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BCYC on Nasdaq

Bicycle Therapeutics (United Kingdom)

Logo: bicycletherapeutics.com4

Bicycle Therapeutics (United Kingdom) is a British pharmaceutical preparations company based in Cambridge, founded in 2009.1 Its website says: “Our aim is to become one of the world’s leading solid tumor medicines companies, initially measured by our pipeline’s potential, and ultimately by the number of patients we are able to treat.”4 Its shares trade on Nasdaq under the symbol BCYC.1

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Last updated Oct 21, 2026.

Overview

$72.6MRevenue, fiscal 20255
-$219.0MNet income, fiscal 20255
2009Founded1

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  • TickerBCYC on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersCambridge1
  • Websitewww.bicycletherapeutics.com
  • Legal formpublic limited company1
  • Incorporated inUnited Kingdom6
  • Business addressBlocks A & B, Portway Building, Granta Park, Great Abington, Cambridge, X0 Cb21 6Gs6
  • Filer categoryNon-accelerated filer, Smaller reporting company6
  • LEI213800XKUI6R7GKC3E433
  • StatusActive3
  • LEI statusIssued and current3
  • Registered addressBlocks A & B, Portway Building Granta Park, CB21 6GS Cambridge, United Kingdom3
  • Registered withCompanies House, 110360043

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Bicycle Therapeutics (United Kingdom) image from its website
Image: bicycletherapeutics.com4

We are a clinical-stage pharmaceutical company developing a novel class of medicines, which we refer to as Bicycle ® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained to form two loops which stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. Bicycle molecules are a unique therapeutic modality combining the pharmacology usually associated with a biologic with the manufacturing and pharmacokinetic, or PK, properties of a small molecule. The relatively large surface area presented by Bicycle molecules allows targets to be drugged that have historically been intractable to non-biological approaches. Bicycle molecules are excreted by the kidney rather than the liver and have s…7 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

-340.4%Operating margin5
-301.7%Net margin5
105.8%Revenue growth, 20255
-35.9%Return on equity5
-$252.0MFree cash flow5

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$240.3M
  • Income tax0¢$152.0K

Out of $72.6M in revenue.5 The company lost money this year.

Financial statements

Revenue891011125$72.6M in 2025+917% since 2018
0$20.0M$40.0M$60.0M$80.0M2018: $7.1M$7.1M20182019: $13.8M$13.8M2019+93%2020: $10.4M$10.4M2020−25%2021: $11.7M$11.7M2021+13%2022: $14.5M$14.5M2022+24%2023: $27.0M$27.0M2023+87%2024: $35.3M$35.3M2024+31%2025: $72.6M$72.6M2025+106%
Operating income891011125-$247.1M in 2025+1036% since 2018
-$300.0M-$200.0M-$100.0M02018: -$21.7M-$21.7M20182019: -$26.3M-$26.3M2019+21%2020: -$52.0M-$52.0M2020+98%2021: -$65.6M-$65.6M2021+26%2022: -$116.7M-$116.7M2022+78%2023: -$189.9M-$189.9M2023+63%2024: -$209.9M-$209.9M2024+10%2025: -$247.1M-$247.1M2025+18%
Net income891011125-$219.0M in 2025+902% since 2018
-$300.0M-$200.0M-$100.0M02018: -$21.8M-$21.8M20182019: -$30.6M-$30.6M2019+40%2020: -$51.0M-$51.0M2020+67%2021: -$66.8M-$66.8M2021+31%2022: -$112.7M-$112.7M2022+69%2023: -$180.7M-$180.7M2023+60%2024: -$169.0M-$169.0M2024−6%2025: -$219.0M-$219.0M2025+30%

Every line of the income statement as filed: the last 3 fiscal years, latest first.5

