Immunovant Inc

Previous wording

We are a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. Our innovative product pipeline includes batoclimab, formerly referred to as IMVT-1401, and IMVT-1402, both of which are novel, fully human monoclonal antibodies that target the neonatal fragment crystallizable receptor (“FcRn”). Batoclimab and IMVT-1402 are the result of a multi-step, multi-year research program conducted by us and HanAll Biopharma Co., Ltd., (“HanAll”) to design highly potent anti-FcRn antibodies that may be optimized as a simple, subcutaneous injection with dosing that we believe can be tailored based on disease severity and stage.

Current wording

Our innovative product pipeline includes IMVT-1402 and batoclimab, formerly referred to as IMVT-1401, both of which are novel, fully human monoclonal antibodies that target the neonatal fragment crystallizable receptor (“FcRn”). Our product candidates are the result of a multi-step, multi-year research program conducted in collaboration with HanAll Biopharma Co., Ltd., (“HanAll”) to design highly potent anti-FcRn antibodies that may be optimized as a simple, subcutaneous injection with dosing that we believe can be tailored based on disease stage and severity.

Previous wording

Batoclimab, our first product candidate, has been dosed in small volumes (e.g., 2 mL) and with a 27-gauge needle, while still generating therapeutically relevant pharmacodynamic activity, important attributes that we believe will drive patient preference and market adoption. In nonclinical studies and in clinical trials conducted to date, batoclimab has been observed to reduce immunoglobulin G (“IgG”) antibody levels. High levels of pathogenic IgG antibodies drive a variety of autoimmune diseases and, as a result, we believe batoclimab has the potential for broad application in these disease areas.

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. We believe these attributes will drive patient preference and market adoption. In clinical trials conducted to date, batoclimab has been observed to reduce IgG antibody levels, which has provided evidence supporting the use of an anti-FcRn antibody in disease areas associated with high levels of pathogenic IgG antibodies.

Previous wording

Likewise, IMVT-1402, our second product candidate, has also been observed in nonclinical studies and in a Phase 1 clinical trial conducted in healthy participants to reduce IgG antibody levels. Importantly, IMVT-1402 has demonstrated no or minimal reductions in albumin and no or minimal increases in low-density lipoprotein (“LDL”) cholesterol levels in healthy adults after four weekly doses of 300 mg and 600 mg, with changes consistent with those participants receiving placebo. This is a key attribute for IMVT-1402, which we believe could potentially allow its use as a treatment of chronic conditions requiring maintenance doses that achieve high degrees of IgG suppression. We are developing batoclimab and IMVT-1402 in autoimmune diseases for which there is robust evidence that pathogenic IgG antibodies drive disease manifestation and for which reduction of IgG antibodies should lead to clinical benefit.

Current wording

Likewise, IMVT-1402, our lead product candidate, has also been observed to reduce IgG antibody levels in a Phase 1 clinical trial conducted in healthy adults, similar to that observed in our original Phase 1 clinical trial of batoclimab. Importantly, although FcRn also plays a role in maintaining serum albumin levels which in turn correlate inversely with low-density lipoprotein (“LDL”) cholesterol levels, no or minimal reduction in albumin and no or minimal increases in LDL cholesterol levels were observed in study participants administered either 300 mg or 600 mg of IMVT-1402 subcutaneously once weekly for four weeks. Across both dose regimens, the changes in albumin and LDL cholesterol were similar to those observed with placebo administration. This is a key attribute for IMVT-1402, which we believe could potentially allow its use as a treatment of chronic conditions requiring maintenance doses that achieve high degrees of IgG suppression.

Previous wording

Based on third-party patient prevalence estimates, for the 22 indications that have been 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 (includes all European Union (“E.U.”) countries, Norway, Lichtenstein, Iceland, (together with the E.U. countries, the “EEA”), the United Kingdom (“U.K.”), and Switzerland). Our long-term goal is to build a leading anti-FcRn franchise that targets multiple underserved autoimmune disease indications across a variety of therapeutic areas. Our current research and development programs under which batoclimab is currently being evaluated are organized around specific therapeutic areas: treatment of neurological diseases, inclusive of myasthenia gravis (“MG”) and chronic inflammatory demyelinating polyneuropathy (“CIDP”), and treatment of endocrine diseases, inclusive of thyroid eye disease (“TED”) and Graves’ disease (“GD”).

