Immunovant(IMVT) - 2026 Q1 - Quarterly Report

PART I. FINANCIAL INFORMATION This section provides a comprehensive overview of the company's financial performance and position Item 1. Financial Statements (unaudited) This section presents the unaudited condensed consolidated financial statements of Immunovant, Inc. for the quarter ended June 30, 2025, including balance sheets, statements of operations, comprehensive loss, stockholders' equity, and cash flows, along with detailed notes explaining the company's business, accounting policies, material agreements, and financial position Condensed Consolidated Balance Sheets This section provides a snapshot of the company's financial position, detailing assets, liabilities, and stockholders' equity at specific dates Condensed Consolidated Balance Sheets (in thousands) | Item | June 30, 2025 | March 31, 2025 | | :---------------------------------- | :-------------- | :--------------- | | Assets: | | | | Cash and cash equivalents | $598,912 | $713,971 | | Total current assets | $651,763 | $767,760 | | Total assets | $661,440 | $776,222 | | Liabilities and Stockholders' Equity: | | | | Total current liabilities | $52,900 | $68,775 | | Total liabilities | $52,900 | $68,775 | | Total stockholders' equity | $608,540 | $707,447 | | Total liabilities and stockholders' equity | $661,440 | $776,222 | - Cash and cash equivalents decreased by $115.059 million from March 31, 2025, to June 30, 2025[12][23] - Total stockholders' equity decreased by $98.907 million from March 31, 2025, to June 30, 2025[12] Condensed Consolidated Statements of Operations This section presents the company's revenues, expenses, and net loss over specific reporting periods Condensed Consolidated Statements of Operations (in thousands, except per share data) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :------------------------------------------ | :------------------------------- | :------------------------------- | | Research and development expenses | $101,200 | $75,473 | | General and administrative expenses | $26,024 | $18,808 | | Total operating expenses | $127,224 | $94,281 | | Interest income, net | $(6,337) | $(7,180) | | Other income, net | $(1,187) | $(28) | | Loss before provision for income taxes | $(119,700) | $(87,073) | | Provision for income taxes | $913 | $77 | | Net loss | $(120,613) | $(87,150) | | Net loss per common share – basic and diluted | $(0.71) | $(0.60) | | Weighted-average common shares outstanding | 170,872,994 | 146,085,729 | - Net loss increased by $33.463 million (38.4%) from $87.150 million in Q2 2024 to $120.613 million in Q2 2025[15] - Research and development expenses increased by $25.727 million (34.1%) year-over-year[15] Condensed Consolidated Statements of Comprehensive Loss This section details the company's net loss and other comprehensive income or loss components Condensed Consolidated Statements of Comprehensive Loss (in thousands) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | | Net loss | $(120,613) | $(87,150) | | Foreign currency translation adjustments | $278 | $(88) | | Total other comprehensive income (loss) | $278 | $(88) | | Comprehensive loss | $(120,335) | $(87,238) | - Comprehensive loss increased by $33.097 million (37.9%) from $87.238 million in Q2 2024 to $120.335 million in Q2 2025[18] - Foreign currency translation adjustments resulted in income of $278 thousand in Q2 2025, compared to a loss of $88 thousand in Q2 2024[18] Condensed Consolidated Statements of Stockholders' Equity This section outlines changes in the company's equity accounts, including common stock, additional paid-in capital, and accumulated deficit Condensed Consolidated Statements of Stockholders' Equity (in thousands, except share data) | Item | Balance at March 31, 2025 | Stock options exercised and RSUs vested | Capital contribution – stock-based compensation | Stock-based compensation | Foreign currency translation adjustments | Net loss | Balance at June 30, 2025 | | :------------------------------------------ | :------------------------ | :-------------------------------------- | :-------------------------------------------- | :----------------------- | :--------------------------------------- | :--------- | :----------------------- | | Common stock (shares) | 170,111,593 | 957,583 | — | — | — | — | 171,069,176 | | Common stock (amount) | $16 | $0 | $0 | $0 | $0 | $0 | $16 | | Additional paid-in capital | $1,945,495 | $2,918 | $115 | $18,395 | $0 | $0 | $1,966,923 | | Accumulated other comprehensive income | $1,459 | $0 | $0 | $0 | $278 | $0 | $1,737 | | Accumulated deficit | $(1,239,523) | $0 | $0 | $0 | $0 | $(120,613) | $(1,360,136) | | Total stockholders' equity | $707,447 | $2,918 | $115 | $18,395 | $278 | $(120,613) | $608,540 | - Total stockholders' equity decreased by $98.907 million from $707.447 million at March 31, 2025, to $608.540 million at June 30, 2025, primarily due to the net loss[20] - Stock-based compensation contributed $18.395 million to additional paid-in capital during the three months ended June 30, 2025[20] Condensed Consolidated Statements of Cash Flows This section summarizes the cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows (in thousands) | Activity | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(117,411) | $(76,199) | | Net cash used in investing activities | $0 | $(182) | | Net cash provided by financing activities | $2,918 | $686 | | Effect of exchange rate changes on cash and cash equivalents | $(566) | $335 | | Net change in cash and cash equivalents | $(115,059) | $(75,360) | | Cash and cash equivalents – beginning of period | $713,971 | $635,365 | | Cash and cash equivalents – end of period | $598,912 | $560,005 | - Net cash used in operating activities increased by $41.212 million (54.1%) to $117.411 million in Q2 2025, compared to $76.199 million in Q2 2024[23] - Net cash provided by financing activities increased by $2.232 million (325.4%) to $2.918 million in Q2 2025, primarily from stock options exercised[23] Notes to Condensed Consolidated Financial Statements This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements Note 1 — Description of Business and Liquidity This note describes the company's business, product candidates, and current liquidity position - Immunovant is a clinical-stage immunology company developing IMVT-1402 and batoclimab, novel FcRn-targeting monoclonal antibodies for autoimmune diseases[26] Liquidity and Financial Position (as of June 30, 2025) | Metric | Amount (in thousands) | | :------------------------- | :-------------------- | | Cash and cash equivalents | $598,912 | | Accumulated deficit | $(1,360,136) | - The company has not generated any revenue to date and expects to incur additional losses, requiring future capital raises through equity, debt, or collaborations[28][29] Note 2 — Summary of Significant Accounting Policies This note outlines the key accounting principles and methods applied in the financial statements - Financial statements are unaudited, prepared in accordance with U.S. GAAP for interim reporting, and include all normal and recurring adjustments. The fiscal year ends March 31[30][31] - Key estimates and assumptions are made for assets, liabilities, stock-based compensation, litigation, clinical trial accruals, R&D costs, and income taxes, with actual results potentially differing[32] - Research and development costs are expensed as incurred, including employee-related costs and third-party expenses for clinical trial activities and manufacturing. Cost-sharing arrangements reduce R&D expenses[37][38] Potentially Dilutive Securities Excluded from EPS Calculation (as of June 30) | Security Type | 2025 | 2024 | | :-------------------------- | :----------- | :----------- | | Preferred stock as converted | 10,000 | 10,000 | | Stock options | 14,776,873 | 14,031,041 | | Restricted stock units | 4,723,316 | 4,016,235 | | Total | 19,510,189 | 18,057,276 | Note 3 — Material Agreements This note details the company's significant contractual agreements, including licensing and manufacturing - Immunovant holds exclusive, royalty-bearing rights to develop, import, use, and commercialize batoclimab and IMVT-1402 in the Licensed Territory through an assignment of the HanAll Agreement[47][49] HanAll Agreement Financials (as of June 30, 2025) | Item | Amount | | :------------------------------------------------ | :------------- | | Upfront payment | $30.0 million | | Shared R&D costs (expired) | Up to $20.0 million | | Milestone payments (aggregate paid) | $32.5 million | | Milestone payments (aggregate remaining potential) | Up to $420.0 million | | Royalties | Mid-single digits to mid-teens % of net sales | Samsung Biologics Product Service Agreement Minimum Purchase Commitment (as of June 30, 2025) | Fiscal Year Ending March 31 | Amount (in millions) | | :---------------------------- | :------------------- | | Remainder of FY2026 | $5.0 | | FY2028 | $10.1 | | FY2029 | $14.0 | | FY2030 | $14.0 | | Total Remaining Commitment | $43.1 | Note 4 — Accrued Expenses and Other Current Liabilities This note provides a breakdown of the company's accrued expenses and other short-term liabilities Accrued Expenses and Other Current Liabilities (in thousands) | Item | June 30, 2025 | March 31, 2025 | | :---------------------------------- | :-------------- | :--------------- | | Research and development expenses | $35,444 | $32,622 | | Accrued bonuses | $4,909 | $15,618 | | Legal and other professional fees | $794 | $789 | | Employee severance | $1,072 | $263 | | Due to Roivant Sciences Ltd. | $862 | $273 | | Other expenses | $1,976 | $1,554 | | Total current liabilities | $45,057 | $51,119 | - Total accrued expenses and other current liabilities decreased by $6.062 million (11.86%) from March 31, 2025, to June 30, 2025, primarily driven by a $10.709 million decrease in accrued bonuses[52] Note 5 — Related Party Transactions This note discloses transactions and agreements with related parties, including affiliates - Expenses incurred under Services Agreements with RSI and RSG increased from $0.1 million for the three months ended June 30, 2024, to $0.8 million for the same period in 2025[54] - The Cooperation Agreement with RSL outlines information sharing and reporting obligations, and indemnification, but no financial transactions have occurred under this agreement[55] Note 6 — Income Taxes This note explains the company's income tax provision, effective tax rate, and deferred tax assets/liabilities Effective Tax Rates (Three Months Ended June 30) | Period | Effective Tax Rate | | :---------------------- | :----------------- | | June 30, 2025 | (0.76)% | | June 30, 2024 | (0.09)% | - The effective tax rate is primarily driven by jurisdictional earnings and a valuation allowance that eliminates global net deferred tax assets[57][58] - The company is evaluating the impact of the One Big Beautiful Bill Act (OBBBA), signed into law on July 4, 2025, which includes broad tax reform provisions[59] Note 7 — Stockholders' Equity This note details the components of stockholders' equity, including common stock and preferred stock - 10,000 shares of Series A preferred stock are outstanding, held by RSL, and will automatically convert to common stock if RSL holds less than 25% of total voting power[60][61] Common Stock Shares Issued and Outstanding | Date | Shares Issued and Outstanding | | :---------------- | :---------------------------- | | June 30, 2025 | 171,069,176 | | March 31, 2025 | 170,111,593 | Shares of Common Stock Reserved for Issuance | Item | June 30, 2025 | March 31, 2025 | | :-------------------------------- | :-------------- | :--------------- | | Conversion of Series A preferred stock | 10,000 | 10,000 | | Stock options outstanding | 14,783,964 | 12,963,834 | | Restricted stock units outstanding | 5,507,546 | 4,043,674 | | Equity awards available for future grants | 8,589,913 | 6,027,035 | | Total | 28,891,423 | 23,044,543 | Note 8 — Stock-Based Compensation This note describes the company's equity incentive plans and the expense recognized for stock-based awards - The 2019 Equity Incentive Plan automatically increased by 6,804,463 shares on April 1, 2025, and as of June 30, 2025, 8,589,913 shares remained available for future grants[65] Stock Option Activity Summary (Three Months Ended June 30, 2025) | Item | Number of Stock Options | Weighted Average Exercise Price | | :-------------------------- | :---------------------- | :------------------------------ | | Balance - March 31, 2025 | 12,963,834 | $12.00 | | Granted | 2,838,551 | $15.28 | | Exercised | (433,635) | $6.97 | | Forfeited | (584,983) | $16.40 | | Expired | (6,894) | $24.88 | | Balance - June 30, 2025 | 14,776,873 | $12.62 | Stock-based Compensation Expense (in thousands) | Expense Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | | Research and development expenses | $7,865 | $7,185 | | General and administrative expenses | $10,530 | $6,258 | | Total stock-based compensation | $18,395 | $13,443 | - Total unrecognized compensation expense for nonvested stock options and RSUs was $61.3 million and $79.6 million, respectively, as of June 30, 2025, to be recognized over approximately 2.79 to 2.92 years[70] Note 9 — Segment Information This note provides information about the company's operating segments and how performance is managed - Immunovant operates in a single operating segment encompassing all activities related to the research, development, and manufacturing of its product candidates[43][72] Significant Segment Expenses (in thousands) for Three Months Ended June 30 | Expense Category | 2025 | 2024 | | :------------------------------------------ | :------- | :------- | | Endocrine diseases R&D | $19,329 | $15,913 | | Neurological diseases R&D | $20,937 | $18,479 | | Rheumatology diseases R&D | $8,209 | $0 | | Dermatology diseases R&D | $5,145 | $0 | | Other clinical and nonclinical R&D | $2,392 | $6,401 | | Other unallocated R&D | $10,685 | $10,160 | | Personnel-related R&D | $34,503 | $24,520 | | Personnel-related G&A | $17,832 | $10,696 | | Other G&A | $8,192 | $8,112 | | Interest income, net | $(6,337) | $(7,180) | | Other segment items | $(274) | $49 | | Net loss | $120,613 | $87,150 | Note 10 — Commitments and Contingencies This note discloses the company's material commitments and potential contingent liabilities - As of June 30, 2025, the company was not party to any material legal proceedings and had no recorded contingent liabilities[75] Samsung Biologics Minimum Purchase Obligation (as of June 30, 2025) | Fiscal Year Ending March 31 | Amount (in millions) | | :---------------------------- | :------------------- | | Remainder of FY2026 | $5.0 | | FY2028 | $10.1 | | FY2029 | $14.0 | | FY2030 | $14.0 | | Total Remaining Obligation | $43.1 | - Macroeconomic and geopolitical factors, including inflation, interest rates, trade policies, and conflicts, could impact the company's future operational and financial performance, especially clinical trial plans and timelines[78] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section analyzes the company's financial condition, results of operations, and liquidity, highlighting key business developments Overview This section introduces the company's business, strategic focus, and key product candidates - Immunovant is a clinical-stage immunology company developing IMVT-1402, a potentially best-in-class FcRn inhibitor, for autoimmune diseases driven by pathogenic IgG antibodies[82] - IMVT-1402 demonstrated deep, dose-dependent IgG reductions in Phase 1, with 600 mg weekly dosing expected to achieve approximately 80% IgG reduction, offering potentially best-in-class efficacy[84][85] - IMVT-1402 showed no or minimal reductions in albumin and no or minimal increases in LDL cholesterol, which are off-target effects observed with some other anti-FcRn antibodies[85] - The company has initiated studies in six indications for IMVT-1402, including potentially registrational trials in GD, D2T RA, MG, CIDP, SjD, and a proof-of-concept trial in CLE, all using the YpsoMate® autoinjector[86] Recent Developments in Our Clinical Programs This section highlights recent progress and milestones in the company's clinical development pipeline Endocrine Diseases This section provides updates on clinical programs targeting endocrine diseases - Two potentially registrational trials for IMVT-1402 in adults with Graves' Disease (GD) were initiated in December 2024 and June 2025, with top-line results expected in 2027[88] - A Phase 2 proof-of-concept trial of batoclimab for uncontrolled GD is ongoing, with additional data, including remission data, expected at the American Thyroid Association (ATA) Annual Meeting in September 2025[89] - Top-line results from the Phase 3 clinical program evaluating batoclimab for active moderate-to-severe Thyroid Eye Disease (TED) are planned for the second half of calendar year 2025[90] Neurological Diseases This section provides updates on clinical programs targeting neurological diseases - A potentially registrational trial for IMVT-1402 in adults with Myasthenia Gravis (MG) was initiated in March 2025, with top-line results expected in 2027[92] - A potentially registrational trial for IMVT-1402 in adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) was initiated in March 2025, with top-line results expected in 2028[93] - The company is leveraging data and learnings from prior batoclimab MG and CIDP studies to inform and accelerate IMVT-1402 programs[91] Rheumatology Diseases This section provides updates on clinical programs targeting rheumatology diseases - A potentially registrational trial for IMVT-1402 in ACPA-positive difficult-to-treat rheumatoid arthritis (D2T RA) was initiated in December 2024, with initial results from the open-label portion expected in 2026[94] - A potentially registrational trial for IMVT-1402 in Sjögren's disease (SjD) was initiated in June 2025, with top-line results expected in 2028[95] Dermatology Diseases This section provides updates on clinical programs targeting dermatology diseases - A proof-of-concept trial evaluating IMVT-1402 in cutaneous lupus erythematosus (CLE) was initiated in February 2025, with top-line results expected in 2026[96] Macroeconomic Considerations This section discusses potential impacts of broader economic and geopolitical factors on the company's business - Unfavorable macroeconomic events, such as changes in inflation, interest rates, international trade policies, and geopolitical tensions (e.g., Russia-Ukraine war, Middle East