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Compass Therapeutics, Inc.

American biological products company based in Boston, listed on Nasdaq (CMPX)1

In its 2026 annual report the company says: “We are a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Our scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth. Our pipeline of novel product candidates is designed to target multiple critical biological pathways required for an effective anti-tumor response.”3

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Last updated Oct 21, 2026.

Overview

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  • TickerCMPX on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersBoston, Massachusetts1
  • Incorporated inDE2
  • Business address80 Guest Street, Boston, Ma 021352
  • Filer categoryNon-accelerated filer, Smaller reporting company2

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We are a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Our scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth. Our pipeline of novel product candidates is designed to target multiple critical biological pathways required for an effective anti-tumor response. These include modulation of the microvasculature via angiogenesis-targeted agents, induction of a potent immune response via activators on effector cells in the tumor microenvironment, and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. We plan to advance our product candidates through clinical development and commercialization as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclin…3 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

-100.0%Revenue growth, 20254
-33.8%Return on equity4
-$49.2MFree cash flow4

Financial statements

Revenue54$0 in 2025
0$250.0K$500.0K$750.0K$1.0M2023: $0$020232024: $850.0K$850.0K20242025: $0$02025
Operating income678954-$72.8M in 2025+114% since 2019
-$100.0M-$75.0M-$50.0M-$25.0M02019: -$34.1M-$34.1M20192020: -$27.8M-$27.8M2020−18%2021: -$81.9M-$81.9M2021+194%2022: -$41.7M-$41.7M2022−49%2023: -$50.4M-$50.4M2023+21%2024: -$56.6M-$56.6M2024+12%2025: -$72.8M-$72.8M2025+29%
Net income678954-$66.5M in 2025+91% since 2019
-$100.0M-$75.0M-$50.0M-$25.0M02019: -$34.7M-$34.7M20192020: -$29.5M-$29.5M2020−15%2021: -$82.2M-$82.2M2021+179%2022: -$39.2M-$39.2M2022−52%2023: -$42.5M-$42.5M2023+8%2024: -$49.4M-$49.4M2024+16%2025: -$66.5M-$66.5M2025+35%

Every line of the income statement as filed: the last 2 fiscal years, latest first.4

Period ending2025-12-312024-12-31
Licensing revenue$0$850.0K
Research and development$56.0M$42.3M
General and administrative$16.9M$15.1M
Total operating expenses$72.8M$57.5M
Loss from operations-$72.8M-$56.6M
Interest income$6.3M$7.2M
Net loss-$66.5M-$49.4M
Net loss per share - basic and diluted (in dollars per share)-$0.42-$0.36
Basic and diluted weighted average shares outstanding (in shares)157.7M shares137.4M shares
Unrealized gain on marketable securities$70.0K$173.0K
Comprehensive loss-$66.4M-$49.2M

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Corporate structure

Compass Therapeutics, Inc. 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 Compass Therapeutics, Inc.

  • Vivo Opportunity Fund Holdings, L.P. Filed SCHEDULE 13G/A on Compass Therapeutics, Inc., latest Aug 14, 2026 (2 filings since Nov 14, 2025)
  • State Street Corporation Filed SCHEDULE 13G on Compass Therapeutics, Inc., latest Aug 7, 2026
  • BIOTECHNOLOGY VALUE FUND L P Filed SCHEDULE 13G/A on Compass Therapeutics, Inc., latest May 15, 2026 (2 filings since Oct 29, 2025)
  • Blackstone Holdings II L.P. Filed SCHEDULE 13G/A on Compass Therapeutics, Inc., latest Feb 13, 2026 (2 filings since Aug 2, 2024)
  • BlackRock Filed SCHEDULE 13G on Compass Therapeutics, Inc., latest Jan 21, 2026 (3 filings since Feb 4, 2025)
  • TANG CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G/A on Compass Therapeutics, Inc., latest Nov 14, 2025 (5 filings since Jan 16, 2025)
  • MONTANOVA CAPITAL, LLC Filed SCHEDULE 13G/A on Compass Therapeutics, Inc., latest Aug 21, 2025 (2 filings since Aug 13, 2025)
  • Commander Aggregator, LP Filed SCHEDULE 13D/A on Compass Therapeutics, Inc., latest Aug 18, 2025 (2 filings since Nov 14, 2022)
  • ORBIMED ADVISORS LLC Filed SCHEDULE 13D/A on Compass Therapeutics, Inc., latest Aug 15, 2025 (5 filings since Nov 9, 2021)
  • RTW INVESTMENTS, LP Filed SCHEDULE 13G/A on Compass Therapeutics, Inc., latest Aug 14, 2025 (2 filings since Aug 14, 2025)
  • MPM BioImpact LLC Filed SCHEDULE 13G/A on Compass Therapeutics, Inc., latest Aug 12, 2025 (2 filings since Feb 14, 2025)
  • ADAGE CAPITAL PARTNERS GP, L.L.C. Filed SCHEDULE 13G/A on Compass Therapeutics, Inc., latest Feb 12, 2025 (3 filings since Nov 27, 2023)
  • Compass Therapeutics, Inc. Boston, Massachusetts

