DTIL on Nasdaq

Precision BioSciences

Logo: precisionbiosciences.com5

American gene editing company

Precision BioSciences, Inc. is a publicly traded American clinical stage gene editing company headquartered in Durham, North Carolina. Founded in 2006, Precision is focused on developing both in vivo and ex vivo gene editing therapies using its proprietary "ARCUS" genome editing platform.3 Its shares trade on Nasdaq under the symbol DTIL.1 Wikipedia text CC BY-SA 4.0

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Last updated Oct 21, 2026.

Overview

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  • TickerDTIL on Nasdaq1
  • Industrybiotechnology industry1
  • HeadquartersDurham1
  • Websiteprecisionbiosciences.com
  • Incorporated inDE6
  • Business address302 East Pettigrew Street, Suite A-100, Durham, Nc 277016
  • Filer categoryNon-accelerated filer, Smaller reporting company6
  • Legal formCorporation4
  • LEI549300I5QGRS3BLHZH414
  • StatusActive4
  • LEI statusLapsed (not renewed)4
  • Registered addressC/O THE CORPORATION TRUST COMPANY, 19801 Wilmington, United States4
  • Registered withDivision of Corporations, Department of State, 41003844
Precision BioSciences image from its website
Image: precisionbiosciences.com8

Precision BioSciences, Inc. is a publicly traded American clinical stage gene editing company headquartered in Durham, North Carolina. Founded in 2006, Precision is focused on developing both in vivo and ex vivo gene editing therapies using its proprietary "ARCUS" genome editing platform.3

Financials

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

Key numbers, fiscal 2025

-152.2%Operating margin9
-133.4%Net margin9
-50.1%Revenue growth, 20259
-49.6%Return on equity9

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$54.2M

Out of $34.3M in revenue.9 The company lost money this year.

Financial statements

Revenue10111213149$34.3M in 2025+54% since 2019
0$50.0M$100.0M$150.0M2019: $22.2M$22.2M20192020: $24.3M$24.3M2020+9%2021: $115.5M$115.5M2021+376%2022: $25.1M$25.1M2022−78%2023: $48.7M$48.7M2023+94%2024: $68.7M$68.7M2024+41%2025: $34.3M$34.3M2025−50%
Operating income10111213149-$52.1M in 2025−40% since 2019
-$150.0M-$100.0M-$50.0M02019: -$87.2M-$87.2M20192020: -$109.8M-$109.8M2020+26%2021: -$39.4M-$39.4M2021−64%2022: -$62.3M-$62.3M2022+58%2023: -$43.7M-$43.7M2023−30%2024: -$26.2M-$26.2M2024−40%2025: -$52.1M-$52.1M2025+99%
Net income10111213149-$45.7M in 2025−51% since 2019
-$150.0M-$100.0M-$50.0M0$50.0M2019: -$92.9M-$92.9M20192020: -$109.0M-$109.0M2020+17%2021: -$30.6M-$30.6M2021−72%2022: -$111.6M-$111.6M2022+265%2023: -$61.3M-$61.3M2023−45%2024: $7.2M$7.2M20242025: -$45.7M-$45.7M2025

Every line of the income statement as filed: the last 2 fiscal years, latest first.9

Period ending2025-12-312024-12-31
Revenue$34.3M$68.7M
Research and development$54.2M$59.6M
General and administrative$32.2M$35.3M
Total operating expenses$86.4M$94.9M
Operating loss-$52.1M-$26.2M
Loss from equity method investment-$5.3M-$1.1M
(Loss) gain on changes in other fair value adjustments-$2.7M$258.0K
Gain on change in fair value of warrant liability$11.1M$29.6M
Interest expense$1.4M$1.8M
Interest income$4.2M$6.8M
Loss on disposal of assets-$421.0K-$436.0K
Impairment charges-$36.0K$0
Total other income$5.5M$33.3M
(Loss) income from continuing operations-$46.6M$7.2M
Gain from discontinued operations$885.0K$0
Net (loss) income-$45.7M$7.2M
Basic (in USD per shares)-$3.56$1.05
Diluted (in USD per shares)-$3.56$1.04
Basic (in shares)12.8M shares6.8M shares
Diluted (in shares)12.8M shares6.9M shares

