Core Viewpoint - Immunovant, Inc. reported a wider-than-expected net loss for Q3 fiscal 2025, leading to a significant decline in stock price due to lack of approved products and revenue generation [1][2]. Financial Performance - The net loss for Q3 fiscal 2025 was 76 cents per share, compared to the Zacks Consensus Estimate of a loss of 73 cents and a loss of 36 cents per share in the same quarter last year [1]. - Research and development (R&D) expenses reached $94.5 million, a 96% increase from the previous year, driven by preparations for future clinical studies and increased clinical study costs [3]. - General and administrative expenses were $19.8 million, up 50% year-over-year, primarily due to higher personnel-related expenses and professional fees [4]. - As of December 31, 2024, the company had a cash balance of $374.7 million, down from $472.9 million as of September 30, 2024 [4]. Pipeline Developments - Immunovant's lead asset, IMVT-1402, is positioned for clinical studies across 10 indications by March 31, 2026, leveraging data from batoclimab studies for financial efficiencies [5]. - The upcoming late-stage studies for IMVT-1402 will target indications such as Graves' disease, Myasthenia Gravis, and Chronic Inflammatory Demyelinating Polyneuropathy [6]. - The company is also evaluating batoclimab in ongoing mid-late-stage studies for various autoimmune conditions, with positive data from a mid-stage study for Graves' disease announced in September [7][8]. - Top-line results from the Myasthenia Gravis study of batoclimab are expected by the end of the fiscal year, which will inform the next steps for IMVT-1402 [9]. Market Performance - Immunovant's shares have decreased by 33.6% over the past three months, contrasting with a 6.6% decline in the industry [6].

Clinical Development - The company is pursuing a broad anti-FcRn strategy with its lead asset, IMVT-1402, targeting 23 indications across endocrinology, neurology, and rheumatology[95]. - The total potential opportunity for the FcRn franchise is estimated to exceed 2 million patients in the U.S. and Europe[101]. - The company plans to initiate clinical trials for IMVT-1402 in a total of ten indications by March 31, 2026, with four to five indications expected by March 31, 2025[102]. - A Phase 2b trial for IMVT-1402 in Graves' disease (GD) will enroll approximately 240 participants, evaluating the proportion of participants who are euthyroid and off anti-thyroid drugs at week 26[109]. - The company has initiated a potentially registrational trial for IMVT-1402 in difficult-to-treat rheumatoid arthritis (D2T RA), expecting to enroll around 120 participants[115]. - The Phase 2b trial for IMVT-1402 in RA will assess the proportion of participants maintaining an ACR20 response at week 28[115]. - The company has received FDA clearance for the IND application for IMVT-1402 in both GD and RA[104][115]. - The Phase 2b trial for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is ongoing, with initial data anticipated by March 31, 2025, which will inform the pivotal study design for IMVT-1402[120]. - In a Phase 2 clinical trial for uncontrolled Graves' Disease (GD), participants experienced a mean IgG reduction of 77% and a 76% response rate after 12 weeks of high-dose batoclimab[121]. Financial Performance - The company reported total operating expenses of $114.3 million for the three months ended December 31, 2024, an increase of $52.7 million compared to the same period in 2023[142]. - Research and development expenses for the same period were $94.5 million, up $46.2 million year-over-year, driven by increased clinical trial costs and preparations for future trials[144]. - The net loss for the three months ended December 31, 2024, was $111.1 million, compared to a net loss of $51.4 million in the prior year[142]. - For the nine months ended December 31, 2024, total operating expenses increased by $122.5 million to $324.3 million compared to the prior-year period[149]. - Research and development expenses rose by $120.4 million to $267.3 million, driven by increased costs in endocrine and neurological diseases[151]. - General and administrative expenses increased by $14.6 million to $57.1 million, primarily due to higher personnel-related expenses and legal fees[156]. - The net loss for the nine months ended December 31, 2024, was $307.4 million, compared to a net loss of $184.0 million in the prior-year period[158]. - Cash used in operating activities for the nine months ended December 31, 2024, was $265.2 million, compared to $154.5 million in the prior-year period[164]. Cash and Funding - Cash and cash equivalents decreased from $635.4 million as of March 31, 2024, to $374.7 million as of December 31, 2024[158]. - The company expects to have cash and cash equivalents of $374.7 million as of December 31, 2024, along with gross proceeds of $450.0 million from a private placement in January 2025, sufficient to fund operations for at least the next 12 months[173]. - The company anticipates substantial increases in short-term and long-term capital requirements to fund clinical trials and development activities[176]. - The company expects to continue incurring significant expenses and increasing operating losses for the next several years[158]. Market and Economic Conditions - The company is facing macroeconomic uncertainties that may negatively impact its business growth and operational results[126]. - The company does not believe inflation had a material effect on its financial condition or results of operations as of December 31, 2024[182]. - The primary exposure to market risk is interest income volatility, with cash equivalents of $374.7 million maintained in accredited financial institutions[180]. - The company is not currently exposed to significant foreign currency exchange rate risk, as expenses are generally denominated in U.S. dollars[181]. Strategic Initiatives - The innovative product pipeline includes IMVT-1402 and batoclimab, both designed for subcutaneous injection with tailored dosing based on disease stage[96]. - The company aims to leverage data from the batoclimab development program to inform the development of IMVT-1402[105]. - The company plans to transition its registrational development programs for Myasthenia Gravis (MG) from batoclimab to IMVT-1402, with top-line data from the batoclimab study expected by March 31, 2025[119]. - The company plans to integrate acquired technologies and expand its intellectual property portfolio as part of its growth strategy[179]. Contractual Obligations and Milestones - The company has a remaining minimum obligation of approximately $43.6 million to Samsung for the manufacturing of batoclimab drug substance[171]. - The maximum potential milestone payments under the HanAll Agreement could reach $420.0 million, with $32.5 million already paid as of December 31, 2024[172]. - A milestone payment of $12.5 million was made in the quarter ended September 30, 2023, following the achievement of regulatory milestones[172]. - There are no significant ongoing material contractual obligations, but the company expects to enter into additional commitments as the business develops[174].

