DiaMedica Therapeutics’ 2025 Earnings Calls Contradict Stroke Enrollment Rates, U.S. Trial Timelines

Date of Call: Mar 31, 2026

Guidance:

• Anticipate completion of preeclampsia Part I-A expansion cohort in H1 2026.
• Reiterate guidance to complete ReMEDy2 stroke trial interim analysis by second half of 2026.
• First patient in fetal growth restriction cohort anticipated to be dosed in Q2 2026.
• Plans to commence site activation for global phase II preeclampsia trial in H2 2026.
• Cash and investments of $59.9M expected to fund operations through end of 2027.

Business Commentary:

Progress in Preeclampsia Program:

• DiaMedica Therapeutics announced positive interim results from part I-A of their investigator-sponsored phase II trial for DM199 in preeclampsia, showing statistically significant reductions in blood pressure and the uterine artery pulsatility index. DM199 did not cross the placental barrier in 35+ patients.
• The results support DM199's potential as a first-in-class disease-modifying therapy for preeclampsia. The company received regulatory clearance from Health Canada to initiate a global phase II clinical trial in early onset preeclampsia.

Stroke Program Enrollment Momentum:

• DiaMedica's ReMEDy2 trial achieved almost 70% of the required enrollment for the interim analysis, with 61 active sites and plans for 25 more site activations in the coming quarter.
• Increased site activations globally, intensified engagement with study sites, and additional resources contributed to the encouraging enrollment momentum.

Financial Position and Resource Allocation:

• As of December 31, 2025, DiaMedica had $59.9 million in cash equivalents and short-term investments, with working capital of $55.5 million, an increase from the previous year.
• The company anticipates this cash position will fund planned clinical studies and corporate operations through the end of 2027, with a focus on advancing their preeclampsia and stroke programs.

Regulatory and Preclinical Development Challenges:

• DiaMedica is addressing an FDA request for an additional reproductive tox study in rabbits, but preliminary results suggest rabbits may not be a suitable animal model due to an unusual immune response.
• The company is evaluating an alternative animal model and working with the FDA to find a solution, while proceeding with plans to initiate a global phase II trial in Canada.

Sentiment Analysis:

Overall Tone: Positive

• "2025 is a year in which we made significant progress across our pipeline, achieving a number of key milestones." "positive interim results" "statistically significant reductions in blood pressure" "very strong year of progress" "encouraging enrollment momentum" "We feel confident about our cash position" "reiterated our guidance"

Q&A:

• Question from Stacy Ku (TD Cowen): Update on rabbit preclinical trials for U.S. IND approval and alternative species with FDA? Key learnings for early onset preeclampsia cohort? Conversations on enrolling right investigators? Criteria for CKD plan?
  Response: Premature to name alternative species; discussions with FDA ongoing. Learnings include using subcutaneous only for early onset. Site selection focuses on experience with preeclampsia and expectant management. CKD is exciting but near-term focus is on preeclampsia and stroke.

• Question from Josh Schimmer (Cantor): Risk of DM199 crossing placental barrier in early onset preeclampsia? Evidence? Potential outcomes for stroke interim analysis and stopping criteria?
  Response: No expectation it will cross; protein size is 50x larger than threshold, and no crossing seen in >35 patients. Interim analysis may lead to termination for lack of efficacy or resample size of 300-728, with sample size adjustment based on drug effect.

• Question from Thomas Flaten (Lake Street): Why is Part One A expansion cohort taking longer? Are Parts One B and Two dependent on completion? Enrollment momentum in ReMEDy2?
  Response: Delays due to staffing challenges at site; enrollment to pick up with new support. Parts One B and Two to initiate in Q2 after protocol amendments, while Part I-A expansion continues. Enrollment momentum has picked up substantially in recent months.

• Question from Matthew Caufield (H.C. Wainwright): Limitations for real-world access if DM199 approved for AIS?
  Response: No limitations expected; safety profile should allow broad use at community and academic hospitals, differing from current enrollment challenges at academic centers.

• Question from Chase Knickerbocker (Craig-Hallum): Differences in prior non-clinical rabbit study? Timelines for FDA feedback on alternative species? Color on stroke enrollment acceleration?
  Response: Prior study had different gestational age and duration; rabbits may not be suitable model due to immunogenicity. No timeline for FDA feedback yet; will provide update when aligned. Enrollment acceleration driven by increased sites and per-site enrollment rates.

