ABUS on Nasdaq

Arbutus Biopharma

Logo: https://www.arbutusbio.com/, Non-free logo, via Wikipedia6

Canadian Bio Tech Company

Arbutus Biopharma Corporation is a publicly traded Canadian (NASDAQ: ABUS) biopharmaceutical company with an expertise in liposomal drug delivery and RNA interference, and is developing drugs for hepatitis B infection. It is headquartered in Warminster, Pennsylvania. The company was formerly known as Tekmira, which was spun out of Inex Pharmaceuticals in 2007.3 Wikipedia text CC BY-SA 4.0

$4.29 up 0.10 (2.27%)Price as of Oct 15, 2026 at 17:33 UTC

Last updated Oct 21, 2026.

Overview

2007Founded1

Compare with Opus Genetics, Inc., Pyxis Oncology, Inc. or CV Sciences, Inc., or pick any stock.

  • TickerABUS on Nasdaq1
  • Industrypharmaceutical industry1
  • HeadquartersBurnaby1
  • Websitearbutusbio.com
  • Incorporated inBritish Columbia, Canada7
  • Business address701 Veterans Circle, Warminster, Pa 189747
  • Filer categoryNon-accelerated filer, Smaller reporting company7
  • Legal formCorporation4
  • LEI25490064CESONAUIAS234
  • StatusActive4
  • LEI statusLapsed (not renewed)4
  • Registered address2500-700 W Georgia St, V7Y 1B3 Vancouver, Canada4
  • Registered withBC Registry Services, BC11473074

Arbutus Biopharma Corporation is a publicly traded Canadian (NASDAQ: ABUS) biopharmaceutical company with an expertise in liposomal drug delivery and RNA interference, and is developing drugs for hepatitis B infection.3

Financials

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

Key numbers, fiscal 2025

-271.0%Operating margin10
-237.9%Net margin10
128.2%Revenue growth, 202510
-43.7%Return on equity10
0.00×Debt to equity10
-$39.6MFree cash flow10

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Collaboration And Contracts brought in 89% of the revenue Arbutus Biopharma broke down this way in fiscal 2025.

  1. Collaboration And Contracts$12.6M1089%up 222% from 2024
  2. Non-Cash Royalty$1.5M1011%down 34% from 2024
Products and services by year
Products and services20242025
Collaboration And Contracts$3.9M$12.6M
Non-Cash Royalty$2.3M$1.5M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$25.2M

Out of $14.1M in revenue.10 The company lost money this year.

Financial statements

Revenue111213141510$14.1M in 2025+134% since 2019
0$10.0M$20.0M$30.0M$40.0M2019: $6.0M$6.0M20192020: $6.9M$6.9M2020+15%2021: $11.0M$11.0M2021+59%2022: $39.0M$39.0M2022+255%2023: $18.1M$18.1M2023−54%2024: $6.2M$6.2M2024−66%2025: $14.1M$14.1M2025+128%
Operating income111213141510-$38.2M in 2025−73% since 2019
-$150.0M-$100.0M-$50.0M02019: -$143.9M-$143.9M20192020: -$57.8M-$57.8M2020−60%2021: -$73.5M-$73.5M2021+27%2022: -$65.5M-$65.5M2022−11%2023: -$78.1M-$78.1M2023+19%2024: -$76.3M-$76.3M2024−2%2025: -$38.2M-$38.2M2025−50%
Net income111213141510-$33.5M in 2025−78% since 2019
-$200.0M-$150.0M-$100.0M-$50.0M02019: -$153.7M-$153.7M20192020: -$63.7M-$63.7M2020−59%2021: -$76.2M-$76.2M2021+20%2022: -$69.5M-$69.5M2022−9%2023: -$72.8M-$72.8M2023+5%2024: -$69.9M-$69.9M2024−4%2025: -$33.5M-$33.5M2025−52%

Every line of the income statement as filed: the last 2 fiscal years, latest first.10

