Immunovant Inc.

05/20/2026 | Press release | Distributed by Public on 05/20/2026 05:28

Annual Report for Fiscal Year Ending March 31, 2026 (Form 10-K)

Management's Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition, results of operations and cash flows together with the audited consolidated financial statements and the related notes thereto included elsewhere in this Annual Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. You should review the "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A Risk Factors" for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. Our fiscal year ends on March 31.
Overview
Immunovant, Inc. ("Immunovant," "we" or the "Company") is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. Our focus is on developing IMVT-1402, a potentially best-in-class inhibitor of the neonatal fragment crystallizable receptor ("FcRn"), to address autoimmune diseases driven by high levels of pathogenic immunoglobulin G ("IgG") antibodies. FcRn is involved in preventing the degradation of IgG antibodies, and inhibition of FcRn has been shown to reduce levels of total IgG and pathogenic IgG antibodies.
We believe that FcRn inhibition has broad therapeutic and commercial potential to address 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 that have been publicly announced for research and development by multiple companies, with two indications that are already approved and launched quickly reaching multi-billions of dollars in global annual sales.
Consistent evidence observed across the class in eight indications in Phase 2 and 3 trials with FcRn inhibitors has indicated that deeper IgG reductions correlate with meaningful improvements in clinical outcomes. This has also been validated with Immunovant's own Phase 2 and 3 studies evaluating its first-generation anti-FcRn antibody, batoclimab, in Graves' disease ("GD"), myasthenia gravis ("MG") and chronic inflammatory demyelinating polyneuropathy ("CIDP") which showed that IgG reductions of greater than or equal to 70% led to meaningfully better outcomes compared to reductions below 70% across a range of clinical measures.
In a Phase 1 clinical trial, healthy adults dosed with IMVT-1402 showed deep, dose-dependent IgG reductions. We expect to be able to reach approximately 80% IgG reductions with continued weekly dosing of 600 mg of IMVT-1402, offering deeper IgG reductions than observed with other competitor anti-FcRn programs, therefore representing a potential best-in-class opportunity. 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 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.
We are currently progressing a broad set of programs for IMVT-1402 and have ongoing 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.
IMVT-1402 and batoclimab are fully human monoclonal antibodies that target FcRn. These antibodies are the result of a multi-step, multi-year research program conducted in collaboration with HanAll to design highly potent anti-FcRn antibodies that may be optimized as a simple, subcutaneous injection with dosing that has been shown to deliver better efficacy at the high dose and similar efficacy at the low dose compared to standard FcRn inhibition by competitors.
In April 2026, we announced top-line results from two Phase 3 clinical studies evaluating batoclimab as an investigational treatment for adults with active, moderate-to-severe thyroid eye disease ("TED"), neither of which met the primary endpoint. The safety profile observed in these studies was consistent with prior batoclimab studies, with no new safety signals identified. Following these results, we made a decision to discontinue further development of batoclimab across all indications to focus fully on IMVT-1402. Learnings from the batoclimab program, including clinical data, operational trial experience, and relationships with investigators, have been and continue to be leveraged to inform the development of IMVT-1402.
Recent Developments in Our Clinical Programs
Endocrine Diseases
IMVT-1402 Trials in GD
In December 2024 and June 2025, we initiated two potentially registrational trials (NCT06727604 and NCT07018323, respectively) evaluating IMVT-1402 in adults with GD. We expect to report top-line results from these trials in calendar year 2027.
Proof-of-Concept Trial with Batoclimab in GD
We initially tested the potential of FcRn inhibition for the treatment of GD in a Phase 2 proof-of-concept trial (NCT05907668) evaluating our first-generation FcRn inhibitor, batoclimab.
