SMMT on Nasdaq

Summit Therapeutics

Biopharmaceutical company based in Menlo Park, founded in 20031

In its 2026 annual report the company says: “Summit Therapeutics Inc. is a biopharmaceutical company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs. The Company’s pipeline of product candidates is designed with the goal to become the patient-friendly, new-era standard-of-care medicines, in the therapeutic area of oncology.”5 Its shares trade on Nasdaq under the symbol SMMT.1

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Last updated Oct 21, 2026.

Overview

2003Founded1

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  • TickerSMMT on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersMenlo Park1
  • Websitewww.summittxinc.com
  • Business address601 Brickell Key Drive, Suite 1000, Miami, Fl 331313
  • Filer categoryLarge accelerated filer3
  • Legal formCorporation

Summit Therapeutics Inc. (“we”, “Summit” or the “Company”) is a biopharmaceutical company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs. The Company’s pipeline of product candidates is designed with the goal to become the patient-friendly, new-era standard-of-care medicines, in the therapeutic area of oncology.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 2024

-56.9%Return on equity6
-$142.2MFree cash flow6

Financial statements

Revenue78910$0 in 2024
0$20.0M$40.0M$60.0M2019: $57.1M$57.1M20192020: $860.0K$860.0K2020−98%2021: $1.8M$1.8M2021+110%2022: $705.0K$705.0K2022−61%2023: $0$020232024: $0$02024
Operating income78910-$226.0M in 2024
-$800.0M-$600.0M-$400.0M-$200.0M0$200.0M2019: $5.4M$5.4M20192020: -$53.2M-$53.2M20202021: -$86.2M-$86.2M2021+62%2022: -$72.1M-$72.1M2022−16%2023: -$609.6M-$609.6M2023+746%2024: -$226.0M-$226.0M2024−63%
Net income789106-$221.3M in 2024
-$800.0M-$600.0M-$400.0M-$200.0M0$200.0M2019: $10.9M$10.9M20192020: -$52.7M-$52.7M20202021: -$88.6M-$88.6M2021+68%2022: -$78.8M-$78.8M2022−11%2023: -$614.9M-$614.9M2023+681%2024: -$221.3M-$221.3M2024−64%
Fiscal year201920202021202220232024
Revenue$57.1M7$860.0K8$1.8M9$705.0K10$010$010
Gross profit2.7M GBP11
Research and development$52.0M7$53.3M8$85.4M9$52.0M14$59.5M14
Operating expenses$109.0M9$87.2M10$609.6M6$226.0M6
Operating income$5.4M7-$53.2M8-$86.2M9-$72.1M10-$609.6M10-$226.0M10
Interest$620.0K7$255.0K8$242.0K9$4.4M9
Income before tax-$88.6M9-$78.8M10-$614.9M6-$221.3M6
Income tax-$1.8M7-$213.0K8$08$06$06
Net income$10.9M7-$52.7M8-$88.6M9-$78.8M10-$614.9M6-$221.3M6
Earnings per share$0.637-$0.768-$0.679-$0.4110-$0.996-$0.316
Earnings per share (diluted)$0.637-$0.768-$0.679-$0.4110-$0.996-$0.316
Shares (weighted, basic)131.7M shares9193.3M shares10619.6M shares6718.5M shares6
Shares (weighted, diluted)131.7M shares9193.3M shares10619.6M shares6718.5M shares6

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Corporate structure

Summit Therapeutics sits at the top of its group. 8 entities, 5 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Summit Therapeutics

  • Robert W. Duggan Filed SC 13D/A on Summit Therapeutics, latest Sep 13, 2024 (4 filings since Aug 18, 2022)
  • Maky Zanganeh Filed SC 13D/A on Summit Therapeutics, latest Mar 13, 2023
  • Polar Capital Holdings Plc Filed SC 13G/A on Summit Therapeutics, latest Feb 14, 2023 (2 filings since Feb 14, 2022)
  • Summit Therapeutics Menlo Park
    • Discuva Limited Subsidiary · United Kingdom
    • Summit (Oxford) Limited Subsidiary · United Kingdom
    • Summit International Holdings Limited (Cayman Islands) Subsidiary · Cayman Islands
    • Summit Therapeutics Global LLC Subsidiary · Delaware, United States
    • Summit Therapeutics Ireland Limited Subsidiary · Ireland
    • Summit Therapeutics Sub Inc. Subsidiary · Delaware, United States
    • Summit Therapeutics Swiss STS GmbH Subsidiary · Switzerland

