Clinical Development and Trials - The company is pursuing a broad anti-FcRn strategy with its lead asset, IMVT-1402, targeting 23 indications across rheumatology, endocrinology, and neurology[93]. - Five IND applications for IMVT-1402 are now active, exceeding the goal of three by the end of 2024, with plans to initiate clinical trials in ten indications by March 31, 2026[100]. - A pivotal trial for IMVT-1402 in Graves' disease is expected to begin by December 31, 2024, with approximately 240 participants enrolled[106][107]. - The company plans to initiate a registrational trial for IMVT-1402 in difficult-to-treat rheumatoid arthritis (D2T RA) by March 31, 2025, enrolling around 120 participants[112]. - Data from a Phase 2 proof of concept trial for batoclimab in Graves' disease indicate that deeper IgG reduction correlates with better clinical outcomes[104]. - The company expects to report top-line data from the batoclimab study for Myasthenia Gravis (MG) by March 31, 2025, with potential transition to IMVT-1402 for registrational development[113]. - The company initiated a pivotal Phase 2b trial of batoclimab for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), with top-line results expected by March 31, 2025[118]. - The company anticipates initiating pivotal trials of IMVT-1402 in GD by December 31, 2024, and in Rheumatoid Arthritis (RA) by March 31, 2025[128]. - Batoclimab was generally well tolerated in clinical trials, with no new safety signals observed[115]. - In a Phase 2 clinical trial for Graves' Disease (GD), participants experienced a mean IgG reduction of 77% and a 76% response rate after 12 weeks of high-dose batoclimab[115]. Financial Performance and Expenses - Research and development expenses for the three months ended September 30, 2024, increased by $49.3 million compared to the prior year, totaling $97.3 million[136]. - Total operating expenses for the three months ended September 30, 2024, were $115.7 million, an increase of $53.9 million from the same period in 2023[134]. - The company has not generated any revenue and has incurred significant operating losses since inception, relying on successful development and commercialization of batoclimab and IMVT-1402[124]. - For the six months ended September 30, 2024, research and development expenses increased by $74.2 million, totaling $172.7 million compared to $98.5 million in the prior-year period[143]. - General and administrative expenses for the six months ended September 30, 2024, increased by $8.0 million, totaling $37.3 million compared to $29.2 million in the prior-year period[147]. - The company reported a net loss of $196.3 million for the six months ended September 30, 2024, compared to a net loss of $132.6 million in the prior-year period[149]. - Cash used in operating activities for the six months ended September 30, 2024, was $164.8 million, compared to $107.4 million in the prior-year period[155]. - Unallocated research and development costs increased by $26.6 million, driven by higher personnel-related expenses of $16.8 million[145]. - The company has not generated any revenue and does not expect to do so until successful development and regulatory approval of its product candidates[149]. Cash and Funding - As of September 30, 2024, the company had cash and cash equivalents of $472.9 million, down from $635.4 million as of March 31, 2024[149]. - The company entered into a sales agreement to potentially offer and sell up to $150.0 million of common stock, subject to market conditions[152]. - As of September 30, 2024, the company has cash and cash equivalents of $472.9 million, expected to fund operating expenses and capital requirements for at least the next 12 months[163]. - The company has a remaining minimum obligation to Samsung of approximately $43.6 million related to the manufacturing of batoclimab, with payments scheduled through fiscal year 2029[161]. - Under the HanAll Agreement, the maximum potential milestone payments could reach $420.0 million, with $32.5 million already paid as of September 30, 2024[162]. - The company anticipates substantial increases in future capital requirements to fund clinical development programs and launch potential clinical trials of IMVT-1402[165]. - The primary use of cash is to fund clinical trials and manufacturing activities, with expectations of continued net losses for the foreseeable future[166]. Market and Economic Conditions - Macroeconomic conditions, including inflation and potential recession, may negatively impact the company's growth and results of operations[120]. - Inflation has not had a material effect on the company's business or financial condition as of September 30, 2024[172]. - The company does not currently face significant market risk related to foreign currency exchange rates, as most expenses are denominated in U.S. dollars[171]. - An immediate hypothetical 10% change in interest rates would not have a material effect on the company's liquidity[170]. Strategic Plans and Growth - The company aims to leverage data from batoclimab and competitor studies to optimize the IMVT-1402 clinical development program[100]. - The treatment paradigm for Graves' disease has seen minimal innovation in over 70 years, highlighting a significant unmet medical need[105]. - The company plans to integrate acquired technologies and expand its intellectual property portfolio as part of its growth strategy[165]. - The company expects to continue increasing research and development expenses as it prepares for multiple clinical trials and regulatory approvals[128].

