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DMAC on Nasdaq

DiaMedica Therapeutics Inc.

In its 2026 annual report the company says: “We are a clinical-stage biopharmaceutical company committed to improving the lives of people suffering from severe ischemic disease with two main clinical programs focused on preeclampsia (PE) / fetal growth restriction (FGR) and acute ischemic stroke (AIS).”3 It is headquartered in Minneapolis, Minnesota.1 Its shares trade on Nasdaq under the symbol DMAC.1

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Last updated Oct 21, 2026.

Overview

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  • TickerDMAC on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersMinneapolis, Minnesota1
  • Incorporated inCanada (Federal Level)2
  • Business address301 Carlson Parkway, Suite 210, Minneapolis, Mn 553052
  • Filer categoryNon-accelerated filer, Smaller reporting company2
  • Legal formCorporation

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We are a clinical-stage biopharmaceutical company committed to improving the lives of people suffering from severe ischemic disease with two main clinical programs focused on preeclampsia (PE) / fetal growth restriction (FGR) and acute ischemic stroke (AIS). Our lead candidate DM199 (rinvecalinase alfa), is the first pharmaceutically active recombinant (synthetic) form of the human tissue kallikrein-1 (rhKLK1) protein to be clinically studied in patients and has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of AIS. Kallikrein-1 (KLK1), extracted from human urine, is an established therapeutic modality in Asia for the treatment of AIS, and KLK1 produced from pig pancreas, is an established therapeutic modality for the treatment of cardio renal disease, including hypertension, in Asia. We plan to advance DM199 through required clinical…3 From its latest annual report

Financials

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

Financial statements

Operating income456789-$34.4M in 2025+197% since 2019
-$40.0M-$30.0M-$20.0M-$10.0M02019: -$11.6M-$11.6M20192020: -$12.7M-$12.7M2020+10%2021: -$13.6M-$13.6M2021+7%2022: -$14.0M-$14.0M2022+3%2023: -$21.3M-$21.3M2023+52%2024: -$26.7M-$26.7M2024+25%2025: -$34.4M-$34.4M2025+29%
Net income456789-$32.8M in 2025+208% since 2019
-$40.0M-$30.0M-$20.0M-$10.0M02019: -$10.6M-$10.6M20192020: -$12.3M-$12.3M2020+15%2021: -$13.6M-$13.6M2021+11%2022: -$13.7M-$13.7M2022+1%2023: -$19.4M-$19.4M2023+42%2024: -$24.4M-$24.4M2024+26%2025: -$32.8M-$32.8M2025+34%

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

Period ending2025-12-312024-12-31
Research and development$24.6M$19.1M
General and administrative$9.8M$7.6M
Total operating expenses$34.4M$26.7M
Operating loss-$34.4M-$26.7M
Other income, net$1.7M$2.3M
Total other income, net$1.7M$2.3M
Loss before income tax expense-$32.7M-$24.4M
Income tax expense-$28.0K-$30.0K
Net loss-$32.8M-$24.4M
Unrealized gain on marketable securities$27.0K$17.0K
Comprehensive loss-$32.7M-$24.4M
Basic and diluted net loss per share (in dollars per share)-$0.70-$0.60
Weighted average shares outstanding basic and diluted (in shares)47.0M shares40.4M shares

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Corporate structure

DiaMedica 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 DiaMedica Therapeutics Inc.

