Immunovant Inc
For the period ended Mar 31, 2025. Filed May 29, 2025.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed May 29, 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-K
Period ended 2024-03-31; filed 2024-05-29.
0001764013-24-000109
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent report: 10-K
Period ended 2025-03-31; filed 2025-05-29.
0001764013-25-000092
ITEM 7. 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.
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Added paragraphs (47)
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 future development and regulatory submissions for batoclimab in the future based on the aggregate information available at the time.
Current report
We are currently progressing a broad set of programs for IMVT-1402. Over the last fiscal year, we announced the clearance of six investigational new drug (“IND”) applications to support clinical trials to evaluate IMVT-1402. We have initiated studies in five indications, including potentially registrational trials in GD, difficult-to-treat rheumatoid arthritis (“D2T RA”), MG and CIDP, and a proof-of-concept trial in cutaneous lupus erythematosus (“CLE”). We also plan to initiate a potentially registrational trial evaluating IMVT-1402 in Sjögren’s disease (“SjD”) and a second potentially registrational trial in GD in the summer of 2025. 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
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. In March 2025, we announced top-line results of our Phase 3 study of batoclimab in MG, which met its primary endpoint of change in the Myasthenia Gravis Activities of Daily Living (“MG-ADL”) score from baseline in acetylcholine receptor antibody positive (“AChR+”) patients. The 680 mg dose set a new benchmark for magnitude of benefit with a 5.6 point mean improvement and 93% MG-ADL response rate. Batoclimab demonstrated strong durability of Minimal Symptom Expression (MG-ADL = 0 or 1) (“MSE”) with 75% of patients who achieved MSE on 680 mg dose by week 6 maintaining MSE status for ≥ 6 weeks. On the same day, we also announced the initial results from period 1 of the Phase 2b study of batoclimab in CIDP following standard of care washout, which demonstrated a mean improvement in the adjusted inflammatory neuropathy cause and treatment (“aINCAT”) disability score of 1.8 across batoclimab arms and an 84% responder rate in those patients who achieved an IgG lowering greater than or equal to 70%. In both batoclimab studies, deeper IgG reductions correlated with better clinical outcomes across a range of assessments and timepoints. IMVT-1402 600 mg dosing was observed in its Phase 1 trial to have similarly deep IgG reductions to batoclimab 680 mg dosing, supporting IMVT-1402 development in these indications, without the albumin and LDL side effects observed with batoclimab. To add to the strong data sets we have previously reported with batoclimab in GD and TED, we expect to report six-month remission data in GD this summer and Phase 3 TED data in the second half of calendar year 2025.
Current report
Endocrine Diseases
Current report
Batoclimab Phase 2 Proof-of-Concept Trial in GD
Current report
In December 2023 and September 2024, we announced results from a proof-of-concept Phase 2 clinical trial (NCT05907668) of batoclimab for the treatment of uncontrolled GD, which enrolled subjects who were hyperthyroid despite ATD therapy. This study represents the first evaluation of an FcRn inhibitor as a potential treatment for GD.
Current report
Participants in the trial received 12 weeks of high dose batoclimab, 680 mg weekly by subcutaneous injection (“SC”), followed by 12 weeks of lower dose batoclimab, 340 mg weekly SC. At the end of the first 12 weeks, a mean IgG reduction of 77% and a 76% response rate (defined as T3 and T4 falling below the upper limit of normal (“ULN”) without increasing the ATD dose) were observed. Also, 56% of subjects treated with higher dose batoclimab achieved an ATD-Free Response (defined as T3 and T4 falling below the ULN and the patient simultaneously tapering completely off their ATD) at the end of the first 12 weeks. During weeks 13 to 24, lower 340 mg dose batoclimab resulted in mean IgG reduction of 65% with a correspondingly lower responder rate of 68% and a lower ATD-Free Response rate of 36% at the end of the second 12 weeks. 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%). Additional data for certain thyroidal and extrathyroidal manifestations of GD 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. Batoclimab was generally well tolerated with no new safety signals observed. This clinical trial is ongoing, with additional data expected in the summer of calendar year 2025, including remission data from the 24-week post-treatment follow-up period.
Current report
IMVT-1402 Potentially Registrational Trials in GD
Current report
We initiated a potentially registrational trial evaluating IMVT-1402 in adults with GD in December 2024. This Phase 2b study (NCT06727604) is a randomized, placebo-controlled, 52-week trial in Graves’ patients who are hyperthyroid despite treatment with an ATD for 12 or more weeks prior to beginning the study. The study is expected to enroll approximately 240 participants randomized (1:1:1) to one of two blinded treatment groups each receiving IMVT-1402, 600 mg weekly 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 IMVT-1402 treatment group 2 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 thyroid-stimulating hormone receptor autoantibodies (“TRAb”) value and euthyroid status determined at week 26. The study’s primary endpoint is 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. We expect to report top-line results from this trial in 2027.
