IMVT on Nasdaq

Immunovant, Inc.

American biological products company based in New York, listed on Nasdaq (IMVT)1

In its 2026 annual report the company says: “Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. Our focus is on developing IMVT-1402 (imeroprubart), a potentially best-in-class inhibitor of the neonatal fragment crystallizable receptor, to address autoimmune diseases driven by high levels of pathogenic immunoglobulin G antibodies.”4

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Last updated Oct 21, 2026.

Overview

-$505.6MNet income, fiscal 20262

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  • TickerIMVT on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersDurham, North Carolina1
  • Incorporated inDE3
  • Business address1000 Park Forty Plaza, Durham, Nc 277133
  • Filer categoryLarge accelerated filer3
  • Legal formCorporation

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 (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.4 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2026

-59.3%Return on equity2
-$407.3MFree cash flow2

Financial statements

Net income567892-$505.6M in 2026+1668% since 2019
-$600.0M-$400.0M-$200.0M02019: -$28.6M-$28.6M20192020: -$66.4M-$66.4M2020+132%2021: -$107.4M-$107.4M2021+62%2022: -$156.7M-$156.7M2022+46%2023: -$211.0M-$211.0M2023+35%2024: -$259.3M-$259.3M2024+23%2025: -$413.8M-$413.8M2025+60%2026: -$505.6M-$505.6M2026+22%

Every line of the income statement as filed: the last 3 fiscal years, latest first.2

Period ending2026-03-312025-03-312024-03-31
Research and development$456.7M$360.9M$212.9M
Acquired in-process research and development$0$0$12.5M
General and administrative$76.2M$77.2M$57.3M
Total operating expenses$532.9M$438.2M$282.7M
Interest income, net-$25.3M-$24.7M-$24.9M
Other (income) expense, net-$2.2M-$471.0K$1.0M
Loss before provision for income taxes-$505.4M-$412.9M-$258.8M
Provision for income taxes$215.0K$891.0K$567.0K
Net loss-$505.6M-$413.8M-$259.3M
Net loss per common share basic (in dollars per share)-$2.77-$2.73-$1.88
Net loss per common share diluted (in dollars per share)-$2.77-$2.73-$1.88
Weighted average common shares outstanding basic (in shares)182.4M shares151.6M shares138.1M shares
Weighted average common shares outstanding diluted (in shares)182.4M shares151.6M shares138.1M shares

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Corporate structure

Immunovant, Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Immunovant, Inc.

  • Deep Track Capital, LP Filed SCHEDULE 13G/A on Immunovant, Inc., latest Aug 14, 2026 (5 filings since Feb 11, 2022)
  • Roivant Filed SCHEDULE 13D/A on Immunovant, Inc., latest Dec 12, 2025 (4 filings since Oct 4, 2023)
  • FMR LLC Filed SCHEDULE 13G/A on Immunovant, Inc., latest Nov 5, 2025 (4 filings since Feb 9, 2024)
  • RTW INVESTMENTS, LP Filed SC 13G/A on Immunovant, Inc., latest Dec 5, 2022 (2 filings since Dec 2, 2022)
  • Immunovant, Inc. Durham, North Carolina

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Immunovant, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, net$443.0K2 Mar 31, 2026$844.0K2 Mar 31, 2025−47.5%
Operating-lease assets (leased space)$72.0K2 Mar 31, 2026$98.0K2 Mar 31, 2025−26.5%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$902.1M2 Mar 31, 2026$714.0M2 Mar 31, 2025+26.4%

Properties, in its own words

We conduct business operations at 1000 Park Forty Plaza, Suite 210, Durham, North Carolina 27713. ISL’s registered office is located at Clarendon House, 2 Church Street, Hamilton HM11, Bermuda and ISL’s principal office is located at 7th Floor, 50 Broadway, London, SW1H 0DB. ISG conducts business operations at Viaduktstrasse 8, 4051 Basel, Switzerland.

We could add new facilities or expand our existing facilities as we add employees, and we believe that suitable additional or substitute space will be available as needed to accommodate any such expansion of our operations.