The study included a 24-week batoclimab 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 GD as documented by presence of elevated TRAb and who were hyperthyroid despite current treatment with standard of care ATD therapy. The primary endpoint of the study measured response 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. A total of 25 subjects were enrolled in the treatment period, and 21 subjects entered the 24-week off-treatment follow-up period and could be assessed for maintenance of response. In data previously disclosed in September 2024 that was reanalyzed to include an additional patient who discontinued prior to Week 12 but remained in off-drug follow-up, at the end of the first 12 weeks, a mean IgG reduction of 77% and an 80% response rate (defined as T3 and T4 falling below the upper limit of normal ("ULN") without increasing the ATD dose) were observed. 60% of subjects treated with higher dose batoclimab were observed to have an ATD-Free Response (defined as T3 and T4 falling below the ULN and the patient simultaneously tapering completely off their ATD) at the end of the first 12 weeks. During weeks 13 to 24, patients receiving lower dose batoclimab were observed to have mean IgG reduction of 65% with a correspondingly lower responder rate of 72% and a lower ATD-Free Response rate of 40% at the end of the second 12 weeks. Patients who were observed to have 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 (64% vs. 23%).
Six-month off-treatment data was presented at the American Thyroid Association Annual Meeting in September 2025. At completion of the follow-up period at Week 48 (i.e., subjects off-treatment for 24 weeks), approximately 80% (17/21) of those subjects maintained T3/T4 values ≤ upper limit of normal ("ULN"), suggestive of strong durability of the response observed at Week 24 as evaluated at approximately six months off treatment at Week 48. Of these 17 subjects, approximately 50% (8/17) were ATD-free and an additional approximately 30% (5/17) were on ATD doses of 2.5 mg/day at six months off batoclimab treatment. Total IgG and TRAb levels declined through Week 24, consistent with previous observations, and while total IgG rebounded after treatment ended, pathogenic TRAb levels remained suppressed at Week 48. Safety and tolerability were observed to be consistent with prior batoclimab studies.
This study is now completed, with its data suggesting the potential of FcRn inhibition for the treatment of GD by modifying the underlying disease pathology, which is driven by TRAb. As such, GD is a key strategic priority for our development of IMVT-1402.
Neurological Diseases
IMVT-1402 Trial in MG
In March 2025, we initiated a potentially registrational trial (NCT07039916) evaluating IMVT-1402 in adults with MG. This trial is a randomized, placebo-controlled, 26-week trial. We expect to report top-line results from this trial in calendar year 2027.
IMVT-1402 Trial in CIDP
In March 2025, we initiated a potentially registrational trial (NCT07032662) evaluating IMVT-1402 in adults with CIDP. 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 calendar year 2028.
Rheumatology Diseases
IMVT-1402 Trial in D2T RA
In December 2024, we initiated a potentially registrational trial (NCT06754462) evaluating IMVT-1402 in anti-citrullinated protein autoantibody ("ACPA") positive D2T RA.
The trial is currently ongoing and has enrolled a total of 170 participants in Period 1. At the completion of Period 1, 165 of the 170 enrolled patients were evaluable for ACR20 response to determine eligibility to continue to Period 2 and the primary efficacy analysis for the study. The enrollment inclusion criteria described above resulted in a heavily pretreated population: 86.7% (143/165) had failed two prior mechanisms of advanced therapies (i.e., biologic or targeted synthetic DMARDs), and the mean time from disease diagnosis was 12.8 years. Baseline disease activity was high, with a mean of 24.2 tender joints, 16.7 swollen joints, and DAS28-CRP score of 6.1.
At Week 16, the ACR20, ACR50, and ACR70 response rates observed were 72.7%, 54.5%, and 35.8%, respectively; participants who discontinued prior to Week 16 were imputed as non-responders. Among the subset of participants who had failed at least a JAK inhibitor and an anti-TNF inhibitor (N=107), the ACR20, ACR50, and ACR70 response rates observed at Week 16 were 72.0%, 53.3%, and 37.4%, respectively. ACR20 response is defined as a ≥ 20% improvement from baseline in tender joint count and swollen joint count and a ≥ 20% improvement from baseline in at least 3 of 5 additional clinical parameters. Similarly, ACR50 and ACR70 responses are a calculation of 50% or 70% improvement, respectively, in the number of swollen and tender joints and 3 of 5 assessment parameters.
