Immunovant Inc
For the period ended Sep 30, 2024. Filed Nov 7, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 7, 2024
IMVT$30.53+7.5%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-06.
0001764013-24-000148
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-07.
0001764013-24-000184
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 128 previous paragraphs and 165 current paragraphs.
99 unchanged; 25 reworded; 33 added; 3 removed; 1 previous and 8 current paragraphs rearranged.
Tables are not compared: 3 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (33)
Current report
IMVT-1402 as a Potential Treatment for Graves’ Disease
Current report
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 report
Current Treatment Paradigm
Current report
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 report
GD Pivotal Study
Current report
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 report
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 report
More details on the study design are described in the figure below:
Current report
GD Pivotal Trial Design
Current report
Rheumatology Diseases
Current report
IMVT-1402 as a Potential Treatment for Rheumatoid Arthritis
Current report
RA Overview
Current report
RA is a chronic progressive autoimmune disease that causes inflammation in the joints and surrounding tissues. Inadequate control of the joint inflammation associated with RA may result in irreversible joint erosions. RA is the most common systemic autoimmune disease. The exact cause of RA is not completely known but is associated with a variety of genetic, hormonal and environmental factors. RA can occur at any age, but it is more commonly diagnosed in middle age and women are more likely to be affected than men. RA affects 18 million persons globally and 1.5 million persons in the United States. Several autoantibodies have been identified in RA. Among these are rheumatoid factor (“RF”) and anti-citrullinated protein antibodies (“ACPA”). These RA-specific autoantibodies are found in 70-80% of RA patients and amplify inflammation via immune complex formation. Autoantibodies are associated with severe disease and poor outcomes on current available therapies. An estimated 5% to 20% of RA patients are characterized as having difficult-to-treat (“D2T”) RA due to a failure to respond to two or more biologic or targeted synthetic disease modifying anti-rheumatic drugs (“DMARDs”).
Current report
Current Treatment Paradigm
Current report
Currently available treatments used to help control joint inflammation include a variety of conventional oral, targeted synthetic and biologic DMARDs, most of which reduce cytokines. For D2T RA patients, who remain symptomatic despite multiple lines of treatment, there remains a significant unmet need.
Current report
Because of the role of FcRn in preventing degradation of IgG autoantibodies, such as ACPAs, FcRn inhibition is an attractive mechanism as a potential treatment for ACPA-positive RA. Recent in-class anti-FcRn data from a Phase 2a placebo-controlled, proof-of-concept trial evaluating nipocalimab in patients with RA demonstrated that both higher baseline ACPA levels and deeper ACPA reduction correlated with better clinical improvement with nipocalimab treatment.
Current report
RA Pivotal Study
Current report
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 report
More details on the study design are described in the figure below:
Current report
RA Pivotal Study Design
Current report
IMVT-1402 as a Potential Treatment for Myasthenia Gravis
Current report
IMVT-1402 as a Potential Treatment for Chronic Inflammatory Demyelinating Polyneuropathy
Current report
Endocrine Diseases
Current report
In September 2024, we announced additional data from our proof-of-concept Phase 2 clinical trial in uncontrolled GD, which enrolled patients who remained hyperthyroid despite ATD therapy. Participants in the trial received 12 weeks of high dose batoclimab, 680 mg weekly SC followed by 12 weeks of lower dose batoclimab, 340 mg weekly SC. At the end of the first 12 weeks, participants experienced a mean IgG reduction of 77% leading to a 76% response rate (defined as T3 and T4 falling below the upper limit of normal (“ULN”) without increasing the ATD dose). Also, by the end of 12 weeks of higher dose batoclimab, 56% of subjects achieved an ATD-Free Response (defined as T3 and T4 falling below the ULN and the patient simultaneously tapering completely off their ATD). Despite benefiting from a lower starting IgG level after 12 weeks of 680 mg therapy, during weeks 13 to 24, the lower 340 mg dose of batoclimab resulted in mean IgG reduction of 65% (vs. 77% on 680 mg dose) with a correspondingly lower responder rate of 68%. In addition, a lower ATD-Free Response rate of 36% was also observed in the second 12 weeks. Finally, patients who achieved at least a 70% IgG reduction at the end of the evaluation period had nearly a threefold higher ATD-Free Response rate than those who did not (60% vs. 23%). Batoclimab was generally well tolerated with no new safety signals observed.