Item 2 of the 10-K filed May 20, 2026.4

Leadership

Who has led Immunovant, Inc., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (26)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerChristopher Van Tuyl named Jan 21, 202545

Former names

  • Health Sciences Acquisitions CorpJan 23, 2019 to Dec 20, 20193

Timeline

  1. Sep 3, 20268-K Shareholder vote46
  2. Aug 6, 20268-K Results of operations47
  3. May 20, 20268-K Results of operations48
  4. Feb 6, 20268-K Results of operations49
  5. Dec 12, 20258-K Other events50
  6. Dec 11, 20258-K Other events51
  7. Nov 21, 20258-K Executive or director change52
  8. Nov 10, 20258-K Results of operations53
  9. Sep 3, 20258-K Regulation FD disclosure; Other events54
  10. Aug 28, 20258-K Shareholder vote55
  11. Aug 11, 20258-K Results of operations56
  12. Jul 30, 2025New chief executive Eric Venker becomes CEO14
  13. Jul 29, 20258-K Executive or director change57
  14. Dec 20, 2019New chief executive Peter Salzmann becomes CEO16
  15. May 9, 2019New chief executive Roderick Wong becomes CEO15

Calendar

Coming up

  1. Nov 9, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.73) a share, on Nov 10, 2025.58

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results47
  2. May 20, 2026Reported quarterly or annual results48
  3. Feb 6, 2026Reported quarterly or annual results49
  4. Nov 10, 2025Reported quarterly or annual results53
  5. Aug 11, 2025Reported quarterly or annual results56
  6. May 29, 2025Reported quarterly or annual results59
  7. Feb 6, 2025Reported quarterly or annual results60
  8. Nov 7, 2024Reported quarterly or annual results61

Drug trials and FDA: coming up

  1. Oct 2026Phase 2 trial readout expected Phase 2 trial of IMVT-1402 in Subacute Cutaneous Lupus Erythematosus: primary completion expected Oct 2026 (ClinicalTrials.gov NCT06980805).62
  2. May 2027Phase 2 trial readout expected Phase 2 trial of IMVT-1402 in Graves' Disease: primary completion expected May 2027 (ClinicalTrials.gov NCT07018323).63
  3. Sep 2027Phase 2 trial readout expected Phase 2 trial of IMVT-1402 in Rheumatoid Arthritis: primary completion expected Sep 2027 (ClinicalTrials.gov NCT06754462).64

Drug trials and FDA: recently

  1. Feb 3, 2026Phase 3 trial completed Phase 3 trial of Batoclimab in Thyroid Eye Disease: primary completion Feb 3, 2026, no results posted yet (ClinicalTrials.gov NCT05524571).65
  2. Nov 2, 2025Phase 3 trial completed Phase 3 trial of Batoclimab in Thyroid Eye Disease: primary completion Nov 2, 2025, no results posted yet (ClinicalTrials.gov NCT05517421).66
  3. Jul 25, 2025Phase 2 trial completed Phase 2 trial of IMVT-1401 (batoclimab) in Graves Disease: primary completion Jul 25, 2025, results posted Aug 13, 2026 (ClinicalTrials.gov NCT05907668).67

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

415 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 53 major events, 269 insider forms, 15 large holders, 1 private raises, 57 other. The latest 20:

  1. Oct 9, 20264 EDGAR
  2. Oct 9, 20264 EDGAR
  3. Oct 9, 20264 EDGAR
  4. Oct 5, 20264 EDGAR
  5. Sep 25, 20264 EDGAR
  6. Sep 3, 20268-K EDGAR
  7. Aug 28, 20264 EDGAR
  8. Aug 21, 20264 EDGAR
  9. Aug 14, 2026SCHEDULE 13G/A EDGAR
  10. Aug 6, 202610-Q EDGAR
  11. Aug 6, 20268-K EDGAR
  12. Jul 24, 20264 EDGAR
  13. Jul 24, 20264 EDGAR
  14. Jul 24, 20264 EDGAR
  15. Jul 22, 2026ARS EDGAR
  16. Jul 22, 2026DEFA14A EDGAR
  17. Jul 22, 2026DEF 14A EDGAR
  18. Jul 10, 20264 EDGAR
  19. Jul 10, 20264 EDGAR
  20. Jul 10, 20264 EDGAR