Built from 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 Summit Therapeutics 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$1.4M10 Dec 31, 2024$1.2M10 Dec 31, 2023+10.1%
Accumulated depreciation$1.1M10 Dec 31, 2024$1.0M10 Dec 31, 2023+7.3%
Property and equipment, net$1.1M6 Dec 31, 2025$254.0K6 Dec 31, 2024+316.9%
Operating-lease assets (leased space)$20.6M6 Dec 31, 2025$7.1M6 Dec 31, 2024+188.6%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$225.3M6 Dec 31, 2025$104.9M6 Dec 31, 2024+114.8%
Marketable securities, current$488.2M6 Dec 31, 2025$307.5M6 Dec 31, 2024+58.8%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$2.0M6 Dec 31, 2025$1.9M6 Dec 31, 2024+7.3%
Intangible assets, net (excluding goodwill)$010 Dec 31, 2024$010 Dec 31, 2023

Properties, in its own words

The following table provides information concerning Summit’s principal leased facilities as of December 31, 2025:

We maintain the following leased properties:

The rest of Item 2

Type/Uses · Location · Size · Lease Expiration

Headquarters · Miami, Florida · 9,425 square feet · April 2029

Executive office · Palo Alto, CA · 36,406 square feet · October 2033

Executive office · Princeton, NJ · 8,857 square feet · August 2028

Executive office · Oxfordshire, United Kingdom · 6,781 square feet · February 2027

Executive office · Menlo Park, California · 11,523 square feet · May 2026

We believe our facilities are suitable and adequate to meet our needs.

Item 2 of the 10-K filed Feb 23, 2026.5

Leadership

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

Board members and other officers (19)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive Officer, DirectorMahkam Zanganeh named Jun 18, 2024 to Sep 26, 202438
  • DirectorKenneth Clark named Jun 18, 2024 to Sep 26, 202438
  • DirectorMostafa Ronaghi named Jun 18, 2024 to Sep 26, 202438

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Discuva Limited England and Wales4
  • Summit (Oxford) Limited England and Wales4
  • Summit International Holdings Limited (Cayman Islands) Cayman Islands4
  • Summit Therapeutics Global LLC Delaware, USA4
  • Summit Therapeutics Ireland Limited Ireland4
  • Summit Therapeutics Limited England and Wales4
  • Summit Therapeutics Sub Inc. Delaware, USA4
  • Summit Therapeutics Swiss STS GmbH Switzerland4

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

Former names

  • Summit Therapeutics plcDec 31, 2014 to Sep 17, 20203
  • Summit Corp plcMar 4, 2014 to Jan 30, 20153

Timeline

  1. Sep 29, 20268-K Entered a material agreement; Unregistered sale of shares; Bylaws or fiscal year changed39
  2. Sep 15, 20268-K Other events40
  3. Sep 14, 20268-K Other events41
  4. Sep 3, 20268-K Other events42
  5. Aug 26, 20268-K Other events43
  6. Aug 5, 20268-K Other events44
  7. Jul 23, 20268-K Results of operations; Regulation FD disclosure45
  8. Jul 23, 20268-K Entered a material agreement46
  9. Jul 22, 20268-K Other events47
  10. Jun 12, 20268-K Shareholder vote48
  11. Jun 11, 20268-K Regulation FD disclosure49
  12. Jun 3, 20268-K Other events50
  13. Aug 18, 2022New chief executive Maky Zanganeh becomes CEO15
  14. Oct 6, 2020New chief executive Robert W. Duggan becomes CEO16
  15. Mar 5, 2015Went public Listed on NASDAQ1
  16. 2003Founded Founded1

