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MREO on Nasdaq

Mereo BioPharma Group plc

In its 2026 annual report the company says: “We are a biopharmaceutical company focused on the development of innovative therapeutics for rare diseases. We have developed a portfolio of late-stage clinical product candidates. Our late-stage rare disease product candidates are setrusumab for the treatment of osteogenesis imperfecta and alvelestat for the treatment of severe alpha-1 antitrypsin deficiency-associated lung disease.”4 It is headquartered in London, United Kingdom.2 Its shares trade on Nasdaq under the symbol MREO.2

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Last updated Oct 21, 2026.

Overview

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  • TickerMREO on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersLondon, United Kingdom2
  • Incorporated inUnited Kingdom3
  • Business addressOne Cavendish Place, Fourth Floor, London, W1G 0Qf3
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formPublic Limited Company2
  • LEI213800U8JQHIJOS5AS092
  • StatusActive2
  • LEI statusIssued and current2
  • Registered address4th Floor, One, W1G 0QF London, United Kingdom2
  • Registered withCompanies House, 094811612

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We are a biopharmaceutical company focused on the development of innovative therapeutics for rare diseases. We have developed a portfolio of late-stage clinical product candidates. Our late-stage rare disease product candidates are setrusumab for the treatment of osteogenesis imperfecta (“OI”) and alvelestat for the treatment of severe alpha-1 antitrypsin deficiency-associated lung disease (“AATD-LD”). Setrusumab has received orphan designation for OI from the European Commission (“EC”) and the FDA, PRIME designation from the EMA and has Breakthrough Therapy designation and rare pediatric disease designation from the FDA. Alvelestat has received orphan designation for AATD from the EC and the FDA, and Fast Track designation for the treatment of AATD-LD from the FDA. We also have an early-stage rare disease program, vantictumab, for the treatment of a second bone disease, autosomal domina…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 2025

-8021.4%Operating margin5
-8375.6%Net margin5
-102.4%Return on equity5
-$31.0MFree cash flow5

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development99¢$17.8M
  • Interest1¢$255.0K

Out of $500.0K in revenue.5 The company lost money this year.

Financial statements

Revenue6785$500.0K in 2025−99% since 2021
0$10.0M$20.0M$30.0M$40.0M2021: $36.5M$36.5M20212022: $0$020222023: $10.0M$10.0M20232024: $0$020242025: $500.0K$500.0K2025
Operating income96785-$40.1M in 2025+1% since 2019
-$60.0M-$40.0M-$20.0M02019: -$39.5M-$39.5M20192020: -$37.6M-$37.6M2020−5%2021: -$20.9M-$20.9M2021−44%2022: -$54.4M-$54.4M2022+160%2023: -$28.4M-$28.4M2023−48%2024: -$47.4M-$47.4M2024+67%2025: -$40.1M-$40.1M2025−15%
Net income785-$41.9M in 2025−1% since 2022
-$60.0M-$40.0M-$20.0M02022: -$42.2M-$42.2M20222023: -$29.5M-$29.5M2023−30%2024: -$43.3M-$43.3M2024+47%2025: -$41.9M-$41.9M2025−3%

Every line of the income statement as filed: the last 2 fiscal years, latest first.5

Period ending2025-12-312024-12-31
Revenue$500.0K$0
Cost of Revenue-$133.0K$0
Research and development-$17.8M-$20.9M
General and administrative-$23.0M-$26.4M
Other income$300.0K$0
Loss from operations-$40.1M-$47.4M
Interest income$2.2M$3.0M
Interest expense-$255.0K-$1.4M
Changes in the fair value of warrants$805.0K-$419.0K
Foreign currency transaction (loss)/gain, net-$6.3M$1.2M
Benefit from research and development tax credit$1.9M$1.6M
Net loss before income tax-$41.9M-$43.3M
Income tax benefit$0$0
Net loss-$41.9M-$43.3M
Loss per share - basic-$0.05-$0.06
Loss per share - diluted-$0.05-$0.06
Weighted average shares outstanding - basic797.1M shares739.6M shares
Weighted average shares outstanding - diluted797.1M shares739.6M shares
Other comprehensive income/(loss) - Foreign currency translation adjustments, net of tax$8.0M-$1.4M
Total comprehensive loss-$33.9M-$44.6M

