Immunovant, Inc.
For the period ended Jun 30, 2025. Filed Aug 11, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 11, 2025
IMVT$30.53+7.5%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-12-31; filed 2025-02-06.
0001764013-25-000026
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-11.
0001764013-25-000129
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 168 previous paragraphs and 133 current paragraphs.
84 unchanged; 27 reworded; 22 added; 53 removed; 4 previous and 0 current paragraphs rearranged.
Tables are not compared: 5 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (22)
Current report
Immunovant is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. Our focus is on developing IMVT-1402, a potentially best-in-class inhibitor of the neonatal fragment crystallizable receptor (“FcRn”), to address autoimmune diseases driven by high levels of pathogenic immunoglobulin G (“IgG”) antibodies. FcRn is involved in preventing the degradation of IgG antibodies, and inhibition of FcRn has been shown to reduce levels of total IgG and pathogenic IgG antibodies.
Current report
We believe that FcRn inhibition has broad therapeutic and commercial potential to address IgG-mediated autoimmune diseases in several therapeutic areas, including but not limited to, endocrinology, neurology, rheumatology and dermatology. Third-party estimates suggest over four million patients in the United States and Europe could benefit from anti-FcRn treatments across more than 20 indications currently being evaluated in clinical trials by multiple companies, with two indications that are already approved and launched quickly reaching billions of dollars in sales.
Current report
In a Phase 1 clinical trial, healthy adults dosed with IMVT-1402 showed deep, dose-dependent IgG reductions. We expect to be able to reach approximately 80% IgG reductions with continued weekly dosing of 600 mg of IMVT-1402, offering deeper IgG reductions than observed with other competitor anti-FcRn programs. There has been consistent evidence observed across the class in eight indications in Phase 2 and 3 trials with FcRn inhibitors that deeper IgG reductions correlate with meaningful improvements in clinical outcomes. This has also been validated with Immunovant’s own Phase 2 and 3 studies evaluating its first-generation anti-FcRn antibody, batoclimab, formerly referred to as IMVT-1401, in Graves’ disease (“GD”), myasthenia gravis (“MG”) and chronic inflammatory demyelinating polyneuropathy (“CIDP”) which showed that IgG reductions of greater than or equal to 70% led to meaningfully better outcomes compared to reductions below 70% across a range of clinical measures.
Current report
In the Phase 1 clinical trial, across all evaluated doses, IMVT-1402 demonstrated no or minimal reductions in albumin and no or minimal increases in LDL cholesterol levels, which are off-target effects observed in some anti-FcRn antibodies, including batoclimab. We are pursuing the rapid development of IMVT-1402 because of its best-in-class potential, with the 600 mg dose expected to reach approximately 80% IgG reduction. We believe IMVT-1402’s profile has the potential to offer best-in-class efficacy, in addition to its potentially favorable safety profile and convenient administration with a simple self-administered auto-injector expected at launch. As previously disclosed, we will make a final decision about the future development and regulatory submissions for batoclimab in the future based on the aggregate information available at the time in consultation with our partner HanAll Biopharma Co., Ltd., (“HanAll”). Data and insights from batoclimab, including our operational trial experience, relationships with investigators and prior results, are being leveraged to inform and potentially accelerate our development programs for IMVT-1402.
Current report
We are currently progressing a broad set of programs for IMVT-1402. Over the last year, we announced the clearance of six investigational new drug (“IND”) applications to support clinical trials to evaluate IMVT-1402. We have now initiated studies in all of these six indications, including potentially registrational trials in GD, difficult-to-treat rheumatoid arthritis (“D2T RA”), MG, CIDP and Sjögren’s disease (“SjD”), and a proof-of-concept trial in cutaneous lupus erythematosus (“CLE”). Our primary focus is to execute these six indications first, with plans to assess new indications in the future. All studies evaluating IMVT-1402 are being conducted using the intended commercial drug formulation and delivery device, the YpsoMate® autoinjector developed by Ypsomed AG, which is utilized for multiple approved products.
Current report
IMVT-1402 Potentially Registrational Trials in GD
Current report
We initiated two potentially registrational trials (NCT06727604 and NCT07018323) evaluating IMVT-1402 in adults with GD in December 2024 and June 2025, respectively. We expect to report top-line results from these trials in 2027.
Current report
This proof-of-concept Phase 2 clinical trial (NCT05907668) of batoclimab for the treatment of uncontrolled GD is ongoing, with additional data expected to be presented at the American Thyroid Association (ATA) Annual Meeting in September 2025, including remission data from the 24-week post-treatment follow-up period.
Current report
Batoclimab Phase 3 Clinical Program in TED
Current report
We are leveraging the data and learnings from the batoclimab MG and CIDP studies, including our operational trial experience, relationships with investigators and prior results, to inform and accelerate our programs with IMVT-1402.
Current report
IMVT-1402 Potentially Registrational Trial in MG
Current report
We initiated a potentially registrational trial (NCT07039916) evaluating IMVT-1402 in adults with MG in March 2025. This trial is a randomized, placebo-controlled, 26-week trial. We expect to report top-line results from this trial in 2027.
Current report
IMVT-1402 Potentially Registrational Trial in CIDP
Current report
We initiated a potentially registrational trial (NCT07032662) evaluating IMVT-1402 in adults with CIDP in March 2025. This trial is a randomized, placebo-controlled, 24-week trial in CIDP patients. We expect to report top-line results from this trial in 2028.
Current report
IMVT-1402 Potentially Registrational Trial in D2T RA
Current report
We initiated a potentially registrational trial (NCT06754462) evaluating IMVT-1402 in ACPA-positive D2T RA in December 2024. We expect to report initial results from the period 1 open label portion of this trial in 2026.