Current report
In the summer of 2025, we plan to initiate a second potentially registrational trial evaluating IMVT-1402 in adults with GD. This study is a randomized, placebo-controlled, 26-week trial in Graves’ patients who are hyperthyroid despite treatment with an ATD for 12 or more weeks prior to beginning the study. The study is expected to enroll approximately 210 participants randomized (1:1:1) to one of three blinded treatment groups receiving IMVT-1402 600 mg weekly SC, IMVT-1402 300 mg weekly SC, or matched placebo group. 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. The study’s primary endpoint is the proportion of participants in the 600 mg weekly SC dose group who are euthyroid and are off ATD versus placebo at study week 26. A key secondary endpoint will measure the proportion of participants in the 600 mg weekly SC dose group who have T3 (Total T3 or FT3) and FT4 ≤ULN and are off ATD versus placebo.
Current report
Batoclimab Phase 3 Clinical Program in TED
Current report
Neurological Diseases
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Batoclimab Phase 3 Trial in MG
Current report
In March 2025, we announced top-line results from a randomized, quadruple-blind, placebo-controlled Phase 3 trial (NCT05403541) to assess the efficacy and safety of batoclimab in adults with MG. Following screening, participants with moderate to severe MG were randomized into Period 1 where they received high dose batoclimab (680 mg) or low dose batoclimab (340 mg) or placebo weekly SC for 12 weeks. Responders to batoclimab in Period 1, defined in the protocol as ≥ 2-point improvement in the MG-ADL score from baseline, were re-randomized 1:1:1 to batoclimab (340 mg SC weekly or 340 mg SC every other week) or placebo weekly SC for 12 weeks (Period 2). The primary endpoint of the study was mean change from baseline in MG-ADL in AChR+ participants at week 12 (end of Period 1).
Current report
Batoclimab met its primary endpoint of mean change from baseline in MG-ADL in AChR+ participants. Among the AChR+ population, participants randomized to 680 mg of batoclimab administered weekly SC (“QW”) achieved a 5.6 point mean improvement in MG-ADL at week 12 (n=57; p < 0.001), while those randomized to 340 mg of batoclimab QW achieved a 4.7 point mean improvement (n=52; p < 0.05) and those randomized to placebo demonstrated a 3.6 point mean improvement (n=55; p < 0.05). 93% of AChR+ participants receiving batoclimab 680 mg QW achieved an MG-ADL response at week 12. Subjects in the 680 mg batoclimab treatment arm showed a mean reduction in IgG levels of 74% vs. 64% in the 340 mg batoclimab arm. 42% of the AChR+ subjects treated with batoclimab 680 mg QW achieved MSE, defined as having an MG-ADL score of 0 or 1 at week 12. Of those subjects that achieved MSE prior to or by week 6, 75% maintained their MSE status for ≥ 6 weeks. Safety and tolerability were observed to be consistent with prior batoclimab studies.
Current report
We are planning to leverage the data and learnings from the batoclimab MG study, including our operational trial experience, relationships with investigators and prior results, to inform and accelerate our program with IMVT-1402.
Current report
IMVT-1402 Potentially Registrational Trial in MG
Current report
We initiated a potentially registrational trial evaluating IMVT-1402 in adults with MG in March 2025. This Phase 3 trial is a randomized, placebo-controlled, 26-week trial. This study is expected to enroll approximately 230 participants randomized (1:1:1) to one of three blinded treatment groups receiving IMVT-1402 600 mg weekly SC, IMVT-1402 300 mg weekly SC, or matched placebo group for the 12-week induction period. Participants on treatment will continue to be on the same treatment for the 14-week maintenance period, while patients on placebo will receive IMVT-1402 600 mg weekly SC. The study’s primary endpoint is the change in MG-ADL from baseline at week 12. We expect to report top-line results from this trial in 2027.
Current report
Batoclimab Phase 2b Trial in CIDP
Current report
In March 2025, we announced initial results from Period 1 of the randomized, quadruple-blind, placebo-controlled Phase 2b trial designed to assess the efficacy and safety of batoclimab in adult patients with active CIDP (NCT05581199). To ensure the enrollment of patients with active CIDP, the trial design incorporates inclusion criteria tied to active disease and a formal adjudication committee, as well as a washout phase during which participants must worsen by at least 1 point on the aINCAT disability scale to remain in the trial. Period 1 was a non-placebo controlled 12-week run-in period, during which participants whose disease had worsened during standard of care washout then received either 340 mg or 680 mg batoclimab QW SC.
