NEW YORK, April 21, 2025 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today announced next phase of growth including changes to its leadership team and the expanded development of IMVT-1402 into two new indications, SjD and CLE. Eric Venker, M.D., Roivant's President and an Immunovant Director, has been appointed as Immunovant's CEO. Dr. Venker brings over two decades of clinical practice and ...

NEW YORK, April 21, 2025 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today announced next phase of growth including changes to its leadership team and the expanded development of IMVT-1402 into two new indications, SjD and CLE. Eric Venker, M.D., Roivant's President and an Immunovant Director, has been appointed as Immunovant's CEO. Dr. Venker brings over two decades of clinical practice and ...

"I want to extend my deepest thanks to Pete Salzmann for his leadership of the company through a period of significant growth and transformation. Under Pete, Immunovant has shown compelling efficacy data in clinical trials for batoclimab in Myasthenia Gravis, Chronic Inflammatory Demyelinating Polyneuropathy, Graves' Disease and Thyroid Eye Disease, while developing the IMVT-1402 program to a total of six indications, now including Sjögren's and CLE," said Eric Venker, M.D., CEO of Immunovant and President ...

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Core Viewpoint - Purcell & Lefkowitz LLP is investigating Immunovant, Inc. to determine if the company's directors breached their fiduciary duties related to recent corporate actions [1] Group 1 - The investigation is on behalf of Immunovant's shareholders [1] - Shareholders can obtain additional information regarding their rights and options at no charge [2] - Purcell & Lefkowitz LLP specializes in representing shareholders affected by securities fraud and corporate misconduct [3]

Core Insights - Immunovant, Inc. reported positive topline results from its Phase 3 study of batoclimab in Myasthenia Gravis (MG) and initial results from its Phase 2b study in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) [1][2] Phase 3 Study in MG - The Phase 3 study was a randomized, quadruple-blind, placebo-controlled trial assessing batoclimab's efficacy and safety in adults with moderate to severe MG [3] - Participants receiving 680mg of batoclimab weekly achieved a 5.6 point improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score at Week 12, while those on 340mg achieved a 4.7 point improvement [6][7] - The study met its primary endpoint with a significant mean change from baseline in MG-ADL for acetylcholine receptor antibody positive (AChR+) participants [6] Phase 2b Study in CIDP - The Phase 2b study is also a randomized, quadruple-blind, placebo-controlled trial designed to evaluate batoclimab in adults with active CIDP [4] - Initial results from Period 1 showed a mean improvement of 1.8 points in the adjusted Inflammatory Neuropathy Cause and Treatment (aINCAT) disability score, with an 84% responder rate among patients achieving an IgG reduction of ≥70% [8] - Other scales demonstrated improvements, including a 15.3 point increase in I-RODS, a 5.6 point increase in MRC-SS, and a 15.1 increase in grip strength at Week 12 [8] Efficacy and Safety - Deeper IgG reductions correlated with better clinical outcomes across both studies [6][8] - Safety and tolerability profiles were consistent with previous batoclimab studies [9] Future Plans - Immunovant plans to initiate potentially registrational studies for both MG and CIDP with its lead asset IMVT-1402, having received clearance for Investigational New Drug (IND) applications [10] - The company does not intend to seek regulatory approval for batoclimab in MG or CIDP at this time, focusing instead on leveraging data from these studies to inform its programs with IMVT-1402 [11]

Core Viewpoint - Immunovant, Inc. is set to host an investor webcast to discuss results from its Phase 3 study of batoclimab in myasthenia gravis (MG) and initial results from its Phase 2b study in chronic inflammatory demyelinating polyneuropathy (CIDP) [1] Group 1 - The investor webcast will take place on March 19th at 8:00 a.m. ET [1][3] - The call will feature Immunovant's CEO Pete Salzmann and Roivant's CEO Matt Gline [2] - A replay of the event and presentation will be available immediately after the live webcast [3] Group 2 - Immunovant, Inc. is a clinical-stage immunology company focused on developing therapies for autoimmune diseases [4] - The company specializes in anti-FcRn technology to create targeted therapies for complex autoimmune conditions [4]

