DiaMedica Therapeutics Inc.

Company Overview

Business Model: DiaMedica Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing novel treatments for severe ischemic diseases, specifically preeclampsia (PE) / fetal growth restriction (FGR) and acute ischemic stroke (AIS). Its lead product candidate, DM199 (rinvecalinase alfa), is a pharmaceutically active recombinant (synthetic) form of the human tissue kallikrein-1 (rhKLK1) protein. DM199's mechanism of action is believed to enhance endothelial health, microcirculatory blood flow, and tissue perfusion by increasing the production of nitric oxide (NO), prostacyclin (PGI2), and endothelium-derived hyperpolarizing factor (EDHF). For PE/FGR, DM199 is intended to lower blood pressure, enhance endothelial health, and improve perfusion to maternal organs and the placenta. For AIS, it aims to enhance blood flow and boost neuronal survival in the ischemic penumbra by dilating arterioles, inhibiting apoptosis, and promoting angiogenesis. Longer-term, DiaMedica Therapeutics Inc. plans to develop DM300, a patented recombinant human ulinastatin, as a potential therapy for severe acute pancreatitis. The company's business model assumes revenue generation through marketing or out-licensing product candidates, with no product sales revenue expected for at least two to three years.

Market Position: DiaMedica Therapeutics Inc. positions DM199 as the first pharmaceutically active recombinant form of human tissue kallikrein-1 (rhKLK1) protein to be clinically studied in patients. While naturally occurring KLK1 (derived from human urine or pig pancreas) is an established therapeutic in Asia for AIS and cardio renal diseases, DiaMedica Therapeutics Inc. believes DM199 overcomes regulatory, commercial, and clinical drawbacks associated with these sources, such as impurities and higher regulatory standards in Western markets. The company is not aware of any other recombinant KLK1 with regulatory approval or in development. DM199 has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of AIS. The company targets significant unmet medical needs: there are currently no FDA-approved therapeutics for PE, and existing AIS treatments (tPA/TNK, mechanical thrombectomy) have narrow therapeutic windows, leaving up to 80% of AIS patients without acute intervention. DM199 aims to offer a therapeutic window of up to 24 hours for AIS.

Recent Strategic Developments:

• Preeclampsia (PE) / Fetal Growth Restriction (FGR):
  • An investigator-sponsored Phase 2 study in PE patients is ongoing at Tygerberg Hospital in Cape Town, South Africa. Interim results (N=28) from Part 1a, released in July 2025, demonstrated DM199's safety, tolerability, clinically-relevant pharmacodynamic activity, and no placental transfer. Subjects showed rapid, statistically significant reductions in blood pressure sustained up to 24 hours post-infusion, and a 13.2% (p=0.0003) mean reduction in uterine artery pulsatility index, suggesting improved uterine artery blood flow and placental perfusion. An extension cohort is currently enrolling.
  • DiaMedica Therapeutics Inc. received Health Canada approval in March 2026 to initiate an open-label, dose-ranging Phase 2 study in early-onset PE in North America (United States & Canada) and the United Kingdom. Site activation is planned for the second half of 2026, with a clinical trial application for UK sites anticipated in Q2 2026.
  • The FDA requested an additional non-clinical 10-day modified embryo-fetal development and pre- and postnatal development (ePPND) study in a rabbit model for the US PE program. Preliminary results indicated an antibody response to DM199 in rabbits, preventing study completion. DiaMedica Therapeutics Inc. is evaluating alternate animal models, which may substantially delay results.
• Acute Ischemic Stroke (AIS):
  • The ReMEDy2 clinical trial (Phase 2/3, adaptive design, randomized, double-blind, placebo-controlled) is ongoing, targeting approximately 300 participants at up to 100 sites globally. An interim analysis by an independent data safety monitoring board is planned after the first 200 participants, with the final sample size potentially ranging from 300 to 728 patients. The interim analysis is estimated for the second half of 2026.
  • The trial protocol was amended in 2024 to allow patients treated with tPA or TNK who continue to experience a persistent neurological deficit to participate. The trial excludes patients eligible for mechanical thrombectomy.
  • DiaMedica Therapeutics Inc. has experienced slower than expected site activations and enrollment in ReMEDy2 due to hospital staffing shortages, study criteria, logistics, prior clinical hold concerns, and competition. Mitigation efforts include expanding the internal clinical team and bringing certain trial activities in-house.
  • Regulatory approval has been received from the European Medicines Agency, and study sites are being initiated in six European countries, in addition to current sites in the United States, Canada, and Georgia.
  • A Phase 1C open-label, single ascending dose (SAD) study of DM199 (with PVC IV bags) completed in Australia in April 2023, confirming DM199 blood concentration levels and safety, with no significant adverse events. An additional cohort of ACEi patients also showed no instances of hypotension.
  • The Phase 2 ReMEDy1 trial (completed Oct 2019, 92 participants) met primary safety and tolerability endpoints. It demonstrated a therapeutic effect on the rate of severe stroke recurrence (0% in DM199 vs. 13% in placebo, p=0.012) and on physical recoveries in non-mechanical thrombectomy patients (36% full/nearly full recovery in DM199 vs. 14% in placebo).
• Manufacturing and Partnerships: DiaMedica Therapeutics Inc. continues manufacturing process development to support clinical and commercial needs and plans to identify strategic partner(s) for clinical development and commercialization.