Current report
IMVT-1402 Potentially Registrational Trial in SjD
Current report
We initiated a potentially registrational trial (NCT06979531) evaluating IMVT-1402 in SjD in June 2025. We expect to report top-line results from this trial in 2028.
Current report
Dermatology Diseases
Current report
IMVT-1402 Proof-of-Concept Trial in CLE
Current report
We initiated a proof-of-concept trial (NCT6980805) evaluating IMVT-1402 in CLE in February 2025. We expect to report top-line results from this trial in 2026.
Current report
Interest Income, net for the Three Months Ended June 30, 2025 and 2024
Removed paragraphs (53)
Previous report
We are a clinical-stage immunology company pursuing a broad anti-FcRn strategy based on the potential best-in-class profile of our lead asset, IMVT-1402, and informed by the breadth of the class, in which 23 indications have been publicly announced for study by multiple companies to date. We expect to initiate programs evaluating IMVT-1402 in several therapeutic areas, including endocrinology, neurology and rheumatology. To address the unmet needs of people with autoantibody-driven diseases, we are committed to initiating a broad set of late-stage programs for IMVT-1402, including first-in-class indications such as Graves’ disease (“GD”), classic autoantibody indications such as myasthenia gravis (“MG”) and other indications with positive in-class data such as chronic inflammatory demyelinating polyneuropathy (“CIDP”) and rheumatoid arthritis (“RA”). We expect to leverage disease state insights, clinical trial data observed to date within the anti-FcRn class, and operational experience from past and ongoing batoclimab trials to inform and potentially accelerate the development of IMVT-1402.
Previous report
The physiologic function of FcRn is to prevent the degradation of immunoglobulin G (“IgG”) antibodies. High levels of pathogenic IgG antibodies drive a variety of autoimmune diseases. Inhibition of FcRn, such as through the use of an anti-FcRn antibody, has been shown to reduce levels of total IgG and pathogenic IgG antibodies. We believe our completed clinical trials and other clinical trials assessing anti-FcRn antibodies in IgG-mediated autoimmune diseases have generated promising results, suggesting that FcRn is a therapeutically important and validated pharmacologic target to reduce levels of disease-causing IgG antibodies. Thus, we are developing IMVT-1402 and batoclimab in autoimmune diseases for which there is robust evidence that pathogenic IgG antibodies drive disease manifestation and for which we believe that reduction of IgG antibodies should lead to clinical benefit.
Previous report
Batoclimab, our initial product candidate, is dosed subcutaneously using a small gauge needle in small volumes (e.g., 2 mL), and has generated therapeutically relevant pharmacodynamic activity. In clinical trials conducted to date, batoclimab has been observed to reduce IgG antibody levels, which has provided evidence supporting the use of an anti-FcRn antibody in disease areas associated with high levels of pathogenic IgG antibodies.
Previous report
Likewise, IMVT-1402, our lead product candidate, has also been observed to reduce IgG antibody levels in a Phase 1 clinical trial conducted in healthy adults, similar to that observed in our original Phase 1 clinical trial of batoclimab. Importantly, although FcRn also plays a role in maintaining serum albumin levels which in turn correlate inversely with low-density lipoprotein (“LDL”) cholesterol levels, no or minimal reduction in albumin and no or minimal increases in LDL cholesterol levels were observed in study participants administered either 300 mg or 600 mg of IMVT-1402 subcutaneously once weekly for four weeks. Across both dose regimens, the changes in albumin and LDL cholesterol were similar to those observed with placebo administration. This is a key attribute for IMVT-1402, which we believe could potentially allow its use as a treatment of chronic conditions requiring maintenance doses that achieve high degrees of IgG suppression.
Previous report
We believe that FcRn inhibition has broad therapeutic and commercial potential to address IgG-mediated autoimmune diseases in a number of therapeutic areas, including but not limited to, endocrinology, neurology and rheumatology. Based on third-party patient prevalence estimates, for the 23 indications that have been publicly announced by multiple companies for clinical development with anti-FcRn assets, we estimate the total potential opportunity for our FcRn franchise to be greater than two million patients in the U.S. and Europe. Our estimates in Europe include all European Union (“E.U.”) countries, Norway, Lichtenstein, Iceland (together with the E.U. countries, the “EEA”), the United Kingdom (“U.K.”), and Switzerland.
Previous report
Our goal is to fully optimize the IMVT-1402 clinical development program consistent with its potential best-in-class profile. Our strategic priority is to build a class-leading portfolio of indications in several therapeutic areas by leveraging data and learning derived from studies with batoclimab and from studies with other FcRn inhibitors, both approved and in development. Currently, a total of six investigational new drug (“IND”) applications are active for IMVT-1402. We have initiated potentially registrational trials for IMVT-1402 in GD and difficult-to-treat RA (“D2T RA”). We expect to have initiated studies evaluating IMVT-1402 in a total of four to five indications by March 31, 2025. Inclusive of these programs, by March 31, 2026, we plan to have initiated clinical trials of IMVT-1402 in a total of ten indications. Studies evaluating IMVT-1402 are expected to be conducted using the intended commercial drug formulation and delivery device, the YpsoMate® autoinjector developed by Ypsomed AG, which is utilized by multiple approved products.
Previous report
As a result of our rational design and current outlook on potential opportunities, we believe our product candidates, if developed and approved for commercial sale, would be differentiated from currently available treatments for advanced IgG-mediated autoimmune diseases. To date, these product candidates have demonstrated potential best-in-class IgG reduction and are being developed for delivery using a simple, self-administered subcutaneous injection.