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Compass Therapeutics, Inc. 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$6.7M4 Dec 31, 2025$6.7M4 Dec 31, 2024+0.4%
Accumulated depreciation$6.6M4 Dec 31, 2025$6.4M4 Dec 31, 2024+4.3%
Property and equipment, net$102.0K4 Dec 31, 2025$353.0K4 Dec 31, 2024−71.1%
Operating-lease assets (leased space)$9.1M4 Dec 31, 2025$6.7M4 Dec 31, 2024+35.2%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$30.6M4 Dec 31, 2025$43.5M4 Dec 31, 2024−29.5%
Marketable securities, current$178.3M4 Dec 31, 2025$83.2M4 Dec 31, 2024+114.2%
Debt securities available for sale$178.3M4 Dec 31, 2025$83.2M4 Dec 31, 2024+114.2%

Properties, in its own words

Our corporate headquarters is located at 80 Guest Street, Boston, Massachusetts, and consists of 29,836 square feet of office space and laboratory space pursuant to a lease agreement that expires in May 2031. We believe that these facilities are adequate for our current needs and that suitable additional or substitute space will be available in the future if needed.

Item 2 of the 10-K filed Mar 5, 2026.3

Leadership

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

Chief executive

  1. Thomas J. Schuetz2020–2024
  2. Vered Bisker-Leib2024

President

  1. Vered Bisker-Leib2021
  2. Thomas J. Schuetz2024

Chief financial officer

  1. Barry Shin2024–now

Chief operating officer

  1. Vered Bisker-Leib2020–2023
2025
Board members and other officers (19)

Former names

  • Olivia Ventures, Inc.May 30, 2018 to Jun 8, 20202

Timeline

  1. Sep 22, 20268-K Regulation FD disclosure35
  2. Aug 6, 20268-K Results of operations36
  3. Jul 1, 20268-K Regulation FD disclosure37
  4. Jun 23, 20268-K Bylaws or fiscal year changed38
  5. Jun 11, 20268-K Shareholder vote39
  6. May 5, 20268-K Results of operations40
  7. Apr 27, 20268-K Regulation FD disclosure; Other events41
  8. Mar 5, 20268-K Results of operations42
  9. Jan 6, 20268-K Results of operations; Other events43
  10. Nov 5, 20258-K Results of operations44
  11. Aug 13, 20258-K Entered a material agreement; Other events45
  12. Aug 11, 20258-K Results of operations; Regulation FD disclosure46
  13. Jan 10, 2024New chief executive Vered Bisker-Leib becomes CEO12
  14. Jun 23, 2020New chief executive Thomas J. Schuetz becomes CEO13

Calendar

Coming up

  1. Nov 4, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.08) a share, on Nov 5, 2025.47

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results36
  2. May 5, 2026Reported quarterly or annual results40
  3. Mar 5, 2026Reported quarterly or annual results42
  4. Jan 6, 2026Reported quarterly or annual results43
  5. Nov 5, 2025Reported quarterly or annual results44
  6. Aug 11, 2025Reported quarterly or annual results46
  7. May 8, 2025Reported quarterly or annual results48
  8. Feb 27, 2025Reported quarterly or annual results49

Drug trials and FDA: coming up

  1. Aug 31, 2027Phase 2/3 trial readout expected Phase 2/3 trial of CTX-009 and Paclitaxel in Biliary Tract Cancer: primary completion expected Aug 31, 2027 (ClinicalTrials.gov NCT05506943).50

