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ENGN on Nasdaq

enGene Therapeutics Inc.

EnGene Therapeutics Inc. is a biological products company, listed on Nasdaq (ENGN).1

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Last updated Oct 21, 2026.

Overview

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  • TickerENGN on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersZ41
  • Incorporated inCanada (Federal Level)2
  • Business address4868 Rue Levy, Suite 220, Saint-Laurent2
  • Filer categoryNon-accelerated filer, Smaller reporting company, Emerging growth company2

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Financials

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

Financial statements

Operating income345-$123.2M in 2025+534% since 2022
-$150.0M-$100.0M-$50.0M02022: -$19.4M-$19.4M20222023: -$26.1M-$26.1M2023+34%2024: -$62.3M-$62.3M2024+139%2025: -$123.2M-$123.2M2025+98%
Net income345-$117.3M in 2025+380% since 2022
-$150.0M-$100.0M-$50.0M02022: -$24.5M-$24.5M20222023: -$99.9M-$99.9M2023+308%2024: -$55.1M-$55.1M2024−45%2025: -$117.3M-$117.3M2025+113%

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

Period ending2025-10-312024-10-31
Research and development$94.5M$38.3M
General and administrative$28.7M$24.0M
Total operating expenses$123.2M$62.3M
Loss from operations$123.2M$62.3M
Interest income-$9.4M-$10.4M
Interest expense$3.0M$2.8M
Gain on extinguishment of debt$0$366.0K
Other expenses (income), net$569.0K$113.0K
Total other income, net-$5.9M-$7.1M
Net loss before income taxes$117.3M$55.2M
Provision for (recovery of) income taxes$0-$19.0K
Net loss$117.3M$55.1M
Unrealized (gain) loss on available-for-sale investments-$531.0K-$403.0K
Total comprehensive loss$116.8M$54.7M
Net loss per share of common shares, basic$2.29$1.46
Net loss per share of common shares, diluted$2.29$1.46
Weighted-average common shares outstanding, basic51.1M shares37.8M shares
Weighted-average common shares outstanding, diluted51.1M shares37.8M shares

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Corporate structure

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

Major holders of enGene Therapeutics Inc.

  • enGene Therapeutics Inc. Z4

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

What it owns

What enGene 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$4.6M5 Oct 31, 2025$2.8M5 Oct 31, 2024+64.8%
Accumulated depreciation$2.1M5 Oct 31, 2025$1.6M5 Oct 31, 2024+30.6%
Property and equipment, net$2.5M5 Oct 31, 2025$1.2M5 Oct 31, 2024+111.9%
Operating-lease assets (leased space)$7.7M5 Oct 31, 2025$1.7M5 Oct 31, 2024+343.2%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$50.2M5 Oct 31, 2025$173.0M5 Oct 31, 2024−71.0%
Marketable securities, current$143.6M5 Oct 31, 2025$65.3M5 Oct 31, 2024+119.8%
Marketable securities, non-current$8.5M5 Oct 31, 2025$59.5M5 Oct 31, 2024−85.7%
Debt securities available for sale$185.6M5 Oct 31, 2025$229.2M5 Oct 31, 2024−19.0%

Properties, in its own words

As of October 31, 2025, we have leased approximately 10,620 sq. feet of laboratory and office space at 4868 Rue Levy Montreal, QC H4R 2P1, 6,450 sq. feet of office space at 200 Fifth Avenue, Waltham, Massachusetts 02451 and 26,355 sq. feet of office space at 99 High Street, Boston, Massachusetts, 02110.

We believe our current facilities are sufficient for our current needs. To meet future needs of our business, we may lease additional or alternate space. We believe that suitable additional or substitute space at commercially reasonable terms will be available as needed to accommodate any future expansion of our operations.

