Batoclimab

Initiated a second potentially registrational study of IMVT-1402 in Graves’ disease (GD) and a potentially registrational study of IMVT-1402 in Sjögren’s disease (SjD), both in June 2025All other clinical trials in previously announced six-indications remain on track with increased focus on clinical executionRemission data from the batoclimab proof-of-concept study in GD to be reported at the American Thyroid Association (ATA) Annual Meeting in September 2025Current cash balance provides runway for announced indications through GD readout expected in 2027 NEW YORK, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported corporate updates and financial results for the quarter ended June 30, 2025. Recent Highlights and Upcoming Milestones: In June 2025, Immunovant initiated a second potentially registrational trial evaluating IMVT-1402 in GD and a potentially registrational trial evaluating IMVT-1402 in SjD. All clinical development timelines remain on track for IMVT-1402 across six announced indications, including potentially registrational trials in Graves’ disease (GD), difficult-to-treat rheumatoid arthritis (D2T RA), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP) and Sjögren’s disease (SjD), and a proof-of-concept trial in cutaneous lupus erythematosus (CLE). “We remain laser-focused on executing on our development plans, and all ongoing trials remain on track as we progress IMVT-1402 through the clinic,” said Eric Venker, M.D., CEO of Immunovant. Immunovant expects to report remission data from the batoclimab proof-of-concept study in GD at the American Thyroid Association (ATA) Annual Meeting in September 2025. In the calendar year 2026, the company expects to report 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 of IMVT-1402 in CLE. In the calendar year 2027, top-line results are expected across three indications from the potentially registrational trials of IMVT-1402 in D2T RA, GD and MG. Financial Highlights for Fiscal First Quarter Ended June 30, 2025: Cash Position: As of June 30, 2025, Immunovant’s cash and cash equivalents totaled approximately $598.9 million, providing runway for announced indications through GD readout expected in 2027. Research and Development Expenses: Research and development (R&D) expenses were $101.2 million for the three months ended June 30, 2025, compared to $75.5 million for the three months ended June 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 $93.3 million for the three months ended June 30, 2025, compared to $68.3 million for the three months ended June 30, 2024. General and Administrative Expenses: General and administrative (G&A) expenses were $26.0 million for the three months ended June 30, 2025, compared to $18.8 million for the three months ended June 30, 2024. The increase was primarily due to higher personnel-related expenses. Non-GAAP G&A expenses were $15.4 million for the three months ended June 30, 2025, compared to $12.5 million for the three months ended June 30, 2024. Net Loss: Net loss was $120.6 million ($0.71 per common share) for the three months ended June 30, 2025, compared to $87.2 million ($0.60 per common share) for the three months ended June 30, 2024. Net loss for the three months ended June 30, 2025 and June 30, 2024 included $18.5 million and $13.5 million, respectively, related to non-cash stock-based compensation expense. Non-GAAP net loss was $102.1 million for the three months ended June 30, 2025, compared to $73.8 million for the three months ended June 30, 2024. Common Stock: As of June 30, 2025, there were 171,069,176 shares of common stock issued and outstanding. 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 StatementsThis 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; Immunovant’s plan to develop IMVT-1402 across a broad range of indications; and Immunovant’s anticipated cash runway. 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 or batoclimab; 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, as updated by its Quarterly Report on Form 10-Q for the quarter ended June 30, 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 EndedJune 30, 2025 2024 Operating expenses: Research and development $101,200 $75,473 General and administrative 26,024 18,808 Total operating expenses 127,224 94,281 Interest income, net (6,337) (7,180)Other income, net (1,187) (28)Loss before provision for income taxes (119,700) (87,073)Provision for income taxes 913 77 Net loss $(120,613) $(87,150)Net loss per common share – basic and diluted $(0.71) $(0.60)Weighted-average common shares outstanding – basic and diluted 170,872,994 146,085,729 IMMUNOVANT, INC.Condensed Consolidated Balance Sheets(Unaudited, in thousands, except share and per share data) June 30, 2025 March 31, 2025Assets Current assets: Cash and cash equivalents $598,912 $713,971 Accounts receivable 1,936 2,084 Prepaid expenses and other current assets 50,915 51,705 Total current assets 651,763 767,760 Property and equipment, net 737 844 Other assets 8,940 7,618 Total assets $661,440 $776,222 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $7,843 $17,656 Accrued expenses and other current liabilities 45,057 51,119 Total current liabilities 52,900 68,775 Total liabilities 52,900 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 June 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 June 30, 2025 and March 31, 2025 — — Common stock, par value $0.0001 per share, 500,000,000 shares authorized, 171,069,176 shares issued and outstanding at June 30, 2025 and 500,000,000 shares authorized, 170,111,593 shares issued and outstanding at March 31, 2025 16 16 Additional paid-in capital 1,966,923 1,945,495 Accumulated other comprehensive income 1,737 1,459 Accumulated deficit (1,360,136) (1,239,523)Total stockholders’ equity 608,540 707,447 Total liabilities and stockholders’ equity $661,400 $776,222 IMMUNOVANT, INC.Reconciliation of GAAP to Non-GAAP Financial Measures(Unaudited, in thousands) Three Months EndedJune 30, Note 2025 2024 Net loss: $(120,613) $(87,150)Adjustments Research and development: Stock-based compensation (1) 7,865 7,185 General and administrative: Stock-based compensation (1) 10,645 6,270 Estimated income tax impact from adjustments 42 (113)Adjusted net loss (Non-GAAP) $(102,061) $(73,808) Three Months EndedJune 30, Note 2025 2024 Research and Development Expenses $101,200 $75,473Adjustments: Stock-based compensation (1) 7,865 7,185Adjusted research and development expenses (Non-GAAP) $93,335 $68,288 Three Months EndedJune 30, Note 2025 2024 General and Administrative Expenses $26,024 $18,808Adjustments: Stock-based compensation (1) 10,645 6,270Adjusted general and administrative expenses (Non-GAAP) $15,379 $12,538 (1) Represents non-cash stock-based compensation expense Contacts:InvestorsKeyur Parekhkeyur.parekh@roivant.com MediaStephanie Leestephanie.lee@roivant.com