Period ending2025-12-312024-12-31
Revenue$14.1M$6.2M
Research and development$25.2M$54.0M
General and administrative$15.9M$22.1M
Change in fair value of contingent consideration-$1.8M$2.6M
Restructuring costs$12.9M$3.7M
Total operating expenses$52.2M$82.5M
Loss from operations-$38.2M-$76.3M
Interest income$4.1M$6.6M
Gain on sale of property and equipment$674.0K$0
Interest expense-$97.0K-$137.0K
Foreign exchange gain / (loss)$14.0K-$49.0K
Total other income$4.7M$6.4M
Net loss-$33.5M-$69.9M
Basic (in USD per share)-$0.17-$0.38
Diluted (in USD per share)-$0.17-$0.38
Basic (in shares)191.6M shares185.6M shares
Diluted (in shares)191.6M shares185.6M shares
Unrealized gain on available-for-sale securities$37.0K$286.0K
Comprehensive loss-$33.5M-$69.6M

Compare Arbutus Biopharma with another company

Corporate structure

Arbutus Biopharma 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 Arbutus Biopharma

  • Morgan Stanley Filed SCHEDULE 13G/A on Arbutus Biopharma, latest Oct 7, 2026 (5 filings since Jun 10, 2024)
  • Roivant Filed SCHEDULE 13D/A on Arbutus Biopharma, latest Oct 5, 2026 (4 filings since Oct 20, 2021)
  • Whitefort Capital Management, LP Filed SCHEDULE 13G on Arbutus Biopharma, latest Sep 4, 2026 (8 filings since Sep 11, 2023)
  • Two Seas Capital LP Filed SCHEDULE 13G/A on Arbutus Biopharma, latest May 15, 2026 (6 filings since Nov 21, 2023)
  • BlackRock Filed SC 13G/A on Arbutus Biopharma, latest Feb 12, 2024 (2 filings since Feb 3, 2023)
  • RTW INVESTMENTS, LP Filed SC 13G/A on Arbutus Biopharma, latest Feb 14, 2022
  • Arbutus Biopharma Burnaby, British Columbia, Canada

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); 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 Arbutus Biopharma 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$245.0K10 Dec 31, 2025$16.3M10 Dec 31, 2024−98.5%
Accumulated depreciation$213.0K10 Dec 31, 2025$13.0M10 Dec 31, 2024−98.4%
Property and equipment, net$32.0K10 Dec 31, 2025$3.3M10 Dec 31, 2024−99.0%
Operating-lease assets (leased space)$010 Dec 31, 2025$1.0M10 Dec 31, 2024−100.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$18.0M10 Dec 31, 2025$36.3M10 Dec 31, 2024−50.4%
Marketable securities, current$73.5M10 Dec 31, 2025$86.3M10 Dec 31, 2024−14.9%
Debt securities available for sale$73.5M10 Dec 31, 2025$86.3M10 Dec 31, 2024−14.9%
Stakes in other companies (equity method)$010 Dec 31, 2025$015 Dec 31, 2024
Long-term investments$010 Dec 31, 2025$010 Dec 31, 2024

Properties, in its own words

In the first quarter of 2025, our Board decided to exit our corporate headquarters at 701 Veterans Circle, Warminster, Pennsylvania. We have had a lease agreement for this headquarters since November 1, 2016, and the lease expires on April 30, 2027. The building has approximately 35,000 square feet of laboratory facilities and office space. Currently, all employees work remotely and are not using our headquarters.

Item 2 of the 10-K filed Mar 23, 2026.18

The story

Tekmira, as the company was formerly called, was formed as a wholly owned subsidiary of Inex Pharmaceuticals in 2005 after that company began collapsing after its regulatory and partnering strategy failed in 2004. Tekmira was fully spun out in 2007 and Tekmira absorbed the assets of Inex, which had been founded in 1992.

Inex had been developing liposomal formulations of off-patent cancer drugs, and licensed them to Talon Pharmaceuticals in 2005; Talon was acquired by Spectrum Pharmaceuticals in 2013, and three former Inex/Tekmira products reached the market and began generating royalties for Tekmira: Marqibo (liposomal vincristine), Alocrest (liposomal vinorelbine) and Brakiva (liposomal topotecan).