  • COOPERMAN LEON G Filed SCHEDULE 13G/A on DiaMedica Therapeutics Inc., latest Feb 17, 2026 (3 filings since Aug 27, 2025)
  • DIALECTIC CAPITAL MANAGEMENT, LP Filed SCHEDULE 13G/A on DiaMedica Therapeutics Inc., latest Feb 17, 2026 (2 filings since Jul 8, 2024)
  • TRILL AB Filed SCHEDULE 13G/A on DiaMedica Therapeutics Inc., latest Feb 6, 2026 (5 filings since Oct 8, 2021)
  • Richard Jacinto Ii. Filed SCHEDULE 13G/A on DiaMedica Therapeutics Inc., latest Nov 7, 2025 (4 filings since May 27, 2022)
  • TomEnterprise AB Filed SCHEDULE 13G/A on DiaMedica Therapeutics Inc., latest Jul 30, 2025 (4 filings since Oct 8, 2021)
  • Timothy P. Lynch Filed SC 13G/A on DiaMedica Therapeutics Inc., latest Feb 13, 2023
  • TomEnterprise Private AB Filed SC 13G/A on DiaMedica Therapeutics Inc., latest Dec 6, 2022
  • Laurence W. Lytton Filed SC 13G/A on DiaMedica Therapeutics Inc., latest Feb 15, 2022 (2 filings since Oct 6, 2021)
  • Stonepine Capital Management, LLC Filed SC 13G/A on DiaMedica Therapeutics Inc., latest Feb 11, 2022
  • DiaMedica Therapeutics Inc. Minneapolis, Minnesota

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

What it owns

What DiaMedica 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$295.0K9 Dec 31, 2025$262.0K9 Dec 31, 2024+12.6%
Accumulated depreciation$150.0K9 Dec 31, 2025$114.0K9 Dec 31, 2024+31.6%
Property and equipment, net$145.0K9 Dec 31, 2025$148.0K9 Dec 31, 2024−2.0%
Operating-lease assets (leased space)$197.0K9 Dec 31, 2025$279.0K9 Dec 31, 2024−29.4%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$15.6M9 Dec 31, 2025$3.0M9 Dec 31, 2024+417.3%
Marketable securities, current$44.2M9 Dec 31, 2025$41.1M9 Dec 31, 2024+7.6%

Properties, in its own words

Our principal executive offices, together with our research and development operations, are at the office of our wholly owned subsidiary, DiaMedica USA Inc., located at 301 Carlson Parkway, Suite 210, Minneapolis, Minnesota, USA 55305. We lease these premises, which consist of approximately 6,000 square feet, pursuant to a lease that expires in January 2028. We believe that our facilities are adequate for our current needs and that suitable additional space will be available if and when needed on acceptable terms.

Item 2 of the 10-K filed Mar 30, 2026.3

Leadership

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

Chief executive

  1. Dietrich John Pauls2018–now

President

  1. Dietrich John Pauls2018–now

Chief financial officer

  1. Scott Kellen2018–now
20202025
Board members and other officers (18)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerLorianne Masuoka named Jul 2, 2024 to Jul 25, 202531
  • Executive Officer, DirectorRick Pauls named Oct 6, 2021 to Jul 25, 202531
  • DirectorDaniel T. O'Connor named Jul 25, 202531
  • DirectorMichael R. Giuffre named Oct 6, 2021 to Jul 25, 202531

Former names

  • DiaMedica Inc.May 16, 2007 to Mar 11, 20142

Timeline

  1. Aug 10, 20268-K Results of operations32
  2. May 21, 20268-K Shareholder vote33
  3. May 6, 20268-K Results of operations34
  4. Mar 31, 20268-K Results of operations35
  5. Jan 5, 20268-K Other events36
  6. Dec 18, 20258-K Regulation FD disclosure; Other events37
  7. Nov 12, 20258-K Results of operations38
  8. Aug 12, 20258-K Results of operations39
  9. Aug 12, 20258-K Entered a material agreement40
  10. Aug 6, 20258-K Executive or director change; Regulation FD disclosure; Other events41
  11. Jul 21, 20258-K Entered a material agreement; Unregistered sale of shares; Other events42
  12. Jul 17, 20258-K Regulation FD disclosure43
  13. Dec 6, 2018New chief executive Dietrich John Pauls becomes CEO12

Calendar

Coming up

  1. Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.17) a share, on Nov 12, 2025.44