Drug trials and FDA: recently

  1. May 15, 2025Phase 2 trial completed Phase 2 trial of CTX-009 in Metastatic Colorectal Cancer: primary completion May 15, 2025, results posted Jul 28, 2026 (ClinicalTrials.gov NCT05513742).51

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

270 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 49 major events, 115 insider forms, 42 large holders, 44 other. The latest 20:

  1. Oct 2, 20264 EDGAR
  2. Sep 25, 20264 EDGAR
  3. Sep 22, 20268-K EDGAR
  4. Aug 14, 2026SCHEDULE 13G/A EDGAR
  5. Aug 7, 2026SCHEDULE 13G EDGAR
  6. Aug 6, 202610-Q EDGAR
  7. Aug 6, 20268-K EDGAR
  8. Jul 1, 20268-K EDGAR
  9. Jun 23, 20268-K EDGAR
  10. Jun 11, 20268-K EDGAR
  11. May 15, 2026SCHEDULE 13G/A EDGAR
  12. May 5, 202610-Q EDGAR
  13. May 5, 20268-K EDGAR
  14. Apr 30, 20264/A EDGAR
  15. Apr 30, 20264/A EDGAR
  16. Apr 29, 20264 EDGAR
  17. Apr 29, 20264 EDGAR
  18. Apr 29, 2026ARS EDGAR
  19. Apr 29, 2026DEFA14A EDGAR
  20. Apr 29, 2026DEF 14A EDGAR

The 270 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

50 open-market trades by officers, directors and large owners since October 2021: 43 buys and 7 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 24, 2026Lerner NeilChief Accounting OfficerBuy2,500$1.14$2.9KForm 4
Apr 29, 2026Lerner NeilChief Accounting OfficerBuy15,000$1.89$28.4KForm 4
Apr 29, 2026Anderman JonathanGeneral CounselBuy25,000$1.89$47.2KForm 4
May 27, 2025Schuetz Thomas J.CHIEF EXECUTIVE OFFICERBuy10,000$2.11$21.1KForm 4
Apr 9, 2025GORDON CARL LDirectorSale3,571,428$1.59$5.7MForm 4
Apr 9, 2025OrbiMed Capital GP VI LLCDirectorSale3,571,428$1.59$5.7MForm 4
Apr 7, 2025Anderman JonathanGeneral CounselBuy20,000$1.54$30.8KForm 4
Apr 7, 2025Lerner NeilChief Accounting OfficerBuy20,000$1.42$28.4KForm 4
Mar 10, 2023Schuetz Thomas J.CHIEF EXECUTIVE OFFICERBuy10,000$3.37$33.7KForm 4
Feb 27, 2023Schuetz Thomas J.CHIEF EXECUTIVE OFFICERBuy20,000$3.98$79.6KForm 4
Feb 15, 2023Schuetz Thomas J.CHIEF EXECUTIVE OFFICERBuy20,000$3.86$77.2KForm 4
Jan 31, 2023Schuetz Thomas J.CHIEF EXECUTIVE OFFICERBuy20,000$4.05$81.0KForm 4
Jan 24, 2023Schuetz Thomas J.CHIEF EXECUTIVE OFFICERBuy20,000$4.19$83.8KForm 4
Nov 25, 2022Bisker-Leib VeredCHIEF EXECUTIVE OFFICERSale2$4.36$9Form 4
Nov 23, 2022Bisker-Leib VeredCHIEF EXECUTIVE OFFICERSale9,569$4.30$41.1KForm 4
Nov 22, 2022Bisker-Leib VeredCHIEF EXECUTIVE OFFICERSale14,929$4.19$62.6KForm 4
Nov 21, 2022Bisker-Leib VeredCHIEF EXECUTIVE OFFICERSale16,035$4.34$69.6KForm 4
Nov 18, 2022Bisker-Leib VeredCHIEF EXECUTIVE OFFICERSale6,226$4.40$27.4KForm 4
Nov 8, 2022ORBIMED ADVISORS LLCDirectorBuy402,000$3.21$1.3MForm 4
Nov 8, 2022GORDON CARL LDirectorBuy402,000$3.21$1.3MForm 4