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Corporate structure

Precision BioSciences 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 Precision BioSciences

  • Benjamin Weinstein Filed SCHEDULE 13G/A on Precision BioSciences, latest Aug 24, 2026 (2 filings since Mar 18, 2025)
  • Empery Asset Management, LP Filed SCHEDULE 13G/A on Precision BioSciences, latest Jul 29, 2026 (3 filings since Jan 22, 2026)
  • Lynx1 Capital Management LP Filed SCHEDULE 13G on Precision BioSciences, latest Jul 20, 2026 (4 filings since Feb 14, 2025)
  • TANG CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G/A on Precision BioSciences, latest Feb 17, 2026 (3 filings since Nov 14, 2024)
  • Bleichroeder LP Filed SCHEDULE 13G/A on Precision BioSciences, latest Feb 13, 2026 (2 filings since Aug 14, 2025)
  • Octagon Capital Advisors LP Filed SCHEDULE 13G on Precision BioSciences, latest Feb 10, 2026
  • Aberdeen Group plc Filed SCHEDULE 13G on Precision BioSciences, latest Jan 27, 2026
  • Readout Capital, LP Filed SCHEDULE 13G/A on Precision BioSciences, latest Aug 14, 2025 (2 filings since Mar 26, 2025)
  • Aquilo Capital Management, LLC Filed SCHEDULE 13G/A on Precision BioSciences, latest Aug 6, 2025 (3 filings since Mar 18, 2024)
  • Novartis Filed SCHEDULE 13G/A on Precision BioSciences, latest Aug 6, 2025 (3 filings since Jun 27, 2022)
  • HIGHBRIDGE CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G/A on Precision BioSciences, latest Apr 25, 2025 (2 filings since Nov 14, 2024)
  • Janus Henderson Group Ltd. Filed SCHEDULE 13G/A on Precision BioSciences, latest Feb 14, 2025 (3 filings since Mar 11, 2024)
  • Precision BioSciences Durham, North Carolina, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Precision BioSciences 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$30.1M9 Dec 31, 2025$31.2M9 Dec 31, 2024−3.4%
Accumulated depreciation$28.7M9 Dec 31, 2025$28.1M9 Dec 31, 2024+2.2%
Property and equipment, net$1.4M9 Dec 31, 2025$3.1M9 Dec 31, 2024−53.9%
Operating-lease assets (leased space)$5.8M9 Dec 31, 2025$7.1M9 Dec 31, 2024−18.1%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$110.8M9 Dec 31, 2025$85.9M9 Dec 31, 2024+29.0%
Marketable securities, current$4.8M9 Dec 31, 2025$413.0K9 Dec 31, 2024+1053.0%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$1.2M9 Dec 31, 2025$622.0K9 Dec 31, 2024+87.5%
Accumulated amortization$284.0K9 Dec 31, 2025$199.0K9 Dec 31, 2024+42.7%
Finite-lived intangibles, net$1.2M9 Dec 31, 2025$622.0K9 Dec 31, 2024+87.5%
Licenses, net$1.5M9 Dec 31, 2025$821.0K9 Dec 31, 2024+81.0%

Properties, in its own words

We currently occupy approximately 71,305 square feet of office and laboratory space, of which we have subleased approximately 18,000 square feet, at our corporate headquarters in Durham, North Carolina under a lease that expires in 2029.

Item 2 of the 10-K filed Mar 12, 2026.17

The story

Derek Jantz and Jeff Smith met as postdoctoral fellows at Duke University, and in March 2006, they founded Precision BioSciences along with Matt Kane, a student at the Duke Fuqua School of Business at the time. The company went through two rounds of early funding: a Series A round led by venBio to fund development of the genome editing platform, and Series B financing to fund product development efforts. The company completed its initial public offering in 2019, and trades under the Nasdaq ticker DTIL.