When it reported results

  1. Aug 10, 2026Reported quarterly or annual results32
  2. May 6, 2026Reported quarterly or annual results34
  3. Mar 31, 2026Reported quarterly or annual results35
  4. Nov 12, 2025Reported quarterly or annual results38
  5. Aug 12, 2025Reported quarterly or annual results39
  6. May 13, 2025Reported quarterly or annual results45
  7. Mar 17, 2025Reported quarterly or annual results46
  8. Nov 13, 2024Reported quarterly or annual results47

Drug trials and FDA: coming up

  1. Dec 2026Phase 2/3 trial readout expected Phase 2/3 trial of Recombinant human tissue kallikrein in Acute Stroke: primary completion expected Dec 2026 (ClinicalTrials.gov NCT05065216).48

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

261 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 50 major events, 113 insider forms, 23 large holders, 5 private raises, 50 other. The latest 20:

  1. Aug 12, 20264 EDGAR
  2. Aug 11, 2026S-8 EDGAR
  3. Aug 10, 202610-Q EDGAR
  4. Aug 10, 20268-K EDGAR
  5. Jun 3, 20264 EDGAR
  6. Jun 3, 20264 EDGAR
  7. Jun 3, 20264 EDGAR
  8. Jun 3, 20264 EDGAR
  9. Jun 3, 20264 EDGAR
  10. Jun 3, 20264 EDGAR
  11. Jun 3, 20264 EDGAR
  12. Jun 3, 20264 EDGAR
  13. Jun 3, 20264 EDGAR
  14. May 21, 20268-K EDGAR
  15. May 6, 202610-Q EDGAR
  16. May 6, 20268-K EDGAR
  17. Apr 1, 2026ARS EDGAR
  18. Apr 1, 2026DEFA14A EDGAR
  19. Apr 1, 2026DEF 14A EDGAR
  20. Mar 31, 20268-K EDGAR

The 261 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

43 open-market trades by officers, directors and large owners since October 2021: 42 buys and 1 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Nov 25, 2025TRILL AB10% ownerBuy73,099$8.57$626.5KForm 4
Nov 24, 2025TRILL AB10% ownerBuy40,253$7.89$317.6KForm 4
Nov 21, 2025TRILL AB10% ownerBuy208,872$7.41$1.5MForm 4
Nov 20, 2025TRILL AB10% ownerBuy128,426$7.41$951.6KForm 4
Nov 19, 2025TRILL AB10% ownerBuy240,352$7.21$1.7MForm 4
Nov 18, 2025TRILL AB10% ownerBuy182,882$6.75$1.2MForm 4
Nov 17, 2025TRILL AB10% ownerBuy187,393$6.52$1.2MForm 4
Aug 27, 2025STAHLBERG JAN10% ownerBuy50,772$6.00$304.6KForm 4
Aug 26, 2025STAHLBERG JAN10% ownerBuy59,648$6.00$357.9KForm 4
Aug 25, 2025STAHLBERG JAN10% ownerBuy338,265$6.00$2.0MForm 4
Aug 22, 2025STAHLBERG JAN10% ownerBuy59,788$5.96$356.3KForm 4
Aug 21, 2025STAHLBERG JAN10% ownerBuy48,172$5.96$287.1KForm 4
Aug 20, 2025STAHLBERG JAN10% ownerBuy71,107$5.86$416.7KForm 4
Aug 15, 2025STAHLBERG JAN10% ownerBuy8,233$6.00$49.4KForm 4
Aug 14, 2025STAHLBERG JAN10% ownerBuy70,414$5.99$421.8KForm 4
Aug 13, 2025STAHLBERG JAN10% ownerBuy293,601$5.91$1.7MForm 4
Jul 23, 2025JACINTO RICHARD II10% ownerBuy400,000$3.50$1.4MForm 4
Jul 23, 2025STAHLBERG JAN10% ownerBuy1,542,857$3.50$5.4MForm 4
Jul 23, 2025Von Koch Thomas10% ownerBuy2,857,142$3.50$10.0MForm 4
Jun 28, 2024TomEnterprise Private AB10% ownerBuy1,200,000$2.50$3.0MForm 4

