IMVT 10-K & 10-Q changes, risk factors and insider trading

We cannot be certain that any of our product candidates will receive regulatory approval or be successfully commercialized even if we receive regulatory approval. The research, testing, manufacturing, labeling, packaging, approval, sale, marketing, distribution, import, export, adverse event reporting, storage, advertising, promotion and recordkeeping of pharmaceutical products, including antibody-based products, are, and will remain, subject to extensive regulation by the FDA and other regulatory authorities in the U.S. and other countries which may vary from one country to another. We are not permitted to market our product candidates in the U.S. until we receive approval of a biologics license application (“BLA”) or in any foreign country until we receive the requisite approvals from the appropriate regulatory authorities in such countries for marketing authorization. In addition, we have not yet demonstrated our ability to complete later-stage or pivotal clinical trials for our product candidates. We have not submitted a BLA for any product candidate to the FDA or any comparable application to any other foreign regulatory authority. Obtaining approval of a BLA or similar foreign regulatory approval is an extensive, lengthy, expensive and inherently uncertain process, and the FDA or other foreign regulatory authorities may delay, limit or deny approval for many reasons, including:

•the FDA or other relevant foreign regulatory authorities may disagree with the number, design, size, conduct or implementation of our clinical trials, including whether the design of our clinical trials is sufficient to support a regulatory approval;

•the FDA or other relevant foreign regulatory authorities may require development of a Risk Evaluation and Mitigation Strategy (“REMS”) drug safety program or similar strategy imposed by foreign regulatory authorities, as a condition of approval;

Our product candidates are still in clinical development and will require extensive clinical testing before we are prepared to submit a BLA or other similar application for regulatory approval. For example, we initiatedare potentially registrationalconducting trials for IMVT-1402 in Graves’ disease (“GD”), difficult-to-treat rheumatoid arthritis (“D2T RA”), myasthenia gravis (“MG”) and chronic inflammatory demyelinating polyneuropathy (“CIDP”) and a proof-of-concept trial in cutaneous lupus erythematosus (“CLE”). We also plan to initiate a potentially registrational trial evaluating IMVT-1402 in Sjögren’sGD, diseaseD2T (“RA, MG, CIDP, SjD”) and aCLE. secondExcept potentiallyfor registrationalD2T trialRA evaluatingand IMVT-1402CLE, in GD. Thethe first top-line data for any of the potentially registrational studies isare not expected until sometime in calendar year 2027, assuming we can fully enroll and successfully complete the relevant trials according to our anticipated timelines. We cannot provide any assurance that we any clinical trials will be conducted as planned or completed on scheduled,schedule, if at all. Clinical trials are very expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The clinical trial process is also time-consuming and costly and is dependent upon collaboration with many contract research organizations (“CROs”) and clinical trial sites.

•imposition of a temporary or permanent clinical hold by regulatory agencies for a number of reasons, including after review of an investigational new drug application (“IND”) or amendment, a clinical trial application (“CTA”) or amendment, or equivalent application or amendment; as a result of a new safety finding that presents unreasonable risk to clinical trial participants; a negative finding from a Good Clinical Practice (“GCP”) inspection of our clinical trial operations or trial sites; developments in trials conducted by in-class competitors that raise regulatory concerns about risk to patients of the class broadly; or if the regulator finds that the investigational protocol or plan is clearly deficient to meet its stated objectives;

•failure to perform in accordance with the FDA’s or any other regulatory authority’s current good clinical practices (“cGCPs”)GCP requirements, or other regulatory guidelines in other countries;

•an institutional review board (“IRB”) or ethics committee,committee refusing to approve, suspending, or terminating the trial at an investigational site, precluding enrollment of additional subjects, or withdrawing their approval of the trial;

•IRBs or ethics committees issuing negative opinions regarding a clinical trial or requiring substantial modifications of a proposed clinical trial;

We may encounter delays or difficulties in enrolling or be unable to enroll a sufficient number of patients to complete any of our clinical trials on our current timelines, or at all, and even once enrolled, we may be unable to retain a sufficient number of patients to complete any of our trials. Enrollment in our clinical trials may be slower than we anticipate or be stopped, leading to delays in our development timelines. For example, we may face difficulty enrolling or maintaining a sufficient number of patients in our clinical trials evaluating IMVT-1402 for MG, CIDP and GD due to existing alternative treatments available, including efgartigimod, rozanolixizumab, and nipocalimab for the treatment of MG, efgartigimod for the treatment of MG and CIDP,efgartigimod, IVIg, plasma exchange and steroids for the treatment of CIDP, and anti-thyroid drugs and ablative treatments for GD. In addition, patients may decline to enroll or decide to withdraw from our clinical trials due to protocol-required washout periods or the risk of receiving placebo.

