EWTX on Nasdaq

Edgewise Therapeutics, Inc.

Edgewise Therapeutics, Inc. is an American pharmaceutical preparations company based in Boulder.1 Its shares trade on Nasdaq under the symbol EWTX.1

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Last updated Oct 21, 2026.

Overview

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  • TickerEWTX on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersBoulder, Colorado1
  • Incorporated inDE2
  • Business address1715 38Th St, Boulder, Co 803012
  • Filer categoryLarge accelerated filer2

Our mission is to discover new medicines that improve the lives of people facing serious muscle disease.3 From its latest annual report

Financials

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

Financial statements

Operating income4567-$191.4M in 2025+1013% since 2020
-$200.0M-$150.0M-$100.0M-$50.0M02020: -$17.2M-$17.2M20202021: -$43.2M-$43.2M2021+151%2022: -$71.7M-$71.7M2022+66%2023: -$114.4M-$114.4M2023+60%2024: -$158.8M-$158.8M2024+39%2025: -$191.4M-$191.4M2025+21%
Net income4567-$167.8M in 2025+880% since 2020
-$200.0M-$150.0M-$100.0M-$50.0M02020: -$17.1M-$17.1M20202021: -$42.8M-$42.8M2021+150%2022: -$67.6M-$67.6M2022+58%2023: -$100.2M-$100.2M2023+48%2024: -$133.8M-$133.8M2024+34%2025: -$167.8M-$167.8M2025+25%

Every line of the income statement as filed: the last 3 fiscal years, latest first.7

Period ending2025-12-312024-12-312023-12-31
Research and development$151.4M$127.0M$90.9M
General and administrative$40.0M$31.9M$23.5M
Total operating expenses$191.4M$158.8M$114.4M
Loss from operations-$191.4M-$158.8M-$114.4M
Interest income$23.6M$25.0M$14.2M
Total other income$23.6M$25.0M$14.2M
Net loss-$167.8M-$133.8M-$100.2M
Unrealized gain on available-for-sale securities$257.0K$321.0K$1.5M
Total comprehensive loss-$167.5M-$133.5M-$98.7M
Net loss per share, basic (in dollars per share)-$1.63-$1.45-$1.57
Net loss per share, diluted (in dollars per share)-$1.63-$1.45-$1.57
Weighted-average shares outstanding, basic (in shares)102.9M shares92.4M shares63.7M shares
Weighted-average shares outstanding, diluted (in shares)102.9M shares92.4M shares63.7M shares

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Corporate structure

Edgewise 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 Edgewise Therapeutics, Inc.

  • BAKER BROS. ADVISORS LP Filed SCHEDULE 13G/A on Edgewise Therapeutics, Inc., latest Aug 14, 2026 (3 filings since Nov 14, 2024)
  • Paradigm Biocapital Advisors LP Filed SCHEDULE 13G/A on Edgewise Therapeutics, Inc., latest Aug 14, 2026 (3 filings since Feb 3, 2025)
  • RA CAPITAL MANAGEMENT, L.P. Filed SCHEDULE 13G/A on Edgewise Therapeutics, Inc., latest Aug 14, 2026 (5 filings since Feb 14, 2022)
  • FMR LLC Filed SCHEDULE 13G on Edgewise Therapeutics, Inc., latest Aug 6, 2026 (7 filings since Feb 9, 2022)
  • Janus Henderson Group Ltd. Filed SCHEDULE 13G on Edgewise Therapeutics, Inc., latest May 15, 2026 (5 filings since Feb 14, 2025)
  • Novo Holdings A/S Filed SCHEDULE 13D/A on Edgewise Therapeutics, Inc., latest Apr 27, 2026 (6 filings since Sep 16, 2022)
  • PERCEPTIVE ADVISORS LLC Filed SCHEDULE 13G/A on Edgewise Therapeutics, Inc., latest Aug 14, 2025 (3 filings since Feb 21, 2025)
  • BlackRock Filed SCHEDULE 13G/A on Edgewise Therapeutics, Inc., latest Jul 17, 2025 (5 filings since Feb 2, 2024)
  • ORBIMED ADVISORS LLC Filed SCHEDULE 13D/A on Edgewise Therapeutics, Inc., latest May 12, 2025 (4 filings since Sep 16, 2022)
  • EcoR1 Capital, LLC Filed SC 13G/A on Edgewise Therapeutics, Inc., latest Nov 14, 2024 (2 filings since Sep 26, 2022)
  • James E. Flynn Filed SC 13G/A on Edgewise Therapeutics, Inc., latest Nov 14, 2024 (3 filings since Feb 10, 2023)
  • VIKING GLOBAL INVESTORS LP Filed SC 13G/A on Edgewise Therapeutics, Inc., latest Nov 14, 2024 (4 filings since Feb 14, 2022)
  • Edgewise Therapeutics, Inc. Boulder, Colorado

