# Immunovant, Inc. (IMVT) FY 2025 MD&A

Verbatim Item 7 Management's Discussion and Analysis from Immunovant, Inc.'s 10-K for fiscal year 2025.

SEC filing source: https://www.sec.gov/Archives/edgar/data/1764013/000176401325000092/imvt-20250331.htm
Accession: 0001764013-25-000092
Filing date: 2025-05-29
Report date: 2025-03-31
Extracted structurally from real Item 7 body heading to real Item 7A/8 boundary.
Confidence: high

Company profile: /company/IMVT/
All MD&A years: /company/IMVT/mda/
Previous year: /company/IMVT/mda/fy2024/ (FY 2024)
Next year: /company/IMVT/mda/fy2026/ (FY 2026)

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

You should read the following discussion and analysis of our financial condition, results of operations and cash flows together with the audited consolidated financial statements and the related notes thereto included elsewhere in this Annual Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. You should review the “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A Risk Factors” for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. Our fiscal year ends on March 31.

Overview

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.

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.

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.

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.

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.

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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.

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.

Recent Developments in Our Clinical Programs

Endocrine Diseases

Batoclimab Phase 2 Proof-of-Concept Trial in GD

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.

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.

IMVT-1402 Potentially Registrational Trials in GD

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.

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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.

Batoclimab Phase 3 Clinical Program in TED

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.

Neurological Diseases

Batoclimab Phase 3 Trial in MG

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).

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.

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.

IMVT-1402 Potentially Registrational Trial in MG

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.

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Batoclimab Phase 2b Trial in CIDP

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.

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.

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.

IMVT-1402 Potentially Registrational Trial in CIDP

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.

Rheumatology Diseases

IMVT-1402 Potentially Registrational Trial in D2T RA

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.

IMVT-1402 Potentially Registrational Trial in SjD

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.

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Dermatology Diseases

IMVT-1402 Proof-of-Concept Trial in CLE

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.

For more information on our clinical trials, refer to Part I, Item 1. Business, “Overview.”

Macroeconomic Considerations

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.

For additional information about risks and uncertainties related to macroeconomic events that may impact our business, financial condition and results of operations, see the section titled “Risk Factors” under Part I, Item 1A in this Annual Report.

Our Key Agreements

License Agreement with HanAll (“HanAll Agreement”)

For a description of our transactions under the HanAll Agreement, refer to Part II, Item 8. Financial Statements and Supplementary Data, Note 3 – Material Agreements.

Product Service Agreement and Master Services Agreement

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.

Related Party Transactions

For a description of our transactions under agreements with related parties, refer to Part II, Item 8. Financial Statements and Supplementary Data, Note 5 – Related Party Transactions.

Financial Operations Overview

Revenue

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.

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Research and Development Expenses

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.

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.

Unallocated costs include:

•personnel-related expenses for research and development personnel, which include employee-related expenses such as salaries, benefits and other staff-related costs;

•stock-based compensation expenses for research and development personnel;

•costs allocated to us under our services agreements with Roivant Sciences Inc. (“RSI”) and Roivant Sciences GmbH (“RSG”) (the “Services Agreements”); and

•other expenses, which include the cost of consultants who assist with our research and development but are not allocated to a specific therapeutic area.

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.

The duration, costs and timing of clinical trials of IMVT-1402, batoclimab and any future product candidates will depend on a variety of factors that include, but are not limited to:

•the number of trials required for approval;

•the per patient trial costs;

•the number of patients that participate in the trials;

•the number of sites included in the trials;

•the countries in which the trial is conducted;

•the length of time required to enroll eligible patients;

•the number of doses that patients receive;

•the drop-out or discontinuation rates of patients;

•the potential additional safety monitoring or other studies requested by regulatory authorities;

•the duration of patient follow-up;

•the timing and receipt of regulatory approvals;

•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;

•the efficacy and safety profile of the product candidate; and

•the cost of manufacturing.

In addition, the probability of success for our product candidates will depend on numerous factors, including our product’s efficacy, safety, ease of use, competition, manufacturing capability and commercial viability.

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Acquired In-Process Research and Development Expenses

Acquired in-process research and development expenses include payments made or due upon the achievement of certain development and regulatory milestones under the HanAll Agreement.

General and Administrative Expenses

General and administrative expenses consist primarily of employee salaries and related benefits, stock-based compensation for general and administrative personnel, legal and accounting fees, consulting services, costs allocated under the Services Agreements and other operating costs relating to corporate matters and daily operations.

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.

