TRDA on Nasdaq

Entrada Therapeutics, Inc.

In its 2026 annual report the company says: “We are a clinical-stage biopharmaceutical company aiming to transform the lives of patients by e stablishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. Through proprietary, versatile and modular approaches, we are advancing a robust development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases, among others.”4 It is headquartered in Boston, Massachusetts.1 Its shares trade on Nasdaq under the symbol TRDA.1

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Last updated Oct 21, 2026.

Overview

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  • TickerTRDA on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersBoston, Massachusetts1
  • Incorporated inDE2
  • Business addressOne Design Center Place, Suite 17-500, Boston, Ma 022102
  • Filer category, Emerging growth company2

We are a clinical-stage biopharmaceutical company aiming to transform the lives of patients by e stablishing a new class of medicines that engage intracellular targets that have long been considered inaccessible . Through proprietary, versatile and modular approaches, we are advancing a robust development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases, among others. In 2026, we expect to progress our ENTR-601-44 and ENTR-601-45 clinical trials, an EU filing for the ENTR-601-50 clinical trial, and regulatory submissions for ENTR-601-51. In addition, our VX-670 partnership with Vertex Pharmaceuticals Incorporated (“Vertex”) continues to progress, with dosing completion anticipated in mid-2026. We anticipate reporting on the results of two cohorts of patient data from our ENTR-601-44 program, and one from our ENTR-601-45 program du…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

-621.1%Operating margin5
-565.5%Net margin5
-87.9%Revenue growth, 20255
-47.0%Return on equity5
-$129.6MFree cash flow5

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development99¢$142.3M
  • Income tax1¢$924.0K

Out of $25.4M in revenue.5 The company lost money this year.

Financial statements

Revenue65$25.4M in 2025−80% since 2023
0$100.0M$200.0M$300.0M2023: $129.0M$129.0M20232024: $210.8M$210.8M2024+63%2025: $25.4M$25.4M2025−88%
Operating income78965-$157.9M in 2025+492% since 2020
-$200.0M-$100.0M0$100.0M2020: -$26.7M-$26.7M20202021: -$51.1M-$51.1M2021+92%2022: -$97.2M-$97.2M2022+90%2023: -$3.2M-$3.2M2023−97%2024: $47.0M$47.0M20242025: -$157.9M-$157.9M2025
Net income78965-$143.8M in 2025+442% since 2020
-$200.0M-$100.0M0$100.0M2020: -$26.5M-$26.5M20202021: -$51.2M-$51.2M2021+93%2022: -$94.6M-$94.6M2022+85%2023: -$6.7M-$6.7M2023−93%2024: $65.6M$65.6M20242025: -$143.8M-$143.8M2025

Every line of the income statement as filed: the last 2 fiscal years, latest first.5

Period ending2025-12-312024-12-31
Collaboration revenue$25.4M$210.8M
Research and development$142.3M$125.3M
General and administrative$41.0M$38.5M
Total operating expenses$183.3M$163.8M
(Loss) income from operations-$157.9M$47.0M
Interest and other income$15.1M$19.5M
Total other income$15.1M$19.5M
(Loss) income before provision for income taxes-$142.8M$66.5M
Total income tax provision$924.0K$859.0K
Net (loss) income-$143.8M$65.6M
Net (loss) income per share, basic (in dollars per share)-$3.47$1.76
Net (loss) income per share, diluted (in dollars per share)-$3.47$1.68
Weighted-average common shares outstanding, basic (in shares)41.4M shares37.3M shares
Weighted-average common shares outstanding, diluted (in shares)41.4M shares39.0M shares
Unrealized gain (loss) on marketable securities, net of tax of $0$695.0K-$238.0K
Total other comprehensive income (loss)$695.0K-$238.0K
Total comprehensive (loss) income-$143.1M$65.4M
Unrealized (loss) gain on marketable securities, tax$0$0

Compare Entrada Therapeutics, Inc. with another company

Corporate structure

Entrada Therapeutics, Inc. sits at the top of its group. 2 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Entrada Therapeutics, Inc.