Inex had also acquired licenses to intellectual property, as well as staff and manufacturing facilities, concerning RNAi technology from Lynx Therapeutics in 1998; this set of technologies became the focus for Tekmira and it initially sought to develop liposomally encapsulated RNAi drugs for a broad range of indications.

Tekmira also worked on providing liposomal delivery technology to other companies. In 2007 it signed a license agreement with Alnylam Pharmaceuticals so that Alnylam could use it to deliver its own RNAi drugs; that deal was expanded into a manufacturing agreement in 2009.

Most of those products not focused on viral diseases faltered, and Tekmira had only $6.3 million in cash when it filed suit against Alnylam in 2011 for breaching its contract and stealing trade secrets. The suit was settled in 2012, with Alnylam agreeing to pay Tekmira $65 million in termination fees, and the companies negotiated a new license agreement with lower milestones and royalties, which covers Alnylam's product patisiran.

Tekmira caught the world's attention and its stock rose dramatically during the 2013 West African Ebola virus epidemic due to its drug candidate for Ebola fever, TKM-Ebola. Tekmira was developing it under a $140 million US Department of Defense contract. While its stock was trading high in January 2015, it acquired OnCore BioPharma, a company focused on hepatitis B.

On December 19, 2014, Tekmira announced the appointment of former Bill & Melinda Gates Foundation CFO Richard Henriques to the company's board of directors. The company simultaneously announced the forthcoming departure of Ian MacLachlan as Executive Vice President and Chief Technical Officer.

Development of TKM-Ebola was terminated in mid June 2015 during a Phase II trial, for lack of efficacy.

Read the full text

The next month, Tekmira changed its name to Arbutus Biopharma and said that it would focus on drugs to treat hepatitis B.

In March 2017 Arbutus signed another license for its liposome delivery technology, this time with Alexion Pharmaceuticals, for delivery of an mRNA drug candidate. This license was terminated in July 2017, when Alexion discontinued preclinical programs outside its core complement franchise.

In 2019, Arbutus began a phase 1 clinical study using AB-506 to treat chronic hepatitis B. The company released preliminary data in July and stopped the trial in October after two patients developed acute hepatitis. Now AB-729 is paving the way for Arbutus, as they recently received the FDA go ahead to pursue phase 2 trials, after having their data voted best in ILC, 2021; after abandoning development of previous investigational agents. AB-836, Arbutus's next generation capsid inhibitor, has shown potential against mutants in its phase 1 trials.

In July 2019, Arbutus Biopharma announced the sale of part of its royalty interest on future global net sales of ONPATTRO, an RNA interference therapeutic currently sold by Alnylam Pharmaceuticals, to OMERS for $20 million.

COVID-19

On March 10, 2023, U.S. District Judge Mitchell Goldberg rejected a bid by Moderna to dismiss some of the patent infringement claims brought against the company by Arbutus and its partner, Genevant Sciences.

Moderna settled their lawsuit and will pay Arbutus $950 million upfront and an additional $1.3 billion contingent upon a favorable resolution of Moderna’s Section 1498 appeal.

From Wikipedia’s article on Arbutus Biopharma, shared under CC BY-SA 4.0.8

Leadership

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

Board members and other officers (39)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Arbutus Biopharma Inc. Delaware, United States of America9

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

Former names

  • TEKMIRA PHARMACEUTICALS CORPJun 8, 2011 to Aug 3, 20157

Timeline

  1. Aug 21, 20268-K Other events61
  2. Aug 12, 20268-K Results of operations62
  3. Jul 16, 20268-K Ended a material agreement; Executive or director change; Other events63
  4. May 27, 20268-K Executive or director change; Shareholder vote64
  5. May 13, 20268-K Results of operations65
  6. Apr 15, 20268-K Other events66
  7. Mar 23, 20268-K Results of operations67
  8. Mar 3, 20268-K Entered a material agreement; Other events68
  9. Feb 20, 20268-K Other events69
  10. Feb 6, 20268-K Other events70
  11. Jan 16, 20268-K Other events71
  12. Dec 11, 20258-K Other events72
  13. Mar 6, 2025New chief executive Lindsay Androski becomes CEO19
  14. Feb 5, 2024New chief executive Michael J. McElhaugh becomes CEO20
  15. Jun 26, 2019New chief executive William H. Collier becomes CEO21
  16. Aug 3, 2015Went public Listed on NASDAQ1
  17. Dec 31, 2014New chief executive Mark J. Murray becomes CEO22
  18. 2007Founded Founded1