Precision entered into a partnership with Eli Lilly in November 2020 to use ARCUS editing for up to six in vivo targets connected to genetic disorders, beginning with Duchenne muscular dystrophy. In September 2021, Precision announced two more collaborations, with UK biotechnology company Tiziana Life Sciences to explore using foralumab to aid chimeric antigen receptor (CAR) T cell therapy, and with Philadelphia-based iECURE to advance candidates into clinical trials and investigate how ARCUS can help treat liver diseases. Michael Amoroso, the former CEO of cell and gene therapy developer Abeona Therapeutics, succeeded Matt Kane as President and CEO in October 2021. That December, Precision announced its entry into an agreement with a syndicate of investors led by ACCELR8 to spin off its subsidiary, Elo Life Systems, and create an independent company focused on food and agriculture business.

From Wikipedia’s article on Precision BioSciences, shared under CC BY-SA 4.0.7

Leadership

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

Board members and other officers (21)

Timeline

  1. Aug 24, 20268-K Regulation FD disclosure; Other events42
  2. Aug 6, 20268-K Results of operations43
  3. Jul 27, 20268-K Executive or director change; Regulation FD disclosure44
  4. Jul 1, 20268-K Regulation FD disclosure; Other events45
  5. Jun 16, 20268-K Entered a material agreement; New debt or obligation46
  6. May 27, 20268-K Regulation FD disclosure; Other events47
  7. May 26, 20268-K Executive or director change; Bylaws or fiscal year changed; Shareholder vote48
  8. May 5, 20268-K Results of operations49
  9. Mar 17, 20268-K Regulation FD disclosure50
  10. Mar 12, 20268-K Results of operations51
  11. Feb 11, 20268-K Regulation FD disclosure; Other events52
  12. Jan 13, 20268-K Results of operations; Regulation FD disclosure; Other events53
  13. Oct 19, 2021New chief executive Michael Amoroso becomes CEO18
  14. Mar 27, 2019New chief executive Matthew R. Kane becomes CEO20
  15. Mar 27, 2019New chief executive Fayaz Khazi becomes CEO19
  16. Jan 26, 2006Founded Precision BioSciences is founded4

Calendar

Coming up

  1. Nov 2, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($1.84) a share, on Nov 3, 2025.54

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results43
  2. May 5, 2026Reported quarterly or annual results49
  3. Mar 12, 2026Reported quarterly or annual results51
  4. Jan 13, 2026Reported quarterly or annual results53
  5. Nov 3, 2025Reported quarterly or annual results55
  6. Aug 7, 2025Reported quarterly or annual results56
  7. May 15, 2025Reported quarterly or annual results57
  8. Mar 26, 2025Reported quarterly or annual results58

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

Filings

396 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 79 major events, 174 insider forms, 46 large holders, 77 other. The latest 20:

  1. Sep 30, 20264 EDGAR
  2. Sep 29, 20264 EDGAR
  3. Sep 29, 20264 EDGAR
  4. Aug 24, 2026SCHEDULE 13G/A EDGAR
  5. Aug 24, 20268-K EDGAR
  6. Aug 7, 2026S-8 EDGAR
  7. Aug 6, 202610-Q EDGAR
  8. Aug 6, 20268-K EDGAR
  9. Aug 3, 20263 EDGAR
  10. Aug 3, 20263 EDGAR
  11. Aug 3, 20263 EDGAR
  12. Jul 29, 2026SCHEDULE 13G/A EDGAR
  13. Jul 27, 20268-K EDGAR
  14. Jul 20, 2026SCHEDULE 13G EDGAR
  15. Jul 1, 20268-K EDGAR
  16. Jun 16, 20268-K EDGAR
  17. Jun 5, 20264 EDGAR
  18. Jun 5, 20264 EDGAR
  19. Jun 5, 20264 EDGAR
  20. Jun 5, 20264 EDGAR