Item 2 of the 10-K filed Dec 22, 2025.8

Leadership

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

Chief executive

  1. Jason David Hanson2023
  2. Ronald Harold Wilfred Cooper2024–now

President

  1. Ronald Harold Wilfred Cooper2025–now

Chief financial officer

  1. Alexandre Jean-Rene Erwan Grassin2023
  2. D. Ryan Daws2023–now

Chief operating officer

  1. Alexander Julian Nichols2023
2025
Board members and other officers (25)

Former names

  • enGene Holdings Inc.Jun 14, 2023 to Mar 9, 20262

Timeline

  1. Sep 8, 20268-K Results of operations38
  2. Aug 11, 20268-K Other events39
  3. Jul 17, 20268-K Regulation FD disclosure40
  4. Jul 16, 20268-K Executive or director change; Regulation FD disclosure41
  5. Jun 18, 20268-K Exit or restructuring costs; Executive or director change42
  6. Jun 15, 20268-K Results of operations; Exit or restructuring costs; Executive or director change43
  7. Jun 10, 20268-K Shareholder vote44
  8. May 7, 20268-K Executive or director change; Regulation FD disclosure; Other events45
  9. Apr 9, 20268-K Bylaws or fiscal year changed; Regulation FD disclosure46
  10. Mar 9, 20268-K Results of operations47
  11. Mar 9, 20268-K Entered a material agreement; Ended a material agreement48
  12. Jan 21, 20268-K Regulation FD disclosure49
  13. Jul 24, 2024New chief executive Ronald Harold Wilfred Cooper becomes CEO9
  14. Oct 31, 2023New chief executive Jason David Hanson becomes CEO10

Calendar

Coming up

  1. Around Dec 2, 2026Next results, estimated About a quarter after its last report. The company hasn't announced the date.

When it reported results

  1. Sep 8, 2026Reported quarterly or annual results38
  2. Jun 15, 2026Reported quarterly or annual results43
  3. Mar 9, 2026Reported quarterly or annual results47
  4. Dec 22, 2025Reported quarterly or annual results50
  5. Sep 11, 2025Reported quarterly or annual results51
  6. Jun 12, 2025Reported quarterly or annual results52
  7. Mar 10, 2025Reported quarterly or annual results53
  8. Dec 19, 2024Reported quarterly or annual results54

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

Filings

267 filings to the SEC since October 2021: 5 annual reports, 9 quarterly reports, 46 major events, 96 insider forms, 44 large holders, 67 other. The latest 20:

  1. Sep 24, 20264 EDGAR
  2. Sep 8, 202610-Q EDGAR
  3. Sep 8, 20268-K EDGAR
  4. Aug 14, 2026SCHEDULE 13G/A EDGAR
  5. Aug 14, 2026SCHEDULE 13G/A EDGAR
  6. Aug 14, 2026SCHEDULE 13G/A EDGAR
  7. Aug 13, 2026SCHEDULE 13G/A EDGAR
  8. Aug 12, 2026SCHEDULE 13G/A EDGAR
  9. Aug 11, 20268-K EDGAR
  10. Jul 22, 2026SCHEDULE 13G EDGAR
  11. Jul 22, 20263 EDGAR
  12. Jul 22, 20263 EDGAR
  13. Jul 17, 20268-K EDGAR
  14. Jul 16, 20268-K EDGAR
  15. Jun 18, 20268-K/A EDGAR
  16. Jun 17, 20264 EDGAR
  17. Jun 17, 20264 EDGAR
  18. Jun 17, 20264 EDGAR
  19. Jun 17, 20264 EDGAR
  20. Jun 17, 20264 EDGAR