Period 1 was conducted in an open-label setting, with joint assessments performed by independent assessors blinded to treatment status to control for the potential for assessor bias in the response measures. IMVT-1402 was observed to be safe and well-tolerated in Period 1, and no new drug-related safety signals were identified. Study participants meeting the criteria for an ACR20 response at Week 16 are eligible to advance to Period 2 of the trial, where the primary endpoint will be assessed at Week 28. Further updates on this program are expected in the second half of calendar year 2026.
IMVT-1402 Trial in SjD
In June 2025, we initiated a potentially registrational trial (NCT06979531) evaluating IMVT-1402 in SjD. We expect to report top-line results from this trial in calendar year 2028.
Dermatology Diseases
IMVT-1402 Proof-of-Concept Trial in CLE
In February 2025, we initiated a proof-of-concept trial (NCT6980805) evaluating IMVT-1402 in CLE. We expect to report top-line results from this trial in the second half of calendar year 2026.
For more information on our clinical trials, refer to Part I, Item 1. Business, "Overview."
Macroeconomic Considerations
Unfavorable conditions in the economy in the U.S., Canada and abroad may negatively affect the growth of our business and our results of operations. For example, macroeconomic events, including changes in inflation and interest rates, changes in international trade policies and tariffs and geopolitical tensions, such as the Russia-Ukraine war and conflicts in the Middle East, including the recent hostilities involving Iran, have led to economic uncertainty globally. The effect of macroeconomic conditions may not be fully reflected in our results of operations until future periods. If, however, economic uncertainty increases or the global economy worsens, our business, financial condition and results of operations may be harmed.
For additional information about risks and uncertainties related to macroeconomic events that may impact our business, financial condition and results of operations, see the section titled "Risk Factors" under Part I, Item 1A in this Annual Report.
Our Key Agreements
License Agreement with HanAll ("HanAll Agreement")
We have commenced discussions with HanAll regarding the future disposition of batoclimab, including the potential return to HanAll of certain rights for batoclimab. In April 2026, we notified HanAll of our decision to indefinitely delay further development of batoclimab and focus our resources fully on IMVT-1402. Under the HanAll Agreement, we retain final decision-making authority over development and regulatory matters for licensed products in our Licensed Territory, and we believe we have satisfied our obligations under the HanAll Agreement, including with respect to batoclimab. HanAll may disagree with our interpretation of the agreement or our actions thereunder, and we may be unable to reach an agreement with HanAll regarding the future of batoclimab. This could result in a dispute with HanAll involving arbitration or litigation.
For a description of our transactions under the HanAll Agreement, refer to Part II, Item 8. Financial Statements and Supplementary Data, Note 3 - Material Agreements.
Related Party Transactions
For a description of our transactions under agreements with related parties, refer to Part II, Item 8. Financial Statements and Supplementary Data, Note 5 - Related Party Transactions.
Financial Operations Overview
Revenue
We have not generated any revenue and have incurred significant operating losses since inception, and we do not expect to generate any revenue from the sale of any products unless or until we obtain regulatory approval of and commercialize IMVT-1402 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.
Research and Development Expenses
We have been primarily engaged in preparing for and conducting clinical trials. Research and development expenses include therapeutic area-specific costs, as well as unallocated costs, and are net of costs reimbursable to the Company pursuant to cost-sharing arrangements with third parties.
Therapeutic area-specific costs include direct third-party costs, which include expenses incurred under agreements with contract research organizations and the cost of consultants who assist with the development of our product candidates with respect to a specific therapeutic area, investigator grants, sponsored research, and any other third-party expenses directly attributable to the development of the product candidates. Therapeutic area-specific costs also include contract manufacturing costs in connection with producing materials for use in conducting nonclinical and clinical studies to the extent they can be allocated to a specific therapeutic area.
Unallocated costs include:
•personnel-related expenses, such as salaries, stock-based compensation and benefits, for research and development personnel;
•costs allocated to us under our services agreements with Roivant Sciences Ltd. ("RSL") and Roivant Sciences GmbH ("RSG") (the "Services Agreements");
•contractual costs related to discontinued batoclimab programs; and
•other expenses, which include the cost of consultants and information technology related to our research and development but are not allocated to a specific therapeutic area.