Results of Operations

Comparison of the Years Ended March 31, 2025, 2024 and 2023

The following table sets forth our results of operations for the years ended March 31, 2025, 2024 and 2023 (in thousands):

[[GREPCENT_TABLE]]
[["","Years Ended March 31,","","Change"],["","2025","","2024","","2023","","2025 vs. 2024","","2024 vs. 2023"],["Operating expenses:"],["Research and development","$","360,917","","","$","212,928","","","$","160,257","","","$","147,989","","","$","52,671"],["Acquired in-process research and development","\u2014","","","12,500","","","10,000","","","(12,500)","","","2,500"],["General and administrative","77,235","","","57,281","","","48,019","","","19,954","","","9,262"],["Total operating expenses","438,152","","","282,709","","","218,276","","","155,443","","","64,433"],["Interest income","(24,732)","","","(24,948)","","","(7,578)","","","216","","","(17,370)"],["Other (income) expense, net","(471)","","","1,008","","","253","","","(1,479)","","","755"],["Loss before provision for income taxes","(412,949)","","","(258,769)","","","(210,951)","","","(154,180)","","","(47,818)"],["Provision for income taxes","891","","","567","","","9","","","324","","","558"],["Net loss","$","(413,840)","","","$","(259,336)","","","$","(210,960)","","","$","(154,504)","","","$","(48,376)"]]
[[/GREPCENT_TABLE]]

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Research and Development Expenses

The following table summarizes the year-over-year changes in research and development expenses for the years ended March 31, 2025, 2024 and 2023 (in thousands):

[[GREPCENT_TABLE]]
[["","Years Ended March 31,","","Change"],["","2025","","2024*","","2023*","","2025 vs. 2024","","2024 vs. 2023"],["Therapeutic area-specific costs:"],["Endocrine diseases","$","63,073","","","$","33,205","","","$","26,377","","","$","29,868","","","$","6,828"],["Neurological diseases","93,224","","","41,060","","","52,100","","","52,164","","","(11,040)"],["Rheumatology diseases","23,897","","","\u2014","","","\u2014","","","23,897","","","\u2014"],["Dermatology diseases","15,633","","","\u2014","","","\u2014","","","15,633","","","\u2014"],["Other clinical and nonclinical","9,327","","","39,811","","","5,553","","","(30,484)","","","34,258"],["Total therapeutic area-specific costs","205,154","","","114,076","","","84,030","","","91,078","","","30,046"],["Unallocated costs:"],["Personnel-related expenses including stock-based compensation","111,499","","","74,290","","","49,767","","","37,209","","","24,523"],["Other","44,264","","","24,562","","","26,460","","","19,702","","","(1,898)"],["Total research and development expenses","$","360,917","","","$","212,928","","","$","160,257","","","$","147,989","","","$","52,671"]]
[[/GREPCENT_TABLE]]

___________

*Certain prior year amounts have been reclassified to conform to current year presentation.

Fiscal 2025 vs. Fiscal 2024

For the year ended March 31, 2025, research and development expenses increased $148.0 million as compared with the prior year.

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.

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.

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Fiscal 2024 vs. Fiscal 2023

For the year ended March 31, 2024, research and development expenses increased $52.7 million as compared with the prior year.

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.

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.

Acquired In-Process Research and Development Expenses

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.

General and Administrative Expenses

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.

Interest Income

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.

Liquidity and Capital Resources

Sources of Liquidity

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.

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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.

We do not currently have any committed external source of funds. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

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.

In January 2025, we entered into a share purchase agreement pursuant to which we issued 22,500,000 shares of our common stock, par value $0.0001 per share, to certain institutional accredited investors (including 16,845,010 shares of common stock to RSL), at a price of $20.00 per share in a private placement exempt from the registration requirements of the Securities Act. The gross proceeds to us were approximately $450.0 million. Pursuant to a registration rights agreement with certain of the investors, we subsequently filed with the SEC a prospectus supplement to the registration statement on Form S-3 (File No. 333-275419), which automatically became effective upon its filing on November 9, 2023, covering the resale of 5,654,990 shares of common stock issued in the private placement. We have agreed to use reasonable best efforts to keep such registration statement effective until the date the shares described above have been sold or may be resold pursuant to Rule 144 under the Securities Act without restriction.

If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. Adequate additional funding may not be available to us on acceptable terms, or at all. If we are unable to raise capital in sufficient amounts or on terms acceptable to us, we may be required to delay, limit, reduce or terminate our drug development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves or potentially discontinue operations.

Cash Flows

The following table sets forth a summary of our cash flows for the years ended March 31, 2025, 2024 and 2023 (in thousands):

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[[/GREPCENT_TABLE]]

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Operating Activities

For the year ended March 31, 2025, $375.9 million of cash was used in operating activities, primarily reflecting a net loss from operations for the year of $413.8 million and a net change in operating assets and liabilities of $12.1 million, partially offset by non-cash charges of $50.0 million. The non-cash charges consisted mainly of stock-based compensation of $49.5 million, reflecting the higher headcount and incentive equity awards as compared with the prior year. The change in operating assets and liabilities reflected higher prepaid expenses and other current assets of $27.0 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 $7.7 million as a result of prepaid expenses related to planned contract manufacturing activities. These changes were partially offset by an increase in accounts payable of $10.7 million, primarily related to clinical trial costs. Accrued expenses increased $8.9 million, primarily reflecting the timing of payments and services related to our ongoing clinical trials and contract manufacturing. In addition, accounts receivable decreased $3.2 million, reflecting the collection of amounts owed to us under research and development cost-sharing arrangements with a third party.