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

What it owns

What Edgewise 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$14.6M7 Dec 31, 2025$14.2M7 Dec 31, 2024+2.9%
Accumulated depreciation$6.8M7 Dec 31, 2025$4.7M7 Dec 31, 2024+44.5%
Property and equipment, net$7.8M7 Dec 31, 2025$9.5M7 Dec 31, 2024−17.6%
Operating-lease assets (leased space)$1.4M7 Dec 31, 2025$1.6M7 Dec 31, 2024−11.6%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$61.1M7 Dec 31, 2025$41.7M7 Dec 31, 2024+46.8%

Properties, in its own words

Our headquarters are based in Boulder, Colorado where the company entered into a lease agreement for approximately 18,614 square feet of office and laboratory space in January 2022. The lease includes escalating rent payments and an 8.2 year term. In February 2023, we signed an amendment to this lease to occupy additional 9,624 square feet of space. The future minimum lease payments are disclosed in Note 5 to our financial statements appearing in this Annual Report. We believe our facilities are adequate and suitable for our current needs, and that suitable additional or alternative space will be available to accommodate our operations if needed.

Item 2 of the 10-K filed Feb 26, 2026.3

Leadership

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

Chief executive

  1. Kevin Koch2021–now

Chief financial officer

  1. Michael Nofi2025–now
2025
Board members and other officers (15)

Timeline

  1. Aug 6, 20268-K Results of operations26
  2. Jul 16, 20268-K Financial statements and exhibits27
  3. Jul 13, 20268-K Completed an acquisition or sale; Regulation FD disclosure28
  4. Jun 5, 20268-K Shareholder vote29
  5. Jun 1, 20268-K Entered a material agreement30
  6. May 7, 20268-K Results of operations31
  7. Feb 26, 20268-K Results of operations32
  8. Nov 20, 20258-K Executive or director change33
  9. Nov 10, 20258-K Executive or director change; Regulation FD disclosure34
  10. Nov 6, 20258-K Results of operations35
  11. Aug 7, 20258-K Results of operations36
  12. Jun 26, 20258-K Regulation FD disclosure; Other events37
  13. Mar 25, 2021New chief executive Kevin Koch becomes CEO11

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.39) a share, on Nov 6, 2025.38

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results26
  2. May 7, 2026Reported quarterly or annual results31
  3. Feb 26, 2026Reported quarterly or annual results32
  4. Nov 6, 2025Reported quarterly or annual results35
  5. Aug 7, 2025Reported quarterly or annual results36
  6. May 8, 2025Reported quarterly or annual results39
  7. Mar 3, 2025Reported quarterly or annual results40
  8. Nov 7, 2024Reported quarterly or annual results41

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

Filings

357 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 47 major events, 170 insider forms, 58 large holders, 62 other. The latest 20:

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

The 357 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

113 open-market trades by officers, directors and large owners since October 2021: 11 buys and 102 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 13, 2026Donovan Joanne M.CMOSale2,919$43.41$126.7KForm 4
Aug 12, 2026Russell Alan JChief Scientific OfficerSale5,901$43.73$258.1KForm 4
Aug 12, 2026Derakhshan BehradChief Business OfficerSale5,100$43.81$223.4KForm 4
Aug 12, 2026Donovan Joanne M.CMOSale6,522$43.85$286.0KForm 4
Aug 12, 2026MOORE JOHN RGeneral CounselSale5,016$43.83$219.8KForm 4
Aug 12, 2026KOCH KEVINPresident and CEOSale17,971$43.68$785.0KForm 4
Jul 1, 2026Russell Alan JChief Scientific OfficerSale200,000$39.41$7.9MForm 4
May 5, 2026Donovan Joanne M.CMOSale50,000$38.57$1.9MForm 4
May 4, 2026Donovan Joanne M.CMOSale5,230$31.29$163.6KForm 4
Apr 1, 2026Donovan Joanne M.CMOSale28,662$32.31$926.1KForm 4
Mar 31, 2026Donovan Joanne M.CMOSale21,338$32.12$685.4KForm 4
Mar 27, 2026Donovan Joanne M.CMOSale16,358$30.98$506.8KForm 4
Jan 21, 2026Edris BadreddinDirectorSale115,471$29.44$3.4MForm 4
Nov 12, 2025Russell Alan JChief Scientific OfficerSale100,000$21.12$2.1MForm 4
Nov 11, 2025Fox Jonathan CDirectorBuy10,700$18.64$199.4KForm 4
Aug 26, 2025Russell Alan JChief Scientific OfficerSale100,000$14.60$1.5MForm 4
Aug 12, 2025MOORE JOHN RGeneral CounselSale2,098$13.39$28.1KForm 4
Aug 12, 2025Derakhshan BehradChief Business OfficerSale2,491$13.39$33.4KForm 4
Aug 12, 2025Carruthers R MichaelChief Financial OfficerSale1,428$13.39$19.1KForm 4
Aug 12, 2025Russell Alan JChief Scientific OfficerSale1,907$13.39$25.5KForm 4

All 113 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Kevin KochPh.D.$670.0K$7.4M58
2025Former Chief Development Officer$525.0K$4.6M58
2025Chief Financial Officer$67.8K$4.3M58
2025Behrad DerakhshanPh.D.$520.0K$2.9M58
2025Joanne M. DonovanM.D., Ph.D.$530.4K$2.8M58
2025Co-Founder and$499.6K$2.7M58
2025Former Chief Financial Officer$465.7K$2.6M58
2024President and$618.7K$7.6M58
2024Chief Medical Officer$507.5K$2.9M58
2024Chief Operating Officer$478.4K$2.9M58
2023Chief Executive Officer$594.9K$4.0M58
2023Chief Operating Officer$446.7K$1.8M58
2023Chief Medical Officer$488.0K$1.7M58

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
Orbimed Advisors LLC15,518,492$630.5M12.0%No change
Paradigm Biocapital Advisors LP10,215,455$415.1M7.8%+2,850,417
Ra Capital Management, L.P.8,392,730$341.0M3.0%−2,035,707
BlackRock, Inc.6,606,336$268.4M0.0%+133,345
Jupiter Topco LLC6,075,331$246.9M0.1%New
Fmr LLC5,489,135$223.0M0.0%+4,472,083
Novo Holdings A/s5,350,000$217.4M12.6%No change
Driehaus Capital Management LLC4,728,623$192.1M1.1%+250,681
Perceptive Advisors LLC4,373,974$177.7M2.8%−50,000
Vanguard Capital Management LLC3,860,670$156.9M0.0%+72,509
Baker Bros. Advisors LP3,701,719$150.4M0.8%−2,874,221
Siren, L.L.C.3,184,629$129.4M2.6%−1,245,634
Cormorant Asset Management, LP2,510,000$102.0M5.2%−750,000
Geode Capital Management, LLC2,174,051$88.3M0.0%+384,232
Integral Health Asset Management, LLC2,000,000$81.3M3.3%+400,000
Braidwell LP1,996,965$81.1M3.1%−350,618
Morgan Stanley1,948,597$79.2M0.0%−297,431
State Street Corp1,827,927$74.3M0.0%+111,104
Alliancebernstein L.P.2,119,024$66.7M0.0%+396,855
Mpm Bioimpact LLC1,620,780$65.9M4.0%−39,916
Bank Of America Corp /de/1,558,260$63.3M0.0%+230,900
Qube Research & Technologies Ltd1,252,507$50.9M0.1%+426,597
Dimensional Fund Advisors LP1,139,726$46.3M0.0%−79,991
American Century Companies Inc1,127,078$45.8M0.0%−20,098
First Light Asset Management, LLC1,095,171$44.5M2.7%+93,325