conflict), may negatively affect business growth and results of operations[97] - The impact of these uncertainties on financial estimates and clinical trial plans, including enrollment and timelines, is uncertain and cannot be fully predicted[78][97] Our Key Agreements This section references the company's significant contractual agreements, including licensing and manufacturing deals - Key agreements include the License Agreement with HanAll for IMVT-1402 and batoclimab, and the Product Service Agreement with Samsung Biologics for batoclimab manufacturing[99][100] - Related party transactions are detailed in Note 5 of the financial statements[101] Financial Operations Overview This section provides a high-level summary of the company's financial performance and operational drivers Revenue This section discusses the company's revenue recognition policies and current revenue status - The company has not generated any revenue since inception and does not expect to until regulatory approval and commercialization of its product candidates[102] - Profitability is entirely dependent on the successful development and commercialization of IMVT-1402, batoclimab, or future product candidates[102] Research and Development Expenses This section details the components and trends of the company's research and development expenditures - R&D expenses primarily consist of therapeutic area-specific costs (direct third-party costs, contract manufacturing) and unallocated costs (personnel-related, stock-based compensation, services agreements, other expenses)[103][104][106] - The company expects R&D expenses to continue increasing due to ongoing IMVT-1402 trials (GD, D2T RA, MG, CIDP, SjD, CLE), batoclimab trials (TED, GD), manufacturing, and regulatory preparations[105] - The duration, costs, and timing of clinical trials are subject to various factors, including the number of trials, per-patient costs, patient enrollment, regulatory requirements, and manufacturing costs[107][112] General and Administrative Expenses This section outlines the components and trends of the company's general and administrative expenditures - G&A expenses include employee salaries, benefits, stock-based compensation for G&A personnel, legal and accounting fees, consulting services, and costs allocated under Services Agreements[109] - G&A expenses are expected to increase to support R&D activities, patent-related costs, and potentially market research and commercial team building if product candidates receive regulatory approval[110] Results of Operations This section analyzes the company's financial results for the reporting period, focusing on key income statement items Condensed Consolidated Statements of Operations (in thousands) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change | | :-------------------------------- | :------------------------------- | :------------------------------- | :------- | | Research and development | $101,200 | $75,473 | $25,727 | | General and administrative | $26,024 | $18,808 | $7,216 | | Total operating expenses | $127,224 | $94,281 | $32,943 | | Interest income, net | $(6,337) | $(7,180) | $843 | | Other income, net | $(1,187) | $(28) | $(1,159) | | Loss before provision for income taxes | $(119,700) | $(87,073) | $(32,627) | | Provision for income taxes | $913 | $77 | $836 | | Net loss | $(120,613) | $(87,150) | $(33,463) | - Net loss increased by $33.5 million (38.4%) from $87.2 million in Q2 2024 to $120.6 million in Q2 2025[15][111] - Total operating expenses increased by $32.9 million (34.9%) to $127.2 million in Q2 2025, primarily due to higher R&D and G&A expenses[15][111] Research and Development Expenses This section details the company's investments in research and development activities for its product candidates Research and Development Expenses (in thousands) | Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change | | :------------------------------------------ | :------------------------------- | :------------------------------- | :------- | | Therapeutic area-specific costs | $56,012 | $40,793 | $15,219 | | Unallocated costs (Personnel-related) | $34,503 | $24,520 | $9,983 | | Unallocated costs (Other) | $10,685 | $10,160 | $525 | | Total research and development expenses | $101,200 | $75,473 | $25,727 | - R&D expenses increased by $25.7 million (34.1%) year-over-year, primarily due to new IMVT-1402 registrational trials in rheumatology ($8.2 million) and dermatology ($5.1 million) diseases[114][115] - Unallocated R&D costs increased by $10.5 million, mainly due to a $10.0 million rise in personnel-related expenses driven by higher headcount for