All 50 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
2025Thomas J. Schuetz, MD., Ph.D.Chief Executive Officer65$630.0K$5.1M69
2025Jonathan AndermanGeneral Counsel and Corporate Secretary43$450.0K$1.4M69
2025Barry ShinChief Financial Officer54$480.0K$1.4M69
2024Thomas J. Schuetz, MD., Ph.D.Chief Executive Officer65$575.0K$3.1M69
2024Barry ShinChief Financial Officer54$296.9K$1.2M69
2024Jonathan AndermanGeneral Counsel and Corporate Secretary43$195.0K$893.6K69

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
Tang Capital Management LLC17,990,782$39.4M1.8%+1,199,973
Orbimed Advisors LLC15,219,994$33.3M0.6%No change
Montanova Capital, LLC14,101,159$30.9M0.6%−206,220
BlackRock, Inc.11,281,781$24.7M0.0%+1,775,701
State Street Corp9,953,653$21.8M0.0%+3,258,677
Enavate Sciences Gp, LLC7,788,150$17.1M4.9%No change
Vivo Capital, LLC7,757,060$17.0M1.6%−1,788,406
Vanguard Capital Management LLC6,118,782$13.4M0.0%+81,607
Palo Alto Investors LP5,831,813$12.8M1.8%+4,317,309
Millennium Management LLC4,713,247$10.3M0.0%+3,867,027
Geode Capital Management, LLC3,815,189$8.4M0.0%+249,419
Vanguard Portfolio Management LLC3,771,032$8.3M0.0%+2,688,381
Qube Research & Technologies Ltd3,687,489$8.1M0.0%+1,137,133
Blue Owl Capital Holdings LP3,624,076$7.9M1.2%+682,551
Citadel Advisors LLC3,570,674$7.8M0.0%+2,849,264
Goldman Sachs Group Inc3,531,000$7.7M0.0%+1,535,606
Rock Springs Capital Management LP3,524,929$7.7M0.4%+219,621
Aqr Capital Management LLC3,509,137$7.7M0.0%+3,308,709
Birchview Capital, LP1,675,000$3.7M1.7%+209,133
Kingdon Capital Management, L.l.c.1,400,000$3.1M0.4%New
Fisher Asset Management, LLC1,391,890$3.0M0.0%+43,631
Royce & Associates LP1,336,780$2.9M0.0%−283,018
Fmr LLC1,212,196$2.7M0.0%−589,525
Adage Capital Partners Gp, L.l.c.1,186,500$2.6M0.0%−7,300,000
Northern Trust Corp1,140,914$2.5M0.0%+92,356

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

SEC filer profile

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

  • Name on EDGARCompass Therapeutics, Inc.1
  • CIK0001738021
  • Employer ID (EIN)82-48764963
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address80 Guest Street, Boston, MA 021351
  • Phone617-500-80991
  • Shares outstanding180,087,915 as of Jul 28, 202611
  • Public float$277.0M as of Jun 30, 20253
  • AuditorCohnReznick LLP, Melville, NY U.S.A. PCAOB ID 596; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceMay 30, 20181
  • Filings359 in all: 4 (114), 8-K (56), 10-Q (25), 3 (23), SCHEDULE 13G/A (13), SC 13G/A (10), SC 13G (9), 10-K (8)1
    All 37 form types

    CORRESP (8), SCHEDULE 13G (8), 424B5 (7), UPLOAD (7), DEF 14A (6), DEFA14A (6), EFFECT (6), 4/A (5), 424B3 (5), ARS (4), S-3 (4), SC 13D (4), SC 13D/A (4), S-8 (3), SCHEDULE 13D/A (3), 144 (2), 8-A12B (2), 8-K/A (2), CERT (2), D (2), S-1 (2), S-1/A (2), 10-12G (1), DEL AM (1), DRS (1), POS AM (1), RW (1), SC 14F1 (1), SC 14F1/A (1)

  • Latest filingsAnnual report (10-K) Mar 5, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 29, 2026
    Latest 8-K (8-K) Sep 22, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 par value per shareCMPXNASDAQ

From the cover page of the 10-K filed Mar 5, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Compass Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 5, 2026: 68 risks under these headings, as written.3