Period ending2025-12-312024-12-312023-12-31
Collaboration revenue$72.6M$35.3M$27.0M
Research and development$240.3M$173.0M$156.5M
General and administrative$79.4M$72.2M$60.4M
Total operating expenses$319.7M$245.1M$216.9M
Loss from operations-$247.1M-$209.9M-$189.9M
Interest and other income$28.5M$34.3M$14.0M
Interest expense-$206.0K-$1.7M-$3.3M
Loss on extinguishment of debt-$954.0K
Gain on extinguishment of research and development funding liability$4.5M
Total other income, net$28.3M$36.1M$10.7M
Net loss before income tax provision-$218.8M-$173.8M-$179.2M
Provision for (benefit from) income taxes$152.0K-$4.8M$1.5M
Net loss-$219.0M-$169.0M-$180.7M
Net loss per share, basic (in dollars per share)-$3.16-$2.90-$5.08
Net loss per share, diluted (in dollars per share)-$3.16-$2.90-$5.08
Weighted average ordinary shares outstanding, basic (in shares)69.3M shares58.2M shares35.6M shares
Weighted average ordinary shares outstanding, diluted (in shares)69.3M shares58.2M shares35.6M shares
Foreign currency translation adjustment-$3.6M$1.4M-$1.7M
Total comprehensive loss-$222.6M-$167.6M-$182.4M

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Corporate structure

Bicycle Therapeutics (United Kingdom) 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 Bicycle Therapeutics (United Kingdom)

  • Bicycle Therapeutics (United Kingdom) Cambridge, 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 Bicycle Therapeutics (United Kingdom) reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, net$6.0M5 Dec 31, 2025$9.5M5 Dec 31, 2024−36.7%
Finance-lease assets$800.0K5 Dec 31, 2025$1.0M5 Dec 31, 2024−20.0%
Operating-lease assets (leased space)$15.9M5 Dec 31, 2025$7.7M5 Dec 31, 2024+107.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$628.1M5 Dec 31, 2025$879.5M5 Dec 31, 2024−28.6%

Properties, in its own words

We occupy approximately 45,000 rentable square feet of office and laboratory space in Cambridge, United Kingdom under a lease that expires in December 2031, and may be renewed for 10 years, cancelable in the fifth year of the extension. We also lease an additional 11,000 rentable square feet of office and laboratory space in Lexington, Massachusetts under a lease that expires in December 2027 and approximately 23,000 rentable square feet of office and laboratory space in Cambridge, Massachusetts under a lease that expires in March 2026. We believe that our office and laboratory spaces are sufficient to meet our current needs and that suitable additional space will be available as and when needed.

Item 2 of the 10-K filed Mar 17, 2026.7

Leadership

Who has led Bicycle Therapeutics (United Kingdom), and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Kevin Lee2019–now

President

  1. Lee Kalowski2019–2023

Chief financial officer

  1. Lee Kalowski2019–2023
  2. Alethia Young2023–now

Chief operating officer

  1. Michael Skynner2019–2021
  2. Alistair Milnes2022–2026
  3. Jennifer Scott Perry2026–now
2010201520202025
Board members and other officers (29)

Former names

  • BICYCLE THERAPEUTICS LtdDec 21, 2018 to May 24, 20196

Timeline

  1. Aug 20, 20268-K Executive or director change50
  2. Jul 30, 20268-K Results of operations51
  3. Jun 18, 20268-K Shareholder vote52
  4. May 21, 20268-K Other events53
  5. Apr 30, 20268-K Results of operations54
  6. Apr 20, 20268-K Other events55
  7. Mar 17, 20268-K Results of operations; Executive or director change56
  8. Feb 3, 20268-K Executive or director change57
  9. Jan 12, 20268-K Other events58
  10. Oct 30, 20258-K Results of operations59
  11. Sep 8, 20258-K Executive or director change60
  12. Aug 8, 20258-K Results of operations; Executive or director change61
  13. May 22, 2019New chief executive Kevin Lee becomes CEO18
  14. 2009Founded Founded1