The 415 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

186 open-market trades by officers, directors and large owners since October 2021: 6 buys and 180 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 23, 2026Van Tuyl ChristopherChief Legal OfficerSale2,846$36.36$103.5KForm 4
Aug 28, 2026Pande AtulDirectorSale1,500$43.27$64.9KForm 4
Aug 20, 2026Gloria MelanieChief Operating OfficerSale3,056$44.16$135.0KForm 4
Jul 24, 2026Pande AtulDirectorSale1,500$39.80$59.7KForm 4
Jul 23, 2026Stout Jay SChief Technology OfficerSale2,857$38.69$110.5KForm 4
Jul 23, 2026Girao TiagoChief Financial OfficerSale6,798$38.69$263.0KForm 4
Jul 8, 2026Gloria MelanieChief Operating OfficerSale2,036$39.55$80.5KForm 4
Jul 8, 2026Van Tuyl ChristopherChief Legal OfficerSale1,206$39.55$47.7KForm 4
Jul 8, 2026Stout Jay SChief Technology OfficerSale3,487$39.55$137.9KForm 4
Jul 2, 2026Venker EricChief Executive OfficerSale3,092$38.48$119.0KForm 4
Jun 26, 2026Gloria MelanieChief Operating OfficerSale17,714$38.31$678.6KForm 4
Jun 26, 2026Stout Jay SChief Technology OfficerSale40,000$38.31$1.5MForm 4
Jun 26, 2026Van Tuyl ChristopherChief Legal OfficerSale17,824$38.31$682.9KForm 4
Jun 26, 2026Girao TiagoChief Financial OfficerSale10,000$38.46$384.6KForm 4
Jun 26, 2026Pande AtulDirectorSale1,500$38.01$57.0KForm 4
Jun 18, 2026Van Tuyl ChristopherChief Legal OfficerSale2,634$35.39$93.2KForm 4
Jun 15, 2026Pande AtulDirectorSale1,500$34.02$51.0KForm 4
May 28, 2026Fromkin Andrew J.DirectorSale221,951$33.51$7.4MForm 4
May 20, 2026Gloria MelanieChief Operating OfficerSale3,115$32.45$101.1KForm 4
May 20, 2026Pande AtulDirectorSale6,000$32.00$192.0KForm 4

All 186 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2026Eric VenkerChief Executive Officer$636.6K$20.2M72
2026Peter SalzmannFormer Chief Executive Officer$39.6K$15.3M72
2026Tiago GirãoChief Financial Officer46$455.5K$7.6M72
2026Michael GeffnerFormer Chief Medical Officer$345.5K$5.3M72
2026Eva Renee BarnettFormer Chief Financial Officer$26.2K$3.2M72
2026Melanie GloriaChief Operating Officer48$495.0K$3.1M72
2026Jay StoutChief Technology Officer$495.0K$3.1M72
2026Christopher Van TuylChief Legal Officer and Corporate Secretary51$495.0K$2.3M72
2025Peter SalzmannFormer Chief Executive Officer$724.5K$10.7M72
2025Christopher Van TuylChief Legal Officer and Corporate Secretary51$140.3K$5.9M72
2025Melanie GloriaChief Operating Officer48$180.4K$5.6M72
2025Michael GeffnerFormer Chief Medical Officer$518.0K$4.1M72
2025Jay StoutChief Technology Officer$481.0K$4.0M72
2025Eva Renee BarnettFormer Chief Financial Officer$481.0K$4.0M72
2024Peter SalzmannFormer Chief Executive Officer$700.0K$8.6M72
2024Jay StoutChief Technology Officer$416.9K$4.0M72
2024Eva Renee BarnettFormer Chief Financial Officer$465.0K$3.3M72

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$450.0M 2025–2025
Money received by yearMoney received by year, 2025–2025: $450.0M in all. Private raises (Form D) $450.0M.$0$200M$400M$600M2025 · Private raises (Form D): $450.0M2025
Figures by year
YearPrivate raises (Form D)Total
2025$450.0M$450.0M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Jan 15, 2025Raised $450 million in a private offering of equity45 Form D: 11 investors so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Fmr LLC16,186,469$623.7M0.0%−761,419
Deep Track Capital, LP9,341,151$359.9M5.3%−2,185,820
BlackRock, Inc.7,180,897$276.7M0.0%+606,400
Farallon Capital Management, L.l.c.5,805,000$223.7M1.3%+4,259,000
Baker Bros. Advisors LP5,435,220$209.4M1.1%−22,661
State Street Corp4,617,005$177.9M0.0%+79,076
Morgan Stanley4,534,833$174.7M0.0%+657,956
TCG Crossover Management, LLC4,457,988$171.8M4.1%No change
Vanguard Portfolio Management LLC3,910,509$150.7M0.0%+205,604
Vanguard Capital Management LLC3,638,681$140.2M0.0%+18,631
Jennison Associates LLC3,310,238$127.5M0.1%+113,533
Rtw Investments, LP3,177,849$122.4M1.0%No change
Two Seas Capital LP3,148,505$121.3M4.6%−53,457
ADAR1 Capital Management, LLC2,330,716$89.8M4.3%−348,294
Geode Capital Management, LLC2,234,602$86.1M0.0%+142,500
Woodline Partners LP1,975,869$76.1M0.2%No change
Goldman Sachs Group Inc1,751,183$67.5M0.0%−33,924
Armistice Capital, LLC1,736,000$66.9M1.9%−1,828,916
Alpine Global Management, LLC1,375,000$53.0M8.7%−1,261,925
Perceptive Advisors LLC1,357,383$52.3M0.8%−240,000
D. E. Shaw & Co., Inc.1,240,654$47.8M0.0%New
Bank Of America Corp /de/1,181,452$45.5M0.0%+287,774
Susquehanna International Group, Llp1,022,513$39.4M0.0%+404,706
Aberdeen Group plc857,030$33.0M0.0%−303,732
Northern Trust Corp794,004$30.6M0.0%+121,230

