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]

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 ...

Core Viewpoint - Immunovant's shares are rising following positive mid-stage study results for batoclimab, an investigational candidate for Graves' Disease (GD) [1] Group 1: Study Results - The phase IIa study involved uncontrolled GD patients who were hyperthyroid despite anti-thyroid drug (ATD) therapy, with a high dose of batoclimab (680 mg weekly) administered for 12 weeks, followed by a lower dose (340 mg weekly) for another 12 weeks [2] - The high-dose treatment resulted in a mean Immunoglobulin G (IgG) reduction of 77%, with a response rate of 76% after 12 weeks; 56% of patients achieved an ATD-Free Response [3] - During the subsequent 12 weeks on the lower dose, mean IgG levels were further reduced by 65%, with a responder rate of 68% and an ATD-Free Response rate dropping to 36% [4] Group 2: Market Opportunity - Real-world claims data indicates that 25-30% of GD patients remain uncontrolled on ATDs annually, highlighting a significant unmet need and commercial opportunity for Immunovant with limited competition [5][6] - The company plans to initiate a pivotal study for IMVT-1402, a fully-human monoclonal antibody for GD, by the end of 2024, having aligned with the FDA on the study design [6][7] Group 3: Future Development Plans - Immunovant is conducting mid to late-stage studies for batoclimab in other autoimmune diseases, including Myasthenia gravis and thyroid eye disease, with plans to study IMVT-1402 for these indications based on positive data [8] - The company aims to initiate four to five registrational programs for IMVT-1402 over the next fiscal year, targeting a total of 10 indications in the following two fiscal years [9]

Core Insights - Two stocks in the health care sector are showing signs of being overbought, which may concern momentum-focused investors [1]. Group 1: Terns Pharmaceuticals Inc (TERN) - On September 9, Terns Pharmaceuticals announced top-line data from its Phase 1 trial for TERN-601, aimed at assessing safety and tolerability in adults with obesity or overweight [3]. - The stock has increased approximately 19% over the past month, reaching a 52-week high of $10.03 [3]. - The Relative Strength Index (RSI) for Terns Pharmaceuticals is at 73.09, indicating it is overbought [3]. - On the same day, shares closed at $7.81 after a gain of 4.7% [3]. Group 2: Immunovant Inc (IMVT) - On September 9, Immunovant reported positive results from the Phase 2a trial of batoclimab for Graves' Disease, highlighting significant unmet medical needs [4]. - The stock has risen around 17% over the past month, with a 52-week high of $45.58 [4]. - The RSI for Immunovant is at 72.34, also indicating it is overbought [4]. - Shares closed at $34.03 after a surge of 1.2% [4].

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 ...

Part I [Business](index=10&type=section&id=Item%201.%20Business) Immunovant is a clinical-stage immunology company developing anti-FcRn antibodies, IMVT-1402 and batoclimab, for autoimmune diseases - The company's core strategy is to develop its lead asset, **IMVT-1402**, for a wide range of autoimmune diseases, leveraging its potential best-in-class profile of **potent IgG reduction** without the associated negative effects on albumin and LDL cholesterol seen in other FcRn inhibitors[27](index=27&type=chunk)[31](index=31&type=chunk)[35](index=35&type=chunk) Development Pipeline | Investigational Compound | Therapeutic Area | Target Indication | Stage of Development | | :--- | :--- | :--- | :--- | | **IMVT-1402** | Autoimmune Diseases | | Phase 1 | | **Batoclimab** | Neurological Diseases | Myasthenia Gravis (MG) | Pivotal Trial (Phase 3) | | | | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Pivotal Trial (Phase 2b) | | | Endocrine Diseases | Thyroid Eye Disease (TED) | Pivotal Trials (Phase 3) | | | | Graves' Disease (GD) | Proof of Concept Study (Phase 2) | - IMVT-1402 demonstrated a statistically significant **74% reduction in mean total IgG levels** after four weekly 600 mg subcutaneous doses in a Phase 1 trial, with no or minimal impact on albumin and LDL cholesterol levels, similar to placebo[56](index=56&type=chunk) - The company plans an aggressive development timeline for IMVT-1402, aiming to initiate **4-5 potentially registrational programs by March 31, 2025**, and a total of **ten indications by March 31, 2026**[35](index=35&type=chunk)[61](index=61&type=chunk) - Under the license agreement with HanAll Biopharma, Immunovant is obligated to pay up to an aggregate of **$420.0 million** in future regulatory and