Research and development activities will continue to be central to our business model. We expect to incur research and development expenses with respect to our IMVT-1402 development activities and we have ongoing clinical trials evaluating IMVT-1402 in GD, D2T RA, MG, CIDP, SjD and 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 and prepare to seek regulatory approval. It is not possible to determine with certainty the duration and completion costs of any clinical trial we may conduct.
The duration, costs and timing of clinical trials of IMVT-1402 and any future product candidates will depend on a variety of factors that include, but are not limited to:
•the number of trials required for approval;
•the per patient trial costs;
•the number of patients that participate in the trials;
•the number of sites included in the trials;
•the countries in which the trial is conducted;
•the length of time required to enroll eligible patients;
•the number of doses that patients receive;
•the drop-out or discontinuation rates of patients;
•the potential additional safety monitoring or other studies requested by regulatory authorities;
•the duration of patient follow-up;
•the timing and receipt of regulatory approvals;
•the potential impact of macroeconomic events, including changes in inflation, interest rates and international trade policies and tariffs and geopolitical tensions, such as the Russia-Ukraine war and the conflicts in the Middle East, including the recent hostilities involving Iran;
•the efficacy and safety profile of the product candidate; and
•the cost of manufacturing.
In addition, the probability of success for our product candidates will depend on numerous factors, including our product's efficacy, safety, ease of use, competition, manufacturing capability and commercial viability.
Acquired In-Process Research and Development Expenses
Acquired in-process research and development expenses include payments made or due upon the achievement of certain development and regulatory milestones under the HanAll Agreement.
General and Administrative Expenses
General and administrative expenses consist primarily of employee-related expenses, such as salaries, stock-based compensation and benefits for employees engaged in general and administrative activities, legal and accounting fees, consulting services, costs allocated under the Services Agreements and other operating costs relating to corporate matters and daily operations.
We anticipate that our general and administrative expenses will continue to support our ongoing research and development activities. These expenses will likely include patent-related costs, including legal and professional fees for filing, prosecution and maintenance of patents and patent applications claiming our product candidates 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.
Results of Operations
Comparison of the Years Ended March 31, 2026, 2025 and 2024
The following table sets forth our results of operations for the years ended March 31, 2026, 2025 and 2024 (in thousands):
Years Ended March 31, Change
2026 2025 2024 2026 vs. 2025 2025 vs. 2024
Operating expenses:
Research and development $ 456,660 $ 360,917 $ 212,928 $ 95,743 $ 147,989
Acquired in-process research and development - - 12,500 - (12,500)
General and administrative 76,242 77,235 57,281 (993) 19,954
Total operating expenses 532,902 438,152 282,709 94,750 155,443
Interest income, net (25,330) (24,732) (24,948) (598) 216
Other (income) expense, net
(2,181) (471) 1,008 (1,710) (1,479)
Loss before provision for income taxes
(505,391) (412,949) (258,769) (92,442) (154,180)
Provision for income taxes
215 891 567 (676) 324
Net loss $ (505,606) $ (413,840) $ (259,336) $ (91,765) $ (154,504)
Research and Development Expenses
The following table summarizes the year-over-year changes in research and development expenses for the years ended March 31, 2026, 2025 and 2024 (in thousands):
Years Ended March 31,
Change
2026 2025 2024 2026 vs. 2025 2025 vs. 2024
Therapeutic area-specific costs:
Endocrine diseases
$ 90,359 $ 63,073 $ 33,205 $ 27,286 $ 29,868
Neurological diseases
82,515 93,224 41,060 (10,709) 52,164
Rheumatology diseases 48,813 23,897 - 24,916 23,897
Dermatology diseases
20,264 15,633 - 4,631 15,633
Other clinical and nonclinical
3,367 9,327 39,811 (5,960) (30,484)
Total therapeutic area-specific costs
245,318 205,154 114,076 40,164 91,078
Unallocated costs:
Personnel-related expenses including stock-based compensation 128,534 111,499 74,290 17,035 37,209
Contractual costs related to batoclimab program discontinuation 38,952 - - 38,952 -
Other 43,856 44,264 24,562 (408) 19,702
Total research and development expenses $ 456,660 $ 360,917 $ 212,928 $ 95,743 $ 147,989
Fiscal 2026 vs. Fiscal 2025
For the year ended March 31, 2026, research and development expenses increased $95.7 million as compared with the prior year.