Calendar

Coming up

  1. Oct 29, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.85) a share, on Oct 30, 2025.62

When it reported results

  1. Jul 30, 2026Reported quarterly or annual results51
  2. Apr 30, 2026Reported quarterly or annual results54
  3. Mar 17, 2026Reported quarterly or annual results56
  4. Oct 30, 2025Reported quarterly or annual results59
  5. Aug 8, 2025Reported quarterly or annual results61
  6. May 1, 2025Reported quarterly or annual results63
  7. Feb 25, 2025Reported quarterly or annual results64
  8. Oct 31, 2024Reported 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

438 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 62 major events, 185 insider forms, 49 large holders, 1 private raises, 121 other. The latest 20:

  1. Oct 7, 20264/A EDGAR
  2. Oct 6, 20264 EDGAR
  3. Oct 6, 20264 EDGAR
  4. Oct 6, 20264 EDGAR
  5. Oct 6, 20264 EDGAR
  6. Oct 6, 20263/A EDGAR
  7. Oct 6, 20264 EDGAR
  8. Oct 6, 20264 EDGAR
  9. Oct 2, 2026144 EDGAR
  10. Aug 20, 20268-K EDGAR
  11. Aug 14, 2026SCHEDULE 13G/A EDGAR
  12. Jul 30, 202610-Q EDGAR
  13. Jul 30, 20268-K EDGAR
  14. Jul 17, 20264 EDGAR
  15. Jul 17, 20264 EDGAR
  16. Jul 17, 20264 EDGAR
  17. Jul 17, 20264 EDGAR
  18. Jul 7, 20264 EDGAR
  19. Jul 7, 20264 EDGAR
  20. Jul 7, 20264 EDGAR

The 438 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

144 open-market trades by officers, directors and large owners since October 2021: 2 buys and 142 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jul 6, 2026Perry Jennifer ScottChief Operating OfficerSale376$4.34$1.6KForm 4
Jul 6, 2026Hannay Michael Charles FergusonCHIEF PROD & SUPPLY CHAIN OFFSale255$4.31$1.1KForm 4
Jul 6, 2026Thompson Travis AlvinChief Financial OfficerSale104$4.31$448Form 4
Jul 6, 2026Lee KevinCHIEF EXECUTIVE OFFICERSale1,737$4.31$7.5KForm 4
Jul 6, 2026Skynner MichaelCHIEF SCIENTIFIC OFFICERSale532$4.31$2.3KForm 4
Jul 2, 2026Perry Jennifer ScottChief Operating OfficerSale1,036$4.27$4.4KForm 4
Jul 2, 2026Hannay Michael Charles FergusonCHIEF PROD & SUPPLY CHAIN OFFSale1,506$4.27$6.4KForm 4
Jul 2, 2026Thompson Travis AlvinChief Financial OfficerSale819$4.27$3.5KForm 4
Jul 2, 2026Lee KevinCHIEF EXECUTIVE OFFICERSale5,905$4.27$25.2KForm 4
Jul 2, 2026Skynner MichaelCHIEF SCIENTIFIC OFFICERSale1,859$4.27$7.9KForm 4
Apr 6, 2026Perry Jennifer ScottChief Operating OfficerSale370$5.04$1.9KForm 4
Apr 6, 2026Hannay Michael Charles FergusonCHIEF PROD & SUPPLY CHAIN OFFSale251$5.05$1.3KForm 4
Apr 6, 2026Thompson Travis AlvinChief Financial OfficerSale102$5.05$515Form 4
Apr 6, 2026Lee KevinCHIEF EXECUTIVE OFFICERSale1,716$5.05$8.7KForm 4
Apr 6, 2026Skynner MichaelCHIEF SCIENTIFIC OFFICERSale525$5.05$2.7KForm 4
Apr 2, 2026Perry Jennifer ScottChief Operating OfficerSale1,038$4.91$5.1KForm 4
Apr 2, 2026Hannay Michael Charles FergusonCHIEF PROD & SUPPLY CHAIN OFFSale1,521$4.91$7.5KForm 4
Apr 2, 2026Thompson Travis AlvinChief Financial OfficerSale799$4.91$3.9KForm 4
Apr 2, 2026Lee KevinCHIEF EXECUTIVE OFFICERSale5,967$4.91$29.3KForm 4
Apr 2, 2026Skynner MichaelCHIEF SCIENTIFIC OFFICERSale1,879$4.91$9.2KForm 4