Previous report
IMVT-1402
Previous report
In the quarter ended June 30, 2023, the FDA cleared our IND application for IMVT-1402 and we initiated a Phase 1 clinical trial in healthy adults in New Zealand after approval of the Clinical Trial Application (“CTA”) by the regulatory authority, MEDSAFE.
Previous report
Based on trial results announced to date and the strength of its potential best-in-class profile, we plan to pursue studies with IMVT-1402 in endocrinology, neurology, rheumatology and other therapeutic areas, with a focus on indications representing first-in-class opportunities, classic autoantibody diseases, and diseases where IgG autoantibodies are believed to play a role. In selecting indications for development, we plan to leverage data from our batoclimab development program and also take advantage of publicly disclosed in-class competitor data, which can be used to establish proof-of-concept as well as provide insights into potentially more informative study designs.
Previous report
IMVT-1402 as a Potential Treatment for Graves’ Disease
Previous report
Current Treatment Paradigm
Previous report
The treatment of GD has seen minimal innovation in treatment options over the past 70-plus years. ATDs, as the only existing pharmacological therapy, do not address the underlying disease pathology characterized by high levels of TRAb. A conservative analysis of Inovalon claims data estimates that the prevalence and incidence of GD patients is approximately 880,000 and 65,000 in the U.S. Further, market-sizing analyses by various methods suggest that 25-30% of GD patients are relapsed, uncontrolled on or intolerant to ATDs, representing a potentially significant unmet medical need.
Previous report
GD Pivotal Study
Previous report
Having received FDA clearance of the IND for IMVT-1402 in GD and leveraging data from the batoclimab proof-of-concept trial, we initiated a potentially registrational trial evaluating IMVT-1402 in adults with GD.
Previous report
This Phase 2b study (NCT06727604) is a randomized, placebo-controlled, 52-week trial in GD patients who are hyperthyroid despite treatment with an ATD for 12 or more weeks prior to beginning the study. The study will enroll approximately 240 participants randomized (1:1:1) to one of two blinded treatment groups each receiving IMVT-1402, 600 mg weekly by subcutaneous injection (“SC”), or a matched placebo group. Participants will be evaluated over two consecutive 26-week blinded treatment periods. Over the course of the treatment periods, background ATD treatment will be titrated to the lowest effective dose, including elimination of ATD treatment, to maintain normal thyroid lab values. Following the initial 26-week period, participants in the group 2 IMVT-1402 treatment group will be assigned to either continued treatment with IMVT-1402 at the same dose or matching placebo for the second 26-week study period based on the participant’s TRAb value and euthyroid status determined at week 26. The study’s primary endpoint will evaluate the proportion of participants who are euthyroid and off ATD at study week 26. A key secondary endpoint will measure the proportion of participants who become euthyroid and stop ATD treatment at week 52.
Previous report
More details on the study design are described in the figure below:
Previous report
GD Pivotal Trial Design
Previous report
IMVT-1402 as a Potential Treatment for Rheumatoid Arthritis
Previous report
RA Overview
Previous report
RA is a chronic progressive autoimmune disease that causes inflammation in the joints and surrounding tissues. Inadequate control of the joint inflammation associated with RA may result in irreversible joint erosions. RA is the most common systemic autoimmune disease. The exact cause of RA is not completely known but is associated with a variety of genetic, hormonal and environmental factors. RA can occur at any age, but it is more commonly diagnosed in middle age and women are more likely to be affected than men. RA affects 18 million persons globally and 1.5 million persons in the United States. Several autoantibodies have been identified in RA. Among these are rheumatoid factor (“RF”) and anti-citrullinated protein antibodies (“ACPA”). These RA-specific autoantibodies are found in 70-80% of RA patients and amplify inflammation via immune complex formation. Autoantibodies are associated with severe disease and poor outcomes on current available therapies. An estimated 5% to 20% of RA patients are characterized as having difficult-to-treat (“D2T”) RA due to a failure to respond to two or more biologic or targeted synthetic disease modifying anti-rheumatic drugs (“DMARDs”).
Previous report
Current Treatment Paradigm
Previous report
Currently available treatments used to help control joint inflammation include a variety of conventional oral, targeted synthetic and biologic DMARDs, most of which reduce cytokines. For D2T RA patients, who remain symptomatic despite multiple lines of treatment, there remains a significant unmet need.
Previous report
Because of the role of FcRn in preventing degradation of IgG autoantibodies, such as ACPAs, FcRn inhibition is an attractive mechanism as a potential treatment for ACPA-positive RA. Recent in-class anti-FcRn data from a Phase 2a placebo-controlled, proof-of-concept trial evaluating nipocalimab in patients with RA demonstrated that both higher baseline ACPA levels and deeper ACPA reduction correlated with better clinical improvement with nipocalimab treatment.
Previous report
RA Pivotal Study
Previous report
Having received FDA clearance of the IND for IMVT-1402 in RA, we initiated a potentially registrational trial evaluating IMVT-1402 in ACPA-positive D2T RA. This Phase 2b trial (NCT06754462) is expected to enroll approximately 120 participants into an initial 16-week open-label, active treatment period. To ensure the enrollment of patients with active D2T RA, the trial inclusion criteria require elevated ACPA levels and prior inadequate response to 2 or 3 (but no more than 3) biologic or targeted synthetic DMARDs. The study will evaluate IMVT-1402’s higher dose (600 mg) during the open-label induction phase of the trial with the intent of maximizing reduction in ACPA levels. Participants achieving a response at weeks 14 and 16 per the American College of Rheumatology (“ACR”) response criteria ACR20 will be randomized in a 1:1:1 ratio to receive blinded treatment with either IMVT-1402 600 mg, IMVT-1402 300 mg, or placebo, weekly SC, for 12 weeks. The primary endpoint will assess the proportion of such participants who maintain the ACR20 response at week 28. Eligible participants who complete week 28 will have the option to receive IMVT-1402 for an additional period of 48 weeks as part of a long-term extension period.