  • MPM BioVentures 2014, L.P. Filed SCHEDULE 13D/A on Entrada Therapeutics, Inc., latest Sep 10, 2026 (2 filings since Nov 12, 2021)
  • TCG Crossover GP I, LLC Filed SCHEDULE 13G/A on Entrada Therapeutics, Inc., latest Aug 14, 2026 (2 filings since Nov 25, 2025)
  • 5AM Ventures V, L.P. Filed SCHEDULE 13D/A on Entrada Therapeutics, Inc., latest Nov 18, 2025 (2 filings since Nov 12, 2021)
  • PRICE T ROWE ASSOCIATES INC /MD/ Filed SCHEDULE 13G/A on Entrada Therapeutics, Inc., latest Nov 14, 2025 (6 filings since Feb 14, 2022)
  • Janus Henderson Group Ltd. Filed SCHEDULE 13G/A on Entrada Therapeutics, Inc., latest Aug 14, 2025 (3 filings since Feb 14, 2025)
  • ROCHE FINANCE LTD Filed SCHEDULE 13G/A on Entrada Therapeutics, Inc., latest Feb 14, 2025 (3 filings since Feb 14, 2022)
  • BlackRock Filed SCHEDULE 13G on Entrada Therapeutics, Inc., latest Feb 4, 2025
  • BAKER BROS. ADVISORS LP Filed SC 13D/A on Entrada Therapeutics, Inc., latest Jun 26, 2024 (3 filings since Nov 10, 2021)
  • Redmile Group, LLC Filed SC 13G/A on Entrada Therapeutics, Inc., latest Feb 14, 2024 (3 filings since Feb 14, 2022)
  • Wellington Management Company Filed SC 13G/A on Entrada Therapeutics, Inc., latest Feb 6, 2023 (2 filings since Feb 4, 2022)
  • MRL Ventures Fund LLC Filed SC 13G on Entrada Therapeutics, Inc., latest Feb 8, 2022
  • Entrada Therapeutics, Inc. Boston, Massachusetts
    • Entrada Securities Corporation Subsidiary · Massachusetts, United States

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Entrada 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$17.2M5 Dec 31, 2025$20.4M5 Dec 31, 2024−15.3%
Accumulated depreciation$9.9M5 Dec 31, 2025$9.4M5 Dec 31, 2024+5.4%
Property and equipment, net$7.3M5 Dec 31, 2025$10.9M5 Dec 31, 2024−33.1%
Operating-lease assets (leased space)$60.5M5 Dec 31, 2025$71.1M5 Dec 31, 2024−15.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$90.4M5 Dec 31, 2025$101.2M5 Dec 31, 2024−10.7%

Properties, in its own words

Our corporate headquarters are located in Boston, Massachusetts, where we lease a facility containing approximately 81,229 square feet of office, research and development and laboratory space. The lease expires in February 2033, subject to an option to extend the lease for five additional years.

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 Feb 26, 2026.4

Leadership

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

Board members and other officers (11)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Entrada Securities Corporation Massachusetts3

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

Former names

  • CycloPorters, Inc.Nov 10, 2016 to Nov 10, 20162

Timeline

  1. Oct 14, 20268-K Regulation FD disclosure; Other events27
  2. Aug 5, 20268-K Results of operations28
  3. Jun 10, 20268-K Executive or director change; Shareholder vote29
  4. May 19, 20268-K Regulation FD disclosure30
  5. May 7, 20268-K Results of operations; Regulation FD disclosure31
  6. Feb 26, 20268-K Results of operations32
  7. Jan 8, 20268-K Results of operations; Regulation FD disclosure; Other events33
  8. Nov 6, 20258-K Results of operations34
  9. Aug 6, 20258-K Results of operations35
  10. Jun 11, 20258-K Shareholder vote36
  11. Jun 3, 20258-K Executive or director change; Regulation FD disclosure37
  12. May 8, 20258-K Results of operations38
  13. Oct 28, 2021New chief executive Dipal Doshi becomes CEO12