The 267 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

17 open-market trades by officers, directors and large owners since October 2021: 14 buys and 3 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 22, 2026Grossman WilliamInterim Chief Medical OfficerBuy5,102$1.97$10.1KForm 4
Oct 30, 2024Forbion Growth Management B.V.10% ownerBuy561,797$8.90$5.0MForm 4
Oct 8, 2024Forbion Growth Opportunities Fund I Cooperatief U.A.10% ownerBuy800$6.60$5.3KForm 4
Oct 7, 2024Forbion Growth Opportunities Fund I Cooperatief U.A.10% ownerBuy11,844$6.55$77.6KForm 4
Oct 4, 2024Forbion Growth Opportunities Fund I Cooperatief U.A.10% ownerBuy5,997$6.54$39.2KForm 4
Oct 3, 2024Forbion Growth Opportunities Fund I Cooperatief U.A.10% ownerBuy5,769$6.48$37.4KForm 4
Oct 2, 2024Forbion Growth Opportunities Fund I Cooperatief U.A.10% ownerBuy10,153$6.37$64.7KForm 4
Oct 1, 2024Forbion Growth Opportunities Fund I Cooperatief U.A.10% ownerBuy35,279$6.44$227.2KForm 4
Sep 30, 2024Forbion Growth Opportunities Fund I Cooperatief U.A.10% ownerBuy341,332$6.34$2.2MForm 4
Sep 27, 2024Forbion Growth Opportunities Fund I Cooperatief U.A.10% ownerBuy41,639$5.97$248.8KForm 4
Sep 27, 2024Cooper Ronald Harold WilfredCEO & PresidentBuy10,000$5.70$57.0KForm 4
Apr 22, 2024FONDS DE SOLIDARITE DES TRAVAILLEURS DU QUEBEC10% ownerSale47,854$15.00$717.8KForm 4
Apr 19, 2024FONDS DE SOLIDARITE DES TRAVAILLEURS DU QUEBEC10% ownerSale100$15.00$1.5KForm 4
Apr 18, 2024FONDS DE SOLIDARITE DES TRAVAILLEURS DU QUEBEC10% ownerSale4,575$15.01$68.7KForm 4
Dec 29, 2023Forbion Growth Opportunities Fund I Cooperatief U.A.10% ownerBuy10,020$9.06$90.8KForm 4
Dec 28, 2023Forbion Growth Opportunities Fund I Cooperatief U.A.10% ownerBuy5,050$7.69$38.8KForm 4
Dec 27, 2023Forbion Growth Opportunities Fund I Cooperatief U.A.10% ownerBuy2,750$7.17$19.7KForm 4

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
2025Ronald H.W. Cooper63$700.0K$5.8M72
2025Hussein Sweiti40$43.8K$3.2M72
2025Ryan Daws52$473.0K$2.2M72
2024Chief Executive Officer and President$197.0K$8.4M72

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 56. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BML Capital Management, LLC6,669,908$11.5M6.6%New
Siren, L.L.C.6,256,662$10.8M0.2%New
Perceptive Advisors LLC4,822,169$8.3M0.1%New
Ameriprise Financial Inc2,675,876$4.6M0.0%New
Nextech Invest Ltd.2,324,943$4.0M0.2%New
ADAR1 Capital Management, LLC2,104,986$3.6M0.2%New
Vestal Point Capital, LP1,667,430$2.9M0.1%New
Acorn Capital Advisors, LLC1,271,257$2.2M0.6%New
Peapod Lane Capital LLC1,102,149$1.9M1.3%New
Balyasny Asset Management L.P.1,007,344$1.7M0.0%New
Millennium Management LLC966,627$1.7M0.0%New
Renaissance Technologies LLC829,700$1.4M0.0%New
Citadel Advisors LLC717,686$1.2M0.0%New
Affinity Asset Advisors, LLC600,000$1.0M0.1%New
UBS Group AG509,087$880.7K0.0%New
Eversept Partners, LP469,584$812.4K0.0%New
Kynam Capital Management, LP457,855$792.1K0.0%New
Seven Fleet Capital Management LP411,065$711.1K0.1%New
Jane Street Group, LLC382,459$661.7K0.0%New
Rangeley Capital, LLC305,102$527.8K0.5%New
Barclays PLC282,515$488.8K0.0%New
Kennedy Capital Management LLC268,735$464.9K0.0%New
Woodline Partners LP250,000$432.5K0.0%New
Quadrature Capital Ltd239,035$413.5K0.0%New
Squarepoint Ops LLC215,381$372.6K0.0%New