Furthermore, any negative results or new safety signals we may report in clinical trials of our product candidates may make it difficult or impossible to recruit and retain patients in other clinical trials we are conducting or to resume enrolling patients onceif a paused clinical trial hasis beenpaused and then subsequently resumed. For example, we previously voluntarily paused dosing in our clinical trials for batoclimab due to elevated total cholesterol and LDL levels observed in some patients treated with batoclimab. Similarly, negative results reported by our competitors about their drug candidates may negatively affect patient recruitment in our clinical trials. Also, marketing authorization of competitors in this same class of drugs may impair our ability to enroll patients into our clinical trials, delaying or potentially preventing us from completing recruitment of one or more of our trials.

The results of our nonclinicalpreclinical studies and clinical trials may not support our proposed claims for our product candidates, or regulatory approval on a timely basis or at all, and the results of earlier studies and trials may not be predictive of future trial results.

Success in nonclinicalpreclinical testing and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the results of later clinical trials will replicate the results of prior nonclinicalpreclinical testing and clinical trials. In addition, preclinical testing may not adequately uncover drug side effects. In particular, we cannot assure you that the reductions in IgG antibodies and favorable analyte profile that we have observed to date in our clinical trials of batoclimab or in the Phase 1 trial of IMVT-1402 will be observed in any future clinical trials, including pivotal trials necessary for regulatory approvals, or that such reductions in IgG antibodies will resultcorrelate inwith clinical benefit that isbenefits sufficient to demonstrate that the efficacy endpoints of the study are met. Likewise, positive results inpromising interim analysesresults or other preliminary analyses do not ensure that the clinical trial as a whole will be successful and achievemay lack statistical significance, which would further limitslimit the reliability of such interim or preliminary data. A number of companies in the pharmaceutical industry, including biotechnology companies, have suffered significant setbacks in, or the discontinuation of, clinical trials, even after positivepromising results were seen with their product candidates in earlier nonclinicalpreclinical studies or clinical trials. These setbacks have been caused by, among other things, nonclinicalpreclinical findings observedmade while clinical trials were underway and safety or efficacy observations inmade ongoingduring clinical trials.trials, including previously unobserved adverse effects.

Further,The results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through nonclinicalpreclinical and initial clinical trials. A future failure of a clinical trial to meet its pre-specified endpoints would likelymay cause us to abandon development of the indication.product candidate in question. For example, our Phase 3 trials evaluating batoclimab in TED failed to meet the primary endpoint, resulting in our decision to discontinue development of batoclimab. Any delay in, or termination of, our clinical trials will delay the submission of a BLA to the FDA or other similar applications with other relevant foreign regulatory authorities and, ultimately, our ability to commercialize our product candidates (if approved) and generate product revenue. Even if our clinical trials are completed as planned, we cannot be certain that their results will support our expectations for differentiation or the effectiveness or safety of our product candidates. The FDA has substantial discretion in the review and approval process and may disagree that our data support the differentiated claims we may propose. In addition, only a small percentage of biologics under development result in the submission of a BLA to the FDA, or other similar applications with other relevant foreign regulatory authorities, and even fewer are approved for commercialization.

From time to time, we may publicly disclose preliminary or “top-line” data from our clinical trials, which is based on a preliminary analysis of then-available top-line data, and the results and related findings and conclusions are subject to change following a full analysis of all data related to the particular trial. We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the top-line results that we report may differ from future results of the same trials, or different conclusions or considerations may qualify such results, once additional data havehas been received and fully evaluated. Top-line data also remainremains subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published.disclosed. As a result, top-line data should be viewed with caution until the final data areis available. We may also disclose interim data from our clinical trials. Interim data from clinical trials that we may complete areis subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data becomebecomes available. Adverse differences between preliminary or interim data and final data could significantly harm our business prospects. Further, disclosure of preliminary or interim data by us or by our competitors could result in volatility in the price of shares of our common stock.

Further, others, including regulatory authorities, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the approvability or commercialization of the particular product candidate or product and our business in general. In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and what we determine is the material or otherwise appropriate information to include in our disclosure is subject to interpretation, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular drug, product candidate or our business. If the top-line data that we report differdiffers from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for and commercialize IMVT-1402, batoclimab, or any future product candidate, our business, operating results, prospects or financial condition may be harmed.

Our product candidates may be associated with adverse events or cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, cause us to suspend or discontinue clinical trials, cause us to abandon further development or limit the commercial viability of any approved label or market acceptance.