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Corporate structure

Mereo BioPharma Group plc 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 Mereo BioPharma Group plc

  • Mereo BioPharma Group plc London, United Kingdom

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Mereo BioPharma Group 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$1.2M5 Dec 31, 2025$1.2M5 Dec 31, 2024+1.3%
Accumulated depreciation$1.1M5 Dec 31, 2025$949.0K5 Dec 31, 2024+14.3%
Property and equipment, net$137.0K5 Dec 31, 2025$257.0K5 Dec 31, 2024−46.7%
Operating-lease assets (leased space)$244.0K5 Dec 31, 2025$727.0K5 Dec 31, 2024−66.4%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$41.0M5 Dec 31, 2025$69.8M5 Dec 31, 2024−41.3%

Intangibles and goodwill

ItemLatestA year beforeChange
Finite-lived intangibles, net$516.0K5 Dec 31, 2025$643.0K5 Dec 31, 2024−19.8%

Properties, in its own words

Mereo’s principal office is located at 4th Floor, One Cavendish Place, London W1G 0QF, United Kingdom, where Mereo leases approximately 7,400 square feet of office space. Mereo leases this office space under leases that terminate on June 24, 2026.

Item 2 of the 10-K filed Mar 19, 2026.4

Leadership

Who has led Mereo BioPharma Group plc, and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Denise Pollard-Knight2024–now
2025
Board members and other officers (12)

Timeline

  1. Aug 19, 20268-K Listing notice or transfer26
  2. Aug 11, 20268-K Entered a material agreement; Regulation FD disclosure27
  3. Aug 11, 20268-K Results of operations28
  4. May 14, 20268-K Shareholder vote29
  5. May 12, 20268-K Completed an acquisition or sale30
  6. May 12, 20268-K Results of operations31
  7. Mar 27, 20268-K Executive or director change32
  8. Mar 19, 20268-K Results of operations33
  9. Feb 17, 20268-K Listing notice or transfer34
  10. Jan 12, 20268-K Regulation FD disclosure; Other events35
  11. Dec 29, 20258-K Regulation FD disclosure; Other events36
  12. Nov 10, 20258-K Results of operations37
  13. Jan 2, 2024New chief executive Denise Pollard-Knight becomes CEO13
  14. Mar 10, 2015Founded Mereo BioPharma Group plc is founded2

Calendar

Coming up

  1. Nov 9, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.01) a share, on Nov 10, 2025.38

When it reported results

  1. Aug 11, 2026Reported quarterly or annual results28
  2. May 12, 2026Reported quarterly or annual results31
  3. Mar 19, 2026Reported quarterly or annual results33
  4. Nov 10, 2025Reported quarterly or annual results37
  5. Aug 12, 2025Reported quarterly or annual results39
  6. May 13, 2025Reported quarterly or annual results40
  7. Mar 26, 2025Reported quarterly or annual results41
  8. Nov 12, 2024Reported quarterly or annual results42

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

Filings

280 filings to the SEC since October 2021: 5 annual reports, 8 quarterly reports, 27 major events, 80 insider forms, 65 large holders, 95 other. The latest 20:

