Immunovant (IMVT) Roivant Investor Day presentation summary

IMVT-1402 clinical and commercial highlights

• IMVT-1402 achieves deep, dose-dependent IgG reductions, with up to ~80% reduction, surpassing current anti-FcRn competitors in efficacy across multiple autoimmune indications.

• Late-stage clinical data show deeper IgG reductions correlate with better efficacy in 8 indications, supporting the "deeper is better" hypothesis.

• IMVT-1402 is positioned as first- and best-in-class in Graves' disease (GD), difficult-to-treat rheumatoid arthritis (D2T RA), and cutaneous lupus erythematosus (CLE), with best-in-class potential in myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), and Sjögren's disease (SjD).

• The product is administered via a simple subcutaneous autoinjector, offering convenient self-administration and a favorable safety profile.

• Anti-FcRn antibodies have generated ~$7B in cumulative revenue in MG and CIDP within four years, highlighting significant commercial potential.

Clinical development and pipeline expansion

• Five potentially registrational datasets for IMVT-1402 are expected within 36 months, with key catalysts in 2026 and 2027 for GD, D2T RA, and CLE.

• IMVT-1402's indication selection balances clinical validation and commercial opportunity, targeting both high and low clinical risk diseases.

• The anti-FcRn class is rapidly expanding, with over 20 indications in development and a total addressable patient population growing from ~700K in 2020 to ~4M in 2025.

• IMVT-1402 could address over 600,000 US patients across its targeted indications.

• The product is expected to be best-in-class in MG, SjD, and CIDP, with topline results in these indications anticipated between 2027 and 2028.

Unmet needs and disease modification in Graves' disease

• Current GD therapies have remained largely unchanged for 75 years, focusing on the thyroid gland rather than the underlying autoimmune pathology.

• Up to 25-30% of GD patients are relapsed, uncontrolled, or intolerant to anti-thyroid drugs (ATDs), with limited alternative options and significant risk of comorbidities.

• Batoclimab proof-of-concept trials show that deeper IgG reduction leads to improved clinical outcomes and durable off-drug responses in uncontrolled GD patients.

• Nearly half of responders achieved ATD-free remission six months after treatment, indicating strong potential for disease modification.

• IMVT-1402 pivotal trials in GD are enrolling, with a design expected to generate improved efficacy data due to continuous dosing.