Previous report
More details on the study design are described in the figure below:
Previous report
RA Pivotal Study Design
Previous report
IMVT-1402 as a Potential Treatment for Myasthenia Gravis
Previous report
We may transition our registrational development programs for MG from batoclimab to IMVT-1402, with a final decision for this program contingent on top-line data from the batoclimab study in this indication. An IND application to support the evaluation of IMVT-1402 in MG has received FDA clearance. We expect to report top-line data from the Phase 3 trial of batoclimab for the treatment of MG by March 31, 2025, with potential registrational development for MG expected to transition from batoclimab to IMVT-1402 in the same timeframe.
Previous report
IMVT-1402 as a Potential Treatment for Chronic Inflammatory Demyelinating Polyneuropathy
Previous report
We may transition our registrational development program for CIDP from batoclimab to IMVT-1402 and the design of the pivotal study with IMVT-1402 in CIDP may be informed by the initial batoclimab CIDP datafrom the Phase 2b trial available by March 31, 2025. An IND application to support the evaluation of IMVT-1402 in CIDP has received FDA clearance.
Previous report
Batoclimab
Previous report
Endocrine Diseases
Previous report
In September 2024, we announced additional data from our proof-of-concept Phase 2 clinical trial in uncontrolled GD, which enrolled patients who remained hyperthyroid despite ATD therapy. Participants in the trial received 12 weeks of high dose batoclimab, 680 mg weekly SC followed by 12 weeks of lower dose batoclimab, 340 mg weekly SC. At the end of the first 12 weeks, participants experienced a mean IgG reduction of 77% leading to a 76% response rate (defined as T3 and T4 falling below the upper limit of normal (“ULN”) without increasing the ATD dose). Also, by the end of 12 weeks of higher dose batoclimab, 56% of subjects achieved an ATD-Free Response (defined as T3 and T4 falling below the ULN and the patient simultaneously tapering completely off their ATD). Despite benefiting from a lower starting IgG level after 12 weeks of 680 mg therapy, during weeks 13 to 24, the lower 340 mg dose of batoclimab resulted in mean IgG reduction of 65% (vs. 77% on 680 mg dose) with a correspondingly lower responder rate of 68%. In addition, a lower ATD-Free Response rate of 36% was also observed in the second 12 weeks. Finally, patients who achieved at least a 70% IgG reduction at the end of the evaluation period had nearly a threefold higher ATD-Free Response rate than those who did not (60% vs. 23%). Batoclimab was generally well tolerated with no new safety signals observed.
Previous report
In November 2024, additional incremental data observed in the study for certain thyroidal and extrathyroidal manifestations of GD were presented at the American Thyroid Association 2024 Annual Meeting. These data showed a 60% response rate achieved by week 2, demonstrating the rapidity of response to weekly higher dose batoclimab. Improvements in proptosis and lid aperture were also observed at both week 12 and week 24. This clinical trial is ongoing, with additional data expected in the summer of calendar year 2025, including remission data describing the percentage of participants that remain euthyroid and off ATD at the 24-week post-treatment follow-up period.
Previous report
Neurological Diseases
Previous report
In the quarter ended December 31, 2022, we initiated a pivotal Phase 2b trial of batoclimab as a treatment for CIDP. Enrollment is completed for patients to be included in the period 1 results, which are expected by March 31, 2025. We believe data from this batoclimab trial, combined with learning from other trials in CIDP, can be used to optimize the IMVT-1402 trial design in active CIDP patients.
Previous report
In the quarter ended June 30, 2022, we initiated our Phase 3 pivotal trial of batoclimab as a treatment for MG. Enrollment in this pivotal trial was completed in the quarter ended September 30, 2024, and we expect top-line data to be available by March 31, 2025. Further potential registrational development with IMVT-1402 is expected to begin in the same timeframe, with a final decision regarding study design to be made based on results from the current batoclimab trial.
Previous report
Acquired In-Process Research and Development Expenses
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Reworded paragraphs (27)
Previous wording
Factors that could cause or contribute to such differences include, but are not limited to, those identified herein, and those discussed in the section titled “Risk Factors” set forth in Part II, Item 1A. of this Quarterly Report and in our other filings with the SEC. These risks are not exhaustive. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.
Current wording
Factors that could cause or contribute to such differences include, but are not limited to, those identified herein, and those discussed in the section titled “Risk Factors” set forth in Part I, Item 1A. of our Annual Report and in our other filings with the SEC. These risks are not exhaustive. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.
Previous wording
Our innovative product pipeline includes IMVT-1402 and batoclimab, formerly referred to as IMVT-1401, both of which are novel, fully human monoclonal antibodies that target the neonatal fragment crystallizable receptor (“FcRn”). Our product candidates are the result of a multi-step, multi-year research program conducted in collaboration with HanAll Biopharma Co., Ltd., (“HanAll”) to design highly potent anti-FcRn antibodies that may be optimized as a simple, subcutaneous injection with dosing that we believe can be tailored based on disease stage and severity.
