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DMAC · DiaMedica Therapeutics Inc.

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$6.68 -0.07 (-1.04%) At close · Aug 14
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$360.22M
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All earnings calls

Earnings call · FY2026 Q1

DiaMedica Therapeutics Inc. Q1 FY2026 Earnings Call

DiaMedica Therapeutics Inc. Q1 FY2026 Earnings Call

Concluded May 7, 2026
May 7, 2026 38 turns
Period
FY2026 Q1
Runtime
Sources
3 artifacts

Executive readout · one minute

What matters this quarter

DiaMedica reported Q1 2026 results with $51.3M in cash and investments and a runway through 2027, while advancing DM199 across preeclampsia and stroke programs, with the ReMEDy2 interim analysis planned for Q4 2026 and preeclampsia Part 1a extension data expected this quarter.

Preeclampsia clinical program 51 Stroke ReMEDy2 trial 48 Geographic trial expansion 21 FDA regulatory interactions 20 Fetal growth restriction study 10 Cash and financial position 9

Management tone

Positive

Net tone +38 · low hedging

Grounding quotes
  • “We're particularly interested in completing the interim analysis for our stroke program.”
  • “With enrollment having surpassed 70%, we expect that the interim analysis will validate all of the hard work that has gone into the program.”
  • “Results of a non-GLP dose-ranging study in rabbit suggest that the animals developed an adverse immune response to DM199, preventing us from completing the requested modified pre- and postnatal development study in a rabbit model.”
  • “These cohorts should be starting very soon.”

Research coverage

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Net income -$10.04M

Research materials

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Key takeaways

What improved, and what deserves a closer read.

Constructive signals

  • ReMEDy2 enrollment has surpassed 70% of the required interim enrollment target, with the interim analysis reiterated for Q4 2026.
  • Health Canada approved the global Phase II early-onset preeclampsia study in March 2026, with first patient dosing anticipated before year-end 2026.
  • ReMEDy1 Phase II showed a 15% absolute increase over placebo in favorable recovery (mRS 0-1) in non-thrombectomy patients and a 19% absolute improvement in the moderate-severity subgroup enrolling into ReMEDy2.
  • Preeclampsia Part 1a interim results were described as 'highly consistent and encouraging,' showing DM199's potential to reduce blood pressure and improve placental perfusion without crossing the placental barrier.
  • Fetal growth restriction study first patient enrollment expected in the current quarter, adding a second indication.
  • $51.3M in cash, cash equivalents and short-term investments as of March 31, 2026, with anticipated runway through 2027.

Risks & pressure points

  • FDA requested an additional nonclinical embryo-fetal/pre- and postnatal development study and has not yet agreed to the company's proposed rat model alternative, delaying U.S. IND clearance.
  • Non-GLP rabbit study suggested animals developed an adverse immune response to DM199, preventing completion of the originally requested study in that model.
  • ReMEDy2 interim includes a futility analysis that could terminate the trial if no drug effect is observed, and sample size may be upsized (between 300 and 700 patients) following resampling.
  • Part 1b, Part 2, and FGR cohort initiations depend on completion of the ongoing Part 1a extension cohort, pushing broader preeclampsia/FGR data into later periods.
  • Site staffing challenges in Cape Town, South Africa previously slowed Part 1a expansion enrollment.

Key moments

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“Most importantly, for our shareholders, we're poised to deliver multiple clinical milestones between now and the end of 2027, all of which could provide significant validation of the value of DM199.” Rick Pauls, CEO
“We anticipate that our current cash and investments will be sufficient to fund our planned clinical studies and operations through 2027.” Scott Kellen, CFO
Full-screen source Call document