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($1.06) a share, on Nov 6, 2025.39

When it reported results

  1. Aug 5, 2026Reported quarterly or annual results28
  2. May 7, 2026Reported quarterly or annual results31
  3. Feb 26, 2026Reported quarterly or annual results32
  4. Jan 8, 2026Reported quarterly or annual results33
  5. Nov 6, 2025Reported quarterly or annual results34
  6. Aug 6, 2025Reported quarterly or annual results35
  7. May 8, 2025Reported quarterly or annual results38
  8. Feb 27, 2025Reported quarterly or annual results40

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

Filings

462 filings to the SEC since October 2021: 6 annual reports, 16 quarterly reports, 51 major events, 242 insider forms, 28 large holders, 119 other. The latest 20:

  1. Oct 14, 20268-K EDGAR
  2. Sep 10, 2026SCHEDULE 13D/A EDGAR
  3. Sep 9, 20264 EDGAR
  4. Sep 9, 20264 EDGAR
  5. Sep 3, 20264 EDGAR
  6. Sep 3, 20264 EDGAR
  7. Sep 3, 20264 EDGAR
  8. Sep 3, 20264 EDGAR
  9. Sep 3, 20264 EDGAR
  10. Sep 3, 20264 EDGAR
  11. Aug 31, 20264 EDGAR
  12. Aug 31, 20264 EDGAR
  13. Aug 26, 20264 EDGAR
  14. Aug 26, 20264 EDGAR
  15. Aug 14, 2026SCHEDULE 13G/A EDGAR
  16. Aug 10, 2026144/A EDGAR
  17. Aug 10, 20264 EDGAR
  18. Aug 10, 20264 EDGAR
  19. Aug 5, 202610-Q EDGAR
  20. Aug 5, 20268-K EDGAR

The 462 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

213 open-market trades by officers, directors and large owners since October 2021: 33 buys and 180 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 9, 2026MPM BioVentures 2018 GP LLC10% ownerSale28,837$7.13$205.6KForm 4
Sep 9, 2026MPM BIOVENTURES 2018 (B), L.P.10% ownerSale28,837$7.13$205.6KForm 4
Sep 8, 2026MPM BioVentures 2018 GP LLC10% ownerSale192,500$7.41$1.4MForm 4
Sep 8, 2026MPM BIOVENTURES 2018 (B), L.P.10% ownerSale192,500$7.41$1.4MForm 4
Sep 4, 2026MPM BioVentures 2018 GP LLC10% ownerSale38,500$7.11$273.7KForm 4
Sep 4, 2026MPM BIOVENTURES 2018 (B), L.P.10% ownerSale38,500$7.11$273.7KForm 4
Sep 3, 2026MPM BioVentures 2018 LLC10% ownerSale32,263$7.17$231.3KForm 4
Sep 3, 2026MPM BioVentures 2014 GP LLC10% ownerSale32,263$7.17$231.3KForm 4
Sep 2, 2026MPM BioVentures 2018 LLC10% ownerSale25,131$7.19$180.7KForm 4
Sep 2, 2026MPM BioVentures 2014 GP LLC10% ownerSale25,131$7.19$180.7KForm 4
Sep 1, 2026MPM BioVentures 2018 LLC10% ownerSale29,088$7.06$205.4KForm 4
Sep 1, 2026MPM BioVentures 2014 GP LLC10% ownerSale29,088$7.06$205.4KForm 4
Aug 31, 2026MPM BioVentures 2018 LLC10% ownerSale44,259$6.99$309.4KForm 4
Aug 31, 2026MPM BioVentures 2014 (B), L.P.10% ownerSale44,259$6.99$309.4KForm 4
Aug 28, 2026MPM BioVentures 2018 LLC10% ownerSale3,733$7.01$26.2KForm 4
Aug 28, 2026MPM BioVentures 2014 (B), L.P.10% ownerSale3,733$7.01$26.2KForm 4
Aug 27, 2026MPM BioVentures 2018 LLC10% ownerSale38,922$7.20$280.2KForm 4
Aug 27, 2026MPM BioVentures 2014 (B), L.P.10% ownerSale38,922$7.20$280.2KForm 4
Aug 26, 2026Foley Todd10% ownerSale14,569$7.06$102.9KForm 4
Aug 26, 2026MPM BioVentures 2018 LLC10% ownerSale14,569$7.06$102.9KForm 4

