Biohaven (BHVN) stock crashed Wednesday after the company's experimental protein-degrading drug — which could be used to treat a myriad of immune-related diseases — lagged investor expectations. X The company tested four doses of its drug, BHV-1300, which is meant to break down immunoglobulin G, or IgG, an autoantibody at the center of diseases like rheumatoid arthritis and myasthenia gravis. In healthy volunteers, the doses reduced IgG by up to 37%. Biohaven called the results "positive," noting that IgG l ...

Shares of Immunovant, Inc. (IMVT) have gained 0.1% over the past four weeks to close the last trading session at $29.39, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $49.56 indicates a potential upside of 68.6%. The average comprises 16 short-term price targets ranging from a low of $32 to a high of $57, with a standard deviation of $6.11. While the lowest estimate indicates ...

Immunovant, Inc. (IMVT) is a New York-based biopharmaceutical company, which develops monoclonal antibodies for the treatment of autoimmune diseases. The company currently has no marketed products in its commercial portfolio.Immunovant’s clinical-stage pipeline comprises its lead product candidate, batoclimab (formerly known as IMVT-1401), and a new candidate, IMVT-1402, which are being developed as a subcutaneous injection for the treatment of IgG-mediated autoimmune diseases.Let’s delve deeper to discuss ...

Investors might want to bet on Immunovant, Inc. (IMVT) , as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.Individual inves ...

Table of Contents 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 December 31, 2023 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) Delaware 83-2771572 (State or other jurisdiction of incorporati ...

Table of Contents 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, 2023 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) Delaware 83-2771572 (State or other jurisdiction of incorporat ...

IMMUNOVANT 2 | --- | --- | --- | --- | --- | |----------------------------------------------------------------------------------------------------------------------------------------|------------|-------|-------|-------| | | | | | | | What we do: | | | | | | We are developing targeted therapies that are designed to address the complex and variable needs of people with autoimmune diseases. | | | | | | | | | | | | Love Trailblazing | All Voices | | | | autoimmune disease indications Differentiated product can ...

Table of Contents 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 June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-38906 Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Excha ...

