Private company

Centessa Pharmaceuticals plc

In its 2026 annual report the company says: “We are a clinical-stage biotechnology company pioneering a new class of therapeutics in orexin-based neuroscience. We are developing a franchise of small molecule orexin receptor 2 (OX2R) agonists designed to address neuroscience diseases underpinned by dysregulation of wakefulness, attention, cognition, mood, and other symptoms, each grounded in the shared biology of the orexin pathway.”5 It is headquartered in Altrincham, United Kingdom.2

Last updated Oct 20, 2026.

Overview

  • IndustryPharmaceutical Preparations2
  • HeadquartersAltrincham, United Kingdom2
  • Incorporated inUnited Kingdom3
  • Business address3Rd Floor, 1 Ashley Road, Altrincham, Cheshire, X0 Wa14 2Dt3
  • Filer category, Emerging growth company3
  • Legal formPublic Limited Company2
  • LEI213800GIDAARDSKOI8272
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered address3RD FLOOR 1 ASHLEY ROAD, WA14 2DT Altrincham, United Kingdom2
  • Registered withCompanies House, 129735762

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We are a clinical-stage biotechnology company pioneering a new class of therapeutics in orexin-based neuroscience. We are developing a franchise of small molecule orexin receptor 2 (OX2R) agonists designed to address neuroscience diseases underpinned by dysregulation of wakefulness, attention, cognition, mood, and other symptoms, each grounded in the shared biology of the orexin pathway.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

-1384.6%Operating margin6
-1316.9%Net margin6
-37.5%Return on equity6
0.21×Debt to equity6
-$194.2MFree cash flow6

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Other costs88¢$13.2M
  • Income tax12¢$1.8M

Out of $15.0M in revenue.6 The company lost money this year.

Financial statements

Revenue786$15.0M in 2025
0$5.0M$10.0M$15.0M2022: $0$020222023: $6.9M$6.9M20232024: $0$020242025: $15.0M$15.0M2025
Operating income9786-$207.7M in 2025+4010% since 2019
-$300.0M-$200.0M-$100.0M02019: -$5.1M-$5.1M20192020: -$10.4M-$10.4M2020+107%2022: -$212.3M-$212.3M2022+1933%2023: -$171.3M-$171.3M2023−19%2024: -$201.1M-$201.1M2024+17%2025: -$207.7M-$207.7M2025+3%
Net income9786-$197.5M in 2025+3803% since 2019
-$300.0M-$200.0M-$100.0M02019: -$5.1M-$5.1M20192020: -$10.7M-$10.7M2020+111%2022: -$216.2M-$216.2M2022+1928%2023: -$151.1M-$151.1M2023−30%2024: -$235.8M-$235.8M2024+56%2025: -$197.5M-$197.5M2025−16%
Fiscal year2019202020212022202320242025
Revenue$07$6.9M8$06$15.0M6
Operating income-$5.1M9-$10.4M9-$212.3M7-$171.3M8-$201.1M6-$207.7M6
Interest$7.3M7$9.9M7
Income before tax-$217.0M7-$176.1M8-$232.9M6-$195.7M6
Income tax$09$09$114.0K13-$747.0K7-$25.1M8$2.8M6$1.8M6
Net income-$5.1M9-$10.7M9-$216.2M7-$151.1M8-$235.8M6-$197.5M6
Earnings per share-$2.317-$1.578-$2.066-$1.466
Earnings per share (diluted)-$2.317-$1.578-$2.066-$1.466
Shares (weighted, basic)93.4M shares796.2M shares8114.5M shares6135.7M shares6
Shares (weighted, diluted)93.4M shares796.2M shares8114.5M shares6135.7M shares6

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Corporate structure

Centessa Pharmaceuticals plc sits at the top of its group. 5 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Centessa Pharmaceuticals plc

