Immunovant, Inc.

Previous wording

We believe that FcRn inhibition has broad therapeutic and commercial potential to address IgG-mediated autoimmune diseases in several therapeutic areas, including but not limited to, endocrinology, neurology, rheumatology and dermatology. Third-party estimates suggest over four million patients in the United States and Europe could benefit from anti-FcRn treatments across more than 20 indications currently being evaluated in clinical trials by multiple companies, with two indications that are already approved and launched quickly reaching billions of dollars in sales.

Current wording

We believe that FcRn inhibition has broad therapeutic and commercial potential to address pathogenic IgG-mediated autoimmune diseases in several therapeutic areas, including but not limited to, endocrinology, neurology, rheumatology and dermatology. Third-party estimates suggest over four million patients in the United States and Europe could benefit from anti-FcRn treatments across more than 20 indications currently being evaluated in clinical trials by multiple companies, with two indications that are already approved and launched quickly reaching billions of dollars in global annual sales.

Previous wording

In the Phase 1 clinical trial, across all evaluated doses, IMVT-1402 demonstrated no or minimal reductions in albumin and no or minimal increases in LDL cholesterol levels, which are off-target effects observed in some anti-FcRn antibodies, including batoclimab. We are pursuing the rapid development of IMVT-1402 because of its best-in-class potential, with the 600 mg dose expected to reach approximately 80% IgG reduction. We believe IMVT-1402’s profile has the potential to offer best-in-class efficacy, in addition to its potentially favorable safety profile and convenient administration with a simple self-administered auto-injector expected at launch. As previously disclosed, we will make a final decision about the future development and regulatory submissions for batoclimab in the future based on the aggregate information available at the time in consultation with our partner HanAll Biopharma Co., Ltd., (“HanAll”). Data and insights from batoclimab, including our operational trial experience, relationships with investigators and prior results, are being leveraged to inform and potentially accelerate our development programs for IMVT-1402.

Current wording

In the Phase 1 clinical trial, across all evaluated doses, IMVT-1402 demonstrated no or minimal reductions in albumin and no or minimal increases in LDL cholesterol levels, which are off-target effects observed in some anti-FcRn antibodies, including batoclimab. We are pursuing the rapid development of IMVT-1402 because of its best-in-class potential, with the 600 mg dose expected to reach approximately 80% IgG reduction. We believe IMVT-1402’s profile has the potential to offer best-in-class efficacy, in addition to its potentially favorable safety profile and convenient administration with a simple self-administered auto-injector expected at launch. As previously disclosed, we will make a final decision about the further development and regulatory submissions for batoclimab in the future based on the aggregate information available at the time in consultation with our partner HanAll Biopharma Co., Ltd. (“HanAll”). Data and insights from batoclimab, including our operational trial experience, relationships with investigators and prior results, have been and continue to be leveraged to inform and potentially accelerate our development programs for IMVT-1402.

Previous wording

We are currently progressing a broad set of programs for IMVT-1402. Over the last year, we announced the clearance of six investigational new drug (“IND”) applications to support clinical trials to evaluate IMVT-1402. We have now initiated studies in all of these six indications, including potentially registrational trials in GD, difficult-to-treat rheumatoid arthritis (“D2T RA”), MG, CIDP and Sjögren’s disease (“SjD”), and a proof-of-concept trial in cutaneous lupus erythematosus (“CLE”). Our primary focus is to execute these six indications first, with plans to assess new indications in the future. All studies evaluating IMVT-1402 are being conducted using the intended commercial drug formulation and delivery device, the YpsoMate® autoinjector developed by Ypsomed AG, which is utilized for multiple approved products.

Current wording

We are currently progressing a broad set of programs for IMVT-1402 and have initiated and are currently enrolling studies in six indications, including potentially registrational trials in GD, difficult-to-treat rheumatoid arthritis (“D2T RA”), MG, CIDP and Sjögren’s disease (“SjD”), and a proof-of-concept trial in cutaneous lupus erythematosus (“CLE”). Our primary focus is to execute these six indications first, with plans to assess new indications for IMVT-1402 in the future. All studies evaluating IMVT-1402 are being conducted using the intended commercial drug formulation and delivery device, the YpsoMate® autoinjector developed by Ypsomed AG, which is utilized for multiple approved products.