increased clinical trials[116] General and Administrative Expenses This section outlines the company's administrative and overhead costs supporting its operations General and Administrative Expenses (in thousands) | Period | General and Administrative Expenses | | :------------------------------- | :---------------------------------- | | Three Months Ended June 30, 2025 | $26,024 | | Three Months Ended June 30, 2024 | $18,808 | | Change | $7,216 | - The $7.2 million increase in G&A expenses was primarily due to higher personnel-related expenses, including a one-time stock-based compensation charge related to the former CEO's retirement[117] Interest Income, net This section reports the company's net interest income or expense from its cash and investments Interest Income, net (in thousands) | Period | Interest Income, net | | :------------------------------- | :------------------- | | Three Months Ended June 30, 2025 | $(6,337) | | Three Months Ended June 30, 2024 | $(7,180) | | Change | $843 | - Interest income decreased by $0.8 million, primarily reflecting lower average interest rates, partially offset by higher average money market fund balances[118] Liquidity and Capital Resources This section assesses the company's cash position, funding sources, and future capital requirements Sources of Liquidity This section describes how the company obtains and manages its cash and capital resources Cash and Cash Equivalents (in millions) | Date | Amount | | :--------------- | :----- | | June 30, 2025 | $598.9 | | March 31, 2025 | $714.0 | - The company has incurred significant operating losses and negative cash flows, with net losses of $120.6 million and $87.2 million for the three months ended June 30, 2025 and 2024, respectively[120] - Future cash needs are expected to be financed through equity offerings, debt financings, and potential collaboration or license agreements, as the company has no committed external source of funds[121][122] - The company has an automatic shelf registration statement for up to $150.0 million in ATM Shares but has not yet issued or sold any[123] Cash Flows This section analyzes the company's cash inflows and outflows from operating, investing, and financing activities Summary of Cash Flows (in thousands) | Activity | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(117,411) | $(76,199) | | Net cash used in investing activities | $0 | $(182) | | Net cash provided by financing activities | $2,918 | $686 | - Net cash used in operating activities increased to $117.4 million in Q2 2025 from $76.2 million in Q2 2024, primarily due to a higher net loss and changes in operating assets and liabilities[126][127] - Cash provided by financing activities increased to $2.9 million in Q2 2025 from $0.7 million in Q2 2024, driven by proceeds from stock options exercised[129] Material Cash Requirements This section identifies significant future cash obligations and commitments Samsung Biologics Minimum Purchase Obligation (as of June 30, 2025) | Fiscal Year Ending March 31 | Amount (in millions) | | :---------------------------- | :------------------- | | Remainder of FY2026 | $5.0 | | FY2028 | $10.1 | | FY2029 | $14.0 | | FY2030 | $14.0 | | Total Remaining Obligation | $43.1 | - Potential future milestone payments under the HanAll Agreement could reach an aggregate maximum of $420.0 million, contingent upon regulatory and sales milestones[133] - Future capital requirements are expected to increase significantly to fund clinical development, launch new trials, increase manufacturing, achieve milestones, expand intellectual property, hire personnel, and build commercial infrastructure[136][137] Outlook This section provides the company's forward-looking perspective on its financial position and operations - Existing cash and cash equivalents of $598.9 million as of June 30, 2025, are expected to fund operating expenses and capital expenditures for announced indications through the GD readout expected in 2027[134] - Current funds are insufficient to complete all necessary development and commercially launch IMVT-1402 or batoclimab, and the company anticipates incurring net losses for the foreseeable future[136] Critical Accounting Estimates This section explains the significant accounting estimates and judgments used in preparing the financial statements - The preparation of financial statements requires subjective estimates and judgments about uncertain matters that materially impact financial condition and results of operations[138] - No material changes to critical accounting estimates were made during the three months ended June 30, 2025, compared to the prior