Sign in

Private company

Barinthus Biotherapeutics plc.

In its 2026 annual report the company says: “We are a clinical-stage biopharmaceutical company focused on developing novel immunotherapeutic drug candidates for treating autoimmune and inflammatory diseases within the immunology and inflammation space. We are prioritizing the development of a pipeline for I&I indications enabled by our proprietary and highly differentiated platform for promoting immune tolerance, referred to as SNAP-TI, that are designed to guide patient's T cells to reduce inflammation and restore the natural state of immune non-responsiveness to healthy tissue.”5 It is headquartered in Altrincham, United Kingdom.2

Last updated Oct 21, 2026.

Overview

  • IndustryPharmaceutical Preparations2
  • HeadquartersAltrincham, United Kingdom2
  • Incorporated inUnited Kingdom3
  • Business address20400 Century Blvd, Suite 210, Germantown, Md 208743
  • Filer category, Emerging growth company3
  • Legal formPublic Limited Company2
  • LEI213800KQ9EAOKPWN8A332
  • StatusActive2
  • LEI statusIssued and current2
  • Registered address3rd Floor 1 Ashley Road, WA14 2DT Altrincham, United Kingdom2
  • Registered withCompanies House, 132826202

See how the biggest companies compare on our leaderboards

We are a clinical-stage biopharmaceutical company focused on developing novel immunotherapeutic drug candidates for treating autoimmune and inflammatory diseases within the immunology and inflammation ("I&I") space. Helping patients and their families is the guiding principle at the heart of Barinthus Bio. We aim to achieve this by developing truly transformational and highly disease-specific immunotherapies.5 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

-100.0%Revenue growth, 20256
-89.5%Return on equity6
-$48.0MFree cash flow6

Financial statements

Revenue789106$0 in 2025
0$20.0M$40.0M$60.0M2020: $4.8M$4.8M20202021: $268.0K$268.0K2021−94%2022: $44.7M$44.7M2022+16580%2023: $802.0K$802.0K2023−98%2024: $15.0M$15.0M2024+1766%2025: $0$02025
Operating income789106-$70.6M in 2025+252% since 2020
-$100.0M-$75.0M-$50.0M-$25.0M02020: -$20.0M-$20.0M20202021: -$45.2M-$45.2M2021+126%2022: -$4.0M-$4.0M2022−91%2023: -$83.9M-$83.9M2023+1977%2024: -$68.0M-$68.0M2024−19%2025: -$70.6M-$70.6M2025+4%
Net income789106-$66.4M in 2025+275% since 2020
-$80.0M-$60.0M-$40.0M-$20.0M0$20.0M2020: -$17.7M-$17.7M20202021: -$50.9M-$50.9M2021+187%2022: $5.3M$5.3M20222023: -$73.3M-$73.3M20232024: -$61.1M-$61.1M2024−17%2025: -$66.4M-$66.4M2025+9%
Fiscal year2019202020212022202320242025
Revenue$4.8M7$268.0K8$44.7M9$802.0K10$15.0M6$06
Research and development$14.4M7$20.4M8$42.4M9$44.9M10$42.2M6$25.6M6
Operating expenses$45.5M8$48.7M9$84.7M10$84.1M6$71.1M6
Operating income-$20.0M7-$45.2M8-$4.0M9-$83.9M10-$68.0M6-$70.6M6
Interest$3.6M7$2.7M8$19.0K9$28.0K9
Income before tax-$51.1M8$850.0K9-$76.5M10-$61.2M6-$66.6M6
Income tax$95.0K7-$28.0K8-$4.5M9-$3.1M10-$44.0K6-$175.0K6
Net income-$17.7M7-$50.9M8$5.3M9-$73.3M10-$61.1M6-$66.4M6
Earnings per share-$2.247-$1.968$0.149-$1.9110-$1.556-$1.646
Earnings per share (diluted)-$2.247-$1.968$0.149-$1.9110-$1.556-$1.646
Shares (weighted, basic)25.9M shares837.2M shares938.4M shares1039.3M shares640.5M shares6
Shares (weighted, diluted)25.9M shares838.2M shares938.4M shares1039.3M shares640.5M shares6

Compare Barinthus Biotherapeutics plc. with another company

Corporate structure

Barinthus Biotherapeutics plc. sits at the top of its group. 9 entities, 4 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Barinthus Biotherapeutics plc.