Previous wording

This proof-of-concept Phase 2 clinical trial (NCT05907668) of batoclimab for the treatment of uncontrolled GD is ongoing, with additional data expected to be presented at the American Thyroid Association (ATA) Annual Meeting in September 2025, including remission data from the 24-week post-treatment follow-up period.

Current wording

In September 2025, we announced and presented six-month off-treatment data generated from our proof-of-concept Phase 2 clinical trial (NCT05907668) of batoclimab for the treatment of uncontrolled GD at the American Thyroid Association Annual Meeting. The study included a 24-week treatment period with a dose step-down midway through the treatment period (Weeks 0-12 at 680 mg weekly (“QW”) subcutaneously (“SC”) and Weeks 13-24 at 340 mg QW SC), followed by a 24-week off-treatment follow-up period. The study enrolled participants with active Graves’ disease as documented by presence of elevated thyrotropin receptor autoantibodies (“TRAb”) and who were hyperthyroid despite current treatment with standard of care antithyroid drug (“ATD”) therapy. Response was measured by the primary endpoint of the study as the proportion of participants who at Week 24 achieved normalization of free triiodothyronine (“T3”) and free thyroxine (“T4”), or have T3/T4 below the lower limit of normal (“LLN”), without an increase in ATD dose from baseline.

Previous wording

Batoclimab Phase 3 Clinical Program in TED

Current wording

Batoclimab Phase 3 Clinical Program in Thyroid Eye Disease (“TED”)

Previous wording

In the quarter ended December 31, 2022, we initiated our Phase 3 clinical program to evaluate batoclimab as a treatment for active moderate-to-severe TED. We plan to report top-line results from this clinical trial in the second half of calendar year 2025.

Current wording

In the quarter ended December 31, 2022, we initiated our Phase 3 clinical program to evaluate batoclimab as a treatment for active moderate-to-severe TED. We remain on track for the first of the two batoclimab Phase 3 TED studies to read out before the end of calendar year 2025. However, due to evolving competitive dynamics, we anticipate sharing top-line results from both TED studies concurrently in the first half of calendar year 2026.

Previous wording

We initiated a potentially registrational trial (NCT07032662) evaluating IMVT-1402 in adults with CIDP in March 2025. This trial is a randomized, placebo-controlled, 24-week trial in CIDP patients. We expect to report top-line results from this trial in 2028.

Current wording

We initiated a potentially registrational trial (NCT07032662) evaluating IMVT-1402 in adults with CIDP in March 2025. This trial is a randomized, placebo-controlled, 24-week trial in participants with active CIDP. We expect to report top-line results from this trial in 2028.

Previous wording

We initiated a potentially registrational trial (NCT06754462) evaluating IMVT-1402 in ACPA-positive D2T RA in December 2024. We expect to report initial results from the period 1 open label portion of this trial in 2026.

Current wording

We initiated a potentially registrational trial (NCT06754462) evaluating IMVT-1402 in anti-citrullinated protein autoantibody (“ACPA”) positive D2T RA in December 2024. We expect to report initial results from the period 1 open label portion of this trial in 2026.

Previous wording

For a description of our transactions under the HanAll Agreement, refer to “Note 3 – Material Agreements” 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 HanAll Agreement, refer to “Note 3 – License Agreement” in our unaudited condensed consolidated financial statements in Part I, Item 1 of this Quarterly Report.

Previous wording

We have not generated any revenue and have incurred significant operating losses since inception, and we do not expect to generate any revenue from the sale of any products unless or until we obtain regulatory approval of and commercialize IMVT-1402, batoclimab or any future product candidates. Our ability to generate revenue sufficient to achieve profitability will depend completely on the successful development and eventual commercialization of IMVT-1402, batoclimab and any future product candidates.

Current wording

We have not generated any revenue and have incurred significant operating losses since inception, and we do not expect to generate any revenue from the sale of any products unless or until we obtain regulatory approval of and commercialize IMVT-1402, batoclimab or any future product candidates. Our ability to generate revenue sufficient to achieve profitability will depend completely on the successful development and eventual commercialization of IMVT-1402 and any other product candidates.

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 agreements 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 to the extent they can be allocated to a specific therapeutic area.

