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's Pipeline and Focus - Immunovant is developing targeted therapies for autoimmune diseases driven by harmful IgG autoantibodies[2,17] - The company has approximately $330 million in cash balance as of June 30, 2023[14] - There are 22 indications currently announced or in development across the anti-FcRn class[14,26] Batoclimab Development - Batoclimab is in pivotal Phase 3 trials for Myasthenia Gravis (MG) and Thyroid Eye Disease (TED)[30] - A Phase 2b trial of batoclimab in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is underway, along with a Phase 2 trial in Graves' Disease[30] - In a Phase 2 trial of batoclimab in MG, subjects experienced -59% to -76% change in total IgG from baseline and -54% to -87% change in Anti-AChR-IgG from baseline at week 7, depending on the dose[50,235] IMVT-1402 Development - IMVT-1402, another product candidate, is in Phase 1 development for autoimmune diseases[30] - Preclinical data in monkeys showed that at comparable doses, IgG lowering is similar for both batoclimab and IMVT-1402[177] Market Opportunities - In Myasthenia Gravis, approximately 65,000 patients are estimated in the US and approximately 100,000 in Europe[35] - In Thyroid Eye Disease, 1/3 of the 15,000-20,000 US patients with active, moderate-to-severe TED annually have less severe disease that may benefit from batoclimab[55] - CIDP represents 22% of the total IVIg market by volume[121]

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 ...