For the year ended March 31, 2026, therapeutic area-specific research and development costs, including contract manufacturing costs, increased $40.2 million as compared with the prior year. Research and development costs related to endocrine diseases, which include GD and TED, increased $27.3 million. This increase was primarily due to our ongoing clinical 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 $10.7 million, primarily due to lower overall clinical trial costs related to our batoclimab Phase 3 and Phase 2b clinical trials, partially offset by clinical trial costs related to our clinical trials of IMVT-1402 in neurological diseases. Research and development costs related to rheumatology diseases increased $24.9 million, reflecting expenses incurred with our clinical trials of IMVT-1402 in D2T RA and SjD. Research and development costs related to dermatology diseases increased $4.6 million, reflecting the initiation of our proof-of-concept trial in CLE. Research and development costs related to other clinical and nonclinical activities decreased $6.0 million, primarily reflecting the transition of IMVT-1402 clinical activities targeting specific therapeutic areas.
For the year ended March 31, 2026, unallocated research and development costs increased $55.6 million as compared with the prior year. This increase included the impact of costs incurred in connection with batoclimab discontinuation of $39.0 million, as well as higher personnel-related expenses of $17.0 million, reflecting a higher average headcount to execute an increased number of clinical trials.
Fiscal 2025 vs. Fiscal 2024
For the year ended March 31, 2025, research and development expenses increased $148.0 million as compared with the prior year.
For the year ended March 31, 2025, therapeutic area-specific research and development costs, including contract manufacturing costs, increased $91.1 million as compared with the prior year. Research and development costs related to endocrine diseases, which include GD and TED, increased $29.9 million. This increase was primarily due to preparation and initiation of our clinical trial of IMVT-1402 in endocrine diseases and higher overall clinical trial costs related to our batoclimab Phase 3 clinical program. Research and development costs related to neurological diseases, which include MG and CIDP, increased $52.2 million. This increase was primarily due to preparation for our clinical trials of IMVT-1402 in neurological diseases and higher overall clinical trial costs related to our batoclimab Phase 3 and Phase 2b clinical trials. Research and development costs related to rheumatology diseases of $23.9 million in fiscal 2025 reflected the initiation of our clinical trial of IMVT-1402 in D2T RA, as well as preparation for our clinical trial of IMVT-1402 in SjD. Research and development costs related to dermatology diseases of $15.6 million in fiscal 2025 reflected the initiation of our proof-of-concept trial in CLE. Research and development costs related to other clinical and nonclinical activities decreased $30.5 million, reflecting the current year transition to clinical activities targeting specific therapeutic areas, as well as lower overall costs related to our IMVT-1402 Phase 1 trial and nonclinical studies.
For the year ended March 31, 2025, unallocated research and development costs increased $56.9 million as compared with the prior year. This increase reflected higher personnel-related expenses of $37.2 million, driven by higher headcount and enhancement of our capabilities to support our strategic objectives as we progress our clinical activities. In addition, other expenses increased $19.7 million, primarily reflecting higher costs to support our research and development activities to advance the clinical development of IMVT-1402 that are not related to a specific therapeutic area.
Acquired In-Process Research and Development Expenses
There were no acquired in-process research and development expenses for the years ended March 31, 2026 and March 31, 2025. During the year ended March 31, 2024, acquired in-process research and development expenses were $12.5 million related to the achievement of our third and fourth development and regulatory milestone events for batoclimab under the terms of the HanAll Agreement.
General and Administrative Expenses
For the year ended March 31, 2026, general and administrative expenses decreased $1.0 million from the year ended March 31, 2025, primarily reflecting lower information technology costs and market research costs, partially offset by higher personnel-related expenses, including stock-based compensation. For the year ended March 31, 2025, general and administrative expenses increased $20.0 million from the year ended March 31, 2024, primarily reflecting higher personnel-related expenses, professional fees, information technology costs and market research costs.
