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DYN on Nasdaq

Dyne Therapeutics, Inc.

In its 2026 annual report the company says: “We are a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. Our proprietary FORCE platform is designed to leverage the transferrin receptor 1, or TfR1, to deliver targeted therapeutics to muscle tissue and the central nervous system, or CNS.”4 It is headquartered in Waltham, Massachusetts.1 Its shares trade on Nasdaq under the symbol DYN.1

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Last updated Oct 21, 2026.

Overview

-$446.2MNet income, fiscal 20252

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  • TickerDYN on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersWaltham, Massachusetts1
  • Incorporated inDE3
  • Business address1560 Trapelo Road, Waltham, Ma 024513
  • Filer categoryLarge accelerated filer3

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We are a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. Our proprietary FORCE platform is designed to leverage the transferrin receptor 1, or TfR1, to deliver targeted therapeutics to muscle tissue and the central nervous system, or CNS. The FORCE platform utilizes an antigen-binding fragment antibody, or Fab, targeting TfR1 conjugated to a payload that we rationally design to target the genetic basis of the disease we are seeking to treat. With our FORCE platform, we have the flexibility to deploy different classes of payloads (such as oligonucleotides and enzymes) with specific mechanisms of action that modify target functions. We currently leverage this modularity to focus on neuromuscular diseases with high unmet need, with etiologic targets and with clear translational potential from preclinical d…4 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

-45.9%Return on equity2
0.15×Debt to equity2
-$405.1MFree cash flow2

Financial statements

Operating income56782-$468.2M in 2025+3286% since 2019
-$600.0M-$400.0M-$200.0M02019: -$13.8M-$13.8M20192020: -$58.6M-$58.6M2020+324%2021: -$150.0M-$150.0M2021+156%2022: -$171.0M-$171.0M2022+14%2023: -$242.2M-$242.2M2023+42%2024: -$343.9M-$343.9M2024+42%2025: -$468.2M-$468.2M2025+36%
Net income56782-$446.2M in 2025+2903% since 2019
-$600.0M-$400.0M-$200.0M02019: -$14.9M-$14.9M20192020: -$59.4M-$59.4M2020+300%2021: -$149.3M-$149.3M2021+151%2022: -$168.1M-$168.1M2022+13%2023: -$235.9M-$235.9M2023+40%2024: -$317.4M-$317.4M2024+35%2025: -$446.2M-$446.2M2025+41%
Fiscal year20182019202020212022202320242025
Research and development$11.0M5$45.2M6$121.3M7$142.8M8$210.8M2$281.4M2$398.3M2
Operating expenses$150.0M7$171.0M8$242.2M2$343.9M2$468.2M2
Operating income-$13.8M5-$58.6M6-$150.0M7-$171.0M8-$242.2M2-$343.9M2-$468.2M2
Income tax$02$02$02
Net income-$14.9M5-$59.4M6-$149.3M7-$168.1M8-$235.9M2-$317.4M2-$446.2M2
Earnings per share-$2.937-$3.238-$3.952-$3.372-$3.472
Earnings per share (diluted)-$2.937-$3.238-$3.952-$3.372-$3.472

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Corporate structure

Dyne 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 Dyne Therapeutics, Inc.