  1. Aug 19, 20268-K EDGAR
  2. Aug 14, 2026SCHEDULE 13G/A EDGAR
  3. Aug 11, 202610-Q EDGAR
  4. Aug 11, 20268-K EDGAR
  5. Aug 11, 20268-K EDGAR
  6. May 15, 2026SCHEDULE 13G/A EDGAR
  7. May 14, 20268-K EDGAR
  8. May 14, 2026SCHEDULE 13G EDGAR
  9. May 12, 20268-K/A EDGAR
  10. May 12, 202610-Q EDGAR
  11. May 12, 20268-K EDGAR
  12. Apr 9, 2026ARS EDGAR
  13. Apr 9, 2026DEF 14A EDGAR
  14. Mar 27, 2026PRE 14A EDGAR
  15. Mar 27, 20268-K EDGAR
  16. Mar 19, 202610-K EDGAR
  17. Mar 19, 20268-K EDGAR
  18. Feb 27, 20264 EDGAR
  19. Feb 27, 20264 EDGAR
  20. Feb 27, 20264 EDGAR

The 280 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

22 open-market trades by officers, directors and large owners since October 2021: 0 buys and 22 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 13, 2024Scots-Knight DeniseChief Executive OfficerSale60,046$4.22$253.4KForm 4
Sep 13, 2024Lewicki John A.Chief Scientific OfficerSale10,937$4.22$46.2KForm 4
Sep 13, 2024Sermon CharlesGeneral CounselSale20,946$4.22$88.4KForm 4
Sep 13, 2024Fox Christine AnnChief Financial OfficerSale19,158$4.22$80.8KForm 4
Sep 13, 2024Hughes-Wilson AlexandraSee RemarksSale100,312$4.22$423.3KForm 4
Sep 12, 2024Scots-Knight DeniseChief Executive OfficerSale28,611$4.47$127.9KForm 4
Sep 12, 2024Lewicki John A.Chief Scientific OfficerSale5,212$4.47$23.3KForm 4
Sep 12, 2024Sermon CharlesGeneral CounselSale9,980$4.47$44.6KForm 4
Sep 12, 2024Fox Christine AnnChief Financial OfficerSale9,128$4.47$40.8KForm 4
Sep 12, 2024Hughes-Wilson AlexandraSee RemarksSale47,798$4.47$213.7KForm 4
Aug 22, 2024PAKIANATHAN DEEPIKADirectorSale105,244$4.43$466.2KForm 4
Jun 26, 2024Sermon CharlesGeneral CounselSale32,187$3.39$109.1KForm 4
Jun 26, 2024Lewicki John A.Chief Scientific OfficerSale16,808$3.39$57.0KForm 4
Jun 26, 2024Fox Christine AnnChief Financial OfficerSale29,439$3.39$99.8KForm 4
Jun 26, 2024Scots-Knight DeniseChief Executive OfficerSale92,273$3.39$312.8KForm 4
Jun 26, 2024Hughes-Wilson AlexandraSee RemarksSale22,968$3.39$77.9KForm 4
Jun 25, 2024Sermon CharlesGeneral CounselSale14,202$3.69$52.4KForm 4
Jun 25, 2024Lewicki John A.Chief Scientific OfficerSale7,416$3.69$27.4KForm 4
Jun 25, 2024Fox Christine AnnChief Financial OfficerSale12,990$3.69$47.9KForm 4
Jun 25, 2024Scots-Knight DeniseChief Executive OfficerSale40,712$3.69$150.2KForm 4

All 22 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
2025Dr. Denise Scots-Knight66$642.9K$2.7M62
2025Charles Sermon56$472.9K$1.2M62
2025Christine Fox45$444.7K$1.1M62
2024Chief Executive Officer$581.9K$3.2M62
2024General Counsel$428.1K$1.3M62
2024Chief Financial Officer$402.5K$1.3M62