Interest Income, net
For the year ended March 31, 2026, interest income, net increased $0.6 million as compared with the year ended March 31, 2025, primarily reflecting higher average money market balances, partially offset by slightly lower interest rates on our money market balances. For the year ended March 31, 2025, interest income, net decreased $0.2 million as compared with the year ended March 31, 2024, primarily reflecting lower average money market balances throughout the year, mostly offset by interest earned on money market fund balances as a result of the proceeds from our January 2025 private placement.
Liquidity and Capital Resources
Sources of Liquidity
We had cash and cash equivalents of $902.1 million and $714.0 million as of March 31, 2026 and 2025, respectively. For the years ended March 31, 2026, 2025 and 2024, we had net losses of $505.6 million, $413.8 million and $259.3 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 or any future product candidate.
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 conflicts between Russia and Ukraine and in the Middle East, including the recent hostilities involving Iran, and changes in inflation, interest rates and international trade policies and tariffs.
We do not currently have any committed external source of funds. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.
We have a sales agreement with Leerink Partners LLC ("Leerink Partners"), as sales agent, pursuant to which we may offer and sell, from time to time, shares of our common stock (the "ATM Shares"), subject to certain conditions as specified in the sales agreement. We agreed to pay Leerink Partners up to 3% of the gross proceeds from each sale of ATM Shares sold through the sales agreement. The ATM Shares would be sold at prevailing market prices at the time of the sale and, as a result, prices may vary. The ATM Shares to be sold under the sales agreement, if any, would be issued and sold pursuant to an automatic shelf registration statement on Form S-3, which we filed with the SEC on November 9, 2023, along with a prospectus supplement relating to the offer and sale of up to $150.0 million of ATM Shares pursuant to the sales agreement. We have not issued or sold any ATM Shares pursuant to the ATM offering program.
In December 2025, we completed an underwritten offering of 26,200,000 shares of our common stock (including 16,666,666 shares of common stock purchased by RSL on the same terms as other investors in the offering) at an offering price of $21.00 per share. The underwriter did not receive any underwriting discounts or commissions with respect to shares sold to RSL in the offering. The net proceeds to us were $543.7 million after deducting underwriting discounts and commissions and other offering expenses.
If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. Adequate additional funding may not be available to us on acceptable terms, or at all. If we are unable to raise capital in sufficient amounts or on terms acceptable to us, we may be required to delay, limit, reduce or terminate our drug development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves or potentially discontinue operations.
Cash Flows
The following table sets forth a summary of our cash flows for the years ended March 31, 2026, 2025 and 2024 (in thousands):
Years Ended March 31,
2026 2025 2024
Net cash used in operating activities $ (407,310) $ (375,874) $ (214,227)
Net cash used in investing activities (8) (759) (360)
Net cash provided by financing activities 595,756 454,492 472,427
Operating Activities
For the year ended March 31, 2026, $407.3 million of cash was used in operating activities, primarily reflecting a net loss from operations for the year of $505.6 million, partially offset by non-cash charges of $56.2 million and a net change in operating assets and liabilities of $42.1 million. The non-cash charges consisted mainly of stock-based compensation of $55.7 million, reflecting the higher average headcount and incentive equity awards as compared with the prior year. The change in operating assets and liabilities primarily reflected an increase in accrued expenses of $45.0 million, which includes $39.0 million for charges related to batoclimab discontinuation, as well as $6.0 million reflecting the timing of payments and services related to our ongoing clinical trials and contract manufacturing. Other changes in operating assets and liabilities, including lower prepaid and other current assets of $8.8 million and a decrease in accounts payable of $10.3 million, were driven mostly by the timing of payments and services related to our ongoing clinical trials.