  • INDEX VENTURES LIFE VI (JERSEY) L.P. Filed SCHEDULE 13G/A on Centessa Pharmaceuticals plc, latest Aug 14, 2026 (2 filings since Feb 14, 2022)
  • Pentwater Capital Management LP Filed SCHEDULE 13G/A on Centessa Pharmaceuticals plc, latest Aug 14, 2026 (2 filings since May 15, 2026)
  • Adage Capital Management, L.P. Filed SCHEDULE 13G/A on Centessa Pharmaceuticals plc, latest Aug 12, 2026 (5 filings since May 12, 2025)
  • Medicxi Growth I LP Filed SCHEDULE 13G/A on Centessa Pharmaceuticals plc, latest Aug 4, 2026 (3 filings since Feb 8, 2022)
  • FMR LLC Filed SCHEDULE 13G/A on Centessa Pharmaceuticals plc, latest Jul 8, 2026 (5 filings since Nov 5, 2025)
  • FARALLON CAPITAL MANAGEMENT, L.L.C. Filed SCHEDULE 13D/A on Centessa Pharmaceuticals plc, latest Jun 26, 2026 (2 filings since Jun 24, 2026)
  • Avoro Capital Advisors LLC Filed SCHEDULE 13G/A on Centessa Pharmaceuticals plc, latest May 15, 2026 (3 filings since Nov 14, 2025)
  • Atlantic Cooperatief U.a. General Filed SCHEDULE 13D/A on Centessa Pharmaceuticals plc, latest Nov 28, 2025 (2 filings since Nov 17, 2025)
  • BIOTECHNOLOGY VALUE FUND L P Filed SC 13G/A on Centessa Pharmaceuticals plc, latest Nov 14, 2024 (3 filings since Jun 16, 2022)
  • EcoR1 Capital, LLC Filed SC 13G/A on Centessa Pharmaceuticals plc, latest Nov 14, 2024 (3 filings since Nov 23, 2022)
  • Janus Henderson Group Ltd. Filed SC 13G/A on Centessa Pharmaceuticals plc, latest Feb 9, 2023 (2 filings since Feb 11, 2022)
  • Centessa Pharmaceuticals plc Altrincham, United Kingdom
    • ApcinteX Limited Subsidiary · United Kingdom
    • Centessa Biosciences, Inc. Subsidiary · Delaware, United States
    • Centessa Pharmaceuticals (UK) Limited Subsidiary · United Kingdom
    • Centessa Pharmaceuticals Holdings Inc. Subsidiary · Delaware, United States

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 Centessa Pharmaceuticals 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$1.9M6 Dec 31, 2025$1.5M6 Dec 31, 2024+24.2%
Accumulated depreciation$1.1M6 Dec 31, 2025$791.0K6 Dec 31, 2024+38.9%
Property and equipment, net$807.0K6 Dec 31, 2025$744.0K6 Dec 31, 2024+8.5%
Operating-lease assets (leased space)$10.0M6 Dec 31, 2025$11.0M6 Dec 31, 2024−8.8%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$61.3M6 Dec 31, 2025$383.2M6 Dec 31, 2024−84.0%
Marketable securities, current$233.3M6 Dec 31, 2025$99.0M6 Dec 31, 2024+135.7%

Properties, in its own words

Our UK corporate registered office is 3rd Floor, 1 Ashley Road, Altrincham, Cheshire, United Kingdom WA14 2DT. On February 7, 2022, we entered into a 10-year lease for approximately 18,922 square feet of office space in Boston, Massachusetts. After a build out of the space, the Boston Lease commenced on March 31, 2023. On October 11, 2023, the

Company entered into a five-year agreement to sublet 4,242 square feet of the Boston Lease, which may be extended at subtenant’s option. The Boston leased premises serve as our U.S. corporate registered office. We continue to operate in a hybrid working model, combining in-person working and remote working.

Item 2 of the 10-K filed Mar 31, 2026.5

Leadership

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

Chief executive

  1. Saurabh Saha2021–2026
  2. Mario Alberto Accardi2026–now

Chair

  1. Antoine Yver2022–2023

President

  1. Mario Alberto Accardi2025–now

Chief financial officer

  1. Gregory M. Weinhoff2021–2024
  2. John J. Crowley2024–now
2025
Board members and other officers (28)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • ApcinteX Limited England and Wales4
  • Centessa Biosciences, Inc. Delaware4
  • Centessa Pharmaceuticals (UK) Limited England and Wales4
  • Centessa Pharmaceuticals Holdings Inc. Delaware4
  • Centessa Pharmaceuticals, LLC. Delaware4

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

Former names

  • Centessa Pharmaceuticals LtdMar 15, 2021 to May 24, 20213

Timeline

  1. Jun 24, 20268-K Ended a material agreement; Completed an acquisition or sale; Listing notice or transfer43
  2. Jun 12, 20268-K Shareholder vote; Other events44
  3. May 22, 20268-K Other events45
  4. Mar 31, 20268-K Entered a material agreement; Regulation FD disclosure46
  5. Feb 13, 20268-K Executive or director change47
  6. Feb 3, 2026New chief executive Mario Alberto Accardi becomes CEO14
  7. Jan 7, 20268-K Executive or director change48
  8. Dec 11, 20258-K Executive or director change; Regulation FD disclosure49
  9. Nov 24, 20258-K Other events50
  10. Nov 13, 20258-K Entered a material agreement; Other events51
  11. Nov 5, 20258-K Results of operations; Regulation FD disclosure52
  12. Aug 12, 20258-K Results of operations53
  13. Jun 20, 20258-K Shareholder vote54
  14. May 27, 2021New chief executive Saurabh Saha becomes CEO15
  15. Oct 26, 2020Founded Centessa Pharmaceuticals plc is founded2