Current report
In November 2024, additional incremental data observed in the study for certain thyroidal and extrathyroidal manifestations of GD were presented at the American Thyroid Association 2024 Annual Meeting. These data 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 report
Neurological Diseases
Current report
Interest Income for the Three Months Ended September 30, 2024 and 2023
Current report
Results of Operations for the Six Months Ended September 30, 2024 and 2023
Current report
Research and Development Expenses for the Six Months Ended September 30, 2024 and 2023
Current report
For the six months ended September 30, 2024, research and development expenses increased $74.2 million as compared with the prior-year period.
Current report
Acquired In-Process Research and Development Expenses for the Six Months Ended September 30, 2024 and 2023
Current report
General and Administrative Expenses for the Six Months Ended September 30, 2024 and 2023
Current report
Interest Income for the Six Months Ended September 30, 2024 and 2023
Removed paragraphs (3)
Previous report
We expect to announce an overview of our development program for IMVT-1402 in GD in the fall of calendar year 2024, supported by additional data from the batoclimab proof-of-concept study in GD that will be disclosed at the same time.
Previous report
In the quarter ended June 30, 2023, we initiated a proof-of-concept Phase 2 clinical trial in GD in Germany. This Phase 2 clinical trial is ongoing, with additional data, as well as an overview of our development program for IMVT-1402 in GD, expected to be announced in the fall of calendar year 2024.
Previous report
Interest Income
Reworded paragraphs (25)
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 endocrinology and neurology. To address the unmet needs of people with autoantibody-driven diseases, we are committed to initiating a broad set of late-stage programs for IMVT-1402, including first-in-class indications such as Graves’ disease (“GD”), classic autoantibody indications such as myasthenia gravis (“MG”), and other indications with positive in-class data such as chronic inflammatory demyelinating polyneuropathy (“CIDP”). We expect to leverage disease state insights, clinical trial data observed to date within the anti-FcRn class, and operational experience from past and ongoing batoclimab studies and trials to inform and accelerate the development of IMVT-1402.
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 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.
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. Following a recently completed Type B meeting with the U.S. Food and Drug Administration (“FDA”), we are on track to initiate four to five potentially registrational programs for IMVT-1402 in several therapeutic areas, including endocrinology and neurology, by March 31, 2025. In support of this goal, we plan to have three Initial New Drug (“IND”) applications for IMVT-1402 activated by the end of calendar year 2024. 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 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.
Previous wording
This Phase 1 clinical trial is ongoing. 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 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 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.
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. We may also transition our registrational development programs for MG and thyroid eye disease (“TED”) from batoclimab to IMVT-1402, with a final decision for these programs contingent on top-line data from the batoclimab studies in these indications. We expect to report top-line data from the batoclimab MG study by March 31, 2025 with potential registrational development for MG expected to transition from batoclimab to IMVT-1402 in the same timeframe. A decision regarding which asset to advance to registration in TED will be made in the first half of calendar year 2025 together with disclosing top-line data from the current batoclimab TED program.
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. 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.
Previous wording
In the quarter ended December 31, 2022, we initiated our Phase 3 clinical program to evaluate batoclimab as a treatment for TED. We expect top-line results to be available in the first half of calendar year 2025, along with a decision on whether to advance batoclimab to registration in TED or pursue IMVT-1402 in this indication.
Current wording
In the quarter ended December 31, 2022, we initiated our Phase 3 clinical program to evaluate batoclimab as a treatment for 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.