For the year ended March 31, 2025, $375.9 million of cash was used in operating activities, primarily reflecting a net loss from operations for the year of $413.8 million and a net change in operating assets and liabilities of $12.1 million, partially offset by non-cash charges of $50.0 million. The non-cash charges consisted mainly of stock-based compensation of $49.5 million, reflecting the higher headcount and incentive equity awards as compared with the prior year. The change in operating assets and liabilities reflected higher prepaid expenses and other current assets of $27.0 million, driven primarily by the timing of payments and services performed related to our ongoing and planned clinical trials, as well as an increase in other assets of $7.7 million as a result of prepaid expenses related to planned contract manufacturing activities. These changes were partially offset by an increase in accounts payable of $10.7 million, primarily related to clinical trial costs. Accrued expenses increased $8.9 million, primarily reflecting the timing of payments and services related to our ongoing clinical trials and contract manufacturing. In addition, accounts receivable decreased $3.2 million, reflecting the collection of amounts owed to us under research and development cost-sharing arrangements with a third party.
For the year ended March 31, 2024, $214.2 million of cash was used in operating activities, primarily reflecting a net loss from operations for the year of $259.3 million, partially offset by non-cash charges of $42.5 million and a net change in operating assets and liabilities of $2.6 million. The non-cash charges consisted mainly of stock-based compensation of $41.1 million, reflecting the higher headcount and incentive equity awards as compared with the prior year. The change in operating assets and liabilities reflected an increase in accounts payable and accrued expenses of $7.1 million, primarily reflecting the timing and level of payments for contract manufacturing and other research and development costs, and lower prepaid expenses and other current assets of $1.6 million, driven primarily by the timing of payments and services performed related to our ongoing clinical trials. These changes were partially offset by an increase in accounts receivable of $4.6 million, reflecting amounts owed to us under a research and development cost-sharing arrangement with a third party.
Investing Activities
For the years ended March 31, 2026, 2025 and 2024, cash used in investing activities was related to the purchase of property and equipment.
Financing Activities
For the year ended March 31, 2026, $595.8 million of cash provided by financing activities primarily consisted of net proceeds from our December 2025 underwritten offering of $543.7 million, after deducting underwriting discounts and commissions and other offering expenses. Cash provided by financing activities also reflected $52.1 million of proceeds from the exercise of stock options, primarily from our former executive officers.
For the year ended March 31, 2025, $454.5 million of cash provided by financing activities primarily consisted of proceeds from our January 2025 private placement of $450.0 million. Cash provided by financing activities also reflected $4.8 million of proceeds from the exercise of stock options.
For the year ended March 31, 2024, $472.4 million of cash provided by financing activities primarily consisted of proceeds from our October 2023 underwritten public offering and concurrent private placement of $466.7 million, combined, after deducting underwriting discounts and commissions, placement agent fees and offering expenses. Cash provided by financing activities also reflected $5.7 million of proceeds from the exercise of stock options.
Material Cash Requirements
Our primary uses of capital have been, and we expect will continue to be, for advancing our clinical 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 manufacturing, potential HanAll milestone payments and our expenditures on other research and development activities.
Because of the numerous risks and uncertainties associated with the development and commercialization of product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures necessary to complete the development of product candidates.
Our short-term and long-term material cash requirements as of March 31, 2026 primarily consisted of those related to our clinical trials and clinical development activities, which we expect to fund primarily with our existing cash balance. Our most significant cash requirements are described below:
Commitments
As of March 31, 2026, we had an accumulated accrual of $42.5 million of non-cancelable contractual costs recognized in connection with the discontinuation of batoclimab, of which $39.0 million was recognized as research and development expenses during the year ended March 31, 2026.
We enter into agreements with vendors in the ordinary course of business that include unconditional purchase obligations for manufacturing and other services. In April 2026, we entered into an agreement that includes provisions for minimum obligations for the contract manufacturing of IMVT-1402 drug substance. As of May 20, 2026, the minimum commitment was approximately $22.8 million, of which $4.2 million and $18.6 million is expected to be paid during the fiscal years ending March 31, 2027 and 2028, respectively. The agreement includes a variable component whereby service prices may be adjusted based on related commitments for raw materials and other costs, and annual inflationary changes in an applicable price index.