Calendar

When it reported results

  1. Nov 5, 2025Reported quarterly or annual results52
  2. Aug 12, 2025Reported quarterly or annual results53
  3. May 14, 2025Reported quarterly or annual results55
  4. Mar 24, 2025Reported quarterly or annual results56
  5. Nov 12, 2024Reported quarterly or annual results57
  6. Aug 13, 2024Reported quarterly or annual results58
  7. May 13, 2024Reported quarterly or annual results59
  8. Apr 24, 2024Reported quarterly or annual results60

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

Filings

545 filings to the SEC since October 2021: 6 annual reports, 16 quarterly reports, 65 major events, 281 insider forms, 32 large holders, 145 other. The latest 20:

  1. Aug 14, 2026SCHEDULE 13G/A EDGAR
  2. Aug 14, 2026SCHEDULE 13G/A EDGAR
  3. Aug 12, 2026SCHEDULE 13G/A EDGAR
  4. Aug 4, 2026SCHEDULE 13G/A EDGAR
  5. Jul 8, 2026SCHEDULE 13G/A EDGAR
  6. Jul 6, 202615-12G EDGAR
  7. Jun 26, 2026SCHEDULE 13D/A EDGAR
  8. Jun 24, 20264 EDGAR
  9. Jun 24, 20264 EDGAR
  10. Jun 24, 20264 EDGAR
  11. Jun 24, 20264 EDGAR
  12. Jun 24, 20264 EDGAR
  13. Jun 24, 20264 EDGAR
  14. Jun 24, 20264 EDGAR
  15. Jun 24, 20264 EDGAR
  16. Jun 24, 20264 EDGAR
  17. Jun 24, 20264 EDGAR
  18. Jun 24, 20264 EDGAR
  19. Jun 24, 20264 EDGAR
  20. Jun 24, 20264 EDGAR

The 545 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

140 open-market trades by officers, directors and large owners since October 2021: 18 buys and 122 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jun 24, 2026Medicxi Ventures Management (Jersey) Ltd10% ownerSale19,963,157Form 4
Jun 24, 2026INDEX VENTURES LIFE VI (JERSEY) L.P.10% ownerSale9,961,789Form 4
Mar 26, 2026Anderson Karen M.Chief People OfficerSale41,076$30.12$1.2MForm 4
Mar 26, 2026Weinhoff Gregory MChief Business OfficerSale23,998$30.00$719.9KForm 4
Mar 17, 2026Anderson Karen M.Chief People OfficerSale10,043$28.10$282.2KForm 4
Mar 16, 2026Anderson Karen M.Chief People OfficerSale64,768$28.21$1.8MForm 4
Mar 13, 2026Anderson Karen M.Chief People OfficerSale120,029$26.25$3.2MForm 4
Mar 13, 2026Anderson Karen M.Chief People OfficerSale120,029$26.25$3.2MForm 4
Mar 13, 2026Weinhoff Gregory MChief Business OfficerSale73,196$26.33$1.9MForm 4
Feb 2, 2026HUSSAIN IQBAL JChief Legal OfficerSale38,951$25.15$979.6KForm 4
Jan 30, 2026HUSSAIN IQBAL JChief Legal OfficerSale1,010$25.01$25.3KForm 4
Dec 9, 2025Accardi Mario AlbertoChief Executive OfficerSale10,000$28.83$288.3KForm 4
Dec 8, 2025Accardi Mario AlbertoChief Executive OfficerSale10,000$30.00$300.0KForm 4
Nov 17, 2025HUSSAIN IQBAL JChief Legal OfficerSale6,000$27.64$165.8KForm 4
Nov 17, 2025Bush Tia LChief Technology & Quality OfcSale40,000$28.00$1.1MForm 4
Nov 12, 2025Bush Tia LChief Technology & Quality OfcSale40,000$26.00$1.0MForm 4
Oct 27, 2025Accardi Mario AlbertoChief Executive OfficerSale8,000$25.00$200.0KForm 4
Oct 15, 2025HUSSAIN IQBAL JChief Legal OfficerSale6,000$22.41$134.5KForm 4
Sep 24, 2025Bush Tia LChief Technology & Quality OfcSale35,000$24.00$840.0KForm 4
Sep 16, 2025Accardi Mario AlbertoChief Executive OfficerSale8,172$21.39$174.8KForm 4