For example, treatment-related side effects associated with batoclimab in our clinical trials previously caused us to pause dosing in our clinical trials of batoclimab. We voluntarily paused dosing in our early phase clinical studies of batoclimab to evaluate treatment-induced elevations in total cholesterol and LDL levels observed in some trial subjects. AfterWe evaluationincurred ofa delay to evaluate the available safety data and following discussions with multiple regulatory authorities, weeventually continued our clinical development of batoclimab. While we do not expect that increases in LDL over a short-term treatment duration would pose a safety concern for patients, the risk-benefit profile of long-term administration of batoclimab atand higher doses will need to incorporate any potential unfavorable effects on lipid profiles. In addition,adjusted protocols that containcontained long-term treatment durations to include frequent monitoring of plasma lipids and guidelines for the management of any observed lipid abnormalities. TheseAlthough our focus is currently on IMVT-1402, which has not been observed to cause the treatment-induced lipid elevations associated with batoclimab, these occurrences have harmed, and any reoccurrencessimilar occurrences may continuein tothe future harm, our business, financial condition and prospects.

In addition to the safety, efficacy, manufacturing, and regulatory hurdles faced by our product candidates, the administration of proteins such as monoclonal antibodies, even those that are fully human in nature, including our product candidate,candidates, can cause an immune response, resulting in the creation of antibodies directed against the therapeutic protein. These anti-drug antibodies can have no effect or can neutralize the effectiveness of the protein or require that higher doses be used to obtain a therapeutic effect. Whether anti-drug antibodies will be created and how they react can often not be predicted from nonclinical studies or clinical trials and their detection or appearance is often delayed. As a result, neutralizing antibodies may be detected at a later date or upon longer exposure periods, such as following more chronic administration in longer lasting clinical trials. In some cases, detection of neutralizing antibodies can even occur after pivotal clinical trials have been completed. Therefore, there can be no assurance that neutralizing antibodies will not be detected in future clinical trials or at a later date upon longer exposure (including after commercialization). If anti-drug antibodies reduce or neutralize the effectiveness of any of our product candidates, the continued clinical development or receipt of marketing approval for such product candidate could be delayed or prevented and, even if such product candidate is approved, its commercial success could be limited, any of which would impair our ability to generate revenue and continue operations.

If we are not able to obtain required regulatory approvals, we will not be able to commercialize batoclimab, IMVT-1402 or any future product candidate, and our ability to generate product revenue will be impaired.

Batoclimab, IMVT-1402 and any future product candidate that we may develop, as well as the activities associated with their development and commercialization, including their design, research, testing, manufacture, safety, efficacy, recordkeeping, labeling, packaging, storage, approval, advertising, promotion, sale and distribution are subject to comprehensive regulation by the FDA and other regulatory authorities in the U.S. and by similar regulatory authorities outside the U.S. Failure to obtain marketing approval for, and thus commercialize any product candidate, could negatively impact our ability to generate any revenue from product sales.

The markets for autoimmune disease therapies are competitive and are characterized by significant technological development and new product introduction. For example, there are several large and small pharmaceutical companies focused on delivering therapeutics for our targeted autoimmune disease indications, including GD, MG, CIDP, TED, RA, CLE and SjD. We anticipate that, if we obtain regulatory approval of any of our product candidates, we will face significant competition from other approved therapies or drugs that become available in the future for the treatment of our target indications. If approved, our product candidates may also compete with unregulated, unapproved and off-label treatments. Even if a biosimilar product is less effective than our product candidates, a less effective biosimilar may be more quickly adopted by physicians and patients than our competing product candidates based upon healthcare cost or convenience. Our product candidates, if approved, are expected to present a novel therapeutic approach for certain indications we are pursuing and will have to compete with existing therapies, some of which are widely known and accepted by physicians and patients. To compete successfully in this market, we will have to demonstrate that the relative cost, safety and efficacy of our product candidates, if approved, provide an attractive alternative to existing standard of care and other new therapies to gain a share of some patients’ discretionary budgets and to gain physicians’ attention and adoption within their clinical practices. Some of the companies that may offer competing products also have a broad range of other product offerings, large direct sales forces, established patient support programs, and long-term customer relationships with our target physicians, which could inhibit our market penetration efforts. Such competition could lead to reduced market share for our product candidates and contribute to downward pressure on the pricing of our product candidates, which could harm our business, financial condition, operating results and prospects.

Our product candidates, if approved, may also face competition from agents with different mechanisms of action. The most commonly prescribed first-line agents for the treatment of MG are acetylcholinesterase inhibitors, such as pyridostigmine, which are marketed by several manufacturers of generic medicines. IVIg is also routinely used for patients with MG. A number of C5 complement inhibitors are approved in gMG including SOLIRIS® (eculizumab), marketed by AstraZeneca, is an antibody inhibitor of the C5 protein approved in 2017 for the treatment of MG in patients who are positive for anti-AChR antibodies. Other C5 complement inhibitors approved in gMG include ULTOMIRIS® (ravulizumab-cwvz), which was approved in April 2022, and ZILBRYSQ® (zilucoplan), approved in October 2023. In October 2024, Amgen announced positive data in patients who are positive for anti-AChR antibodies for. UPLIZNA® (inebilizumab), a CD19-targeted humanized monoclonal antibody, currentlyis in Phase 3 developmentapproved for the treatment of gMG.

