Immunovant Inc

Previous wording

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 rheumatology, 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”) and rheumatoid arthritis (“RA”). We expect to leverage disease state insights, clinical trial data observed to date within the anti-FcRn class, and operational experience from past and ongoing batoclimab studies and trials to inform and accelerate the development of IMVT-1402.

Current wording

We are a clinical-stage immunology company pursuing a broad anti-FcRn strategy based on the potential best-in-class profile of our lead asset, IMVT-1402, and informed by the breadth of the class, in which 23 indications have been publicly announced for study by multiple companies to date. We expect to initiate programs evaluating IMVT-1402 in several therapeutic areas, including endocrinology, neurology and rheumatology. To address the unmet needs of people with autoantibody-driven diseases, we are committed to initiating a broad set of late-stage programs for IMVT-1402, including first-in-class indications such as Graves’ disease (“GD”), classic autoantibody indications such as myasthenia gravis (“MG”) and other indications with positive in-class data such as chronic inflammatory demyelinating polyneuropathy (“CIDP”) and rheumatoid arthritis (“RA”). We expect to leverage disease state insights, clinical trial data observed to date within the anti-FcRn class, and operational experience from past and ongoing batoclimab trials to inform and potentially accelerate the development of IMVT-1402.

Previous wording

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.

Current wording

Batoclimab, our initial product candidate, is dosed subcutaneously using a small gauge needle in small volumes (e.g., 2 mL), and has generated therapeutically relevant pharmacodynamic activity. In clinical trials conducted to date, batoclimab has been observed to reduce IgG antibody levels, which has provided evidence supporting the use of an anti-FcRn antibody in disease areas associated with high levels of pathogenic IgG antibodies.

Previous wording

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.

Current wording

We believe that FcRn inhibition has broad therapeutic and commercial potential to address IgG-mediated autoimmune diseases in a number of therapeutic areas, including but not limited to, endocrinology, neurology and rheumatology. Based on third-party patient prevalence estimates, for the 23 indications that have been publicly announced by multiple companies for clinical development with anti-FcRn assets, we estimate the total potential opportunity for our FcRn franchise to be greater than two million patients in the U.S. and Europe. Our estimates in Europe include all European Union (“E.U.”) countries, Norway, Lichtenstein, Iceland (together with the E.U. countries, the “EEA”), the United Kingdom (“U.K.”), and Switzerland.

Previous wording

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. We are on track to initiate four to five potentially registrational programs for IMVT-1402 in several therapeutic areas, including rheumatology, endocrinology and neurology, by March 31, 2025, and exceeded the goal of having three Initial New Drug (“IND”) applications for IMVT-1402 cleared by the end of calendar year 2024, with five IND applications now active for IMVT-1402. 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.

Current wording

Our goal is to fully optimize the IMVT-1402 clinical development program consistent with its potential best-in-class profile. Our strategic priority is to build a class-leading portfolio of indications in several therapeutic areas by leveraging data and learning derived from studies with batoclimab and from studies with other FcRn inhibitors, both approved and in development. Currently, a total of six investigational new drug (“IND”) applications are active for IMVT-1402. We have initiated potentially registrational trials for IMVT-1402 in GD and difficult-to-treat RA (“D2T RA”). We expect to have initiated studies evaluating IMVT-1402 in a total of four to five indications by March 31, 2025. Inclusive of these programs, by March 31, 2026, we plan to have initiated clinical trials of IMVT-1402 in a total of ten indications. Studies evaluating IMVT-1402 are expected to be conducted using the intended commercial drug formulation and delivery device, the YpsoMate® autoinjector developed by Ypsomed AG, which is utilized by multiple approved products.

Previous wording

Based on trial results announced to date and the strength of its potential best-in-class profile, we plan to pursue studies with IMVT-1402 in rheumatology, 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.

Current wording

Based on trial results announced to date and the strength of its potential best-in-class profile, we plan to pursue studies with IMVT-1402 in endocrinology, neurology, rheumatology and other therapeutic areas, with a focus on indications representing first-in-class opportunities, classic autoantibody diseases, and diseases where IgG autoantibodies are believed to play a role. In selecting indications for development, we plan to leverage data from our batoclimab development program and also take advantage of publicly disclosed in-class competitor data, which can be used to establish proof-of-concept as well as provide insights into potentially more informative study designs.