All 43 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
2025Rick Pauls$645.0K$2.7M58
2025Julie Krop, M.D.Chief Medical Officer$199.0K$1.7M58
2025Scott Kellen$408.5K$1.2M58
2024President and Chief Executive Officer$593.2K$1.6M58
2024Chief Financial Officer and Secretary$374.2K$814.0K58

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$110.2M 2021–2025
Money received by yearMoney received by year, 2021–2025: $110.2M in all. Private raises (Form D) $110.2M.$0$10M$20M$30M$40M2021 · Private raises (Form D): $30.0M202120222023 · Private raises (Form D): $38.3M20232024 · Private raises (Form D): $11.8M20242025 · Private raises (Form D): $30.1M2025
Figures by year
YearPrivate raises (Form D)Total
2025$30.1M$30.1M
2024$11.8M$11.8M
2023$38.3M$38.3M
2021$30.0M$30.0M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Jul 23, 2025Raised $30.1 million in a private offering of equity31 Form D: 14 investors so far Form D
  2. Jun 28, 2024Raised $11.8 million in a private offering of equity59 Form D: 10 investors so far Form D
  3. Jun 23, 2023Raised $37.5 million in a private offering of equity60 Form D: 34 investors so far Form D
  4. Apr 10, 2023Raised $750,000 in a private offering of equity61 Form D: 1 investor so far Form D
  5. Sep 28, 2021Raised $30 million in a private offering of equity62 Form D: 10 investors 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 89. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Cooperman Leon G3,450,000$24.3M0.7%+1,430,000
BlackRock, Inc.2,252,285$15.9M0.0%+396,098
Geode Capital Management, LLC894,115$6.3M0.0%+113,599
Millennium Management LLC845,309$6.0M0.0%−90,283
State Street Corp646,743$4.6M0.0%+2,532
Bleichroeder LP382,317$2.7M0.5%No change
Vanguard Capital Management LLC355,523$2.5M0.0%+22,067
Osaic Holdings, Inc.338,107$2.4M0.0%+18,432
Northern Trust Corp327,518$2.3M0.0%−11,008
Vanguard Portfolio Management LLC251,671$1.8M0.0%+48,212
LPL Financial LLC233,500$1.6M0.0%+7,450
Vanguard Fiduciary Trust Co207,438$1.5M0.0%+19,714
Goldman Sachs Group Inc168,066$1.2M0.0%+108,778
Citadel Advisors LLC145,870$1.0M0.0%+146
Squarepoint Ops LLC145,247$1.0M0.0%New
Bank of New York Mellon Corp117,820$829.4K0.0%+6,741
Members Wealth LLC101,382$713.7K0.4%No change
Charles Schwab Investment Management Inc96,691$680.7K0.0%+8,270
Cobalt Capital Management, Inc.90,000$633.6K0.5%New
Trexquant Investment LP84,648$595.9K0.0%+62,387
Magnolia Capital Advisors LLC77,405$544.9K0.1%No change
Diametric Capital, LP76,621$539.4K0.1%New
Blue Trust, Inc.69,122$486.6K0.0%No change
Bank Of America Corp /de/57,712$406.3K0.0%+14,944
Bank Of Montreal /can/54,944$386.8K0.0%+36,309

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

SEC filer profile

How DiaMedica 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 EDGARDiaMedica Therapeutics Inc.1
  • CIK0001401040
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inBritish Columbia3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address301 Carlson Parkway, Suite 210, Minneapolis, MN 553051
  • Phone(763) 496-54541
  • Shares outstanding53,925,697 as of Aug 3, 202611
  • Public float$95.8M as of Jun 30, 20253
  • AuditorBaker Tilly US, LLP, Minneapolis, Minnesota PCAOB ID 23; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceMay 16, 20071
  • Filings427 in all: 4 (153), 8-K (80), 10-Q (23), 3 (23), UPLOAD (13), CORRESP (12), SC 13G/A (12), SC 13G (10)1
    All 39 form types

