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EX-99.1

2 exhibit9912026520.htm

EX-99.1

Document

Exhibit 99.1

Immunovant Provides Corporate Updates and Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2026

•IMVT-1402 showed clinically meaningful response rates of 72.7% ACR20, 54.5% ACR50 and 35.8% ACR70 at Week 16 in the open label period of its trial in difficult-to-treat rheumatoid arthritis (D2T RA); Immunovant will provide further updates on this program in the second half of calendar year 2026

•IMVT-1402 proof-of-concept trial in cutaneous lupus erythematosus (CLE) fully enrolled with topline data expected in the second half of calendar year 2026

•All other clinical development timelines remain on track for IMVT-1402, including potentially registrational studies in Graves’ disease (GD), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP) and Sjögren’s disease (SjD)

•Current cash balance provides runway to the potential launch of IMVT-1402 in GD

•Roivant will host a live conference call and webcast at 8:00 a.m. ET on Wednesday, May 20, 2026, to discuss these updates

DURHAM, N.C. May 20, 2026– 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 fourth quarter and fiscal year ended March 31, 2026.

Recent Highlights and Upcoming Milestones:

The Company announced preliminary Week 16 (end of Period 1) results from the IMVT-1402 trial in D2T RA with ACR20, ACR50, and ACR70 response rates of 72.7%, 54.5%, and 35.8%, respectively, observed. Further updates on this program, as well as topline data from the fully enrolled proof-of-concept trial in CLE, are expected in the second half of calendar year 2026. Other clinical development timelines remain on track for IMVT-1402, including potentially registrational trials in GD, MG, CIDP, and SjD. Immunovant’s cash position provides runway to the potential launch of IMVT-1402 in GD.

In calendar year 2027, topline data are expected across potentially registrational trials of IMVT-1402 in GD and MG.

In April 2026, we announced topline results from the two Phase 3 clinical studies evaluating batoclimab for adults with active, moderate-to-severe thyroid eye disease (TED), neither of which met the primary endpoint. The safety profile observed in these studies was consistent with prior batoclimab studies. Following these results, we discontinued further development of batoclimab across all indications to focus fully on IMVT-1402. Learnings from the batoclimab program, including clinical data, operational trial experience and relationships with investigators, have been and continue to be leveraged to inform the development of IMVT-1402.

Preliminary Results from IMVT-1402 Trial in D2T RA:

The trial evaluating IMVT-1402 in participants with D2T RA who have failed two or more prior mechanisms of advanced therapies (including biologic and targeted synthetic DMARDs) is currently

ongoing. A total of 170 participants have been enrolled in the initial 16-week open label period (Period 1) of the study evaluating weekly subcutaneous (SC) dosing of IMVT-1402 600 mg. Participants achieving a response at Week 14 and Week 16 in Period 1 per the American College of Rheumatology response criteria 20 (ACR20) will be randomized in a 1:1:1 ratio to receive blinded treatment in Period 2 with either IMVT-1402 600 mg, IMVT-1402 300 mg or placebo, weekly SC for 12 weeks. The primary endpoint will assess the proportion of such participants who maintain the ACR20 response at Week 28. ACR20 response is defined as a ≥ 20% improvement from baseline in tender joint count and swollen joint count and a ≥ 20% improvement from baseline in at least 3 of 5 additional clinical parameters. Similarly, ACR50 and ACR70 responses are a calculation of 50% or 70% improvement, respectively, in the number of swollen and tender joints and 3 of 5 assessment parameters.

At the completion of Period 1, 165 of the 170 patients were evaluable for ACR20 response. Of these patients, 86.7% (143/165) had failed two prior mechanisms of advanced therapies, and the mean time since diagnosis was 12.8 years. Baseline disease activity was high, with mean counts of 24.2 tender joints, 16.7 swollen joints, and a DAS28-CRP score of 6.1. At Week 16, the observed ACR20, ACR50, and ACR70 response rates were 72.7%, 54.5%, and 35.8%, respectively; participants who discontinued prior to Week 16 were imputed as non-responders. Among the subset of participants who had failed at least a JAK inhibitor and an anti-TNF inhibitor (N=107), the Week 16 observed ACR20, ACR50 and ACR70 response rates were 72.0%, 53.3% and 37.4%, respectively.

Period 1 was conducted in an open-label setting, with joint assessments performed by independent assessors blinded to treatment status, which we believe reduces the potential for assessor bias in the response measures. IMVT-1402 was obse

imvt-202602060001764013FALSE00017640132026-02-062026-02-06

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 6, 2026

IMMUNOVANT, INC.

(Exact name of Registrant as specified in its Charter)

Delaware001-3890683-2771572 (State or other jurisdiction of incorporation or organization) (Commission File Number)(IRS Employer Identification No.)

1000 Park Forty Plaza, Suite 210 Durham,NC27713 (Address of principal executive offices)(Zip Code)

Registrant’s telephone number, including area code: (917) 410-3120

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐        Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐        Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐        Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐        Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol(s) Name of each exchange on which registered

Common Stock, $0.0001 par value per shareIMVTThe Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02. Results of Operations and Financial Condition.

On February 6, 2026, Immunovant, Inc. (“the Company”) issued a press release announcing its financial results for its fiscal third quarter and nine months ended December 31, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information contained in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information in this Item 2.02 shall not be incorporated by reference in any filing with the U.S. Securities and Exchange Commission, or the SEC, made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.Description 99.1Press release, dated February 6, 2026.

104Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

IMMUNOVANT, INC.

By: /s/ Tiago Girao Tiago Girao Chief Financial Officer Date: February 6, 2026