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, neurology, endocrinology, hematology, rheumatology, and dermatology. Based on third-party patient prevalence estimates, for the 23 indications that have been publicly announced by multiple companies for clinical development with anti-FcRn assets, we estimate the total potential opportunity for our FcRn franchise to be greater than two million patients in the U.S. and Europe. Our estimates in Europe include all European Union (“E.U.”) countries, Norway, Lichtenstein, Iceland, (together with the E.U. countries, the “EEA”), the United Kingdom (“U.K.”), and Switzerland.

Previous wording

Likewise, we believe IMVT-1402 has the potential to treat a class-leading portfolio of indications in several therapeutic areas.

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. 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.

Previous wording

As a result of our rational design and current outlook on potential opportunities, we believe that batoclimab and IMVT-1402, if developed and approved for commercial sale, would be differentiated from currently available treatments for advanced IgG-mediated autoimmune diseases.

Current wording

As a result of our rational design and current outlook on potential opportunities, we believe our product candidates, if developed and approved for commercial sale, would be differentiated from currently available treatments for advanced IgG-mediated autoimmune diseases. To date, these product candidates have demonstrated potential best-in-class IgG reduction and are being developed for delivery using a simple, self-administered subcutaneous injection.

Previous wording

In the quarter ended June 30, 2023, the FDA cleared our Investigational New Drug (“IND”) application for IMVT-1402, our next generation FcRn inhibitor. Concurrently, we initiated a Phase 1 clinical trial in healthy adults in New Zealand after approval of the Clinical Trial Application (“CTA”) by the regulatory authority, MEDSAFE. In the quarter ended September 30, 2023, we announced initial data from this Phase 1 clinical trial of IMVT-1402, which is a randomized, double-blind, placebo-controlled ascending dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IMVT-1402 in healthy adults.

Current wording

In the quarter ended June 30, 2023, the FDA cleared our IND application for IMVT-1402 and we initiated a Phase 1 clinical trial in healthy adults in New Zealand after approval of the Clinical Trial Application (“CTA”) by the regulatory authority, MEDSAFE.

Previous wording

Unfavorable conditions in the economy in the U.S., Canada and abroad may negatively affect the growth of our business and our results of operations. For example, macroeconomic events, including the post-COVID-19 environment, changes in inflation, the U.S. Federal Reserve raising interest rates, potential recession in the U.S., recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures and the Russia-Ukraine war and conflict in the Middle East, have led to economic uncertainty globally. The effect of macroeconomic conditions may not be fully reflected in our results of operations until future periods. If, however, economic uncertainty increases or the global economy worsens, our business, financial condition and results of operations may be harmed.

Current wording

Unfavorable conditions in the economy in the U.S., Canada and abroad may negatively affect the growth of our business and our results of operations. For example, macroeconomic events, including changes in inflation, 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.

Previous wording

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

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.

Previous wording

We have been primarily engaged in preparing for and conducting clinical trials. Research and development expenses include program-specific costs, as well as unallocated costs, and are net of costs reimbursable to the Company pursuant to cost-sharing arrangements with third parties.

Current wording

We have been primarily engaged in preparing for and conducting clinical trials. Research and development expenses include therapeutic area-specific costs, as well as unallocated costs, and are net of costs reimbursable to the Company pursuant to cost-sharing arrangements with third parties.

Previous wording

Program-specific costs include direct third-party costs, which include expenses incurred under agreements with contract research organizations and the cost of consultants who assist with the development of our product candidates on a program-specific basis, investigator grants, sponsored research, and any other third-party expenses directly attributable to the development of the product candidates. Program-specific costs also include contract manufacturing costs in connection with producing materials for use in conducting preclinical and clinical studies, including under our agreement with Samsung, to the extent they can be allocated to a specific program.

Current wording

Therapeutic area-specific costs include direct third-party costs, which include expenses incurred under agreements with contract research organizations and the cost of consultants who assist with the development of our product candidates with respect to a specific therapeutic area, investigator grants, sponsored research, and any other third-party expenses directly attributable to the development of the product candidates. Therapeutic area-specific costs also include contract manufacturing costs in connection with producing materials for use in conducting nonclinical and clinical studies, including under our agreement with Samsung, to the extent they can be allocated to a specific therapeutic area.