    EFFECT (9), 10-K (8), DEF 14A (8), DEFA14A (8), S-3 (8), SCHEDULE 13G/A (8), S-8 (7), D (6), 424B5 (4), ARS (4), 424B3 (3), DRSLTR (3), S-1/A (3), CT ORDER (2), DRS (2), DRS/A (2), PRE 14A (2), 10-K/A (1), 144 (1), 20FR12B (1), 20FR12B/A (1), 424B2 (1), 424B4 (1), 8-A12B (1), 8-A12B/A (1), 8-K/A (1), CERT (1), REGDEX (1), RW (1), S-1 (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Mar 30, 2026
    Quarterly report (10-Q) Aug 10, 2026
    Proxy statement (DEF 14A) Apr 1, 2026
    Latest 8-K (8-K) Aug 10, 2026

Securities registered for trading

ClassSymbolExchange
Voting Common Shares, no par value per shareDMACNasdaq

From the cover page of the 10-K filed Mar 30, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks DiaMedica Therapeutics Inc. names in Item 1A of its 10-K filed Mar 30, 2026: 61 risks under these headings, as written.3

  • Risks Related to Our Business Model
  • Risks Related to Our Current and Future Clinical Trials and DM199 Product Candidate
  • Risks Related to Our Financial Position and Need for Additional Capital
  • Risks Related to Governmental and Regulatory Compliance and Approvals
  • Risks Related to Our Reliance on Third Parties
  • Risks Related to Intellectual Property
  • Risks Related to Human Capital Management
  • Risks Related to the Future Commercialization of DM199 or Any Future Product Candidate
  • Risks Related to Our Common Shares
  • Risks Related to Our Jurisdiction of Organization
  • Our business model assumes we will generate revenue by, among other activities, marketing or out-licensing the product candidates we develop. Since our product candidates are in various stages of development and we have no products approved for commercialization, there is a limited amount of information about us upon which you can base an evaluation of our business and prospects.
  • We may need to establish relationships with strategic partners to fully develop our product candidates and, if approved, market any product candidates that are approved.
The other 59 risks
  • We have had and may continue to have difficulty enrolling patients in our ReMEDy2 trial or we may experience other clinical testing delays or setbacks, which would delay our ability or the ability of a future partner to obtain regulatory approval for DM199 to treat AIS and commercialize it, which would substantially harm our business and prospects.
  • The adaptive design of our ReMEDy2 trial could result in the trial being required to enroll more patients than anticipated, which would increase the time and costs to complete the trial.
  • The expansion of our DM199 clinical development program into PE involves certain risks related to timing, regulatory approvals, costs and enrollment, and the fact that the initial PE trial is investigator-sponsored, raises additional risks.
  • DM199 and any other product candidates we choose to develop may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if granted.
  • We face the risk of product liability claims, which could exceed our insurance coverage, deplete our cash resources and lead to clinical trial delays.
  • If we are unable to maintain product liability insurance required by third parties, certain agreements, such as those with clinical trial sites, contract research organizations and other supporting vendors, would be subject to termination, which could have a material adverse impact on our operations.
  • The initial investigator-sponsored PE trial is being conducted in South Africa, we are commencing a PE trial in Canada and we are in the process of globally expanding our ReMEDy2 trial to countries outside the United States, raising additional international risks, which could materially adversely affect our business.
  • It is possible that the FDA and comparable foreign regulatory authorities may not accept trial data from countries located outside the United States.
  • Data from the investigator-sponsored PE trial, which we expect earlier than data from our ReMEDy2 trial, may adversely affect our ReMEDy2 trial, which could adversely impact our business, prospects, operating results and financial position and harm our ability to raise additional financing, if and when needed.
  • Interim, “topline” and preliminary results from our clinical 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.
  • If our ReMEDy2 trial fails to adequately demonstrate the safety and efficacy of DM199 to treat AIS or if the PE trials fail to adequately demonstrate the safety and initial signs of efficacy of DM199 to treat PE, we will not be able to obtain required regulatory approvals, which would substantially harm our business, prospects and financial condition.
  • We may be required to suspend, repeat or terminate our clinical trials if they are deemed not conducted in accordance with regulatory requirements, the results are negative or inconclusive, or the trial is not well designed.
  • Our prospects depend on the clinical and commercial success of our DM199 product candidate.
  • Since we currently have no revenue from product sales and do not expect any revenue from product sales for at least two to three years, we will need additional funding to continue our clinical development activities and other operations, which may not be available to us on acceptable terms, or at all.