Calendar

When it reported results

  1. Jul 23, 2026Reported quarterly or annual results45
  2. Apr 30, 2026Reported quarterly or annual results51
  3. Feb 23, 2026Reported quarterly or annual results52
  4. Jan 12, 2026Reported quarterly or annual results53
  5. Oct 20, 2025Reported quarterly or annual results54
  6. Aug 11, 2025Reported quarterly or annual results55
  7. May 1, 2025Reported quarterly or annual results56
  8. Feb 24, 2025Reported quarterly or annual results57

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

Filings

287 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 102 major events, 104 insider forms, 7 large holders, 2 private raises, 51 other. The latest 20:

  1. Oct 14, 20264 EDGAR
  2. Oct 6, 2026PRE 14A EDGAR
  3. Sep 29, 20268-K EDGAR
  4. Sep 15, 20268-K EDGAR
  5. Sep 14, 20268-K EDGAR
  6. Sep 3, 20268-K EDGAR
  7. Aug 26, 20268-K EDGAR
  8. Aug 5, 20268-K EDGAR
  9. Jul 23, 202610-Q EDGAR
  10. Jul 23, 20268-K EDGAR
  11. Jul 23, 20268-K EDGAR
  12. Jul 23, 2026424B5 EDGAR
  13. Jul 22, 20268-K EDGAR
  14. Jun 12, 20268-K EDGAR
  15. Jun 12, 20264 EDGAR
  16. Jun 12, 20264 EDGAR
  17. Jun 11, 20268-K EDGAR
  18. Jun 10, 2026424B5 EDGAR
  19. Jun 9, 2026S-3ASR EDGAR
  20. Jun 4, 20264 EDGAR

The 287 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

28 open-market trades by officers, directors and large owners since October 2021: 28 buys and 0 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jun 12, 2026Zanganeh MahkamCo-Chief Executive OfficerBuy3,810,000$13.12$50.0MForm 4
Jun 12, 2026DUGGAN ROBERT WCo-Chief Executive OfficerBuy3,810,000$13.12$50.0MForm 4
Jun 4, 2026Soni Manmeet SinghCOO and CFOBuy50,000$14.45$722.2KForm 4
Jun 4, 2026Zanganeh MahkamCo-Chief Executive OfficerBuy100,000$14.60$1.5MForm 4
Jun 4, 2026DUGGAN ROBERT WCo-Chief Executive OfficerBuy100,000$14.60$1.5MForm 4
Oct 21, 2025Xia YuDirectorBuy533,617$18.74$10.0MForm 4
Oct 21, 2025Zanganeh MahkamCo-Chief Executive OfficerBuy26,680$18.74$500.0KForm 4
Oct 21, 2025DUGGAN ROBERT WCo-Chief Executive OfficerBuy26,680$18.74$500.0KForm 4
Sep 11, 2025Zanganeh MahkamCo-Chief Executive OfficerBuy5,000$18.07$90.3KForm 4
Sep 11, 2025DUGGAN ROBERT WCo-Chief Executive OfficerBuy5,000$18.07$90.3KForm 4
Sep 10, 2025Zanganeh MahkamCo-Chief Executive OfficerBuy333,394$17.68$5.9MForm 4
Sep 10, 2025DUGGAN ROBERT WCo-Chief Executive OfficerBuy333,394$17.68$5.9MForm 4
Mar 27, 2024Zanganeh MahkamCo-Chief Executive OfficerBuy80,321$3.72$298.6KForm 4
Mar 26, 2024Zanganeh MahkamCo-Chief Executive OfficerBuy30,000$3.75$112.5KForm 4
Mar 26, 2024Dhingra AnkurChief Financial OfficerBuy100,000$3.75$375.0KForm 4
Dec 13, 2023Dhingra AnkurChief Financial OfficerBuy20,400$2.17$44.3KForm 4
Dec 12, 2023Zanganeh MahkamCo-Chief Executive OfficerBuy5,000$2.07$10.3KForm 4
Oct 13, 2023Soni Manmeet SinghCOO and CFOBuy2,976,190$1.68$5.0MForm 4
Mar 8, 2023Zanganeh MahkamCo-Chief Executive OfficerBuy23,527,044$1.05$24.7MForm 4
Mar 8, 2023Zanganeh MahkamCo-Chief Executive OfficerBuy23,527,044$1.05$24.7MForm 4