Previous wording

Data from our Phase 2 proof of concept trial evaluating batoclimab in GD demonstrate the potential of FcRn inhibition for the treatment of GD by modifying the underlying disease pathology, which is driven by thyroid-stimulating hormone receptor autoantibodies (“TRAb”). In addition, the data represent strong evidence that deeper IgG reduction correlates with better clinical outcomes in GD.

Current wording

Data from our Phase 2 proof-of-concept trial evaluating batoclimab in GD demonstrate the potential of FcRn inhibition for the treatment of GD by modifying the underlying disease pathology, which is driven by thyroid-stimulating hormone receptor autoantibodies (“TRAb”). In addition, the data represent strong evidence that deeper IgG reduction correlates with better clinical outcomes in GD for patients whose disease remains uncontrolled on anti-thyroid drugs (“ATDs”).

Previous wording

The treatment of GD has seen minimal innovation in treatment options over the past 70-plus years. Anti-thyroid drugs (“ATDs”), as the only existing pharmacological therapy, do not address the underlying disease pathology characterized by high levels of TRAb. A conservative analysis of Inovalon claims data estimates that the prevalence and incidence of GD patients is approximately 880,000 and 65,000 in the U.S. Further, market-sizing analyses by various methods suggest that 25-30% of GD patients are relapsed, uncontrolled on or intolerant to ATDs, representing a potentially significant unmet medical need.

Current wording

The treatment of GD has seen minimal innovation in treatment options over the past 70-plus years. ATDs, as the only existing pharmacological therapy, do not address the underlying disease pathology characterized by high levels of TRAb. A conservative analysis of Inovalon claims data estimates that the prevalence and incidence of GD patients is approximately 880,000 and 65,000 in the U.S. Further, market-sizing analyses by various methods suggest that 25-30% of GD patients are relapsed, uncontrolled on or intolerant to ATDs, representing a potentially significant unmet medical need.

Previous wording

In September 2024 we announced receipt of IND clearance from the FDA for IMVT-1402 in GD. Leveraging the data from the batoclimab proof-of-concept trial, we expect to initiate a pivotal trial by December 31, 2024 to evaluate IMVT-1402 in Graves’ patients who are hyperthyroid despite treatment with ATDs.

Current wording

Having received FDA clearance of the IND for IMVT-1402 in GD and leveraging data from the batoclimab proof-of-concept trial, we initiated a potentially registrational trial evaluating IMVT-1402 in adults with GD.

Previous wording

The IMVT-1402 pivotal study is a randomized, placebo-controlled, 52-week trial in Graves’ disease patients who are hyperthyroid (as evidenced by TRAb levels) despite treatment with an ATD for 12 or more weeks prior to beginning the study. The study will enroll approximately 240 participants randomized (1:1:1) to one of two blinded treatment groups each receiving IMVT-1402, 600 mg weekly by subcutaneous injection (“SC”), or a matched placebo group. Participants will be evaluated over two consecutive 26-week blinded treatment periods. Over the course of the treatment periods, background ATD treatment will be titrated to the lowest effective dose, including elimination of ATD treatment, to maintain normal thyroid lab values. Following the initial 26-week period, participants in the group 2 IMVT-1402 treatment group will be assigned to either continued treatment with IMVT-1402 at the same dose or matching placebo for the second 26-week study period based on the participant’s TRAb value and euthyroid status determined at week 26. The study’s primary endpoint will evaluate the proportion of participants who are euthyroid and off ATD at study week 26. A key secondary endpoint will measure the proportion of participants who become euthyroid and stop ATD treatment at week 52.

Current wording

This Phase 2b study (NCT06727604) is a randomized, placebo-controlled, 52-week trial in GD patients who are hyperthyroid despite treatment with an ATD for 12 or more weeks prior to beginning the study. The study will enroll approximately 240 participants randomized (1:1:1) to one of two blinded treatment groups each receiving IMVT-1402, 600 mg weekly by subcutaneous injection (“SC”), or a matched placebo group. Participants will be evaluated over two consecutive 26-week blinded treatment periods. Over the course of the treatment periods, background ATD treatment will be titrated to the lowest effective dose, including elimination of ATD treatment, to maintain normal thyroid lab values. Following the initial 26-week period, participants in the group 2 IMVT-1402 treatment group will be assigned to either continued treatment with IMVT-1402 at the same dose or matching placebo for the second 26-week study period based on the participant’s TRAb value and euthyroid status determined at week 26. The study’s primary endpoint will evaluate the proportion of participants who are euthyroid and off ATD at study week 26. A key secondary endpoint will measure the proportion of participants who become euthyroid and stop ATD treatment at week 52.