The 396 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

66 open-market trades by officers, directors and large owners since October 2021: 24 buys and 42 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 28, 2026Frankel StanleyDirectorBuy1,000$6.00$6.0KForm 4
Sep 25, 2026Brown MelindaDirectorBuy1,135$6.27$7.1KForm 4
Sep 25, 2026Germano Geno JDirectorBuy2,609$6.28$16.4KForm 4
Feb 18, 2026Amoroso MichaelPresident and CEOSale20,559$3.84$78.9KForm 4
Feb 18, 2026Kelly John AlexanderChief Financial OfficerSale8,149$3.84$31.3KForm 4
Feb 18, 2026Scimeca DarioGeneral Counsel and SecretarySale4,925$3.84$18.9KForm 4
Feb 18, 2026SMITH J. JEFFERSONChief Research OfficerSale4,925$3.84$18.9KForm 4
Jan 22, 2026Amoroso MichaelPresident and CEOSale34,799$4.17$145.1KForm 4
Jan 21, 2026Scimeca DarioGeneral Counsel and SecretarySale8,854$4.03$35.7KForm 4
Jan 21, 2026Kelly John AlexanderChief Financial OfficerSale15,213$4.03$61.3KForm 4
Jan 21, 2026SMITH J. JEFFERSONChief Research OfficerSale10,200$4.03$41.1KForm 4
Dec 16, 2025Germano Geno JDirectorBuy3,000$4.72$14.2KForm 4
Dec 16, 2025Frankel StanleyDirectorBuy2,700$4.70$12.7KForm 4
Dec 15, 2025Brown MelindaDirectorBuy1,381$4.97$6.9KForm 4
Nov 3, 2025Kelly John AlexanderChief Financial OfficerSale1,303$6.49$8.5KForm 4
Nov 3, 2025Scimeca DarioGeneral Counsel and SecretarySale665$6.49$4.3KForm 4
Nov 3, 2025Amoroso MichaelPresident and CEOSale3,409$6.49$22.1KForm 4
Sep 26, 2025Frankel StanleyDirectorBuy2,700$4.97$13.4KForm 4
Sep 22, 2025Brown MelindaDirectorBuy1,400$4.89$6.8KForm 4
Jul 3, 2025Kelly John AlexanderChief Financial OfficerSale14,827$4.26$63.2KForm 4

All 66 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
2025Michael AmorosoPresident, Chief Executive Officer and Director$650.9K$2.2M79
2025Alex KellyChief Financial Officer$472.5K$1.1M79
2025Dario ScimecaGeneral Counsel and Secretary$445.9K$911.6K79
2024Michael AmorosoPresident, Chief Executive Officer and Director$635.0K$4.3M79
2024Alex KellyChief Financial Officer$461.0K$1.9M79

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 94. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Aberdeen Group plc2,230,178$17.5M0.0%No change
Bleichroeder LP2,018,190$15.9M2.8%+355,690
Octagon Capital Advisors LP1,350,000$10.6M1.0%−886,732
Boothbay Fund Management, LLC1,346,004$10.6M0.2%+279,954
BlackRock, Inc.1,172,873$9.2M0.0%+973,112
Vanguard Capital Management LLC1,116,241$8.8M0.0%+205,501
Lynx1 Capital Management LP950,466$7.5M0.9%−34,647
Driehaus Capital Management LLC946,707$7.4M0.0%−48,664
Empery Asset Management, LP776,093$6.1M7.1%−1,192,786
Affinity Asset Advisors, LLC646,576$5.1M0.3%+48,630
Geode Capital Management, LLC620,981$4.9M0.0%+333,891
Mackenzie Financial Corp480,997$3.8M0.0%New
State Street Corp427,325$3.4M0.0%+354,383
ArrowMark Colorado Holdings LLC274,140$2.2M0.1%+95,000
Corient Private Wealth LP245,058$1.9M0.0%+101,206
Two Sigma Investments, LP237,863$1.9M0.0%−69,927
Northern Trust Corp190,188$1.5M0.0%+114,119
Jpmorgan Chase & Co180,452$1.4M0.0%+180,444
Vanguard Fiduciary Trust Co166,538$1.3M0.0%+10,912
Vanguard Portfolio Management LLC161,782$1.3M0.0%New
Goldman Sachs Group Inc139,828$1.1M0.0%+100,076
Squarepoint Ops LLC137,106$1.1M0.0%+93,258
Morgan Stanley130,536$1.0M0.0%+8,259
Commonwealth Equity Services, LLC115,929$911.2K0.0%+3,258
Quarry LP97,915$769.6K0.1%+29,604