All 144 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
2025Kevin LeePh.D., MBA$862.3K$6.3M83
2025Michael SkynnerPh.D.$612.5K$2.3M83
2025Alistair Milnes$578.2K$2.3M83
2024Chief Executive Officer$759.6K$4.9M83
2024Chief Corporate Development Officer$538.9K$2.6M83

Funding

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

Money received by year$555.5M 2024–2024
Money received by yearMoney received by year, 2024–2024: $555.5M in all. Private raises (Form D) $555.5M.$0$200M$400M$600M2024 · Private raises (Form D): $555.5M2024
Figures by year
YearPrivate raises (Form D)Total
2024$555.5M$555.5M

Private raises

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

  1. May 28, 2024Raised $555.5 million in a private offering of equity84 Form D: 19 investors so far Form D

Held by these funds

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

FundSharesValueShare of the fundChange
Baker Bros. Advisors LP10,885,357$46.2M0.2%No change
Fcpm III Services B.v.3,468,430$14.7M2.0%No change
Armistice Capital, LLC3,398,000$14.4M0.4%No change
Long Focus Capital Management, LLC3,310,687$14.0M0.6%No change
Renaissance Technologies LLC1,533,400$6.5M0.0%+554,100
GSK plc1,529,561$6.5M1.1%No change
Marshall Wace, Llp797,940$3.4M0.0%+420,605
Qube Research & Technologies Ltd775,567$3.3M0.0%+466,950
Morgan Stanley667,269$2.8M0.0%+48,942
Schroder Investment Management Group615,833$2.6M0.0%No change
Citadel Advisors LLC554,225$2.3M0.0%+177,140
Millennium Management LLC553,967$2.3M0.0%+269,981
Peapod Lane Capital LLC537,978$2.3M1.5%+416,872
Diadema Partners LP462,724$2.0M0.7%−13,700
Two Sigma Investments, LP434,577$1.8M0.0%+269,777
Flax Pond Capital, LLC376,222$1.7M0.6%+200,086
Jane Street Group, LLC392,163$1.7M0.0%+174,048
Birchview Capital, LP313,616$1.3M0.6%−149,983
BlackRock, Inc.280,386$1.2M0.0%+1,394
Moore Capital Management, LP275,000$1.2M0.0%No change
Rangeley Capital, LLC253,500$1.1M1.0%+21,240
Palo Alto Investors LP201,890$856.0K0.1%No change
Sculptor Capital LP197,904$839.1K0.0%New
Eversept Partners, LP190,715$808.6K0.0%No change
Pinnacle Associates Ltd189,990$805.6K0.0%+4,580

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

SEC filer profile

How Bicycle Therapeutics (United Kingdom) is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARBICYCLE THERAPEUTICS PLC2
  • CIK0001761612
  • Employer ID (EIN)00-00000007
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company7
  • Incorporated inEngland and Wales7
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business addressBlocks A & B, Portway Building, Granta Park, Great Abington, Cambridge, X0 CB21 6GS2
  • Phone0114412232615032
  • Shares outstanding50,269,082 Common Stock shares; 19,437,944 Non Voting Ordinary Shares shares as of Mar 12, 20267
  • Public float$266.7M as of Jun 30, 20257
  • AuditorPricewaterhouseCoopers LLP, Cambridge, United Kingdom PCAOB ID 876; no auditor attestation of internal control over financial reporting7
  • On EDGAR sinceDec 21, 20182
  • Filings658 in all: 4 (253), 8-K (93), 144 (85), 3 (38), 10-Q (22), SC 13G/A (21), SCHEDULE 13G/A (13), SC 13D/A (12)2
    All 40 form types