  • Atlas Venture Fund XI, L.P. Filed SCHEDULE 13G/A on Dyne Therapeutics, Inc., latest Aug 13, 2026 (6 filings since Feb 11, 2022)
  • Janus Henderson Group Ltd. Filed SCHEDULE 13G/A on Dyne Therapeutics, Inc., latest Aug 13, 2026 (8 filings since Nov 14, 2024)
  • FMR LLC Filed SCHEDULE 13G/A on Dyne Therapeutics, Inc., latest Aug 6, 2026 (5 filings since Nov 12, 2024)
  • BlackRock Filed SCHEDULE 13G/A on Dyne Therapeutics, Inc., latest Jul 28, 2026 (7 filings since Feb 8, 2023)
  • T. Rowe Price Investment Management, Inc. Filed SCHEDULE 13G/A on Dyne Therapeutics, Inc., latest May 15, 2026 (3 filings since Jan 8, 2026)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Dyne Therapeutics, Inc., latest Mar 26, 2026 (3 filings since Nov 4, 2024)
  • RA CAPITAL MANAGEMENT, L.P. Filed SCHEDULE 13G/A on Dyne Therapeutics, Inc., latest Nov 14, 2025 (6 filings since Feb 14, 2022)
  • Forbion Capital Fund IV Cooperatief U.A. Filed SCHEDULE 13G/A on Dyne Therapeutics, Inc., latest May 15, 2025 (2 filings since Nov 14, 2024)
  • Point72 Asset Management, L.P. Filed SCHEDULE 13G/A on Dyne Therapeutics, Inc., latest May 15, 2025 (2 filings since Feb 3, 2025)
  • RTW INVESTMENTS, LP Filed SCHEDULE 13G/A on Dyne Therapeutics, Inc., latest May 15, 2025 (3 filings since Nov 14, 2024)
  • CITADEL ADVISORS LLC Filed SC 13G/A on Dyne Therapeutics, Inc., latest Nov 14, 2024 (4 filings since Feb 14, 2022)
  • Deep Track Capital, LP Filed SC 13G/A on Dyne Therapeutics, Inc., latest Nov 14, 2024 (6 filings since Jan 20, 2022)
  • Dyne Therapeutics, Inc. Waltham, Massachusetts

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

What it owns

What Dyne 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$32.8M2 Dec 31, 2025$12.2M2 Dec 31, 2024+169.1%
Accumulated depreciation$8.7M2 Dec 31, 2025$6.8M2 Dec 31, 2024+28.8%
Property and equipment, net$24.0M2 Dec 31, 2025$5.4M2 Dec 31, 2024+345.1%
Operating-lease assets (leased space)$20.7M2 Dec 31, 2025$24.6M2 Dec 31, 2024−15.7%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$893.4M2 Dec 31, 2025$435.4M2 Dec 31, 2024+105.2%
Marketable securities, current$217.2M2 Dec 31, 2025$206.8M2 Dec 31, 2024+5.0%
Debt securities available for sale$217.2M2 Dec 31, 2025$83.9M7 Dec 31, 2022+159.0%

Properties, in its own words

Our principal facilities are located at 1560 Trapelo Road, Waltham, Massachusetts, where we lease and occupy approximately 68,000 square feet of office and laboratory space. The current term of our lease expires in March 2030, with an option to extend the lease for two successive five-year terms. We believe our facilities are adequate and suitable for our current needs and that should it be needed, suitable additional or alternative space will be available to accommodate our operations.

Item 2 of the 10-K filed Mar 2, 2026.4

Leadership

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

Chief executive

  1. Joshua T. Brumm2024

President

  1. Joshua T. Brumm2024

Chief financial officer

  1. Erick Lucera2025–now

Chief operating officer

  1. Susanna Gatti High2020–2024
2025
Board members and other officers (18)

Timeline

  1. Sep 29, 20268-K Regulation FD disclosure; Other events33
  2. Jul 29, 20268-K Results of operations34
  3. Jul 22, 20268-K Entered a material agreement; Other events35
  4. Jul 20, 20268-K Other events36
  5. Jun 22, 20268-K Executive or director change37
  6. Jun 17, 20268-K Entered a material agreement; New debt or obligation38
  7. Jun 8, 20268-K Shareholder vote39
  8. Jun 3, 20268-K Regulation FD disclosure; Other events40
  9. May 11, 20268-K Results of operations41
  10. Mar 2, 20268-K Results of operations42
  11. Jan 12, 20268-K Results of operations; Regulation FD disclosure43
  12. Dec 23, 20258-K Executive or director change44
  13. Jan 4, 2024New chief executive Joshua T. Brumm becomes CEO13