  • Barinthus Biotherapeutics plc. Altrincham, United Kingdom
    • BARINTHUS BIOTHERAPEUTICS (UK) LIMITED Subsidiary · 75% · Oxford, United Kingdom
    • Barinthus Biotherapeutics (UK) Limited (formerly Vaccitech (UK) Limited) Subsidiary · United Kingdom
    • Barinthus Biotherapeutics North America, Inc. (formerly Vaccitech North America, Inc.) Subsidiary · Delaware, United States
    • Barinthus Biotherapeutics Pty Limited (formerly Vaccitech Australia Pty Limited) Subsidiary · Australia
    • Barinthus Biotherapeutics Switzerland GmbH (formerly Vaccitech Switzerland GmbH) Subsidiary · Switzerland
    • Beacon Topco, Inc. Subsidiary · Delaware, United States
    • Cdog Merger Sub, Inc. Subsidiary · Delaware, United States
    • Vaccitech Oncology Limited Subsidiary · United Kingdom

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Barinthus Biotherapeutics plc. 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$11.1M6 Dec 31, 2025$16.8M6 Dec 31, 2024−33.8%
Accumulated depreciation$7.6M6 Dec 31, 2025$9.4M6 Dec 31, 2024−19.4%
Property and equipment, net$3.5M6 Dec 31, 2025$7.4M6 Dec 31, 2024−52.2%
Operating-lease assets (leased space)$1.6M6 Dec 31, 2025$4.4M6 Dec 31, 2024−62.6%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$70.5M6 Dec 31, 2025$110.7M6 Dec 31, 2024−36.3%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$010 Dec 31, 2024$12.2M10 Dec 31, 2023−100.0%
Intangible assets, net (excluding goodwill)$14.3M6 Dec 31, 2025$21.9M6 Dec 31, 2024−34.9%

Properties, in its own words

We lease and occupy approximately 19,700 square feet of state-of-the-art wet laboratory and office space in Germantown, Maryland, United States. We also lease approximately 31,000 square feet of office and laboratory space on the Harwell Science and Innovation Campus, Harwell, Oxfordshire, U.K. We are currently marketing the Harwell facility for sublease for the remainder of the lease term.

Item 2 of the 10-K filed Mar 13, 2026.5

Leadership

Who has led Barinthus Biotherapeutics plc., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. William Enright2021–now

Chief financial officer

  1. Georgy Egorov2021–2022
  2. Gemma Brown2022–2025
2025
Board members and other officers (14)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Barinthus Biotherapeutics (UK) Limited (formerly Vaccitech (UK) Limited) England and Wales4
  • Barinthus Biotherapeutics North America, Inc. (formerly Vaccitech North America, Inc.) Delaware4
  • Barinthus Biotherapeutics Pty Limited (formerly Vaccitech Australia Pty Limited) Australia4
  • Barinthus Biotherapeutics Switzerland GmbH (formerly Vaccitech Switzerland GmbH) Switzerland4
  • Beacon Topco, Inc. Delaware4
  • Cdog Merger Sub, Inc. Delaware4
  • Vaccitech Oncology Limited England and Wales4

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

Former names

  • Vaccitech plcJan 19, 2021 to Oct 5, 20233
  • Vaccitech LtdDec 23, 2020 to Mar 23, 20213

Timeline

  1. Sep 9, 20268-K Ended a material agreement; Completed an acquisition or sale; Listing notice or transfer29
  2. Sep 1, 20268-K Listing notice or transfer; Other events30
  3. Aug 25, 20268-K Listing notice or transfer; Regulation FD disclosure; Other events31
  4. Aug 6, 20268-K Results of operations32
  5. Jul 2, 20268-K Shareholder vote; Other events33
  6. May 21, 20268-K Shareholder vote34
  7. Apr 30, 20268-K Results of operations35
  8. Apr 22, 20268-K Executive or director change36
  9. Mar 31, 20268-K Executive or director change37
  10. Mar 13, 20268-K Results of operations; Regulation FD disclosure38
  11. Feb 23, 20268-K Entered a material agreement39
  12. Jan 6, 20268-K Listing notice or transfer40
  13. Apr 29, 2021New chief executive William Enright becomes CEO13
  14. Mar 22, 2021Founded Barinthus Biotherapeutics plc. is founded2

Calendar

Coming up

  1. Around Nov 12, 2026Next results, estimated About a quarter after its last report. The company hasn't announced the date.

