Roivant provides update on Graves’ disease development program Page 1

• High-dose batoclimab achieved a 76% response rate in patients uncontrolled on antithyroid drugs (ATDs) at week 12
• High-dose batoclimab achieved an ATD-free response rate of 56% in patients uncontrolled with ATDs at week 12
• Strong correlation observed between the degree of IgG lowering and clinical outcomes yields potential best-in-class and first-in-class opportunity for IMVT-1402 in Graves’ disease (GD)
• Real-world claims data indicate that 25-30% of Graves’ disease patients per year are uncontrolled with ATDs and few to no therapeutic options exist, representing an attractive commercial opportunity with limited competition.
• IND approved with start of IMVT-1402 pivotal test in GD expected by end of calendar year

NEW YORK, September 9, 2024 (GLOBE NEWSWIRE) — Immunogenic, Inc. (Nasdaq: (IMVT)Immunovant, Inc., a clinical-stage immunology company focused on enabling normal lives for people with autoimmune diseases, today reported positive results from its Phase 2a study of batoclimab in Graves’ disease. Immunovant also announced data from several proprietary market studies demonstrating consistent unmet need among ATD-treated patients who are intolerant to, uncontrolled, or relapsed after ATD. Finally, Immunovant also announced alignment with U.S. Food & Drug Administration (FDA) approval and Investigational New Drug Application (IND) to initiate a pivotal study of IMVT-1402 in GD, expected on December 31, 2024.

As previously announced, the Phase 2a batoclimab trial enrolled uncontrolled GD patients who were hyperthyroid despite ATD therapy. Study participants received 12 weeks of high-dose batoclimab, 680 mg weekly via subcutaneous injection (SC), followed by 12 weeks of lower-dose batoclimab, 340 mg weekly SC. At the end of the first 12 weeks, participants experienced a mean IgG reduction of 77%, leading to a 76% response rate (defined as T3 and T4 falling below the upper limit of normal (ULN) without increasing the ATD dose). Additionally, at the end of 12 weeks of higher-dose batoclimab, 56% achieved an ATD-free response (defined as T3 and T4 falling below the ULN while the patient is fully weaned off their ATD). Despite the benefit of a lower starting IgG level after 12 weeks of 680 mg therapy, the lower dose of 340 mg batoclimab resulted in a mean IgG reduction of 65% (vs. 77% at the 680 mg dose) during weeks 13 to 24 with a corresponding lower response rate of 68%. In addition, a lower ATD-free response rate of 36% was also observed during the second 12 weeks. Finally, patients who achieved at least a 70% IgG reduction at the end of the trial had a nearly three-fold higher ATD-free response rate than those who did not (60% vs. 23%).

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