Previous wording
In the quarter ended December 31, 2022, we initiated a pivotal Phase 2b trial of batoclimab as a treatment for CIDP. To better ensure that we can optimize the level of disease activity and patient population for an IMVT-1402 clinical trial, we have decided to continue to enroll the batoclimab CIDP trial approximately two quarters longer prior to unblinding period 1 of this trial. We believe this will better ensure that the data from the batoclimab trial, combined with learning from the other CIDP trials, can be used to optimize the IMVT-1402 trial design in active CIDP by March 31, 2025.
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 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.
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, the U.S. Federal Reserve raising interest rates, potential recession in the U.S., recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures and the Russia-Ukraine war and conflict in the Middle East, have led to economic uncertainty globally. The effect of macroeconomic conditions may not be fully reflected in our results of operations until future periods. If, however, economic uncertainty increases or the global economy worsens, our business, financial condition and results of operations may be harmed.
Current wording
Unfavorable conditions in the economy in the U.S., Canada and abroad may negatively affect the growth of our business and our results of operations. For example, macroeconomic events, including changes in inflation and interest rates, 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.
Previous wording
Research and development activities will continue to be central to our business model. We expect to incur research and development expenses as we continue our Phase 3 trial of batoclimab as a treatment for MG, our Phase 3 clinical program to evaluate batoclimab for the treatment of TED, a pivotal Phase 2b trial of batoclimab as a treatment for CIDP and a proof-of-concept Phase 2 clinical trial of batoclimab as a treatment for GD. In addition, we are continuing our Phase 1 clinical trial of IMVT-1402 in healthy adults in New Zealand. We expect our research and development expenses to increase as we seek to execute our plan to initiate four to five potentially registrational programs for IMVT-1402 by March 31, 2025 and initiate trials of IMVT-1402 in ten indications (inclusive of the four to five programs initiated in fiscal 2025) by March 31, 2026. Our research and development expenses are 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 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.
Previous wording
•the potential impact of macroeconomic events, including changes in inflation, the U.S. Federal Reserve raising interest rates, potential recession in the U.S., recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures and the Russia-Ukraine war and the conflict in the Middle East;
Current wording
•the potential impact of macroeconomic events, including changes in inflation 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;
Previous wording
For the three months ended June 30, 2024, research and development expenses increased $24.9 million as compared with the prior-year period.
Current wording
For the three months ended September 30, 2024, research and development expenses increased $49.3 million as compared with the prior-year period.
Previous wording
For the three months ended June 30, 2024, unallocated research and development costs increased $10.1 million as compared with the prior-year period. This increase reflected higher personnel-related expenses of $7.6 million, primarily reflecting higher headcount and enhancement of our capabilities to support our strategic objectives as we progress our clinical activities in existing and new therapeutic areas. In addition, other expenses increased $2.5 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 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.
Previous wording
For the three months ended June 30, 2024, general and administrative expenses increased $3.4 million as compared with the prior-year period, primarily reflecting higher personnel-related expenses, legal and other professional fees, information technology costs and market research costs.
Current wording
For the three months ended 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.
Previous wording
For the three months ended June 30, 2024, interest income increased $3.1 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 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.
Previous wording
For the three months ended June 30, 2024, therapeutic area-specific research and development costs, including contract manufacturing costs for drug substance, increased $14.8 million as compared with the prior-year period. Research and development costs related to neurological diseases, which include MG and CIDP, increased $7.2 million. This increase was primarily due to activities in 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 $9.6 million. This increase was primarily due to higher overall clinical trial costs related to our batoclimab Phase 3 clinical program and activities in preparation for potential future clinical trials of IMVT-1402 in endocrine diseases. Research and development costs related to other clinical and nonclinical activities decreased $2.0 million, reflecting lower overall costs related to our IMVT-1402 Phase 1 trial and nonclinical studies, partially offset by higher overall costs in preparation for future IMVT-1402 clinical programs.
Current 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.