Geographic Footprint: DiaMedica Therapeutics Inc.'s principal executive offices and research and development operations are located in Minneapolis, Minnesota, USA, through its wholly owned subsidiary DiaMedica USA Inc. Its registered office is in Kelowna, British Columbia, Canada. Clinical trials for PE are being conducted in South Africa and are planned for North America (United States & Canada) and the United Kingdom. The ReMEDy2 trial for AIS is being conducted in the United States, Canada, Georgia, the United Kingdom, and is initiating sites in six European countries. The company has a wholly owned subsidiary, DiaMedica Australia Pty Ltd., and is subject to income taxes in Canada, the United States, and Australia. Substantially all of the company's assets are held in the United States.

Financial Performance

Revenue Analysis

Profitability Metrics:

• Gross Margin: 0% (No product sales)
• Operating Margin: -100% (Operating loss of $34.4 million on $0 revenue)
• Net Margin: -100% (Net loss of $32.8 million on $0 revenue)

Investment in Growth:

• R&D Expenditure: $24.6 million (increased from $19.1 million in 2024)
• Capital Expenditures: $0.04 million (purchase of property and equipment)
• Strategic Investments: Primary investment is in the clinical development programs for DM199, including the global expansion of the ReMEDy2 trial and the expansion of the PE clinical development program.

Business Segment Analysis

Single Operating Segment: Development of Treatments for Severe Ischemic Diseases

Financial Performance:

• Revenue: $0 billion (0% YoY)
• Operating Loss: $(34.4) million (increased from $(26.7) million in 2024)
• Net Loss: $(32.8) million (increased from $(24.4) million in 2024)
• R&D Expenses: $24.6 million (+28.8% YoY)
• Operating Margin: Not applicable due to no revenue.
• Key Growth Drivers: The increase in operating losses and R&D expenses is primarily driven by the continuation and global expansion of the ReMEDy2 clinical trial for AIS, the expansion of the DM199 clinical development program into PE/FGR, and the expansion of the internal clinical team. General and administrative expenses also increased by $2.2 million due to higher non-cash share-based compensation, personnel costs, investor relations expenses, and patent prosecution costs.

Product Portfolio:

• DM199 (rinvecalinase alfa): A recombinant human tissue kallikrein-1 (rhKLK1) protein.
  • Preeclampsia (PE) / Fetal Growth Restriction (FGR): Currently in a Phase 2 investigator-sponsored study in South Africa, with interim results showing promising safety and pharmacodynamic activity. A global Phase 2 study in early-onset PE is planned for North America and the UK, with Health Canada approval received.
  • Acute Ischemic Stroke (AIS): In a Phase 2/3 adaptive design clinical trial (ReMEDy2) globally, with Fast Track Designation from the FDA. Prior Phase 2 data showed positive therapeutic effects in a relevant patient population.
• DM300 (recombinant human ulinastatin): A broad-spectrum serine protease inhibitor, currently in preclinical development for severe acute pancreatitis.