  • We have incurred substantial losses since our inception and expect to continue to incur substantial losses for at least two to three years and may never achieve or sustain profitability.
  • The regulatory approval process is expensive, time-consuming and uncertain and may prevent us or any future partner or collaborator from obtaining approvals for the commercialization of DM199 or any future product candidate.
  • Any product candidate for which we or any future partner or collaborator obtains marketing approval could be subject to post-marketing restrictions or recall or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with the product candidate.
  • We may be unable to obtain regulatory acceptances necessary to conduct clinical trials in the jurisdictions or on the timelines we expect.
  • We have received Fast Track designation for DM199 for the treatment of AIS, and we may seek such designation for other uses of DM199 or future product candidates. Fast Track designation may not lead to faster development or a faster FDA review or approval process, and it does not increase the likelihood that DM199 will receive marketing approval in the United States. Further, there is no guarantee we will be able to maintain such designation.
  • Current and future legislation may increase the difficulty and cost for us and any future partner or collaborator to obtain marketing approval of and commercialize DM199 or any future product candidate and affect the prices we may obtain.
  • Changes in funding or disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new or modified products from being developed, authorized or commercialized in a timely manner or at all, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could adversely impact our business.
  • Future legislation in the United States, Europe or other countries, and/or regulations and policies adopted by the FDA, the EMA or comparable regulatory authorities, may increase the time and cost required for us or any future partners or collaborators to conduct and complete clinical trials of our current or any future product candidates.
  • We rely and will continue to rely on third parties to support the planning, execution and/or monitoring of our preclinical and clinical trials, and their failure to perform as required could cause delays in completing our product development and substantial harm to our business.
  • We rely extensively on contract development and manufacturing organizations (CDMOs) for the manufacture and testing of DM199 under current good manufacturing procedures (cGMP), and we are subject to many manufacturing risks, any of which could substantially increase our costs and/or limit supply of DM199.
  • Future development collaborations are expected to be important to us. If we are unable to enter into or maintain these collaborations, or if these collaborations are not successful, our business could be adversely affected.
  • Our inability to maintain contractual relationships with physicians could have a negative impact on our research and development.
  • We could lose important intellectual property rights that we currently license from a third party if we fail to comply with our obligations under the license agreements under which we license intellectual property rights from this third party or otherwise experience disruptions to our business relationships with our licensor.
  • We may be unable to adequately protect our technology and enforce our intellectual property rights and our competitors may take advantage of our development efforts or acquired technology and compromise our prospects for marketing and selling DM199 or any future product candidate.
  • We or a future partner may require additional third-party licenses to effectively develop, manufacture and commercialize DM199, or any future product candidate, and such licenses might not be available on commercially acceptable terms, or at all.
  • Changes in patent law and its interpretation could diminish the value of our patents in general, thereby impairing our ability to protect DM199 or any future product candidate.
  • Intellectual property litigation may be expensive, time consuming and may cause delays in the development, manufacturing and commercialization of DM199 or any future product candidate.
  • Our reliance on third parties may require us to share our trade secrets, which increases the possibility that a competitor will discover them.
  • Patent terms may be inadequate to protect the competitive position of DM199 or any future product candidate for an adequate amount of time.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
  • 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.
  • We may not be able to protect our intellectual property rights throughout the world.
  • We rely heavily on the capabilities and experience of our key executives and clinical personnel and advisors; and the loss of any of them could affect our ability to develop DM199 or any future product candidate.
  • We will likely need to expand our operations and increase the size of our Company and we may experience difficulties in managing our growth.
