Immunovant, Inc. (IMVT) SEC Filing 10-K Annual Report for the fiscal year ending Friday, March 31, 2023

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Immunovant, Inc.

CIK: 1764013 Ticker: IMVT

Exhibit 99.1

Immunovant Provides Corporate Updates and Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2023

Investigational New Drug (IND) application and Clinical Trial Application (CTA) for IMVT-1402 cleared by the FDA and MEDSAFE, respectively

Phase 1 clinical trial in healthy subjects initiated in New Zealand

Phase 2 proof-of-concept clinical trial of batoclimab in Graves’ disease (GD) initiated in Germany

Global clinical trials of batoclimab are ongoing in myasthenia gravis (MG), thyroid eye disease (TED), and chronic inflammatory demyelinating polyneuropathy (CIDP)

NEW YORK, May 22, 2023 – Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported corporate updates and financial results for its fiscal fourth quarter and fiscal year ended March 31, 2023.

“During the past quarter, we made significant progress with IMVT-1402, including receiving the IND clearance by the FDA, and the initiation of a Phase 1 clinical trial following the approval by MEDSAFE to proceed,” said Pete Salzmann, M.D., chief executive officer at Immunovant. “This is an important step as we seek to expeditiously generate Phase 1 data and accelerate a global development program for IMVT-1402.”

Clinical Development Updates:
Immunovant received IND clearance for IMVT-1402 from the U.S. Food and Drug Administration (FDA) and initiated a Phase 1 clinical trial of IMVT-1402 in healthy volunteers in New Zealand after approval of the CTA by the regulatory authority, MEDSAFE. The clinical trial will evaluate the safety, tolerability and pharmacodynamic profiles of IMVT-1402, a subcutaneously administered, FcRn inhibitor. In the multiple ascending dose (MAD) portion of the study, Immunovant plans to evaluate subcutaneous doses of 300 mg and 600 mg, at a concentration of 150 mg/mL vs. placebo.

Initial data from single-ascending dose cohorts are expected in August/September 2023 and initial data from MAD cohorts are expected in October/November 2023. In a head-to-head, placebo-controlled nonclinical study, IMVT-1402 has been observed to achieve similarly deep IgG reduction as batoclimab and have minimal or no impact on levels of albumin and low-density lipoprotein cholesterol at doses well above the anticipated human effective dose. Immunovant believes this profile could be best in class.

A Phase 2 proof-of-concept clinical trial of batoclimab in GD was initiated in Germany, with initial results expected in the fourth quarter of calendar year 2023.

As previously disclosed, Immunovant expects to have initial results from period 1 of the Phase 2b clinical trial in CIDP in the first half of calendar year 2024 and expects to have top-line results from the Phase 3 MG clinical trial and the Phase 3 TED program in the second half of calendar year 2024 and the first half of calendar year 2025, respectively.

The following information was filed by Immunovant, Inc. (IMVT) on Monday, May 22, 2023 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
Consolidated Balance Sheets
Consolidated Balance Sheets (Parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Comprehensive Loss
Consolidated Statements Of Operations
Consolidated Statements Of Stockholders' Equity
Accrued Expenses
Accrued Expenses (Details)
Accrued Expenses (Tables)
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 (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: 0001764013-23-000065
Submitted to the SEC: Mon May 22 2023 7:10:20 AM EST
Accepted by the SEC: Mon May 22 2023
Period: Friday, March 31, 2023
Industry: Blank Checks

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