Market Dynamics:

• DiaMedica Therapeutics Inc. operates in highly competitive markets. For PE, there are no FDA-approved treatments, presenting a significant opportunity for DM199. In AIS, DM199 aims to address the large patient population (approximately 80%) not eligible for existing acute interventions like tPA/TNK or mechanical thrombectomy, by offering a broader therapeutic window. The company faces competition from major pharmaceutical and biotechnology companies with greater resources and established market presence.

Capital Allocation Strategy

Shareholder Returns:

• Share Repurchases: DiaMedica Therapeutics Inc. did not purchase any common shares during the fourth quarter ended December 31, 2025, or in 2024.
• Dividend Payments: No cash dividends have been declared or paid, and there are no current plans to do so. Future earnings, if any, are expected to be retained for business operations and expansion.
• Dividend Yield: 0%
• Future Capital Return Commitments: None explicitly stated.

Balance Sheet Position:

• Cash and Equivalents: $15.6 million (as of December 31, 2025)
• Total Debt: $0.015 million (Finance lease obligation, current and non-current, as of December 31, 2025)
• Net Cash Position: $59.9 million (comprising cash, cash equivalents, and marketable securities as of December 31, 2025), an increase from $44.1 million in 2024.
• Credit Rating: Not disclosed.
• Debt Maturity Profile: Finance lease obligations of $0.011 million are current, and $0.004 million are non-current.

Cash Flow Generation:

• Operating Cash Flow: $(29.1) million (net cash used in operating activities for 2025), an increase from $(22.1) million in 2024, primarily due to increased net loss.
• Free Cash Flow: Not explicitly reported, but negative given operating cash flow and minimal capital expenditures.
• Cash Conversion Metrics: Not explicitly detailed.

Operational Excellence

Production & Service Model: DiaMedica Therapeutics Inc. does not own or operate manufacturing facilities for DM199. It relies on contract development and manufacturing organizations (CDMOs) for process development, analytical method development, formulation development, and manufacturing of active pharmaceutical ingredient (API) and drug product under current good manufacturing procedures (cGMP) for clinical trials.

Supply Chain Architecture: Key Suppliers & Partners:

• Catalent Pharma Solutions, LLC (Catalent):
  • Role and Importance: Serves as the primary CDMO, responsible for procuring raw materials and manufacturing DM199 drug substance. DiaMedica Therapeutics Inc. licenses certain gene expression technology from Catalent, which is exclusive for the production of DM199 or any human KLK1 protein.
  • Relationship: The license agreement includes milestone and royalty payments (less than 1% of net sales post-launch) dependent on clinical trials, regulatory approvals, and successful commercialization. The license is indefinite but can be canceled by DiaMedica Therapeutics Inc. with 90 days' notice.
• Contract Research Organizations (CROs): Engaged to support a significant portion of preclinical and clinical development activities, including trial design, regulatory submissions, site/patient recruitment, monitoring, data management, and safety monitoring.
• Other Supporting Vendors: Includes central laboratory and pharmacy services, clinical study sites, and home nursing services.

Facility Network:

• Manufacturing: No owned manufacturing facilities; relies on CDMOs.
• Research & Development: Conducted at its principal executive offices in Minneapolis, Minnesota, USA (approximately 6,000 square feet under a lease expiring January 2028), and through third-party service providers.
• Distribution: Not yet defined, as no products are commercialized.

Operational Metrics:

• DiaMedica Therapeutics Inc. has experienced slower than expected site activations and enrollment in its ReMEDy2 trial for AIS. To mitigate this, the company significantly expanded its internal clinical team and brought certain trial activities (site identification, qualification, activation, clinical site monitoring, supporting vendor management, and overall program management) in-house.

Market Access & Customer Relationships

Go-to-Market Strategy: Distribution Channels:

• Direct Sales: Not yet defined.
• Channel Partners: DiaMedica Therapeutics Inc. currently expects to partner with a large pharmaceutical company for sales execution of DM199, if approved.
• Digital Platforms: Not explicitly mentioned.