Previous wording
There were no acquired in-process research and development expenses for the three months ended June 30, 2024. During the three months ended June 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 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.
Previous wording
We had cash and cash equivalents of $560.0 million and $635.4 million as of June 30, 2024 and March 31, 2024, respectively. For the three months ended June 30, 2024 and 2023, we had net losses of $87.2 million and $73.9 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 $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.
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, heightened interest rates and recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures.
Current wording
To date, we have financed our operations primarily from equity offerings. Until such time, if ever, as we can generate substantial product revenue from sales of 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.
Previous wording
The following table sets forth a summary of our cash flows for the three months ended June 30, 2024 and 2023 (in thousands):
Current wording
The following table sets forth a summary of our cash flows for the six months ended September 30, 2024 and 2023 (in thousands):
Previous wording
For the three months ended June 30, 2024, $76.2 million of cash was used in operating activities, primarily reflecting a net loss from operations for the period of $87.2 million and a net change in operating assets and liabilities of $2.6 million, partially offset by non-cash charges of $13.6 million. The non-cash charges consisted mainly of stock-based compensation of $13.5 million, reflecting the higher headcount and incentive equity awards as compared with the prior year. The change in operating assets and liabilities reflected a decrease in accrued expenses of $7.5 million, primarily reflecting payments related to employee incentive compensation, partially offset by the timing of payments and services related to our ongoing clinical trials. In addition, prepaid expenses and other current assets increased $1.8 million, driven primarily by the timing of payments and services performed related to our ongoing and planned clinical trials. These changes were partially offset by an increase in accounts payable of $3.9 million, primarily related to contract manufacturing costs, and a decrease in accounts receivable of $2.9 million, reflecting the collection of amounts owed to us under research and development cost-sharing arrangements with a third party.
Current wording
For the six months ended September 30, 2024, $164.8 million of cash was used in operating activities, primarily reflecting a net loss from operations for the period of $196.3 million, partially offset by non-cash charges of $26.4 million and a net change in operating assets and liabilities of $5.0 million. The non-cash charges consisted mainly of stock-based compensation of $26.1 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 of $13.2 million, primarily related to clinical trial and contract manufacturing costs and a decrease in accounts receivable of $3.3 million, reflecting the collection of amounts owed to us under research and development cost-sharing arrangements with a third party. In addition, accrued expenses increased $3.1 million, primarily reflecting the timing of payments and services related to contract manufacturing and our ongoing clinical trials, partially offset by payments related to employee incentive compensation. These changes were partially offset by an increase in other assets of $8.1 million as a result of prepaid expenses related to planned contract manufacturing activities, as well as higher prepaid expenses and other current assets of $6.5 million, driven primarily by the timing of payments and services performed related to our ongoing and planned clinical trials.
Previous wording
For the three months ended June 30, 2023, $47.4 million of cash was used in operating activities, primarily reflecting a net loss from operations for the period of $73.9 million, partially offset by a net change in operating assets and liabilities of $15.5 million and non-cash charges of $11.0 million. The non-cash charges consisted mainly of stock-based compensation of $10.7 million, reflecting the higher headcount and incentive equity awards as compared with the prior year. The change in operating assets and liabilities reflected $25.0 million of higher accounts payable, driven by $12.5 million payable as a result of the achievement of our third and fourth development and regulatory milestones under the HanAll Agreement, which was paid in the quarter ended September 30, 2023, as well as the timing and level of payments related to contract manufacturing and research and development costs related to our clinical trials. Prepaid expenses and other current assets decreased $8.3 million, driven primarily by the timing of payments related to our ongoing clinical trials. These changes were partially offset by a decrease in accrued expenses of $17.3 million, primarily reflecting payments for contract manufacturing costs.