Current wording
IMVT-1402 and batoclimab are fully human monoclonal antibodies that target FcRn. These antibodies are the result of a multi-step, multi-year research program conducted in collaboration with HanAll to design highly potent anti-FcRn antibodies that may be optimized as a simple, subcutaneous injection with dosing that has been shown to deliver better efficacy at the high dose and similar efficacy at the low dose compared to standard FcRn inhibition by competitors.
Previous wording
Data from our Phase 2 proof-of-concept trial evaluating batoclimab in GD demonstrate the potential of FcRn inhibition for the treatment of GD by modifying the underlying disease pathology, which is driven by thyroid-stimulating hormone receptor autoantibodies (“TRAb”). In addition, the data represent strong evidence that deeper IgG reduction correlates with better clinical outcomes in GD for patients whose disease remains uncontrolled on anti-thyroid drugs (“ATDs”).
Current wording
Batoclimab Phase 2 Proof-of-Concept Trial in GD
Previous wording
In the quarter ended December 31, 2022, we initiated our Phase 3 clinical program to evaluate batoclimab as a treatment for TED. The trial is ongoing with top-line results estimated to be available in the second half of calendar year 2025, along with a decision on whether to advance batoclimab to registration in TED. Data from this trial may also inform the IMVT-1402 program in GD.
Current wording
In the quarter ended December 31, 2022, we initiated our Phase 3 clinical program to evaluate batoclimab as a treatment for active moderate-to-severe TED. We plan to report top-line results from this clinical trial in the second half of calendar year 2025.
Previous wording
Unfavorable conditions in the economy in the U.S., Canada and abroad may negatively affect the growth of our business and our results of operations. For example, macroeconomic events, including changes in inflation and interest rates, changes in trade policy and the Russia-Ukraine war and conflict in the Middle East have led to economic uncertainty globally. The effect of macroeconomic conditions may not be fully reflected in our results of operations until future periods. If, however, economic uncertainty increases or the global economy worsens, our business, financial condition and results of operations may be harmed.
Current wording
Unfavorable conditions in the economy in the U.S., Canada and abroad may negatively affect the growth of our business and our results of operations. For example, macroeconomic events, including changes in inflation and interest rates, changes in international trade policies and tariffs and geopolitical tensions, such as the Russia-Ukraine war and conflict in the Middle East, have led to economic uncertainty globally. The effect of macroeconomic conditions may not be fully reflected in our results of operations until future periods. If, however, economic uncertainty increases or the global economy worsens, our business, financial condition and results of operations may be harmed.
Previous wording
We have not generated any revenue and have incurred significant operating losses since inception, and we do not expect to generate any revenue from the sale of any products unless or until we obtain regulatory approval of and commercialize batoclimab, IMVT-1402 or any future product candidates. Our ability to generate revenue sufficient to achieve profitability will depend completely on the successful development and eventual commercialization of batoclimab, IMVT-1402 and any future product candidates.
Current wording
We have not generated any revenue and have incurred significant operating losses since inception, and we do not expect to generate any revenue from the sale of any products unless or until we obtain regulatory approval of and commercialize IMVT-1402, batoclimab or any future product candidates. Our ability to generate revenue sufficient to achieve profitability will depend completely on the successful development and eventual commercialization of IMVT-1402, batoclimab and any future product candidates.
Previous wording
•other expenses, which include the cost of consultants who assist with our research and development but are not allocated to a specific therapeutic area.
Current wording
•other expenses, which include the cost of consultants and information technology related to our research and development but are not allocated to a specific therapeutic area.
Previous wording
Research and development activities will continue to be central to our business model. We expect to incur research and development expenses as we continue our Phase 3 trial of batoclimab as a treatment for MG, our Phase 3 clinical program to evaluate batoclimab for the treatment of TED, a pivotal Phase 2b trial of batoclimab as a treatment for CIDP and a proof-of-concept Phase 2 clinical trial of batoclimab as a treatment for GD. With respect to our IMVT-1402 development activities, our Phase 1 clinical trial of IMVT-1402 in New Zealand remains open and we initiated potentially registrational trials for IMVT-1402 in GD and D2T RA. Our research and development expenses are expected to further increase as we seek to execute our plan to initiate studies evaluating IMVT-1402 in additional indications by March 31, 2025 and ultimately initiate trials of IMVT-1402 in a total of ten indications (inclusive of those programs to be initiated in fiscal 2025) by March 31, 2026. Our research and development expenses are also expected to continue to increase over the next several years as we execute IMVT-1402 trials, increase manufacturing of IMVT-1402, hire personnel and prepare to seek regulatory approval. It is not possible to determine with certainty the duration and completion costs of any clinical trial we may conduct.
Current wording
Research and development activities will continue to be central to our business model. We expect to incur research and development expenses with respect to our IMVT-1402 development activities, our Phase 1 clinical trial of IMVT-1402 in New Zealand remains open and we initiated potentially registrational trials for IMVT-1402 in GD, D2T RA, MG, CIDP and SjD, and a proof-of-concept trial in CLE. We also expect to incur research and development expenses related to our ongoing Phase 3 clinical program to evaluate batoclimab for the treatment of TED and a proof-of-concept Phase 2 clinical trial of batoclimab as a treatment for GD. We expect to continue to incur research and development expenses over the next several years as we execute IMVT-1402 trials, manufacture IMVT-1402, and prepare to seek regulatory approval. It is not possible to determine with certainty the duration and completion costs of any clinical trial we may conduct.