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

SEC filer profile

How enGene 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 EDGARenGene Therapeutics Inc.1
  • CIK0001980845
  • Employer ID (EIN)00-00000008
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company8
  • Incorporated inA18
  • Fiscal year endsOctober 311
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address4868 Rue Levy, Suite 220, Saint-Laurent, Quebec, Canada1
  • Phone(514) 332-48881
  • Shares outstanding67,016,316 as of Sep 2, 20267
  • Public float$154.2M as of Apr 30, 20258
  • AuditorKPMG LLP, Montreal, Canada PCAOB ID 85; no auditor attestation of internal control over financial reporting8
  • On EDGAR sinceJun 14, 20231
  • Filings267 in all: 4 (65), 8-K (44), 3 (31), SCHEDULE 13G/A (18), 424B3 (13), CORRESP (11), 10-Q (9), SC 13G (9)1
    All 31 form types

    UPLOAD (8), SCHEDULE 13G (7), EFFECT (5), SC 13G/A (5), 424B5 (4), S-8 (4), 10-K (3), ARS (3), DEF 14A (3), S-3 (3), SC 13D/A (3), 10-K/A (2), 425 (2), 8-K/A (2), S-1/A (2), S-4/A (2), SC 13D (2), SEC STAFF LETTER (2), 8-A12B (1), CERT (1), DRS (1), S-1 (1), S-4 (1)

  • Latest filingsAnnual report (10-K) Dec 22, 2025
    Quarterly report (10-Q) Sep 8, 2026
    Proxy statement (DEF 14A) May 8, 2026
    Latest 8-K (8-K) Sep 8, 2026

Securities registered for trading

ClassSymbolExchange
Common SharesENGNThe Nasdaq Stock Market LLC
Warrants, each exercisable for one Common Share, at an exercise price of $11.50 per shareENGNWThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Dec 22, 2025 (Section 12(b) of the Exchange Act).8

Risk factors and legal proceedings

The risks enGene Therapeutics Inc. names in Item 1A of its 10-K filed Dec 22, 2025: 73 risks under these headings, as written.8