Five Investigational New Drug (IND) applications cleared across a range of therapeutic areas and FDA divisions for lead asset, IMVT-1402Proof 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); initiation of potentially registrational trial to evaluate IMVT-1402 in GD expected by year endIND cleared for IMVT-1402 in rheumatoid art ...

Shares of Immunovant (IMVT) are rising in the pre-market hours on Sept. 9 after the company announced positive data from the mid-stage study of its investigational candidate, batoclimab, which is being developed for Graves' Disease (GD). IMVT's Batoclimab Shows Superior Efficacy in GD Patients The enrolled patient population of the phase IIa study of batoclimab comprised uncontrolled GD patients who were hyperthyroid despite anti-thyroid drugs (ATD) therapy. Patients were then treated with the high batoclim ...

As of Sept. 9, 2024, two stocks in the health care sector could be flashing a real warning to investors who value momentum as a key criteria in their trading decisions. The RSI is a momentum indicator, which compares a stock's strength on days when prices go up to its strength on days when prices go down. When compared to a stock's price action, it can give traders a better sense of how a stock may perform in the short term. An asset is typically considered overbought when the RSI is above 70, according to ...

High dose batoclimab achieved 76% response rate in patients uncontrolled on antithyroid drugs (ATDs) at week 12 High dose batoclimab achieved 56% ATD-Free response rate in patients uncontrolled on ATDs at week 12 Strong correlation observed between degree of IgG lowering and clinical outcomes yields potential bestin-class and first-in-class opportunity for IMVT-1402 in Graves' Disease (GD) Real world claims data indicates 25-30% of Graves' Disease patients per year are uncontrolled on ATDs with minimal to n ...

It has been about a month since the last earnings report for Immunovant, Inc. (IMVT) . Shares have added about 13.8% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Immunovant due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important catalysts. Immunovant's Q1 Earnings Miss Estimates ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________ FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-38906 IMMUNOVANT, INC. (Exact name of registrant as specified in its Charter) _____________________ (State or other jurisdiction ...

Exhibit 99.1 Immunovant Provides Corporate Updates and Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2024 NEW YORK, May 29, 2024 – 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 its fourth quarter and fiscal year ended March 31, 2024. "We are very excited about the immunology market evolution that we believe positions the ...

NEW YORK, May 29, 2024 (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 its fourth quarter and fiscal year ended March 31, 2024. "We are very excited about the immunology market evolution that we believe positions the anti-FcRn mechanism to be the leading therapeutic class across a broad range of autoantibody-driven indications. Within the ...

Core Insights - Immunovant, Inc. is focused on developing IMVT-1402 as a leading therapeutic asset in the immunology market, particularly for autoantibody-driven diseases [2][3] - The company plans to initiate multiple late-stage clinical programs for IMVT-1402 across various therapeutic areas, including endocrinology and neurology, with a goal of starting 4 to 5 registrational studies by March 31, 2025 [3][7] Clinical Development Updates - Immunovant is prioritizing IMVT-1402 for first-in-class indications such as Graves' disease and Myasthenia Gravis (MG), with plans to initiate studies in a total of 10 indications by March 31, 2026 [3][9] - The company has received a U.S. patent for IMVT-1402, which will extend until June 2043, covering its composition and methods of use [4] - The ongoing batoclimab trials are expected to inform the design of future registrational studies for IMVT-1402 in MG and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) [5][6][8] Financial Highlights - As of March 31, 2024, Immunovant reported cash and cash equivalents of approximately $635 million [11] - Research and development expenses for the fourth quarter were $66.1 million, up from $51.8 million in the same period the previous year, primarily due to increased costs associated with IMVT-1402 [12] - The net loss for the fourth quarter was $75.3 million, compared to a net loss of $59.4 million in the prior year [14] - For the fiscal year ended March 31, 2024, total research and development expenses were $212.9 million, an increase from $160.3 million in the previous fiscal year [15]