All 213 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
2025Dipal Doshi50$635.0K$3.8M52
2025Natarajan Sethuraman Ph. D.64$520.0K$2.3M52
2025Nathan J. Dowden56$499.2K$2.2M52
2024Chief Executive Officer$610.0K$3.9M52
2024President andChief Operating Officer$480.0K$2.5M52
2024President of Research and Development$493.2K$2.0M52

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
Baker Bros. Advisors LP5,072,730$37.3M0.2%No change
5AM Venture Management, LLC4,056,379$29.9M10.4%No change
BlackRock, Inc.2,583,333$19.0M0.0%+224,540
Merck & Co., Inc.1,739,768$12.8M2.4%New
Vanguard Capital Management LLC1,269,634$9.3M0.0%+13,621
Mpm Bioimpact LLC1,253,053$9.2M0.6%New
TCG Crossover Management, LLC1,060,230$7.8M0.2%−1,227,270
Wellington Management Group Llp954,419$7.0M0.0%−80,363
Millennium Management LLC763,959$5.6M0.0%+244,603
StepStone Group LP761,277$5.6M0.3%No change
Geode Capital Management, LLC717,430$5.3M0.0%+50,083
Aqr Capital Management LLC699,537$5.1M0.0%+620,044
Nantahala Capital Management, LLC601,150$4.4M0.1%+441,818
State Street Corp596,677$4.4M0.0%+62,879
Jpmorgan Chase & Co496,457$3.8M0.0%+481,610
Citadel Advisors LLC394,323$2.9M0.0%+179,305
Dimensional Fund Advisors LP376,136$2.8M0.0%+51,665
Northern Trust Corp309,942$2.3M0.0%+74,950
Jacobs Levy Equity Management, Inc303,459$2.2M0.0%−30,455
Vanguard Portfolio Management LLC254,130$1.9M0.0%+33,636
Charles Schwab Investment Management Inc197,136$1.5M0.0%−17,615
Longaeva Partners L.P.195,237$1.4M0.0%−9,741
Morgan Stanley191,650$1.4M0.0%+15,524
Renaissance Technologies LLC191,000$1.4M0.0%−11,084
Quantinno Capital Management LP188,839$1.4M0.0%+117,821

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

SEC filer profile

How Entrada 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 EDGAREntrada Therapeutics, Inc.1
  • CIK0001689375
  • Employer ID (EIN)81-39833994
  • Filer statusAccelerated filer an emerging growth company; 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 addressOne Design Center Place, Suite 17-500, Boston, MA 022101
  • Phone857-305-18251
  • Shares outstanding38,936,669 as of Jul 31, 202611
  • Public float$191.2M as of Jun 30, 20254
  • AuditorErnst & Young LLP, Boston, Massachusetts PCAOB ID 42; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceNov 10, 20161
  • Filings472 in all: 4 (215), 144 (69), 8-K (51), 3 (20), 10-Q (15), CORRESP (7), DEFA14A (7), S-8 (7)1
    All 40 form types

    SC 13G/A (7), 4/A (6), SC 13G (6), SCHEDULE 13G/A (6), UPLOAD (6), 10-K (5), DEF 14A (5), ARS (4), D (3), EFFECT (3), SC 13D (3), SCHEDULE 13G (3), 424B5 (2), S-3 (2), SCHEDULE 13D/A (2), SEC STAFF LETTER (2), 10-K/A (1), 10-Q/A (1), 144/A (1), 3/A (1), 424B4 (1), 8-A12B (1), CERT (1), D/A (1), DRS (1), DRS/A (1), DRSLTR (1), PRE 14A (1), S-1 (1), S-1/A (1), S-1MEF (1), SC 13D/A (1)