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Immunovant, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARImmunovant, Inc.1
  • CIK0001764013
  • Employer ID (EIN)83-27715724
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsMarch 311
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address1000 Park Forty Plaza, Durham, NC 277131
  • Phone917-410-31201
  • Shares outstanding206,552,682 as of Aug 3, 202612
  • Public float$1.3B as of Sep 30, 20254
  • AuditorErnst & Young LLP, Iselin, New Jersey PCAOB ID 42; it also attests to the company’s internal control over financial reporting4
  • On EDGAR sinceJan 23, 20191
  • Filings646 in all: 4 (322), 8-K (84), 3 (34), 144 (26), 10-Q (23), DEFA14A (16), CORRESP (13), UPLOAD (12)1
    All 46 form types

    SC 13G/A (11), S-8 (8), 10-K (7), 424B3 (7), DEF 14A (7), SC 13D/A (7), SC 13G (6), 424B5 (5), EFFECT (5), S-1/A (5), S-1 (4), 424B4 (3), ARS (3), DRS (3), FWP (3), SCHEDULE 13D/A (3), SCHEDULE 13G/A (3), POS EX (2), PRER14A (2), S-1MEF (2), SC 13D (2), SEC STAFF LETTER (2), 25-NSE (1), 4/A (1), 424B7 (1), 8-A12B (1), 8-K/A (1), CERT (1), D (1), DEFM14A (1), DEFR14A (1), DRS/A (1), DRSLTR (1), PRE 14A (1), PREM14A (1), S-3 (1), S-3ASR (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) May 20, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Jul 22, 2026
    Latest 8-K (8-K) Sep 3, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 par value per shareIMVTThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed May 20, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Immunovant, Inc. names in Item 1A of its 10-K filed May 20, 2026: 76 risks under these headings, as written.4