Previous wording

Having received FDA clearance of the IND for IMVT-1402 in RA, we plan to initiate a potentially registrational trial evaluating our lead asset IMVT-1402 in D2T RA by March 31, 2025. The trial is expected to build on in-class learning in terms of its target population (enriched for above-normal ACPA levels) and study design (open-label lead-in followed by randomized withdrawal). The trial is expected to enroll approximately 120 participants into an initial 16-week open-label, active treatment period, followed by a blinded, randomized withdrawal period of 12 weeks. To ensure the enrollment of patients with active D2T RA, the trial inclusion criteria require elevated ACPA levels and prior inadequate response to 2 or 3 (but no more than 3) biologic or target synthetic DMARDs. The study will leverage IMVT-1402’s higher dose (600 mg) during the open-label induction phase of the trial with the intent of maximizing reduction in ACPA levels. For participants achieving a response at weeks 14 and 16 per the American College of Rheumatology (“ACR”) response criteria ACR20, the primary endpoint will assess the proportion of such participants who maintain the ACR20 response at week 28.

Current wording

Having received FDA clearance of the IND for IMVT-1402 in RA, we initiated a potentially registrational trial evaluating IMVT-1402 in ACPA-positive D2T RA. This Phase 2b trial (NCT06754462) is expected to enroll approximately 120 participants into an initial 16-week open-label, active treatment period. To ensure the enrollment of patients with active D2T RA, the trial inclusion criteria require elevated ACPA levels and prior inadequate response to 2 or 3 (but no more than 3) biologic or targeted synthetic DMARDs. The study will evaluate IMVT-1402’s higher dose (600 mg) during the open-label induction phase of the trial with the intent of maximizing reduction in ACPA levels. Participants achieving a response at weeks 14 and 16 per the American College of Rheumatology (“ACR”) response criteria ACR20 will be randomized in a 1:1:1 ratio to receive blinded treatment with either IMVT-1402 600 mg, IMVT-1402 300 mg, or placebo, weekly SC, for 12 weeks. The primary endpoint will assess the proportion of such participants who maintain the ACR20 response at week 28. Eligible participants who complete week 28 will have the option to receive IMVT-1402 for an additional period of 48 weeks as part of a long-term extension period.

Previous wording

We may transition our registrational development programs for MG from batoclimab to IMVT-1402, with a final decision for this program contingent on top-line data from the batoclimab study in this indication. 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.

Current wording

We may transition our registrational development programs for MG from batoclimab to IMVT-1402, with a final decision for this program contingent on top-line data from the batoclimab study in this indication. An IND application to support the evaluation of IMVT-1402 in MG has received FDA clearance. We expect to report top-line data from the Phase 3 trial of batoclimab for the treatment of MG by March 31, 2025, with potential registrational development for MG expected to transition from batoclimab to IMVT-1402 in the same timeframe.

Previous wording

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 by March 31, 2025.

Current wording

We may transition our registrational development program for CIDP from batoclimab to IMVT-1402 and the design of the pivotal study with IMVT-1402 in CIDP may be informed by the initial batoclimab CIDP datafrom the Phase 2b trial available by March 31, 2025. An IND application to support the evaluation of IMVT-1402 in CIDP has received FDA clearance.

Previous wording

In November 2024, additional incremental data observed in the study for certain thyroidal and extrathyroidal manifestations of GD were presented at the American Thyroid Association 2024 Annual Meeting. These data show that a 60% response rate was achieved by week 2, demonstrating the rapidity of response to batoclimab 680 mg dosed weekly. Meaningful improvements in proptosis and lid aperture were also observed at both week 12 and week 24. Pronounced improvements in multiple Thyroid-Related Patient-Reported Outcomes (ThyPRO-39) measurement scales were also observed, with ATD-Free Responders reporting greater improvements than other participants. This clinical trial is ongoing.

