Immunovant(IMVT) - 2026 Q2 - Quarterly Report

Financial Performance - Immunovant has not generated any revenue and has incurred significant operating losses since inception, with no expected revenue until regulatory approval and commercialization of IMVT-1402 or other product candidates [108]. - For the three months ended September 30, 2025, total operating expenses increased by $16.0 million to $131.8 million compared to $115.7 million in the prior year [117]. - The net loss for the three months ended September 30, 2025, was $126.5 million, compared to a net loss of $109.1 million in the same period last year, reflecting an increase of $17.4 million [117]. - For the six months ended September 30, 2025, research and development expenses increased by $42.7 million to $215.4 million compared to $172.7 million in the prior year [128]. - Net cash used in operating activities for the six months ended September 30, 2025, was $219.9 million, an increase from $164.8 million in the prior year [139]. - For the six months ended September 30, 2025, the company used $219.9 million in cash for operating activities, reflecting a net loss of $247.1 million [140]. - The company expects to continue incurring net losses for the foreseeable future, indicating ongoing financial challenges [151]. Research and Development - The company is currently enrolling studies in six indications for IMVT-1402, including potentially registrational trials in Graves' disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and Sjögren's disease [91]. - Top-line results from two potentially registrational trials evaluating IMVT-1402 in Graves' disease are expected to be reported in 2027 [93]. - A Phase 2 proof-of-concept trial for batoclimab in Graves' disease showed that approximately 80% of subjects maintained T3/T4 values within normal limits after 24 weeks off treatment [95]. - The Phase 3 clinical program for batoclimab in thyroid eye disease is on track to read out before the end of calendar year 2025, with top-line results expected in the first half of 2026 [96]. - The company initiated a potentially registrational trial for IMVT-1402 in myasthenia gravis in March 2025, with top-line results expected in 2027 [98]. - The company is leveraging data and insights from batoclimab to inform and potentially accelerate the development programs for IMVT-1402 [90]. - Research and development expenses are expected to continue as the company executes IMVT-1402 trials and prepares for regulatory approval [111]. Cash and Financing - The company reported cash and cash equivalents of $521.9 million as of September 30, 2025, down from $714.0 million as of March 31, 2025 [134]. - The company plans to finance its operations through a combination of equity offerings, debt financings, and potential collaborations, as it has no committed external sources of funds [135]. - The company expects its existing cash and cash equivalents of $521.9 million will be sufficient to fund operating expenses through the GD readout expected in 2027 [148]. - The company anticipates increased future capital requirements to fund clinical development programs and launch potential clinical trials of IMVT-1402 [150]. - As of September 30, 2025, the company has a remaining minimum obligation of approximately $39.1 million for contract manufacturing of batoclimab, with payments scheduled through fiscal year 2030 [146]. - The maximum potential milestone payments under the HanAll Agreement could reach $420.0 million, following $32.5 million already paid [147]. Economic Conditions - Macroeconomic conditions, including inflation and geopolitical tensions, may negatively affect the company's growth and results of operations [103]. - Inflation has not had a material effect on the company's business or financial condition as of September 30, 2025 [158]. - Interest income for the three months ended September 30, 2025, decreased by $0.5 million to $(5.6) million, primarily due to lower average interest rates [124]. - General and administrative expenses for the three months ended September 30, 2025, decreased by $1.0 million to $17.5 million, reflecting improved cost management [123].