  • Risks Related to Development, Regulatory Approval and Commercialization
  • Our business is dependent on the successful and timely development, regulatory approval and commercialization of our product candidates.
  • Clinical trials are very expensive, time-consuming, difficult to design and implement, and involve uncertain outcomes.
  • Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control and we may not be able to enroll patients in our trials on our anticipated timelines.
  • The results of our preclinical 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.
  • Interim, “top-line” or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • 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.
  • Our product candidates are antibody proteins that could cause an immune response in patients, resulting in the creation of harmful or neutralizing antibodies against these therapeutic proteins, preventing or limiting regulatory approval or our ability to commercialize our product candidates.
  • If we are not able to obtain required regulatory approvals, we will not be able to commercialize IMVT-1402 or any future product candidate, and our ability to generate product revenue will be impaired.
  • We have in-licensed the rights to IMVT-1402 and batoclimab in limited territories. Any adverse developments that occur during any clinical trials or manufacturing conducted by third parties, including HanAll, in other jurisdictions may affect our ability to obtain regulatory approval or commercialize our product candidates.
  • We face significant competition from other biotechnology and pharmaceutical companies targeting autoimmune disease indications. Our operating results will suffer if we fail to compete effectively.
  • Additional time may be required to obtain marketing authorizations for the autoinjector presentation of IMVT-1402 because it would be subject to regulation as a combination product.
The other 65 risks
  • The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time-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.
  • Even if we obtain regulatory approval for a product candidate, we will still face extensive ongoing quality and regulatory compliance requirements and our product may face future development and quality or regulatory compliance difficulties.
  • Even if we receive marketing approval for any product candidate, it may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success.
  • We may expend our limited resources to pursue particular indications and fail to capitalize on indications that may be more profitable or for which there is a greater likelihood of success.
  • If we are unable to establish sales, marketing and distribution capabilities, either on our own, or in collaboration with third parties, we may not be successful in commercializing our product candidates, if approved.
  • We may seek orphan drug designations for IMVT-1402 or other product candidates we develop, but we may be unable to obtain such further designation or to maintain the benefits associated with orphan drug status even if that designation is granted.
  • If we obtain approval to commercialize our product or any future product candidate outside of the U.S., a variety of risks associated with international operations could adversely affect our business.
  • Our current and future relationships with investigators, healthcare professionals, consultants, third-party payors and customers are subject to applicable healthcare regulatory laws, which could expose us to penalties or other negative actions.
  • Legislation targeting biotechnology companies with ties to certain foreign adversaries, including the BIOSECURE Act, could materially adversely affect our business, supply chain and results of operations.
  • Changes in healthcare law and implementing regulations, as well as changes in healthcare policy, may impact our business in ways that we cannot currently predict and may have a significant adverse effect on our business and results of operations.
  • Coverage and adequate reimbursement may not be available for our product candidates, which could make it difficult for us to sell it profitably, if approved.
  • Risks Related to Our Business, Financial Position and Capital Requirements
  • We expect to incur significant losses for the foreseeable future and may never achieve or maintain profitability.
  • We have a limited operating history and have never generated any product revenue.
  • We may not be successful in our efforts to identify and acquire or in-license additional product candidates or technologies or to enter into collaborations or strategic alliances for the development and commercialization of any such future product candidates.
  • We will require additional capital to fund our operations. If we fail to obtain necessary financing, we may not be able to complete the development and commercialization of our product candidates.
  • Raising additional funds by issuing equity securities will cause dilution to existing stockholders. Raising additional funds through debt financings may involve restrictive covenants and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights.
  • We rely on the HanAll Agreement to provide us rights to the core intellectual property relating to IMVT-1402 and batoclimab. Any termination or loss of significant rights under the HanAll Agreement could adversely affect our development or commercialization of IMVT-1402.
  • The HanAll Agreement obligates us to make milestone payments, some of which may be triggered prior to our potential commercialization of any product candidate.
  • We may not be able to attract or retain qualified management, scientific, clinical and commercial personnel due to the intense competition for qualified individuals among biotechnology, pharmaceutical and other businesses.
  • Our or our affiliates’ employees, independent contractors, principal investigators, consultants, commercial collaborators, service providers and other vendors or potential collaborators may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.
  • International expansion of our business exposes us to business, legal, regulatory, political, operational, financial and economic risks associated with conducting business outside of the U.S.
  • We and the third parties with whom we work are subject to stringent and changing privacy, data protection and information security laws, contractual obligations, self-regulatory schemes, government regulation, industry standards and other obligations related to data privacy and security. The actual or perceived failure by us or the third parties with whom we work to comply with such obligations could result in harm to our reputation, regulatory investigations or actions, significant fines and liability, disruption of our clinical trials or other material adverse effects on our business.
  • If our information technology systems or data, or those of our affiliates, service providers or other third parties with whom we work, are or were compromised now or in the future, this could result in a material adverse effect on our business, including without limitation, a material interruption to our operations, harm to our reputation, regulatory investigations or actions, significant fines, penalties and liability, breach or triggering of Data Protection Laws, Privacy Policies and Data Protection Obligations or material disruption of our clinical trials or other business activity.
  • Potential product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of any products that we may develop.
  • The biopharmaceutical industry is subject to extensive regulatory obligations and policies that may be subject to significant and abrupt change, including due to judicial challenges, election cycles, and resulting regulatory updates and changes in policy priorities.