Core Viewpoint - Immunovant, Inc. reported a wider-than-expected net loss for Q3 fiscal 2025, leading to a significant decline in stock price due to lack of approved products and revenue generation [1][2]. Financial Performance - The net loss for Q3 fiscal 2025 was 76 cents per share, compared to the Zacks Consensus Estimate of a loss of 73 cents and a loss of 36 cents per share in the same quarter last year [1]. - Research and development (R&D) expenses reached $94.5 million, a 96% increase from the previous year, driven by preparations for future clinical studies and increased clinical study costs [3]. - General and administrative expenses were $19.8 million, up 50% year-over-year, primarily due to higher personnel-related expenses and professional fees [4]. - As of December 31, 2024, the company had a cash balance of $374.7 million, down from $472.9 million as of September 30, 2024 [4]. Pipeline Developments - Immunovant's lead asset, IMVT-1402, is positioned for clinical studies across 10 indications by March 31, 2026, leveraging data from batoclimab studies for financial efficiencies [5]. - The upcoming late-stage studies for IMVT-1402 will target indications such as Graves' disease, Myasthenia Gravis, and Chronic Inflammatory Demyelinating Polyneuropathy [6]. - The company is also evaluating batoclimab in ongoing mid-late-stage studies for various autoimmune conditions, with positive data from a mid-stage study for Graves' disease announced in September [7][8]. - Top-line results from the Myasthenia Gravis study of batoclimab are expected by the end of the fiscal year, which will inform the next steps for IMVT-1402 [9]. Market Performance - Immunovant's shares have decreased by 33.6% over the past three months, contrasting with a 6.6% decline in the industry [6].

Clinical Development - The company is pursuing a broad anti-FcRn strategy with its lead asset, IMVT-1402, targeting 23 indications across endocrinology, neurology, and rheumatology[95]. - The total potential opportunity for the FcRn franchise is estimated to exceed 2 million patients in the U.S. and Europe[101]. - The company plans to initiate clinical trials for IMVT-1402 in a total of ten indications by March 31, 2026, with four to five indications expected by March 31, 2025[102]. - A Phase 2b trial for IMVT-1402 in Graves' disease (GD) will enroll approximately 240 participants, evaluating the proportion of participants who are euthyroid and off anti-thyroid drugs at week 26[109]. - The company has initiated a potentially registrational trial for IMVT-1402 in difficult-to-treat rheumatoid arthritis (D2T RA), expecting to enroll around 120 participants[115]. - The Phase 2b trial for IMVT-1402 in RA will assess the proportion of participants maintaining an ACR20 response at week 28[115]. - The company has received FDA clearance for the IND application for IMVT-1402 in both GD and RA[104][115]. - The Phase 2b trial for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is ongoing, with initial data anticipated by March 31, 2025, which will inform the pivotal study design for IMVT-1402[120]. - In a Phase 2 clinical trial for uncontrolled Graves' Disease (GD), participants experienced a mean IgG reduction of 77% and a 76% response rate after 12 weeks of high-dose batoclimab[121]. Financial Performance - The company reported total operating expenses of $114.3 million for the three months ended December 31, 2024, an increase of $52.7 million compared to the same period in 2023[142]. - Research and development expenses for the same period were $94.5 million, up $46.2 million year-over-year, driven by increased clinical trial costs and preparations for future trials[144]. - The net loss for the three months ended December 31, 2024, was $111.1 million, compared to a net loss of $51.4 million in the prior year[142]. - For the nine months ended December 31, 2024, total operating expenses increased by $122.5 million to $324.3 million compared to the prior-year period[149]. - Research and development expenses rose by $120.4 million to $267.3 million, driven by increased costs in endocrine and neurological diseases[151]. - General and administrative expenses increased by $14.6 million to $57.1 million, primarily due to higher personnel-related expenses and legal fees[156]. - The net loss for the nine months ended December 31, 2024, was $307.4 million, compared to a net loss of $184.0 million in the prior-year period[158]. - Cash used in operating activities for the nine months ended December 31, 2024, was $265.2 million, compared to $154.5 million in the prior-year period[164]. Cash and Funding - Cash and cash equivalents decreased from $635.4 million as of March 31, 2024, to $374.7 million as of December 31, 2024[158]. - The company expects to have cash and cash equivalents of $374.7 million as of December 31, 2024, along with gross proceeds of $450.0 million from a private placement in January 2025, sufficient to fund operations for at least the next 12 months[173]. - The company anticipates substantial increases in short-term and long-term capital requirements to fund clinical trials and development activities[176]. - The company expects to continue incurring significant expenses and increasing operating losses for the next several years[158]. Market and Economic Conditions - The company is facing macroeconomic uncertainties that may negatively impact its business growth and operational results[126]. - The company does not believe inflation had a material effect on its financial condition or results of operations as of December 31, 2024[182]. - The primary exposure to market risk is interest income volatility, with cash equivalents of $374.7 million maintained in accredited financial institutions[180]. - The company is not currently exposed to significant foreign currency exchange rate risk, as expenses are generally denominated in U.S. dollars[181]. Strategic Initiatives - The innovative product pipeline includes IMVT-1402 and batoclimab, both designed for subcutaneous injection with tailored dosing based on disease stage[96]. - The company aims to leverage data from the batoclimab development program to inform the development of IMVT-1402[105]. - The company plans to transition its registrational development programs for Myasthenia Gravis (MG) from batoclimab to IMVT-1402, with top-line data from the batoclimab study expected by March 31, 2025[119]. - The company plans to integrate acquired technologies and expand its intellectual property portfolio as part of its growth strategy[179]. Contractual Obligations and Milestones - The company has a remaining minimum obligation of approximately $43.6 million to Samsung for the manufacturing of batoclimab drug substance[171]. - The maximum potential milestone payments under the HanAll Agreement could reach $420.0 million, with $32.5 million already paid as of December 31, 2024[172]. - A milestone payment of $12.5 million was made in the quarter ended September 30, 2023, following the achievement of regulatory milestones[172]. - There are no significant ongoing material contractual obligations, but the company expects to enter into additional commitments as the business develops[174].