Previous wording

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

Current wording

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

Previous wording

•other expenses, which include the cost of consultants who assist with our research and development and costs related to contract manufacturing, but are not allocated to a specific program.

Current wording

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

Previous wording

Research and development activities will continue to be central to our business model. We expect to incur research and development expenses as we continue our Phase 3 trial of batoclimab as a treatment for MG, our Phase 3 clinical program to evaluate batoclimab for the treatment of TED, a pivotal Phase 2b trial of batoclimab as a treatment for CIDP and a proof-of-concept Phase 2 clinical trial of batoclimab as a treatment for GD. In addition, we are continuing our Phase 1 clinical trial of IMVT-1402 in healthy adults in New Zealand. Our research and development expenses are expected to continue to increase over the next several years as we hire personnel and our compensation costs increase, commence additional clinical trials for batoclimab and IMVT-1402, increase manufacturing of batoclimab and IMVT-1402 drug substance 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. 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.

Previous wording

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

Previous wording

•the potential impact of macroeconomic events, including the post-COVID-19 environment, changes in inflation, the U.S. Federal Reserve raising interest rates, potential recession in the U.S., recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures and the Russia-Ukraine war and the conflict in the Middle East;

Current wording

•the potential impact of macroeconomic events, including changes in inflation, 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;

Previous wording

In addition, the probability of success for batoclimab and IMVT-1402 will depend on numerous factors, including our product’s efficacy, safety, ease of use, competition, manufacturing capability and commercial viability.

Current wording

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

Previous wording

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

Previous wording

Unallocated research and development costs increased by $5.7 million, from $17.2 million for the three months ended December 31, 2022 to $22.9 million for the three months ended December 31, 2023. This increase reflected higher personnel-related expenses of $4.7 million, primarily reflecting higher headcount and enhancement of our capabilities to support our strategic objectives as we progress our clinical activities in existing and new indications. Also contributing to the increase were higher costs related to cross-indication research and development activities supporting batoclimab and IMVT-1402 programs of $1.0 million.

Current 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.

Previous wording

There were no acquired in-process research and development expenses for the three months ended December 31, 2023. During the three months ended December 31, 2022, acquired in-process research and development expenses were $10.0 million related to the achievement of a development and regulatory milestone for batoclimab in MG under the terms of the HanAll Agreement.

Current 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.

Previous wording

General and administrative expenses increased by $1.4 million, from $11.8 million for the three months ended December 31, 2022 to $13.2 million for the three months ended December 31, 2023. The increase was primarily related to higher personnel-related expenses, legal and other professional fees, market research costs and information technology costs.

Current 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.

Previous wording

We had cash and cash equivalents of $690.9 million and $376.5 million as of December 31, 2023 and March 31, 2023, respectively. For the three months ended December 31, 2023 and 2022, we had net losses of $51.4 million and $63.2 million, respectively, and for the nine months ended December 31, 2023 and 2022, we had net losses of $184.0 million and $151.5 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 $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.

Previous wording

To date, we have financed our operations primarily from equity offerings. Until such time, if ever, as we can generate substantial product revenue from sales of batoclimab, IMVT-1402 or any future product candidate, we expect to finance our cash needs through a combination of equity offerings, debt financings and potential collaboration, license or development agreements. Our ability to raise additional capital may be adversely impacted by worsening global economic conditions and the continuing disruptions to, and volatility in, the credit and financial markets in the U.S. and worldwide, including disruptions resulting from the ongoing military conflict between Russia and Ukraine and in the Middle East, the post-COVID-19 environment, changes in inflation, heightened interest rates and recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures.

Current wording

To date, we have financed our operations primarily from equity offerings. Until such time, if ever, as we can generate substantial product revenue from sales of 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.

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 will 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, will 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

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.

Previous wording

The following table sets forth a summary of our cash flows for the nine months ended December 31, 2023 and 2022 (in thousands):

Current wording

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

Previous wording

For the nine months ended December 31, 2023, $154.5 million of cash was used in operating activities, primarily reflecting a net loss from operations for the year of $184.0 million and a net change in operating assets and liabilities of $3.0 million, partially offset by non-cash charges of $32.5 million. The non-cash charges consisted mainly of stock-based compensation of $31.4 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 $14.1 million, primarily reflecting payments for contract manufacturing costs. This change was partially offset by $10.1 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.

Current 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.

