VIR on Nasdaq

VIR Biotechnology

VIR Biotechnology is a biotech company based in San Francisco, founded in 2016.1 Its chief executive is George Scangos (since 2017).1

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Last updated Oct 21, 2026.

Overview

Apr 7, 2016Founded1

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  • TickerVIR on Nasdaq1
  • Industrybiotechnology industry1
  • HeadquartersSan Francisco1
  • Websitewww.vir.bio
  • Incorporated inDE3
  • Business address1800 Owens Street, Suite 900, San Francisco, Ca 941583
  • Filer categoryLarge accelerated filer3
VIR Biotechnology image from its website
Image: vir.bio5

Vir Biotechnology, Inc. (including its subsidiaries, referred to as “Vir Bio,” “the Company,” “we,” “our” or “us”) is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer.6 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 2025

-699.2%Operating margin7
-638.9%Net margin7
-7.6%Revenue growth, 20257
-57.2%Return on equity7
-$396.6MFree cash flow7

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Other Revenue brought in 62% of the revenue VIR Biotechnology broke down this way in fiscal 2025.

  1. Other Revenue$3.4M762%up 45% from 2024
  2. Grant$2.0M738%down 81% from 2024
Products and services by year
Products and services202320242025
Other Revenue$2.1M$2.3M$3.4M
Grant$46.7M$10.5M$2.0M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue0¢$26.0K
  • Research and development83¢$456.0M
  • Selling, general and admin17¢$92.1M
  • Income tax0¢$217.0K

Out of $68.6M in revenue.7 The company lost money this year.

Financial statements

Revenue8910117$68.6M in 2025+747% since 2019
0$500.0M$1.0B$1.5B$2.0B2019: $8.1M$8.1M20192020: $76.4M$76.4M2020+844%2021: $1.1B$1.1B2021+1334%2022: $1.6B$1.6B2022+48%2023: $86.2M$86.2M2023−95%2024: $74.2M$74.2M2024−14%2025: $68.6M$68.6M2025−8%
Operating income8910117-$479.3M in 2025+169% since 2019
-$1.0B-$500.0M0$500.0M$1.0B2019: -$178.0M-$178.0M20192020: -$297.0M-$297.0M2020+67%2021: $420.8M$420.8M20212022: $833.1M$833.1M2022+98%2023: -$684.3M-$684.3M20232024: -$587.2M-$587.2M2024−14%2025: -$479.3M-$479.3M2025−18%
Net income8910117-$438.0M in 2025+151% since 2019
-$1.0B-$500.0M0$500.0M$1.0B2019: -$174.7M-$174.7M20192020: -$298.7M-$298.7M2020+71%2021: $528.6M$528.6M20212022: $515.8M$515.8M2022−2%2023: -$615.1M-$615.1M20232024: -$522.0M-$522.0M2024−15%2025: -$438.0M-$438.0M2025−16%

Every line of the income statement as filed: the last 3 fiscal years, latest first.7

Period ending2025-12-312024-12-312023-12-31
Total revenues$68.6M$74.2M$86.2M
Cost of revenue$26.0K$845.0K$2.8M
Research and development$456.0M$506.5M$579.7M
Selling, general and administrative$92.1M$119.0M$174.4M
Restructuring, long-lived assets impairment and related charges, net-$182.0K$35.0M$13.6M
Total operating expenses$547.9M$661.4M$770.5M
Loss from operations-$479.3M-$587.2M-$684.3M
Change in fair value of equity investments$1.7M-$5.5M-$21.9M
Interest income$40.2M$71.8M$87.0M
Other expense, net-$409.0K-$2.2M-$9.0M
Total other income$41.6M$64.1M$56.1M
Loss before (provision for) benefit from income taxes-$437.8M-$523.1M-$628.2M
(Provision for) benefit from income taxes-$217.0K$1.1M$13.1M
Net loss-$438.0M-$522.0M-$615.1M
Net loss attributable to noncontrolling interest$0$0-$56.0K
Net loss attributable to Vir Bio-$438.0M-$522.0M-$615.1M
Net loss per share attributable to VirBio, basic (in USD per share)-$3.16-$3.83-$4.59
Net loss per share attributable to VirBio, diluted (in USD per share)-$3.16-$3.83-$4.59
Weighted-average shares outstanding, basic (in shares)138.5M shares136.2M shares134.1M shares
Weighted-average shares outstanding, diluted (in shares)138.5M shares136.2M shares134.1M shares