All 140 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
2025Saurabh Saha, M.D., Ph.D.Former Chief Executive Officer$683.9K$11.9M72
2025Stephen Kanes, M.D., Ph.D.Chief Medical Officer61$519.0K$6.8M72
2025John CrowleyChief Financial Officer52$534.6K$3.8M72
2024Saurabh Saha, M.D., Ph.D.Former Chief Executive Officer$670.0K$5.6M72
2024John CrowleyChief Financial Officer52$295.3K$4.1M72

SEC filer profile

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

  • Name on EDGARCentessa Pharmaceuticals plc1
  • CIK0001847903
  • Employer ID (EIN)98-16122945
  • 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 address3Rd Floor, 1 Ashley Road, Altrincham, Cheshire, X0 WA14 2DT1
  • Phone44 7391 7897841
  • Shares outstanding154,728,966 as of Apr 28, 202612
  • Public float$1.2B as of Jun 30, 20255
  • AuditorKPMG LLP, Boston, Massachusetts PCAOB ID 185; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceMar 15, 20211
  • Filings614 in all: 4 (278), 144 (95), 8-K (65), 3 (28), 10-Q (15), SCHEDULE 13G/A (13), DEFA14A (10), 4/A (9)1
    All 46 form types

    424B5 (8), CORRESP (8), S-8 (6), S-8 POS (6), SC 13G/A (6), 10-K (5), DEF 14A (5), SC 13G (5), UPLOAD (5), ARS (4), SCHEDULE 13G (4), 3/A (3), EFFECT (3), S-1/A (3), SCHEDULE 13D/A (3), 10-Q/A (2), 8-K/A (2), PRE 14A (2), SEC STAFF LETTER (2), 10-K/A (1), 144/A (1), 15-12G (1), 25-NSE (1), 424B4 (1), 8-A12B (1), CERT (1), DEFM14A (1), DFAN14A (1), DRS (1), F-6 (1), POSASR (1), PREM14A (1), S-1 (1), S-1MEF (1), S-3 (1), S-3ASR (1), SC 13D (1), SCHEDULE 13D (1)

  • Latest filingsAnnual report (10-K) Mar 31, 2026
    Quarterly report (10-Q) May 5, 2026
    Proxy statement (DEF 14A) Apr 29, 2026
    Latest 8-K (8-K) Jun 24, 2026

Securities registered for trading

ClassSymbolExchange
Ordinary shares, nominal value £0.002 per shareCNTAThe Nasdaq Stock Market LLC
American Depositary Shares, each representing one ordinary share, nominal value £0.002 per shareCNTAThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 31, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Centessa Pharmaceuticals plc names in Item 1A of its 10-K filed Mar 31, 2026: 72 risks under these headings, as written.5