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

SEC filer profile

How Edgewise 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 EDGAREdgewise Therapeutics, Inc.1
  • CIK0001710072
  • Employer ID (EIN)82-17255863
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address1715 38Th St, Boulder, CO 803011
  • Phone720-262-70021
  • Shares outstanding108,604,129 as of Jul 31, 20269
  • Public float$1.2B as of Jun 30, 20253
  • AuditorKPMG LLP, Denver, Colorado PCAOB ID 185; it also attests to the company’s internal control over financial reporting3
  • On EDGAR sinceSep 26, 20191
  • Filings419 in all: 4 (174), 8-K (49), 144 (28), 3 (22), SC 13G/A (20), 10-Q (17), SC 13G (14), SCHEDULE 13G/A (12)1
    All 38 form types

    SC 13D/A (9), DEFA14A (7), S-8 (7), 424B5 (6), 10-K (5), 4/A (5), DEF 14A (5), SCHEDULE 13G (5), CORRESP (4), SC 13D (3), ARS (2), D (2), DRS/A (2), EFFECT (2), S-1/A (2), SCHEDULE 13D/A (2), UPLOAD (2), 424B3 (1), 424B4 (1), 8-A12B (1), 8-K/A (1), CERT (1), DRS (1), DRSLTR (1), PRE 14A (1), S-1 (1), S-1MEF (1), S-3 (1), S-3ASR (1), S-3MEF (1)

  • Latest filingsAnnual report (10-K) Feb 26, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 23, 2026
    Latest 8-K (8-K) Aug 6, 2026

Securities registered for trading

ClassSymbolExchange
Common stock, par value $0.0001 per shareEWTXNasdaq Global Select Market

From the cover page of the 10-K filed Feb 26, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Edgewise Therapeutics, Inc. names in Item 1A of its 10-K filed Feb 26, 2026: 76 risks under these headings, as written.3