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 61. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Rubric Capital Management LP15,307,347$4.9M0.0%No change
683 Capital Management, LLC11,777,856$3.7M0.4%−222,144
Bank Of America Corp /de/8,195,281$2.6M0.0%−6
Defilade Capital Management, L.P.7,558,756$2.4M0.3%No change
Newtyn Management, LLC3,000,000$953.1K0.1%−4,079,056
Tejara Capital Ltd2,037,520$647.3K0.3%No change
UBS Group AG1,447,627$460.3K0.0%−42,501
Two Sigma Investments, LP1,319,241$419.1K0.0%+1,131,402
EcoR1 Capital, LLC1,000,000$317.7K0.0%−12,368,855
Jane Street Group, LLC774,944$246.2K0.0%+634,971
Ishara Investments LP768,750$244.2K0.2%New
Wealthspire Advisors, LLC765,000$243.0K0.0%−31,036
Citadel Advisors LLC444,158$141.1K0.0%New
Rangeley Capital, LLC329,200$104.6K0.1%No change
Susquehanna International Group, Llp213,270$67.8K0.0%+17,350
Marshall Wace, Llp179,884$57.6K0.0%−507,103
XTX Topco Ltd174,481$55.4K0.0%+90,012
Group One Trading LLC167,515$53.2K0.0%−168,312
State Street Corp134,772$42.8K0.0%+1,393
Nomura Holdings Inc104,361$33.2K0.0%New
James J. Burns & Company, LLC95,400$30.3K0.0%New
Quarry LP93,750$29.8K0.0%New
Goldman Sachs Group Inc85,180$27.1K0.0%New
JMN Financial LLC76,748$24.4K0.0%New
BlackRock, Inc.69,678$22.1K0.0%−233,313

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

SEC filer profile

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

  • Name on EDGARMereo BioPharma Group plc1
  • CIK0001719714
  • Employer ID (EIN)00-00000004
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inEngland and Wales4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business addressOne Cavendish Place, Fourth Floor, London, W1G 0QF, United Kingdom1
  • Phone44033302373001
  • Shares outstanding798,454,864 as of Aug 7, 202610
  • Public float$368.5M as of Jun 30, 20254
  • AuditorPricewaterhouseCoopers LLP, United Kingdom PCAOB ID 876; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceDec 1, 20171
  • Filings438 in all: 6-K (123), 4 (64), SC 13G/A (30), 8-K (26), 3 (15), SC 13D/A (15), SC 13G (15), SCHEDULE 13G/A (14)1
    All 47 form types

    144 (12), 425 (11), CORRESP (9), EFFECT (9), UPLOAD (9), 10-Q (8), S-8 (8), 144/A (5), 20-F (5), SCHEDULE 13G (5), 424B5 (4), 10-K (3), 8-A12B/A (3), ARS (3), DEF 14A (3), DRS/A (3), F-1/A (3), F-3 (3), 424B3 (2), CERT (2), CT ORDER (2), F-1 (2), F-3/A (2), F-6/A (2), F-6EF (2), S-3 (2), SC 13D (2), 20-F/A (1), 4/A (1), 8-A12B (1), 8-K/A (1), D (1), DRS (1), F-4 (1), F-4/A (1), F-6 (1), POS AM (1), PRE 14A (1), RW (1)

  • Latest filingsAnnual report (10-K) Mar 19, 2026
    Quarterly report (10-Q) Aug 11, 2026
    Proxy statement (DEF 14A) Apr 9, 2026
    Latest 8-K (8-K) Aug 19, 2026

Securities registered for trading

ClassSymbolExchange
American Depositary Shares, each representing five ordinary shares, nominal value of £0.003 per shareThe Nasdaq Stock Market LLC
Ordinary Shares, nominal value of £0.003 per shareThe Nasdaq Stock Market LLC
MREO

From the cover page of the 10-K filed Mar 19, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Mereo BioPharma Group plc names in Item 1A of its 10-K filed Mar 19, 2026: 71 risks under these headings, as written.4