  • Risks Related to the Transaction with Lilly
  • The Transaction may not be completed within the expected timeframe, or at all, and significant delay or the failure to complete the Transaction could adversely affect our business and the market price of our ADSs.
  • The announcement and pendency of our acquisition by Lilly could adversely affect our business, prospects, financial condition, and results of operations.
  • The Transaction Agreement contains provisions that could discourage a potential competing acquirer of our Company or could result in any competing proposal being at a lower price than it might otherwise be.
  • While the Transaction Agreement is in effect, we are subject to restrictions on our business activities.
  • Litigation against us, Lilly, or the members of the respective boards, could prevent or delay the completion of the Transaction or result in the payment of damages following completion of the Transaction.
  • Our shareholders may not receive any payment on the CVR and the CVR may expire valueless and our shareholders will otherwise not be able to participate in any further upside to our business if the Transaction is consummated.
  • Risks Related to our Business Model and Structure
  • We may not be successful in our efforts to build a pipeline of product candidates with commercial value.
  • A single or limited number of programs, developmental assets or product candidates may comprise a large proportion of our value.
  • 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.
  • We face challenges, risks and expenses related to our operations as well as the management of the expected growth in the scale and complexity of our operations.
The other 62 risks
  • Achieving our business strategy depends in large part on the success of our recent CEO transition.
  • Our reliance on a small team of employees located in different geographies who provide services (including administrative, research and development, and other services) across our organization presents operational challenges that may adversely affect our business.
  • Some of our officers currently serve, and in the future may serve, as directors or officers of our Centessa Subsidiaries, and, as a result, have and may continue to have, statutory, fiduciary and other duties to our subsidiaries causing conflicts of interest with respect to their duties to us and their duties to our subsidiaries and in determining how to devote themselves to our affairs and the affairs of our subsidiaries. Our subsidiaries’ partners may also disagree with the sufficiency of resources that we provide to each Centessa Subsidiary.
  • Certain of our programs are subject to certain agreements that provide our licensors and/or collaborators with rights that could delay or impact our ability to sell assets, or enter into strategic alliances, collaborations or licensing arrangements with other third parties or the potential sale of our Centessa Subsidiaries.
  • Preclinical and clinical development is a long and expensive process and the outcomes are uncertain, and we may terminate one or more of our current preclinical and/or clinical development programs.
  • Risks Related to our Financial Position, Need for Additional Capital and Growth Strategy
  • We have incurred net losses since inception, and we expect to continue to incur losses for the foreseeable future and may never achieve or maintain profitability.
  • Our limited operating history may make it difficult for investors to evaluate our business, operations and prospects.
  • We have never generated revenue from product sales and may never be profitable.
  • If the Transaction is not completed, we will need substantial additional funds to advance development of our product candidates, and we cannot guarantee that we will have sufficient funds available in the future to develop and commercialize our current or future product candidates.
  • Our loan facility and payment obligations under the Loan and Security Agreement (“LSA”), with Oxford Finance contain operating and financial covenants that restrict our business and financing activities, are subject to acceleration in specified circumstances and may adversely affect our financial position or results of operations and our ability to raise additional capital which in turn may increase our vulnerability to adverse regulatory developments or economic or
  • business downturns or which may result in Oxford Finance taking possession of our assets and disposing of any collateral.
  • If we engage in acquisitions or 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.
  • If we acquire additional assets and/or companies in the future, it could adversely affect our operating results and the value of our ADSs.
  • Risks Related to Our Business and the Clinical Development, Regulatory Review and Approval
  • Our product candidates are in various stages of development, including several in discovery, preclinical, and clinical stages, and may fail in development or suffer delays that materially adversely affect their commercial viability and we may fail to differentiate our molecules, including cleminorexton, ORX142, ORX489 and other orexin agonist molecules from other available treatment options including other molecules in development.
  • We may not be successful in our efforts to identify, discover, in-license or otherwise acquire additional product candidates and may fail to capitalize on programs or product candidates that may be a greater commercial opportunity or for which there is a greater likelihood of success.
  • Success in preclinical studies or early clinical trials may not be indicative of results obtained in later trials.
  • We may encounter substantial delays or challenges in the initiation, conduct or completion of our clinical trials, and the results of clinical development are uncertain.
  • 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 from obtaining approvals for the commercialization of our product candidates.
  • 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.
  • We are dependent on third parties having accurately generated, collected, interpreted and reported data from certain preclinical studies and clinical trials that were previously conducted for our product candidates.
  • We may be unable to obtain U.S. or foreign regulatory approval and, as a result, unable to develop and/or commercialize our product candidates.
  • Interim, “top-line,” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or as additional analyses are conducted, and as the data are subject to audit and verification procedures, there could be material changes in the final data.
  • We may be unable to obtain orphan drug designation or exclusivity. If our competitors are able to obtain orphan drug exclusivity for products that constitute the same drug and treat the same indications as our product candidates, we may not be able to have our product candidates approved by the applicable regulatory authority for a significant period of time.
  • We face significant competition in an environment of rapid technological change and the possibility that our competitors may achieve regulatory approval before us or develop therapies that are more advanced or effective than ours, which may adversely affect our ability to successfully market or commercialize our product candidates and our financial condition.
  • Our product candidates and the process for administering our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial potential or result in significant negative consequences following any potential marketing approval.
  • We may not be able to submit INDs or IND amendments to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed or may subject its approval to certain conditions.
