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Immunovant, Inc. (IMVT) SEC Filing 10-K Annual Report for the fiscal year ending Thursday, March 31, 2022

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Immunovant, Inc.

CIK: 1764013 Ticker: IMVT

Exhibit 99.1

Immunovant Achieves Alignment with FDA on Plans for Phase 3 Clinical Trials of Batoclimab in Thyroid Eye Disease and Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2022

Immunovant plans to initiate two placebo-controlled Phase 3 clinical trials of batoclimab in thyroid eye disease (TED) in the second half of calendar year 2022 with top-line data expected for both in the first half of calendar year 2025
Immunovant estimates annual addressable U.S. TED population for a new mechanism of action to be 8,000-18,000 patients
Immunovant on track to initiate pivotal Phase 3 clinical trial of batoclimab in myasthenia gravis (MG), by the end of June 2022
Cash balance of $494 million as of March 31, 2022 expected to provide cash runway into calendar year 2025

NEW YORK, June 8, 2022 (GLOBE NEWSWIRE) – Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for people with autoimmune diseases, today announced that it has achieved alignment with the United States Food and Drug Administration (FDA) Division of Ophthalmology on plans to initiate two placebo-controlled Phase 3 clinical trials to evaluate batoclimab in TED. Immunovant expects to initiate its Phase 3 TED program in the second half of calendar year 2022.

“TED represents a unique opportunity with meaningful unmet need despite recent therapeutic innovation. As a heterogeneous disease with varied symptom presentation, we believe this indication lends itself well to new mechanistic approaches,” said Pete Salzmann, M.D., Chief Executive Officer of Immunovant. “In our TED Phase 2 program, we observed batoclimab’s potential to provide deep reductions of stimulating anti-TSHR autoantibodies and we are enthusiastic about the potential of this first-in-class program in TED,” continued Dr. Salzmann.

Immunovant’s Phase 3 development program for TED will include two placebo-controlled trials (run in-parallel) followed by an open label extension that will enroll subjects from both Phase 3 studies. The Phase 3 trials will have the same design and are expected to enroll about 100 subjects for each trial. After randomization to either treatment or placebo, the standard 24-week treatment period will include 12 weeks of 680 mg of batoclimab followed by 12 weeks of 340 mg of batoclimab. Batoclimab and placebo will be delivered weekly by a simple subcutaneous injection. The primary efficacy endpoint will be a responder analysis versus placebo, where responders are defined as patients with a ≥ 2 mm reduction from baseline in proptosis.

If successful, Immunovant believes these trials can support registration of batoclimab for TED. Top-line results from both trials are expected in the first half of calendar year 2025. Additional details of Immunovant’s clinical program in TED will be presented in an investor call described below.

Immunovant’s upcoming Phase 3 TED trials represent the Company’s second pivotal program, with a Phase 3 pivotal trial in MG expected to initiate by the end of June 2022, and a top-line readout expected in the second half of calendar year 2024. The Company continues to make meaningful progress on additional strategic priorities for batoclimab’s broad development and expects to announce two new indications by August 2022.




The following information was filed by Immunovant, Inc. (IMVT) on Wednesday, June 8, 2022 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Immunovant, Inc.'s 10-K Annual Report:

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Audit Information
Cover
Consolidated Balance Sheets
Consolidated Balance Sheets (Parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Comprehensive Loss
Consolidated Statements Of Operations
Consolidated Statements Of Operations (Parenthetical)
Consolidated Statements Of Stockholders' Equity
Accrued Expenses
Accrued Expenses (Tables)
Accrued Expenses - Accrued Expenses (Details)
Commitments And Contingencies
Commitments And Contingencies (Details)
Income Taxes
Income Taxes (Tables)
Income Taxes - Additional Information (Details)
Income Taxes - Loss Before Income Taxes And The Related Tax (Benefit) Provision (Details)
Income Taxes - Reconciliation Of The Benefit For Income Taxes (Details)
Income Taxes - Significant Components Of The Deferred Tax Assets (Liabilities) (Details)
Leases
Leases (Tables)
Leases - Additional Information (Details)
Leases - Schedule Of Remaining Undiscounted Contractual Rent Obligations (Details)
Material Agreements
Material Agreements (Details)
Organization And Nature Of Business
Organization And Nature Of Business (Details)
Related Party Transactions
Related Party Transactions (Details)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Additional Information (Details)
Stock-Based Compensation - Fair Value Of Weighted-Average Assumptions (Details)
Stock-Based Compensation - Restricted Stock Unit Awards Activity (Details)
Stock-Based Compensation - Stock Option Activity (Details)
Stock-Based Compensation - Stock-Based Compensation Expense (Details)
Stockholders' Equity
Stockholders' Equity (Tables)
Stockholders' Equity - Additional Information (Details)
Stockholders' Equity - Common Stock Reserved For Future Issuance (Details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies (Tables)
Summary Of Significant Accounting Policies - Additional Information (Details)
Summary Of Significant Accounting Policies - Dilutive Securities Have Been Excluded From The Calculation Of Diluted Net Loss Per Common Share Due To Their Anti-Dilutive Effect (Details)
Ticker: IMVT
CIK: 1764013
Form Type: 10-K Annual Report
Accession Number: 0001764013-22-000059
Submitted to the SEC: Wed Jun 08 2022 7:09:32 AM EST
Accepted by the SEC: Wed Jun 08 2022
Period: Thursday, March 31, 2022
Industry: Blank Checks

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