Annual Report[139] Recent Accounting Pronouncements This section discusses the impact of newly issued accounting standards on the company's financial reporting - ASU 2023-09 (Income Taxes) requires disaggregated information on effective rate reconciliation and income taxes paid by jurisdiction, effective for fiscal years beginning after December 15, 2024[44] - ASU 2024-03 (Expense Disaggregation) requires disclosures about specific types of expenses on the income statement, effective for fiscal years beginning after December 15, 2026[45] - Other recent guidance is not expected to have a material impact on the financial statements[46] Item 3. Quantitative and Qualitative Disclosures About Market Risk This section details the company's exposure to market risks, primarily interest rate fluctuations, and their potential financial impact - Primary market risk is interest income volatility, but a hypothetical 10% change in interest rates would not materially affect liquidity due to investments in high-quality, short-term U.S. government securities[142] - The company is not currently exposed to significant foreign currency exchange rate risk, as most operations and expenses are U.S. dollar-denominated[143] - Inflation has not had a material effect on the company's business, financial condition, or results of operations as of June 30, 2025[144] Item 4. Controls and Procedures This section assesses the effectiveness of the company's disclosure controls and internal control over financial reporting - Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of June 30, 2025, at the reasonable assurance level[147] - No material changes in internal control over financial reporting occurred during the fiscal quarter ended June 30, 2025[148] - Control systems provide only reasonable, not absolute, assurance that objectives are met, acknowledging inherent limitations and resource constraints[149] PART II. OTHER INFORMATION This section presents additional disclosures not covered in the financial statements, including legal, risk, and equity matters Item 1. Legal Proceedings This section outlines any material legal or regulatory proceedings affecting the company's business or financial condition - The company does not currently expect any legal or regulatory proceedings to have a material adverse effect on its business, operating results, or financial condition[150] - Further details on legal proceedings are provided in Note 10 – Commitments and Contingencies[151] Item 1A. Risk Factors This section identifies and discusses significant risks that could materially impact the company's business, operations, and financial results - The company's business involves a high degree of risk, and risk factors have not materially changed from the Annual Report, except as noted[152] - Reliance on the HanAll Agreement for core intellectual property rights to IMVT-1402 and batoclimab is a critical risk; termination or loss of rights would adversely affect development and commercialization[153][156][157] - Potential disputes with HanAll regarding batoclimab development or commercialization plans could be expensive, time-consuming, and materially impact the business[155] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section reports on any unregistered sales of equity securities and the use of proceeds during the period - None[158] Item 3. Defaults Upon Senior Securities This section discloses any defaults on senior securities during the reporting period - None[159] Item 4. Mine Safety Disclosures This section provides mine safety disclosures, if applicable to the company's operations - Not applicable[160] Item 5. Other Information This section includes any other material information not specifically covered in other items - No directors or Section 16 reporting officers adopted, modified, or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter ended June 30, 2025[161] Item 6. Exhibits This section lists all documents filed as exhibits to the report, including agreements and certifications - The exhibits include the Share Exchange Agreement, Amended and Restated Certificate of Incorporation and Bylaws, employment and separation agreements for key personnel, and equity incentive plan documents[162] - Certifications from the Chief Executive Officer and Chief Financial Officer pursuant to the Securities Exchange Act and Sarbanes-Oxley Act are included[162] SIGNATURES This section contains the official signatures certifying the accuracy and submission of the report - The report was signed by Eric Venker, M.D., Pharm.D., Chief Executive Officer, and Tiago Girao, Chief Financial Officer, on August 11, 2025[168]