Immunovant (IMVT) Status Update summary

Key clinical results and efficacy insights

• Batoclimab achieved statistically significant and clinically meaningful outcomes in MG and CIDP, with the 680 mg dose showing a 74% mean IgG reduction and a 5.6-point MG-ADL improvement at 12 weeks, outperforming placebo and lower doses.

• Deep IgG suppression (≥70%) consistently correlated with higher response rates, durable symptom control, and super-responder status across MG, CIDP, and Graves' disease, supporting the "lower is better" thesis for FcRn inhibition.

• Maintenance of minimal symptom expression was achieved in 75% of patients on high-dose Batoclimab, nearly double the standard dose, with over 40% achieving this at week 12.

• In CIDP, Batoclimab showed a mean adjusted INCAT improvement of 1.8 and an 84% responder rate among patients with ≥70% IgG reduction, outperforming Vyvgart Hytrulo.

• Safety profile was generally favorable and consistent with prior studies, though higher Batoclimab doses saw more analyte abnormalities; IMVT-1402 is engineered to avoid these issues.

Strategic and development updates

• IMVT-1402, the next-generation FcRn inhibitor, is prioritized for future development due to its deep IgG lowering without albumin or cholesterol changes, and will be the focus for regulatory filings in MG and CIDP.

• Upcoming pivotal trials for IMVT-1402 in MG will include both 300 mg and 600 mg doses, with a design aimed at demonstrating superiority in deep and durable responses, enrolling AChR-, MuSK-, and LRP4-positive patients.

• Multiple INDs are cleared, with pivotal studies for IMVT-1402 expected to start soon and a rich catalyst path expected over the next 12–18 months, including new indications and data readouts in 2026–2027.

• Batoclimab will not be pursued for regulatory approval in MG or CIDP but may be considered for rare indications in the future; decision on regulatory submission will follow results from ongoing thyroid eye disease studies.

• IMVT-1402 is positioned as the only FcRn inhibitor to launch in an autoinjector for all indications, with a long intellectual property runway.

Commercial and market positioning

• Absolute efficacy and deep, durable responses are emphasized as key differentiators, with physicians and patients prioritizing these over placebo-adjusted rates.

• IMVT-1402's autoinjector form factor and flexible dosing are expected to enhance adoption and switching from first-generation FcRn inhibitors, especially for patients with residual or breakthrough symptoms.

• Graves' disease is highlighted as a particularly large commercial opportunity, with IMVT-1402 positioned as first-in-class and best-in-class.

• The company is fully capitalized to execute its development and commercialization plans, aiming to expand into multiple autoimmune indications.

• Market research indicates strong unmet need for therapies offering deeper and more durable disease control in MG.