For CIDP, our product candidatesIMVT-1402 may also face competition in CIDP from agents in Phase 3 development with different mechanisms of action including C1 inhibitors riliprubart (Sanofi), DNTH103 (Dianthus) and C2 inhibitor empasiprubart (Argenx SE).

ForCLE CLE,is a dermatology focused therapeutic category with no treatment innovation for more than 50 years, but treatment options include prevention of exposure to sunlight with the utilization of both topical and systemic therapies such as antimalarials, immunomodulators, and immunosuppressives (methotrexate, mycophenolate). With the significant unmet need and increasing demand for biologic therapies in dermatology and rheumatology, the competitive landscape for SCLE and CCLE is a growing market for novel therapies and diagnostic tools in development. Biogen is in Phase 2/3 with litifilimab (BDCA2) and, AstraZeneca is in Phase 3 anifrolumab (IFNAR1) with many other early development programs.programs, and Merck has entered Phase 3 evaluations of enpatoran.

For SjD, therapeuticTherapeutic approaches for SjD include a variety of local agents to address the associated dry eye and mouth and/or immunosuppressive treatments to address the systemic manifestations of disease. AlthoughIn aaddition variety of drug classes have been trialed to-date, there are no disease-modifying therapies approved forto the treatmentanti-FcRn ofcompetitors SjD.mentioned Anti-FcRnsabove, nipocalimab (The Janssen Pharmaceutical Companies of Johnson & Johnson) and efgartigimod (Argenx SE) are currently in Phase 3 trials in SjD. Our productIMVT-1402 may also face competition from other drug classes, including inhibitors of TYK2 (deucravacitinib), CD40 (dazodalibep), BAFF (ianalumab) or BLyS/APRIL (telitacicept).

Many of our existing or potential competitors have substantially greater financial, technical and human resources than we do and significantly greater experience in the discovery and development of product candidates, as well as in obtaining regulatory approvals of those product candidates in the U.S. and in foreign countries. Many of our current and potential future competitors also have significantly more experience commercializing drugs that have been approved for marketing. Mergers and acquisitions in the pharmaceutical and biotechnology industries could result in even more resources being concentrated among a smaller number of our competitors. In October 2023, Amgen completed its previously announced acquisition of Horizon Therapeutics for approximately $27.8 billion, expanding its rare disease pipeline. In February 2025, Alumic Inc. and ACELYRIN, INC., who is advancing a subcutaneously delivered anti-IGF-1R antibody for the treatment of TED, announced they will merge in an all-stock transaction. Competition may reduce the number and types of patients available to us to participate in clinical trials because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors.

•demonstrate through our clinical trials that IMVT-1402, batoclimab,IMVT-1402 or any future product candidate is differentiated from existing and future therapies;

•obtain patent or other proprietary protection for IMVT-1402, batoclimab, or any future product candidates;

•obtain required regulatory approvals, including approvals to market IMVT-1402, batoclimab,IMVT-1402 or any future product candidate we develop, in ways that are differentiated from existing and future products and treatments;

•successfully commercialize IMVT-1402, batoclimab,IMVT-1402 or any future product candidate, if approved;

Additional time may be required to obtain marketing authorizations for pre-filled syringe orthe autoinjector presentationspresentation of batoclimab or IMVT-1402 because it would be subject to regulation as a combination product.

Combination products are therapeutic and diagnostic products that combine drugs, devices and/or biological products. A pre-filled syringe orThe autoinjector presentation of our product candidatesIMVT-1402 would be considered a combination product that requires coordination within the FDA and in similar foreign regulatory authorities for review of its device and biologic components. Although the FDA and similar foreign regulatory authorities have systems in place for the review and approval of combination products such as ours, we may experience delays in the development and commercialization of these product candidatescandidate presentations due to uncertainties in the product development and approval process.

In the E.U.,EU, combination products are not subject to a single regulatory pathway. Products combining a medical device and a medicinal product are either regulated as a medicinal product or a medical device depending on which product has the primary mode of action. Alternatively, they can be regulated by two separate procedures, with elements regulated as a medicinal product and elements as a medical device. Authorities involved in the regulatory assessment of combination products may include the EMA, national competent authorities of E.U.EU Member States and Notified Bodies.

The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consumingtime-consuming and inherently unpredictable, and even if we obtain approval for a product candidate in one country or jurisdiction, we may never obtain approval for or commercialize it in any other jurisdiction, which would limit our ability to realize our full market potential.