Previous wording

For the nine months ended December 31, 2022, $132.4 million of cash was used in operating activities, primarily reflecting a net loss from operations for the year of $151.5 million and a net change in operating assets and liabilities of $6.6 million, partially offset by non-cash charges of $25.7 million. The non-cash charges consisted mainly of stock-based compensation of $24.8 million, reflecting the higher headcount and incentive equity awards as compared with the prior year. The change in operating assets and liabilities reflected $14.3 million of higher prepaid expenses and other current assets, driven primarily by payments related to clinical research activities in advance of ongoing and planned clinical trials. Accounts payable decreased $4.5 million, primarily reflecting the timing and level of payments related to contract manufacturing and upfront and start-up research and development costs related to our clinical trials of $14.5 million, partially offset by the $10.0 million payable as a result of the achievement of our second development and regulatory milestone under the HanAll Agreement, which was paid in the fiscal 2023 fourth quarter. These changes were partially offset by a decrease in accounts receivable of $11.8 million reflecting the collection of amounts owed to us under research and development cost-sharing arrangements with third parties.

Current 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.

Previous wording

For the nine months ended December 31, 2023 and 2022, cash used in investing activities was related to the purchase of property and equipment.

Current 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.

Previous wording

For the nine months ended December 31, 2023, $470.9 million of cash provided by financing activities primarily consisted of proceeds from our October 2023 underwritten public offering and concurrent private placement of $466.7 million, combined, after deducting underwriting discounts and commissions, placement agent fees and offering expenses. Cash provided by financing activities also reflected $4.1 million of proceeds from the exercise of stock options. For the nine months ended December 31, 2022, $70.7 million of cash provided by financing activities primarily consisted of proceeds from our October 2022 underwritten offering of $70.2 million, after deducting underwriting discounts and commissions and offering expenses. Cash provided by financing activities also reflected $0.4 million of proceeds from the exercise of stock options.

Current 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.

Previous wording

Our primary uses of capital have been, and we expect will continue to be, for advancing our clinical and preclinical development programs. We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Our net losses and operating cash flows may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our planned clinical trials, timing of batoclimab or IMVT-1402 manufacturing, HanAll milestone payments and our expenditures on other research and development activities.

Current wording

Our primary uses of capital have been, and we expect will continue to be, for advancing our clinical and nonclinical development programs. We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Our net losses and operating cash flows may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our planned clinical trials, timing of IMVT-1402 or batoclimab manufacturing, HanAll milestone payments and our expenditures on other research and development activities.

Previous wording

During the year ended March 31, 2022, we entered into an agreement with Samsung to manufacture a certain quantity of batoclimab drug substance for, among other things, commercial sale, if approved. As of December 31, 2023, in connection with this agreement, we have a remaining minimum obligation to Samsung of approximately $18.3 million, of which $1.9 million, $3.7 million and $12.7 million is expected to be paid during the remainder of the fiscal year ending March 31, 2024, and for the fiscal years ending March 31, 2025 and 2026, respectively.

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 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.

Previous wording

Potential future payments due under the HanAll Agreement are contingent upon future events. As of December 31, 2023, the aggregate maximum amount of milestone payments we could be required to make under the HanAll Agreement is $420.0 million (after an aggregate amount of $32.5 million of milestone achievements as of December 31, 2023) upon the achievement of certain development, regulatory and sales milestone events. During the quarter ended June 30, 2023, we achieved our third and fourth development and regulatory milestones under the HanAll Agreement and made a $12.5 million milestone payment in the quarter ended September 30, 2023 in accordance with the terms of the agreement.

Current wording

Potential future payments due under the HanAll Agreement are contingent upon future events. As of June 30, 2024, the aggregate maximum amount of milestone payments we could be required to make under the HanAll Agreement is $420.0 million (after an aggregate amount of $32.5 million paid for milestone events achieved as of June 30, 2024) upon the achievement of certain regulatory and sales milestone events. During the quarter ended June 30, 2023, we achieved our third and fourth development and regulatory milestones under the HanAll Agreement and made a $12.5 million milestone payment in the quarter ended September 30, 2023 in accordance with the terms of the agreement.

Previous wording

We currently expect that our existing cash and cash equivalents as of December 31, 2023 of $690.9 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.

Current 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.

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

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 and nine months ended December 31, 2023, 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, 2023 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 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.