Current wording

In November 2024, additional incremental data observed in the study for certain thyroidal and extrathyroidal manifestations of GD were presented at the American Thyroid Association 2024 Annual Meeting. These data showed a 60% response rate achieved by week 2, demonstrating the rapidity of response to weekly higher dose batoclimab. Improvements in proptosis and lid aperture were also observed at both week 12 and week 24. This clinical trial is ongoing, with additional data expected in the summer of calendar year 2025, including remission data describing the percentage of participants that remain euthyroid and off ATD at the 24-week post-treatment follow-up period.

Previous wording

In the quarter ended December 31, 2022, we initiated our Phase 3 clinical program to evaluate batoclimab as a treatment for TED. Over the course of the program to date, we observed increasing competition for patients with TED to participate in clinical trials. We completed a robust review of the inclusion and exclusion criteria of our Phase 3 batoclimab clinical trials in TED to determine if modifications could be made to improve patient enrollment without a resulting negative impact to the potential clinical trial results. In conjunction with input from key opinion leaders, we determined that no such modifications should be made, and we are therefore continuing enrollment in the study with the inclusion and exclusion criteria as originally designed to maximize effect size on proptosis response in TED. As a result, we expect top-line results to be available in the second 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 TED. The trial is ongoing with top-line results estimated to be available in the second half of calendar year 2025, along with a decision on whether to advance batoclimab to registration in TED. Data from this trial may also inform the IMVT-1402 program in GD.

Previous wording

In the quarter ended December 31, 2022, we initiated a pivotal Phase 2b trial of batoclimab as a treatment for CIDP. Enrollment is completed for patients to be included in the period 1 top-line results, which are expected by March 31, 2025. We believe data from this batoclimab trial, combined with learning from other trials in CIDP, can be used to optimize the IMVT-1402 trial design in active CIDP patients.

Current wording

In the quarter ended December 31, 2022, we initiated a pivotal Phase 2b trial of batoclimab as a treatment for CIDP. Enrollment is completed for patients to be included in the period 1 results, which are expected by March 31, 2025. We believe data from this batoclimab trial, combined with learning from other trials in CIDP, can be used to optimize the IMVT-1402 trial design in active CIDP patients.

Previous wording

In the quarter ended June 30, 2022, we initiated our Phase 3 pivotal trial of batoclimab as a treatment for MG. Enrollment in this pivotal trial has now completed and we expect top-line data to be available by March 31, 2025. Further potential registrational development with IMVT-1402 is expected to begin in the same timeframe, with a final decision to be made based on results from the current batoclimab trial.

Current wording

In the quarter ended June 30, 2022, we initiated our Phase 3 pivotal trial of batoclimab as a treatment for MG. Enrollment in this pivotal trial was completed in the quarter ended September 30, 2024, and we expect top-line data to be available by March 31, 2025. Further potential registrational development with IMVT-1402 is expected to begin in the same timeframe, with a final decision regarding study design to be made based on results from the current batoclimab trial.

Previous 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, a 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 trade policy and the Russia-Ukraine war and conflict in the Middle East have led to economic uncertainty globally. The effect of macroeconomic conditions may not be fully reflected in our results of operations until future periods. If, however, economic uncertainty increases or the global economy worsens, our business, financial condition and results of operations may be harmed.

Previous wording

For a description of our transactions under the Product Service Agreement and Master Services Agreement with Samsung Biologics Co., Ltd., refer to “Note 3 – Material Agreements” and “Note 9 – Commitments and Contingencies” in our unaudited condensed consolidated financial statements in Part I, Item 1 of this Quarterly Report.

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 “Note 3 – Material Agreements” and “Note 9 – Commitments and Contingencies” in our unaudited condensed consolidated financial statements in Part I, Item 1 of this Quarterly Report.

Previous 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 agreement with Samsung, to the extent they can be allocated to a specific therapeutic area.