Financial Performance - Immunovant reported a net loss of $111.1 million ($0.76 per common share) for the three months ended December 31, 2024, compared to a net loss of $51.4 million ($0.36 per common share) for the same period in 2023[15]. - Total operating expenses for the three months ended December 31, 2024, were $114.3 million, compared to $61.6 million for the same period in 2023[23]. - Accumulated deficit increased from $(825,683) to $(1,133,074), reflecting a worsening financial position[25]. - Total stockholders' equity decreased significantly from $617,757 to $352,617, a decline of approximately 43%[25]. Research and Development - Research and development expenses increased to $94.5 million for the three months ended December 31, 2024, up from $48.3 million for the same period in 2023, primarily due to preparations for future clinical trials of IMVT-1402[13]. - The company anticipates sharing top-line results from the pivotal study of batoclimab in myasthenia gravis (MG) and initial results from the chronic inflammatory demyelinating polyneuropathy (CIDP) study by March 31, 2025[3]. - Immunovant plans to initiate clinical trials for IMVT-1402 in a total of ten indications by March 31, 2026[4]. - The company expects to report additional data from the batoclimab proof-of-concept study in Graves' disease (GD) in summer 2025[6]. - The company has six Investigational New Drug (IND) applications cleared for its lead asset, IMVT-1402, with pivotal studies now enrolling[8]. Cash and Assets - As of December 31, 2024, Immunovant's cash and cash equivalents totaled approximately $374.7 million[12]. - Immunovant's pro forma cash balance was approximately $825 million as of December 31, 2024, including approximately $450 million from a private placement that closed on January 15, 2025[8]. - Total current assets decreased from $665,770 to $412,541, a decline of approximately 38%[25]. - Cash and cash equivalents dropped from $635,365 to $374,685, a decrease of about 41%[25]. - Prepaid expenses and other current assets rose from $25,068 to $35,632, an increase of about 42%[25]. - Property and equipment, net increased from $462 to $752, reflecting a growth of approximately 63%[25]. Liabilities and Equity - Total liabilities remained constant at $68,315, compared to $48,608 in the previous period, indicating an increase in current liabilities[25]. - Accounts payable rose from $7,155 to $19,816, an increase of about 177%[25]. - Additional paid-in capital increased from $1,441,518 to $1,483,198, showing a growth of approximately 3%[25]. - Accumulated other comprehensive income improved from $1,908 to $2,479, an increase of about 30%[25]. General and Administrative Expenses - General and administrative expenses rose to $19.8 million for the three months ended December 31, 2024, compared to $13.2 million for the same period in 2023[14].

Core Viewpoint - Immunovant, Inc. reported financial results for its fiscal third quarter ended December 31, 2024, highlighting significant progress in its lead asset IMVT-1402 and upcoming clinical milestones [1][12]. Financial Highlights - As of December 31, 2024, Immunovant's cash and cash equivalents totaled $374.7 million [12]. - Research and development expenses for the third quarter were $94.5 million, up from $48.3 million in the same period of 2023, primarily due to preparations for future clinical trials [13]. - General and administrative expenses increased to $19.8 million from $13.2 million year-over-year, driven by higher personnel-related expenses and professional fees [14]. - The net loss for the third quarter was $111.1 million ($0.76 per share), compared to a net loss of $51.4 million ($0.36 per share) in the prior year [15]. Development Progress - The company has six Investigational New Drug (IND) applications cleared for IMVT-1402, with pivotal studies in Graves' disease (GD) and difficult-to-treat rheumatoid arthritis (D2T RA) currently enrolling [10]. - Top-line results from the pivotal trial of batoclimab in myasthenia gravis (MG) are expected by March 31, 2025, which will inform the next steps for IMVT-1402 in MG [7]. - Additional data from the batoclimab proof-of-concept study in GD, including 6-month treatment-free remission data, is anticipated in summer 2025 [5]. Upcoming Milestones - Immunovant plans to initiate clinical trials for IMVT-1402 in a total of ten indications by March 31, 2026 [3]. - Top-line results from the pivotal program of batoclimab for thyroid eye disease (TED) are expected in the second half of 2025, which may also inform the IMVT-1402 program in GD [6]. Stock Information - As of December 31, 2024, there were 147,203,565 shares of common stock issued and outstanding [15].