Prior to obtaining approval to commercialize a product candidate in any jurisdiction, we or our collaborators must demonstrate with substantial evidence from well-controlled clinical trials, and to the satisfaction of the FDA or comparable foreign regulatory authorities, that such product candidate is safe and effective for its intended use. Results from nonclinical studies and clinical trials can be interpreted in different ways. Even if we believe the nonclinical or clinical data for a product candidate are positive, such data may not be sufficient to support approval by the FDA and other regulatory authorities. In order to market any products in any particular jurisdiction, we must establish and comply with numerous and varying regulatory requirements on a country-by-country basis regarding safety and efficacy. Approval by the FDA does not ensure approval by regulatory authorities in any other country or jurisdiction outside the U.S. In addition, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not guarantee regulatory approval in any other country. Approval processes vary among countries and can involve additional product testing and validation, as well as additional administrative review periods. Seeking regulatory approval could result in difficulties and costs for us and require additional nonclinical studies or clinical trials, which could be costly and time consuming.time-consuming. We do not have any product candidates approved for sale in any jurisdiction, including in international markets. If we fail to comply with regulatory requirements in international markets or to obtain and maintain required approvals, or if regulatory approvals in international markets are delayed, our target market will be reduced and our ability to realize the full market potential of any product we develop will be unrealized.

The FDA and other foreign regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of batoclimab, IMVT-1402,IMVT-1402 or any future product candidate. For example, onin AprilDecember 26, 2023,2025, the European CommissionUnion legislators adopted a proposal for a new Directive and RegulationRegulation, to reviserevising the existing pharmaceutical legislation. If adopted in the form proposed, aA number of changes to the regulatory framework governing medicinal products in the European Economic Area (“EEA”) maywill occur.now Theseoccur, includeincluding a possibleone year decrease in data and market exclusivity for our product candidatesavailable in the EEA. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the U.S. or abroad. If we are slow or unable to adapt to changes in existing requirements or to the adoption of new requirements or policies or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained.

•the availability of third-party coverage and adequate reimbursement at any given price level of our product candidates;

Market acceptance of new products for the treatment of the indications we pursue with our product candidates, including MG, CIDP, GD, TED, RA, SjD and CLE, may also be affected by the perception that existing available treatments are sufficient to treat the majority of these patients. In addition, our product candidates, if approved, may compete with other approved FcRn inhibitors or other FcRn inhibitors under development that have demonstrated similar levels of IgG reductions and shown clinical benefit by meeting their efficacy endpoints in completed clinical trials to date. In addition, the potential patient population for certain autoimmune indications that we may target are relatively small. This could affect the rate of adoption and as a result, market acceptance of our product candidates, if approved, could be much slower than anticipated.

We cannot assure you that batoclimab, IMVT-1402,IMVT-1402 or any future product candidate, if approved, will achieve broad market acceptance among physicians, patients and third-party payors. The failure of any such product candidate that receives regulatory approval or clearance to achieve market acceptance or commercial success would adversely affect our business and results of operations.

If we are unable to establish sales, marketing and distribution capabilities, either on our ownown, or in collaboration with third parties, we may not be successful in commercializing our product candidates, if approved.

We do not currently have our own sales or distribution capabilities and our marketing capabilities are limited. The cost of establishing and maintaining such an organization may exceed the cost-effectiveness of doing so. In order to effectively market anyour product thatcandidates mayif bewe approved,obtain regulatory approval, we must successfully build out our sales, distribution, marketing, compliance, managerialdistribution and other nontechnicalrelated capabilities or make arrangements with third parties to perform these services. To achieve commercial success for any product for which we obtain marketing approval, weWe will also need a sales and marketing organization and a patient support services organization.organization to ensure patients have appropriate access to our products, once approved.

We expect to build a focused sales, distribution and marketing infrastructure to market our product candidates in the U.S., if approved. There are significant expenses and risks involved with establishing our own sales, marketing and distribution capabilities, including our ability to hire, retain and appropriately incentivize qualified individuals, develop an appropriate and effective compliance function, provide adequate training to sales and marketing personnel and effectively manage geographically dispersed sales and marketing teams to generate sufficient demand. Any failure or delay in the development of our internal sales, marketing and distribution capabilities could delay any product launch, which would adversely impact its commercialization. If the commercial launch of our first product candidate, if approved, for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly and our investment would be lost if we cannot retain or reposition our sales and marketing personnel. The costs associated with a sales, marketing and distribution infrastructure may exceed the net revenues we are able to generate from the sale of a product candidate following regulatory approval.

•our inability to recruit, train and retain adequate numbers of effective salessales, marketing, reimbursement, patient support, medical affairs and marketingother support personnel;

•unforeseen costs and expenses associated with creating aan salesindependent and marketingcommercialization organization.