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.04) a share, on Nov 13, 2025.73

When it reported results

  1. Aug 12, 2026Reported quarterly or annual results62
  2. May 13, 2026Reported quarterly or annual results65
  3. Mar 23, 2026Reported quarterly or annual results67
  4. Nov 13, 2025Reported quarterly or annual results74
  5. Aug 6, 2025Reported quarterly or annual results75
  6. May 14, 2025Reported quarterly or annual results76
  7. Mar 27, 2025Reported quarterly or annual results77
  8. Jan 13, 2025Reported quarterly or annual results78

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

Filings

258 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 94 major events, 78 insider forms, 26 large holders, 1 private raises, 39 other. The latest 20:

  1. Oct 7, 20264 EDGAR
  2. Oct 7, 20264 EDGAR
  3. Oct 7, 20264 EDGAR
  4. Oct 7, 20264 EDGAR
  5. Oct 7, 2026SCHEDULE 13G/A EDGAR
  6. Oct 5, 2026SCHEDULE 13D/A EDGAR
  7. Oct 5, 20264 EDGAR
  8. Oct 1, 2026SC TO-I/A EDGAR
  9. Sep 30, 2026SC TO-I/A EDGAR
  10. Sep 23, 20264 EDGAR
  11. Sep 23, 20264 EDGAR
  12. Sep 23, 20264 EDGAR
  13. Sep 23, 20264 EDGAR
  14. Sep 4, 2026SCHEDULE 13G EDGAR
  15. Aug 24, 2026SC TO-I EDGAR
  16. Aug 21, 2026SC TO-C EDGAR
  17. Aug 21, 20268-K EDGAR
  18. Aug 12, 202610-Q EDGAR
  19. Aug 12, 20268-K EDGAR
  20. Aug 12, 2026SCHEDULE 13G/A EDGAR

The 258 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

10 open-market trades by officers, directors and large owners since October 2021: 0 buys and 10 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Feb 4, 2025HASTINGS DAVID CChief Financial OfficerSale22,183$3.28$72.8KForm 4
Feb 4, 2025Sims KarenChief Medical OfficerSale19,348$3.28$63.5KForm 4
Feb 4, 2025McElhaugh Michael J.Interim President & CEOSale23,790$3.28$78.0KForm 4
Feb 4, 2025Naftzger J. ChristopherGeneral Counsel and CCOSale11,333$3.28$37.2KForm 4
Aug 14, 2024MANCHESTER KEITH SDirectorSale8,846$3.69$32.6KForm 4
Feb 2, 2024Sims KarenChief Medical OfficerSale4,358$2.31$10.1KForm 4
Feb 2, 2024HASTINGS DAVID CChief Financial OfficerSale9,593$2.31$22.2KForm 4
Feb 2, 2024Sofia Michael J.Chief Scientific OfficerSale9,982$2.31$23.1KForm 4
Feb 2, 2024McElhaugh Michael J.Interim President & CEOSale10,164$2.31$23.5KForm 4
Dec 1, 2021Sofia Michael J.Chief Scientific OfficerSale200,000$5.09$1.0MForm 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
2025Michael McElhaughFormer Interim President and Chief Executive Officer$109.7K$3.6M85
2025Tuan NguyenChief Financial Officer50$359.8K$2.4M85
2025David C. HastingsFormer Chief Financial Officer$138.6K$2.2M85
2025Lindsay AndroskiPresident and Chief Executive Officer$437.8K$1.4M85
2024Michael McElhaughFormer Interim President and Chief Executive Officer$642.5K$2.1M85
2024David C. HastingsFormer Chief Financial Officer$502.0K$1.8M85