  • Risks Related to Our Financial Position, Need for Additional Capital and Limited Operating History
  • Risks Related to the Discovery, Development and Commercialization of Our Product Candidates
  • Risks Related to Regulatory Approval and Other Legal Compliance Matters
  • Risks Related to Employee Matters, Managing Our Growth and Other Risks Related to Our Business
  • Risks Related to Our Intellectual Property
  • Risks Related to Our Dependence on Third Parties
  • We have a limited operating history and while we are moving toward becoming a commercial-ready biopharmaceutical company, some of our product candidates are early in development and we have no products approved for commercial sale, which may make it difficult for you to evaluate our current business and likelihood of success and future viability.
  • We have not generated any revenue to date, have incurred significant net losses since our inception, and expect to continue to incur significant net losses for the foreseeable future.
  • Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve several objectives relating to the discovery, development and commercialization of our product candidates, if approved.
  • We will require substantial additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or future commercialization efforts.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • Our ability to utilize our net operating loss carryforwards and certain other tax attributes to offset future taxable income may be limited.
The other 67 risks
  • Changes in tax laws could have a material adverse effect on our business, cash flow, results of operations or financial conditions.
  • Market conditions and changing circumstances, some of which may be beyond our control, could impair our ability to access our existing cash, cash equivalents and investments and to timely pay key vendors and others.
  • Our operations and financial results could be adversely impacted by public health pandemics, such as COVID-19 and other related outbreaks in the United States and the rest of the world.
  • We are substantially dependent on the success of our lead product candidates, sevasemten and EDG-7500. If we are unable to complete further development of, obtain approval for and commercialize sevasemten or EDG-7500 for one or more indications in a timely manner, our business will be harmed.
  • In addition to sevasemten and EDG-7500, our prospects depend in part upon developing and commercializing EDG-15400 and product candidates from our EDG-003 cardiometabolic discovery program and discovering, developing and commercializing product candidates in future programs, which may fail or suffer delays that adversely affect their commercial viability.
  • Clinical drug development involves a lengthy and expensive process with an uncertain outcome. The clinical trials of our product candidates may not demonstrate safety and efficacy to the satisfaction of the FDA, EMA or other comparable foreign regulatory authorities or otherwise produce positive results and the results of preclinical studies and early clinical trials may not be predictive of future results. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
  • Our product candidates may cause serious adverse events, toxicities or other undesirable side effects when used alone or in combination with other approved products or investigational new drugs that may result in a safety profile that could prevent regulatory approval, prevent market acceptance, limit their commercial potential or result in significant negative consequences.
  • The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and the results of our clinical trials may not satisfy the requirements of the FDA, EMA or other comparable foreign regulatory authorities.
  • If we experience delays or difficulties in the enrollment and/or maintenance of patients in clinical trials, our regulatory submissions or receipt of necessary marketing approvals could be delayed or prevented.
  • We have limited resources and are currently focusing the majority of our efforts on developing sevasemten and EDG-7500 for particular indications. As a result, we may fail to capitalize on other indications or product candidates that may ultimately have proven to be more profitable.
  • We face significant competition and if our competitors develop and market technologies or products more rapidly than we do or that are more effective, safer or less expensive than the products we develop, our commercial opportunities will be negatively impacted.
  • Interim, topline and preliminary data from our clinical trials that we announce or publish may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data.
  • We may not be successful in our efforts to develop a proprietary drug discovery platform to build a pipeline of product candidates.
  • We may develop sevasemten and potentially other programs in combination with other therapies, which would expose us to additional risks.
  • The manufacture of drugs is complex, and our third-party manufacturers may encounter difficulties in production. If any of our third-party manufacturers encounter such difficulties, our ability to provide adequate supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or prevented.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
  • Our product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community necessary for commercial success.
  • The patient population suffering from Duchenne, Becker and Limb-girdle muscular dystrophy (LGMD) is small and has not been established with precision. If the actual number of patients is smaller than we estimate, our revenue and ability to achieve profitability may be adversely affected. Because the target patient populations of our programs are small and the addressable patient population may be even smaller, we must be able to successfully identify patients and capture a significant market share to achieve profitability and growth.
  • We may not be successful in augmenting our product pipeline through acquisitions and in-licenses.
  • Any product candidates we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations.
  • Our business entails a significant risk of product liability and if we are unable to obtain sufficient insurance coverage, such inability could have an adverse effect on our business and financial condition. If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our products.
  • The regulatory approval processes of the FDA, EMA and other comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable. If we are ultimately unable to obtain regulatory approval of our product candidates, we will be unable to generate product revenue and our business will be substantially harmed.