Customer Portfolio: Enterprise Customers:

• As a clinical-stage company, DiaMedica Therapeutics Inc. does not currently have enterprise customers or product sales. Its focus is on developing product candidates through clinical trials.
• Strategic Partnerships: The company actively seeks strategic partners for the future development, funding, and/or commercialization of DM199 for various indications.
• Customer Concentration: Not applicable as no products are commercialized.

Geographic Revenue Distribution:

• Not applicable, as DiaMedica Therapeutics Inc. has not generated any revenues from product sales. The company's clinical development programs, however, have a global reach, with trials for PE in South Africa and planned for North America (United States & Canada) and the United Kingdom, and trials for AIS (ReMEDy2) in the United States, Canada, Georgia, the United Kingdom, and six European countries.

Competitive Intelligence

Market Structure & Dynamics

Industry Characteristics: The biopharmaceutical industry is highly competitive, characterized by rapid technological advancements and a focus on proprietary drugs. DiaMedica Therapeutics Inc. operates in therapeutic areas with significant unmet needs. The preeclampsia market currently lacks FDA-approved treatments, while the acute ischemic stroke market has limitations with existing thrombolytic agents (tPA/TNK) and mechanical thrombectomy, leaving a large patient population without acute intervention. Established KLK1 therapies exist in Asia (human urine-derived for AIS, porcine-derived for cardio renal disease), indicating a validated therapeutic mechanism.

Competitive Positioning Matrix:

Direct Competitors

Primary Competitors:

• Preeclampsia:
  • Metformin: An established treatment for type 2 diabetes, currently in late-stage clinical trials for PE in South Africa and Sweden.
  • CBP-4888 (Comanche Biopharma): A short interfering RNA (siRNA) targeting sFlt-1, which has completed healthy volunteer studies and is expected to be studied in pregnant PE patients.
• Acute Ischemic Stroke:
  • Thrombolytic Agents: Alteplase (tPA, Activase, Genentech) and Tenecteplase (TNK, TNKase, Genentech) are FDA-approved but have a narrow therapeutic window (3-4.5 hours) and risk of intracranial hemorrhage.
  • Mechanical Thrombectomy (MT): A surgical procedure for large vessel occlusion (LVO) stroke, growing in use with a widening time window, but applicable to only approximately 30% of AIS patients and requires comprehensive healthcare infrastructure.
  • Pipeline Competitors: Other companies actively pursuing AIS treatments include Basking Biosciences (BB-031), Translational Sciences (TS23), Pharmazz (Solvateltide), Simcere Pharmaceuticals (Edaravone/dexborneol, Sanbexin), Lumosa Therapeutics (LT3001), Bayer (Asundexian), and Janssen/BMS (Milvexian).

Emerging Competitive Threats:

• New entrants and disruptive technologies in both PE and AIS.
• Continued advancements and expanded use of mechanical thrombectomy.
• The increasing use of artificial intelligence and telemedicine, which may enable smaller hospitals to retain AIS patients not eligible for mechanical thrombectomy, potentially impacting patient referral patterns to larger stroke centers where DiaMedica Therapeutics Inc.'s trials are typically conducted.

Competitive Response Strategy: DiaMedica Therapeutics Inc.'s strategy focuses on developing DM199 to address the significant unmet need for AIS patients beyond the current 4.5-hour therapeutic window, aiming for a 24-hour window. For PE, DM199's potential safety advantage (no placental transfer observed) over small molecules is a key differentiator. The company also emphasizes the purity, cost-effectiveness, and scalability of its recombinant DM199 compared to urine- or animal-derived KLK1. Strategic partnerships are a core component of its plan to advance clinical development and commercialization.

Risk Assessment Framework

Strategic & Market Risks

Market Dynamics:

• Product Commercialization: DiaMedica Therapeutics Inc.'s business model relies on generating revenue from marketing or out-licensing product candidates, but currently has no approved products. Failure to demonstrate safety and efficacy, obtain regulatory approval, achieve market acceptance, or secure adequate reimbursement would materially harm the business.
• Technology Disruption: The biopharmaceutical industry is highly competitive. Competitors, many with substantially greater financial and technical resources, may develop more effective, safer, or less expensive products, or bring them to market faster, potentially rendering DM199 non-competitive or obsolete.
• Market Opportunity Estimates: Estimates for the addressable markets of DM199 in AIS and PE are based on complex assumptions and may prove inaccurate. If the actual market size or growth is smaller than anticipated, it could adversely affect DiaMedica Therapeutics Inc.'s business and financial condition.