Current report
Combined data for 73 patients (both dose cohorts of Period 1) demonstrated a 1.8-point improvement in aINCAT disability score (compared to Period 1 baseline) at week 12. An 84% responder rate (with response defined as an aINCAT score improvement ≥ 1) was observed among all patients whose level of IgG was reduced by ≥ 70% as compared to 44% among patients with < 70% IgG reductions. Other CIDP scales also demonstrated meaningful improvements for the pooled dose cohorts at week 12. The study remains blinded and is ongoing. No new safety signals were observed.
Current report
We are planning to leverage the data and learnings from the batoclimab CIDP study, including our operational trial experience, relationships with investigators and prior results, to inform and accelerate our program with IMVT-1402.
Current report
IMVT-1402 Potentially Registrational Trial in CIDP
Current report
We initiated a potentially registrational trial evaluating IMVT-1402 in adults with CIDP in March 2025. This Phase 2b trial is a randomized, placebo-controlled, 24-week trial in CIDP patients. The study is expected to enroll approximately 162 participants randomized (2:1) to one either receiving IMVT-1402 600 mg weekly SC, or matched placebo for the 24-week treatment period. The study’s primary endpoint will evaluate the proportion of participants remaining relapse free (aINCAT) at week 24. We expect to report top-line results from this trial in 2028.
Current report
Rheumatology Diseases
Current report
IMVT-1402 Potentially Registrational Trial in D2T RA
Current report
We initiated a potentially registrational trial evaluating IMVT-1402 in ACPA-positive D2T RA in December 2024. This 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 two or three (but no more than three) classes of biologics or targeted synthetic DMARDs. The study will evaluate IMVT-1402’s 600 mg weekly SC 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 response criteria 20 (“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. 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 plan to initiate a potentially registrational trial evaluating IMVT-1402 in SjD in the summer of 2025. This trial (NCT06979531) is a randomized, double-blind, placebo controlled, parallel-group study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with moderate to severe systemic primary SjD. The trial is anticipated to enroll approximately 180 participants randomized in a 1:1:1 ratio to receive IMVT-1402 600 mg, IMVT-1402 300 mg or placebo weekly SC for two 24-week blinded treatment periods. The primary endpoint will assess the efficacy of IMVT-1402 compared to placebo as assessed by ClinESSDAI score at week 24. Participants assessed as responders at week 24, defined as participants that show an improvement of ≥ 4 points from baseline ClinESSDAI score, will continue on treatment for a second 24-week period. A key secondary endpoint will assess change from baseline in ClinESSDAI score at week 48. 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 of IMVT-1402 in CLE in February 2025. This Phase 2b trial (NCT06980805) is a randomized, double-blind, placebo-controlled trial to assess the safety, tolerability and efficacy of IMVT-1402 in participants with active SCLE and/or CCLE with or without systemic manifestations. This trial is anticipated to enroll approximately 56 participants randomized 1:1 to IMVT-1402 600 mg QW SC or placebo QW SC for 12 weeks during Period 1. Participants who complete Period 1 will enter Period 2, during which all participants will receive IMVT-1402 600 mg QW SC for 14 weeks. After completion of Period 2, participants will be rerandomized 1:1 to blinded IMVT-1402 300 mg or 600 mg SC QW for 26 weeks. The primary endpoint will evaluate the efficacy of IMVT-1402 compared to placebo based on percent change from Period 1 baseline in CLASI-A score at week 12. We expect to report top-line results from this trial in 2026.
Current report
For more information on our clinical trials, refer to Part I, Item 1. Business, “Overview.”
Current report
*Certain prior year amounts have been reclassified to conform to current year presentation.
Current report
Fiscal 2025 vs. Fiscal 2024
Current report
For the year ended March 31, 2025, research and development expenses increased $148.0 million as compared with the prior year.
Current report
For the year ended March 31, 2025, therapeutic area-specific research and development costs, including contract manufacturing costs, increased $91.1 million as compared with the prior year. Research and development costs related to endocrine diseases, which include GD and TED, increased $29.9 million. This increase was primarily due to preparation and initiation of our potentially registrational trial 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 $52.2 million. This increase was primarily due to preparation for our potentially registrational clinical trials of IMVT-1402 in neurological diseases and higher overall clinical trial costs related to our batoclimab Phase 3 and Phase 2b clinical trials. Research and development costs related to rheumatology diseases of $23.9 million in the current year reflected the initiation of our potentially registrational trial of IMVT-1402 in RA, as well as preparation for our potentially registrational trial of IMVT-1402 in SjD. Research and development costs related to dermatology diseases of $15.6 million in the current year reflected the initiation of our proof-of-concept trial in CLE. Research and development costs related to other clinical and nonclinical activities decreased $30.5 million, reflecting the current year transition to clinical activities targeting specific therapeutic areas, as well as lower overall costs related to our IMVT-1402 Phase 1 trial and nonclinical studies.
