Immunovant (IMVT) Study update presentation summary

Disease background and unmet need

• Graves' disease is an autoimmune disorder caused by autoantibodies stimulating the thyroid, leading to excess hormone production and significant comorbidities such as thyroid eye disease and cardiovascular events.

• 25-30% of patients are relapsed, uncontrolled, or intolerant to anti-thyroid drugs (ATDs), with limited new medical therapies and declining use of ablation.

• Patients with uncontrolled Graves' disease face higher risks of severe complications and reduced quality of life.

• There is a significant incident and prevalent patient pool in the U.S. with high unmet need for disease-modifying therapies.

Batoclimab phase 2 study results

• Batoclimab demonstrated an 80% response rate at six months off-treatment, with 47% of responders achieving ATD-free remission.

• 60% of patients on high-dose batoclimab achieved normal thyroid hormone levels and ceased ATD by 12 weeks.

• Sustained reductions in thyroid-stimulating hormone receptor antibodies (TRAb) were observed, supporting disease modification potential.

• Batoclimab was well-tolerated, with no new safety signals and only mild or moderate treatment-related adverse events.

Clinical development and future directions

• Two potentially registrational trials for IMVT-1402 in Graves' disease are enrolling, with data expected in 2027.

• IMVT-1402 pivotal trial design features continuous high-dose therapy, aiming for improved efficacy and remission rates compared to batoclimab's step-down dosing.

• Primary endpoints focus on achieving euthyroidism and ATD discontinuation, with off-treatment follow-up to assess durability of remission.

• IMVT-1402 could become the first-in-class disease-modifying therapy for Graves' disease if successful.