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Dec 13, 2016Raised $15 million in a private offering of equity Form D: 1 investor so far Form D

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
Two Seas Capital LP19,095,583$91.7M3.5%+538,040
Morgan Stanley17,698,305$85.0M0.0%−8,193,175
Whitefort Capital Management, LP15,794,261$75.8M19.4%+863,376
BlackRock, Inc.13,766,071$66.1M0.0%+799,125
State Street Corp7,869,179$37.8M0.0%+1,526,669
Rubric Capital Management LP7,532,937$36.2M0.3%+906,548
Vanguard Capital Management LLC7,010,679$33.7M0.0%+321,768
Barclays PLC4,207,914$20.2M0.0%−108,181
Geode Capital Management, LLC4,117,691$19.8M0.0%+345,885
Goldman Sachs Group Inc3,506,802$16.8M0.0%+2,406,368
Bank Of America Corp /de/2,646,197$12.7M0.0%+962,569
BlackBarn Capital Partners LP2,500,000$12.0M3.0%No change
Legal & General Group Plc2,466,127$11.8M0.0%+64,738
Woodline Partners LP2,281,856$11.0M0.0%+271,684
Jefferies Financial Group Inc.1,711,672$8.2M0.1%−182,395
Nomura Holdings Inc1,637,081$7.9M0.0%New
Vanguard Portfolio Management LLC1,541,458$7.4M0.0%+149,434
Charles Schwab Investment Management Inc1,431,218$6.9M0.0%+30,061
Northern Trust Corp1,419,024$6.8M0.0%+141,165
Osaic Holdings, Inc.1,347,866$6.5M0.0%−261
ADAR1 Capital Management, LLC1,268,147$6.1M0.3%−1,865,028
Deltroit Asset Management (UK) LLP1,200,000$5.8M0.9%+400,000
Vanguard Fiduciary Trust Co1,135,362$5.4M0.0%+72,308
Citigroup Inc879,237$4.2M0.0%−19,184
Bank Of Montreal /can/777,938$3.7M0.0%−4,825

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

SEC filer profile

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

  • Name on EDGARArbutus Biopharma Corp2
  • CIK0001447028
  • Employer ID (EIN)98-059777618
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company18
  • Incorporated inBritish Columbia, Canada18
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address701 Veterans Circle, Warminster, PA 189742
  • Phone604-419-32002
  • Shares outstanding197,847,835 as of Aug 10, 202617
  • Public float$472.1M as of Jun 30, 202518
  • AuditorErnst & Young LLP, Philadelphia, Pennsylvania PCAOB ID 42; no auditor attestation of internal control over financial reporting18
  • On EDGAR sinceSep 30, 20082
  • Filings1,046 in all: 8-K (309), 4 (212), 6-K (135), 3 (56), 10-Q (38), SC 13D/A (36), SC 13G/A (31), SC 13G (19)2
    All 52 form types

    DEFA14A (17), CT ORDER (16), 10-K (13), DEF 14A (13), CORRESP (12), 144 (11), S-8 (11), UPLOAD (11), SC 13D (10), EFFECT (9), 424B5 (8), S-3 (6), SCHEDULE 13D/A (6), SCHEDULE 13G/A (6), SUPPL (6), 4/A (5), 10-K/A (4), 20-F (3), 20-F/A (3), 8-K/A (3), F-10 (3), F-10/A (3), F-X (3), 10-Q/A (2), D (2), PRE 14A (2), REGDEX (2), S-3/A (2), SC TO-I/A (2), SCHEDULE 13G (2), 3/A (1), 424B2 (1), 6-K/A (1), 8-A12B (1), CERTNAS (1), DEFM14A (1), DEFR14A (1), FWP (1), NT 10-K (1), PREM14A (1), PRER14A (1), S-3MEF (1), SC TO-C (1), SC TO-I (1)

  • Latest filingsAnnual report (10-K) Mar 23, 2026
    Quarterly report (10-Q) Aug 12, 2026
    Proxy statement (DEF 14A) Apr 14, 2026
    Latest 8-K (8-K) Aug 21, 2026