Previous wording

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

Current wording

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

Previous wording

Research and development activities will continue to be central to our business model. We expect to incur research and development expenses with respect to our IMVT-1402 development activities, our Phase 1 clinical trial of IMVT-1402 in New Zealand remains open and we initiated potentially registrational trials for IMVT-1402 in GD, D2T RA, MG, CIDP and SjD, and a proof-of-concept trial in CLE. We also expect to incur research and development expenses related to our ongoing Phase 3 clinical program to evaluate batoclimab for the treatment of TED and a proof-of-concept Phase 2 clinical trial of batoclimab as a treatment for GD. We expect to continue to incur research and development expenses over the next several years as we execute IMVT-1402 trials, manufacture IMVT-1402, and prepare to seek regulatory approval. It is not possible to determine with certainty the duration and completion costs of any clinical trial we may conduct.

Current wording

Research and development activities will continue to be central to our business model. We expect to incur research and development expenses with respect to our IMVT-1402 development activities and we initiated potentially registrational trials for IMVT-1402 in GD, D2T RA, MG, CIDP and SjD, and a proof-of-concept trial in CLE. We expect to continue to incur research and development expenses over the next several years as we execute IMVT-1402 trials, manufacture IMVT-1402, complete our batoclimab trials 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 duration, costs and timing of clinical trials of IMVT-1402, batoclimab and any future product candidates will depend on a variety of factors that include, but are not limited to:

Current wording

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

Previous wording

We anticipate that our general and administrative expenses will continue to support our ongoing research and development activities. These expenses will likely include patent-related costs, including legal and professional fees for filing, prosecution and maintenance of patents and patent applications claiming our product candidates and fees to outside consultants for professional services. In addition, if either IMVT-1402 or batoclimab obtains regulatory approval, we expect that we would incur significant additional expenses associated with market research activities and building commercial teams.

Current wording

We anticipate that our general and administrative expenses will continue to support our ongoing research and development activities. These expenses will likely include patent-related costs, including legal and professional fees for filing, prosecution and maintenance of patents and patent applications claiming our product candidates and fees to outside consultants for professional services. In addition, if IMVT-1402 or any other product candidate obtains regulatory approval, we expect that we would incur significant additional expenses associated with market research activities and building commercial teams.

Previous wording

For the three months ended June 30, 2025, research and development expenses increased $25.7 million as compared with the prior-year period.

Current wording

For the three months ended September 30, 2025, research and development expenses increased $17.0 million as compared with the prior-year period.

Previous wording

For the three months ended June 30, 2025, unallocated research and development costs increased $10.5 million as compared with the prior-year period. This increase reflected higher personnel-related expenses of $10.0 million, driven by higher headcount hired to conduct a higher number of clinical trials.

Current wording

For the three months ended September 30, 2025, unallocated research and development costs increased $6.7 million as compared with the prior-year period. This increase reflected higher personnel-related expenses of $6.3 million, driven by higher headcount hired to conduct a higher number of clinical trials.

Previous wording

For the three months ended June 30, 2025, interest income decreased $0.8 million as compared with the prior-year period, primarily reflecting lower average interest rates, partially offset by higher average money market fund balances.

Current wording

For the three months ended September 30, 2025, interest income decreased $0.5 million as compared with the prior-year period, primarily reflecting lower average interest rates, partially offset by higher average money market fund balances.

Previous wording

For the three months ended June 30, 2025, therapeutic area-specific research and development costs, including contract manufacturing costs, increased $15.2 million as compared with the prior-year period. Research and development costs related to endocrine diseases, which include GD and TED, increased $3.4 million. This increase was primarily due to the initiation of our potentially registrational trials of IMVT-1402 in endocrine diseases, partially offset by lower overall clinical trial costs related to our batoclimab Phase 3 clinical program. Research and development costs related to neurological diseases, which include MG and CIDP, increased $2.5 million. This increase was primarily due to the initiation of our potentially registrational trials of IMVT-1402 in neurological diseases, partially offset by lower overall clinical trial costs related to our batoclimab Phase 3 and Phase 2b clinical trials. Research and development costs related to rheumatology diseases of $8.2 million in the current-year period reflect expenses incurred with the initiation of our potentially registrational trials of IMVT-1402 in RA and SjD. Research and development costs related to dermatology diseases of $5.1 million in the current-year period reflect the initiation of our proof-of-concept trial in CLE. Research and development costs related to other clinical and nonclinical activities decreased $4.0 million, primarily reflecting the transition of IMVT-1402 clinical activities targeting specific therapeutic areas.