sales milestones, in addition to tiered royalties on net sales[107](index=107&type=chunk) - The company faces **significant competition** from other FcRn inhibitors, including approved products like VYVGART® (efgartigimod) from argenx and RYSTIGGO® (rozanolixizumab) from UCB, as well as candidates in development from Johnson & Johnson and Viridian Therapeutics[120](index=120&type=chunk)[268](index=268&type=chunk) [Risk Factors](index=52&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks related to product development, regulatory approval, competition, financial sustainability, and third-party reliance - The business is entirely dependent on the **successful and timely development, regulatory approval, and commercialization** of its product candidates, IMVT-1402 and batoclimab[235](index=235&type=chunk) - Adverse events are a significant risk. Batoclimab clinical trials were previously paused due to **treatment-induced elevations in total cholesterol and LDL levels**, which could impact long-term risk-benefit assessment and regulatory approval[239](index=239&type=chunk)[241](index=241&type=chunk) - The company faces **intense competition** from other FcRn inhibitors, including FDA-approved VYVGART® Hytrulo and RYSTIGGO®, and candidates in development from major pharmaceutical companies like Johnson & Johnson[268](index=268&type=chunk) - As of May 22, 2024, Roivant Sciences Ltd. (RSL) beneficially owned approximately **54.6% of the company's voting power**, making Immunovant a "controlled company" and giving RSL significant influence over matters subject to stockholder approval[457](index=457&type=chunk) - The company has a limited operating history, has never generated product revenue, and expects to incur significant losses for the foreseeable future. As of March 31, 2024, the accumulated deficit was **$825.7 million**[324](index=324&type=chunk)[327](index=327&type=chunk) - The company relies on a license agreement with HanAll Biopharma for the core intellectual property of IMVT-1402 and batoclimab. **Termination of this agreement would severely impact the business**[340](index=340&type=chunk) [Unresolved Staff Comments](index=106&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the SEC - There are **no unresolved staff comments**[486](index=486&type=chunk) [Cybersecurity](index=106&type=section&id=Item%201C.%20Cybersecurity) The company has established processes to manage cybersecurity risks, integrated into its overall enterprise risk management - The company's cybersecurity risk management is integrated into its overall enterprise risk management process, focusing on **data protection, access control, and incident response**[487](index=487&type=chunk) - Oversight is provided by the Audit Committee of the Board of Directors, which receives management updates on cybersecurity matters **at least twice annually**[492](index=492&type=chunk) - Operational leadership for cybersecurity is provided by the VP of Information Technology and Facilities and the Head of Cybersecurity, who possess over **16 and 15 years of relevant experience**, respectively[493](index=493&type=chunk) [Properties](index=108&type=section&id=Item%202.%20Properties) The company conducts its business operations from leased office spaces in New York, NY, and Durham, NC, with international subsidiary offices - The company's primary U.S. operations are located at **320 West 37th Street, New York, NY** and **1000 Park Forty Plaza, Durham, NC**[495](index=495&type=chunk) - International subsidiary offices are located in **Hamilton, Bermuda; London, UK; and Basel, Switzerland**[495](index=495&type=chunk) [Legal Proceedings](index=108&type=section&id=Item%203.%20Legal%20Proceedings) A securities class action complaint filed in February 2021 was dismissed with prejudice in March 2024, concluding the litigation - A putative securities class action complaint filed against the company in February 2021 was **dismissed with prejudice on March 29, 2024**. The litigation is now concluded as the plaintiffs did not appeal the judgment[698](index=698&type=chunk) [Mine Safety Disclosures](index=108&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[499](index=499&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=109&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on The Nasdaq Global Select Market, and it has never paid cash dividends - The company's common stock is listed on **The Nasdaq Global Select Market** under the ticker symbol **"IMVT"**[502](index=502&type=chunk) - The company has **never declared or paid dividends** and does not plan to in the foreseeable future, retaining all future earnings for