ImmunovantImmunovant, 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 currentlythat beinghave evaluatedbeen inpublicly clinicalannounced trialsfor research and development by multiple companies, with two indications that are already approved and launched quickly reaching billionsmulti-billions of dollars in global annual sales.

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. There has been consistentConsistent 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, formerly referred to as IMVT-1401, 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 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 future development and regulatory submissions for batoclimab in the future based on the aggregate information available at the time.

We are currently progressing a broad set of programs for IMVT-1402.IMVT-1402 Over the last fiscal year, we announced the clearance of six investigational new drug (“IND”) applications to support clinical trials to evaluate IMVT-1402. Weand have initiatedongoing studies in fivesix indications, including potentially registrational trials in GD, difficult-to-treat rheumatoid arthritis (“D2T RA”), MGMG, CIDP and CIDP,Sjögren’s disease (“SjD”), and a proof-of-concept trial in cutaneous lupus erythematosus (“CLE”). We also plan to initiate a potentially registrational trial evaluating IMVT-1402 in Sjögren’s disease (“SjD”) and a second potentially registrational trial in GD in the summer of 2025. 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 the neonatal fragment crystallizable receptor (“FcRn”).FcRn. These antibodies 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 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.

IMVT-1402 Potentially Registrational Trials in GD

In the quarter ended December 31,2024 2022,and June 2025, we initiated ourtwo Phasepotentially 3registrational clinicaltrials program(NCT06727604 toand evaluateNCT07018323, batoclimabrespectively) asevaluating aIMVT-1402 treatmentin foradults activewith moderate-to-severe TED.GD. We planexpect to report top-line results from thisthese clinical trialtrials in the second half of calendar year 2025.2027.

IMVT-1402 Potentially Registrational Trial in MG

WeIn March 2025, we initiated a potentially registrational trial (NCT07039916) evaluating IMVT-1402 in adults with CIDP in March 2025.MG. This Phase 2b trial is a randomized, placebo-controlled, 24-week26-week trial in CIDP patients. The study is expected to enroll approximately 162 participants randomized (2:1) to one either receiving IMVT-1402 600 mg weekly SC, or matched placebo for the 24-week treatment period. The study’s primary endpoint will evaluate the proportion of participants remaining relapse free (aINCAT) at week 24.trial. We expect to report top-line results from this trial in 2028.calendar year 2027.

IMVT-1402 Potentially Registrational Trial in D2T RA

IMVT-1402 Potentially Registrational Trial in SjD

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 conflictconflicts 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.

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, batoclimabIMVT-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, batoclimabIMVT-1402 and any futureother product candidates.

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

•personnel-related expenses, such as salaries, stock-based compensation expensesand benefits, for research and development personnel;

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

•other expenses, which include the cost of consultants whoand assistinformation withtechnology 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 as we continue our 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. Withwith respect to our IMVT-1402 development activities, our Phase 1 clinical trial of IMVT-1402 in New Zealand remains openactivities and we initiatedhave potentiallyongoing registrationalclinical trials forevaluating IMVT-1402 in GD, D2T RA, MGMG, CIDP, SjD and CIDP and a proof-of-concept trial in CLE. We also planexpect to initiatecontinue ato potentially registrational trial evaluating IMVT-1402 in SjD and a second potentially registrational trial evaluating IMVT-1402 in GD. Ourincur research and development expenses are also expected to continue to increase over the next several years as we execute IMVT-1402 trials, increasemanufacture manufacturing of IMVT-1402, hire personnelIMVT-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, batoclimabIMVT-1402 and any future product candidates will depend on a variety of factors that include, but are not limited to:

•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 conflictconflicts in the Middle EastEast, including the recent hostilities involving Iran;

Our business involves a high degree of risk. You should carefully consider the risks described in “Part I, Item 1A. Risk Factors” of our Annual Report filed with the SEC on May 29,20, 2025,2026, together with the other information contained in this Quarterly Report, including our unaudited condensed consolidated financial statements and the related notes appearing elsewhere in this Quarterly Report. We cannot assure you that any of the events discussed in these risk factors will not occur. These risks could have a material and adverse impact on our business, results of operations, financial condition and cash flows and, if so, our future prospects would likely be materially and adversely affected. If any of such events were to happen, the trading price of shares of our common stock could decline, and you could lose all or part of your investment. During the quarter ended DecemberJune 31,30, 2025,2026, our risk factors have not changed materially from those described in our Annual Report, except for the risk factors noted below.

Clinical trials and preclinical studies are very expensive, time-consuming, difficult to design and implement,implement and involve uncertain outcomes. We may encounter substantial delays in clinical trials, or may not be able to conduct or complete clinical trials or preclinical studies on the expected timelines, if at all.