All 28 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
2025Manmeet SoniChief Operating Officer, Chief Financial Officer and Director48$616.5K$249.1M61
2025Mahkam ZanganehCo-Chief Executive Officer, President and Director55$616.5K$246.0M61
2025Robert W. DugganCo-Chief Executive Officer and Chairman81$172.4K61
2024Manmeet SoniChief Operating Officer, Chief Financial Officer and Director48$600.0K$4.8M61
2024Mahkam ZanganehCo-Chief Executive Officer, President and Director55$600.0K$1.2M61
2024Robert W. DugganCo-Chief Executive Officer and Chairman81$158.6K61
2023Manmeet SoniChief Operating Officer, Chief Financial Officer and Director48$100.0K$23.6M61
2023Mahkam ZanganehCo-Chief Executive Officer, President and Director55$600.0K$20.6M61

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Sep 11, 2024Raised $235 million in a private offering of equity Form D: 17 investors so far Form D
  2. Jun 3, 2024Raised $200 million in a private offering of equity Form D: 2 investors so far Form D

SEC filer profile

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

  • Name on EDGARSummit Therapeutics Inc.2
  • CIK0001599298
  • Employer ID (EIN)37-19797175
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address601 Brickell Key Drive, Suite 1000, Miami, FL 331312
  • Phone305-203-20342
  • Shares outstanding797,749,602 as of Jul 17, 202613
  • Public float$2.5B as of Jun 30, 20255
  • AuditorPricewaterhouseCoopers LLP, San Jose, California PCAOB ID 238; it also attests to the company’s internal control over financial reporting5
  • On EDGAR sinceMar 4, 20142
  • Filings556 in all: 8-K (125), 6-K (115), 4 (106), SC 13D/A (22), 3 (21), 10-Q (18), UPLOAD (14), CT ORDER (13)2
    All 44 form types

    CORRESP (12), EFFECT (10), DEF 14A (9), 10-K (6), 20-F (6), 424B5 (6), D (6), S-8 (6), SC 13G/A (6), 424B4 (5), PRE 14A (5), S-3 (5), SC 13D (5), DEFA14A (4), S-3ASR (4), F-3 (3), 4/A (2), ARS (2), F-1/A (2), SC 13G (2), 10-K/A (1), 25-NSE (1), 424B3 (1), 5 (1), 6-K/A (1), 8-A12B (1), 8-K/A (1), 8-K12B (1), CERTNAS (1), DRS (1), DRS/A (1), F-1 (1), F-3/A (1), F-6 (1), S-3/A (1), S-8 POS (1)

  • Latest filingsAnnual report (10-K) Feb 23, 2026
    Quarterly report (10-Q) Jul 23, 2026
    Proxy statement (DEF 14A) Apr 17, 2026
    Latest 8-K (8-K) Sep 29, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.01 per shareSMMTThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Feb 23, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Summit Therapeutics names in Item 1A of its 10-K filed Feb 23, 2026: 69 risks under these headings, as written.5