business operations[504](index=504&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=110&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company reported an increased net loss for FY2024, driven by higher R&D and G&A expenses, with its cash position significantly strengthened by a recent equity offering Results of Operations | | Years Ended March 31, | Change | | :--- | :--- | :--- | :--- | | | **2024 (in thousands)** | **2023 (in thousands)** | **$ (in thousands)** | | Research and development | $212,928 | $160,257 | $52,671 | | Acquired in-process R&D | $12,500 | $10,000 | $2,500 | | General and administrative | $57,281 | $48,019 | $9,262 | | **Net loss** | **$(259,336)** | **$(210,960)** | **$(48,376)** | - The increase in R&D expenses was primarily driven by a **$32.8 million** rise in costs for the IMVT-1402 program and a **$25.2 million** increase in unallocated personnel-related expenses due to higher headcount[547](index=547&type=chunk)[548](index=548&type=chunk) - The company's cash and cash equivalents increased to **$635.4 million** as of March 31, 2024, from **$376.5 million** a year prior, mainly due to net proceeds of **$466.7 million** from an underwritten public offering and concurrent private placement in October 2023[552](index=552&type=chunk)[555](index=555&type=chunk) - Management expects that existing cash and cash equivalents are sufficient to fund operating expenses and capital expenditure requirements for **at least the next 12 months** from the filing date[572](index=572&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=120&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is not required to provide this information as it qualifies as a "smaller reporting company" - The company is **exempt from this disclosure requirement** because it is a "smaller reporting company"[579](index=579&type=chunk) [Financial Statements and Supplementary Data](index=121&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The audited financial statements for FY2024 show an increased net loss, a substantial accumulated deficit, and a significant rise in stockholders' equity due to recent equity financing Consolidated Balance Sheet Data | | March 31, 2024 (in thousands) | March 31, 2023 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $635,365 | $376,532 | | Total assets | $666,365 | $405,838 | | Total liabilities | $48,608 | $43,344 | | Accumulated deficit | $(825,683) | $(566,347) | | Total stockholders' equity | $617,757 | $362,494 | Consolidated Statement of Operations Data | | Year Ended March 31, 2024 (in thousands) | Year Ended March 31, 2023 (in thousands) | | :--- | :--- | :--- | | Research and development | $212,928 | $160,257 | | General and administrative | $57,281 | $48,019 | | **Net loss** | **$(259,336)** | **$(210,960)** | | **Net loss per share** | **$(1.88)** | **$(1.71)** | - The company achieved development and regulatory milestones under the HanAll Agreement, resulting in acquired IPR&D expenses of **$12.5 million** in fiscal 2024 and **$10.0 million** in fiscal 2023[651](index=651&type=chunk) - As of March 31, 2024, the company has a remaining minimum purchase commitment of approximately **$46.2 million** under its manufacturing agreement with Samsung Biologics[654](index=654&type=chunk)[699](index=699&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=146&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - **None reported**[702](index=702&type=chunk) [Controls and Procedures](index=146&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of March 31, 2024 - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were **effective as of March 31, 2024**[705](index=705&type=chunk) - Management concluded that the company's internal control over financial reporting was **effective as of March 31, 2024**, based on the COSO 2013 framework[709](index=709&type=chunk) - The independent registered public accounting firm, Ernst & Young LLP, issued an **unqualified opinion on the effectiveness of the company's internal control over financial reporting as of March 31, 2024**[710](index=710&type=chunk)[714](index=714&type=chunk) [Other Information](index=149&type=section&id=Item%209B.