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

SEC filer profile

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

  • Name on EDGARPRECISION BIOSCIENCES INC2
  • CIK0001357874
  • Employer ID (EIN)20-420601717
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company17
  • Incorporated inDelaware17
  • Fiscal year endsMay 212
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address302 East Pettigrew Street, Suite A-100, Durham, NC 277012
  • Phone919-314-55122
  • Shares outstanding27,601,554 as of Aug 3, 202616
  • Public float$47.1M as of Jun 30, 202517
  • AuditorDeloitte & Touche LLP, Raleigh, North Carolina PCAOB ID 34; no auditor attestation of internal control over financial reporting17
  • On EDGAR sinceMar 15, 20062
  • Filings597 in all: 4 (238), 8-K (125), 144 (38), 3 (28), 10-Q (23), SC 13G/A (17), SC 13G (16), SCHEDULE 13G/A (15)2
    All 37 form types

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

  • Latest filingsAnnual report (10-K) Mar 12, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 8, 2026
    Latest 8-K (8-K) Aug 24, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.000005 per shareDTILNasdaq

From the cover page of the 10-K filed Mar 12, 2026 (Section 12(b) of the Exchange Act).17

Risk factors and legal proceedings

The risks Precision BioSciences names in Item 1A of its 10-K filed Mar 12, 2026: 75 risks under these headings, as written.17