Current wording
For the six months ended September 30, 2023, $107.4 million of cash was used in operating activities, primarily reflecting a net loss from operations for the year of $132.6 million, partially offset by non-cash charges of $21.9 million and a net change in operating assets and liabilities of $3.3 million. The non-cash charges consisted mainly of stock-based compensation of $21.2 million, reflecting the higher headcount and incentive equity awards as compared with the prior year. The change in operating assets and liabilities reflected $7.2 million of lower prepaid expenses and other current assets, driven primarily by the timing of payments and services performed related to our ongoing clinical trials. Changes in accounts payable reflected an increase of $6.1 million driven by the timing and level of payments related to contract manufacturing and research and development costs related to our clinical trials. These changes were partially offset by a decrease in accrued expenses of $8.8 million, primarily reflecting payments for contract manufacturing costs.
Previous wording
For the three months ended June 30, 2024 and 2023, cash used in investing activities was related to the purchase of property and equipment.
Current wording
For the six months ended September 30, 2024 and 2023, cash used in investing activities was related to the purchase of property and equipment.
Previous wording
For the three months ended June 30, 2024 and 2023, cash provided by financing activities consisted of proceeds from the exercise of stock options.
Current wording
For the six months ended September 30, 2024 and 2023, cash provided by financing activities consisted of proceeds from the exercise of stock options.
Previous wording
During the year ended March 31, 2022, we entered into an agreement with Samsung to manufacture a certain quantity of batoclimab drug substance for, among other things, commercial sale, if approved. As of June 30, 2024, in connection with this agreement, we have a remaining minimum obligation to Samsung of approximately $44.5 million, of which $1.9 million, $11.7 million, $16.9 million and $14.0 million is expected to be paid during the remainder of the fiscal year ending March 31, 2025, and for the fiscal years ending March 31, 2026, 2027 and 2029, respectively. See “Note 3 - Material Agreements” in our unaudited condensed consolidated financial statements in Part I, Item 1 of this Quarterly Report for additional details.
Current wording
During the year ended March 31, 2022, we entered into an agreement with Samsung to manufacture a certain quantity of batoclimab drug substance for, among other things, commercial sale, if approved. As of September 30, 2024, in connection with this agreement, we have a remaining minimum obligation to Samsung of approximately $43.6 million, of which $3.0 million, $12.6 million, $14.0 million and $14.0 million is expected to be paid during the remainder of the fiscal year ending March 31, 2025, and for the fiscal years ending March 31, 2026, 2027 and 2029, respectively. See “Note 3 - Material Agreements” in our unaudited condensed consolidated financial statements in Part I, Item 1 of this Quarterly Report for additional details.
Previous wording
We currently expect that our existing cash and cash equivalents as of June 30, 2024 of $560.0 million will be sufficient to fund our operating expenses and capital expenditure requirements for at least the next 12 months from the date of the filing of this Quarterly Report and in the long term beyond the next 12 months.
Current wording
We currently expect that our existing cash and cash equivalents as of September 30, 2024 of $472.9 million will be sufficient to fund our operating expenses and capital expenditure requirements for at least the next 12 months from the date of the filing of this Quarterly Report and in the long term beyond the next 12 months.
Previous wording
We define our critical accounting estimates as those under U.S. GAAP that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. During the three months ended June 30, 2024, there were no material changes to our critical accounting estimates from those disclosed in the audited consolidated financial statements for the year ended March 31, 2024 included in our Annual Report.
Current wording
We define our critical accounting estimates as those under U.S. GAAP that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. During the three and six months ended September 30, 2024, there were no material changes to our critical accounting estimates from those disclosed in the audited consolidated financial statements for the year ended March 31, 2024 included in our Annual Report.
Rearranged current paragraphs (8)
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
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 report — wording carried from elsewhere
The following table sets forth our results of operations for the six months ended September 30, 2024 and 2023 (in thousands):
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
*Certain prior year amounts have been reclassified to conform to current year presentation.
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
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 report — wording carried from elsewhere
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.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Acquired In-Process Research and Development Expenses for the Three Months Ended June 30, 2024 and 2023