Securities registered for trading

ClassSymbolExchange
Common shares, without par valueABUSThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 23, 2026 (Section 12(b) of the Exchange Act).18

Risk factors and legal proceedings

The risks Arbutus Biopharma names in Item 1A of its 10-K filed Mar 23, 2026: 41 risks under these headings, as written.18

  • Risks Related to Our Business, Our Financial Results and Need for Additional Capital
  • We are involved in patent infringement lawsuits to protect and assert our intellectual property rights against large, well-capitalized companies and the United States, which requires that we continue to expend substantial resources, and we may not be successful in these proceedings.
  • We face risks associated with the Contingent Settlement Payment under the Moderna Settlement Agreement.
  • We are in the early stages of our development, and there is a limited amount of information about us upon which you can evaluate our product candidates.
  • We may require substantial additional capital to fund our operations. Additional funds may be dilutive to shareholders or impose operational restrictions. Further, if additional capital is not available, we may need to delay, limit or eliminate our development and commercialization programs and modify our business strategy.
  • We have incurred operating losses in nearly every year since our inception and we anticipate that we will not achieve operating profits for the foreseeable future. To date, we have had no product revenues.
  • We do not generate revenues from product sales and may never be profitable from operations.
  • Risks Related to Development, Clinical Testing, Regulatory Approval, Marketing, and Coverage and Reimbursement of our Product Candidates
  • Our product candidates are in early stages of development and must go through clinical trials, which are very expensive, time-consuming and difficult to design and implement. The outcomes of clinical trials are uncertain, and delays in the completion of or the termination of any clinical trial of our product candidates could harm our business, financial condition and prospects.
  • Preclinical studies and preliminary and interim data from clinical trials of our product candidates are not necessarily predictive of the results or success of ongoing or later clinical trials of our product candidates. If we cannot replicate the results from our preclinical studies and initial clinical trials of our product candidates in later clinical trials, we may be unable to successfully develop, obtain regulatory approval for and commercialize our product candidates.
  • Because we have limited operational resources, we may decide to pursue a particular product candidate and fail to advance product candidates that later demonstrate a greater chance of clinical and commercial success.
  • Several of our clinical trials are currently or were conducted outside the United States, and the FDA may not accept data from trials conducted in locations outside the United States.
The other 30 risks
  • We cannot guarantee how long it will take regulatory agencies to review our applications for product candidates, and we may fail to obtain the necessary regulatory approvals to market our product candidates.
  • Disruptions at the FDA, including due to a reduction in the FDA’s workforce and/or inadequate funding for the FDA, could prevent the FDA from performing normal functions on which our business relies, which could negatively impact our business.
  • If a particular product candidate causes undesirable side effects, then we may be unable to receive regulatory approval of or commercialize such product candidate.
  • We may find it difficult to enroll patients in our clinical trials, which could delay or prevent clinical trials of our product candidates.
  • It may take considerable time and expense to resolve the clinical hold that has been placed on our IND application of AB-101 by the FDA, and no assurance can be given that the FDA will remove the clinical hold, in which case our business and financial prospects may be adversely affected.
  • Even if our product candidates obtain regulatory approval, they will remain subject to ongoing regulatory requirements and oversight.
  • We face significant competition from other biotechnology and pharmaceutical companies targeting HBV.
  • Our ability to generate product revenues and become profitable from operations is largely dependent on the future commercial success of our HBV product candidates.
  • We may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability lawsuits.
  • Coverage and adequate reimbursement may not be available for our product candidates, which could make it difficult for us to sell our products profitably.
  • We are subject to United States and Canadian healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages and reputational harm, fines, disgorgement, exclusion from participation in United States federal healthcare programs, curtailment or restricting of our operations and diminished profits from operations and future earnings.
  • If we participate in the Medicaid Drug Rebate Program and other governmental pricing programs, failure to comply with obligations under these programs could result in additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
  • Failure to comply with the United States Foreign Corrupt Practices Act (FCPA), and potentially other global anti-corruption and anti-bribery laws such as the Canadian Corruption of Foreign Public Officials Act, could subject us to penalties and other adverse consequences.
  • Risks Related to Our Dependence on Third Parties
  • We depend on our license agreement with Alnylam for the commercialization of ONPATTRO (Patisiran).
  • We expect to depend in part on our licensing agreements for a significant portion of our revenues for the foreseeable future and to develop, conduct clinical trials with, obtain regulatory approvals for, and manufacture, market and sell some of our product candidates. If these licensing agreements are unsuccessful, or anticipated milestone or royalty payments are not received, our business could be materially adversely affected.
  • If conflicts arise between our licensing partners and us, our licensing partners may act in their best interest and not in our best interest, which could adversely affect our business.
  • We rely on third parties to conduct our clinical trials, and if they fail to fulfill their obligations, perform services in a satisfactory manner, and/or comply with applicable legal or regulatory requirements, our development plans may be adversely affected.
  • We rely exclusively on third parties to formulate and manufacture our product candidates, which exposes us to a number of risks that may delay development, regulatory approval and commercialization of our products or result in higher product costs.
  • Risks Related to Our Intellectual Property
  • Other companies or organizations may assert patent rights that prevent us from developing or commercializing our products.
  • Certain of our patents and patent applications have been challenged and found to be invalid, and additional challenges may occur in the future, which could adversely affect our business.
  • We have incurred, and may in the future continue to incur, substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights, and we may not be successful in one or more of these lawsuits or
  • proceedings, any of which could have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to decline.
  • Confidentiality agreements with employees and others, including collaborators, may not adequately prevent disclosure of trade secrets and other proprietary information.
  • Risks Related to the Ownership of our Common Shares
  • The concentration of common share ownership will likely limit the ability of the other shareholders to influence corporate matters.
  • We are incorporated in Canada, with our assets located both in Canada and the United States, with the result that it may be difficult for investors to enforce judgments obtained against us or some of our officers.
  • If we are deemed to be a “passive foreign investment company” for the current or any future taxable year, investors who are subject to United States federal taxation would likely suffer materially adverse United States federal income tax consequences.
  • Our articles and certain Canadian laws could delay or deter a change of control.
  • General Risk Factors
  • We could face liability from our controlled use of hazardous and radioactive materials in our development processes.
  • Our business, reputation, and operations could suffer in the event of information technology system failures, such as a cybersecurity incident.
  • We may form strategic alliances or collaborations that could harm our financial condition, results of operations or cash flows, dilute our shareholders’ ownership, incur debt or cause us to incur significant expense.