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Removed paragraphs (30)
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 and neurology. 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”). 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 studies and trials to inform and 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. We believe these attributes will drive patient preference and market adoption. 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 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, neurology, endocrinology, hematology, rheumatology, and dermatology. 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 derived from studies with batoclimab and from studies with other FcRn inhibitors, both approved and in development. Following a recently completed Type B meeting with the U.S. Food and Drug Administration (“FDA”), we are on track to initiate four to five potentially registrational programs for IMVT-1402 in several therapeutic areas, including endocrinology and neurology, 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. The current development program for batoclimab remains important, in particular for accelerating and optimizing the registrational development program of IMVT-1402. In addition, we expect to achieve financial efficiencies in our IMVT-1402 development program by taking advantage of batoclimab data and by applying learning from publicly disclosed in-class competitor data and trial designs.
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 Investigational New Drug (“IND”) application for IMVT-1402, our next generation FcRn inhibitor. Concurrently, 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. In the quarter ended September 30, 2023, we announced initial data from this Phase 1 clinical trial of IMVT-1402, which is a randomized, double-blind, placebo-controlled ascending dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IMVT-1402 in healthy adults.
Previous report
In the single-ascending dose portion of the study, IMVT-1402 was administered subcutaneously and demonstrated a consistent reduction in IgG with potency that was similar to that of batoclimab as observed in our original Phase 1 trial of batoclimab. No or minimal reductions in albumin and no or minimal increases in LDL cholesterol levels were observed in healthy adults administered IMVT-1402 in the single-ascending dose portion of the study; the changes in albumin and LDL were similar to those observed with placebo administration.
Previous report
We also announced initial multiple-ascending dose (“MAD”) results for the 300 mg cohort. After four weekly 300 mg subcutaneous doses of IMVT-1402, we observed a statistically significant reduction of 63% from baseline in mean total IgG levels, with no or minimal reductions in albumin and no or minimal increases in LDL cholesterol levels observed; the changes in albumin and LDL were similar to those observed with placebo administration.
Previous report
In the quarter ended December 31, 2023, we announced initial MAD results from the cohort of participants receiving a weekly subcutaneous dose of 600 mg IMVT-1402. After four weekly subcutaneous doses of IMVT-1402, we observed a statistically significant reduction of 74% from baseline in mean total IgG levels, similar to the 76% reduction in mean total IgG levels observed in the Phase 1 trial of batoclimab after four weekly doses of 680 mg given subcutaneously. After four weekly subcutaneous doses of 600 mg IMVT-1402, no or minimal reductions in albumin and no or minimal increases in LDL cholesterol levels were observed; the changes in albumin and LDL were similar to those observed with placebo administration.
Previous report
Across all doses evaluated, treatments with IMVT-1402 were generally well tolerated, with only mild or moderate treatment-emergent adverse events observed.
Previous report
Based on the strength of its potential best-in-class profile, we plan to pursue studies with IMVT-1402 in endocrinology, neurology 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
We expect to announce an overview of our development program for IMVT-1402 in GD in the fall of calendar year 2024, supported by additional data from the batoclimab proof-of-concept study in GD that will be disclosed at the same time.
Previous report
We may transition our registrational development program for CIDP from batoclimab to IMVT-1402 and the pivotal study with IMVT-1402 in CIDP may be optimized based on unblinded batoclimab CIDP data available before March 31, 2025. We may also transition our registrational development programs for MG and thyroid eye disease (“TED”) from batoclimab to IMVT-1402, with a final decision for these programs contingent on top-line data from the batoclimab studies in these indications. We expect to report top-line data from the batoclimab MG study by March 31, 2025 with potential registrational development for MG expected to transition from batoclimab to IMVT-1402 in the same timeframe. A decision regarding which asset to advance to registration in TED will be made in the first half of calendar year 2025 together with disclosing top-line data from the current batoclimab TED program.