  • Risks Related to Our Financial Position and Need for Additional Capital
  • We have a limited operating history and no products approved for commercial sale. We have a history of significant losses, expect to continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability.
  • We have never generated revenue from product sales and may never be profitable.
  • We will require substantial additional financing to pursue our business objectives, which may not be available on acceptable terms, or at all. A failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development, commercialization efforts or other operations.
  • Recent volatility in capital markets and lower market prices for our securities may affect our ability to access new capital through sales of shares of our common stock or issuance of indebtedness, which may harm our liquidity and limit our ability to grow our business, pursue acquisitions, or improve our operating infrastructure.
  • Risks Related to the Discovery and Development of Our Product Candidates
  • Our business is dependent on our ability to advance our current and future product candidates through clinical trials, obtain marketing approval and ultimately commercialize them.
  • Clinical development involves a lengthy and expensive process with uncertain outcomes. We may incur additional costs and experience delays in developing and commercializing or be unable to develop or commercialize our current and future product candidates.
  • Preclinical development is uncertain. Our preclinical programs may experience delays or may never advance to clinical trials, which would adversely affect our ability to obtain regulatory approvals or commercialize these programs on a timely basis or at all.
  • Positive results from preclinical studies and early-stage clinical trials may not be predictive of future results. Initial positive results in any of our clinical trials may not be indicative of results obtained when the trial is completed or in later stage trials.
  • Interim and preliminary results from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit, validation and verification procedures that could result in material changes in the final data.
  • Our bispecific and monoclonal antibody product candidates are a new potential class of therapeutics, which makes it difficult to predict the time and cost of development and of subsequently obtaining regulatory approval, if at all.
The other 58 risks
  • 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, delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.
  • As an organization, we have limited experience designing and implementing clinical trials and we have never conducted pivotal clinical trials. Failure to adequately design a trial, or incorrect assumptions about the design of the trial, could adversely affect the ability to initiate the trial, enroll patients, complete the trial, or obtain regulatory approval on the basis of the trial results, as well as lead to increased or unexpected costs and in delayed timelines.
  • If we or our collaborators encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise be adversely affected.
  • Because the number of subjects in our clinical trials are small, the results from these trials, once completed, may be less reliable than results achieved in larger clinical trials.
  • We have chosen to prioritize certain product candidates for development as described in this Annual Report on Form 10-K. We may expend our limited resources on product candidates or indications that do not yield a successful product and fail to capitalize on other candidates or indications for which there may be a greater likelihood of success or may be more profitable.
  • Our clinical trials may be conducted in overseas jurisdictions, which may subject us to delays and expenses.
  • Risks Related to Regulatory Approval of Our Product Candidates
  • The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be materially harmed.
  • We may be unable to obtain FDA approval of our product candidates under applicable regulatory requirements. The denial or delay of any such approval would prevent or delay commercialization of our product candidates and adversely impact our potential to generate revenue, our business and our results of operations.
  • Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved, or commercialized in a timely manner or at all, which could negatively impact our business.
  • We may be required to suspend, repeat or terminate our clinical trials if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive or the trials are not well designed.
  • We intend to develop our product candidates in part in combination with other therapies and may develop our future product candidates in combination with other therapies, which exposes us to additional regulatory risks.
  • 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. If we fail to comply or experience unanticipated problems with our products, we may be subject to administrative and judicial enforcement, including monetary penalties, for non-compliance and our approved products, if any, could be deemed misbranded or adulterated and prohibited from continued distribution.
  • Accelerated approval by the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive regulatory approval.
  • Risks Related to the Commercialization of Our Product Candidates
  • Even if a current or future 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.
  • The market opportunities for any current or future product candidate we develop, if approved, may be limited to those patients who are ineligible for established therapies or for whom prior therapies have failed, and may be small.
  • 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 and maintaining marketing approval of our current and future product candidates in other jurisdictions.
  • If we are unable to establish marketing, sales and distribution capabilities for any product candidate that may receive regulatory approval, we may not be successful in commercializing those product candidates if and when they are approved.
  • Risks Related to Healthcare, Insurance and Legal Matters
  • Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of our product candidates.
  • The successful commercialization of our product candidates will depend in part on the extent to which third-party payors, including governmental authorities and private health insurers, provide coverage and adequate reimbursement levels, as well as implement pricing policies favorable for our product candidates. Failure to obtain or maintain coverage and adequate reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue.