Calendar

Coming up

  1. Nov 4, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.76) a share, on Nov 5, 2025.45

When it reported results

  1. Jul 29, 2026Reported quarterly or annual results34
  2. May 11, 2026Reported quarterly or annual results41
  3. Mar 2, 2026Reported quarterly or annual results42
  4. Jan 12, 2026Reported quarterly or annual results43
  5. Nov 5, 2025Reported quarterly or annual results46
  6. Jul 28, 2025Reported quarterly or annual results47
  7. May 8, 2025Reported quarterly or annual results48
  8. Feb 27, 2025Reported quarterly or annual results49

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

Filings

688 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 56 major events, 304 insider forms, 61 large holders, 247 other. The latest 20:

  1. Oct 6, 20264 EDGAR
  2. Sep 29, 20268-K EDGAR
  3. Sep 8, 2026144 EDGAR
  4. Sep 8, 2026144 EDGAR
  5. Sep 8, 20264 EDGAR
  6. Sep 8, 20264 EDGAR
  7. Sep 8, 20264 EDGAR
  8. Sep 4, 2026144 EDGAR
  9. Aug 17, 20264 EDGAR
  10. Aug 17, 20264 EDGAR
  11. Aug 17, 20264 EDGAR
  12. Aug 17, 20264 EDGAR
  13. Aug 17, 20264 EDGAR
  14. Aug 14, 2026144 EDGAR
  15. Aug 14, 2026144 EDGAR
  16. Aug 14, 2026144 EDGAR
  17. Aug 13, 2026144 EDGAR
  18. Aug 13, 2026144 EDGAR
  19. Aug 13, 2026144 EDGAR
  20. Aug 13, 2026SCHEDULE 13G/A EDGAR

The 688 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

279 open-market trades by officers, directors and large owners since October 2021: 12 buys and 267 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 8, 2026Friedl-Naderer JohannaChief Commercial OfficerSale185$18.88$3.5KForm 4
Sep 8, 2026Kerr DouglasChief Medical OfficerSale1,290$18.88$24.4KForm 4
Sep 8, 2026Cox JohnCEO & PresidentSale5,658$18.88$106.8KForm 4
Sep 4, 2026Friedl-Naderer JohannaChief Commercial OfficerSale900$24.35$21.9KForm 4
Sep 4, 2026Kerr DouglasChief Medical OfficerSale3,745$24.35$91.2KForm 4
Aug 14, 2026Rhodes Jason PDirectorSale2,160,516$25.00$54.0MForm 4
Aug 13, 2026Friedl-Naderer JohannaChief Commercial OfficerSale226$26.28$5.9KForm 4
Aug 13, 2026Kerr DouglasChief Medical OfficerSale1,556$26.28$40.9KForm 4
Aug 13, 2026Lucera ErickChief Financial OfficerSale1,797$26.28$47.2KForm 4
Aug 13, 2026Rhodes Jason PDirectorSale426,412$26.20$11.2MForm 4
Aug 13, 2026Cox JohnCEO & PresidentSale4,986$26.28$131.0KForm 4
Jul 27, 2026Kersten DirkDirectorSale261,460$25.51$6.7MForm 4
Jul 7, 2026Rhodes Jason PDirectorSale297,211$23.26$6.9MForm 4
Jul 6, 2026Rhodes Jason PDirectorSale480,240$22.79$10.9MForm 4
Jun 29, 2026Rhodes Jason PDirectorSale195,427$21.14$4.1MForm 4
Jun 26, 2026Rhodes Jason PDirectorSale309,268$21.28$6.6MForm 4
Jun 25, 2026Rhodes Jason PDirectorSale24,100$21.10$508.5KForm 4
Jun 25, 2026Lucera ErickChief Financial OfficerSale2,362$20.37$48.1KForm 4
Jun 24, 2026Rhodes Jason PDirectorSale95,900$21.02$2.0MForm 4
Jun 23, 2026Rhodes Jason PDirectorSale147,760$21.13$3.1MForm 4