Compare VIR Biotechnology with another company

Corporate structure

VIR Biotechnology sits at the top of its group. 7 entities, 3 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of VIR Biotechnology

  • VIR Biotechnology San Francisco
    • Agenovir Corporation Subsidiary · Delaware, United States
    • Encentrio Therapeutics, Inc. Subsidiary · Delaware, United States
    • Humabs BioMed SA Subsidiary · Switzerland
    • TomegaVax, Inc. Subsidiary · Delaware, United States
    • Vir AU Biotechnology Pty Ltd. Subsidiary · Australia
    • Vir Biotechnology (Switzerland) Subsidiary · Switzerland

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; subsidiaries, stakes and holdings from Wikidata (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What VIR Biotechnology 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, before depreciation$102.8M7 Dec 31, 2025$100.0M7 Dec 31, 2024+2.8%
Accumulated depreciation$47.2M7 Dec 31, 2025$36.8M7 Dec 31, 2024+28.2%
Property and equipment, net$55.6M7 Dec 31, 2025$63.2M7 Dec 31, 2024−12.0%
Operating-lease assets (leased space)$62.1M7 Dec 31, 2025$59.7M7 Dec 31, 2024+4.1%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$232.2M7 Dec 31, 2025$222.9M7 Dec 31, 2024+4.1%
Marketable securities, current$228.8M7 Dec 31, 2025$678.1M7 Dec 31, 2024−66.3%
Equity securities at fair value$6.1M7 Dec 31, 2025$4.3M7 Dec 31, 2024+39.7%
Long-term investments$314.6M7 Dec 31, 2025$190.0M7 Dec 31, 2024+65.6%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$16.9M7 Dec 31, 2025$16.9M7 Dec 31, 20240%
Intangible assets, net (excluding goodwill)$7.8M7 Dec 31, 2025$8.1M7 Dec 31, 2024−3.3%
Finite-lived intangibles, gross$5.2M7 Dec 31, 2025$5.2M7 Dec 31, 20240%
Accumulated amortization$3.8M7 Dec 31, 2025$3.6M7 Dec 31, 2024+7.6%
Finite-lived intangibles, net$1.3M7 Dec 31, 2025$1.6M7 Dec 31, 2024−16.9%

Properties, in its own words

Our corporate headquarters is located in San Francisco, California, where we lease approximately 133,896 square feet of office, research and development, engineering, and laboratory space pursuant to one lease agreement that expires in 2033. We also have leased approximately 58,265 square feet of office and laboratory space in Bellinzona, Switzerland. The lease agreements associated with our Bellinzona, Switzerland site will expire by 2035, with an option to extend for five years. We believe that our existing facilities are adequate for our near-term needs, but if required, we believe that suitable additional alternative spaces will be available in the future on commercially reasonable terms.

Item 2 of the 10-K filed Feb 23, 2026.6

Leadership

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

Board members and other officers (27)

Subsidiaries and ownership

Subsidiaries

  • Vir Biotechnology (Switzerland)

Subsidiaries (Exhibit 21)

  • Agenovir Corporation Delaware4
  • Encentrio Therapeutics, Inc. Delaware4
  • Humabs BioMed SA Switzerland4
  • TomegaVax, Inc. Delaware4
  • Vir AU Biotechnology Pty Ltd. Australia4

From Wikidata.1 The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Timeline

  1. Oct 14, 20268-K Unregistered sale of shares; Other events47
  2. Oct 8, 20268-K Other events48
  3. Oct 1, 20268-K Executive or director change; Regulation FD disclosure49
  4. Aug 5, 20268-K Results of operations50
  5. Jul 24, 20268-K Executive or director change51
  6. Jun 10, 20268-K Executive or director change52
  7. May 28, 20268-K Executive or director change; Shareholder vote53
  8. May 6, 20268-K Results of operations54
  9. Apr 10, 20268-K Executive or director change55
  10. Mar 4, 20268-K Executive or director change56
  11. Mar 2, 20268-K Other events57
  12. Feb 26, 20268-K Entered a material agreement58
  13. Apr 4, 2023New chief executive Backer Marianne De becomes CEO15
  14. Jan 2017New chief executive George Scangos becomes CEO1
  15. Apr 7, 2016Founded Founded1