    SC 13G (12), S-8 (11), 4/A (9), CORRESP (8), 10-K (7), 424B5 (7), DEF 14A (7), SCHEDULE 13G (7), PRE 14A (6), SC 13D (6), UPLOAD (6), 3/A (4), ARS (4), EFFECT (4), DEFA14A (3), S-1/A (2), S-3 (2), S-3ASR (2), 424B3 (1), 424B4 (1), 424B7 (1), 8-A12B (1), CERT (1), CT ORDER (1), D (1), DRS (1), DRS/A (1), DRSLTR (1), F-6 (1), F-6/A (1), F-6EF (1), S-1 (1)

  • Latest filingsAnnual report (10-K) Mar 17, 2026
    Quarterly report (10-Q) Jul 30, 2026
    Proxy statement (DEF 14A) Apr 22, 2026
    Latest 8-K (8-K) Aug 20, 2026

Securities registered for trading

ClassSymbolExchange
Ordinary shares, nominal value £0.01 per share*The Nasdaq Stock Market LLC
American Depositary Shares, each representing one ordinary share, nominal value £0.01 per shareBCYCThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 17, 2026 (Section 12(b) of the Exchange Act).7

Risk factors and legal proceedings

The risks Bicycle Therapeutics (United Kingdom) names in Item 1A of its 10-K filed Mar 17, 2026: 73 risks under these headings, as written.7