All 279 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
2025Erick Lucera58$392.0K$2.7M66
2025John G. Cox63$721.0K$2.1M66
2025Johanna Friedl-Naderer58$610.7K$1.1M66
2025Douglas Kerr$537.0K$1.1M66
2025Oxana Beskrovnaya$531.5K$992.6K66
2025Richard Scalzo$107.5K$727.6K66
2024President and Chief Executive Officer$537.0K$20.7M66
2024Chief Commercial Officer$171.2K$8.2M66
2024Chief Medical Officer$172.8K$7.7M66
2024Chief Innovation Officer;$506.0K$3.8M66
2024Former Senior Vice PresidentHead of Finance and Administration$403.0K$2.5M66
2023Former Chief Scientific Officer$477.1K$2.0M66

SEC filer profile

How Dyne 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 EDGARDyne Therapeutics, Inc.1
  • CIK0001818794
  • Employer ID (EIN)36-48839094
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address1560 Trapelo Road, Waltham, MA 024511
  • Phone(781) 786-82301
  • Shares outstanding186,746,431 as of Jul 24, 202611
  • Public float$948.0M as of Jun 30, 20254
  • AuditorDeloitte & Touche LLP, Boston, Massachusetts PCAOB ID 34; it also attests to the company’s internal control over financial reporting4
  • On EDGAR sinceJul 23, 20201
  • Filings793 in all: 4 (328), 144 (207), 8-K (65), 3 (29), SC 13G/A (26), SCHEDULE 13G/A (23), 10-Q (18), SC 13G (16)1
    All 34 form types

    424B5 (11), S-8 (10), CORRESP (7), 10-K (6), DEF 14A (6), DEFA14A (6), ARS (4), UPLOAD (4), EFFECT (3), SCHEDULE 13G (3), 4/A (2), 424B4 (2), DRS (2), S-1 (2), S-1MEF (2), 3/A (1), 8-A12B (1), CERT (1), D (1), PRE 14A (1), S-1/A (1), S-3 (1), S-3ASR (1), S-3MEF (1), SC 13D (1), SC 13D/A (1)

  • Latest filingsAnnual report (10-K) Mar 2, 2026
    Quarterly report (10-Q) Jul 29, 2026
    Proxy statement (DEF 14A) Apr 23, 2026
    Latest 8-K (8-K) Sep 29, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 par value per shareDYNNasdaq Global Select Market

From the cover page of the 10-K filed Mar 2, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Dyne Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 2, 2026: 71 risks under these headings, as written.4