Core Viewpoint - Kuehn Law, PLLC is investigating potential breaches of fiduciary duties by officers and directors of Immunovant, Inc. related to self-dealing, which may entitle shareholders to damages and corporate governance reforms [1]. Group 1 - The investigation by Kuehn Law focuses on whether Immunovant's leadership acted in the best interests of shareholders [1]. - Shareholders are encouraged to contact Kuehn Law for a free consultation regarding their rights and potential claims [2]. - The firm emphasizes the importance of shareholder participation in maintaining the integrity of financial markets [3].

Company Overview - Immunovant Inc is a clinical-stage immunology company focused on enabling normal lives for people with autoimmune diseases [6] - The company is a trailblazer in anti-FcRn technology, developing innovative, targeted therapies for autoimmune diseases [6] Financing Details - Immunovant has agreed to sell 22,500,000 shares of common stock at $20 00 per share in a private investment in public equity (PIPE) transaction [5] - The PIPE is expected to generate approximately $450 million in gross proceeds [5] - The transaction involves three institutional accredited investors, including a US-based healthcare-focused investor, a large mutual fund complex, and Roivant [4] - The PIPE is expected to close on or about January 15, 2025, subject to customary closing conditions [5] Use of Proceeds - The proceeds from the PIPE will be used to advance the company's development pipeline, working capital, and other general corporate purposes [5] - Specifically, the funds will help advance the development program for the company's lead asset IMVT-1402 [4] Transaction Structure - The shares sold in the PIPE are not registered under the Securities Act of 1933 and are being sold in a transaction not involving a public offering [4] - Immunovant has agreed to register the resale of the shares with the Securities and Exchange Commission [4]

Company Overview - Immunovant, Inc. (NASDAQ: IMVT) is planning to initiate a pivotal registration study for its lead candidate IMVT-1402, targeting the treatment of Graves' Disease before the end of 2024 [2]. Product Development - IMVT-1402 is an FcRn inhibitor designed to block the receptor involved in the pathophysiology of Graves' Disease, indicating a focused approach to addressing this specific condition [2].

Core Viewpoint - Immunovant, Inc. reported a wider net loss for Q2 fiscal 2025 than expected, with no approved products and no revenue generation [1] Financial Performance - The net loss for Q2 fiscal 2025 was 74 cents per share, exceeding the Zacks Consensus Estimate of a loss of 61 cents and wider than the previous year's loss of 45 cents per share [1] - Research and development (R&D) expenses reached $97.3 million, a 103% increase from the same quarter last year, driven by preparations for future clinical studies and increased personnel-related expenses [2] - General and administrative expenses were $18.5 million, up 33% year-over-year, primarily due to higher personnel-related expenses and legal fees [3] - As of September 30, 2024, the cash balance was $472.9 million, down from $560 million as of June 30, 2023 [3] Pipeline Developments - Immunovant is focusing on IMVT-1402, a next-generation FcRn inhibitor, as its lead asset, with plans to initiate four to five registrational programs over the next fiscal year [4][5] - The company aims to start studies in a total of 10 indications for IMVT-1402 over the next two fiscal years, leveraging existing data from batoclimab studies for financial efficiencies [5] - Late-stage studies for IMVT-1402 will include indications such as Graves' disease, Myasthenia Gravis, and Chronic Inflammatory Demyelinating Polyneuropathy [6] - Immunovant is also evaluating batoclimab in ongoing mid-late-stage studies for various autoimmune indications [7] Upcoming Milestones - Positive data from a mid-stage study on batoclimab for Graves' disease was announced, with plans to initiate a pivotal study for IMVT-1402 by the end of 2024 [8] - Top-line results from the Myasthenia Gravis study of batoclimab are expected by the end of the fiscal year on March 31, 2025 [8] - The company may transition its batoclimab CIDP study to a registrational program with IMVT-1402, with top-line data from the phase IIb study expected by March 31, 2025 [9] - Top-line data from the late-stage thyroid eye disease study of batoclimab is scheduled for the second half of 2025 [10]

Table of Contents Title of each classTrading Symbol(s)Name of each exchange on which registered Common Stock, $0.0001 par value per share IMVT The Nasdaq Stock Market LLC UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission Fil ...

Exhibit 99.1 Immunovant Provides Development Updates and Reports Financial Results for the Quarter Ended September 30, 2024 • Five Investigational New Drug (IND) applications cleared across a range of therapeutic areas and FDA divisions for lead asset, IMVT-1402 • Proof of concept data from batoclimab trial in Graves' disease (GD) demonstrate potential of deeper IgG reduction with potent FcRn inhibition to transform treatment for GD patients who are not well controlled on antithyroid drugs (ATDs); initiatio ...