Previous report
Batoclimab
Previous report
In the quarter ended June 30, 2023, we initiated a proof-of-concept Phase 2 clinical trial in GD in Germany and in the quarter ended December 31, 2023, we announced initial results from this trial. Consistent with studies of batoclimab in other indications, subcutaneous doses of 680 mg administered in the initial cohort demonstrated potential best-in-class IgG reduction, up to 87%, with a mean IgG reduction of 81% after 12 weeks of treatment. The 340 mg IgG reductions were lower.
Previous report
Similar to changes in IgG levels, deeper reductions in anti-thyroid stimulating hormone receptor autoantibodies were also observed following treatment with subcutaneous doses of 680 mg of batoclimab as compared to subcutaneous doses of 340 mg of batoclimab. In addition, across a range of clinical parameters, numerically higher responses were observed following treatment with 680 mg of batoclimab as compared to treatment with 340 mg of batoclimab. These parameters included the percentage of patients whose antithyroid drug (“ATD”) dose was reduced and the percentage of patients whose ATD was discontinued. Batoclimab was generally well tolerated with no new safety signals observed in the initial data set. This Phase 2 clinical trial is ongoing, with additional proof-of-concept data, as well as an overview of our development program for IMVT-1402 in GD, expected to be announced in the fall of calendar year 2024.
Previous report
In the quarter ended December 31, 2022, we initiated a pivotal Phase 2b trial of batoclimab as a treatment for CIDP. To better ensure that we can optimize the level of disease activity and patient population for an IMVT-1402 clinical trial, we have decided to run the batoclimab CIDP trial approximately two quarters longer prior to unblinding period 1 of this study. We believe this will better ensure that the data from the batoclimab trial, combined with learning from the other CIDP trials, can be used to optimize the IMVT-1402 CIDP trial design in active CIDP prior to March 31, 2025.
Previous report
In the quarter ended June 30, 2022, we initiated our phase 3 pivotal trial of batoclimab as a treatment for MG. 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 to be made based on results from the current batoclimab trial.
Previous report
Research and development expenses increased by $52.7 million, from $160.3 million for the year ended March 31, 2023 to $212.9 million for the year ended March 31, 2024.
Previous report
Research and development costs related to the development of IMVT-1402 increased by $32.8 million, from $10.3 million for the year ended March 31, 2023 to $43.1 million for the year ended March 31, 2024. This increase primarily reflected higher contract manufacturing costs and costs related to our Phase 1 clinical trial and pre-clinical study.
Previous report
In October 2023, we completed an underwritten public offering of 8,475,500 shares of our common stock (including 1,526,316 shares of common stock purchased by Roivant Sciences Ltd. (“RSL”) on the same terms as other investors in the offering and the full exercise of the underwriters’ option to purchase 1,105,500 additional shares of common stock) at a price to the public of $38.00 per share. Concurrent with the public offering, RSL purchased 4,473,684 shares of our common stock in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended, at the same price per share as investors in the public offering. The net proceeds to us were approximately $466.7 million after deducting underwriting discounts and commissions, placement agent fees and offering expenses.
Previous report
Lease Agreements
Previous report
In June 2020, we entered into two sublease agreements with RSI for two floors of office space in New York, which expired on February 27, 2024 and April 29, 2024, respectively. In March 2024, we entered into a short-term lease agreement with an unrelated party for office space in New York.
Previous report
In March 2022, we entered into a lease agreement with an unrelated party for office space in a building in North Carolina that was scheduled to expire on March 31, 2024. In February 2024, we amended the lease agreement to extend the non-cancelable lease term through March 31, 2025. The amended lease agreement includes an option at our election to renew for one additional year.
Previous report
Our future minimum lease payments as of March 31, 2024 totaled $0.6 million.
Previous report
For more information on our leases, see Part II, Item 8. Financial Statements and Supplementary Data, Note 9 –Leases.
Previous report
Research and Development and Acquired In-Process Research and Development Expenses
Reworded paragraphs (28)
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 severity and stage.
Current wording
IMVT-1402 and batoclimab are fully human monoclonal antibodies that target the neonatal fragment crystallizable receptor (“FcRn”). These antibodies 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 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
In the quarter ended December 31, 2022, we initiated our Phase 3 clinical program to evaluate batoclimab as a treatment for TED. We expect top-line results to be available in the first half of calendar year 2025, along with a decision on whether to advance batoclimab to registration in TED or pursue IMVT-1402 in this indication.
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 the post-COVID-19 environment, changes in inflation, the U.S. Federal Reserve raising interest rates, potential recession in the U.S., recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures 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
For a description of our transactions under the Product Service Agreement and Master Services Agreement with Samsung Biologics Co., Ltd., refer to Part II, Item 8. Financial Statements and Supplementary Data, Note 3 – Material Agreements and Note 10 – Commitments and Contingencies.