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results32
  2. Apr 30, 2026Reported quarterly or annual results35
  3. Mar 13, 2026Reported quarterly or annual results38
  4. Nov 7, 2025Reported quarterly or annual results41
  5. Aug 8, 2025Reported quarterly or annual results42
  6. Aug 7, 2025Reported quarterly or annual results43
  7. May 7, 2025Reported quarterly or annual results44
  8. Mar 20, 2025Reported quarterly or annual results45

Drug trials and FDA: recently

  1. Jan 13, 2026Phase 2 trial completed Phase 2 trial of ChAdOx1-HBV, MVA-HBV and others in Chronic Hepatitis B: primary completion Jan 13, 2026, no results posted yet (ClinicalTrials.gov NCT05343481).46

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

210 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 57 major events, 82 insider forms, 11 large holders, 40 other. The latest 20:

  1. Sep 21, 202615-12G EDGAR
  2. Sep 14, 2026EFFECT EDGAR
  3. Sep 11, 2026SCHEDULE 13G/A EDGAR
  4. Sep 11, 20264/A PRIMARY DOCUMENT EDGAR
  5. Sep 9, 202625 EDGAR
  6. Sep 9, 20264 OWNERSHIP DOCUMENT EDGAR
  7. Sep 9, 20264 OWNERSHIP DOCUMENT EDGAR
  8. Sep 9, 20264 OWNERSHIP DOCUMENT EDGAR
  9. Sep 9, 20264 OWNERSHIP DOCUMENT EDGAR
  10. Sep 9, 20264 OWNERSHIP DOCUMENT EDGAR
  11. Sep 9, 20264 OWNERSHIP DOCUMENT EDGAR
  12. Sep 9, 20264 OWNERSHIP DOCUMENT EDGAR
  13. Sep 9, 2026S-8 POS EDGAR
  14. Sep 9, 2026S-8 POS EDGAR
  15. Sep 9, 2026S-8 POS EDGAR
  16. Sep 9, 2026S-8 POS EDGAR
  17. Sep 9, 2026S-8 POS EDGAR
  18. Sep 9, 2026POS AM EDGAR
  19. Sep 9, 20264 OWNERSHIP DOCUMENT EDGAR
  20. Sep 9, 20268-K EDGAR

The 210 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

20 open-market trades by officers, directors and large owners since October 2021: 6 buys and 14 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jun 26, 2023Scheeren JosephDirectorBuy10,000$2.44$24.4KForm 4
May 25, 2023Wright RobinDirectorBuy13,750$2.66$36.6KForm 4
Mar 27, 2023Enright WilliamChief Executive OfficerSale15,000$2.42$36.3KForm 4
Aug 25, 2022Griffiths GrahamChief Business OfficerSale10,000$7.39$73.9KForm 4
Aug 25, 2022Ellis ChristopherChief Operating OfficerSale39,176$6.57$257.4KForm 4
Aug 24, 2022Ellis ChristopherChief Operating OfficerSale450$4.78$2.2KForm 4
Aug 18, 2022Ellis ChristopherChief Operating OfficerSale2,175$4.84$10.5KForm 4
Aug 17, 2022Ellis ChristopherChief Operating OfficerSale649$4.77$3.1KForm 4
Aug 17, 2022Griffiths GrahamChief Business OfficerSale500$4.76$2.4KForm 4
Aug 16, 2022Ellis ChristopherChief Operating OfficerSale2,200$4.78$10.5KForm 4
Aug 16, 2022Griffiths GrahamChief Business OfficerSale1,220$4.82$5.9KForm 4
Aug 15, 2022Ellis ChristopherChief Operating OfficerSale5,350$4.76$25.5KForm 4
Aug 15, 2022Griffiths GrahamChief Business OfficerSale2,400$4.75$11.4KForm 4
Aug 12, 2022Griffiths GrahamChief Business OfficerSale5,000$4.50$22.5KForm 4
Jun 28, 2022Ellis ChristopherChief Operating OfficerSale5$6.00$30Form 4
Jun 23, 2022Griffiths GrahamChief Business OfficerSale8$5.28$42Form 4
Apr 1, 2022Scheeren JosephDirectorBuy10,000$5.09$50.9KForm 4
Mar 31, 2022Hammacher AlexDirectorBuy2,000$5.14$10.3KForm 4
Dec 31, 2021Hammacher AlexDirectorBuy1,000$10.86$10.9KForm 4
Dec 22, 2021Wright RobinDirectorBuy10,000$9.97$99.7KForm 4

