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Mar 31, 2021
Immunovant Q4 2021 Earnings Report
Reported financial results for the fourth quarter and fiscal year ended March 31, 2021 and plans to resume clinical development of IMVT-1401 in Myasthenia Gravis (MG) and Warm Autoimmune Hemolytic Anemia (WAIHA).
Key Takeaways
Immunovant reported a net loss of $28.2 million for the quarter ended March 31, 2021, and plans to resume clinical development of IMVT-1401 in MG and WAIHA.
Immunovant plans to resume clinical development of IMVT-1401 in Myasthenia Gravis (MG) and Warm Autoimmune Hemolytic Anemia (WAIHA) as well as initiate two additional mid-to-late stage studies in the next year.
Program-wide data review suggests that IMVT-1401 has a broader therapeutic window than previously anticipated and that lipid elevations are predictable and manageable.
Observed increases in LDL in multiple studies that were consistent, dose-related, and appear to be driven by reductions in albumin levels.
Company plans to return to the clinic and initiate a pivotal MG trial in late 2021 or early 2022 as well as resume its trial in WAIHA on a similar timeframe.
Forward Guidance
Immunovant plans to resume clinical development of IMVT-1401 in Myasthenia Gravis (MG) and Warm Autoimmune Hemolytic Anemia (WAIHA) as well as initiate two additional mid-to-late stage studies in the next year.
Positive Outlook
- Plan to develop IMVT-1401 across a broad range of autoimmune indications.
- Plan to return to the clinic and initiate a pivotal MG trial in late 2021 or early 2022.
- Resume trial in WAIHA on a similar timeframe.
- Plans to initiate 2-3 additional clinical studies over the next 12 months, including another pivotal trial in 2022, after discussions with regulators.
- The anti-FcRn mechanism is unique within Immunology, and IMVT-1401 holds the potential to benefit many patients across a broad range of 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.
- Any product candidates that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all.
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