Previous wording
•the potential impact of macroeconomic events, including changes in inflation, interest rates and trade policy and the Russia-Ukraine war and the conflict in the Middle East;
Current wording
•the potential impact of macroeconomic events, including changes in inflation, interest rates and international trade policies and tariffs and geopolitical tensions, such as the Russia-Ukraine war and the conflict in the Middle East;
Previous wording
We anticipate that our general and administrative expenses will continue to support our ongoing research and development activities. These expenses will likely include patent-related costs, including legal and professional fees for filing, prosecution and maintenance of patents and patent applications claiming our product candidates, increased costs related to the hiring of additional personnel and fees to outside consultants for professional services. In addition, if either IMVT-1402 or batoclimab obtains regulatory approval, we expect that we would incur significant additional expenses associated with market research activities and building commercial teams.
Current wording
We anticipate that our general and administrative expenses will continue to support our ongoing research and development activities. These expenses will likely include patent-related costs, including legal and professional fees for filing, prosecution and maintenance of patents and patent applications claiming our product candidates and fees to outside consultants for professional services. In addition, if either IMVT-1402 or batoclimab obtains regulatory approval, we expect that we would incur significant additional expenses associated with market research activities and building commercial teams.
Previous wording
For the three months ended December 31, 2024, research and development expenses increased $46.2 million as compared with the prior-year period.
Current wording
For the three months ended June 30, 2025, research and development expenses increased $25.7 million as compared with the prior-year period.
Previous wording
For the three months ended December 31, 2024, therapeutic area-specific research and development costs, including contract manufacturing costs, increased $29.1 million as compared with the prior-year period. Research and development costs related to endocrine diseases, which include GD and TED, increased $8.6 million. This increase was primarily due to preparation for potential future clinical trials of IMVT-1402 in endocrine diseases and higher overall clinical trial costs related to our batoclimab Phase 3 clinical program. Research and development costs related to neurological diseases, which include MG and CIDP, increased $12.2 million. This increase was primarily due to preparation for potential future clinical trials of IMVT-1402 in neurological diseases and higher overall clinical trial costs related to our batoclimab Phase 2b and Phase 3 clinical trials. Research and development costs related to rheumatology diseases of $7.5 million in the current-year period reflected preparation for potential future clinical trials of IMVT-1402. Research and development costs related to other clinical and nonclinical activities increased $0.8 million, reflecting overall costs in preparation for future IMVT-1402 clinical programs in additional indications, partially offset by lower overall costs related to our IMVT-1402 Phase 1 trial and nonclinical studies.
Current wording
For the three months ended June 30, 2025, therapeutic area-specific research and development costs, including contract manufacturing costs, increased $15.2 million as compared with the prior-year period. Research and development costs related to endocrine diseases, which include GD and TED, increased $3.4 million. This increase was primarily due to the initiation of our potentially registrational trials of IMVT-1402 in endocrine diseases, partially offset by lower overall clinical trial costs related to our batoclimab Phase 3 clinical program. Research and development costs related to neurological diseases, which include MG and CIDP, increased $2.5 million. This increase was primarily due to the initiation of our potentially registrational trials of IMVT-1402 in neurological diseases, partially offset by lower overall clinical trial costs related to our batoclimab Phase 3 and Phase 2b clinical trials. Research and development costs related to rheumatology diseases of $8.2 million in the current-year period reflect expenses incurred with the initiation of our potentially registrational trials of IMVT-1402 in RA and SjD. Research and development costs related to dermatology diseases of $5.1 million in the current-year period reflect the initiation of our proof-of-concept trial in CLE. Research and development costs related to other clinical and nonclinical activities decreased $4.0 million, primarily reflecting the transition of IMVT-1402 clinical activities targeting specific therapeutic areas.
Previous wording
For the three months ended December 31, 2024, unallocated research and development costs increased $17.1 million as compared with the prior-year period. This increase reflected higher personnel-related expenses of $12.2 million, driven by higher headcount and enhancement of our capabilities to support our strategic objectives as we progress our clinical activities. In addition, other expenses increased $4.9 million, primarily reflecting higher costs to support our research and development activities to advance the clinical development of IMVT-1402 that are not related to a specific therapeutic area.
Current wording
For the three months ended June 30, 2025, unallocated research and development costs increased $10.5 million as compared with the prior-year period. This increase reflected higher personnel-related expenses of $10.0 million, driven by higher headcount hired to conduct a higher number of clinical trials.
Previous wording
For the three months ended December 31, 2024, general and administrative expenses increased $6.6 million as compared with the prior-year period, primarily reflecting higher personnel-related expenses, legal and other professional fees, information technology costs and market research costs.
Current wording
For the three months ended June 30, 2025, general and administrative expenses increased $7.2 million as compared with the prior-year period, primarily reflecting higher personnel-related expenses, driven by a one-time stock-based compensation charge related to the retirement of our former chief executive officer.
Previous wording
For the nine months ended December 31, 2024, interest income increased $1.3 million as compared with the prior-year period, primarily reflecting interest earned on higher money market fund balances as a result of proceeds from our October 2023 underwritten public offering and concurrent private placement.
Current wording
For the three months ended June 30, 2025, interest income decreased $0.8 million as compared with the prior-year period, primarily reflecting lower average interest rates, partially offset by higher average money market fund balances.
Previous wording
We had cash and cash equivalents of $374.7 million and $635.4 million as of December 31, 2024 and March 31, 2024, respectively. For the three months ended December 31, 2024 and 2023, we had net losses of $111.1 million and $51.4 million, respectively and for the nine months ended December 31, 2024 and 2023, we had net losses of $307.4 million and $184.0 million, respectively. We expect to continue to incur significant expenses and increasing operating losses at least for the next several years. We have never generated any revenue and we do not expect to generate product revenue unless and until we successfully complete development and obtain regulatory approval for batoclimab, IMVT-1402 or any future product candidate.