  • Risks Related to Our Financial Condition, Limited Operating History and Need for Additional Capital
  • We have incurred significant operating losses since our inception and expect to continue to incur losses for the foreseeable future. We have not been profitable and may not achieve or maintain profitability.
  • We will need substantial additional funding, and if we are unable to raise a sufficient amount of capital when needed on acceptable terms, or at all, we may be forced to delay, reduce or eliminate some or all of our research programs, product development activities and commercialization efforts.
  • Provisions of our debt instruments may restrict our ability to pursue our business strategies, and our ability to access credit on favorable terms, if necessary, for the funding of our operations, trials and programs may be limited due to changes in credit markets.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations, or require us to relinquish rights to our technologies or product candidates.
  • We have a limited operating history, which makes it difficult to evaluate our current business and future prospects and may increase the risk of your investment.
  • We may expend our limited resources on pursuing particular research programs or product candidates that may be less successful or profitable than other programs or product candidates.
  • Risks Related to the Identification, Development and Commercialization of Our Product Candidates
  • ARCUS is a novel technology, making it difficult to predict the time, cost and potential success of product candidate development. We have not yet been able to assess the safety and efficacy of most of our product candidates in humans.
  • The genome editing field is relatively new and evolving rapidly, and other existing or future technologies may provide significant advantages over our ARCUS platform, which could materially harm our business.
  • We are heavily dependent on the successful development and translation of ARCUS, and due to the early stages of our product development operations, we cannot give any assurance that any product candidates will be successfully developed and commercialized.
  • Our research and development programs may not lead to the successful identification, development or commercialization of any products.
The other 63 risks
  • If our product candidates do not achieve projected development milestones or commercialization in the announced or expected timeframes, the further development or commercialization of such product candidates may be delayed, and our business will be harmed.
  • Adverse public perception of genome editing may negatively impact the developmental progress or commercial success of products that we develop alone or with collaborators.
  • We face significant competition in industries experiencing rapid technological change, and there is a possibility that our competitors may achieve regulatory approval before us or develop product candidates or treatments that are safer or more effective than ours, which may harm our financial condition and our ability to successfully market or commercialize any of our product candidates.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any products that we develop alone or with collaborators.
  • Additional Risks Related to the Identification, Development and Commercialization of Our Therapeutic Product Candidates
  • The regulatory landscape that will apply to development of therapeutic product candidates by us or our collaborators is rigorous, complex, uncertain and subject to change, which could result in delays or termination of development of such product candidates or unexpected costs in obtaining regulatory approvals.
  • We may not be able to submit INDs to the FDA or CTAs to comparable foreign authorities to commence clinical trials on the timelines we expect, and even if we are able to, the FDA or comparable foreign authorities may not permit us to proceed.
  • The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.
  • Clinical trials are difficult to design and implement, expensive, time-consuming and involve an uncertain outcome, and the inability to successfully and timely conduct clinical trials and obtain regulatory approval for our product candidates would substantially harm our business.
  • Any product candidates that we or our collaborators may develop will be novel and may be complex and difficult to manufacture, and if we experience manufacturing problems, it could result in delays in development and commercialization of such product candidates or otherwise harm our business.
  • Any delays or difficulties in our or our collaborators’ ability to enroll patients in clinical trials could delay or prevent receipt of regulatory approvals.
  • Results of preclinical studies and early clinical trials of product candidates may not be predictive of results of later studies or trials. Our product candidates may not have favorable results in later clinical trials, if any, or receive regulatory approval.
  • Interim, “top-line” and initial data from studies or trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Our product candidates may not work as intended or cause undesirable side effects that could hinder or prevent receipt of regulatory approval or realization of commercial potential for them or our other product candidates and substantially harm our business.
  • We are subject to federal, state and foreign healthcare laws and regulations relating to our business, and could face substantial penalties if we are determined not to have fully complied with such laws, which would have an adverse impact on our business.
  • Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements, and the increasing use of social media, could adversely affect our business, results of operations, and financial condition.
  • Our business and operations may suffer in the event of information technology system failures, cyber-attacks or deficiencies in our security, which could materially affect our results.
  • We may seek orphan drug designation for our product candidates, but we may be unable to obtain such designations or to maintain the benefits associated with orphan drug designation, which may negatively impact our ability to develop or obtain regulatory approval for such product candidates and may reduce our revenue if we obtain such approval.
  • We have obtained a rare pediatric disease designation for PBGENE-DMD, however, there is no guarantee that FDA approval of PBGENE-DMD will result in issuance of a priority review voucher
  • A Fast Track Designation from the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive regulatory approval.
  • If the product candidates that we or our collaborators may develop receive regulatory approval in the United States or another jurisdiction, they may never receive approval in other jurisdictions, which would limit market opportunities for such product candidate and adversely affect our business.
  • Current and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize any product candidates we or our collaborators develop and may adversely affect the prices for such product candidates.
  • Even if we obtain regulatory approval for any products that we develop alone or with collaborators, such products will remain subject to ongoing regulatory requirements, which may result in significant additional expense.
  • The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. If we are found or alleged to have improperly promoted off-label uses, we may become subject to significant liability.
  • Disruptions at the FDA and other government agencies caused by funding shortages, staffing limitations, or policy changes could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