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

Research and development activities will continue to be central to our business model. We expect to incur research and development expenses as we continue our Phase 3 trial of batoclimab as a treatment for MG, our Phase 3 clinical program to evaluate batoclimab for the treatment of TED, a pivotal Phase 2b trial of batoclimab as a treatment for CIDP and a proof-of-concept Phase 2 clinical trial of batoclimab as a treatment for GD. With respect to our IMVT-1402 development activities, our Phase 1 clinical trial of IMVT-1402 in New Zealand remains open and we anticipate initiating pivotal trials of IMVT-1402 in GD by December 31, 2024 and RA by March 31, 2025. Our research and development expenses are expected to further increase as we seek to execute our plan to initiate an additional two to three potentially registrational programs for IMVT-1402 in other indications by March 31, 2025 and ultimately initiate trials of IMVT-1402 in a total of ten indications (inclusive of those programs to be initiated in fiscal 2025) by March 31, 2026. Our research and development expenses are also expected to continue to increase over the next several years as we hire personnel and our compensation costs increase, 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 trial of batoclimab as a treatment for MG, our Phase 3 clinical program to evaluate batoclimab for the treatment of TED, a pivotal Phase 2b trial of batoclimab as a treatment for CIDP and a proof-of-concept Phase 2 clinical trial of batoclimab as a treatment for GD. With respect to our IMVT-1402 development activities, our Phase 1 clinical trial of IMVT-1402 in New Zealand remains open and we initiated potentially registrational trials for IMVT-1402 in GD and D2T RA. Our research and development expenses are expected to further increase as we seek to execute our plan to initiate studies evaluating IMVT-1402 in additional indications by March 31, 2025 and ultimately initiate trials of IMVT-1402 in a total of ten indications (inclusive of those programs to be initiated in fiscal 2025) by March 31, 2026. Our research and development expenses are also expected to continue to increase over the next several years as we execute IMVT-1402 trials, increase manufacturing of IMVT-1402, hire personnel and prepare to seek regulatory approval. It is not possible to determine with certainty the duration and completion costs of any clinical trial we may conduct.

Previous wording

•the potential impact of macroeconomic events, including changes in inflation and interest rates, a 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 trade policy and the Russia-Ukraine war and the conflict in the Middle East;

Previous wording

For the three months ended September 30, 2024, research and development expenses increased $49.3 million as compared with the prior-year period.

Current wording

For the three months ended December 31, 2024, research and development expenses increased $46.2 million as compared with the prior-year period.

Previous wording

For the three months ended September 30, 2024, therapeutic area-specific research and development costs, including contract manufacturing costs for drug substance, increased $34.2 million as compared with the prior-year period. Research and development costs related to neurological diseases, which include MG and CIDP, increased $24.5 million. This increase was primarily due to preparation for potential future clinical trials of IMVT-1402 in neurological diseases and higher overall clinical trial costs related to our batoclimab Phase 3 clinical trial. Research and development costs related to endocrine diseases, which include TED and GD, increased $6.5 million. This increase was primarily due to preparation for potential future clinical trials of IMVT-1402 in endocrine diseases and, to a lesser extent, higher overall clinical trial costs related to our batoclimab Phase 3 clinical program. Research and development costs related to rheumatology diseases of $7.2 million in the current-year period reflected preparation for potential future clinical trials of IMVT-1402. Research and development costs related to other clinical and nonclinical activities decreased $4.0 million, reflecting lower overall costs related to our IMVT-1402 Phase 1 trial and nonclinical studies, partially offset by overall costs in preparation for future IMVT-1402 clinical programs.

Current wording

For the three months ended December 31, 2024, therapeutic area-specific research and development costs, including contract manufacturing costs, increased $29.1 million as compared with the prior-year period. Research and development costs related to endocrine diseases, which include GD and TED, increased $8.6 million. This increase was primarily due to preparation for potential future clinical trials of IMVT-1402 in endocrine diseases and higher overall clinical trial costs related to our batoclimab Phase 3 clinical program. Research and development costs related to neurological diseases, which include MG and CIDP, increased $12.2 million. This increase was primarily due to preparation for potential future clinical trials of IMVT-1402 in neurological diseases and higher overall clinical trial costs related to our batoclimab Phase 2b and Phase 3 clinical trials. Research and development costs related to rheumatology diseases of $7.5 million in the current-year period reflected preparation for potential future clinical trials of IMVT-1402. Research and development costs related to other clinical and nonclinical activities increased $0.8 million, reflecting overall costs in preparation for future IMVT-1402 clinical programs in additional indications, partially offset by lower overall costs related to our IMVT-1402 Phase 1 trial and nonclinical studies.