  • Risks Related to Our Business and Industry
  • We have a limited operating history and have never generated any revenue from product sales.
  • We will need additional funding to complete the development of our current product candidates; to license, acquire, and develop future product candidates; and to commercialize our product candidates, if approved. If we are unable to raise capital when needed, we could be forced to delay, reduce, or eliminate research and development programs, any future commercialization efforts or acquisitions of potential product candidates.
  • 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 may not be successful in our efforts to identify and acquire additional product candidates.
  • Raising additional capital may cause dilution to, or adversely affect the rights of, our security holders, restrict our operations; or require us to relinquish rights to our technologies or product candidates.
  • We depend heavily on the success of setrusumab and alvelestat. We cannot give any assurance that any of these product candidates will receive regulatory approval, which is necessary before they can be commercialized. If we are unable to commercialize setrusumab and alvelestat, whether on our own or through agreements with third parties, or experience significant delays in doing so, our ability to generate revenue and our financial condition will be adversely affected.
  • Exchange rate fluctuations may materially affect our results of operations and financial condition.
  • Following the licensing agreements for vantictumab, leflutrozole and navicixizumab, and the completion of a strategic partnership for setrusumab, and if we out-license or sell our non-core product candidates or out-license any of our core rare disease product candidates for any territories, we could be exposed to future liabilities.
  • Unfavorable global economic, political and trade conditions could adversely affect our business, financial condition or results ofoperations and may exacerbate the effects of the risks described herein.
  • Our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel.
  • Changes in our tax rates, unavailability of certain tax credits or reliefs, or exposure to additional tax liabilities or assessments could adversely affect our results of operations and financial condition.
The other 60 risks
  • The U.K.’s withdrawal from the EU, commonly referred to as Brexit, could negatively impact our business.
  • Risks Related to Development, Clinical Testing, Manufacturing and Regulatory Approval
  • Prior to our acquisition of setrusumab, alvelestat, vantictumab, etigilimab, acumapimod, leflutrozole and navicixizumab, we were not involved in the development of these product candidates and, as a result, we are dependent on Novartis, AstraZeneca and Mereo BioPharma 5 (formerly OncoMed) having accurately reported the results and correctly collected and interpreted the data from all clinical trials conducted prior to our acquisition.
  • Clinical and preclinical development involves a lengthy and expensive process with an uncertain outcome. Any difficulties or delays in the commencement or completion, or the termination or suspension, of our or our partners current or planned clinical trials could result in increased costs to us, delay or limit our ability to generate revenue or adversely affect our commercial prospects.
  • Interim, “top-line” and preliminary data from our clinical trials and preclinical 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.
  • Our product candidates may have serious adverse, undesirable, or unacceptable side effects which may delay or prevent marketing approval or lead to the withdrawal of approval after it has been granted. If such side effects are identified during the development of these product candidates or following approval, if any, we may need to abandon our development of these product candidates, the commercial profile of any approved label may be limited, or we may be subject to other significant negative consequences following marketing approval, if any.
  • Manufacturing tests of setrusumab have shown that it may cause an opalescence appearance to the liquid antibody formulation.
  • We depend on enrollment of patients in our clinical trials for our product candidates. If we are unable to enroll patients in our clinical trials, or enrollment is slower than anticipated, in particular for our product candidates with rare disease indications, our research and development efforts could be adversely affected.
  • We may become exposed to costly and damaging liability claims, either when testing our product candidates in the clinic or at the commercial stage, and our product liability insurance may not cover all damages from such claims.
  • The regulatory approval processes of the FDA and comparable foreign authorities, such as the EMA and MHRA, are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be harmed substantially.
  • Disruptions at the FDA and other government agencies funding shortages, staffing limitations or other factors could hinder their ability to hire and retain key leadership and other personnel, delay or prevent new products 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.
  • Even if any of our product candidates obtains regulatory approval, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. Additionally, any of our product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with such product.
  • Even if we obtain marketing approval of any of our product candidates in a major pharmaceutical market such as the U.S. or the EU, we may not be able to obtain approval or commercialize that product in other markets, which would limit our ability to realize our full market potential.