Contradiction Point 1

Stroke Trial Enrollment Rate Assumption

Inconsistent disclosure of the assumed enrollment rate needed to meet the 2026 target.

Chase Knickerbocker (Craig-Hallum) - Chase Knickerbocker (Craig-Hallum)

2025Q4: Acceleration is driven by a combination of increased enrollment rates per site and an increase in the number of active sites... This supports the guidance to complete the interim analysis in the second half of 2026. - Rick Pauls(CEO)

What are the key differences between the prior rabbit study (no toxicity) and the current one, the timeline for FDA feedback, and the drivers behind the accelerated enrollment in the stroke study? - Chase Knickerbocker (Craig-Hallum Capital Group LLC)

2025Q3: The company did not provide the specific enrollment rate assumption at this time. - Dietrich Pauls(CEO)

Contradiction Point 2

U.S. Preeclampsia Trial Site Selection Criteria

Contradictory statements on the primary factors for selecting U.S. trial sites.

Stacy Ku (TD Cowen) - Stacy Ku (TD Cowen)

2025Q4: The focus is on selecting sites with experience in preeclampsia studies and comfort with expectant management... - Rick Pauls(CEO)

1) Update on rabbit preclinical trials for U.S. IND approval and thoughts on alternative species for reproductive tox studies. 2) Key learnings from IST for early onset preeclampsia cohort and potential timing for fetal growth updates. 3) Progress on U.S. trial preparation and criteria for enrolling investigators. 4) Timeline for a detailed plan to pursue DM199 in treatment-resistant hypertension in CKD patients. - Stacy Ku (TD Cowen)

2025Q3: The answer did not specify particular factors, focusing instead on the positive data driving the development. - Dietrich Pauls(CEO)

Contradiction Point 3

Preeclampsia Trial Protocol Amendment Status

Inconsistency regarding the finalized status of protocol amendments.

Thomas Flaten (Lake Street) - Thomas Flaten (Lake Street)

2025Q4: Protocol amendments are being finalized. Parts One B and Two are anticipated to initiate in Q2 2026... - Rick Pauls(CEO)

Could you provide insights on the reasons for slower-than-expected enrollment in the Part One A expansion cohort, whether Parts One B and Two depend on its completion, and the enrollment trends for the ReMEDy2 trial comparing Q1 2026 to Q4 2025? - Thomas Flaten (Lake Street Capital Markets)

2025Q3: The plan is to proceed with the U.S. Phase 2 study... Additional data received before initiation could help refine the protocol. - Dietrich Pauls(CEO)

Contradiction Point 4

U.S. Phase IIb Trial Timing and Enrollment Expectations

Expectations for when the U.S. Phase IIb study will start shifted from next year to an earlier timeline.

Stacy Ku (TD Cowen) - Stacy Ku (TD Cowen)

2025Q4: The focus is on selecting sites... for the U.S. trial... The acceleration is a recent trend. - Rick Pauls(CEO)

Can you provide an update on rabbit preclinical trials for U.S. IND approval, alternative species for reproductive tox studies, key learnings from IST for early onset preeclampsia, timing for fetal growth updates, progress on U.S. trial preparation, criteria for enrolling investigators, and the timeline for a detailed plan to pursue DM199 in treatment-resistant hypertension in CKD patients? - Thomas Flaten (Lake Street Capital Markets, LLC)

2025Q2: Plans to file a pre-IND request with the FDA... with study startup expected next year. - Dietrich John Pauls(CEO)

Contradiction Point 5

Enrollment Trends for the Stroke Trial

Contradictory statements on the timing and nature of enrollment momentum.

What were the key takeaways from the earnings call with Thomas Flaten of Lake Street? - Thomas Flaten (Lake Street)

2025Q4: Enrollment has increased substantially over the last two months, correlating with increased site activations (now 61 active sites) and efforts to support sites. The acceleration is a recent trend. - Rick Pauls

What are the reasons for the slower-than-expected enrollment in the Part One A expansion cohort, does enrollment in Parts One B and Two depend on its completion, and what are the enrollment trends for the ReMEDy2 trial comparing Q1 2026 to Q4 2025? - Chase Knickerbocker (Craig-Hallum)

2025Q1: Current enrollment momentum is above plan and encouraging. ... Yes, there is a clear uptick in enrollment momentum compared to the last earnings call, and the company is encouraged by the recent trajectory. - Rick Pauls