Legal proceedings

Patent Infringement Litigation vs. Pfizer and BioNTech

On April 4, 2023, we and Genevant filed a lawsuit in the United States District Court for the District of New Jersey against Pfizer/BioNTech seeking damages for infringement of United States Patent Nos. 9,504,651; 8,492,359; 11,141,378; 11,298,320; and 11,318,098 in the manufacture and sale of any COVID-19 mRNA-LNP vaccines. The patents relate to nucleic acid-lipid particles and their composition, manufacture, delivery and methods of use. In the lawsuit, we seek fair compensation for Pfizer’s and BioNTech’s use of our patented technology that was developed with great effort and at great expense, without which their COVID-19 mRNA-LNP vaccines would not have been successful. The claim construction hearing occurred in December 2024, and in September 2025, the court issued a claim construction ruling, which construed the disputed claim terms in a manner we generally consider to be favorable. The parties are awaiting further scheduling in the litigation.

Patent Infringement Litigation vs. Moderna

On February 28, 2022, we and Genevant filed a lawsuit in the United States District Court for the District of Delaware against Moderna seeking damages for infringement of United States Patent Nos. 8,058,069, 8,492,359, 8,822,668, 9,364,435, 9,504,651, and 11,141,378 in the manufacture and sale of MRNA-1273, Moderna’s vaccine for COVID-19. On March 3, 2025, we and Genevant filed five international lawsuits against Moderna seeking to enforce patents protecting our patented LNP technology. Together, these lawsuits comprise the Moderna LNP Litigation.

The opening of Item 3, Legal Proceedings.18

Sources

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