Failures can occur at any stage of development, including clinical trials,trials or preclinical studies, and we could encounter problems that cause us to abandon or repeat clinical trials.trials or preclinical studies. In addition, results from clinical trials or preclinical studies may require further evaluationevaluation, delaying the next stage of clinical development or submission of aan BLA.IND or an NDA or similar application in the U.S. or another jurisdiction. Further, product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traitsresults despite having successfully progressed through nonclinical studiespreclinical and initialearlier stage clinical trials,trials. and suchSuch product candidates may exhibit negative safety signals in later stage clinical trials that they did not exhibit in nonclinicalearlier studies or earlier-stage clinical trials. A number of companies in the pharmaceutical industry, including biotechnology and biopharmaceutical companies,industry have suffered significant setbacks inin, or the discontinuation ofof, advanced clinical trials with a product candidate due to lack of efficacy or adverse safety profiles,findings, notwithstandingdespite positivehaving promising results in earlier trials.trials or studies. Likewise, the results of early nonclinical studies and clinical trials or preclinical studies of our product candidates, some of which were not conducted by us,candidates may not be predictive of the results of our current or plannedfuture development programs. There can also be no assurance that the results of studies conducted by collaborators or other third parties with similar product candidates in similar indications will be viewed favorably or indicative of our own future trial results.

The commencement and completion of clinical trials and other studies may be delayed by several factors, including:

•failurethe inability to identify,generate qualify,sufficient data to support the initiation or initiate a sufficient numbercontinuation of clinical trial sitestrials;

•the failure to manufacture or release sufficient quantities of our product candidates or placebofailure to obtain sufficient quantities of active comparator medications for our clinical trialstrials, if applicable, that in each case meet our and global quality standardsstandards, for use in clinical trials;

•the inability to monitor patients adequately during or after treatment; or

•inappropriate unblinding of trial results.results;

Therefore, we cannot predict with any certainty the schedule for commencement and completion of future clinical trials. If we experience delays in the commencement, enrollment,commencement or completion of our clinical trials, or if we terminate a clinical trial prior to completion, the commercial prospects of our product candidates could be harmed, and our ability to generate product revenue from any of our product candidates, if approved, may be delayed. In addition, any delays in our clinical trials could increase our costs, cause a decline in our share price, slow down the approval process, and jeopardize our ability to commence product sales and generate revenue. Any of these occurrences may harm our business, financial condition and results of operations. In addition, many of the factors that cause or lead to a termination or suspension of, or delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates. We may make formulation or manufacturing changes to our product candidates, in which case we may need to conduct additional preclinical or clinical studies to bridge our modified product candidates to earlier versions. Any delays to our clinical trials that occur as a result could shorten any period during which we may have the exclusive right to commercialize our product candidates and our competitors may be able to bring product candidates to market before we do, and the commercial viability of our product candidates could be significantly reduced.

Cautionary Note Regarding Forward-Looking Statements

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,IMVT-1402 (imeroprubart), 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, includingincluding, 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 studyresearch and development by multiple companies, with two indications that are already approved and launchedlaunched, quickly reaching billionsmulti-billions of dollars in global annual sales.

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. There has been consistentConsistent 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, formerly referred to as IMVT-1401, 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.

IMVT-1402 Potentially Registrational Trials in GD

WeIn December 2024 and June 2025, we initiated two potentially registrational trials (NCT06727604 and NCT07018323NCT07018323, respectively) evaluating IMVT-1402 in adults with GD in December 2024 and June 2025, respectively.GD. We expect to report top-line results from these trials in calendar year 2027.

IMVT-1402 Potentially Registrational Trial in D2T RA

WeIn December 2024, we initiated a potentially registrational trial (NCT06754462) evaluating IMVT-1402 in anti-citrullinated protein autoantibody (“ACPA”) positive D2T RA in December 2024. The trial is fully enrolled, and we now expect to report top-line results from this trial in the second half of calendar year 2026.RA.

IMVT-1402 Potentially Registrational Trial in SjD

WeIn June 2025, we initiated a potentially registrational trial (NCT06979531) evaluating IMVT-1402 in SjD in June 2025.SjD. We expect to report top-line results from this trial in calendar year 2028.

WeIn February 2025, we initiated a proof-of-concept trial (NCT6980805NCT06980805) evaluating IMVT-1402 in CLECLE. inThe Februarytrial 2025.is Wefully enrolled and we expect to report top-line results from this trial in the second half of calendar year 2026.

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 conflictconflicts 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.

