Immunovant Updates Development and Reports Q3 2024 Financials

Immunovant, Inc., a clinical-stage immunology company dedicated to improving the lives of people with autoimmune diseases, reported significant progress in the development of its lead asset, IMVT-1402, for the fiscal second quarter ending September 30, 2024. The company has made substantial advancements across various therapeutic areas and FDA divisions with five Investigational New Drug (IND) applications cleared.

IMVT-1402 is poised to enter potentially registrational trials in multiple indications by March 31, 2025. These trials are anticipated to explore IMVT-1402’s efficacy in treating Graves’ disease (GD), rheumatoid arthritis (RA), and other autoimmune conditions. Specifically, proof-of-concept data from a batoclimab trial in GD have shown the potential for deep IgG reduction with potent FcRn inhibition, which could significantly improve treatment for GD patients who do not respond well to antithyroid drugs (ATDs). Consequently, a potentially registrational trial for IMVT-1402 in GD is expected to commence by the end of the year.

Additionally, an IND for IMVT-1402 in rheumatoid arthritis (RA) has been cleared, and a potentially registrational trial for difficult-to-treat (D2T) RA patients is expected to begin by March 31, 2025. This trial aims to evaluate IMVT-1402’s potential best-in-class profile in treating RA patients with elevated RA-specific autoantibodies. The company is also on track to initiate trials in four to five indications, including GD and D2T RA, by March 31, 2025.

Immunovant’s batoclimab trials in myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP) are fully enrolled, with data disclosures expected by March 31, 2025. Data from a batoclimab trial in thyroid eye disease (TED) are anticipated in the second half of 2025. All insights from the batoclimab trials will help inform future trials with IMVT-1402.

The company’s CEO, Pete Salzmann, M.D., highlighted the significant progress made since the Phase 1 data for IMVT-1402 was announced. The company has exceeded its goal of activating three INDs by the year's end and is excited about the potential of IMVT-1402 in transforming the treatment of GD and expanding into rheumatology. Deeper IgG reduction with IMVT-1402 could potentially lead to better clinical outcomes for patients with elevated RA-specific autoantibodies who suffer from continued disease and disability despite exhausting multiple therapeutic options.

Immunovant aims to utilize FcRn inhibition as a promising mechanism to treat approximately 70,000 US patients with D2T, ACPA+ RA. Initial data has shown that higher baseline ACPA levels and deeper ACPA reduction correlate with clinical improvement in these patients. The company plans to leverage this data in the upcoming registrational trial for IMVT-1402 in RA.

The company also provided updates on its endocrinology and neurology programs. In September 2024, new data on unmet needs in GD patients were presented, along with additional results from the batoclimab GD study. In November 2024, further efficacy and safety data for batoclimab in Graves’ thyroidal and extrathyroidal disease were presented at the American Thyroid Association Annual Meeting. These data demonstrated rapid and meaningful improvements in GD patients treated with batoclimab.

Immunovant remains on track to initiate its first potentially registrational trial of IMVT-1402 in GD by the end of the year. The company’s batoclimab trial in TED has experienced increased competition for trial participants, which shifted the top-line results expectation to the second half of 2025. The findings from this trial will guide the overall GD program for IMVT-1402.

In the neurology program, Immunovant has completed enrollment for the batoclimab pivotal trial in MG, with top-line results expected by March 31, 2025. Similarly, the Phase 2b trial for batoclimab in CIDP has completed enrollment, with data expected by the same date. These results will guide the future clinical trial designs for IMVT-1402 in these indications.

On the corporate front, the company announced the appointment of Melanie Gloria as Chief Operating Officer, effective November 18, 2024. With over 20 years of experience in biotechnology, Gloria brings valuable expertise to Immunovant.

Financially, Immunovant reported cash and cash equivalents totaling approximately $472.9 million as of September 30, 2024. Research and development expenses increased significantly due to preparation for future clinical trials, while general and administrative expenses also rose due to higher personnel-related costs and professional fees.

Immunovant remains committed to advancing its pipeline and unlocking the potential of IMVT-1402 across multiple therapeutic areas to benefit patients with autoimmune diseases.