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Mar 31, 2022
Immunovant Q4 2022 Earnings Report
Achieved alignment with FDA on Phase 3 clinical trials for batoclimab in TED and reported financial results for Q4 and FY 2022.
Key Takeaways
Immunovant announced alignment with the FDA on Phase 3 clinical trials for batoclimab in Thyroid Eye Disease (TED) and reported financial results for the fourth quarter and fiscal year ended March 31, 2022. They are planning to initiate two placebo-controlled Phase 3 clinical trials of batoclimab in thyroid eye disease (TED) in the second half of calendar year 2022 with top-line data expected for both in the first half of calendar year 2025. They had a cash balance of $493.8 million as of March 31, 2022, expected to provide cash runway into calendar year 2025.
Aligned with FDA on Phase 3 clinical trials for batoclimab in Thyroid Eye Disease (TED).
Plan to initiate two Phase 3 clinical trials for TED in the second half of calendar year 2022, with top-line data expected in the first half of calendar year 2025.
On track to initiate pivotal Phase 3 clinical trial of batoclimab in myasthenia gravis (MG) by the end of June 2022.
Cash balance of $493.8 million as of March 31, 2022, expected to provide cash runway into calendar year 2025.
Immunovant
Immunovant
Forward Guidance
Immunovant provided forward-looking statements regarding clinical trials, data readouts, and cash runway.
Positive Outlook
- Plan to initiate two Phase 3 clinical trials for batoclimab in TED in the second half of calendar year 2022 with expected topline data readouts in the first half of calendar year 2025
- Plan to initiate a Phase 3 clinical trial in MG by the end of June 2022, with an expected topline data readout in the second half of calendar year 2024
- Timing of the announcement of additional indications
- Expected cash runway
- Plan to develop batoclimab across a broad range of autoimmune indications.
Challenges Ahead
- Initial results or other preliminary analyses or results of early clinical trials may not be predictive final trial results or of the results of later clinical trials
- Timing and availability of data from clinical trials
- The potential impact of the ongoing COVID-19 pandemic on Immunovant’s clinical development plans and timelines
- Immunovant’s business is heavily dependent on the successful development, regulatory approval and commercialization of its sole product candidate, batoclimab
- Immunovant is at an early stage in development of batoclimab