  • Our employees and independent contractors, including principal investigators, CROs, CMOs, consultants, vendors, and any other third parties or partners we may engage in connection with the development and commercialization of our product candidates may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could adversely affect our business.
  • Risks Related to Healthcare Laws and Other Legal Compliance Matters
  • Enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and may affect the prices we may set.
  • Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations, and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties.
  • We are subject to governmental regulation and other legal obligations related to privacy, data protection and data security. Our actual or perceived failure to comply with such obligations could harm our business.
  • Due to our international operations, we are subject to anti-corruption laws, as well as export control laws, customs laws, sanctions laws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures and legal expenses.
  • Our business and operations may suffer in the event of information technology system failures, cyberattacks or deficiencies in our cybersecurity.
  • Risks Related to Commercialization
  • We operate in a highly competitive and rapidly changing industry, which may result in others acquiring, developing, or commercializing competing product candidates before or more successfully than we or our partners do.
  • Our collaborator Ultragenyx has obtained orphan drug designation for setrusumab for the treatment of OI in the U.S. and we have obtained orphan designation for setrusumab for the treatment of OI in the EU. We have also obtained orphan drug designation for alvelestat for the treatment of AATD in the U.S. and in the EU. We may be unable to obtain or maintain the benefits associated with orphan drug designation, including the potential for orphan drug exclusivity, for setrusumab, alvelestat or any other product for which we obtain orphan drug designation.
  • Although we have obtained a rare pediatric disease designation for setrusumab, there is no guarantee that FDA approval will result in issuance of a priority review voucher.
  • A Fast Track Designation from 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 does not increase the likelihood that our product candidates will receive marketing approval.
  • We or our partners may seek and fail to obtain Breakthrough Therapy designation by the FDA for alvelestat or etigilimab or any future product candidates or access to the PRIME scheme by the EMA for alvelestat, etigilimab or any future product candidates. Even if we obtain such designation or access, the designation or access may not lead to faster development or regulatory review or approval, and it does not increase the likelihood that our product candidates will receive marketing approval.
  • We intend to directly commercialize or co-commercialize our product candidates for rare diseases and to out-license or sell our other product candidates for further development and/or commercialization. If we are unable to develop our own sales, marketing, and distribution capabilities or enter into business arrangements, we may not be successful in commercializing our product candidates.
  • The successful commercialization of our product candidates will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage, reimbursement levels, and pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our product candidates, if approved, could limit our ability to market those product candidates and decrease our ability to generate revenue.
  • Our existing and future product candidates may not gain market acceptance, in which case our ability to generate revenues from product sales will be compromised.
  • Any product candidates for which we intend to seek approval as biologic product candidates in the U.S. may face competition sooner than anticipated.
  • Risks Related to Our Dependence on Third Parties
  • We rely, and expect to continue to rely, on our partners to develop and commercialize our licensed or partnered product candidates. If our partners do not secure adequate funding or satisfy their obligations under our agreements with them, or if they terminate our licenses, partnerships or collaborations with them, we may not be able to develop or commercialize our licensed or partnered product candidates as planned.
  • We rely, and expect to continue to rely, on third parties, including independent investigators and CROs, to conduct our clinical trials. If these CROs do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates, or such approval or commercialization may be delayed, and our business could be substantially harmed.
  • We currently rely on third-party CMOs for the production of clinical supply of our product candidates and intend to rely on CMOs for the production of commercial supply of our product candidates, if approved. Our dependence on CMOs may impair the development of our product candidates and may impair the commercialization of our product candidates, which would adversely impact our business and financial position.
  • We intend to enter into strategic relationships with third parties, based on a product-by-product assessment, for the development of some of our product candidates. If we fail to enter into these arrangements, our business, development and commercialization prospects could be adversely affected.
  • Risks Related to Intellectual Property