Previous wording

For the three months ended September 30, 2024, unallocated research and development costs increased $15.1 million as compared with the prior-year period. This increase reflected higher personnel-related expenses of $9.3 million, driven by higher headcount and enhancement of our capabilities to support our strategic objectives as we progress our clinical activities in existing and new therapeutic areas. In addition, other expenses increased $5.9 million, primarily reflecting higher costs to support our research and development activities to advance the clinical development of IMVT-1402 that are not related to a specific therapeutic area.

Current wording

For the three months ended December 31, 2024, unallocated research and development costs increased $17.1 million as compared with the prior-year period. This increase reflected higher personnel-related expenses of $12.2 million, driven by higher headcount and enhancement of our capabilities to support our strategic objectives as we progress our clinical activities. In addition, other expenses increased $4.9 million, primarily reflecting higher costs to support our research and development activities to advance the clinical development of IMVT-1402 that are not related to a specific therapeutic area.

Previous wording

For the three months ended September 30, 2024, general and administrative expenses increased $4.6 million as compared with the prior-year period, primarily reflecting higher personnel-related expenses, legal and other professional fees, and information technology costs.

Current wording

For the three months ended December 31, 2024, general and administrative expenses increased $6.6 million as compared with the prior-year period, primarily reflecting higher personnel-related expenses, legal and other professional fees, information technology costs and market research costs.

Previous wording

For the six months ended September 30, 2024, interest income increased $5.6 million as compared with the prior-year period, primarily reflecting interest earned on higher money market fund balances as a result of proceeds from our October 2023 underwritten public offering and concurrent private placement.

Current wording

For the three months ended December 31, 2024, interest income decreased $4.3 million as compared with the prior-year period, primarily reflecting lower money market fund balances in the current-year period, coupled with interest earned on higher money market fund balances in the prior-year period as a result of proceeds from our October 2023 underwritten public offering and concurrent private placement.

Previous wording

The following table sets forth our results of operations for the six months ended September 30, 2024 and 2023 (in thousands):

Current wording

The following table sets forth our results of operations for the nine months ended December 31, 2024 and 2023 (in thousands):

Previous wording

The following table summarizes the period-over-period changes in research and development expenses for the six months ended September 30, 2024 and 2023 (in thousands):

Current wording

The following table summarizes the period-over-period changes in research and development expenses for the nine months ended December 31, 2024 and 2023 (in thousands):

Previous wording

For the six months ended September 30, 2024, research and development expenses increased $74.2 million as compared with the prior-year period.

Current wording

For the nine months ended December 31, 2024, research and development expenses increased $120.4 million as compared with the prior-year period.

Previous wording

For the six months ended September 30, 2024, therapeutic area-specific research and development costs, including contract manufacturing costs for drug substance, increased $47.6 million as compared with the prior-year period. Research and development costs related to neurological diseases, which include MG and CIDP, increased $31.6 million. This increase was primarily due to preparation for potential future clinical trials of IMVT-1402 in neurological diseases and higher overall clinical trial costs related to our batoclimab Phase 3 clinical trial. Research and development costs related to endocrine diseases, which include TED and GD, increased $16.2 million. This increase was primarily due to preparation for potential future clinical trials of IMVT-1402 in endocrine diseases and higher overall clinical trial costs related to our batoclimab Phase 3 clinical program. Research and development costs related to rheumatology diseases of $7.2 million in the current-year period reflected preparation for potential future clinical trials of IMVT-1402. Research and development costs related to other clinical and nonclinical activities decreased $7.4 million, reflecting lower overall costs related to our IMVT-1402 Phase 1 trial and nonclinical studies, partially offset by overall costs in preparation for future IMVT-1402 clinical programs.

Current wording

For the nine months ended December 31, 2024, therapeutic area-specific research and development costs, including contract manufacturing costs, increased $76.6 million as compared with the prior-year period. Research and development costs related to endocrine diseases, which include GD and TED, increased $24.8 million. This increase was primarily due to preparation for potential future clinical trials of IMVT-1402 in endocrine diseases and higher overall clinical trial costs related to our batoclimab Phase 3 clinical program. Research and development costs related to neurological diseases, which include MG and CIDP, increased $43.7 million. This increase was primarily due to preparation for potential future clinical trials of IMVT-1402 in neurological diseases and higher overall clinical trial costs related to our batoclimab Phase 3 clinical trial. Research and development costs related to rheumatology diseases of $14.7 million in the current-year period reflected preparation for potential future clinical trials of IMVT-1402. Research and development costs related to other clinical and nonclinical activities decreased $6.6 million, reflecting lower overall costs related to our IMVT-1402 Phase 1 trial and nonclinical studies, partially offset by overall costs in preparation for future IMVT-1402 clinical programs in additional indications.