HanAll Agreement
Potential future payments due under the HanAll Agreement are contingent upon future events. As of March 31, 2026, the aggregate maximum amount of milestone payments we could be required to make under the HanAll Agreement is $420.0 million (after an aggregate amount of $32.5 million paid for milestone events achieved as of March 31, 2026) upon the achievement of certain regulatory and sales milestone events. We have commenced discussions with HanAll regarding the future disposition of batoclimab, including the potential return to HanAll of certain rights for batoclimab, which could impact the aggregate amount (if any) of potential future payments under the HanAll Agreement. In April 2026, we notified HanAll of our decision to indefinitely delay further development of batoclimab and focus our resources fully on IMVT-1402. For additional considerations regarding associated risks, see Part I, Item 1-Key Agreements and Part I, Item 1A-Risk Factors of this annual report on Form 10-K.
Outlook
We currently expect that our existing cash and cash equivalents as of March 31, 2026 of $902.1 million will be sufficient to fund our operating expenses and capital expenditure requirements for announced indications to date through the potential commercial launch of IMVT-1402 in GD.
Except as discussed above, we did not have any other ongoing material contractual obligations for which cash flows were fixed and determinable. We expect to enter into other commitments as the business further develops. In the normal course of business, we enter into agreements with CROs for clinical trials and with vendors for nonclinical studies, manufacturing and other services and products for operating purposes, which agreements are generally cancellable by us at any time, subject to payment of remaining obligations under binding purchase orders and, in certain cases, nominal early-termination fees. These commitments are not deemed significant. There are certain contracts wherein we have a minimum purchase commitment, however, most of it is due and payable within one year.
We anticipate that our short-term and long-term future capital requirements will increase as we:
•fund our clinical development programs;
•launch any potential additional clinical trials of IMVT-1402 in current and additional indications;
•increase manufacturing of IMVT-1402 drug substance and drug product to support clinical trials;
•achieve milestones under our agreements with third parties, including the HanAll Agreement, that will require us to make substantial payments to those parties;
•integrate acquired technologies into a comprehensive regulatory and product development strategy;
•maintain, expand and protect our intellectual property portfolio;
•hire scientific, clinical, quality control and administrative personnel;
•add operational, financial and management information systems and personnel, including personnel to support our drug development efforts;
•commence the number of clinical trials required for approval;
•seek regulatory approvals for any product candidates that successfully complete clinical trials;
•seek to identify, acquire, develop and commercialize additional product candidates;
•ultimately establish a sales, marketing and distribution infrastructure and scale up external manufacturing capabilities to commercialize any drug candidates for which we may obtain regulatory approval; and
•incur additional insurance, legal and other regulatory compliance expenses to operate as a public company.
Our primary use of cash is to fund our clinical trials, clinical development and manufacturing activities. Our current funds will not be sufficient to enable us to complete all necessary development and, if approved, commercially launch IMVT-1402 in all indications we are currently evaluating. We anticipate that we will continue to incur net losses for the foreseeable future.
Critical Accounting Estimates
Our management's discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States ("U.S. GAAP"). The preparation of these consolidated financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the date of the balance sheet, and the reported amounts of expenses during the reporting periods. In accordance with U.S. GAAP, we evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
We define our critical accounting estimates as those under U.S. GAAP that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. While our significant accounting policies are more fully described in "Note 2 - Summary of Significant Accounting Policies" to our consolidated financial statements in Part II, Item 8 of this Annual Report, we believe the following critical accounting estimate used in the preparation of our consolidated financial statements requires significant estimates and judgments. We did not make any material changes to these assumptions for the year ended March 31, 2026. We do not expect any material changes in the near term to the underlying assumptions during the year ended March 31, 2026.
Research and Development Expenses and Related Accruals
Research and development costs with no alternative future use are expensed as incurred. We accrue costs for clinical trial activities based upon estimates of the services received and related expenses incurred that have yet to be invoiced by contract research organizations. In making these estimates, we consider various factors, including status and timing of services performed, the number of patients enrolled and the rate of patient enrollment. Research and development costs are charged to expense when incurred and primarily consist of employee compensation and expenses from third parties who conduct research and development activities (including manufacturing) on our behalf.
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