  • Risks Related to Our Financial Position and Need for Additional Capital
  • We have a history of significant operating losses and expect to incur significant and increasing losses for the foreseeable future, and we may never achieve or maintain profitability.
  • Our limited operating history may make it difficult for holders of our ADSs or ordinary shares to evaluate the success of our business to date and to assess our future viability.
  • We may need substantial additional funding, and if we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product discovery and development programs or commercialization efforts.
  • Raising additional capital may cause dilution to our existing shareholders or holders of our ADSs, restrict our operations or cause us to relinquish valuable rights.
  • Risks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates
  • We are substantially dependent on the success of our internal development programs and of our product candidates from our BDC and BRC programs, which may not successfully complete clinical trials, receive regulatory approval or be successfully commercialized.
  • We are at an early stage in our development efforts, and our product candidates and those of our collaborators represent a new category of medicines and may be subject to heightened regulatory scrutiny until they are established as a therapeutic modality.
  • We may find it difficult to enroll patients in our clinical trials, which could delay or prevent us from proceeding with clinical trials of our product candidates.
  • Results of preclinical studies and early clinical trials may not be predictive of results of future clinical trials.
  • Failure to successfully validate, develop and obtain regulatory approval for companion diagnostics could harm our drug development strategy.
  • Our current or future product candidates may cause undesirable side effects or have other properties when used alone or in combination with other approved products or investigational new drugs that could halt their clinical development, prevent their marketing approval, limit their commercial potential or result in significant negative consequences.
The other 62 risks
  • We may be delayed or may not be successful in our efforts to identify or discover additional product candidates.
  • We may expend our limited resources to pursue a particular development strategy, product candidate or indication and fail to capitalize on strategies, product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • We face potential product liability, and, if successful claims are brought against us, we may incur substantial liability and costs. If the use of our product candidates harms patients, or is perceived to harm patients even when such harm is unrelated to our product candidates, our regulatory approvals could be revoked or otherwise negatively impacted and we could be subject to costly and damaging product liability claims.
  • We may seek designations for our product candidates with the FDA and other comparable regulatory authorities that are intended to confer benefits such as a faster development process or an accelerated regulatory pathway, but there can be no assurance that we will successfully obtain such designations. In addition, even if one or more of our product candidates are granted such designations, we may not be able to realize the intended benefits of such designations.
  • We may seek priority review designation for one or more of our product candidates, but we might not receive such designation, and even if we do, such designation may not lead to a faster regulatory review or approval process.
  • Obtaining and maintaining marketing approval of our current and future product candidates in one jurisdiction does not mean that we will be successful in obtaining marketing approval of our current and future product candidates in other jurisdictions.
  • Changes in the regulatory landscape, policies, or processes, as well as disruptions at the FDA and other government agencies caused by layoffs, changes in personnel, funding shortages or global health concerns could negatively impact our business.
  • Risks Related to Commercialization of Our Product Candidates and Other Regulatory Compliance Matters
  • Even if we complete the necessary preclinical studies and clinical trials, the marketing approval process is expensive, time consuming and uncertain and may prevent us or any collaborators from obtaining approvals for the commercialization of some or all of our product candidates. As a result, we cannot predict when or if, and in which territories, we, or any collaborators, will obtain marketing approval to commercialize a product candidate.
  • We currently have limited marketing, sales or distribution infrastructure with respect to our product candidates. If we are unable to develop our sales, marketing and distribution capability on our own or through collaborations with marketing partners, we will not be successful in commercializing our product candidates.
  • The market opportunities for any current or future product candidate we develop, if and when approved, may be limited to those patients who are ineligible for established therapies or for whom prior therapies have failed, and may be small.
  • Even if we receive marketing approval of a product candidate, 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 products, if approved.
  • We face significant competition and if our competitors develop and market products that are more effective, safer or less expensive than the product candidates we develop, our commercial opportunities will be negatively impacted.
  • The commercial success of any current or future product candidate will depend upon the degree of market acceptance by physicians, patients, payors and others in the medical community.
  • If the market opportunities for our product candidates are smaller than we believe they are, our product revenues may be adversely affected and our business may suffer.
  • The insurance coverage and reimbursement status of newly approved products is 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.
  • If the FDA or comparable foreign regulatory authorities approve generic versions of any of our product candidates that receive marketing approval, or such authorities do not grant such products appropriate periods of data exclusivity before approving generic versions of such products, the sales of such products could be adversely affected.
  • We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, health information privacy and security laws, and other health care laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • work) actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions, litigation, fines and penalties, disruptions of our business operations, reputational harm, loss of revenues or profits, and other adverse business consequences.”
  • Healthcare legislative reform measures may have a negative impact on our business and results of operations.
  • We are subject to the U.K. Bribery Act 2010, or the Bribery Act, the U.S. Foreign Corrupt Practices Act of 1977, as amended, or the FCPA, and other anti-corruption laws, as well as export control laws, import and customs laws, trade and economic sanctions laws and other laws governing our operations.