Financial Performance - Immunovant reported a net loss of $111.1 million ($0.76 per common share) for the three months ended December 31, 2024, compared to a net loss of $51.4 million ($0.36 per common share) for the same period in 2023[15]. - Total operating expenses for the three months ended December 31, 2024, were $114.3 million, compared to $61.6 million for the same period in 2023[23]. - Accumulated deficit increased from $(825,683) to $(1,133,074), reflecting a worsening financial position[25]. - Total stockholders' equity decreased significantly from $617,757 to $352,617, a decline of approximately 43%[25]. Research and Development - Research and development expenses increased to $94.5 million for the three months ended December 31, 2024, up from $48.3 million for the same period in 2023, primarily due to preparations for future clinical trials of IMVT-1402[13]. - The company anticipates sharing top-line results from the pivotal study of batoclimab in myasthenia gravis (MG) and initial results from the chronic inflammatory demyelinating polyneuropathy (CIDP) study by March 31, 2025[3]. - Immunovant plans to initiate clinical trials for IMVT-1402 in a total of ten indications by March 31, 2026[4]. - The company expects to report additional data from the batoclimab proof-of-concept study in Graves' disease (GD) in summer 2025[6]. - The company has six Investigational New Drug (IND) applications cleared for its lead asset, IMVT-1402, with pivotal studies now enrolling[8]. Cash and Assets - As of December 31, 2024, Immunovant's cash and cash equivalents totaled approximately $374.7 million[12]. - Immunovant's pro forma cash balance was approximately $825 million as of December 31, 2024, including approximately $450 million from a private placement that closed on January 15, 2025[8]. - Total current assets decreased from $665,770 to $412,541, a decline of approximately 38%[25]. - Cash and cash equivalents dropped from $635,365 to $374,685, a decrease of about 41%[25]. - Prepaid expenses and other current assets rose from $25,068 to $35,632, an increase of about 42%[25]. - Property and equipment, net increased from $462 to $752, reflecting a growth of approximately 63%[25]. Liabilities and Equity - Total liabilities remained constant at $68,315, compared to $48,608 in the previous period, indicating an increase in current liabilities[25]. - Accounts payable rose from $7,155 to $19,816, an increase of about 177%[25]. - Additional paid-in capital increased from $1,441,518 to $1,483,198, showing a growth of approximately 3%[25]. - Accumulated other comprehensive income improved from $1,908 to $2,479, an increase of about 30%[25]. General and Administrative Expenses - General and administrative expenses rose to $19.8 million for the three months ended December 31, 2024, compared to $13.2 million for the same period in 2023[14].