Calendar

Coming up

  1. Nov 4, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($1.17) a share, on Nov 5, 2025.59

When it reported results

  1. Aug 5, 2026Reported quarterly or annual results50
  2. May 6, 2026Reported quarterly or annual results54
  3. Feb 23, 2026Reported quarterly or annual results60
  4. Jan 12, 2026Reported quarterly or annual results61
  5. Nov 5, 2025Reported quarterly or annual results62
  6. Aug 6, 2025Reported quarterly or annual results63
  7. May 7, 2025Reported quarterly or annual results64
  8. Feb 26, 2025Reported quarterly or annual results65

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

488 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 66 major events, 284 insider forms, 24 large holders, 94 other. The latest 20:

  1. Oct 14, 20268-K EDGAR
  2. Oct 8, 20268-K EDGAR
  3. Oct 6, 20263 EDGAR
  4. Oct 1, 20268-K EDGAR
  5. Sep 17, 2026144 EDGAR
  6. Sep 9, 2026144 EDGAR
  7. Aug 25, 2026144 EDGAR
  8. Aug 24, 2026144 EDGAR
  9. Aug 21, 2026144 EDGAR
  10. Aug 12, 20264 EDGAR
  11. Aug 7, 2026SCHEDULE 13G EDGAR
  12. Aug 5, 202610-Q EDGAR
  13. Aug 5, 20268-K EDGAR
  14. Jul 31, 2026SCHEDULE 13G/A EDGAR
  15. Jul 24, 20268-K EDGAR
  16. Jun 29, 2026144 EDGAR
  17. Jun 10, 20264 EDGAR
  18. Jun 10, 20263 EDGAR
  19. Jun 10, 20268-K EDGAR
  20. Jun 2, 20264 EDGAR

The 488 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

240 open-market trades by officers, directors and large owners since October 2021: 5 buys and 235 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jun 1, 2026Napolitano JanetDirectorSale3,200$9.45$30.2KForm 4
Jun 1, 2026Sabatini BrentSVP, Chief Accounting OfficerSale379$9.45$3.6KForm 4
May 1, 2026SATO VICKI LDirectorSale22,000$10.05$221.1KForm 4
Apr 6, 2026De Backer MariannePresident and CEOSale72,559$9.16$664.6KForm 4
Apr 1, 2026SATO VICKI LDirectorSale22,000$9.07$199.5KForm 4
Mar 23, 2026Sabatini BrentSVP, Chief Accounting OfficerSale7,711$9.12$70.3KForm 4
Mar 2, 2026SATO VICKI LDirectorSale22,000$9.50$209.1KForm 4
Feb 25, 2026Eisner MarkEVP and Chief Medical OfficerSale1,889$9.82$18.6KForm 4
Feb 25, 2026de Verneuil VaninaEVP, General Counsel, Corp SecSale13,700$9.82$134.5KForm 4
Feb 24, 2026SATO VICKI LDirectorSale42,377$9.75$413.3KForm 4
Feb 24, 2026Sabatini BrentSVP, Chief Accounting OfficerSale1,430$9.53$13.6KForm 4
Feb 24, 2026O'Byrne JasonEVP & Chief Financial OfficerSale1,634$9.53$15.6KForm 4
Feb 24, 2026Eisner MarkEVP and Chief Medical OfficerSale1,616$9.53$15.4KForm 4
Feb 24, 2026de Verneuil VaninaEVP, General Counsel, Corp SecSale3,117$9.53$29.7KForm 4
Feb 24, 2026De Backer MariannePresident and CEOSale14,762$9.53$140.7KForm 4
Feb 23, 2026Sabatini BrentSVP, Chief Accounting OfficerSale1,829$7.45$13.6KForm 4
Feb 23, 2026O'Byrne JasonEVP & Chief Financial OfficerSale2,089$7.45$15.6KForm 4
Feb 23, 2026Eisner MarkEVP and Chief Medical OfficerSale2,089$7.45$15.6KForm 4
Feb 23, 2026de Verneuil VaninaEVP, General Counsel, Corp SecSale4,445$7.45$33.1KForm 4
Feb 23, 2026De Backer MariannePresident and CEOSale19,039$7.45$141.8KForm 4