Current wording
We had cash and cash equivalents of $598.9 million and $714.0 million as of June 30, 2025 and March 31, 2025, respectively. For the three months ended June 30, 2025 and 2024, we had net losses of $120.6 million and $87.2 million, respectively. We expect to continue to incur significant expenses at least for the next several years. We have never generated any revenue and we do not expect to generate product revenue unless and until we successfully complete development and obtain regulatory approval for IMVT-1402, batoclimab or any future product candidate.
Previous wording
To date, we have financed our operations primarily from equity offerings. Until such time, if ever, as we can generate substantial product revenue from sales of batoclimab, IMVT-1402 or any future product candidate, we expect to finance our cash needs through a combination of equity offerings, debt financings and potential collaboration, license or development agreements. Our ability to raise additional capital may be adversely impacted by worsening global economic conditions and the continuing disruptions to, and volatility in, the credit and financial markets in the U.S. and worldwide, including disruptions resulting from the ongoing military conflict between Russia and Ukraine and in the Middle East, and changes in inflation, interest rates and trade policy.
Current wording
To date, we have financed our operations primarily from equity offerings. Until such time, if ever, as we can generate substantial product revenue from sales of IMVT-1402, batoclimab or any future product candidate, we expect to finance our cash needs through a combination of equity offerings, debt financings and potential collaboration, license or development agreements. Our ability to raise additional capital may be adversely impacted by worsening global economic conditions and the continuing disruptions to, and volatility in, the credit and financial markets in the U.S. and worldwide, disruptions resulting from geopolitical tensions, including the ongoing military conflict between Russia and Ukraine and in the Middle East, and changes in inflation, interest rates and international trade policies and tariffs.
Previous wording
The following table sets forth a summary of our cash flows for the nine months ended December 31, 2024 and 2023 (in thousands):
Current wording
The following table sets forth a summary of our cash flows for the three months ended June 30, 2025 and 2024 (in thousands):
Previous wording
For the nine months ended December 31, 2023, $154.5 million of cash was used in operating activities, primarily reflecting a net loss from operations for the year of $184.0 million and a net change in operating assets and liabilities of $3.0 million, partially offset by non-cash charges of $32.5 million. The non-cash charges consisted mainly of stock-based compensation of $31.4 million, reflecting the higher headcount and incentive equity awards as compared with the prior year. The change in operating assets and liabilities reflected a decrease in accrued expenses of $14.1 million, primarily reflecting payments for contract manufacturing costs. This change was partially offset by $10.1 million of lower prepaid expenses and other current assets, driven primarily by the timing of payments and services performed related to our ongoing clinical trials.
Current wording
For the three months ended June 30, 2025, $117.4 million of cash was used in operating activities, primarily reflecting a net loss from operations for the period of $120.6 million and a net change in operating assets and liabilities of $15.4 million, partially offset by non-cash charges of $18.6 million. The non-cash charges consisted mainly of stock-based compensation of $18.5 million, reflecting the higher headcount and incentive equity awards as compared with the prior year. The change in operating assets and liabilities reflected a decrease in accounts payable of $9.4 million, primarily related to payments to CROs for clinical trial costs. Accrued expenses and other current liabilities decreased $5.3 million, primarily reflecting payments related to employee incentive compensation, partially offset by the timing of payments and services related to our ongoing clinical trials.
Previous wording
For the nine months ended December 31, 2024, $265.2 million of cash was used in operating activities, primarily reflecting a net loss from operations for the period of $307.4 million, partially offset by non-cash charges of $38.2 million and a net change in operating assets and liabilities of $4.0 million. The non-cash charges consisted mainly of stock-based compensation of $37.8 million, reflecting the higher headcount and incentive equity awards as compared with the prior year. The change in operating assets and liabilities reflected an increase in accounts payable of $13.0 million, primarily related to clinical trial costs. Accrued expenses increased $7.3 million, primarily reflecting the timing of payments and services related to our ongoing clinical trials and contract manufacturing, partially offset by payments related to employee incentive compensation. In addition, accounts receivable decreased $3.1 million, reflecting the collection of amounts owed to us under research and development cost-sharing arrangements with a third party. These changes were partially offset by higher prepaid expenses and other current assets of $11.8 million, driven primarily by the timing of payments and services performed related to our ongoing and planned clinical trials, as well as an increase in other assets of $7.5 million as a result of prepaid expenses related to planned contract manufacturing activities.
Current wording
For the three months ended June 30, 2024, $76.2 million of cash was used in operating activities, primarily reflecting a net loss from operations for the period of $87.2 million and a net change in operating assets and liabilities of $2.6 million, partially offset by non-cash charges of $13.6 million. The non-cash charges consisted mainly of stock-based compensation of $13.5 million, reflecting the higher headcount and incentive equity awards as compared with the prior year. The change in operating assets and liabilities reflected a decrease in accrued expenses and other current liabilities of $7.6 million, primarily reflecting payments related to employee incentive compensation, partially offset by the timing of payments to CROs and services related to our ongoing clinical trials. In addition, prepaid expenses and other current assets increased $1.8 million, driven primarily by the timing of payments and services performed related to our ongoing and planned clinical trials. These changes were partially offset by an increase in accounts payable of $3.9 million, primarily related to contract manufacturing costs, and a decrease in accounts receivable of $2.9 million, reflecting the collection of amounts owed to us under research and development cost-sharing arrangements with a third party.
Previous wording
For the nine months ended December 31, 2024 and 2023, cash used in investing activities was related to the purchase of property and equipment.