  • We and the third parties with whom we work are subject to stringent and evolving U.S. and foreign laws, regulations, rules, contractual obligations, industry standards, policies and other obligations related to data privacy and security. Our (and third parties with whom we work) actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions, litigation (including class claims), fines and penalties, disruptions of our business operations, reputational harm, loss of revenue or profits, and other adverse business consequences.
  • Our activities subject us to various laws relating to foreign investment and the export of certain technologies, and our failure to comply with these laws or adequately monitor the compliance of our suppliers and others we do business with could subject us to substantial fines, penalties and even injunctions, the imposition of which on us could have a material adverse effect on the success of our business.
  • If we fail to comply with environmental, health and safety 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.
  • Risks Related to Our Business and Our International Operations
  • As a company with operations outside of the United States, we are subject to economic, political, regulatory and other risks associated with international operations.
  • International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.
  • Cyber-attacks, failures in or interruptions of, or other compromise to our information technology systems, or those of third parties with whom we work, or our data could result in adverse consequences that materially affect our business, including without limitation, regulatory investigations or actions, litigation, fines and penalties, information theft, data corruption, harm to our reputation and brand, significant disruption of our business operations, and other adverse consequences.
  • Social media platforms and artificial intelligence-based platforms present new risks and challenges to our business.
  • Exchange rate fluctuations may materially affect our results of operations and financial condition.
  • Risks Related to Our Dependence on Third Parties
  • For certain product candidates, we depend, or may depend, on development and commercialization collaboration partners to develop, conduct clinical trials, obtain regulatory approvals of, and if approved, market and sell product candidates. If such partnerships fail to perform as expected, the potential for us to generate future revenue from such product candidates would be significantly reduced and our business would be harmed.
  • If conflicts arise with our development and commercialization collaborators or licensors, they may act in their own self-interest, which may be adverse to the interests of our company.
  • We rely on third parties, including independent clinical investigators and CROs, to conduct and sponsor some of the clinical trials of our product candidates. Any failure by a third party to meet its obligations with respect to the clinical development of our product candidates may delay or impair our ability to obtain regulatory approval for our product candidates.
  • We intend to rely on third parties to manufacture product candidates and supply raw materials used in our product candidates, such as 212Pb, which increases the risk that we will not have sufficient quantities of such product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain patent and other intellectual property protection for our products and product candidates, or if the scope of the patent and other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our products and product candidates may be adversely affected.
  • Issued patents covering our products and product candidates could be found invalid or unenforceable if challenged in court or in administrative proceedings. We may not be able to protect our trade secrets in court.
  • We may be subject to claims challenging the inventorship or ownership of the patents and other intellectual property.
  • Obtaining and maintaining 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.
  • If we do not obtain patent term extension and data exclusivity for our products and product candidates, our business may be materially harmed.
  • Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products and product candidates.
  • We may not be able to protect our intellectual property rights throughout the world.
  • If we are sued for infringing intellectual property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or commercializing our product candidates.
  • We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
  • We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
  • If we fail to comply with our obligations under any future intellectual property licenses with third parties, we could lose license rights that are important to our business.
  • 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.
  • Risks Related to Employee Matters and Managing Growth
  • Our recent workforce reductions were undertaken to significantly reduce our ongoing operating expenses, but they may not result in our intended outcomes and may yield unintended consequences and additional costs.
  • Our future success depends on our ability to retain key employees, consultants and advisors and to attract, retain and motivate qualified personnel.
  • Our employees, independent contractors, consultants, collaborators and CROs may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation.
  • We may encounter difficulties in managing our growth, which could disrupt our operations.
  • Risks Related to Ownership of Our Securities
  • The market price of our ADSs is highly volatile, and holders of our ADSs may not be able to resell their ADSs at or above the price at which they purchased their ADSs.
  • The dual class structure of our shares may limit your ability to influence corporate matters and may limit your visibility with respect to certain transactions.
  • Substantial future sales or issuances of shares of our ordinary shares or ADSs or other equity-related securities could adversely affect the price of our ADSs and dilute shareholders.
  • Our existing shareholders may consult with our management and have various impacts on our business affairs.
  • Because we do not anticipate paying any cash dividends on our ADSs in the foreseeable future, capital appreciation, if any, will be the sole source of gains for holders of our ADSs, and they may never receive a return on their investment.
  • Risks Related to Our Incorporation Under the Laws of England and Wales
  • Claims of U.S. civil liabilities may not be enforceable against us.
  • If we are a passive foreign investment company, there could be adverse U.S. federal income tax consequences to U.S. holders.
  • We may be unable to use net operating loss and tax credit carryforwards and certain built-in losses to reduce future tax payments or benefit from favorable U.K. tax legislation.
  • Future changes to tax laws could materially adversely affect our company 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.
  • Provisions in the U.K. City Code on Takeovers and Mergers that may have anti-takeover effects do not apply to us.
  • The rights of our shareholders may differ from the rights typically offered to shareholders of a U.S. corporation.

Legal proceedings

From time to time, we may become subject to various legal proceedings and claims that arise in the ordinary course of our business activities. We are not currently subject to any material legal proceedings.

The opening of Item 3, Legal Proceedings.7

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