  • Risks related to our financial position and need for additional capital
  • We have incurred significant losses since our inception, have no products approved for sale and we expect to incur losses for the foreseeable future.
  • We have never generated revenue from product sales and may never achieve or maintain profitability.
  • We will need substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development activities or 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 limited operating history may make it difficult to evaluate the success of our business to date and to assess our future viability.
  • Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be subject to limitations.
  • Risks related to our indebtedness
  • Our Loan Agreement contains restrictive and financial covenants that may limit our operating flexibility.
  • Our failure to comply with the covenants or other terms of the Loan Agreement, including as a result of events beyond our control, could result in a default under the Loan Agreement that could materially and adversely affect our business.
  • Risks related to discovery and development
  • Our product candidates are in varying stages of preclinical and clinical development and we have not completed clinical development of any product candidate. We do not expect to complete the
The other 62 risks
  • commercialization of any product candidate at least until 2027, if ever. If we are unable to identify and advance product candidates through preclinical studies and clinical trials, obtain marketing approval and ultimately commercialize them, or experience significant delays in doing so, our business will be materially harmed.
  • We may encounter substantial delays in commencement, enrollment or completion of our clinical trials and the data from the clinical trials of our product candidates may fail to demonstrate sufficient safety and efficacy to the satisfaction of applicable regulatory authorities, which could prevent us from commercializing any product candidates on a timely basis, if at all.
  • Our approach to the discovery and development of product candidates based on our FORCE platform is unproven, and we may not be successful in our efforts to identify, discover or develop potential product candidates.
  • The outcome of preclinical studies and data from earlier-stage clinical trials may not be predictive of final results or future results of clinical trials or the success of later clinical trials and data from clinical trials in one indication may not be predictive of results of clinical trials in other indications.
  • If we experience delays or difficulties in the enrollment of patients in clinical trials, our ability to complete clinical trials may be adversely impacted.
  • If any product candidates we may develop cause undesirable side effects or have other unexpected adverse properties, such side effects or properties could delay or prevent us from conducting clinical trials or seeking or obtaining regulatory approval, limit the commercial potential of our product candidates or result in significant negative consequences to the extent such effects or adverse properties are observed following any marketing approval.
  • We may expend our limited resources to pursue a particular program, product candidate or indication and fail to capitalize on programs, product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Clinical trial and product liability lawsuits against us could divert our resources, could cause us to incur substantial liabilities and could limit commercialization of our product candidates.
  • Risks related to our dependence on third parties
  • We rely, and expect to continue to rely, on third parties to conduct some or all aspects of our product manufacturing, or our research and preclinical and clinical testing, and these third parties may not perform satisfactorily.
  • We currently depend on a small number of third-party suppliers for the manufacture of our Fab, the linkers and payloads. The loss of these or future third-party suppliers, or their inability to provide us with sufficient supply, could harm our business.
  • We may from time to time be dependent on single-source suppliers for some of the components and materials used in the product candidates we may develop.
  • We may enter into collaborations with third parties for the research, development and commercialization of certain of the product candidates we may develop. If any such collaborations are not successful, we may not be able to capitalize on the market potential of those product candidates.
  • If conflicts arise between us and our potential collaborators, these parties may act in a manner adverse to us and could limit our ability to implement our strategies.
  • If we are not able to establish collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans.
  • We are dependent on third-party vendors to provide certain licenses, products and services and our business and operations, including clinical trials, could be disrupted by any problems with our significant third-party vendors.
  • Risks related to commercialization
  • We face substantial competition, which may result in others discovering, developing or commercializing products before us or more successfully than we do.
  • Even if any product candidate that we may develop receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payers and others in the medical community necessary for commercial success.
  • If the market opportunities for any product candidates we develop are smaller than we believe they are, our revenue may be adversely affected, and our business may suffer. Because the target patient populations of our programs are small, and the addressable patient population even smaller, we must be able to successfully identify patients and capture a significant market share to achieve profitability and growth.
  • The pricing, insurance coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for our future product candidates, if approved, could limit our ability to market those products and decrease our ability to generate product revenue.
  • If we are unable to establish sales, marketing and distribution capabilities or enter into sales, marketing and distribution agreements with third parties, we may not be successful in commercializing any product candidates we may develop if and when they are approved.
  • The biologic product candidates for which we intend to seek approval may face competition sooner than anticipated.
  • Risks related to our intellectual property
  • If we or our licensors are unable to obtain, maintain and defend patent and other intellectual property protection for any product candidates or technology, or if the scope of the patent or other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully develop and commercialize any product candidates we may develop or our technology may be adversely affected due to such competition.
  • Our rights to develop and commercialize any product candidates are subject and may in the future be subject, in part, to the terms and conditions of licenses granted to us by third parties. If we fail to comply with our obligations under our current or future intellectual property license agreements or otherwise experience disruptions to our business relationships with our current or any future licensors, we could lose intellectual property rights that are important to our business.
  • 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, 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 successful in obtaining necessary rights to product candidates we may develop through acquisitions and in-licenses.