  • We rely on patents and other intellectual property rights to protect our product candidates, the obtainment, enforcement, defense and maintenance of which may be challenging and costly. Failure to enforce or protect these rights adequately could harm our ability to compete and impair our business.
  • We enjoy only limited geographical protection with respect to certain patents and may not be able to protect our intellectual property rights throughout the world.
  • Our patents and other proprietary rights may not adequately protect our technologies and product candidates and may not necessarily address all potential threats to our competitive advantage.
  • We may become subject to third parties’ claims alleging infringement of third-party patents and proprietary rights, or we may be involved in lawsuits to protect or enforce our patents and other proprietary rights, which could be costly and time consuming, delay or prevent the development and commercialization of our product candidates, or put our patents and other proprietary rights at risk.
  • 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, manufacture and market our product candidates.
  • If we fail to comply with our obligations under our existing and any future intellectual property licenses with third parties, we could lose license rights that are important to our business, and our business may be substantially harmed as a result.
  • We may not be successful in maintaining necessary rights to our product candidates or obtaining patent or other intellectual property rights important to our business through acquisitions and in-licenses.
  • 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 non-compliance with these requirements.
  • We may be subject to claims challenging the inventorship of our patents and other intellectual property.
  • Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • If we do not obtain protection under the Hatch-Waxman Amendments and similar non-U.S. legislation for extending the term of patents covering our product candidates, our ability to compete effectively could be impaired.
  • If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest and our competitive position may be adversely affected.
  • If we are unable to protect the confidentiality of our trade secrets and know-how, our business and competitive position would be harmed.
  • We may be subject to claims by third parties asserting that we or our employees have misappropriated third-party intellectual property, or claiming ownership of what we regard as our own intellectual property. These claims may be costly to defend and if we do not successfully do so, we may be required to pay monetary damages and lose valuable intellectual property rights or personnel.
  • Our business and operations may suffer, and proprietary information may be lost, in the event of information technology system failures, cyberattacks or deficiencies in our cybersecurity.
  • Risks Related to our ADSs
  • The trading price of our ADSs may be volatile, and you could lose all or part of your investment.
  • We may not satisfy Nasdaq’s requirements for continued listing. If we cannot satisfy these requirements, Nasdaq could delist our ADSs, which could have an adverse impact on the liquidity and market price of our ADSs.
  • You may be subject to limitations on the transfer of ADSs and the withdrawal of the underlying ordinary shares.
  • The rights of our shareholders may differ from the rights typically offered to shareholders of a U.S. corporation.
  • If securities or industry analysts do not publish research or publish inaccurate research or unfavorable research about our business, the price and trading volume of ADSs could decline.
  • Our ADS holders may not be entitled to a jury trial with respect to claims arising under the deposit agreement, which could result in less favorable results to the plaintiff(s) in any such action.
  • You may not receive distributions on ordinary shares represented by ADSs or any value for them if it is unlawful or impractical to make them available to holders of ADSs.
  • Holders of ADSs may not have the same voting rights as holders of ordinary shares and may not receive voting materials in time to be able to exercise their right to vote.
  • We are entitled to amend the deposit agreement and to change the rights of ADS holders under the terms of such agreement, or to terminate the deposit agreement, without the prior consent of the ADS holders.
  • It may be difficult for you to bring any action or enforce any judgment obtained in the U.S. against us or members of our Board, which may limit the remedies otherwise available to us.
  • Shareholders in countries other than the U.K. will suffer dilution if they are unable to participate in future preemptive equity offerings.
  • Failure to establish and maintain effective internal controls could have a material adverse effect on our business and stock price.
  • We may be a passive foreign investment company (“PFIC”) for any taxable year, which could result in material adverse U.S. federal income tax consequences if you are a U.S. investor.
  • Commencing January 1, 2024, we were required to comply with the domestic reporting regime under the Exchange Act and will continue to incur significant legal, accounting and other expenses, and our management must devote substantial time to public company compliance initiatives and corporate governance matters.

Legal proceedings

The information set forth in Note 20, Subsequent Events, to the consolidated financial statements included elsewhere in this Annual Report on Form 10-K under the caption “Putative Securities Class Action” is incorporated herein by reference.

The opening of Item 3, Legal Proceedings.4

Sources

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