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents Immunovant's unaudited condensed consolidated financial statements, highlighting changes in cash, net loss, and R&D expenses Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | September 30, 2022 | March 31, 2022 | Change | | :-------------------------------- | :----------------- | :------------- | :----- | | Cash and cash equivalents | $405,773 | $493,817 | $(88,044) | | Total assets | $428,146 | $515,564 | $(87,418) | | Total liabilities | $32,398 | $45,739 | $(13,341) | | Total stockholders' equity | $395,748 | $469,825 | $(74,077) | Condensed Consolidated Statements of Operations Highlights (in thousands) | Metric | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Six Months Ended Sep 30, 2022 | Six Months Ended Sep 30, 2021 | | :-------------------------------- | :------------------------------ | :------------------------------ | :---------------------------- | :---------------------------- | | Research and development | $37,739 | $21,361 | $66,168 | $40,066 | | General and administrative | $11,875 | $16,289 | $23,821 | $27,469 | | Total operating expenses | $49,614 | $37,650 | $89,989 | $67,535 | | Net loss | $(47,928) | $(37,703) | $(88,301) | $(68,174) | | Net loss per common share (basic and diluted) | $(0.41) | $(0.35) | $(0.76) | $(0.66) | Condensed Consolidated Statements of Cash Flows Highlights (Six Months Ended September 30, in thousands) | Metric | 2022 | 2021 | | :-------------------------------- | :--------- | :--------- | | Net cash used in operating activities | $(86,005) | $(41,261) | | Net cash used in investing activities | $(73) | $(62) | | Net cash provided by financing activities | $21 | $200,129 | | Net change in cash and cash equivalents | $(88,044) | $158,806 | | Cash and cash equivalents – end of period | $405,773 | $558,952 | [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20September%2030,%202022%20and%20March%2031,%202022) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20for%20the%20Three%20and%20Six%20Months%20Ended%20September%2030,%202022%20and%202021) [Condensed Consolidated Statements of Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss%20for%20the%20Three%20and%20Six%20Months%20Ended%20September%2030,%202022%20and%202021) [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20for%20the%20Three%20and%20Six%20Months%20Ended%20September%2030,%202022%20and%202021) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20Six%20Months%20Ended%20September%2030,%202022%20and%202021) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Detailed notes cover business, liquidity, accounting policies, agreements, and financial position, highlighting significant losses and capital needs - Immunovant is a clinical-stage biopharmaceutical company focused on autoimmune diseases, with product candidates batoclimab and IMVT-1402 targeting the neonatal fragment crystallizable receptor (FcRn)[32](index=32&type=chunk) - The company has incurred significant losses and negative cash flows since inception, with an accumulated deficit of **$443.7 million** as of September 30, 2022. It does not anticipate generating revenue until successful development and regulatory approval of its product candidates[34](index=34&type=chunk)[35](index=35&type=chunk) - The company expects its existing cash and cash equivalents of **$405.8 million** as of September 30, 2022, to fund operations for at least the next 12 months[34](index=34&type=chunk)[36](index=36&type=chunk) - Immunovant has a license agreement with HanAll Biopharma for batoclimab and IMVT-1402, involving potential milestone payments up to **$442.5 million** and tiered royalties[52](index=52&type=chunk)[54](index=54&type=chunk) - A Product Service Agreement with Samsung Biologics commits the company to minimum purchases of batoclimab drug substance, estimated at approximately **$36.0 million** as of September 30, 2022[55](index=55&type=chunk)[57](index=57&type=chunk) - In October 2022, the company completed a public offering, raising approximately **$70.2 million** in net proceeds[86](index=86&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition and operations, detailing clinical pipeline advancements, increased R&D, decreased G&A, and liquidity - Immunovant is a clinical-stage biopharmaceutical company developing batoclimab and IMVT-1402, novel FcRn-targeting monoclonal antibodies for autoimmune diseases[90](index=90&type=chunk) - Batoclimab is currently in Phase 3 trials for Myasthenia Gravis (MG) and Thyroid Eye Disease (TED), with plans for Phase 2b in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Phase 2 in Graves' Disease[96](index=96&type=chunk)[97](index=97&type=chunk) - IMVT-1402, a second product candidate, is expected to initiate a Phase 1 trial in early calendar year 2023, contingent on IND clearance, with initial data anticipated in mid-2023[93](index=93&type=chunk)[98](index=98&type=chunk) - Research and development expenses increased significantly by **$16.3 million** (three months) and **$26.1 million** (six months) due to advancing batoclimab trials (MG, CIDP) and IMVT-1402 development[119](index=119&type=chunk)[120](index=120&type=chunk)[121](index=121&type=chunk)[126](index=126&type=chunk)[127](index=127&type=chunk)[128](index=128&type=chunk) - General and administrative expenses decreased by **$4.4 million** (three months) and **$3.7 million** (six months), primarily due to lower financial advisory, legal, and other professional fees, partially offset by higher personnel and IT costs[123](index=123&type=chunk)[130](index=130&type=chunk) - The company expects its existing cash and cash equivalents, combined with proceeds from the October 2022 public offering, to fund operations into the second half of calendar year 2025[149](index=149&type=chunk) [Overview](index=19&type=section&id=Overview) [Recent Developments in Our Clinical Programs](index=20&type=section&id=Recent%20Developments%20in%20Our%20Clinical%20Programs) [COVID-19 Business Update](index=20&type=section&id=COVID-19%20Business%20Update) [Our Key Agreements](index=20&type=section&id=Our%20Key%20Agreements) [Financial Operations Overview](index=21&type=section&id=Financial%20Operations%20Overview) [Results of Operations for the Three Months Ended September 30, 2022 and 2021](index=23&type=section&id=Results%20of%20Operations%20for%20the%20Three%20Months%20Ended%20September%2030,%202022%20and%202021) [Research and Development Expenses for the Three Months Ended September 30, 2022 and 2021](index=23&type=section&id=Research%20and%20Development%20Expenses%20for%20the%20Three%20Months%20Ended%20September%2030,%202022%20and%202021) [General and Administrative Expenses for the Three Months Ended September 30, 2022 and 2021](index=24&type=section&id=General%20and%20Administrative%20Expenses%20for%20the%20Three%20Months%20Ended%20September%2030,%202022%20and%202021) [Results of Operations for the Six Months Ended September 30, 2022 and 2021](index=24&type=section&id=Results%20of%20Operations%20for%20the%20Six%20Months%20Ended%20September%2030,%202022%20and%202021) [Research and Development Expenses for the Six Months Ended September 30, 2022 and 2021](index=25&type=section&id=Research%20and%20Development%20Expenses%20for%20the%20Six%20Months%20Ended%20September%2030,%202022%20and%202021) [General and Administrative Expenses for the Six Months Ended September 30, 2022 and 2021](index=25&type=section&id=General%20and%20Administrative%20Expenses%20for%20the%20Six%20Months%20Ended%20September%2030,%202022%20and%202021) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) [Critical Accounting Estimates](index=29&type=section&id=Critical%20Accounting%20Estimates) [Recent Accounting Pronouncements](index=29&type=section&id=Recent%20Accounting%20Pronouncements) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a 'smaller reporting company,' Immunovant is exempt from detailed market risk disclosures - Immunovant, as a 'smaller reporting company,' is not required to provide detailed quantitative and qualitative disclosures about market risk[158](index=158&type=chunk) [Item 4. Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management evaluated disclosure controls and procedures as effective, with no material changes in internal control over financial reporting - Disclosure controls and procedures were evaluated as effective at a reasonable assurance level as of September 30, 2022[162](index=162&type=chunk) - No material changes in internal control over financial reporting occurred during the fiscal quarter ended September 30, 2022[163](index=163&type=chunk) - Management acknowledges that control systems provide only reasonable, not absolute, assurance and have inherent limitations[164](index=164&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in various lawsuits, including a securities class action, which it intends to vigorously defend - A putative securities class action complaint was filed against the company and certain officers in February 2021, alleging false and misleading statements regarding batoclimab's safety[82](index=82&type=chunk) - The company is vigorously defending the lawsuit and has not recorded a liability, as it cannot reasonably estimate possible losses or determine the probability of an unfavorable outcome[82](index=82&type=chunk) [Item 1A. Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) Significant risks include product development, regulatory approval, clinical trials, competition, third-party reliance, intellectual property, and financial position - The business is highly dependent on the successful development, regulatory approval, and commercialization of product candidates batoclimab and IMVT-1402, with no guarantee of market approval or commercial viability[169](index=169&type=chunk)[255](index=255&type=chunk)[256](index=256&type=chunk) - Product candidates may cause adverse events or undesirable side effects, such as the previously observed elevations in total cholesterol and LDL levels with batoclimab, which could delay or prevent regulatory approval or limit market acceptance[173](index=173&type=chunk)[175](index=175&type=chunk) - Clinical trials are expensive, time-consuming, difficult to design, and involve uncertain outcomes, with potential for delays due to patient enrollment, safety issues, or regulatory disagreements[180](index=180&type=chunk)[182](index=182&type=chunk)[185](index=185&type=chunk) - The company faces significant competition from other biotechnology and pharmaceutical companies in autoimmune disease indications, including other FcRn inhibitors and therapies with different mechanisms of action[209](index=209&type=chunk)[210](index=210&type=chunk)[211](index=211&type=chunk) - Immunovant expects to incur significant losses for the foreseeable future and has a limited operating history with no product revenue to date, requiring additional capital to fund operations[264](index=264&type=chunk)[267](index=267&type=chunk)[275](index=275&type=chunk) - Reliance on third parties for manufacturing and clinical trials poses risks, including production difficulties, quality issues, and compliance failures, which could delay development or commercialization[324](index=324&type=chunk)[325](index=325&type=chunk)[330](index=330&type=chunk)[331](index=331&type=chunk) - The company's ability to compete effectively depends on obtaining and maintaining broad patent protection for its product candidates, which is uncertain due to complex legal processes, potential challenges, and limited patent lifespans[338](index=338&type=chunk)[340](index=340&type=chunk)[346](index=346&type=chunk)[351](index=351&type=chunk) - Roivant Sciences Ltd. (RSL) owns a significant percentage of the company's common stock (**57.1%** as of October 28, 2022), allowing it to exert significant control over stockholder approval matters and potentially creating conflicts of interest[394](index=394&type=chunk)[396](index=396&type=chunk) [Risks Related to Development, Regulatory Approval and Commercialization](index=31&type=section&id=Risks%20Related%20to%20Development,%20Regulatory%20Approval%20and%20Commercialization) [Risks Related to Our Business, Financial Position and Capital Requirements](index=46&type=section&id=Risks%20Related%20to%20Our%20Business,%20Financial%20Position%20and%20Capital%20Requirements) [Risks Related to Our Dependence on Third Parties](index=55&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) [Risks Related to Our Intellectual Property](index=57&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) [General Risks Related to an Investment in Our Securities](index=80&type=section&id=General%20Risks%20Related%20to%20an%20Investment%20in%20Our%20Securities) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=86&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds to report for the period - No unregistered sales of equity securities or use of proceeds to report[422](index=422&type=chunk) [Item 3. Defaults Upon Senior Securities](index=86&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities during the reporting period - No defaults upon senior securities[423](index=423&type=chunk) [Item 4. Mine Safety Disclosures](index=86&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Mine Safety Disclosures are not applicable to Immunovant, Inc[423](index=423&type=chunk) [Item 5. Other Information](index=86&type=section&id=Item%205.%20Other%20Information) No other information to report for the period - No other information to report[423](index=423&type=chunk) [Item 6. Exhibits](index=87&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report, including corporate documents and certifications - The exhibits include key corporate documents such as the Share Exchange Agreement, Certificate of Incorporation, Bylaws, and certifications from the CEO and CFO[428](index=428&type=chunk) - Certifications under Section 302 of Sarbanes-Oxley Act are filed herewith, while those under Section 906 are deemed to accompany the report and are not 'filed' for Section 18 purposes[427](index=427&type=chunk)[428](index=428&type=chunk) [SIGNATURES](index=88&type=section&id=SIGNATURES) The report is duly signed by the Chief Executive Officer and Chief Financial Officer on November 4, 2022 - The report was signed by Peter Salzmann, M.D., Chief Executive Officer, and Eva Renee Barnett, Chief Financial Officer, on November 4, 2022[432](index=432&type=chunk)

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, 2022 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 incorporation o ...

Immunovant, Inc. (NASDAQ:IMVT) Q4 2022 Earnings Conference Call June 8, 2022 8:00 AM ET Company Participants Pete Salzmann - CEO Conference Call Participants Robyn Karnauskas - Truist Securities Derek Archila - Wells Fargo Thomas Smith - SVB Leerink Douglas Tsao - H.C. Wainwright Operator Good morning. My name is Melissa and I will serve as your conference call operator. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation [Operato ...

IMMUNOVANT | --- | --- | --- | --- | --- | |-------------------------------------------------------------|-------|-------|-------|-------| | | | | | | | Phase 3 Development for Batoclimab in Thyroid Eye Disease | | | | | | Investor Presentation June 8, 2022 | | | | | Forward-looking statements This presentation 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 ...