  • The FDA, EMA and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction.
  • Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
  • The regulatory approval processes for product candidates that target rare diseases, including Duchenne, Becker and LGMD are uncertain.
  • Even if our product candidates receive regulatory approval, they will be subject to significant post-marketing regulatory requirements and oversight.
  • We may not be able to obtain orphan drug designation or obtain or maintain orphan drug exclusivity for our product candidates and, even if we do, that exclusivity may not prevent the FDA, EMA or other comparable foreign regulatory authorities, from approving competing products.
  • We may face difficulties from changes to current regulations and future legislation.
  • Inadequate funding for and other disruptions at the FDA, the SEC and other government agencies, including government shutdowns, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • 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 our business.
  • Our business activities may be subject to the U.S. Foreign Corrupt Practices Act and similar anti-bribery and anti-corruption laws of other countries in which we operate, as well as other trade laws, including U.S. and certain foreign export and import controls, trade sanctions, and foreign investment and data export laws and regulations. Compliance with these legal requirements could limit our ability to compete in foreign markets and subject us to liability if we violate them.
  • Our success is highly dependent on our ability to attract and retain highly skilled executive officers and employees.
  • If we are unable to establish sales or marketing capabilities or enter into agreements with third parties to sell or market our product candidates, we may not be able to successfully sell or market our product candidates that obtain regulatory approval.
  • In order to successfully implement our plans and strategies, we will need to grow the size of our organization, and we may experience difficulties in managing this growth.
  • Our computer systems, or those of any of our CROs, manufacturers, other contractors, consultants, service providers, or potential future collaborators, may fail or suffer security or data privacy breaches or incidents or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data, or personal data, which could result in additional costs, loss of revenue, significant liabilities, harm to our brand and material disruption of our operations.
  • Our operations are vulnerable to interruption by fire, earthquakes, power loss, telecommunications failure, terrorist activity, pandemics and other events beyond our control, which could harm our business.
  • Our business may become subject to economic, political, regulatory and other risks associated with international operations directly or indirectly. A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business.
  • Inflation in the global economy could negatively impact our business and results of operations.
  • Our success depends on our ability to protect our intellectual property and our proprietary technologies.
  • If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical product candidates would be adversely affected.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties. Claims by third parties that we infringe their proprietary rights may result in liability for damages or prevent or delay our developmental and commercialization efforts.
  • We may not be successful in obtaining or maintaining necessary rights to our product candidates through acquisitions and in-licenses.
  • We may be involved in lawsuits to protect or enforce our patents or any licensor’s patents, which could be expensive, time consuming and unsuccessful. Further, our issued patents or any licensor’s patents could be found invalid or unenforceable if challenged in court.
  • Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common shares to decline.
  • Derivation proceedings may be necessary to determine priority of inventions, and an unfavorable outcome may require us to cease using the related technology or to attempt to license rights from the prevailing party.
  • Changes in U.S. patent law, or laws in other countries, could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • 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 for our product candidates, our business may be materially harmed.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by regulations and governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • 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.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may be subject to claims that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets.
  • We may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers.
  • Our rights to develop and commercialize our technology and product candidates may be subject, in part, to the terms and conditions of licenses granted to us by others.
  • If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with any licensors, we could lose license rights that are important to our business.
  • The patent protection and patent prosecution for some of our product candidates may be dependent on third parties.
  • Intellectual property discovered through government funded programs may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers.
  • We rely, and expect to continue to 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 trials, research and studies, which may harm our business.
  • Our reliance on third parties may require us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
  • If we decide to establish collaborations, but are not able to establish those collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans.
  • We may enter into collaborations with third parties for the development and commercialization of product candidates. If those collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates.
  • Risks Related to the Securities Markets and Ownership of Our Common Stock
  • An active, liquid and orderly trading market may not continue to be developed or sustained for our common stock and as a result it may be difficult for you to sell your shares of our common stock.

Legal proceedings

From time to time, we may be involved in various claims and legal proceedings relating to claims arising out of our operations. We are not currently a party to any material legal proceedings. The outcome of litigation cannot be predicted with certainty and some lawsuits, claims or proceedings may be disposed of unfavorably to us, which could materially affect our financial condition or results of operations.

The opening of Item 3, Legal Proceedings.3

Sources

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