  • Enacted healthcare legislation, changes in healthcare law and implementation of regulations, as well as changes in healthcare policy, may increase the difficulty and cost for us to commercialize our product candidates, may impact our business in ways that we cannot currently predict, could affect the prices we may set, and could have a material adverse effect on our business and financial condition.
  • Our relationships with customers, third-party payors and others may 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, administrative burdens and diminished profits and future earnings.
  • Risks Related to Manufacturing of Our Product Candidates
  • The loss of our third-party manufacturing partners or our, or our partners’, failure to comply with applicable regulatory requirements or to supply sufficient quantities at acceptable quality levels or prices, or at all, would materially and adversely affect our business.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
  • We are subject to multiple manufacturing risks, any of which could substantially increase our costs and limit supply of our product candidates.
  • Risks Related to Intellectual Property
  • If we are unable to obtain and maintain patent protection for our product candidates, or if the scope of the patent protection obtained is not sufficiently broad or robust, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our product candidates may be adversely affected.
  • Our intellectual property agreements with third parties may be subject to disagreements over contract interpretation, which could narrow the scope of our rights to the relevant intellectual property or technology, resulting in termination of our access to such intellectual property or increase our financial or other obligations to our licensors.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • If we do not obtain patent term extension and data exclusivity for our product candidates, our business may be materially harmed.
  • Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court. We may not be able to protect our trade secrets in court.
  • 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 the success of our business and financial condition.
  • Others may claim an ownership interest in our intellectual property and our product candidates, which could expose us to litigation and have a significant adverse effect on our prospects.
  • If we are unable to protect the confidentiality of our proprietary information, the value of our technology and products could be adversely affected.
  • We may be subject to claims asserting that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • Collaborations with third parties, including academic collaborations, may limit our ability to obtain, maintain, enforce or defend intellectual property necessary to conduct our business.
  • Intellectual property rights do not necessarily address all potential threats.
  • Risks Related to Information Technology and Data Privacy
  • We depend on our information technology systems, and any failure of these systems could harm our business. Cybersecurity incidents, data breaches, loss of data, and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business, results of operations and financial condition.
  • Our use of new and evolving technologies, such as artificial intelligence, may present risks and challenges that can impact our business, including by posing cybersecurity and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to reputational harm and liability.
  • European data collection is governed by restrictive regulations governing the use, processing and cross-border transfer of personal information.
  • Risks Related to Our Work with Third Parties
  • We rely or will rely on third parties to help conduct our ongoing and planned preclinical studies and clinical trials for our current product candidates and any future product candidates we develop. If these third parties do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain marketing approval for or commercialize our current product candidates and any current or future product candidates we develop and our business could be materially harmed.
  • We may depend on other third-party collaborators for the discovery, development and commercialization of certain of our current and future product candidates. If our collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates.
  • We may seek to establish collaborations, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.
  • Risks Related to Our Business
  • We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
  • We will need to grow the size of our organization, and we may experience difficulties in managing this growth.
  • We have broad discretion in the use of our cash resources and may not use them effectively.
  • We are highly dependent on our key personnel, and if we are not successful in attracting, motivating and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
  • If we fail to maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely financial statements could be impaired, investors may lose confidence in our financial reporting and the trading price of our common stock may decline.
  • Our business, results of operations and future growth prospects could be or continue to be affected by global pandemics, such as the COVID-19 pandemic, or the future outbreak of other highly infectious or contagious diseases.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • Risks Related to Our Common Stock
  • Our principal stockholders and management own a significant percentage of our stock and will be able to exercise significant influence over matters subject to stockholder approval.
  • Future issuances of common or preferred stock to fund our operations may substantially dilute your investment and reduce your equity interest in our company.
  • Provisions in our charter documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders, and may prevent attempts by our stockholders to replace or remove our current management.
  • Our amended and restated bylaws designate certain courts 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, or employees.
  • Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
  • General Risk Factors

Legal proceedings

From time to time, we may become involved in litigation or other legal proceedings as part of our ordinary course of business. We are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business.

The opening of Item 3, Legal Proceedings.3

Sources

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