All 240 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
2025Marianne De Backer, M.Sc., Ph.D., MBAPresident, Chief Executive Officer and Director$950.0K$7.8M76
2025Mark Eisner, M.D., M.P.H. Executive Vice President and Chief Medical Officer$660.8K$2.4M76
2025Jason O’Byrne, MBAExecutive Vice President and Chief Financial Officer$534.4K$2.0M76
2025Vanina de Verneuil, J.D.Executive Vice President, General Counsel and Corporate Secretary$506.3K$1.7M76
2024Marianne De Backer, M.Sc., Ph.D., MBAPresident, Chief Executive Officer and Director$920.8K$9.3M76
2024Mark Eisner, M.D., M.P.H. Executive Vice President and Chief Medical Officer$379.2K$2.8M76
2024Jason O’Byrne, MBAExecutive Vice President and Chief Financial Officer$130.5K$1.9M76
2024Vanina de Verneuil, J.D.Executive Vice President, General Counsel and Corporate Secretary$486.7K$1.7M76
2023Marianne De Backer, M.Sc., Ph.D., MBAPresident, Chief Executive Officer and Director$675.0K$39.5M76

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
BlackRock, Inc.20,678,283$210.7M0.0%+2,679,954
ARCH Venture Management, LLC12,694,163$129.4M11.8%−222,500
Vanguard Portfolio Management LLC11,495,215$117.1M0.0%+2,279,638
Sb Investment Advisers (uk) Ltd10,948,093$111.6M1.5%No change
State Street Corp9,964,151$101.5M0.0%+2,823,057
GSK plc8,550,954$87.1M14.5%No change
Vanguard Capital Management LLC6,388,775$65.1M0.0%+1,006,672
Point72 Asset Management, L.P.5,666,821$57.7M0.1%+3,714,587
Geode Capital Management, LLC3,348,366$34.1M0.0%+690,523
Dimensional Fund Advisors LP3,119,421$31.8M0.0%+539,743
ADAR1 Capital Management, LLC2,456,677$25.0M1.2%−288,037
Goldman Sachs Group Inc2,365,219$24.1M0.0%−885,008
Fmr LLC2,318,294$23.6M0.0%+246,446
Morgan Stanley2,211,077$22.5M0.0%−643,128
Nuveen, LLC1,982,942$20.2M0.0%+963,978
Pictet Asset Management Holding SA1,953,316$19.9M0.0%+472,488
Boxer Capital Management, LLC1,866,000$19.0M1.4%No change
Northern Trust Corp1,432,165$14.6M0.0%+446,730
Hudson Bay Capital Management LP1,364,000$13.9M0.1%−105,510
GordonMD Global Investments LP1,353,552$13.8M6.7%−165,000
Charles Schwab Investment Management Inc1,323,185$13.5M0.0%+151,501
Bank Of America Corp /de/1,142,539$11.6M0.0%+176,725
Two Sigma Investments, LP1,110,227$11.3M0.0%−329,267
Sio Capital Management, LLC1,075,274$11.0M1.9%−423,346
Savvy Advisors, Inc.1,040,665$10.6M0.2%New

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

SEC filer profile

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

  • Name on EDGARVir Biotechnology, Inc.2
  • CIK0001706431
  • Employer ID (EIN)81-27303696
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company6
  • Incorporated inDelaware6
  • Fiscal year endsDecember 312
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address1800 Owens Street, Suite 900, San Francisco, CA 941582
  • Phone415-906-43242
  • Shares outstanding169,215,958 as of Jul 29, 202613
  • Public float$689.2M as of Jun 30, 20256
  • AuditorErnst & Young LLP, San Mateo, California PCAOB ID 42; it also attests to the company’s internal control over financial reporting6
  • On EDGAR sinceJun 29, 20182
  • Filings792 in all: 4 (433), 8-K (105), 144 (71), 3 (38), 10-Q (21), SC 13G/A (14), 4/A (11), SC 13G (10)2
    All 37 form types

    DEFA14A (9), S-8 (8), 10-K (7), CORRESP (7), DEF 14A (7), SC 13D/A (6), SCHEDULE 13G/A (5), ARS (4), UPLOAD (4), 5 (3), D (3), 424B4 (2), 424B5 (2), DRS (2), EFFECT (2), S-1 (2), S-3ASR (2), SCHEDULE 13G (2), SEC STAFF LETTER (2), 3/A (1), 8-A12B (1), CERT (1), DRS/A (1), DRSLTR (1), POS EX (1), S-1/A (1), S-1MEF (1), SC 13D (1), SCHEDULE 13D/A (1)