  • We are currently conducting and plan to conduct future clinical trials for certain product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials.
  • Even if we obtain and maintain approval for our product candidates from the FDA, we may never obtain approval for our product candidates outside of the United States, which would limit our market opportunities and adversely affect our business.
  • We may seek Fast Track designation for any of our other current or future product candidates. This designation 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 may seek accelerated approval for any of our current or future product candidates. Accelerated approval, even if granted, may not lead to a faster commercial launch of the product and does not increase the likelihood that our product candidates will receive marketing approval.
  • We may seek designation for a current or future platform as a designated platform technology, 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.
  • Even if we receive regulatory approval of one or more of our product candidates, we would 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 market opportunities for any future oncology product candidates from our LockBody platform may be relatively small since the patients who may potentially be treated with such oncology product candidates are those who are ineligible for or have failed prior treatments, and our estimates of the prevalence of our target patient populations may be inaccurate.
  • If we decide in the future to develop our product candidates in combination with other therapies, such strategy may expose us to additional risks.
  • Risks Related to our Reliance on Third Parties
  • We rely, and expect to continue to rely, on third parties to conduct our preclinical studies and clinical trials and if these third parties perform in an unsatisfactory manner, our business could be substantially harmed.
  • We could experience manufacturing problems that result in delays or other material disruptions in our development or commercialization of our programs or otherwise harm our business.
  • We currently rely and expect to rely in the future on the use of third parties to manufacture our product candidates. Our business could be harmed if the third-party manufacturers experience supply chain shortages, fail to provide us with sufficient quantities of our product candidates or fail to do so at acceptable quality levels or prices or deliver defective products.
  • Certain third parties upon whom we rely for the supply of the active pharmaceutical ingredient used in our product candidates are our sole source of supply, and the loss of any of these suppliers could significantly harm our business.
  • 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.
  • If we are unable to obtain licenses from third parties on commercially reasonable terms or fail to comply with our obligations under such agreements, our business could be harmed.
  • Risks Related to Intellectual Property
  • If we are unable to obtain and maintain sufficient patent and other intellectual property protection for our product candidates and technology or other product candidates that may be identified, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize product candidates similar or identical to the product candidates, and our ability to successfully commercialize the product candidates and other product candidates that we may pursue may be impaired.
  • 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.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Third-party claims of intellectual property infringement, misappropriation or other violations may be costly and time consuming and may prevent or delay our product discovery and development efforts.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful, and issued patents covering our technology and product candidates could be found invalid or unenforceable if challenged.
  • Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • The patent protection we obtain for our product candidates and technology may be challenged or not sufficient enough to provide us with any competitive advantage.
  • We may be subject to claims by third parties asserting that we or our employees have infringed upon, misappropriated or otherwise violated their intellectual property rights, or claiming ownership of what we regard as our own intellectual property.
  • We may not be able to protect our intellectual property rights throughout the world.
  • A number of our programs and associated product candidates are heavily dependent on licensed intellectual property. If we were to lose our rights to licensed intellectual property, we may not be able to continue developing or commercializing our product candidates, if approved. If we breach any of the agreements under which we license the use, development and commercialization rights to our product candidates or technology from third parties or, in certain cases, we fail to meet certain development deadlines, we could lose license rights that are important to our business.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time. If we are not able to obtain patent term extension or non-patent exclusivity in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the marketing exclusivity term of our product candidates, our business may be materially harmed.
  • Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • Intellectual property rights do not necessarily address all potential threats.
  • 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 engage consultants employed by academic institutions in jurisdictions that contain inventorship laws mandating that any inventions developed by such consultants while performing consultancy services automatically or otherwise shall reside in the employing institution and granting such institutions the first right to develop and/or commercialize such inventions. We may not be able to secure rights (whether through ownership or license interest) in inventions developed by such consultants during performance of consulting services for our companies.
  • Risks Related to Commercialization
  • We have never commercialized a product candidate and we may lack the necessary expertise, personnel and resources to successfully commercialize any of our products that receive regulatory approval on our own or together with collaborators.
  • The commercial success of any of our product candidates, if approved, will depend upon its degree of market acceptance by physicians, patients, third-party payors and others in the medical community.
  • If the market opportunities for our product candidates, if and when approved, are smaller than we believe they are, it may not be financially viable to commercialize, and if we do commercialize, our product revenues for any therapies that are approved for commercial sale may be adversely affected and our business may suffer.
  • If we are unable to establish sales, medical affairs and marketing capabilities or enter into agreements with third parties to market and sell our product candidates, if and when approved, we may be unable to generate any product revenue.
  • Healthcare legislative reform measures may have a material adverse effect on our business and results of operations and may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may charge for such product candidates.
  • The insurance coverage and reimbursement status of newly-approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for our products, if approved, could limit our ability to market those products and decrease our ability to generate product revenue.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidates that we may develop.
  • Risks Related to our Business and Industry

Sources

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