Current wording

For the six months ended September 30, 2025, therapeutic area-specific research and development costs, including contract manufacturing costs, increased $25.5 million as compared with the prior-year period. Research and development costs related to endocrine diseases, which include GD and TED, increased $13.4 million. This increase was primarily due to the initiation of our potentially registrational trials of IMVT-1402 in endocrine diseases, partially offset by lower overall clinical trial costs related to our batoclimab clinical trials. Research and development costs related to neurological diseases, which include MG and CIDP, decreased $4.1 million, primarily due to lower overall clinical trial costs related to our batoclimab Phase 3 and Phase 2b clinical trials, partially offset by costs related to the initiation of our potentially registrational trials of IMVT-1402 in neurological diseases. Research and development costs related to rheumatology diseases, which include RA and SjD, increased $12.8 million, reflecting expenses incurred with the initiation of our potentially registrational trials of IMVT-1402. Research and development costs related to dermatology diseases increased $8.2 million, reflecting the initiation of our proof-of-concept trial in CLE. Research and development costs related to other clinical and nonclinical activities decreased $4.8 million, primarily reflecting the transition of IMVT-1402 clinical activities targeting specific therapeutic areas.

Previous wording

For the three months ended June 30, 2025, general and administrative expenses increased $7.2 million as compared with the prior-year period, primarily reflecting higher personnel-related expenses, driven by a one-time stock-based compensation charge related to the retirement of our former chief executive officer.

Current wording

For the six months ended September 30, 2025, general and administrative expenses increased $6.3 million as compared with the prior-year period, primarily reflecting higher personnel-related expenses, driven by a one-time stock-based compensation charge related to the retirement of our former chief executive officer.

Previous wording

We had cash and cash equivalents of $598.9 million and $714.0 million as of June 30, 2025 and March 31, 2025, respectively. For the three months ended June 30, 2025 and 2024, we had net losses of $120.6 million and $87.2 million, respectively. We expect to continue to incur significant expenses at least for the next several years. We have never generated any revenue and we do not expect to generate product revenue unless and until we successfully complete development and obtain regulatory approval for IMVT-1402, batoclimab or any future product candidate.

Current wording

We had cash and cash equivalents of $521.9 million and $714.0 million as of September 30, 2025 and March 31, 2025, respectively. For the three months ended September 30, 2025 and 2024, we had net losses of $126.5 million and $109.1 million, respectively, and for the six months ended September 30, 2025 and 2024, we had net losses of $247.1 million and $196.3 million, respectively. We expect to continue to incur significant expenses at least for the next several years. We have never generated any revenue and we do not expect to generate product revenue unless and until we successfully complete development and obtain regulatory approval for IMVT-1402, batoclimab or any future product candidate.

Previous wording

To date, we have financed our operations primarily from equity offerings. Until such time, if ever, as we can generate substantial product revenue from sales of IMVT-1402, batoclimab or any future product candidate, we expect to finance our cash needs through a combination of equity offerings, debt financings and potential collaboration, license or development agreements. Our ability to raise additional capital may be adversely impacted by worsening global economic conditions and the continuing disruptions to, and volatility in, the credit and financial markets in the U.S. and worldwide, disruptions resulting from geopolitical tensions, including the ongoing military conflict between Russia and Ukraine and in the Middle East, and changes in inflation, interest rates and international trade policies and tariffs.

Current wording

To date, we have financed our operations primarily from equity offerings. Until such time, if ever, as we can generate substantial product revenue from sales of IMVT-1402 or any other product candidate, we expect to finance our cash needs through a combination of equity offerings, debt financings and potential collaboration, license or development agreements. Our ability to raise additional capital may be adversely impacted by worsening global economic conditions and the continuing disruptions to, and volatility in, the credit and financial markets in the U.S. and worldwide, disruptions resulting from geopolitical tensions, including the ongoing military conflict between Russia and Ukraine and in the Middle East, and changes in inflation, interest rates and international trade policies and tariffs.

