Development Expenses $215,449 $172,745Adjustments: Stock-based compensation (1) 15,571 13,941Adjusted research and development expenses (Non-GAAP) $199,878 $158,804 Six Months EndedSeptember 30, Note 2025 2024 General and Administrative Expenses $43,537 $37,279Adjustments: Stock-based compensation (1) 16,297 12,207Adjusted general and administrative expenses (Non-GAAP) $27,240 $25,072 (1) Represents non-cash stock-based compensation expense Contacts:InvestorsKeyur Parekhkeyur.parekh@roivant.com MediaStephanie Leestephanie.lee@roivant.com

#头号创作者激励计划# Graves病的治疗正在经历一场 从传统药物到精准靶向免疫疗法的深刻变革 。传统的抗甲状腺药物（ATD）虽能控制症状， 但存在复发率高、副作用等问题。 随着对疾病免疫机制理解的深入， B细胞清除、 TSHR靶向阻断、 免疫耐受诱导等新策略， 正为患者带来新的希望。 目前主要研究方向的核心特点和进展 治疗策略 核心机制 代表药物/疗法 研发进展与特点 B细胞靶向 消耗B细胞， 减少致病抗体 利妥昔单抗 主要在研究阶段，对早期、活动性炎症患者可能更有效。 TSHR阻断 直接阻断TSHR信号通路 抗TSHR单抗（如K1-70）、小分子拮抗剂 部分药物处于临床试验阶段，旨在从源头阻止激素过度分泌。 FcRn拮抗 加速致病性抗体降解 Batoclimab (HL161)、Imerofrubart Batoclimab在II期临床试验中显示，治疗后约80%的患者甲状腺激素水平在6个月内维持正常。 免疫耐受诱导 调节免疫系统，使其不再攻击甲状腺 间充质干细胞（MSC） 早期临床研究显示可调节免疫、修复组织，有案例报告患者指标恢复正常并长期停药。 多靶点协同 阻断IGF-1R与TSHR的协同作用 替妥尤单抗 已获批用于治疗甲状腺眼病，能显著改善眼球突出和复视。 新疗法带来的治疗理念变革 这些新兴疗法不仅提供了新药物， 更在推动Graves病治疗理念的进步： · 从“控制”到“缓解”： 传统ATD旨在控制激素水平，而免疫疗法（如Batoclimab、干细胞治疗）在部分患者中展现出停药后长期维持疗效的潜力，这可能改变疾病的自然进程。 · 从“广谱抑制”到“精准靶向”： 靶向疗法特异性更高，旨在精确打击致病环节，同时减少对整体免疫系统的影响，有望带来更好的安全性。 · 个体化治疗成为可能： 随着不同作用机制药物的涌现，未来医生可以根据患者具体的抗体水平、病程阶段及并发症情况，组合不同的疗法，实现“量体裁衣”式的治疗。 面临的挑战与未来方向 尽管前景光明， 但Graves病的免疫治疗仍面临一些挑战： · 长期安全性与疗效： 多数新药的长期安全性和持久疗效仍需更大规模、更长时间的临床试验来验证。 · 治疗成本与可及性： 生物制剂和细胞疗法通常成本较高，其可及性是未来临床应用中必须考虑的现实问题。 · 最佳治疗方案待探索： 例如，不同靶向药物之间如何序贯或联合使用，以及它们与传统疗法如何最佳搭配，都是待解答的问题。 总结 总的来说， Graves病的治疗正在迈入一个全新的免疫干预时代。 虽然传统ATD目前仍是基础， 但以Batoclimab、 TSHR阻断剂、 替妥尤单抗和干细胞疗法为代表的创新治疗， 正为不同情况的患者， 特别是传统治疗疗效不佳或有禁忌的患者， 提供了前所未有的选择。