For the year ended March 31, 2024, $214.2 million of cash was used in operating activities, primarily reflecting a net loss from operations for the year of $259.3 million, partially offset by non-cash charges of $42.5 million and a net change in operating assets and liabilities of $2.6 million. The non-cash charges consisted mainly of stock-based compensation of $41.1 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 and accrued expenses of $7.1 million, primarily reflecting the timing and level of payments for contract manufacturing and other research and development costs, and lower prepaid expenses and other current assets of $1.6 million, driven primarily by the timing of payments and services performed related to our ongoing clinical trials. These changes were partially offset by an increase in accounts receivable of $4.6 million, reflecting amounts owed to us under a research and development cost-sharing arrangement with a third party.

For the year ended March 31, 2023, $188.2 million of cash was used in operating activities, primarily reflecting a net loss from operations of $211.0 million and a net change in operating assets and liabilities of $10.8 million, partially offset by non-cash charges of $33.6 million. The non-cash charges consisted mainly of stock-based compensation of $32.3 million. The change in our operating assets and liabilities was primarily due to a decrease of $17.1 million in accounts payable driven by the timing of payments related to contract manufacturing costs. The change in operating assets and liabilities also reflected $20.1 million of higher prepaid expenses and other current assets, driven by payments related to clinical research and contract manufacturing activities. These changes were partially offset by an increase in accrued expenses of $15.6 million primarily related to contract manufacturing costs, and a decrease in accounts receivable of $11.8 million reflecting the collection of amounts owed to us under research and development cost-sharing arrangements with third parties.

Investing Activities

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.

Financing Activities

For the year ended March 31, 2025, $454.5 million of cash provided by financing activities primarily consisted of proceeds from our January 2025 private placement of $450.0 million. Cash provided by financing activities also reflected $4.8 million of proceeds from the exercise of stock options.

For the year ended March 31, 2024, $472.4 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 $5.7 million of proceeds from the exercise of stock options.

For the year ended March 31, 2023, $70.9 million of cash provided by financing activities primarily consisted of proceeds from our October 2022 underwritten offering of approximately $70.2 million, after deducting underwriting discounts and commissions and offering expenses. Cash provided by financing activities also reflected $0.7 million of proceeds from the exercise of stock options.

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Material Cash Requirements

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.

Because of the numerous risks and uncertainties associated with the development and commercialization of product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures necessary to complete the development of product candidates.

Our short-term and long-term material cash requirements as of March 31, 2025 primarily consisted of those related to our clinical trials and clinical development activities, which we expect to fund primarily with our existing cash balance. Our most significant cash requirements are described below:

Product Service Agreement

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, of which $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.

HanAll Agreement

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.

Outlook

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.

Except as discussed above, we did not have any other ongoing material contractual obligations for which cash flows were fixed and determinable. We expect to enter into other commitments as the business further develops. In the normal course of business, we enter into agreements with CROs for clinical trials and with vendors for nonclinical studies, manufacturing and other services and products for operating purposes, which agreements are generally cancellable by us at any time, subject to payment of remaining obligations under binding purchase orders and, in certain cases, nominal early-termination fees. These commitments are not deemed significant. There are certain contracts wherein we have a minimum purchase commitment, however, most of it is due and payable within one year.

We anticipate that our short-term and long-term future capital requirements will increase as we:

•fund our clinical development programs;

•launch any potential clinical trials of IMVT-1402 in additional indications;

•increase manufacturing of IMVT-1402 drug substance to support clinical trials;

•achieve milestones under our agreements with third parties, including the HanAll Agreement, that will require us to make substantial payments to those parties;

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•integrate acquired technologies into a comprehensive regulatory and product development strategy;

•maintain, expand and protect our intellectual property portfolio;

•hire scientific, clinical, quality control and administrative personnel;

•add operational, financial and management information systems and personnel, including personnel to support our drug development efforts;

•commence the number of clinical trials required for approval;

•seek regulatory approvals for any product candidates that successfully complete clinical trials;

•seek to identify, acquire, develop and commercialize additional product candidates;

•ultimately establish a sales, marketing and distribution infrastructure and scale up external manufacturing capabilities to commercialize any drug candidates for which we may obtain regulatory approval; and

•incur insurance, legal and other regulatory compliance expenses to operate as a public company.

Our primary use of cash is to fund our clinical trials, clinical development and manufacturing activities. Our current funds will not be sufficient to enable us to complete all necessary development and, if approved, commercially launch IMVT-1402 or batoclimab. We anticipate that we will continue to incur net losses for the foreseeable future.

Critical Accounting Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these consolidated financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the date of the balance sheet, and the reported amounts of expenses during the reporting period. In accordance with U.S. GAAP, we evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

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. While our significant accounting policies are more fully described in “Note 2 — Summary of Significant Accounting Policies” to our consolidated financial statements in Part II, Item 8 of this Annual Report, we believe the following critical accounting estimate used in the preparation of our consolidated financial statements requires significant estimates and judgments. We did not make any material changes to these assumptions for the year ended March 31, 2025. We do not expect any material changes in the near term to the underlying assumptions during the year ended March 31, 2025.

Research and Development Expenses and Related Accruals

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.

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