Current wording
For the three months ended June 30, 2024, cash used in investing activities was related to the purchase of property and equipment.
Previous wording
For the nine months ended December 31, 2024, cash provided by financing activities consisted of proceeds from the exercise of stock options. For the nine months ended December 31, 2023, $470.9 million of cash provided by financing activities primarily consisted of proceeds from our October 2023 underwritten public offering and concurrent private placement of $466.7 million, combined, after deducting underwriting discounts and commissions, placement agent fees and offering expenses. Cash provided by financing activities also reflected $4.1 million of proceeds from the exercise of stock options.
Current wording
For the three months ended June 30, 2025 and 2024, cash provided by financing activities consisted of proceeds from the exercise of stock options.
Previous wording
During the year ended March 31, 2022, we entered into an agreement with Samsung to manufacture a certain quantity of batoclimab drug substance for, among other things, commercial sale, if approved. As of December 31, 2024, in connection with this agreement, we have a remaining minimum obligation to Samsung of approximately $43.6 million, of which $1.7 million, $13.5 million, $14.4 million and $14.0 million is expected to be paid during the remainder of the fiscal year ending March 31, 2025, and for the fiscal years ending March 31, 2026, 2027 and 2029, respectively. See “Note 3 - Material Agreements” in our unaudited condensed consolidated financial statements in Part I, Item 1 of this Quarterly Report for additional details.
Current wording
During the year ended March 31, 2022, we entered into an agreement with Samsung to manufacture a certain quantity of batoclimab drug substance for, among other things, commercial sale, if approved. As of June 30, 2025, in connection with this agreement, we have a remaining minimum obligation to Samsung of approximately $43.1 million, of which $5.0 million, $10.1 million, $14.0 million and $14.0 million is expected to be paid during the remainder of the fiscal year ending March 31, 2026, and for the fiscal years ending March 31, 2028, 2029 and 2030, respectively. See “Note 3 - Material Agreements” in our unaudited condensed consolidated financial statements in Part I, Item 1 of this Quarterly Report for additional details.
Previous wording
Potential future payments due under the HanAll Agreement are contingent upon future events. As of December 31, 2024, the aggregate maximum amount of milestone payments we could be required to make under the HanAll Agreement is $420.0 million (after an aggregate amount of $32.5 million paid for milestone events achieved as of December 31, 2024) upon the achievement of certain regulatory and sales milestone events. During the quarter ended June 30, 2023, we achieved our third and fourth development and regulatory milestones under the HanAll Agreement and made a $12.5 million milestone payment in the quarter ended September 30, 2023 in accordance with the terms of the agreement.
Current wording
Potential future payments due under the HanAll Agreement are contingent upon future events. As of June 30, 2025, the aggregate maximum amount of milestone payments we could be required to make under the HanAll Agreement is $420.0 million (after an aggregate amount of $32.5 million paid for milestone events achieved as of June 30, 2025) upon the achievement of certain regulatory and sales milestone events.
Previous wording
We currently expect that our existing cash and cash equivalents as of December 31, 2024 of $374.7 million, together with the gross proceeds of $450.0 million from our private placement in January 2025 discussed above, will be sufficient to fund our operating expenses and capital expenditure requirements for at least the next 12 months from the date of the filing of this Quarterly Report and in the long term beyond the next 12 months.
Current wording
We currently expect that our existing cash and cash equivalents as of June 30, 2025 of $598.9 million will be sufficient to fund our operating expenses and capital expenditure requirements for announced indications to date through our GD readout expected in 2027.
Previous wording
We anticipate that our short-term and long-term future capital requirements will increase substantially as we:
Current wording
We anticipate that our short-term and long-term future capital requirements will increase as we:
Previous wording
We define our critical accounting estimates as those under U.S. GAAP that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. During the three and nine months ended December 31, 2024, there were no material changes to our critical accounting estimates from those disclosed in the audited consolidated financial statements for the year ended March 31, 2024 included in our Annual Report.
Current wording
We define our critical accounting estimates as those under U.S. GAAP that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. During the three months ended June 30, 2025, there were no material changes to our critical accounting estimates from those disclosed in the audited consolidated financial statements for the year ended March 31, 2025 included in our Annual Report.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
The following table sets forth our results of operations for the nine months ended December 31, 2024 and 2023 (in thousands):
Previous report — wording carried elsewhere
The following table summarizes the period-over-period changes in research and development expenses for the nine months ended December 31, 2024 and 2023 (in thousands):
Previous report — wording carried elsewhere
*Certain prior year amounts have been reclassified to conform to current year presentation.
Previous report — wording carried elsewhere
For the nine months ended December 31, 2024, therapeutic area-specific research and development costs, including contract manufacturing costs, increased $76.6 million as compared with the prior-year period. Research and development costs related to endocrine diseases, which include GD and TED, increased $24.8 million. This increase was primarily due to preparation for potential future clinical trials of IMVT-1402 in endocrine diseases and higher overall clinical trial costs related to our batoclimab Phase 3 clinical program. Research and development costs related to neurological diseases, which include MG and CIDP, increased $43.7 million. This increase was primarily due to preparation for potential future clinical trials of IMVT-1402 in neurological diseases and higher overall clinical trial costs related to our batoclimab Phase 3 clinical trial. Research and development costs related to rheumatology diseases of $14.7 million in the current-year period reflected preparation for potential future clinical trials of IMVT-1402. Research and development costs related to other clinical and nonclinical activities decreased $6.6 million, reflecting lower overall costs related to our IMVT-1402 Phase 1 trial and nonclinical studies, partially offset by overall costs in preparation for future IMVT-1402 clinical programs in additional indications.