  • Even if any product we develop alone or with collaborators receives marketing approval, such product may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success.
  • If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market any products we develop alone or with collaborators, the commercialization of such products may not be successful if and when they are approved.
  • If the market opportunities for any products we develop alone or with collaborators are smaller than our estimates, or if we are unable to successfully identify enough patients, our revenues may be adversely affected.
  • The successful commercialization of potential products will depend in part on the extent to which governmental authorities and health insurers establish coverage, and the adequacy of reimbursement levels and pricing policies, and failure to obtain or maintain coverage and adequate reimbursement for any potential products that may receive approval, could limit marketability of those products and decrease our ability to generate revenue.
  • Our product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
  • Risks Related to Our Organization, Structure and Operations
  • We may experience difficulties in managing the needs of our business, which could disrupt our operations.
  • We may engage in transactions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources.
  • Our future success depends on our key executives, as well as attracting, retaining and motivating qualified personnel.
  • We are subject to increased costs as a result of operating as a public company, and our management will be required to devote substantial time to maintaining compliance initiatives and corporate governance practices, including establishing and maintaining proper and effective internal control over financial reporting.
  • Our insurance policies are expensive and protect us only from some business risks, which leaves us exposed to significant uninsured liabilities.
  • If we or any of our contract manufacturers or other suppliers fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur significant costs.
  • Our business operations, including our current and future relationships with third parties, may expose us to penalties for potential misconduct or improper activity, including non-compliance with regulatory standards and requirements.
  • We are subject to complex tax rules relating to our business, and any audits, investigations or tax proceedings could have a material adverse effect on our business, results of operations and financial condition.
  • We may not be able to utilize all, or any, of our net operating loss carryforwards.
  • Risks Related to Our Reliance on Third Parties
  • We have entered into significant arrangements with collaborators and expect to depend on collaborations with third parties for certain research, development and commercialization activities, and if any such collaborations are not successful, it may harm our business and prospects.
  • If we are not able to establish collaborations on commercially reasonable terms, we may have to alter our research, development and commercialization plans.
  • We rely on third parties to conduct, supervise and monitor our clinical trials and some aspects of our research and preclinical testing, and if those third parties do not successfully carry out their contractual duties, comply with regulatory requirements, or otherwise perform in a satisfactory manner, we may not be able to obtain regulatory approval or commercialize product candidates, or such approval or commercialization may be delayed, and our business may be substantially harmed.
  • We rely on third parties to supply raw materials or manufacture product supplies that are necessary for the conduct of preclinical studies, clinical trials and manufacturing of our product candidates, and failure by third parties to provide us with sufficient quantities of products, or to do so at acceptable quality levels or prices and on a timely basis, could harm our business.
  • We rely on third parties for the manufacturing process of product candidates, and failure by those parties to adequately perform their obligations could harm our business.
  • Risks Related to Intellectual Property
  • Our ability to compete may decline if we do not adequately protect our proprietary rights, and if our proprietary rights do not provide a competitive advantage.
  • 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 our licensors, we could lose license rights that are important to our business.
  • Some of our in-licensed intellectual property has been discovered through government funded research and thus may be subject to federal regulations such as “march-in rights”, certain reporting requirements and a preference for U.S.-based companies, and compliance with such regulations may limit our exclusive rights and our ability to contract with foreign manufacturers.
  • If we do not obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation with respect to our product candidates, thereby potentially extending the term of marketing exclusivity for such product candidates, our business may be harmed.
  • Patents and patent applications involve highly complex legal and factual questions, which, if determined adversely to us, could negatively impact our patent position.
  • Third parties may assert claims against us alleging infringement of their patents and proprietary rights, or we may need to become involved in lawsuits to defend or enforce our patents, either of which could result in substantial costs or loss of productivity, delay or prevent the development and commercialization of product candidates, prohibit our use of proprietary technology or sale of potential products or put our patents and other proprietary rights at risk.
  • Developments in patent law could have a negative impact on our business.
  • If we were unable to protect the confidentiality of our trade secrets and enforce our intellectual property assignment agreements, our business and competitive position would be harmed.
  • We will not seek to protect our intellectual property rights in all jurisdictions throughout the world, and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection.
  • We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses.
  • 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.
  • Risks Related to Owning Our Common Stock
  • We could be subject to securities class action litigation.
  • We do not currently intend to pay dividends on our common stock.
  • Provisions in our amended and restated certificate of incorporation and amended and restated bylaws or Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and therefore depress the trading price of our common stock.
  • Our amended and restated certificate of incorporation and our amended and restated bylaws include exclusive forum provisions for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • We are a “smaller reporting company” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.
  • General Risk Factors
  • We or third parties with whom we have relationships may be adversely affected by natural or manmade disasters, public health emergencies and other natural catastrophic events, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.
  • The market price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock.

Legal proceedings

From time to time we may be involved in claims and proceedings arising in the course of our business. The outcome of any such claims or proceedings, regardless of the merits, is inherently uncertain. We are not currently party to any material legal proceedings.

The opening of Item 3, Legal Proceedings.17

Sources

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