Current wording
For a description of our transactions under the Product Service Agreement and Master Services Agreement with Samsung Biologics Co., Ltd. (“Samsung”), refer to Part II, Item 8. Financial Statements and Supplementary Data, Note 3 – Material Agreements and Note 10 – Commitments and Contingencies.
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
We have been primarily engaged in preparing for and conducting clinical trials. Research and development expenses include program-specific costs, as well as unallocated costs, and are net of costs reimbursable to the Company pursuant to cost-sharing arrangements with third parties.
Current wording
We have been primarily engaged in preparing for and conducting clinical trials. Research and development expenses include therapeutic area-specific costs, as well as unallocated costs, and are net of costs reimbursable to the Company pursuant to cost-sharing arrangements with third parties.
Previous wording
Program-specific costs include direct third-party costs, which include expenses incurred under agreements with contract research organizations and the cost of consultants who assist with the development of our product candidates on a program-specific basis, investigator grants, sponsored research, and any other third-party expenses directly attributable to the development of the product candidates. Program-specific costs also include contract manufacturing costs in connection with producing materials for use in conducting preclinical and clinical studies, including under our agreement with Samsung, to the extent they can be allocated to a specific program.
Current wording
Therapeutic area-specific costs include direct third-party costs, which include expenses incurred under agreements with contract research organizations and the cost of consultants who assist with the development of our product candidates with respect to a specific therapeutic area, investigator grants, sponsored research, and any other third-party expenses directly attributable to the development of the product candidates. Therapeutic area-specific costs also include contract manufacturing costs in connection with producing materials for use in conducting nonclinical and clinical studies, including under our agreements with Samsung, to the extent they can be allocated to a specific therapeutic area.
Previous wording
•personnel-related expenses for research and development personnel, which includes employee-related expenses such as salaries, benefits and other staff-related costs;
Current wording
•personnel-related expenses for research and development personnel, which include employee-related expenses such as salaries, benefits and other staff-related costs;
Previous wording
•other expenses, which include the cost of consultants who assist with our research and development and costs related to contract manufacturing, but are not allocated to a specific program.
Current 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.
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. In addition, we are continuing our Phase 1 clinical trial of IMVT-1402 in healthy adults in New Zealand. We expect our research and development expenses to increase as we seek to execute our plan to initiate four to five potentially registrational programs for IMVT-1402 by March 31, 2025 and initiate trials of IMVT-1402 in ten indications (inclusive of the four to five programs initiated in fiscal 2025) by March 31, 2026. Our research and development expenses are expected to continue to increase over the next several years as we hire personnel and our compensation costs increase, commence additional clinical trials for IMVT-1402, increase manufacturing of IMVT-1402 and batoclimab drug substance and drug product and prepare to seek regulatory approval for our product candidates. 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 as we continue our 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. 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 and CIDP and a proof-of-concept trial in CLE. We also plan to initiate a potentially registrational trial evaluating IMVT-1402 in SjD and a second potentially registrational trial evaluating IMVT-1402 in GD. 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.
Previous wording
•the potential impact of macroeconomic events, including the post-COVID-19 environment, changes in inflation, the U.S. Federal Reserve raising interest rates, potential recession in the U.S., recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures 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, 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.
Previous wording
Batoclimab program-specific research and development costs, including contract manufacturing costs for drug substance process performance qualification activities, decreased by $4.2 million, from $78.5 million for the year ended March 31, 2023 to $74.3 million for the year ended March 31, 2024. Program costs related to neurological diseases, which include MG and CIDP, decreased $11.0 million, primarily reflecting higher overall clinical trial costs in the prior-year period that included upfront and start-up costs for our Phase 3 and Phase 2b clinical trials. Program costs related to endocrine diseases, which include TED and GD, increased $6.8 million, primarily reflecting higher clinical trial costs, due in part to the initiation of our proof-of-concept Phase 2 clinical trial.
Current wording
For the year ended March 31, 2024, therapeutic area-specific research and development costs, including contract manufacturing costs for drug substance process performance qualification activities, increased $30.0 million as compared with the prior year. Research and development costs related to endocrine diseases, which include TED and GD, increased $6.8 million, primarily reflecting higher clinical trial costs, due in part to the initiation of our batoclimab proof-of-concept Phase 2 clinical trial. Research and development costs related to neurological diseases, which include MG and CIDP, decreased $11.0 million, primarily reflecting higher overall batoclimab clinical trial costs in the prior year that included upfront and start-up costs for our Phase 3 and Phase 2b clinical trials. Research and development costs related to other clinical and nonclinical activities increased $34.3 million, primarily reflecting higher IMVT-1402 contract manufacturing costs and costs related to our IMVT-1402 Phase 1 clinical trial and pre-clinical study.