  • Risks Related to Our Business
  • We depend heavily on the success of our lead product candidate, detalimogene voraplasmid, or detalimogene, formerly known as EG-70, which is currently in a clinical trial. Our clinical trial of detalimogene may not be successful. If we are unable to successfully develop, obtain regulatory approval for, and commercialize detalimogene, or experience significant delays in doing so, our business will be materially harmed.
  • We expect to make significant investments in our continued research and development of detalimogene and other new product candidates and genetic medicines and services we may develop, which may not be successful, and if they are not successful, we may not be able to achieve or sustain profitability in the future. As an organization, we do not have experience in any such new lines of business, and failure to identify other product candidates and/or execute on the expansion of our business would adversely affect our business and results of operations.
  • We have incurred net losses in every year since our inception and anticipate that we will continue to incur net losses in the foreseeable future.
  • The estimates of market sizes and forecasts of market growth for the potential demand of detalimogene and any other product candidates we develop, as provided in this Annual Report and as may be provided in our future public filings and press releases are based on a number of assumptions and may prove to be inaccurate. The actual market may be smaller than we believe, which would adversely affect our business and results of operations.
  • If our internal controls over financial reporting or our disclosure controls and procedures are not effective, we may not be able to accurately report our financial results or file our periodic reports in a timely manner, which may cause investors to lose confidence in our reported financial information and may lead to a decline in the trading price of our common stock.
  • To date, we have not generated any product revenue, have a history of losses and will need to raise additional capital to fund our operations. If we fail to obtain necessary financing, we will not be able to complete the development and commercialization of detalimogene or our other product candidates.
  • We face significant competition from other entities, including biotechnology and pharmaceutical companies, which may result in our competitors discovering, developing or commercializing products before us or more successfully than we do. Our business and results of operations could be adversely affected if we fail to compete effectively.
  • The genetic medicine field is relatively new and evolving rapidly. Because of our limited technical, financial and human resources, we are focusing our research and development efforts on detalimogene, as well as further development of our genetic medicine platform and other product candidates we may develop. As a result, we may forego or delay pursuit of other genetic medicine technologies or other therapeutic product candidates that provide significant advantages over our platform or product candidates, which could materially harm our business and results of operations.
  • Detalimogene and our genetic medicine platform are based on novel technologies that are unproven, which makes it difficult to predict the time and cost of development and the probability or timing of subsequently obtaining regulatory approval.
  • Development of new therapeutics involves a lengthy and expensive process, with an uncertain outcome. We may incur additional costs, fail to replicate the positive results from our earlier preclinical or clinical studies of our product candidates in later preclinical studies or clinical trials or experience delays in completing or ultimately be unable to complete, the development and commercialization of any product candidates, including, but not limited to, detalimogene.
  • Interim top-line and preliminary data from our clinical trials that we announce or publish from time to time will 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.
The other 62 risks
  • If we encounter difficulties enrolling patients in clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • Although we have conducted the Phase 1 portion of the LEGEND clinical study of detalimogene, we have not as an organization completed later-stage or pivotal clinical trials or submitted a BLA, and we may be unable to do so for detalimogene or any future product candidates in a timely manner or at all.
  • Even if detalimogene or any other therapeutic product candidates that we develop receives regulatory approval, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors (including government health administration authorities and private health insurers) and others in the medical community necessary for commercial success, in which case we may not generate significant revenues and become profitable, which could adversely affect our ability to conduct our business and our results of operations.
  • We may not be successful in our efforts to utilize our novel genetic medicine platform to identify and develop additional product candidates. Due to our limited technical, financial and human resources and access to capital, we may choose to prioritize development of certain product candidates, such as our initial focus on developing detalimogene, which may prove to be the wrong choice and may adversely affect our business and results of operations.
  • Our use of third parties to manufacture, develop and test our therapeutic product candidates for preclinical studies and clinical trials increases the risk that we will not have sufficient quantities of our product candidates or products, or necessary quantities of such materials on time or at an acceptable cost.
  • We have no experience in developing a manufacturing facility for our biologic products and may never be successful in developing our own manufacturing facility or capability.
  • Changes in the manufacturing or formulation of detalimogene or any other product candidate we develop may result in additional costs or delay, which could adversely affect our business and results of operations.
  • Detalimogene is, and any other product candidates we develop may be, complex to analyze and we may encounter difficulties in product release testing, particularly with respect to bioassay potency testing. If we or any of our contract testing laboratories encounter difficulties, our ability to provide supply of detalimogene or any other product candidates that we develop for clinical trials or our products for patients, if approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure.
  • The market opportunities for detalimogene and any other product candidates we develop may be limited to a small group of patients who are ineligible for or have failed prior treatments and our estimates of the prevalence of our target patient populations may be inaccurate.