Operational & Execution Risks

Supply Chain Vulnerabilities:

• Supplier Dependency: DiaMedica Therapeutics Inc. is entirely reliant on third-party CDMOs, primarily Catalent Pharma Solutions, LLC, for the manufacturing and testing of DM199. This single-source dependency creates risks of supply interruptions, delays, increased costs, or termination of agreements due to manufacturing, quality, or compliance issues.
• Capacity Constraints: CDMOs may lack sufficient manufacturing capacity or the ability to scale up production for larger clinical trials or commercialization, leading to delays.
• Manufacturing Complexity: The manufacture of biologics like DM199 is complex and highly regulated, posing risks such as product loss, quality control issues, yield difficulties, stability challenges, and comparability issues between different manufacturing processes or facilities.
• Raw Material Sourcing: Difficulties in sourcing raw materials or components by CDMOs could necessitate additional testing and regulatory approvals for new suppliers, delaying manufacturing timelines.

Clinical Trial Delays & Setbacks:

• Enrollment Difficulties: The ReMEDy2 trial for AIS has experienced slower than expected site activations and patient enrollment due attributed to hospital staffing shortages, study protocol criteria, logistics, prior clinical hold concerns, and competition from other trials.
• Adaptive Design Risks: The adaptive design of the ReMEDy2 trial could require enrolling significantly more patients (up to 728 from 300), increasing the time and costs to complete the trial and potentially necessitating additional funding.
• Investigator-Sponsored Trial Risks: The investigator-sponsored PE trial in South Africa provides less direct control over timing, costs, and patient recruitment. Data from this trial may not be generalizable to other populations, potentially affecting future study designs and leading to delays and additional expenses.
• Undesirable Side Effects: DM199 may cause undesirable side effects, such as transient hypotension during IV infusion, constipation, nausea, headache, and injection site reactions. Such events could delay or prevent regulatory approval, limit the commercial label, or lead to product liability claims.
• Regulatory Acceptance of Foreign Data: There is a risk that the FDA or other regulatory authorities may not accept clinical trial data from studies conducted outside their respective jurisdictions, potentially requiring additional costly and time-consuming trials.
• Interim Data Changes: Interim or topline results from clinical trials are subject to change as more data become available and undergo audit/verification, which could materially impact business prospects and share price.
• Trial Suspension/Termination: Clinical trials may be suspended, repeated, or terminated if they are not conducted in accordance with regulatory requirements (cGCP), yield negative or inconclusive results, are poorly designed, or if unforeseen adverse side effects or product quality issues arise.
• Dependence on DM199: DiaMedica Therapeutics Inc. is highly dependent on the clinical and commercial success of DM199. Failure to obtain regulatory approval or successfully commercialize DM199 would substantially harm the business.

Financial & Regulatory Risks

Market & Financial Risks:

• Need for Additional Capital: DiaMedica Therapeutics Inc. will require substantial additional capital to fund its R&D activities, clinical trials, and regulatory processes. While current cash resources are expected to last at least 12 months, future funding needs are uncertain and may not be available on acceptable terms, or at all, potentially leading to program delays or curtailment.
• Substantial Losses: The company has incurred significant operating losses since its inception ($172.8 million accumulated deficit as of December 31, 2025) and expects to continue incurring losses for at least two to three years, with no assurance of achieving or sustaining profitability.
• Share Ownership Dilution: Future equity issuances, including under its at-the-market (ATM) offering program and through the exercise of stock options and deferred stock units, will dilute the ownership interests of existing shareholders.
• PFIC Status: DiaMedica Therapeutics Inc. was classified as a "passive foreign investment company" (PFIC) for the taxable years ended December 31, 2022, 2023, 2024, and 2025, which may have adverse U.S. federal income tax consequences for U.S. shareholders and could negatively affect investor interest.