We have commenced discussions with HanAll regarding the future disposition of batoclimab, including the potential return to HanAll of certain rights for batoclimab. TheIn April 2026, we notified HanAll Agreementof givesour usdecision to indefinitely delay further development of batoclimab and focus our resources fully on IMVT-1402. Under the HanAll Agreement, we retain final controldecision-making authority over development and regulatory decisionsmatters relatingfor tolicensed batoclimabproducts in our Licensed TerritoriesTerritory, and we believe we have performedsatisfied our obligations under the HanAll Agreement.Agreement, including with respect to batoclimab. HanAll may disagree with our position,interpretation of the agreement or our actions thereunder, and we may notbe unable to reach an agreement with HanAll with respect toregarding the returnfuture of batoclimab to them.batoclimab. This could result in a dispute with HanAll that may result ininvolving arbitration or litigation.

For furthera 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 and Part II, Item 1A – Risk Factors of this Quarterly Report.

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, batoclimabIMVT-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.

•personnel-related expenses, such as salaries, stock-based compensation expensesand 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”); and

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 initiatedhave potentiallyongoing registrationalclinical trials forevaluating IMVT-1402 in GD, D2T RA, MG, CIDPCIDP, SjD 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 trialsIMVT-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, any potential future batoclimab trials,IMVT-1402 and any future product candidates will depend on a variety of factors that include, but are not limited to:

•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 conflictconflicts in the Middle EastEast, including the recent hostilities involving Iran;

General and administrative expenses consist primarily of employeeemployee-related salariesexpenses, andsuch relatedas benefits,salaries, stock-based compensation and benefits for employees engaged in general and administrative personnel,activities, legal and accounting fees, consulting services, costs allocated under the Services Agreements and other operating costs relating to corporate matters and daily operations.

Results of Operations for the Three Months Ended DecemberJune 31,30, 20252026 and 20242025

The following table sets forth our results of operations for the three months ended DecemberJune 31,30, 20252026 and 20242025 (in thousands):

Research and Development Expenses for the Three Months Ended DecemberJune 31,30, 20252026 and 20242025

The following table summarizes the period-over-period changes in research and development expenses for the three months ended DecemberJune 31,30, 20252026 and 20242025 (in thousands):

For the three months ended DecemberJune 31,30, 2025,2026, research and development expenses increased $4.4$41.4 million as compared with the prior-year period.

For the three months ended DecemberJune 31,30, 2025,2026, therapeutic area-specific research and development costs, including contract manufacturing costs, increased $1.5$44.8 million as compared with the prior-year period. Research and development costs related to endocrine diseases, which include GD and TED, increased $4.3$23.6 million. This increase was primarily due to the recently initiated andour ongoing potentially registrationalclinical trials of IMVT-1402 in endocrine diseases,GD, partially offset by lower overall clinical trial costs related to the wind-down of our batoclimab clinical trials. Research and development costs related to neurological diseases, which include MG and CIDP, decreasedincreased $7.3$4.5 million. This decrease wasmillion, primarily due to lower overall clinical trialhigher costs related to our batoclimab Phase 3 and Phase 2b clinical trials, partially offset by the ongoing potentially registrational trials of IMVT-1402 in neurological diseases.diseases, partially offset by lower costs related to the wind-down of our batoclimab clinical trials. Research and development costs related to rheumatology diseases increased $5.9$14.1 million, reflecting higher expenses incurred with the initiation of our potentiallyongoing registrationalclinical trialtrials of IMVT-1402 in SjDD2T RA and the ongoing potentially registrational trial of IMVT-1402 in RA.SjD. Research and development costs related to dermatology diseases decreasedincreased $1.9$2.4 million, reflecting lowerhigher ongoingoverall clinical trial costs after the initiation offor our proof-of-concept trial in CLE.

For the three months ended DecemberJune 31,30, 2025,2026, unallocated research and development costs increaseddecreased $2.9$3.4 million as compared with the prior-year period. This increasedecrease primarily reflected higherlower costs that were not allocated to specific therapeutic areas as a result of the Company’s focus on the development of IMVT-1402 of $2.4 million and a decrease in personnel-related expenses of $2.7$1.0 million,million drivenaligned by higher headcount hired to conductwith a higherdecrease numberin of clinical trials.headcount.

General and Administrative Expenses for the Three Months Ended DecemberJune 31,30, 20252026 and 20242025

For the three months ended DecemberJune 31,30, 2025,2026, general and administrative expenses decreased $4.3$8.3 million as compared with the prior-year period, primarily reflecting lower personnel-related expenses, driven by a one-time stock-based compensation charge in the prior-year period related to the retirement of our former chief executive officer, as well as lower professional fees, market research costs and information technology costs.

Interest Income, net for the Three Months Ended DecemberJune 31,30, 20252026 and 20242025

For the three months ended DecemberJune 31,30, 2025,2026, interest income increased $0.7$0.8 million as compared with the prior-year period, primarily reflecting higher average money market fund balances.balances, partially offset by lower average interest rates.