Previous wording

For the six months ended September 30, 2024, unallocated research and development costs increased $26.6 million as compared with the prior-year period. This increase reflected higher personnel-related expenses of $16.8 million, driven by higher headcount and enhancement of our capabilities to support our strategic objectives as we progress our clinical activities in existing and new therapeutic areas. In addition, other expenses increased $9.8 million, primarily reflecting higher costs to support our research and development activities to advance the clinical development of IMVT-1402 that are not related to a specific therapeutic area.

Current wording

For the nine months ended December 31, 2024, unallocated research and development costs increased $43.8 million as compared with the prior-year period. This increase reflected higher personnel-related expenses of $29.1 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 $14.7 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.

Previous wording

There were no acquired in-process research and development expenses for the six months ended September 30, 2024. During the six months ended September 30, 2023, acquired in-process research and development expenses were $12.5 million related to the achievement of development and regulatory milestones for batoclimab as specified in the HanAll Agreement.

Current wording

There were no acquired in-process research and development expenses for the nine months ended December 31, 2024. During the nine months ended December 31, 2023, acquired in-process research and development expenses were $12.5 million related to the achievement of development and regulatory milestones for batoclimab as specified in the HanAll Agreement.

Previous wording

For the six months ended September 30, 2024, general and administrative expenses increased $8.0 million as compared with the prior-year period, primarily reflecting higher personnel-related expenses, legal and other professional fees, and information technology costs.

Current wording

For the nine months ended December 31, 2024, general and administrative expenses increased $14.6 million as compared with the prior-year period, primarily reflecting higher personnel-related expenses, legal and other professional fees, information technology costs and market research costs.

Previous wording

Interest Income for the Six Months Ended September 30, 2024 and 2023

Current wording

Interest Income for the Nine Months Ended December 31, 2024 and 2023

Previous wording

For the three months ended September 30, 2024, interest income increased $2.5 million as compared with the prior-year period, primarily reflecting interest earned on higher money market fund balances as a result of proceeds from our October 2023 underwritten public offering and concurrent private placement.

Current wording

For the nine months ended December 31, 2024, interest income increased $1.3 million as compared with the prior-year period, primarily reflecting interest earned on higher money market fund balances as a result of proceeds from our October 2023 underwritten public offering and concurrent private placement.

Previous wording

We had cash and cash equivalents of $472.9 million and $635.4 million as of September 30, 2024 and March 31, 2024, respectively. For the three months ended September 30, 2024 and 2023, we had net losses of $109.1 million and $58.7 million, respectively and for the six months ended September 30, 2024 and 2023, we had net losses of $196.3 million and $132.6 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 $374.7 million and $635.4 million as of December 31, 2024 and March 31, 2024, respectively. For the three months ended December 31, 2024 and 2023, we had net losses of $111.1 million and $51.4 million, respectively and for the nine months ended December 31, 2024 and 2023, we had net losses of $307.4 million and $184.0 million, respectively. We expect to continue to incur significant expenses and increasing operating losses at least for the next several years. We have never generated any revenue and we do not expect to generate product revenue unless and until we successfully complete development and obtain regulatory approval for batoclimab, IMVT-1402 or any future product candidate.

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, changes in inflation and 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 batoclimab, IMVT-1402 or any future product candidate, we expect to finance our cash needs through a combination of equity offerings, debt financings and potential collaboration, license or development agreements. Our ability to raise additional capital may be adversely impacted by worsening global economic conditions and the continuing disruptions to, and volatility in, the credit and financial markets in the U.S. and worldwide, including disruptions resulting from the ongoing military conflict between Russia and Ukraine and in the Middle East, and changes in inflation, interest rates and trade policy.

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

The following table sets forth a summary of our cash flows for the six months ended September 30, 2024 and 2023 (in thousands):

Current wording

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