  • Risks Related to our Financial Position and Need for Additional Capital
  • We are a development-stage company and have incurred significant losses since our inception. We expect to incur losses for at least the next several years and may never generate or maintain profits.
  • We have not yet demonstrated an ability to successfully complete development of any product candidates, which may make it difficult for you to evaluate our success and future viability.
  • We will need substantial additional capital to fund our operations and to make payments under the License Agreement, and if we fail to obtain necessary financing, we could be forced to delay, reduce or eliminate the development and commercialization of our product candidates.
  • Raising additional capital may cause dilution to our investors, restrict our operations or require us to relinquish rights to our product candidates.
  • Worldwide economic, social and geopolitical instability could adversely affect our operations, revenue, financial condition, results of operations or ability to raise capital.
  • We depend heavily on the success of ivonescimab. If we are unable to successfully develop or commercialize ivonescimab, or experience significant delays in doing so, we may continue to incur significant financial losses.
  • Risks Related to the Development and Commercialization of our Product Candidates
  • Clinical development is a lengthy process with an uncertain outcome, and results of earlier studies and trials, conducted by us or Akeso, as well any interim results thereof, may not be predictive of future trial results and may negatively impact the size and scope of our ongoing or future Phase III clinical trials.
  • If we experience delays or difficulties in the enrollment of patients in our clinical trials, our receipt of necessary marketing approvals could be delayed or prevented.
  • If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities, or do not otherwise produce favorable results, we may incur additional costs or experience delays, or ultimately be unable to, develop and commercialize any product candidate.
  • Regulatory requirements and timelines may affect the scope and timeline of our trials and the potential market for our product candidates.
The other 59 risks
  • If we experience any number of possible unforeseen events in connection with our clinical trials, potential marketing approval or commercialization of our product candidates could be delayed or prevented.
  • If serious adverse or inappropriate side effects are identified during the development of any product candidate, we may need to abandon or limit our development of that product candidate.
  • We have conducted, and may in the future conduct, clinical trials for current or future product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials.
  • Even if a product candidate receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
  • If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be successful in commercializing a product candidate if and when such product candidates are approved.
  • Biologics, such as ivonescimab, carry unique risks and uncertainties that could negatively impact our business.
  • We may expend our limited resources to pursue a particular product candidate and fail to capitalize on product candidates that may be more profitable or for which there is a greater likelihood of success.
  • We face substantial competition, which may result in others discovering, developing or commercializing products before us or more successfully than we do.
  • If we fail to plan, execute and manage our growth effectively, our ability to develop and commercialize products could suffer.
  • Risks Related to our Dependencies on Third Parties
  • We depend on our relationship with, and the comprehensiveness of the intellectual property licensed from, Akeso, and termination of the License Agreement, or issues related to intellectual property could have a material adverse effect on our business.
  • We may be reliant on Akeso for knowledge transfer relating to any improvements in manufacturing of ivonescimab. The loss of any of the knowledge transferred relating to ivonescimab from Akeso may cause us to incur additional transition costs or result in delays in the manufacturing and delivery of ivonescimab.
  • We depend on collaborations with third parties for the development and commercialization of some of our product candidates. If those collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates.
  • We rely on the use of third parties, including Akeso, to manufacture our product candidate, which may increase the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable time and cost, which could delay, prevent or impair our development or commercialization efforts.
  • We rely on third parties to conduct our clinical trials and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such clinical trials.
  • If we are not able to establish additional collaborations, we may have to alter our development and commercialization plans.
  • Legal, Tax, Regulatory, and Compliance Risks
  • Even if we are able to commercialize a product candidate, it may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, which could harm our business.
  • Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.
  • U.S.-China trade relations may adversely impact our supply chain operations and business.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
  • 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.
  • Recent and potential future changes to U.S. and non-U.S. tax laws or the interpretation thereof or the imposition of new or increased taxes or fees could increase our future tax liabilities and adversely affect our operating results and cash flows.
  • Our future tax liabilities may be greater than expected if our net operating loss carryforwards and other tax attributes are limited or tax authorities challenge our tax positions.
  • Laws and regulations affecting government contracts make it more costly and difficult for us to successfully conduct our business. Failure to comply with these laws and regulations could result in significant civil and criminal penalties and adversely affect our business.
  • The marketing approval process is expensive, time-consuming and uncertain, and may prevent us from obtaining approvals for the commercialization of some or all of our product candidates. If we are unsuccessful or delayed in obtaining required regulatory approvals, we will not be able to commercialize our product candidates, and our ability to generate revenue will be materially impaired.
  • Our failure to obtain marketing approval in a jurisdiction would prevent our product candidates from being marketed in such jurisdiction, and any approval we are granted for our product candidates in one jurisdiction would not ensure approval of our product candidates in any other jurisdictions.