  • Latest filingsAnnual report (10-K) Feb 26, 2026
    Quarterly report (10-Q) Aug 5, 2026
    Proxy statement (DEF 14A) Apr 24, 2026
    Latest 8-K (8-K) Oct 14, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per shareTRDAThe Nasdaq Global Market

From the cover page of the 10-K filed Feb 26, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Entrada Therapeutics, Inc. names in Item 1A of its 10-K filed Feb 26, 2026: 76 risks under these headings, as written.4

  • Risks Related to Our Limited Operating History, Financial Position and Capital Requirements
  • We have a limited operating history, have incurred significant operating losses since our inception and expect to incur significant losses for the foreseeable future. We may never generate any revenue from product sales or become profitable or, if we achieve profitability, we may not be able to sustain it.
  • We will require additional financing to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our development programs, commercialization efforts or other operations.
  • Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or our guidance.
  • Risks Related to the Discovery, Development and Regulatory Approval of Our Therapeutic Candidates
  • We are early in our development efforts and as a result it will be years before we commercialize a therapeutic candidate, if ever. If we are unable to identify and advance therapeutic candidates through preclinical studies and/or clinical trials, obtain marketing approval and ultimately commercialize them, or experience significant delays in doing so, our business will be materially harmed.
  • Our business is highly dependent on the clinical advancement of our programs and modalities and is especially dependent on the success of our lead therapeutic candidates, ENTR-601-44, ENTR-601-45, ENTR-601-50,
  • ENTR-601-51, ENTR-801 and our partnered candidate VX-670. Delay or failure to advance programs or modalities, including ENTR-601-44, ENTR-601-45, ENTR-601-50, ENTR-601-51, ENTR-801 and VX-670 could adversely impact our business.
  • Our EEV therapeutic candidates are based on a novel therapeutic approach, which makes it difficult to predict the time and cost of development and of subsequently obtaining regulatory approval, if at all.
  • Preclinical and clinical development involves a lengthy and expensive process with an uncertain outcome, and the results of preclinical studies are not necessarily predictive of the results of later preclinical studies and any clinical trials of our therapeutic candidates. We have not yet completed the testing of any of our therapeutic candidates in clinical
  • trials and our therapeutic candidates may not have favorable results in clinical trials or receive regulatory approval on a timely basis, if at all.
  • Substantial delays in the commencement, enrollment or completion of our planned clinical trials, or failure to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities could prevent us from commercializing any therapeutic candidates we determine to develop on a timely basis, if at all.
The other 64 risks
  • Delays or difficulties in the enrollment of patients in clinical trials could delay or prevent our receipt of necessary regulatory approvals.
  • Use of our therapeutic candidates could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude approval, cause us to suspend or discontinue clinical trials, abandon a therapeutic candidate, limit the commercial profile of an approved label or result in other significant negative consequences that could severely harm our business, prospects, operating results and financial condition.
  • Our therapeutic candidates are subject to extensive regulation and compliance, which is costly and time-consuming, and such regulation may cause unanticipated delays or prevent the receipt of the required approvals to commercialize our therapeutic candidates.
  • Our approach to the discovery and development of therapeutic candidates that are based on our EEV Platform is unproven, and we do not know whether we will be able to develop any products of commercial value, or if competing technological approaches will limit the commercial value of our therapeutic candidates or render our EEV Platform obsolete.
  • Interim, topline and preliminary data from our preclinical studies and clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • We may expend our limited resources to pursue particular therapeutic candidates or indications, such as our initial focuses on developing ENTR-601-44 and ENTR-601-45, and fail to capitalize on therapeutic candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • We may not be successful in our efforts to expand our development portfolio of therapeutic candidates.
  • We have sought and may continue to seek Fast Track designation, Breakthrough Therapy designation and/or orphan drug designation from the FDA or similar designations from other regulatory authorities for one or more of our therapeutic candidates. Even if one or more of our therapeutic candidates receive any of these designations, we may be unable to obtain or maintain the benefits associated with such designation.
  • Although we have obtained rare pediatric disease designation for ENTR-601-44, we may not be eligible to receive a priority review voucher in the event the FDA determines we no longer meet the criteria for designation, revokes the designation or FDA approval does not occur prior to September 30, 2029.