  • Latest filingsAnnual report (10-K) Feb 23, 2026
    Quarterly report (10-Q) Aug 5, 2026
    Proxy statement (DEF 14A) Apr 16, 2026
    Latest 8-K (8-K) Oct 14, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 par valueVIRNasdaq Global Select Market

From the cover page of the 10-K filed Feb 23, 2026 (Section 12(b) of the Exchange Act).6

Risk factors and legal proceedings

The risks VIR Biotechnology names in Item 1A of its 10-K filed Feb 23, 2026: 58 risks under these headings, as written.6

  • Risks Related to Our Financial Position and Capital Needs
  • We have incurred net losses and anticipate that we will continue to incur net losses in the foreseeable future.
  • Our limited commercialization history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
  • We may require substantial additional funding to finance our operations. If we are unable to raise capital when needed, we could be forced to delay, reduce or terminate certain of our research and development programs or other operations.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates.
  • Risks Related to Development and Commercialization
  • Our future success is substantially dependent on the successful clinical development, regulatory approval and commercialization of our product candidates in a timely manner. If we are not able to obtain required regulatory approvals, we will not be able to commercialize our product candidates and our ability to generate product revenue will be adversely affected.
  • The development of additional product candidates is risky and uncertain, and we can provide no assurances that we will be able to successfully develop the additional product candidates we identify or replicate our approach for other diseases.
  • We are developing, and in the future may develop, product candidates in combination with other therapies, which exposes us to additional risks.
  • Success in preclinical or early-stage clinical studies may not be indicative of results in future clinical studies and we cannot assure you that any ongoing, planned or future clinical studies will lead to results sufficient for the necessary regulatory approvals and marketing authorizations. We have and may continue to commit substantial financial resources with respect to clinical studies that may not be successful, and we may not be able to recoup those investments.
  • Interim, “top-line” and preliminary data from our clinical studies 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.
  • Although the combination of tobevibart and elebsiran has received Fast Track and Breakthrough Therapy designation from the FDA, as well as PRIME designation from the EMA and European orphan drug designation, in each case for the treatment of CHD, there can be no assurance that any of our product candidates that receive such designations in the United States or similar designations in any other regulatory jurisdictions will maintain such designations or receive regulatory approval any sooner than other product candidates that do not have such designations, or at all.
The other 48 risks
  • Clinical product development involves a lengthy and expensive process. We may incur additional costs and encounter substantial delays or difficulties in our clinical studies.
  • Enrollment and retention of patients in clinical studies is an expensive and time-consuming process and could be delayed, made more difficult or rendered impossible by factors outside our control.
  • Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences following any potential marketing approval.
  • We are a party to strategic collaboration and license agreements pursuant to which we are obligated to make substantial payments upon achievement of milestone events and, in certain cases, have relinquished important rights over the development and commercialization of certain current and future product candidates. We may explore additional strategic collaborations, which may never materialize or may require that we spend significant additional capital or that we relinquish rights to and control over the development and commercialization of our product candidates.
  • The deployment of AI in our or our collaborators’ efforts to discover, develop and engineer next-generation antibodies or other investigational products or components, could adversely affect our business, reputation or financial results, and our competitors may be able to utilize such technologies more effectively than we can.
  • If the market opportunities for our product candidates are smaller than we believe they are or any approval we obtain is based on a narrower definition of the patient population, our business may suffer.
  • We face substantial competition, which may result in others developing or commercializing products before or more successfully than we do.
  • Our product candidates, if approved, may fail to achieve adoption by physicians, patients, third-party payors, clinical guidelines or others in the healthcare community necessary for commercial success.
  • Our product candidates, if approved, will remain subject to ongoing regulatory oversight and potential enforcement actions.
  • We may never obtain approval for our product candidates outside of the United States, which would limit our market opportunities.
  • Negative developments and negative public opinion of new technologies on which we rely may damage public perception of our product candidates or adversely affect our ability to conduct our business or obtain regulatory approvals for our product candidates.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidate that we may develop. In addition, our insurance policies may be inadequate and potentially expose us to unrecoverable risks.
  • Risks Related to Regulatory Compliance
  • Any product candidates for which we intend to seek approval may face competition sooner than anticipated.
  • Our relationships with customers, physicians, and third-party payors are subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, and other healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • Coverage and adequate reimbursement may not be available for any product candidates that we commercialize, which could make it difficult for us to sell profitably.