Previous wording
Unallocated research and development costs increased by $24.1 million, from $71.5 million for the year ended March 31, 2023 to $95.6 million for the year ended March 31, 2024. This increase reflected higher personnel-related expenses of $25.2 million, primarily reflecting higher headcount and enhancement of our capabilities to support our strategic objectives as we progress our clinical activities in existing and new indications. Partially offsetting this increase were lower costs related to cross-indication research and development activities supporting IMVT-1402 and batoclimab programs of $1.2 million, primarily reflecting our shift to project-related activities to advance the clinical development of batoclimab, including our clinical trials in MG, TED, CIDP and GD, and IMVT-1402.
Current wording
For the year ended March 31, 2024, unallocated research and development costs increased $22.6 million as compared with the prior year. This increase reflected higher personnel-related expenses of $24.5 million, primarily reflecting higher headcount and enhancement of our capabilities to support our strategic objectives to progress our clinical activities in existing and new indications. Partially offsetting this increase were lower costs related to cross-indication research and development activities supporting IMVT-1402 and batoclimab programs of $1.9 million, primarily reflecting our shift to project-related activities to advance the clinical development of batoclimab, including our clinical trials in MG, TED, CIDP and GD, and IMVT-1402.
Previous wording
During the years ended March 31, 2024 and 2023, acquired in-process research and development expenses were $12.5 million and $10.0 million, respectively, related to the achievement of development and regulatory milestones for batoclimab under the terms of the HanAll Agreement.
Current wording
There were no acquired in-process research and development expenses for the year ended March 31, 2025. During the years ended March 31, 2024 and 2023, acquired in-process research and development expenses were $12.5 million and $10.0 million, respectively, related to the achievement of development and regulatory milestones for batoclimab under the terms of the HanAll Agreement.
Previous wording
General and administrative expenses increased by $9.3 million, from $48.0 million for the year ended March 31, 2023 to $57.3 million for the year ended March 31, 2024. The increase was primarily related to higher personnel-related expenses, market research costs, legal and other professional fees and information technology costs.
Current wording
For the year ended March 31, 2025, general and administrative expenses increased $20.0 million from the year ended March 31, 2024, primarily reflecting higher personnel-related expenses, professional fees, information technology costs and market research costs. For the year ended March 31, 2024, general and administrative expenses increased $9.3 million from the year ended March 31, 2023, primarily reflecting higher personnel-related expenses, market research costs, legal and other professional fees and information technology costs.
Previous wording
Interest income increased by $17.4 million, from $7.6 million for the year ended March 31, 2023 to $24.9 million for the year ended March 31, 2024, 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 year ended March 31, 2025, interest income decreased $0.2 million as compared with the year ended March 31, 2024, primarily reflecting lower average money market balances throughout the year, mostly offset by interest earned on money market fund balances as a result of the proceeds from our January 2025 private placement. For the year ended March 31, 2024, interest income increased $17.4 million as compared with the year ended March 31, 2023, 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.
Previous wording
We had cash and cash equivalents of $635.4 million and $376.5 million as of March 31, 2024 and 2023, respectively. For the years ended March 31, 2024 and 2023, we had net losses of $259.3 million and $211.0 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 $714.0 million and $635.4 million as of March 31, 2025 and 2024, respectively. For the years ended March 31, 2025, 2024 and 2023 we had net losses of $413.8 million, $259.3 million and $211.0 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 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, the post-COVID-19 environment, changes in inflation, heightened interest rates and recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures.
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
On November 9, 2023, we entered into a sales agreement with Leerink Partners LLC (“Leerink Partners”), as sales agent, pursuant to which we may offer and sell, from time to time, shares of our common stock (the “ATM Shares”), subject to certain conditions as specified in the sales agreement. We agreed to pay Leerink Partners up to 3% of the gross proceeds from each sale of ATM Shares sold through the sale agreement. The ATM Shares would be sold at prevailing market prices at the time of the sale and, as a result, prices may vary. The ATM Shares to be sold under the sales agreement, if any, would be issued and sold pursuant to an automatic shelf registration statement on Form S-3, which we filed with the SEC on November 9, 2023, along with a prospectus supplement relating to the offer and sale of up to $150.0 million of ATM Shares pursuant to the sales agreement. We have not issued or sold any ATM Shares pursuant to the ATM offering program.