  • Obtaining and maintaining marketing approval or commercialization of our therapeutic candidates in the United States does not mean that we will be successful in obtaining marketing approval of our therapeutic candidates in other jurisdictions. Failure to obtain marketing approval in foreign jurisdictions would prevent any therapeutic candidates we may develop from being marketed in such jurisdictions, which, in turn, would materially impair our ability to generate revenue.
  • The FDA, EMA and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction.
  • Changes in methods of therapeutic candidate manufacturing or formulation may result in additional costs or delay, which could adversely affect our business, results of operations and financial condition.
  • Even if we, or any collaborators we may have, obtain marketing approvals for any therapeutic candidates we may develop, the terms of approvals and ongoing regulation of our therapeutics could require the substantial expenditure of resources and may limit how we, or they, manufacture and market our therapeutics, which could materially impair our ability to generate revenue.
  • Clinical trial and product liability lawsuits against us could divert our resources, could cause us to incur substantial liabilities and could limit commercialization of any therapeutic candidates we may develop.
  • We may develop our current or future therapeutic candidates in combination with other therapies, which would expose us to additional risks.
  • Risks Related to Our Reliance on Third Parties
  • We rely, and expect to continue to rely, on third parties to conduct some or all aspects of our product manufacturing, research and preclinical and clinical testing, and these third parties may not perform satisfactorily.
  • 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.
  • Our EEV-based therapeutic candidates are based on novel technologies and any therapeutic candidates we develop may be complex and difficult to manufacture. We may encounter difficulties in manufacturing, product release, shelf life, testing, storage, supply chain management or shipping. If we or any of our third-party manufacturers encounter such difficulties, our ability to supply material for clinical trials or any approved product could be delayed or stopped.
  • 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 them or that our trade secrets will be misappropriated or disclosed.
  • We may from time to time be dependent on single- or limited-source suppliers for some of the components and materials used in the therapeutic candidates we may develop.
  • We have and may in the future enter into collaborations, licenses and other similar arrangements with third parties for the research, development and commercialization of certain of the therapeutic candidates we may develop, including our collaboration with Vertex. If any such arrangements are not successful, we may not be able to capitalize on the market potential of those therapeutic candidates.
  • If conflicts arise between us and our current or 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.
  • Risks Related to Commercialization of Our Therapeutic Candidates
  • The commercial success of our therapeutic candidates will depend upon the degree of market acceptance of such therapeutic candidates by physicians, patients, healthcare payors and others in the medical community.
  • Even if we are able to commercialize any of our therapeutic candidates, if approved, such therapeutic candidate may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which would harm our business.
  • We face significant competition, and if our competitors develop technologies or therapeutic candidates more rapidly than we do or their technologies are more effective, our business and our ability to develop and successfully commercialize products may be adversely affected.
  • Risks Related to Our Business Operations and Industry
  • Our future success depends on our ability to retain key employees and to attract, retain and motivate qualified personnel.
  • Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our therapeutic candidates and decrease the prices we may obtain.
  • Cybersecurity incidents, data breaches, loss or leakage of data and other disruptions or failures of our internal information technology systems, or those of our third-party CROs or other vendors, contractors or consultants could result in the disruption of our development programs, compromise sensitive information related to our business or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business.
  • A pandemic, epidemic or outbreak of an infectious disease may materially and adversely affect our business and could cause a disruption to the development of our therapeutic candidates.
  • Failure to comply with environmental, health and safety laws and regulations could subject us to fines or penalties or incur costs that could harm our business.
  • Our relationships with customers, third-party payors, physicians and healthcare providers will be subject to applicable anti-kickback, fraud and abuse, and other laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, and diminished profits.
  • Our employees and independent contractors, including principal investigators, CROs, consultants and vendors, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • We are subject to certain U.S. and certain foreign anti-corruption, anti-money laundering, export control, sanctions and other trade laws and regulations. We can face serious consequences for violations.