  • We depend on our executive team and key personnel, and if we lose one or more of our executive officers or key employees or are unable to attract and retain highly skilled employees, such events could harm our business.
  • Our research and development initiatives, manufacturing processes and business depend on our ability to attract and retain highly skilled scientists and other specialized individuals. We may not be able to attract or retain such qualified scientists and other specialized individuals in the future due to the competition for qualified personnel among life science and technology businesses.
  • We face risks related to epidemics and other outbreaks of communicable diseases which could significantly disrupt our operations, including our clinical trials and preclinical studies, and adversely affect our business and results of operations.
  • We or the third parties upon whom we depend may be adversely affected by risks beyond our control, such as natural disasters, political crises, acts of terrorism, epidemics and other outbreaks of communicable diseases, war or other catastrophic events and our business continuity and disaster recovery plans may not adequately protect us from the adverse effects of such events.
  • Regulatory Risks
  • We cannot predict whether or when we will obtain regulatory approval to commercialize detalimogene or any other product candidate we may develop in the United States or any other jurisdiction and any such approval may be for a narrower indication than we seek.
  • If we are not able to obtain or if there are delays in obtaining required regulatory approvals for detalimogene or any other product candidates that we may develop, we will not be able to commercialize or will be delayed in commercializing detalimogene or any other product candidates that we may develop and our ability to generate revenue will be adversely affected. Even if we eventually gain approval for detalimogene or any of other product candidates, we may be unable to commercialize them.
  • Fast Track designation and Regenerative Medicine Advanced Therapy designation by the FDA for detalimogene and our participation in the FDA’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot (“CDRP”) Program may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that detalimogene or any future product candidate that may receive these designations or is selected for the CDRP Program will receive regulatory approval.
  • We may seek priority review designation for detalimogene or any other product candidates we develop, but we might not receive such designation, and even if we do, such designation may not lead to a faster regulatory review or approval process.
  • Even if we receive regulatory approval of detalimogene or any other product candidates or therapies that we may develop, we will be subject to ongoing regulatory obligations, reporting requirements and continued regulatory review, which may result in significant additional expenses. If we fail to comply with regulatory requirements or experience unanticipated problems with our products or product candidates, we may be subject to substantial penalties, fines, delays, suspensions, refusals and withdrawals of approvals.
  • Changes in regulatory requirements could result in delays or the discontinuation of development of detalimogene or other product candidates or therapies that we may develop, or unexpected costs in obtaining or maintaining regulatory approval, and thereby adversely affect our business and results of operations.
  • Our contract manufacturers are subject to significant regulation with respect to the manufacturing of our current and future product candidates. The manufacturing facilities on which we rely may not meet or continue to meet regulatory requirements and/or may have limited capacity.
  • Ongoing healthcare legislative and regulatory reform measures, including the U.S. federal government’s determination that any of our product candidates, including detalimogene, is an “essential” biologic medicine, may have a material adverse effect on our business and results of operations.
  • Any product candidates we develop, including detalimogene, may become subject to unfavorable or unprofitable third-party coverage and reimbursement practices, as well as pricing regulations.
  • Drug marketing, price controls and reimbursement regulations may materially affect our ability to market and receive coverage for our product candidates, if approved, in the European Union, the United Kingdom, Japan and other non-U.S. jurisdictions.
  • Guidelines and recommendations published by various organizations may impact the use or reimbursement of detalimogene, if approved, as well as other future products.
  • 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 could adversely affect our business and results of operations.
  • Cyber-attacks or other failures in our or our third-party vendors’, contractors’ or consultants’ telecommunications or information technology systems could result in information theft, data corruption and significant disruption of our business operations.
  • Inadequate funding for, or changes in leadership at, or disruptions at the FDA, the SEC and other government agencies could hinder their ability to hire and retain key personnel, prevent new products and services from being developed, approved or commercialized in a timely manner or otherwise prevent those agencies from performing normal functions on which the operation of our business may rely, which could negatively impact our business.
  • Our employees, independent contractors and contract manufacturers, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Our relationships with healthcare providers and physicians and third-party payors are 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 result in diminished profits and future earnings and thereby adversely affect our business and results of operations.
  • We are subject to certain U.S. and non-U.S. anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations. We can face serious consequences for violations thereof.
  • Risks Related to International Operations
  • We are an international organization and we plan to expand operations internationally where we have limited operating experience and where we may be subject to increased regulatory risks and local competition. If we are unsuccessful in any efforts to expand internationally, our business and results of operations may be adversely affected.
  • Global economic uncertainty, changes in geopolitical conditions and weakening product demand caused by political instability, changes in trade agreements and disputes, such as the armed conflicts between Russia and Ukraine and in the Middle East and other macroeconomic factors, could adversely affect our business and results of operations.