  • Disruptions at the FDA and other government authorities caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
  • Our business could be adversely affected by economic downturns, changes in inflation and interest rates, changes in international trade policies and tariffs, natural disasters, political crises, geopolitical events, such as the crises and conflicts in Ukraine and the Middle East, or other macroeconomic conditions, which may negatively impact our business and financial performance in the future.
  • Risks Related to Our Dependence on Third Parties
  • We do not have our own manufacturing capabilities and rely on third parties to produce clinical supplies and commercial supplies of our product candidates. The manufacture of biologics is complex and we or our third-party manufacturers may encounter difficulties in production or our quality management program may fail to detect quality issues at our third-party manufacturers, which may delay or prevent our ability to obtain marketing approval or commercialize our product candidates if approved.
  • A portion of our manufacturing, clinical trial activities and laboratory research takes place in Asia. A significant disruption in that region, such as a trade war or political unrest, or adverse legislation could materially adversely affect our business, financial condition and results of operations.
  • We rely on third parties to conduct, supervise and monitor our clinical trials and if those third parties perform in an unsatisfactory manner or fail to comply with applicable requirements or our quality management program fails to detect such events in a timely manner, it may harm our business.
  • Risks Related to Our Intellectual Property
  • Our product candidates for which we intend to seek approval as a biological product may face competition sooner than anticipated.
  • The validity, scope and enforceability of any patents that cover a biologic subject to approval by the FDA via a BLA, such as IMVT-1402 or batoclimab, can be challenged by third parties.
  • If we are unable to obtain and maintain patent protection for IMVT-1402, batoclimab, or any future product candidates or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.
  • We may not be able to protect or enforce our intellectual property rights throughout the world.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • If we are not able to obtain patent term extension in the U.S. under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the term of our marketing exclusivity for batoclimab, IMVT-1402 or other product candidates that we may identify, our business may be harmed.
  • We do not have rights to protect intellectual property in certain territories and may be unable to adequately protect our rights.
  • If we fail to comply with our obligations under any license, collaboration or other agreements, including the HanAll Agreement, we may be required to pay damages and could lose intellectual property rights that are necessary for developing and protecting our product candidates.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies and our patent protection could be reduced or eliminated for noncompliance with these requirements.
  • We may not be successful in obtaining necessary intellectual property rights to future products through acquisitions and in-licenses.
  • We may need to license intellectual property from third parties and such licenses may not be available or may not be available on commercially reasonable terms.
  • Third-party claims or litigation alleging infringement of patents or other proprietary rights or us seeking to invalidate patents or other proprietary rights may delay or prevent the development and commercialization of our product candidates.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our product candidates or any future product candidates.
  • We may become involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
  • Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties.
  • Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect batoclimab, IMVT-1402 or any of our future product candidates.
  • If we are unable to protect the confidentiality of our trade secrets and other proprietary information, including as a result of our reliance on third parties, our business and competitive position could be harmed.
  • We may be subject to claims that our licensors, employees, consultants, independent contractors or we have wrongfully used or disclosed confidential information of their former employers or other third parties.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • Any trademarks and trade names we have obtained or may obtain may be infringed or successfully challenged, resulting in harm to our business.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • General Risks Related to an Investment in Our Securities
  • RSL owns a significant percentage of shares of our common stock and may exert significant control over matters subject to stockholder approval.
  • RSL has the right to elect a certain number of directors to our board of directors.
  • Our organizational and ownership structure may create significant conflicts of interests.
  • The market price of shares of our common stock has been and is likely to be highly volatile, and you may lose some or all of your investment.
  • We have been and could be subject to securities litigation, which is expensive and could divert management attention and adversely impact our business.
  • We are a “controlled company” within the meaning of the applicable Nasdaq Global Select Market (“Nasdaq”) listing rules and, as a result, qualify for exemptions from certain corporate governance requirements. If we rely on these exemptions, you will not have the same protections afforded to stockholders of companies that are subject to such requirements.
  • If securities or industry analysts do not publish research or reports about our business or publish negative reports about our business, our share price and trading volume could decline and has declined in the past upon downgrades of our common stock.
  • Because we do not anticipate paying any cash dividends on shares of our common stock in the foreseeable future, capital appreciation, if any, would be your sole source of gain.
  • As a public company, we are obligated to develop and maintain proper and effective internal controls over financial reporting and any failure to maintain the adequacy of these internal controls may adversely affect investor confidence in our company and, as a result, the value of shares of our common stock.
  • We may become subject to unanticipated tax liabilities and higher effective tax rates.
  • Our intercompany arrangements depend on the application of the tax laws of various jurisdictions and on how we operate our business.
  • Changes in tax laws or our effective tax rate may reduce our net income in future periods.
  • Our ability to use our U.S. net operating loss carryforwards and certain other U.S. tax attributes may be limited.

Legal proceedings

From time to time, we have been and may become involved in legal or regulatory proceedings arising in the ordinary course of our business. We do not currently, however, expect such legal proceedings to have a material adverse effect on our business, operating results or financial condition. However, depending on the nature and timing of a given dispute, an unfavorable resolution could materially affect our current or future results of operations or cash flows.

For a description of our legal proceedings, see Part II, Item 8. Financial Statements and Supplementary Data, Note 10 – Commitments and Contingencies for more information.

The opening of Item 3, Legal Proceedings.4

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