%20Other%20Information) No directors or Section 16 reporting officers adopted, modified, or terminated any Rule 10b5-1 trading arrangement during the fourth quarter - **No directors or Section 16 officers adopted, modified, or terminated a Rule 10b5-1 trading plan during the fourth quarter**[721](index=721&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=149&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company - Not applicable[722](index=722&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=150&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information for this item will be provided in the company's 2024 Proxy Statement and is incorporated by reference - Information for this item is **incorporated by reference** from the registrant's definitive Proxy Statement for its 2024 Annual Meeting of Stockholders[724](index=724&type=chunk)[725](index=725&type=chunk) [Executive Compensation](index=150&type=section&id=Item%2011.%20Executive%20Compensation) Information for this item will be provided in the company's 2024 Proxy Statement and is incorporated by reference - Information for this item is **incorporated by reference** from the registrant's definitive Proxy Statement for its 2024 Annual Meeting of Stockholders[724](index=724&type=chunk)[727](index=727&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=150&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information for this item will be provided in the company's 2024 Proxy Statement and is incorporated by reference - Information for this item is **incorporated by reference** from the registrant's definitive Proxy Statement for its 2024 Annual Meeting of Stockholders[724](index=724&type=chunk)[728](index=728&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=150&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information for this item will be provided in the company's 2024 Proxy Statement and is incorporated by reference - Information for this item is **incorporated by reference** from the registrant's definitive Proxy Statement for its 2024 Annual Meeting of Stockholders[724](index=724&type=chunk)[729](index=729&type=chunk) [Principal Accountant Fees and Services](index=150&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information for this item will be provided in the company's 2024 Proxy Statement and is incorporated by reference - Information for this item is **incorporated by reference** from the registrant's definitive Proxy Statement for its 2024 Annual Meeting of Stockholders[724](index=724&type=chunk)[730](index=730&type=chunk) Part IV [Exhibit and Financial Statement Schedules](index=151&type=section&id=Item%2015.%20Exhibit%20and%20Financial%20Statement%20Schedules) This section lists the documents filed as part of the Annual Report, including financial statements and a comprehensive list of exhibits - All required financial statements are included in **Part II, Item 8** of the report[732](index=732&type=chunk) - A list of exhibits filed with the report is provided, including the **License Agreement with HanAll BioPharma**, the **Master Services Agreement with Samsung Biologics**, and various equity incentive plans[734](index=734&type=chunk)[735](index=735&type=chunk) [Form 10-K Summary](index=153&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company has not provided a summary for its Form 10-K - None[738](index=738&type=chunk)

[Corporate and Clinical Development Updates](index=1&type=section&id=Corporate%20and%20Clinical%20Development%20Updates) Immunovant strategically prioritizes IMVT-1402 for broad autoantibody-driven diseases, planning extensive late-stage clinical expansion and securing a key U.S. patent [General Clinical Development Updates](index=1&type=section&id=General%20Clinical%20Development%20Updates) Immunovant prioritizes IMVT-1402 for autoantibody-driven diseases, planning 4-5 registrational studies by March 2025 and securing a U.S. patent until 2043 - Immunovant is prioritizing the development of IMVT-1402 as its lead asset, citing its potential best-in-class features for treating a wide range of autoantibody-driven indications[4](index=4&type=chunk) - The company plans to initiate **4-5 potentially registrational programs** for IMVT-1402 by March 31, 2025, and expand to a total of **10 indications** by March 31, 2026, covering areas like Endocrinology and Neurology[5](index=5&type=chunk)[7](index=7&type=chunk) - A new U.S. Patent (No. 11,926,669) has been awarded for IMVT-1402, covering its composition of matter, with the patent term extending until **June 2043**[6](index=6&type=chunk) - Key data readouts are expected in the current fiscal year, including topline data for batoclimab in Myasthenia Gravis (MG) and detailed results for Graves' disease in the **fall of 2024**[7](index=7&type=chunk) [Neurology Clinical Development Updates](index=2&type=section&id=Neurology%20Clinical%20Development%20Updates) Immunovant plans a registrational program for IMVT-1402 in MG this fiscal year, while extending the batoclimab CIDP trial to optimize future IMVT-1402 studies - A potentially registrational program for IMVT-1402 in