[Part I](index=10&type=section&id=PART%20I) [Business](index=10&type=section&id=Item%201.%20Business) Immunovant is a clinical-stage biopharmaceutical company focused on developing treatments for autoimmune diseases, with a pipeline centered on two anti-FcRn monoclonal antibodies, batoclimab and IMVT-1402 [Overview and Pipeline](index=10&type=section&id=1.1%20Overview%20and%20Pipeline) Immunovant is a clinical-stage biopharmaceutical company developing therapies for autoimmune diseases, with lead product candidates batoclimab and IMVT-1402 targeting FcRn to reduce pathogenic IgG antibody levels * The company's core focus is on its two anti-FcRn antibodies, **batoclimab** and **IMVT-1402**, for treating IgG-mediated autoimmune diseases[28](index=28&type=chunk) Development Pipeline as of March 31, 2023 | Product Candidate | Target Indication / Therapeutic Area | Stage of Development | | :--- | :--- | :--- | | **Batoclimab** | Myasthenia Gravis | Pivotal Phase 3 | | | Thyroid Eye Disease | Pivotal Phase 3 | | | Chronic Inflammatory Demyelinating Polyneuropathy | Phase 2b | | | Graves' Disease | Phase 2 | | **IMVT-1402** | Autoimmune Disease | Phase 1 | * IMVT-1402 is designed to be a potentially best-in-class FcRn inhibitor by demonstrating minimal or no impact on albumin and LDL cholesterol levels in nonclinical studies, a key differentiator from batoclimab[30](index=30&type=chunk)[77](index=77&type=chunk) * The company has received orphan drug designation for batoclimab for the treatment of MG from both the FDA and the European Commission[40](index=40&type=chunk) [Clinical Programs](index=13&type=section&id=1.2%20Clinical%20Programs) The company is advancing multiple clinical trials, with batoclimab Phase 3 MG data expected in H2 2024, TED results in H1 2025, CIDP initial data in H1 2024, and IMVT-1402 Phase 1 data in Q3 2023 * The Phase 3 trial for MG will evaluate both induction (680 mg QW) and maintenance (340 mg QW and Q2W) dosing regimens, with top-line data expected in the **second half of calendar year 2024**[48](index=48&type=chunk)[49](index=49&type=chunk) * The Phase 3 program for TED consists of two trials, with top-line results anticipated in the **first half of calendar year 2025**[59](index=59&type=chunk) * A pivotal Phase 2b trial for CIDP was initiated, with initial data from the open-label period expected in the **first half of calendar year 2024**[65](index=65&type=chunk) * A Phase 1 trial for IMVT-1402 was initiated in Q2 2023, with initial single-ascending dose data expected in **August or September 2023** and multiple-ascending dose data in **October or November 2023**[78](index=78&type=chunk) [Key Agreements and Relationships](index=24&type=section&id=1.3%20Key%20Agreements%20and%20Relationships) Immunovant's operations are supported by a license agreement with HanAll Biopharma for batoclimab and IMVT-1402, a commercial supply agreement with Samsung Biologics, and its status as a majority-owned subsidiary of Roivant Sciences Ltd * Under the HanAll Agreement, Immunovant is obligated to pay up to an aggregate of **$432.5 million** in future development, regulatory, and sales milestones, plus tiered royalties[93](index=93&type=chunk) * A **$10.0 million** development and regulatory milestone was achieved and paid to HanAll in the fiscal year ended March 31, 2023[93](index=93&type=chunk) * The company has a commercial manufacturing agreement with Samsung Biologics for batoclimab, with a remaining minimum purchase commitment of approximately **$33.3 million** as of March 31, 2023[97](index=97&type=chunk)[99](index=99&type=chunk) * Immunovant is a majority-owned subsidiary of Roivant Sciences Ltd (RSL) and benefits from access to RSL's centralized functions, technology platforms, and expertise[100](index=100&type=chunk) [Competition and Intellectual Property](index=27&type=section&id=1.4%20Competition%20and%20Intellectual%20Property) The company faces intense competition from other biopharmaceutical firms developing anti-FcRn inhibitors, including argenx and Johnson & Johnson, and relies on in-licensed and owned patents for intellectual property protection * Key competitors in the anti-FcRn class include **argenx SE (efgartigimod)**, **Johnson & Johnson (nipocalimab)**, and **UCB (rozanolixizumab)**[105](index=105&type=chunk) * The in-licensed patent family covering batoclimab composition of matter has a projected expiration of **2035**, while the family for IMVT-1402 is projected to expire in **2043**[113](index=113&type=chunk)[116](index=116&type=chunk) * The company also owns patent families directed to methods of treating specific diseases like TED, GD, and CIDP with anti-FcRn antibodies, with projected expirations between **2039 and 2043**[115](index=115&type=chunk)[117](index=117&type=chunk) [Government Regulation](index=30&type=section&id=1.5%20Government%20Regulation) The company's products are subject to extensive regulation by the FDA and comparable authorities abroad, covering all stages from R&D to post-approval marketing, including specific requirements for combination products and adherence to healthcare laws * The company must navigate the FDA's BLA process for biologics and similar MAA processes in the EU before marketing its products[123](index=123&type=chunk)[125](index=125&type=chunk) * Pre-filled syringe and autoinjector presentations of the company's products are regulated as combination products, requiring review of both biologic and device components[124](index=124&type=chunk) * The company is subject to U.S healthcare laws, including the federal Anti-Kickback Statute, False Claims Act, and the Sunshine Act, which regulate interactions with healthcare professionals and payors[175](index=175&type=chunk)[176](index=176&type=chunk)[181](index=181&type=chunk) * Recent healthcare reforms, such as the Inflation Reduction Act of 2022 (IRA), are expected to impact drug pricing and reimbursement through measures like Medicare price negotiation and inflation-based rebates[197](index=197&type=chunk)[199](index=199&type=chunk) [Human Capital](index=48&type=section&id=1.6%20Human%20Capital) As of March 31, 2023, Immunovant had 164 full-time employees, with approximately 82% in R&D and over half of the workforce and senior management being women, fostering a collaborative and inclusive culture Employee Statistics as of March 31, 2023 | Metric | Value | | :--- | :--- | | Full-time employees | 164 | | Employees in R&D | ~82% | | Employees with advanced degrees | ~70% | | Women in workforce | >50% | | Women in senior management | >50% | * The company expects significant growth in employee numbers, particularly in clinical development, quality, and regulatory affairs, as its product candidates progress[207](index=207&type=chunk) [Risk Factors](index=50&type=section&id=Item%201A.