  • Healthcare legislative, administrative and other reform measures may have a negative impact on our business, financial condition, results of operations and prospects.
  • We are subject to anti-corruption, anti-bribery, anti-money laundering, and similar laws, and non-compliance with such laws can subject us to criminal and/or civil liability and harm our business.
  • Risks Related to Our Dependence on Third Parties
  • We rely on third parties to produce clinical and future commercial supplies of our product candidates. There could be delays or supply shortages beyond our control limiting our access to clinical and future commercial supplies.
  • Changes in U.S. and international trade policies may adversely impact our business and operating results.
  • Our business involves the use of hazardous materials, and we and our third-party suppliers and CDMOs must comply with environmental, health and safety laws and regulations, which can be expensive and restrict how we do, or interrupt our, business.
  • We rely on third parties to conduct, supervise and monitor our preclinical and clinical studies, and if those third parties perform in an unsatisfactory manner, it may harm our business.
  • Risks Related to Our Intellectual Property
  • If we breach our license agreements or any of the other agreements under which we acquired, or will acquire, the intellectual property rights to our product candidates, we could lose the ability to continue the development and commercialization of the related product candidates.
  • If we are unable to obtain and maintain patent protection for our product candidates and technology, or if the scope of the patent protection obtained is not sufficiently broad or robust, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our product candidates and technology may be adversely affected.
  • Obtaining and maintaining our patent rights depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.
  • Patent terms may be inadequate to protect the competitive position of our product candidates or any products approved in the future for an adequate amount of time and additional competitors could enter the market with generic or biosimilar versions of such products.
  • Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a negative impact on the success of our business.
  • We may be subject to claims asserting that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
  • We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Any trademarks we may obtain may be infringed or successfully challenged, resulting in harm to our business.
  • The potential exercise by the Gates Foundation of its licenses to certain of our intellectual property and its development and commercialization of products that we are also developing and commercializing could have an adverse impact on our market position.
  • Risks Related to Our Business Operations, Employee Matters and Managing Growth
  • We are highly dependent on our key personnel, and if we are not able to retain these members of our management team or recruit and retain additional management, clinical and scientific personnel, our business could be harmed.
  • We have in the past and may in the future acquire or invest in other companies or technologies, which could divert management’s attention from our core business, result in dilution to our stockholders and otherwise disrupt our operations and adversely affect our operating results.
  • Our success depends on our ability to manage our growth.
  • Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
  • If our information systems, or those maintained on our behalf, fail or suffer security breaches, such events could result in, without limitation, the following: a significant disruption of our product development programs; an inability to operate our business effectively; unauthorized access to or disclosure of the personal information we process; and other adverse effects on our business, financial condition, results of operations and prospects.
  • We and the third parties with whom we work are subject to stringent and evolving laws, regulations, policies and contractual obligations related to data privacy and security, and failure by us or the third parties with whom we work to comply with such requirements could subject us to significant fines, penalties, investigations and/or reputational harm.
  • Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, insider trading laws, or contractual obligations.
  • Our ability to use our net operating losses, or NOLs, to offset future taxable income may be subject to certain limitations.
  • Risks Related to Ownership of Our Common Stock
  • Our financial condition and results of operations may fluctuate from quarter to quarter and year to year, which makes them difficult to predict.
  • The market price of our common stock has been, and in the future, may be, volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock.
  • If research analysts publish unfavorable research or reports about us, our business or our market, our stock price and trading volume could decline.
  • Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
  • We have incurred and we will continue to incur significant increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.
  • If we fail to develop or maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely financial statements could be impaired, investors may lose confidence in us and the trading price of our common stock may decline.
  • Our reported financial results may be adversely affected by changes in accounting principles generally accepted in the United States.
  • Provisions in our corporate charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
  • Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.

Legal proceedings

From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. We are not currently party to any material legal proceedings, and we are not aware of any pending or threatened legal proceeding against us that we believe could have an adverse effect on our business, operating results or financial condition.

The opening of Item 3, Legal Proceedings.6

Sources

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