  • We expect certain of our research and development and manufacturing activities may take place in non-U.S. jurisdictions, such as China, through third-party CROs, collaborators or manufacturers. A significant disruption in the operation of those CROs, collaborators or manufacturers could materially adversely affect our business and results of operations.
  • Additional laws and regulations governing international operations may preclude or delay us from developing, manufacturing or selling certain products and product candidates outside the United States, which could limit our growth potential and increase our development costs.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain, enforce and defend patent protection for any product candidates we develop or for our novel genetic medicine platform, or if the scope of the patent protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize products or technology similar or identical to ours and our ability to successfully commercialize any product candidates we may develop and our technology may be adversely affected.
  • Issued patents covering our product candidates or genetic medicine platform could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or other jurisdictions.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Changes in either patent laws or interpretation of the patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidates and genetic medicine platform.
  • Patent terms may be inadequate to protect our competitive position, product candidates or genetic medicine platform for an adequate amount of time, and we may need to obtain patent term extension and equivalent extensions outside of the United States for our product candidates or genetic medicine platform.
  • Our rights to develop and commercialize our product candidates and genetic medicine platform may be subject, in part, to the terms and conditions of licenses.
  • We may be unable to acquire or in-license any relevant third-party intellectual property rights that we identify as necessary or important to our business and results of operations.
  • If we fail to comply with our obligations under the agreements pursuant to which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose the rights to intellectual property that are important to our business.
  • We may not be able to protect our intellectual property and proprietary rights throughout the world.
  • We may be involved in legal proceedings in relation to intellectual property rights and to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be adversely affected.
  • Third-party claims of intellectual property infringement, misappropriation or other violation against us, our licensors or our collaborators may prevent or delay the development and commercialization of our novel genetic medicine platform, our product candidates and other technologies.
  • 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.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • We may not be able to protect and enforce our trademarks and trade names, or build name recognition in our markets of interest thereby harming our competitive position.
  • Risks Related to Acquisitions and Collaborations
  • We will need to grow the size of our organization, both organically and through acquisitions, and we may experience difficulties identifying and hiring the right employees and successfully managing this growth.
  • Acquisitions, collaborations or other strategic partnerships may increase our capital requirements, dilute our shareholders, cause us to incur debt or assume contingent liabilities and subject us to other risks.
  • We may make acquisitions to expand our business and as a result, our results of operations may be adversely affected.
  • Risks Related to Investment in our Securities
  • Because we are a Canadian company, shareholder protections differ from shareholder protections in the United States and elsewhere, and we are subject to a variety of additional risks that may negatively impact our operations.
  • The Articles and certain Canadian legislation contain provisions that may have the effect of delaying, preventing or making undesirable an acquisition of all or a significant portion of our shares or assets or preventing a change in control.
  • The Articles designate specific courts in Canada and the United States as the exclusive forum for certain litigation that may be initiated by our shareholders without our prior written consent, which could limit our shareholders’ ability to obtain a favorable judicial forum for disputes with us.
  • Because we are a Canadian company, it may be difficult to serve legal process or enforce judgments against us.
  • Our ability to use net operating loss carry-forwards and certain other tax attributes are limited.
  • We believe that we are and there is a significant risk that we may continue to be a passive foreign investment company (a “PFIC”), which could result in adverse U.S. federal income tax consequences to U.S. Holders of our Common Shares or Warrants.
  • Our Articles include provisions that may discourage takeover attempts, including a classified or “staggered” board.
  • Risks Related to Our Common Shares and Warrants and to Being a Public Company
  • Sales of Common Shares, or the perception of such sales, by us or the Selling Holders in the public market or otherwise could cause the market price for our Common Shares to decline and certain Selling Holders still may receive a significant rate of return.
  • Certain existing securityholders acquired their securities in our Company at prices that may be below the current trading price of such securities, and may experience a positive rate of return based on such current trading price. Future investors in our Company may not experience a similar rate of return.
  • There is no assurance that Warrants will be and/or remain “in the money” prior to their expiration or that the holders of Warrants will elect to exercise any or all of their Warrants for cash; the Warrants may expire worthless.

Legal proceedings

From time to time, we may be involved in legal proceedings that arise in the regular course of our business. Our management believes that we are not currently involved in any legal proceedings that are likely to have a significant negative effect on our business. However, legal proceedings can negatively affect our business, financial condition, results, and future prospects, regardless of the outcome, due to costs associated with defense and settlement, as well as the diversion of management resources, among other factors.

The opening of Item 3, Legal Proceedings.8

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