%20Risk%20Factors) The company's business faces high risks, including dependence on successful development of batoclimab and IMVT-1402, clinical trial uncertainties, intense competition, reliance on third parties, financial losses, and control by Roivant Sciences Ltd * The business is highly dependent on the success of its two product candidates, **batoclimab** and **IMVT-1402**[212](index=212&type=chunk) * Adverse events, such as the previously observed elevations in total cholesterol and LDL with batoclimab, could delay or prevent regulatory approval or limit market acceptance[217](index=217&type=chunk)[219](index=219&type=chunk) * The company faces significant competition from other FcRn inhibitors, including the FDA-approved **VYVGART™ (efgartigimod)**, and other therapies for autoimmune diseases[249](index=249&type=chunk)[250](index=250&type=chunk) * Roivant Sciences Ltd (RSL) owns approximately **56.6%** of the company's common stock, making Immunovant a "controlled company" and giving RSL significant influence over corporate matters[440](index=440&type=chunk) * The company has a history of significant losses, expects to incur more losses, and will require additional capital to fund operations, which may not be available on favorable terms[307](index=307&type=chunk)[319](index=319&type=chunk) * Reliance on the HanAll Agreement is critical; termination or loss of rights under this agreement would severely impact the development of batoclimab and IMVT-1402[324](index=324&type=chunk) [Unresolved Staff Comments](index=105&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the SEC * None[469](index=469&type=chunk) [Properties](index=105&type=section&id=Item%202.%20Properties) The company's headquarters are in New York, NY, with operations in Durham, NC, and subsidiary offices in Bermuda, London, and Basel, Switzerland, with New York subleases expiring in 2024 * The company's principal executive offices are located at **320 West 37th Street, New York, New York 10018**[470](index=470&type=chunk) [Legal Proceedings](index=105&type=section&id=Item%203.%20Legal%20Proceedings) The company is involved in a putative securities class action lawsuit filed in February 2021, alleging violations related to batoclimab's safety, which it intends to vigorously defend without recording a liability * A putative securities class action complaint was filed against the Company in February 2021, alleging false and misleading statements regarding the safety of batoclimab[669](index=669&type=chunk) * The company is unable to reasonably estimate possible losses and has not recorded a liability for this lawsuit[669](index=669&type=chunk) [Mine Safety Disclosures](index=105&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company * Not applicable[474](index=474&type=chunk) [Part II](index=106&type=section&id=PART%20II) [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=106&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 under 'IMVT', with three holders of record as of May 17, 2023, and no history or plans for cash dividends * Common stock trades on **The Nasdaq Global Select Market** under the ticker symbol '**IMVT**'[476](index=476&type=chunk) * The company has never declared or paid dividends and does not plan to in the foreseeable future[478](index=478&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=107&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For fiscal year ended March 31, 2023, Immunovant reported a net loss of $211.0 million, driven by increased R&D expenses for clinical trials, with $376.5 million in cash expected to fund operations into H2 2025 [Results of Operations](index=111&type=section&id=7.1%20Results%20of%20Operations) For fiscal year ended March 31, 2023, net loss increased to $211.0 million from $156.7 million, primarily due to a $58.4 million rise in R&D expenses for clinical trials and a $10.0 million milestone payment to HanAll Comparison of Operations (in thousands) | | Years Ended March 31, | Change | | :--- | :--- | :--- | | | **2023** | **2022** | **$** | | Research and development | $160,257 | $101,808 | $58,449 | | Acquired in-process R&D | $10,000 | $0 | $10,000 | | General and administrative | $48,019 | $54,225 | $(6,206) | | **Total operating expenses** | **$218,276** | **$156,033** | **$62,243** | | **Net loss** | **$(210,960)** | **$(156,730)** | **$(54,230)** | * The increase in R&D expenses was primarily driven by **$19.1 million** in costs for the CIDP trial and **$18.7 million** for the MG trial, including higher contract manufacturing costs[514](index=514&type=chunk) * A **$10.0 million** milestone payment was made to HanAll for batoclimab in MG, recorded as acquired in-process R&D[517](index=517&type=chunk) [Liquidity and Capital Resources](index=113&type=section&id=7.2%20Liquidity%20and%20Capital%20Resources) As of March 31, 2023, the company had $376.5 million in cash and cash equivalents, bolstered by a $70.2 million equity offering, expected to fund operations into H2 2025, with future commitments including $33.3 million to Samsung and up to $432.5 million to HanAll Cash Position | | March 31, 2023 | March 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $376.5 