Myasthenia Gravis (MG) is expected to be initiated this fiscal year, with a final decision based on topline results from the current batoclimab trial, expected by **March 31, 2025**[8](index=8&type=chunk) - The company is extending the ongoing batoclimab CIDP trial by about **two quarters** before unblinding, aiming to use data from this trial and learnings from other CIDP studies to optimize the design of a future IMVT-1402 CIDP trial[9](index=9&type=chunk)[10](index=10&type=chunk) [Endocrinology Clinical Development Updates](index=2&type=section&id=Endocrinology%20Clinical%20Development%20Updates) Detailed batoclimab Graves' disease results and IMVT-1402 program overview are due in fall 2024, with a TED asset decision expected in early 2025 - Detailed results from the batoclimab study in Graves' disease and an overview of the IMVT-1402 development program are expected to be announced in the **fall of 2024**[11](index=11&type=chunk) - For Thyroid Eye Disease (TED), a decision on which asset (batoclimab or IMVT-1402) to advance to registration will be made in the **first half of calendar year 2025**, coinciding with the release of topline data from the current batoclimab TED program[12](index=12&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) Immunovant reported increased net losses for both the fourth quarter and full fiscal year 2024, primarily driven by higher R&D expenses, while maintaining a strong cash position [Fourth Quarter Fiscal Year 2024 Financial Highlights](index=2&type=section&id=Financial%20Highlights%20for%20Fiscal%20Fourth%20Quarter%20Ended%20March%2031%2C%202024) Immunovant reported a **$75.3 million net loss** for Q4 FY2024, driven by increased R&D expenses, while maintaining a strong **$635 million cash position** - As of March 31, 2024, the company's cash and cash equivalents totaled approximately **$635 million**[13](index=13&type=chunk) Fourth Quarter Fiscal Year 2024 Financial Metrics | Financial Metric | Three Months Ended March 31, 2024 (Millions USD) | Three Months Ended March 31, 2023 (Millions USD) | | :--- | :--- | :--- | | R&D Expenses | $66.1 | $51.8 | | G&A Expenses | $14.8 | $12.4 | | Net Loss | $75.3 | $59.4 | | Net Loss per Share | $0.52 | $0.46 | [Fiscal Year 2024 Financial Highlights](index=3&type=section&id=Financial%20Highlights%20for%20Fiscal%20Year%20Ended%20March%2031%2C%202024) Immunovant's full fiscal year 2024 net loss widened to **$259.3 million**, primarily due to increased R&D and G&A expenses, alongside acquired in-process R&D costs Fiscal Year 2024 Financial Metrics | Financial Metric | Fiscal Year Ended March 31, 2024 (Millions USD) | Fiscal Year Ended March 31, 2023 (Millions USD) | | :--- | :--- | :--- | | R&D Expenses | $212.9 | $160.3 | | IPR&D Expenses | $12.5 | $10.0 | | G&A Expenses | $57.3 | $48.0 | | Net Loss | $259.3 | $211.0 | | Net Loss per Share | $1.88 | $1.71 | [Consolidated Financial Statements](index=5&type=section&id=Consolidated%20Financial%20Statements) Immunovant's consolidated financial statements reflect increased operating expenses and a widened net loss for fiscal year 2024, alongside a strengthened balance sheet with higher assets and equity [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) Total operating expenses increased to **$282.7 million** in fiscal year 2024, leading to a net loss of **$259.3 million**, primarily due to higher R&D and G&A costs Consolidated Statements of Operations (Thousands USD) | (In thousands) | Year Ended March 31, 2024 | Year Ended March 31, 2023 | | :--- | :--- | :--- | | Research and development | $212,928 | $160,257 | | Acquired in-process R&D | $12,500 | $10,000 | | General and administrative | $57,281 | $48,019 | | **Total operating expenses** | **$282,709** | **$218,276** | | Interest income | ($24,948) | ($7,578) | | **Net loss** | **($259,336)** | **($210,960)** | [Consolidated Balance Sheets](index=6&type=section&id=Consolidated%20Balance%20Sheets) Immunovant's total assets grew to **$666.4 million** by March 31, 2024, driven by increased cash and equivalents, resulting in a substantial rise in stockholders' equity Consolidated Balance Sheets (Thousands USD) | (In thousands) | March 31, 2024 | March 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $635,365 | $376,532 | | Total current assets | $665,770 | $404,333 | | **Total assets** | **$666,365** | **$405,838** | | **Liabilities and Equity** | | | | Total current liabilities | $48,608 | $43,297 | | **Total liabilities** | **$48,608** | **$43,344** | | **Total stockholders' equity** | **$617,757** | **$362,494** | | **Total liabilities and stockholders' equity** | **$666,365** | **$405,838** |