Immunovant, Inc. (IMVT) 10K Annual Reports & 10Q SEC Filings

•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:

IMVT-1402:

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.

Batoclimab:

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 - Expense Highlight
The change in our operating assets and liabilities was primarily due to a decrease of $17.1 million in accounts payable driven by the timing of payments related to contract manufacturing costs.

Financial - Expense Highlight
The change in operating assets and liabilities also reflected $2.1 million of lower prepaid expenses and other current assets, driven by the timing of payments related to clinical research and contract manufacturing activities.
Financial - Expense Highlight
Our research and development expenses are expected to continue to increase over the next several years as we hire personnel and our compensation costs increase, commence additional clinical trials for batoclimab, increase manufacturing of batoclimab and IMVT-1402 substance and prepare to seek regulatory approval for our product candidates.
Financial - Expense Highlight
Unallocated costs include: personnel-related expenses for research and development personnel, which includes employee-related expenses such as salaries, benefits and other staff-related costs; stock-based compensation expenses for research and development personnel; costs allocated to us under our services agreements with RSI and RSG (the "Services Agreements"); and other expenses, which include the cost of consultants who assist with our research and development and costs related to contract manufacturing, but are not allocated to a specific program.
Financial - Expense Highlight
We expect to continue to incur significant expenses and increasing operating losses at least for the next several years.
Revenue - Product
As of March 31, 2023,...Read more
Other - Other
Under the HanAll Agreement, the...Read more
Revenue - Geography
For example, macroeconomic events, including...Read more
Financial - Expense
Research and development expenses include...Read more
Financial - Expense
We accrue costs for clinical...Read more
Financial - Expense
The change in our operating...Read more
Other - Other
While our significant accounting policies...Read more
Other - Other
In addition, either party may...Read more
Financial - Expense
We expect our research and...Read more
Revenue - Product
Product Service Agreement and Master...Read more
Financial - Expense
Research and development expenses increased...Read more
Other - Other
There are certain contracts wherein...Read more
Revenue - Product
We agreed to pay SVB...Read more
Financial - Shares
In October 2022, we completed...Read more
Revenue - Product
If we raise additional funds...Read more
Financial - Expense
As of March 31, 2022,...Read more
Financial - Expense
As of March 31, 2023,...Read more
Other - Other
Importantly, based on the anticipated...Read more
Financial - Expense
This increase reflected $19.1 million...Read more
Financial - Expense
These changes were partially offset...Read more
Financial - Expense
General and Administrative Expenses General...Read more
Financial - Expense
Upon such termination of the...Read more
Financial - Expense
We are obligated to reimburse...Read more
Revenue - Product
Upon execution of the PSA,...Read more
Financial - Expense
This increase reflected higher personnel-related...Read more
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It is not possible to...Read more

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Material Contracts, Statements, Certifications & more

Immunovant, Inc. provided additional information to their SEC Filing as exhibits

Exhibit 10.24: Material Contract

Exhibit 23.1: Consents Of Experts And Counsel

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Exhibit 32.2: Section 1350 Certification

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