  • The successful commercialization of DM199 or any future product candidate, if approved, will depend on achieving market acceptance and we may not be able to gain sufficient acceptance to generate significant revenue.
  • If we fail to obtain coverage and adequate reimbursement for DM199 or any future product candidate, its revenue-generating ability will be diminished and there is no assurance that the anticipated market for the product will develop or be sustained.
  • We or any future partner will likely face competition from other biotechnology and pharmaceutical companies, many of which have substantially greater resources, and our DM199 product candidate may face competition sooner than expected and our financial condition and operations will suffer if we fail to compete effectively.
  • Our DM199 product candidate may face competition sooner than expected.
  • Our estimates of the market opportunity for our DM199 product candidate for the treatment of AIS, PE and any other indications we choose to pursue or any other product candidates we develop 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, prospects, operating results and financial condition.
  • Our common share price has been volatile and may continue to be volatile.
  • We do not have a history of a very active trading market for our common shares.
  • We may issue additional common shares resulting in share ownership dilution.
  • If there are substantial sales of our common shares or the perception that such sales may occur, the market price of our common shares could decline.
  • We are a “smaller reporting company,” and because we have opted to use the reduced disclosure requirements available to us, certain investors may find investing in our common shares less attractive.
  • A limited number of shareholders possess substantial voting power and could limit other shareholders’ ability to influence the outcome of key transactions, including changes of control.
  • We are governed by the corporate laws of British Columbia, which in some cases have a different effect on shareholders than the corporate laws in effect in the United States.
  • We were classified as a “passive foreign investment company” in 2025, 2024 and 2023 and certain other prior years and may be so classified in the current and/or future taxable years, which may have adverse U.S. federal income tax consequences for U.S. shareholders and adversely affect the level of interest in our common shares by U.S. investors.
  • It may be difficult for non-Canadian shareholders or investors to obtain and enforce judgments against us because of our organization as a British Columbia corporation.
  • General Risk Factors
  • We may not achieve our publicly announced milestones according to schedule, or at all.
  • If securities or industry analysts do not continue to publish research or reports about our business, or publish negative reports about our business, the market price of our common shares and trading volume could decline.
  • We, or our third-party contract research organizations or consultants, may be subject to information technology (IT) systems failures, network disruptions, breaches in data security and computer crime and cyber-attacks, which could result in a material disruption of our product candidates' development programs, compromise sensitive information related to our business or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business.
  • We could be subject to securities class action litigation, which is expensive and could divert management attention.
  • Our insurance policies are expensive and protect us only from certain business risks, which could leave us exposed to significant uninsured liabilities. Additionally, future fluctuations in insurance cost and availability could adversely affect our operating results or risk management profile.
  • The widespread outbreak of communicable diseases could delay our clinical trials and otherwise materially and adversely affect our business, operating results and financial condition.
  • Our business or the value of our common shares could be negatively affected as a result of actions by activist shareholders.

Legal proceedings

Resolution of Litigation with Pharmaceutical Research Associates Group B.V.

Beginning in 2018, we initiated legal proceedings against Pharmaceutical Research Associates Group B.V., acquired by ICON plc as of July 1, 2021, (ICON/PRA Netherlands). As previously disclosed, in October 2025, we entered into a Settlement Agreement, pursuant to which the parties agreed to settle any and all disputes, claims, and liabilities that had arisen, or will arise, out of their relationship, past and present, including, but not limited to, the pending legal proceedings.

From time to time, we may be subject to other various ongoing or threatened legal actions and proceedings, including those that arise in the ordinary course of business, which may include employment matters and breach of contract disputes. Such matters are subject to many uncertainties and to outcomes that are not predictable with assurance and that may not be known for extended periods of time. We are not currently engaged in or aware of any threatened legal actions.

The opening of Item 3, Legal Proceedings.3

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