Rare Daily Staff

Immunovant has received a $200 million strategic investment from Roivant Sciences, which it will use to advance the development of IMVT-1401 in multiple indications including myasthenia gravis and warm autoimmune hemolytic anemia.

Roivant purchased 17million shares of Immunovant’s common stock at a price of $11.75 per share, representing approximately a 15 percent premium to Immunovant’s 20 trading day volume weighted average price. After giving effect to the investment, Immunovant has a pro forma cash balance of approximately $600 million and Roivant has increased its ownership stake in Immunovant from 57.5 percent to 63.8 percent, based on Immunovant’s cash balance and share count as of March 31, 2021.

The company will use the funds to continue development of IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, designed to be delivered as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies. FcRn is the primary protein responsible for preventing the degradation of IgG antibodies and albumin, the most abundant protein found in the blood. The role of FcRn is to bind to the IgG antibodies in the endosome, and transport them to the cell surface, where they are released back into circulation.

Immunovant plans to start a pivotal study in myasthenia gravis and resume mid-stage studies in warm autoimmune hemolytic anemia (WAIHA) and thyroid eye disease (TED), plus move two additional programs into clinical studies.

Myasthenia gravis (MG) is a rare chronic autoimmune neuromuscular disease characterized by weakness and fatigue of voluntary muscles. The disease is caused by pathogenic antibodies that target the neuromuscular junction, including the acetylcholine receptor and the muscle specific tyrosine kinase receptor, disrupting normal function. MG affects approximately 46,000 to 66,000 people in the United States and is more prevalent in women.

Warm autoimmune hemolytic anemia (WAIHA) is a rare hematologic disease in which autoantibodies mediate hemolysis, or the destruction of red blood cells. The clinical presentation is variable and most commonly includes non-specific symptoms of anemia such as fatigue, weakness, skin paleness, and shortness of breath. Immunovant believes that there are approximately 42,000 patients in the United States and 66,000 patients in Europe living with WAIHA.

“We are excited to announce this significant investment by Roivant, which will expedite our development of IMVT-1401 for a wide range of autoimmune disorders,” said Pete Salzmann, CEO of Immunovant. “Over the next 12 months, we plan to initiate a pivotal trial for myasthenia gravis, resume our trials in WAIHA and TED and initiate at least two additional clinical studies, including another pivotal trial in 2022.”

Roivant and Immunovant had explored several options, including Roivant potentially buying out its minority interest in the company, before agreeing to this cash infusion to increase its stake and support development of IMVT-1401.

Photo: Pete Salzmann, CEO of Immunovant

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