  • Issued patents covering any product candidates we may develop could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could harm our business.
  • Intellectual property litigation or other proceedings could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • 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 we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be harmed.
  • We may be subject to claims challenging the inventorship or ownership of our patent and other intellectual property rights.
  • 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.
  • Intellectual property rights do not necessarily address all potential threats.
  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor or other third party will discover our trade secrets or that our trade secrets will be misappropriated or disclosed.
  • Risks related to regulatory approval and other regulatory and legal compliance matters
  • Even if we complete the necessary preclinical studies and clinical trials, the marketing approval process is expensive, time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization of any product candidates we may develop. If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize, or will be delayed in commercializing, product candidates we may develop, and our ability to generate revenue will be materially impaired.
  • Obtaining and maintaining marketing approval or commercialization of our product candidates in the United States does not mean that we will be successful in obtaining marketing approval of our product candidates in other jurisdictions. Failure to obtain marketing approval in foreign
  • jurisdictions would prevent any product candidates we may develop from being marketed in such jurisdictions, which, in turn, would materially impair our ability to generate revenue.
  • We are conducting and intend to conduct certain of our clinical trials globally. However, the FDA and other foreign equivalents may not accept data from such trials, in which case our development plans will be delayed, which could materially harm our business.
  • Fast Track designation by the FDA may not actually lead to a faster development or regulatory review or approval process and does not assure FDA approval of any product candidates we may develop.
  • Breakthrough or RMAT therapy designation by the FDA may not lead to a faster regulatory review or approval process and, in any event, does not assure FDA approval of any product candidates we may develop.
  • Priority review designation by the FDA may not lead to a faster regulatory review or approval process and, in any event, does not assure FDA approval of any product candidates we may develop.
  • We may not be able to obtain orphan drug exclusivity for product candidates we may develop, and even if we do, that exclusivity may not prevent regulatory authorities from approving other competing products.
  • Even if we, or any collaborators we may have, obtain marketing approvals for any product candidates we may develop, the terms of approvals and ongoing regulation of our products could require the substantial expenditure of resources and may limit how we, or they, manufacture and market our products, which could materially impair our ability to generate revenue.
  • Any product candidate we may develop for which we obtain marketing approval will be subject to restrictions, such as the laws and regulations prohibiting the promotion of off-label uses, or may need to be withdrawn from the market, and we may be subject to substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our medicines, when and if any of them are approved.
  • We and our contract manufacturers are subject to significant regulation. The manufacturing facilities on which we rely may not continue to meet regulatory requirements, which could materially harm our business.
  • Our relationships with healthcare providers, physicians and third-party payers 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.
  • Legislative and regulatory changes may increase the difficulty and cost for us and any future collaborators to obtain reimbursement for our product candidates, if and when approved.
  • The prices of prescription pharmaceuticals in the United States and foreign jurisdictions are subject to considerable legislative and executive actions and could impact the prices we obtain for our products, if and when approved.
  • We are subject to stringent privacy laws, information security laws, regulations, policies and contractual obligations related to data privacy and security and changes in such laws, regulations, policies, and contractual obligations and failure to comply with such requirements could subject us to significant fines and penalties, which may have a material adverse effect on our business, financial condition, results of operations or prospects.
  • Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
  • Laws and regulations governing any international operations we may have may preclude us from developing, manufacturing and selling certain product candidates outside of the United States or adversely impact our ability to operate our business outside the United States. In addition, changes in and uncertainty surrounding U.S. trade policy could have a material adverse impact on our business, financial condition and results of operations.
  • Changes in and uncertainty surrounding United States trade policy could have a material adverse impact on our business, financial condition and results of operations.
  • If we or any contract manufacturers and suppliers we engage fail to comply with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur significant costs.
  • Disruptions at the FDA and other government agencies from funding cuts, personnel losses, regulatory reforms, government shutdowns and other developments could hinder our ability to obtain guidance from the FDA regarding our clinical development programs and develop and secure approval of our product candidates in a timely manner, which would negatively impact our business.
  • Risks related to employee matters, managing growth and other operational matters
  • Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
  • We expect to expand our development and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • Future acquisitions or strategic alliances could disrupt our business and harm our financial condition and results of operations.
  • Our internal information technology systems, or those of our vendors, collaborators or other contractors or consultants, may fail or suffer security breaches, loss or leakage of data and other disruptions or compromise, which could result in a material disruption of our product development programs, compromise sensitive information related to our business or prevent us from accessing critical information, trigger contractual and legal obligations, potentially exposing us to liability, reputational harm or otherwise adversely affecting our business and financial results.
  • Our operations or those of the third parties upon whom we depend might be affected by the occurrence of a natural disaster, pandemic or other catastrophic event.
  • Risks related to ownership of our common stock and our status as a public company
  • The price of our common stock is volatile and fluctuates substantially, which could result in substantial losses for our stockholders.

Legal proceedings

We are not currently subject to any material legal proceedings.

The opening of Item 3, Legal Proceedings.4

Sources

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    SEC EDGAROther events
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