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
2025William EnrightChief Executive Officer63$653.4K$1.2M53
2025Leon Hooftman Chief Medical Officer68$441.3K$1.1M53
2025Gemma Jones Former Chief Financial Officer$729.4K53
2025Geoffrey Lynn Former Chief Scientific Officer$301.8K$570.1K53
2024William EnrightChief Executive Officer63$634.4K$2.4M53
2024Gemma Jones Former Chief Financial Officer$357.9K$1.1M53

SEC filer profile

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

  • Name on EDGARBarinthus Biotherapeutics plc.1
  • CIK0001828185
  • Employer ID (EIN)00-00000005
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inEngland and Wales5
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address20400 Century Blvd, Suite 210, Germantown, MD 208741
  • Phone44 (0) 1865 8188081
  • Shares outstanding40,848,893 as of Jul 30, 202612
  • Public float$13.7M as of Jun 30, 20255
  • AuditorPricewaterhouseCoopers LLP, United Kingdom PCAOB ID 876; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceDec 23, 20201
  • Filings274 in all: 4 (87), 8-K (57), 3 (20), 10-Q (17), 5 (7), CORRESP (7), DEF 14A (6), 10-K (5)1
    All 39 form types

    S-8 (5), S-8 POS (5), UPLOAD (5), 8-K/A (4), ARS (4), EFFECT (4), SC 13G (4), SC 13G/A (4), 425 (3), DRS/A (3), 4/A (2), DEFA14A (2), S-1/A (2), S-3 (2), SCHEDULE 13G/A (2), SEC STAFF LETTER (2), 15-12G (1), 25 (1), 3/A (1), 424B4 (1), 8-A12B (1), CERT (1), DEFM14A (1), DEFR14A (1), DRS (1), DRSLTR (1), POS AM (1), PRE 14A (1), S-1 (1), S-3/A (1), SCHEDULE 13D (1)

  • Latest filingsAnnual report (10-K) Mar 13, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Jun 10, 2026
    Latest 8-K (8-K) Sep 9, 2026

Securities registered for trading

ClassSymbolExchange
American Depositary SharesBRNSThe Nasdaq Global Market
Ordinary shares, nominal value £0.000025 per share

From the cover page of the 10-K filed Mar 13, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Barinthus Biotherapeutics plc. names in Item 1A of its 10-K filed Mar 13, 2026: 70 risks under these headings, as written.5

