🧾 What This Document Is

This is a Form 8-K, a required report companies file with the SEC to announce major news. Attached to it is Exhibit 99.1, which is DiaMedica's detailed press release. In simple terms, the company is using this to officially share its 2025 financial results and update everyone on its clinical drug trials. Think of it as a mandatory public announcement that combines a progress report with a financial snapshot.

🏢 What The Company Does

👉 In simple terms, DiaMedica is trying to create new drugs for serious conditions affecting blood flow. They are a clinical-stage biopharmaceutical company, which means they are focused on testing their drugs in people but aren't selling any yet. Their main drug, DM199, is a synthetic version of a natural protein (KLK1) used in Asia for vascular diseases. Their primary targets are three major health issues: preeclampsia (a dangerous pregnancy complication), fetal growth restriction (when a baby doesn't grow properly in the womb), and acute ischemic stroke (caused by a blood clot in the brain).

🚀 Key Clinical Moves

This section is all about progress on their main drug, DM199. Here’s what they're doing:

• 🤰 Preeclampsia (PE) - Investigator-Sponsored Trial (IST):

  • An ongoing study run by doctors (not directly by DiaMedica). They are currently adding more patients to the first part (Part 1a) and expect to finish enrolling by mid-2026.
  • Why it matters: This early data will help design the next, larger parts of the study (Parts 1b, 2, and 3) for different types of PE and fetal growth restriction. The first patient in the fetal growth restriction part is expected to be treated in Q2 2026.

• 🤰 Early-Onset Preeclampsia - DiaMedica's Own Phase 2 Trial:

  • They received a key "No Objection Letter" from Health Canada, allowing them to start this trial in Canada.
  • They plan to file paperwork to also run this trial in the United Kingdom in Q2 2026.
  • Why it matters: This is the company's own, pivotal study to test the drug's effect and find the right dose. Getting approval in multiple countries (Canada, UK, and hoping for the US) is a major step forward.

• 🧠 Acute Ischemic Stroke (AIS) - ReMEDy2 Phase 2/3 Trial:

  • This larger trial is approaching 70% of the enrollment needed for a planned mid-2026 interim check-up (an interim analysis).
  • Why it matters: The interim analysis is a critical milestone. If the early results look promising, it could accelerate the path to potential approval. They are firmly on track for this analysis in the second half of 2026.

💰 Financial Snapshot

Let's break down the money story for 2025.

• 💵 Cash is King: They ended 2025 with $59.9 million in cash and investments, up from $44.1 million the year before. This increase came from selling new shares.
• ⏳ Cash Runway: This pile of money is expected to fund their operations through the second half of 2027.
• 📉 The Operating Loss: They lost $32.8 million in 2025 (or $0.70 per share). This is expected for a company spending heavily on research before having a product to sell.
• 📊 Where the Money Went (Expenses):
  • Research & Development (R&D): $24.6 million (up from $19.1M). This increase is mainly from running and expanding their ReMEDy2 stroke trial and growing their clinical team. They expect R&D costs to rise moderately as their preeclampsia trials also ramp up.
  • General & Administrative (G&A): $9.8 million (up from $7.6M). These are the corporate overhead costs (salaries, admin, investor relations), which also increased.

📦 Financial Position

This is a snapshot of what the company owns and owes.

• Assets: Total assets were $61.4 million, almost all of it current (cash and short-term investments). This is a strong, liquid position.
• Liabilities: Total liabilities were tiny in comparison, at only $5.3 million (mostly accounts payable and accrued costs).
• Shareholders' Equity: $56.1 million. The big change here was the increase in "Paid-in Capital" from $180.7M to $228.8M, reflecting the new shares they issued to raise cash.
• What this signals: The balance sheet is very clean. They are funded for the next ~2 years and don't carry significant debt, which reduces financial risk as they burn cash on trials.

🔮 What's Next

The company has a clear roadmap for the coming year.

• 2026 is Packed with Milestones: Finish the current preeclampsia IST enrollment, start their own Phase 2 preeclampsia trial in multiple countries, and crucially, conduct the interim analysis for the ReMEDy2 stroke trial in the second half of the year.
• Funding the Journey: The $60 million cash position is specifically earmarked to get them through these 2026 milestones and fund operations into late 2027.
• The Big Picture Goal: Use 2026's clinical data to advance DM199 toward becoming a viable, approved treatment for these serious conditions.

⚖️ Big Picture: Strengths & Risks

👍 Strengths:

• Well-Funded: Strong cash runway through late 2027 removes immediate financial pressure.
• Multiple Shots on Goal: Clinical programs are advancing in both preeclampsia and stroke, diversifying their potential.
• Clear Catalysts: Key data readouts and trial milestones are scheduled for 2026, providing clear news flow for investors.

⚠️ Risks:

• Clinical Trial Risk: All value hinges on DM199 proving safe and effective in ongoing trials. Failure in any major trial would be a severe setback.
• Regulatory Hurdles: They are still working with the FDA on an "alternate species" for the preeclampsia trial, which adds a layer of regulatory uncertainty.
• Dilution: They fund operations by issuing new shares, which can reduce existing shareholders' ownership percentage over time.

🧠 The Analogy

DiaMedica is like a construction crew building three bridges at once (for PE, FGR, and stroke). Right now, they are in the intense, expensive phase of laying foundations and erecting support beams (running Phase 2/3 trials). They just secured enough fuel (cash) to keep the generators running for over two years. The next big event is a city inspection in mid-2026 (interim analysis on the stroke bridge) to see if the structure is solid enough to justify pouring the final concrete (pivotal trials). The company's entire future depends on these bridges eventually being declared safe and usable.

📇 Key Contacts & People

• Rick Pauls, President and Chief Executive Officer
• Scott Kellen, Chief Financial Officer
  • Phone: (763) 496-5118
  • Email: [email protected]
• Mike Moyer, Managing Director, LifeSci Advisors, LLC (For Investor Inquiries)
  • Phone: (617) 308-4306
  • Email: [email protected]
• Madelin Hawtin, LifeSci Communications (Media Contact)
  • Email: [email protected]

🧩 Final Takeaway

DiaMedica is a well-funded clinical-stage company with all its chips on the DM199 drug. 2026 is a make-or-break year, with critical data expected from both its stroke and preeclampsia programs. The strong cash position gives it the time needed to reach these pivotal milestones.