  • Our ability to obtain and maintain conditional marketing authorizations in the E.U. is limited to specific circumstances and subject to several conditions and obligations. A failure to renew any conditional approval that we obtain prior to full approval for the applicable indication would prevent us from continuing to market our products.
  • Even if we obtain marketing approvals for our product candidates, the terms of approvals and ongoing regulation of our products may limit how we manufacture and market our products and compliance with such requirements may involve substantial resources, which could materially impair our ability to generate revenue.
  • Any product candidate for which we obtain marketing approval will be subject to strict enforcement of post-marketing requirements and we could be subject to substantial penalties, including withdrawal of our product from the market, if we fail to comply with all regulatory requirements or if we experience unanticipated problems with our products, when and if any of them are approved.
  • Our relationships with customers, healthcare providers and professionals and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • Inadequate funding for or other disruptions to government agencies could hinder 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.
  • Current and future legislation may increase the difficulty and cost to obtain marketing approval of and commercialize our product candidates and could affect the prices we may obtain.
  • 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, which could adversely affect our business, results of operations and financial condition.
  • Environmental, social and governance (“ESG”) matters may impact our business and reputation.
  • Risks Related to Our Intellectual Property, Cybersecurity and Data Privacy
  • If we are unable to obtain and maintain patent protection for our technology and product candidates, our competitors could develop and commercialize technology and drug products similar or identical to ours, and our ability to successfully commercialize our technology and drug product candidates may be impaired.
  • We may become involved in lawsuits or other enforcement proceedings to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and potentially unsuccessful.
  • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on our business.
  • We may be subject to claims by third parties asserting that we or our employees have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
  • Intellectual property litigation could cause us to spend substantial resources and could distract our personnel from their normal responsibilities.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We operate in the biotechnology sector and rely heavily on information technology. Any interruption, malfunction, or lapse related to that technology, including any cybersecurity incidents, could harm our ability to operate our business effectively.
  • If our information technology systems or data, or those of third parties upon whom we rely or interact, are or were compromised, we could experience material adverse consequences resulting from such compromise.
  • We are subject to stringent and changing obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to material adverse consequences.
  • Risks Related to Operations
  • Our future success depends on our ability to retain our Co-Chief Executive Officers, Chief Operating Officer and other key executives.
  • We or the third parties we rely on may be adversely affected by social unrest or terrorism.
  • We or the third parties we rely on may be adversely affected by natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • Widespread health concerns, pandemics or epidemics, and other outbreaks of illness may negatively affect the Company’s ability to maintain operations and execute its business plan.
  • Our employees 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.
  • Key personnel have been, and may continue to be, difficult to attract and retain.
  • Risks Related to Owning Our Common Stock
  • Our principal stockholder and Co-Chief Executive Officer maintains the ability to control or significantly influence all matters submitted to stockholders for approval.
  • As a “controlled company” under the listing requirements of the Nasdaq Stock Market, we have an exemption from certain corporate governance requirements, which could adversely affect our stockholders by denying them certain rights and protections.
  • The price of our shares of common stock have in the past, and may continue to be volatile and fluctuate substantially, which could result in substantial losses for our stockholders.
  • Substantial future sales of our shares of common stock in the public market, or the perception that these sales could occur, could cause the price of the shares to decline significantly, even if our business is doing well.
  • If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our shares of common stock.
  • Our restated certificate of incorporation designates the Court of Chancery of the State of Delaware and the federal district courts of the U.S. as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers and employees.
  • Because we do not anticipate paying any cash dividends on our shares of common stock in the foreseeable future, capital appreciation, if any, will be the sole source of gain for our stockholders.
  • If equity research analysts stop publishing research or reports about our business or if they issue unfavorable commentary or downgrade our shares of common stock, the price of the shares could decline.
  • We are exposed to risks related to currency exchange rates.
  • We have broad discretion in the use of our cash and cash equivalents and may not use them effectively.
  • We may complete a future acquisition that may not achieve intended results or could increase the number of our outstanding shares or amount of outstanding debt or result in a change of control.

Legal proceedings

From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. Except as described below, we are not aware of any legal proceedings arising outside the ordinary course of business.

On March 17, 2025, Rainaldi Revocable Trust, a purported stockholder of the Company, filed a derivative lawsuit in the Delaware Court of Chancery against certain of the Company’s current and former directors and the Company, solely as a nominal defendant, concerning the December 2022 Notes entered into by the Company, Mr. Duggan and Dr. Zanganeh in connection with the License Agreement. The suit asserts claims for breach of fiduciary duty and unjust enrichment and seeks, among other things, unspecified damages, rescission of the shares that Mr. Duggan and Dr. Zanganeh received as part of prepaid interest payments under the December 2022 Notes, as well as attorneys’ fees and costs.

The opening of Item 3, Legal Proceedings.5

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