Previous wording

The following table sets forth a summary of our cash flows for the three months ended June 30, 2025 and 2024 (in thousands):

Current wording

The following table sets forth a summary of our cash flows for the six months ended September 30, 2025 and 2024 (in thousands):

Previous wording

For the three months ended June 30, 2025, $117.4 million of cash was used in operating activities, primarily reflecting a net loss from operations for the period of $120.6 million and a net change in operating assets and liabilities of $15.4 million, partially offset by non-cash charges of $18.6 million. The non-cash charges consisted mainly of stock-based compensation of $18.5 million, reflecting the higher headcount and incentive equity awards as compared with the prior year. The change in operating assets and liabilities reflected a decrease in accounts payable of $9.4 million, primarily related to payments to CROs for clinical trial costs. Accrued expenses and other current liabilities decreased $5.3 million, primarily reflecting payments related to employee incentive compensation, partially offset by the timing of payments and services related to our ongoing clinical trials.

Current wording

For the six months ended September 30, 2025, $219.9 million of cash was used in operating activities, primarily reflecting a net loss from operations for the period of $247.1 million and a net change in operating assets and liabilities of $4.9 million, partially offset by non-cash charges of $32.1 million. The non-cash charges consisted mainly of stock-based compensation of $31.9 million, reflecting the higher headcount and incentive equity awards as compared with the prior year, as well as a one-time stock-based compensation charge related to the retirement of our former chief executive officer. The change in operating assets and liabilities reflected a decrease in accounts payable of $10.5 million, primarily related to payments for clinical trial costs and contract manufacturing. These changes were partially offset by an increase in accrued expenses and other current liabilities of $5.0 million, primarily reflecting costs incurred for our ongoing clinical trials.

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 and other current liabilities of $7.6 million, primarily reflecting payments related to employee incentive compensation, partially offset by the timing of payments to CROs and services related to our ongoing clinical trials. In addition, prepaid expenses and other current assets increased $1.8 million, driven primarily by the timing of payments and services performed related to our ongoing and planned clinical trials. These changes were partially offset by an increase in accounts payable of $3.9 million, primarily related to contract manufacturing costs, and a decrease in accounts receivable of $2.9 million, reflecting the collection of amounts owed to us under research and development cost-sharing arrangements with a third party.

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, 2025 and 2024, cash provided by financing activities consisted of proceeds from the exercise of stock options.

Current wording

For the six months ended September 30, 2025 and 2024, cash provided by financing activities consisted of proceeds from the exercise of stock options, primarily from our former executive officers.

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, 2025, in connection with this agreement, we have a remaining minimum obligation to Samsung of approximately $43.1 million, of which $5.0 million, $10.1 million, $14.0 million and $14.0 million is expected to be paid during the remainder of the fiscal year ending March 31, 2026, and for the fiscal years ending March 31, 2028, 2029 and 2030, respectively. See “Note 3 - Material Agreements” in our unaudited condensed consolidated financial statements in Part I, Item 1 of this Quarterly Report for additional details.

Current wording

As of September 30, 2025, we have a remaining minimum obligation for the contract manufacturing of batoclimab drug substance of approximately $39.1 million, of which $1.0 million, $10.1 million, $14.0 million and $14.0 million is expected to be paid, subject to the terms of such contract manufacturing agreement, during the remainder of the fiscal year ending March 31, 2026, and for the fiscal years ending March 31, 2028, 2029 and 2030, respectively.

Previous wording

We currently expect that our existing cash and cash equivalents as of June 30, 2025 of $598.9 million will be sufficient to fund our operating expenses and capital expenditure requirements for announced indications to date through our GD readout expected in 2027.

Current wording

We currently expect that our existing cash and cash equivalents as of September 30, 2025 of $521.9 million will be sufficient to fund our operating expenses and capital expenditure requirements for announced indications to date through our GD readout expected in 2027.

Previous wording

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

Current wording

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

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, 2025, there were no material changes to our critical accounting estimates from those disclosed in the audited consolidated financial statements for the year ended March 31, 2025 included in our Annual Report.

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, 2025, there were no material changes to our critical accounting estimates from those disclosed in the audited consolidated financial statements for the year ended March 31, 2025 included in our Annual Report.