million | $493.8 million | * The company expects its cash balance of **$376.5 million** to fund operating expenses and capital requirements into the **second half of calendar year 2025**[540](index=540&type=chunk) * In October 2022, the company raised approximately **$70.2 million** in net proceeds from an underwritten public offering[523](index=523&type=chunk) * Future material cash requirements include a remaining minimum commitment of **$33.3 million** to Samsung and potential milestone payments up to **$432.5 million** to HanAll[533](index=533&type=chunk)[534](index=534&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=118&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is not required to provide quantitative and qualitative disclosures about market risk as it qualifies as a 'smaller reporting company' under SEC rules * As a 'smaller reporting company', the company is exempt from providing quantitative and qualitative disclosures about market risk[546](index=546&type=chunk) [Financial Statements and Supplementary Data](index=119&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The consolidated financial statements for fiscal years ended March 31, 2023 and 2022, show a net loss of $211.0 million for fiscal 2023, with total assets at $405.8 million and stockholders' equity at $362.5 million [Financial Highlights](index=122&type=section&id=8.1%20Financial%20Highlights) For fiscal year ended March 31, 2023, the company reported a net loss of $211.0 million, or ($1.71) per share, with cash and cash equivalents of $376.5 million and total stockholders' equity of $362.5 million Key Financial Data (in thousands, except per share data) | Metric | FY 2023 | FY 2022 | | :--- | :--- | :--- | | **Statement of Operations** | | | | Research and development | $160,257 | $101,808 | | General and administrative | $48,019 | $54,225 | | Net loss | $(210,960) | $(156,730) | | Net loss per share | $(1.71) | $(1.43) | | **Balance Sheet (as of Mar 31)** | | | | Cash and cash equivalents | $376,532 | $493,817 | | Total assets | $405,838 | $515,564 | | Total liabilities | $43,344 | $45,739 | | Total stockholders' equity | $362,494 | $469,825 | [Notes to Financials](index=127&type=section&id=8.2%20Notes%20to%20Financials) Key notes detail material agreements including HanAll and Samsung commitments, related party transactions with Roivant, significant net operating loss carryforwards with full valuation allowance, and the ongoing securities class action lawsuit * The company has a remaining minimum purchase commitment of approximately **$33.3 million** under its manufacturing agreement with Samsung[622](index=622&type=chunk) * As of March 31, 2023, the company has significant net operating loss carryforwards, including **$447.6 million** in Switzerland and **$27.7 million** in the U.S, which are fully offset by a valuation allowance[632](index=632&type=chunk)[633](index=633&type=chunk) * In October 2022, the company raised approximately **$70.2 million** in net proceeds from an underwritten offering, which included participation from its majority shareholder, RSL[648](index=648&type=chunk) * The company is defending a putative securities class action lawsuit filed in February 2021; an outcome cannot be reasonably estimated at this time[669](index=669&type=chunk) [Controls and Procedures](index=145&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, 2023, with no material changes during the fourth fiscal quarter * Management concluded that the company's disclosure controls and procedures were effective as of **March 31, 2023**[677](index=677&type=chunk) * Management concluded that the company's internal control over financial reporting was effective as of **March 31, 2023**[681](index=681&type=chunk) * The report does not include an attestation report from the independent registered public accounting firm on internal controls, as the company is a smaller reporting company and a non-accelerated filer[682](index=682&type=chunk) [Part III](index=147&type=section&id=PART%20III) [Directors, Executive Officers, Corporate Governance, Compensation, Security Ownership, and Accountant Fees](index=147&type=section&id=Item%2010%2C%2011%2C%2012%2C%2013%2C%2014) Information for Items 10 through 14 is incorporated by reference from the company's forthcoming 2023 Annual Meeting of Stockholders proxy statement, to be filed within 120 days of fiscal year-end * Information regarding directors, executive officers, corporate governance, executive compensation, security ownership, related party transactions, and principal accountant fees and services is incorporated by reference from the forthcoming **2023 Proxy Statement**[688](index=688&type=chunk)[689](index=689&type=chunk)[691](index=691&type=chunk)[692](index=692&type=chunk)[693](index=693&type=chunk)[694](index=694&type=chunk) [Part IV](index=148&type=section&id=PART%20IV) [Exhibit and Financial Statement Schedules](index=148&type=section&id=Item%2015.%20Exhibit%20and%20Financial%20Statement%20Schedules) This section lists financial statements and exhibits filed as part of the Annual Report on Form 10-K, with all financial statement schedules omitted as information is included in notes or not applicable * The financial statements are included in Part II, Item 8. All financial statement schedules are omitted[696](index=696&type=chunk)[697](index=697&type=chunk) * A list of exhibits is provided, incorporating by reference key documents such as the HanAll License Agreement, Samsung Services Agreements, and various equity incentive plans[698](index=698&type=chunk)[699](index=699&type=chunk) [Form 10-K Summary](index=150&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company reports that there is no Form 10-K summary * None[702](index=702&type=chunk)

For the quarterly period ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Table of Contents 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 Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the pr ...