Regulatory & Compliance Risks:

• Expensive, Time-Consuming, Uncertain Approval Process: The regulatory approval process is lengthy, costly, and uncertain. DM199 is subject to the Biological License Application (BLA) process. Failure to obtain approval, or approval with significant restrictions (e.g., due to PVC IV bag limitations in some countries), would substantially harm the business.
• Post-Marketing Restrictions/Recall: Even if approved, DM199 would be subject to extensive post-marketing regulation, including potential restrictions, recalls, or withdrawal from the market if compliance failures or previously unknown adverse events occur.
• Regulatory Clearances: Delays in obtaining necessary regulatory clearances (e.g., IND acceptance, additional non-clinical studies for PE) can significantly delay or terminate product development.
• Healthcare Legislation/Policies: Changes in healthcare legislation and policies (e.g., ACA, Inflation Reduction Act of 2022) could increase the difficulty and cost of obtaining marketing approval, restrict post-approval activities, and negatively impact pricing and reimbursement.
• Government Agency Disruptions: Funding shortages or global health concerns affecting regulatory agencies (e.g., FDA) could hinder their ability to review and authorize products, leading to development delays.

Geopolitical & External Risks

Geopolitical Exposure:

• International Operations: Conducting clinical trials in multiple countries (South Africa, Canada, Georgia, UK, Europe) exposes DiaMedica Therapeutics Inc. to risks related to differing standards of care, regulatory requirements, competitive landscapes, foreign taxes, currency fluctuations, and geopolitical events.
• Trade Relations: International operations could be impacted by trade tensions, sanctions, and export controls.

External Risks:

• Communicable Diseases: Widespread outbreaks of communicable diseases could delay clinical trials, disrupt supply chains, and materially affect business operations and financial condition.
• Cybersecurity Threats: Reliance on IT systems makes DiaMedica Therapeutics Inc. vulnerable to system failures, network disruptions, data breaches, and cyber-attacks, which could compromise sensitive information, disrupt development programs, and expose the company to liability.
• Activist Shareholders: Actions by activist shareholders could be costly, time-consuming, disrupt operations, and negatively affect the company's share price.

Innovation & Technology Leadership

Research & Development Focus: Core Technology Areas:

• Recombinant Human Tissue Kallikrein-1 (rhKLK1) - DM199: This is DiaMedica Therapeutics Inc.'s primary R&D focus, with $24.6 million in expenditure in 2025. DM199 is strategically important as the lead candidate for severe ischemic diseases, aiming to leverage KLK1's role in enhancing endothelial health, microcirculatory blood flow, and tissue perfusion. Its competitive position is strengthened by being the first pharmaceutically active recombinant form of rhKLK1 clinically studied, designed to overcome limitations of urine/animal-derived KLK1s.
• Recombinant Human Ulinastatin - DM300: A patented broad-spectrum serine protease inhibitor, currently in the preclinical stage of development for severe acute pancreatitis.

Innovation Pipeline:

• DM199:
  • Preeclampsia (PE) / Fetal Growth Restriction (FGR): Currently in a Phase 2 investigator-sponsored study in South Africa, with plans for a global Phase 2 study in North America and the UK.
  • Acute Ischemic Stroke (AIS): In a global Phase 2/3 adaptive design clinical trial (ReMEDy2), with Fast Track Designation from the FDA.
• DM300: Preclinical development for severe acute pancreatitis.

Intellectual Property Portfolio:

• Patent Strategy: DiaMedica Therapeutics Inc. actively files patent applications to protect its product candidates, manufacturing methods, administration, and use. It conducts prior art searches and requires confidentiality agreements from employees, consultants, and collaborators.
• Patent Holdings:
  • DM199 Patent Family: Includes five granted U.S. patents, one granted European patent, one granted Canadian patent, and one granted Australian patent. Claims cover composition of matter (optimized glycosylation isoforms), pharmaceutical compositions, specific formulations and dosing levels, and methods for treating various ischemic conditions (stroke, chronic kidney disease, vascular dementia, pulmonary arterial hypertension, cardiac ischemia) and pregnancy disorders (preeclampsia). Predicted expiration dates range from 2033 to 2046, with several pending applications globally.
  • DM300 Patent Family: Includes one issued patent in the United States, Taiwan, and Japan. Claims cover composition of matter (mutants and optimized glycosylation patterns of human ulinastatin) and methods for treating acute pancreatitis, with a predicted expiration date of 2041. Pending claims also relate to treating diseases associated with neutrophil elastase (e.g., inflammatory lung diseases), predicted to expire in 2042.
• Licensing Programs: DiaMedica Therapeutics Inc. licenses gene expression technology from Catalent Pharma Solutions, LLC for the production of DM199 and DM300. This license is exclusive for the production of human KLK1 protein.
• IP Litigation: DiaMedica Therapeutics Inc. settled prior legal proceedings with Pharmaceutical Research Associates Group B.V. (acquired by ICON plc) in October 2025. No other material IP litigation is currently active or threatened.

Technology Partnerships:

• Strategic Alliances: Catalent Pharma Solutions, LLC is a key strategic partner for gene expression technology and manufacturing.
• Research Collaborations: DiaMedica Therapeutics Inc. collaborates with physicians and institutions for clinical trial design and conduct.

Leadership & Governance

Executive Leadership Team

Leadership Continuity: Not explicitly detailed beyond executive team information.

Board Composition: The Board of Directors includes Rick Pauls (President and CEO), James Parsons (Chairman), Michael Giuffre, M.D., Richard Kuntz, M.D., M.Sc., Tanya N. Lewis, Daniel J. O’Connor, and Charles Semba, M.D. The Audit Committee of the Board is responsible for overseeing cybersecurity risk management and strategy.

Human Capital Strategy

Workforce Composition:

• Total Employees: As of December 31, 2025, DiaMedica Therapeutics Inc. had 35 full-time employees, an increase from 28 full-time employees as of December 31, 2024.
• Geographic Distribution: Employees are located across the company's operational footprint, including Canada, the United States, and Australia, with a clinical team expanded to support global trials.
• Skill Mix: The workforce comprises scientific, managerial, medical, clinical, and regulatory personnel.

Talent Management: Acquisition & Retention:

• Hiring Strategy: DiaMedica Therapeutics Inc. has significantly expanded its internal clinical team to support its growing clinical programs and administrative operations.
• Retention Metrics: Not explicitly disclosed.
• Employee Value Proposition: The company offers an employee 401(k) retirement savings plan, with employer contributions up to 4% of employee compensation, which vest immediately.

Diversity & Development:

• Diversity Metrics: Not explicitly disclosed.
• Development Programs: Not explicitly detailed.
• Culture & Engagement: DiaMedica Therapeutics Inc. reports good employee relations, with no history of work stoppages and no employees covered by collective bargaining agreements.

Environmental & Social Impact

Environmental Commitments: No specific environmental commitments or strategies are explicitly detailed in the provided filing.

Supply Chain Sustainability: No specific supply chain sustainability initiatives or programs are explicitly detailed in the provided filing.

Social Impact Initiatives: No specific social impact initiatives or philanthropic programs are explicitly detailed in the provided filing.

Business Cyclicality & Seasonality

Demand Patterns:

• Seasonal Trends: Not explicitly detailed for product candidates, as they are in the clinical development stage and not yet commercialized.
• Economic Sensitivity: The company's ability to raise capital and its overall business prospects are sensitive to general economic and financial market conditions.
• Industry Cycles: The biopharmaceutical product development industry is inherently speculative, characterized by substantial upfront financial expenditures and significant risks that product candidates may not achieve regulatory approval or commercial viability.

Planning & Forecasting: Demand forecasting, inventory management, and capacity planning are future considerations that will become relevant as product candidates approach commercialization. Current planning focuses on the execution and management of clinical trials.