  • Risks Related to the Contemplated Transactions with Clywedog
  • Our failure to complete the Contemplated Transactions would have a material adverse effect on our business, results of operations, financial condition and stock price.
  • The failure to successfully integrate our business with that of Clywedog in the expected timeframe would adversely affect our future business and financial performance and the value of our stockholders’ investment following the Combinations.
  • Our shareholders and Clywedog’s stockholders may not realize a benefit from the Contemplated Transactions commensurate with the ownership dilution they will experience in connection with the Contemplated Transactions.
  • Our shareholders and Clywedog’s stockholders will generally have a reduced ownership and voting interest in, and will exercise less influence over the management of, Topco following the completion of the Contemplated Transactions as compared to their current ownership and voting interests in the respective companies.
  • During the period prior to the closing of the Contemplated Transactions, our business is exposed to certain inherent risks due to the effect of the announcement or pendency of the Contemplated Transactions on our business relationships, financial condition, operating results and business.
  • Litigation may arise in connection with the Contemplated Transactions, which could be costly, prevent consummation of the Contemplated Transactions, divert management’s attention and otherwise materially harm our business.
  • We are subject to restrictions on our business activities under the Merger Agreement.
  • Risks Related to Our Financial Position and Capital Needs
  • We are a clinical-stage biopharmaceutical company with a limited operating history. We have incurred significant losses since inception. We expect to incur losses for at least the next several years and may never achieve or maintain profitability.
  • We have not yet generated any material revenue from our current product candidates.
  • If we engage in acquisitions or future strategic partnerships, this may increase our capital requirements, dilute our shareholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
The other 60 risks
  • Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
  • We will need to raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or other operations.
  • Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • We may require substantial additional funding in the future. If we are unable to raise capital when needed, we would be compelled to delay, reduce or eliminate our product development programs or commercialization efforts.
  • Recent volatility in capital markets and lower market prices for many securities may affect our ability to access new capital through sales of shares of our ordinary shares or issuance of indebtedness, which may harm our liquidity, limit our ability to grow our business, pursue acquisitions or improve our operating infrastructure and restrict our ability to compete in our markets.
  • Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and its financial condition and results of operations.
  • Risks Related to Our Business and Industry and Risks Related to Clinical Development
  • If we are unable to advance our current or future product candidates into and through clinical trials, obtain marketing approval or reimbursement and ultimately commercialize any product candidates we develop, or experience significant delays in doing so, our business will be materially harmed.
  • Interim, “topline,” and preliminary data from our clinical trials that we announce or publish from time to time may change as more participant data becomes available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Our product candidates are based on a novel approach to the treatment of autoimmunity, which makes it difficult to predict the time and cost of product candidate development.
  • Difficulty in enrolling participants could delay or prevent clinical trials of our product candidates and prevent us from realizing the full commercial potential of any products we may develop.
  • Our product candidates may cause serious adverse events, serious side effects or have other properties that could halt their clinical development, prevent their marketing authorization, require expansion of the trial size, limit their commercial potential or result in significant negative consequences.
  • Risks Related to Our Approach
  • The market opportunities for certain of our product candidates may be relatively small as it may be limited to those patients who are ineligible for or have failed prior treatments and our estimates of the prevalence of our target patient populations may be inaccurate.
  • Negative developments in the field of immunotherapeutics could damage public perception of any of our product candidates and negatively affect our business.
  • We may not be successful in our efforts to identify and successfully commercialize additional product candidates.
  • We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Risks Related to Sales, Marketing and Competition
  • We face substantial competition in an environment of rapid technological change, which may result in others discovering, developing, obtaining marketing authorization approval or commercializing products before or more successfully than we do, which may adversely affect our financial condition and our ability to successfully market or commercialize our product candidates.
  • Risks Related to the Development of Our Product Candidates
  • Our preclinical studies and clinical trials may fail to demonstrate adequately the safety, potency, purity, and efficacy of any of our product candidates, which would prevent or delay development, marketing authorization and commercialization. Furthermore, success in preclinical studies or clinical trials may not be indicative of results in future clinical trials for the same or other product candidates.
  • Even if we obtain marketing authorization for our product candidates, the products may not gain market acceptance among physicians, patients, hospitals and others in the medical community.
  • We currently have no marketing and sales organization and have no experience in marketing products. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, if approved, we may not be able to generate product revenue.
  • Insurance policies are expensive and protect us only from some business risks, which leaves us exposed to significant uninsured liabilities.
  • Risks Related to Our Reliance on Third Parties
  • We rely, and expect to continue to rely, on third parties to conduct certain of our preclinical studies and clinical trials. If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain marketing authorizations for, or commercialize, our product candidates and our business could be substantially harmed.
  • We may form or seek additional collaborations or strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such collaborations, alliances or licensing arrangements.
  • We currently rely and expect to rely in the future on the use of manufacturing suites in third-party facilities or third parties to manufacture our product candidates, if approved. Our business could be harmed if we are unable to use third-party manufacturing suites or if the third party manufacturers fail to provide us with sufficient quantities of our product candidates or fail to do so at acceptable quality levels or prices.
  • Our manufacturing process needs to comply with FDA and comparable foreign regulatory authority regulations relating to the quality and reliability of such processes. Any failure to comply with relevant regulations could result in delays in or termination of our clinical programs and suspension or withdrawal of any marketing authorizations.
  • If our third-party manufacturers use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages.
  • Risks Related to Government Regulation
  • The marketing authorization processes of the FDA, the EMA, MHRA and other comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable, and if we are ultimately unable to obtain marketing authorizations for our product candidates, or the marketing authorization is for a narrower indication than we seek, our business will be substantially harmed.
  • We may seek Orphan Drug Designation for drug candidates we develop, and we may be unsuccessful or may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity. In addition, even if we obtain orphan drug exclusivity for any of our product candidates, such exclusivity may not protect us from competition.
  • A Breakthrough Therapy designation by the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval.
  • A Fast Track designation by the FDA, even if granted for certain of our current or future product candidates, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive marketing approval.
  • Accelerated approval by the FDA, even if granted for certain of our current or future product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval.
  • If approved, our investigational products regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway.
  • Even if we obtain FDA, European Commission or MHRA approval for our current or future product candidates that we may identify and pursue in the United States, the European Union or the U.K., we may never obtain approval to commercialize any such product candidates outside of those jurisdictions.
  • Future changes to tax laws could materially adversely affect our financial condition and results of operations, and reduce net returns to our shareholders.
  • Tax authorities may disagree with our positions and conclusions regarding certain tax positions, or may apply existing rules in an unforeseen manner, resulting in unanticipated costs, taxes or non-realization of expected benefits.
  • We may be unable to use net operating loss and tax credit carryforwards and certain built-in losses or tax credits to reduce future tax payments or to benefit from favorable U.K. tax legislation.
  • Risks Related to Ongoing Regulatory Obligations
  • Even if we receive marketing authorization for our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
  • The FDA and other regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses.
  • The insurance coverage and reimbursement status of newly-approved products are uncertain. Failure to obtain or maintain adequate coverage and reimbursement for any of our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue.
  • Healthcare legislative or regulatory reform measures may have a material adverse effect on our business and results of operations.
  • Our business activities will be subject to the Foreign Corrupt Practices Act ("FCPA"), and similar anti-bribery and anti- corruption laws in other jurisdictions.
  • Inadequate funding for the FDA, the SEC and other government agencies, including from government shutdowns, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Our business operations and current and future relationships with principal investigators, healthcare providers, including physicians, consultants, third-party payors and customers may be subject, directly or indirectly, to U.S. federal and state, as well as foreign, healthcare fraud and abuse laws, false claims laws, health information privacy and cybersecurity 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.
  • Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • If we fail to comply with data protection, privacy, and cybersecurity laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • The U.S. Congress, the Trump administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain patent protection for any products we develop and for our technology, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize any product candidates we may develop and our technology may be adversely affected.
  • Our rights to develop and commercialize our technology and product candidates are subject, in part, to the terms and conditions of licenses granted to us by others and if we fail to comply with our current or future obligations in any agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • The intellectual property landscape around immunotherapeutic, nanoparticle and viral vector-based products is crowded and dynamic, and third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights and such claims may be costly and time-consuming and may prevent or delay our product discovery and development efforts.
  • We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses.
  • We may be involved in lawsuits to protect or enforce our intellectual property rights, including any patents we may own or in- license in the future, which could be expensive, time-consuming and unsuccessful.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and patent protection could be reduced or eliminated for non- compliance with these requirements.
  • Any issued patents we in-license or may own now or in the future covering our product candidates could be narrowed or found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad, including the USPTO.
  • We may be subject to claims challenging the inventorship or ownership of any intellectual property, including any patents we may in-license or own in the future.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information or alleged trade secrets of third parties or competitors or are in breach of non-competition or non- solicitation agreements with our competitors or other third parties.
  • If we do not obtain patent term extension and data exclusivity for any of our current or future product candidates we may develop, our business may be materially harmed.
  • Changes to patent law in the United States and in foreign jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • We may not be able to protect our intellectual property and proprietary rights throughout the world.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our marks of interest and our business may be adversely affected.
  • Numerous factors may limit any potential competitive advantage provided by the relevant patent rights.