Current wording
We have a sales agreement with Leerink Partners LLC (“Leerink Partners”), as sales agent, pursuant to which we may offer and sell, from time to time, shares of our common stock (the “ATM Shares”), subject to certain conditions as specified in the sales agreement. We agreed to pay Leerink Partners up to 3% of the gross proceeds from each sale of ATM Shares sold through the sales agreement. The ATM Shares would be sold at prevailing market prices at the time of the sale and, as a result, prices may vary. The ATM Shares to be sold under the sales agreement, if any, would be issued and sold pursuant to an automatic shelf registration statement on Form S-3, which we filed with the SEC on November 9, 2023, along with a prospectus supplement relating to the offer and sale of up to $150.0 million of ATM Shares pursuant to the sales agreement. We have not issued or sold any ATM Shares pursuant to the ATM offering program.
Previous wording
For the years ended March 31, 2024 and 2023, cash used in investing activities was related to the purchase of computer equipment.
Current wording
For the years ended March 31, 2025, 2024 and 2023, cash used in investing activities was related to the purchase of equipment for our expanded workforce.
Previous wording
Our primary uses of capital have been, and we expect will continue to be, for advancing our clinical and preclinical development programs. We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Our net losses and operating cash flows may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our planned clinical trials, timing of IMVT-1402 or batoclimab manufacturing, HanAll milestone payments and our expenditures on other research and development activities.
Current wording
Our primary uses of capital have been, and we expect will continue to be, for advancing our clinical and nonclinical development programs. We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Our net losses and operating cash flows may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our planned clinical trials, timing of IMVT-1402 or batoclimab manufacturing, HanAll milestone payments and our expenditures on other research and development activities.
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 March 31, 2024, in connection with this agreement, we have a remaining minimum obligation to Samsung of approximately $46.2 million, which $3.6 million, $11.7 million, $16.9 million and$14.0 million is expected to be paid during the fiscal years ending March 31, 2025, 2026, 2027 and 2029, respectively. See Part II, Item 8. Financial Statements and Supplementary Data, Note 3 – Material Agreements 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 March 31, 2025, in connection with this agreement, we have a remaining minimum obligation to Samsung of approximately $43.6 million, ofwhich $5.5 million, $10.1 million, $14.0 million and$14.0 million is expected to be paid during the fiscal years ending March 31, 2026, 2028,2029 and 2030, respectively. See Part II, Item 8. Financial Statements and Supplementary Data, Note 3 – Material Agreements for additional details.
Previous wording
Potential future payments due under the HanAll Agreement are contingent upon future events. As of March 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 March 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 March 31, 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 March 31, 2025) 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 milestone events 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. During the quarter ended December 31, 2022, we achieved our second development and regulatory milestone event under the HanAll Agreement and made a $10.0 million milestone payment in the quarter ended March 31, 2023 in accordance with the terms of the agreement.
Previous wording
We currently expect that our existing cash and cash equivalents as of March 31, 2024 of $635.4 million 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 Annual Report and in the long term beyond the next 12 months.
Current wording
We currently expect our existing cash and cash equivalents as of March 31, 2025 of $714.0 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
•increase manufacturing of IMVT-1402 and batoclimab drug substance to support clinical trials;
Current wording
•increase manufacturing of IMVT-1402 drug substance to support clinical trials;
Previous wording
Research and development costs with no alternative future use are expensed as incurred. We accrue costs for clinical trial activities based upon estimates of the services received and related expenses incurred that have yet to be invoiced by contract research organizations. In making these estimates, we consider various factors, including status and timing of services performed, the number of patients enrolled and the rate of patient enrollment. Payments for a product license prior to regulatory approval of the product and payments for milestones achieved prior to regulatory approval of the product are expensed in the period incurred as acquired in-process research and development expenses. Research and development costs are charged to expense when incurred and primarily consist of employee compensation and expenses from third parties who conduct research and development activities (including manufacturing) on our behalf.
Current wording
Research and development costs with no alternative future use are expensed as incurred. We accrue costs for clinical trial activities based upon estimates of the services received and related expenses incurred that have yet to be invoiced by contract research organizations. In making these estimates, we consider various factors, including status and timing of services performed, the number of patients enrolled and the rate of patient enrollment. Research and development costs are charged to expense when incurred and primarily consist of employee compensation and expenses from third parties who conduct research and development activities (including manufacturing) on our behalf.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
For the year ended March 31, 2025, unallocated research and development costs increased $56.9 million as compared with the prior year. This increase reflected higher personnel-related expenses of $37.2 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 $19.7 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 report — wording carried from elsewhere
Acquired In-Process Research and Development Expenses
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Acquired In-Process Research and Development Expenses for the Years Ended March 31, 2024 and 2023