Regulatory Environment & Compliance

Regulatory Framework: Industry-Specific Regulations:

• United States: DiaMedica Therapeutics Inc. is subject to extensive regulation by the FDA, including the review and approval process for therapeutic products. DM199, as a recombinant protein, is likely subject to a Biological License Application (BLA) under the Public Health Service Act, and also regulated under the Food, Drug & Cosmetic Act (FDCA).
• Europe: The European Medicines Agency (EMA) governs drug approval processes.
• Canada: Health Canada provides regulatory oversight.
• Global Compliance: Other national regulatory agencies have similar requirements, though approval in one jurisdiction does not guarantee approval in another. The development process involves controlled research and testing, governmental review of preclinical and clinical data (safety and efficacy), approval of manufacturing facilities (adherence to GMP), and control of marketing activities (labeling and advertising).
• Post-Approval Requirements: If approved, products are subject to ongoing FDA regulation, including record-keeping, adverse event reporting, safety and efficacy updates, product sampling and distribution, and strict promotion and advertising requirements.
• Other Healthcare Laws: Activities are also subject to various federal, state, and local authorities, including the Centers for Medicare and Medicaid Services, Department of Health and Human Services, Department of Justice, federal False Claims Act, federal Anti-Kickback Statute, Physician Payments Sunshine Act, HIPAA, Medicaid rebate requirements (OBRA), Medicare Prescription Drug Improvement and Modernization Act of 2003, the Affordable Care Act (ACA), and the Inflation Reduction Act of 2022.
• Data Exclusivity: DM199 may qualify for 4 years of data exclusivity and 12 years of market exclusivity in the United States under the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

Trade & Export Controls:

• Export Restrictions: International operations are subject to U.S. and foreign trade laws, including export controls and sanctions.
• Sanctions Compliance: Compliance with sanctioned entity restrictions and monitoring is required.

Legal Proceedings:

• DiaMedica Therapeutics Inc. resolved prior legal proceedings with Pharmaceutical Research Associates Group B.V. (acquired by ICON plc) in October 2025 through a settlement agreement.
• The company is not currently engaged in or aware of any other threatened material legal actions or proceedings.

Tax Strategy & Considerations

Tax Profile:

• Effective Tax Rate: The company's income tax provision is computed based on the actual effective tax rate for the year.
• Geographic Tax Planning: DiaMedica Therapeutics Inc. is subject to income taxes in Canada, the United States, and Australia. The Canadian federal tax rate of 15% is used for tax rate reconciliation.
• Tax Reform Impact: The company acknowledges that current and future legislation (e.g., the Inflation Reduction Act of 2022) may impact drug pricing and healthcare spending, which could affect its tax planning initiatives.
• PFIC Status: DiaMedica Therapeutics Inc. was classified as a "passive foreign investment company" (PFIC) for the taxable years ended December 31, 2022, 2023, 2024, and 2025. This classification may have adverse U.S. federal income tax consequences for U.S. shareholders.
• NOLs and Credit Carryforwards: As of December 31, 2025, the company had non-capital income tax losses (domestic) of $145.7 million (expiring beginning 2027), research and development expense carryforwards of $3.0 million (indefinite expiration), and tax credits of $0.5 million (expiring beginning 2026).
• Valuation Allowance: A full valuation allowance of $42.4 million was maintained against gross deferred tax assets as of December 31, 2025, due to the uncertainty of realizing these assets.

Insurance & Risk Transfer

Risk Management Framework: DiaMedica Therapeutics Inc. recognizes the importance of identifying, assessing, and managing material risks, including cybersecurity threats. Its cybersecurity risk management program is based on prevailing security standards and the National Institute of Standards and Technology (NIST) framework. The Audit Committee of the Board of Directors oversees cybersecurity risk management and strategy.

• Insurance Coverage: DiaMedica Therapeutics Inc. maintains various insurance policies, including product and general liability insurance, directors' and officers' liability insurance, property insurance, and workers' compensation insurance.
• Risk Transfer Mechanisms: Not explicitly detailed beyond insurance coverage.
• Cybersecurity Risk Management: The company augments its capabilities through employee training, data and system redundancy, network security, and comprehensive monitoring. It engages third-party experts, including managed IT service providers and cybersecurity consultants, to evaluate and support its risk management systems, monitor vulnerabilities, and test controls. Management, led by the Chief Financial Officer, is responsible for day-to-day cybersecurity risk management. As of the filing date, cybersecurity threats have not materially affected the company's business strategy, results of operations, or financial condition.