  • We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.
  • Legislation or other changes in U.S. tax law could adversely affect our business and financial condition.
  • Our ability to use our U.S. net operating loss carryforwards and certain other U.S. tax attributes may be limited.
  • We plan to distribute our technology, biology, execution and financing risks across a wide variety of therapeutic areas, disease states, programs, and technologies. However, our assessment of, and approach to, risk may not be comprehensive or effectively avoid delays or failures in one or more of our programs or modalities. Failures in one or more of our programs or modalities could adversely impact other programs or modalities in our development portfolio and have a material adverse impact on our business, results of operations and ability to fund our business.
  • While we will attempt to diversify our risks by developing one or more programs in each modality, there are risks that are unique to each modality and risks that are applicable across modalities. These risks may impair our ability to advance one or more of our programs in clinical development, obtain regulatory approval, or ultimately commercialize our programs, or cause us to experience significant delays in doing so, any of which may materially harm our business.
  • Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional counterparties, could adversely affect the Company’s current and projected business operations and its financial condition and results of operations.
  • The U.S. Congress, the Trump administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business.
  • Risks Related to Our Intellectual Property
  • If we or our collaborators are unable to obtain and maintain patent protection for our therapeutic programs and other proprietary technologies we develop, or if the scope of the patent 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 commercialize our therapeutic programs and other proprietary technologies we may develop may be adversely affected.
  • Our rights to develop and commercialize any therapeutic 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.
  • Issued patents covering any therapeutic candidates we may develop could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad.
  • 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.
  • Changes in patent law in the United States or worldwide could diminish the value of patents in general, thereby impairing our ability to protect any therapeutic candidates we may develop and our technology.
  • If we do not obtain patent term extension and data exclusivity for any therapeutic 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 we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may not be successful in obtaining necessary rights to any therapeutic candidate we may develop through acquisitions and in-licenses.
  • We may be subject to claims 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.
  • Third-party claims of intellectual property infringement, misappropriation or other violations against us or our collaborators may prevent or delay the development and commercialization of our therapeutic programs and other proprietary technologies we may develop.
  • We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
  • 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.
  • We partially depend on intellectual property licensed from third parties, and our licensors may not always act in our best interest. If we fail to comply with our obligations under our intellectual property licenses, if the licenses are terminated or if disputes regarding these licenses arise, we could lose significant rights that are important to our business.
  • We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development portfolio through acquisitions and in-licenses.
  • We, our collaborators and our service providers may be subject to a variety of privacy and data security laws and contractual obligations, which could increase compliance costs and our failure to comply with them could subject us to potentially significant fines or penalties and otherwise harm our business.
  • The use of new and evolving technologies, such as AI, in our offerings may result in spending material resources and presents risks and challenges that can impact our business including by posing security and other risks to our confidential information, proprietary information and personal information, and as a result we may be exposed to reputational harm and liability.
  • Use of open source software could impose limitations on us that may adversely affect our business.
  • 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.
  • Rights to improvements to our therapeutic candidates may be held by third parties.
  • 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.

Legal proceedings

From time to time, claims are made against the Company in the ordinary course of business, which could result in litigation. Claims and associated litigation are subject to inherent uncertainties, and unfavorable outcomes could occur. In the opinion of management, the resolution of these matters, if any, will not have a material adverse impact on the Company’s financial position or results of operations.

The opening of Item 3, Legal Proceedings.4

Sources

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