Legal proceedings

We are not currently a party to any material legal proceedings. From time to time, we may become involved in other litigation or legal proceedings relating to claims arising from the ordinary course of business.

We have no penalties to report in accordance with The Revenue Procedure 2005-51 and Section 6707A(e) of the Internal Revenue Code, which requires the Company to disclose any IRS demand for payment of certain penalties related to tax-avoidance transactions under I.R.C. Sections 6662(h), 6662A, or 6707A.

The opening of Item 3, Legal Proceedings.5

Sources

The numbers on this page point here. Each one links to the record it came from.

  1. 1
  2. 2
  3. 3
  4. 4
  5. 5
  6. 6
  7. 7
  8. 8
  9. 9
  10. 10
  11. 11
  12. 12
  13. 13
  14. 14
  15. 15
  16. 16
  17. 17
  18. 18
  19. 19
  20. 20
  21. 21
  22. 22
  23. 23
  24. 24
  25. 25
  26. 26
  27. 27
  28. 28
  29. 29
  30. 30
  31. 31
  32. 32
  33. 33
  34. 34
  35. 35
  36. 36
  37. 37
  38. 38
  39. 39
  40. 40
  41. 41
  42. 42
  43. 43
  44. 44
  45. 45
  46. 46
  47. 47
  48. 48
  49. 49
  50. 50
  51. 51
  52. 52
  53. 53