DiaMedica Therapeutics Third Quarter 2026 Financial Results and Business Update Conference Call - DIAMEDICA THERAPEUTICS INC

Based on the transcript provided, here are the extracted forward-looking statements:

• Explicit Guidance:

  • Cash Runway: Expected to fund planned clinical studies and corporate operations into the fourth quarter of 2027.
  • R&D Expenses: Expected to increase moderately relative to recent periods as Remedy 2 enrollment continues and global Phase 2 preeclampsia study startups progress.
  • G&A Expenses: Expected to remain relatively steady compared to recent prior periods.
  • Enrollment Target (Stroke): Remedy 2 final enrollment target expected to range between 300 and 728 participants pending the outcome of the interim analysis (specifically, ~300 if drug effect mirrors Phase 2; ~728 if impact approaches 6%).
  • Enrollment Pacing (Stroke): Targeting approximately 300 total patients to be reached within "a few months" after the interim analysis readout.
  • Enrollment Pacing (Preeclampsia): Company-sponsored Phase 2 preeclampsia study expected to initiate enrollment in Q4 2026 (Canada/UK), with a worst-case scenario of early 2027 due to site administrative constraints.

• Business-Segment Outlook:

  • Fetal Growth Restriction (FGR):
    • Enrolled 12 participants in the first two cohorts (5 µg/kg and 10 µg/kg) of the Phase 2 study; dose selection for the third cohort to be announced following the Nov 24 Key Opinion Leader (KOL) event.
    • Preliminary safety and clinical observations to be presented at the November 24, 2026 virtual KOL event.
    • Future studies may evaluate lower dose levels in addition to higher levels.
  • Preeclampsia:
    • Investigator-Sponsored: Two additional studies (Part 2 for early-onset; Part 1B for late-onset) expected to begin enrollment by the end of 2026. Part 1B will utilize continuous intravenous infusion for acutely hypertensive patients.
    • Company-Sponsored Phase 2: Design includes 30 patients across three dose levels to inform future larger trials; will expand to the UK subject to regulatory authorization.
    • US Regulatory: Pending completion of an additional reproductive toxicology study (rat) to support an Investigational New Drug (IND) application for preeclampsia in the United States; submission expected "in the coming weeks" post-report completion.
  • Acute Ischemic Stroke (Remedy 2):
    • Interim Analysis: Independent Data Safety Monitoring Board (DSMB) analysis expected to be completed in the first quarter of 2027.
    • Decision Logic: If no drug effect is observed, the study will stop for futility; if a drug effect is seen, enrollment will continue to a size between 300 and 728 based on statistical efficacy data.

• Market and Competitive Outlook:

  • Unmet Need: Emphasizes that current stroke reperfusion therapies (thrombolytics/thrombectomy) are limited by time windows and eligibility, creating significant demand for DM-109's mechanism of improving collateral blood flow in the ischemic penumbra.
  • Competitive Advantage: DM-109 offers a novel mechanism targeting vascular health and blood flow rather than clot dissolution or removal; potential to control severe hypertension in preeclampsia patients, addressing a primary driver for delivery in 50% of cases.
  • Geographic Expansion: Preeclampsia Phase 2 study initiated in Canada with conditional EMA authorization for future European expansion; US IND submission planned to address FDA feedback on non-clinical data.

• Macro / Industry Outlook:

  • Regulatory Environment: Specific focus on navigating FDA feedback regarding reproductive toxicology data (rat models) to enable US clinical trials for preeclampsia.
  • Regulatory Approvals: Health Canada authorized protocol amendment for the open-label Phase 2 dose-finding study; European Medicines Agency (EMA) granted conditional authorization for future European sites.

• Strategic Initiatives:

  • Clinical Trial Expansion: Global expansion of Remedy 2 (stroke); expansion of preeclampsia trials to the UK and potential US expansion if IND is approved.
  • Dosing Strategy: Evaluation of IV infusion (Part 1B) vs. subcutaneous dosing (Part 2) for preeclampsia to determine optimal method for prolonging pregnancy and controlling hypertension.
  • KOL Engagement: Scheduled virtual event on November 24, 2026, featuring experts from University of Melbourne and King's College London to discuss preliminary FGR data.
  • Cost Management: Ongoing expansion of clinical team and manufacturing development activity, partially offset by lower professional fees in G&A.

• Risks and Headwinds to Outlook:

  • Clinical Futility: Risk that interim analysis of Remedy 2 shows no drug effect, leading to immediate cessation of the trial.
  • Regulatory Delays: US IND submission for preeclampsia is contingent on demonstrating adequate drug exposure and pharmacologic effect in rats; delays in reporting results could postpone submission.
  • Operational Constraints: Preeclampsia trial enrollment subject to administrative and site-specific process delays, potentially pushing start dates to early 2027.
  • Interpretation of Data: Preliminary open-label data requires context from historical controls and expert benchmarking to confirm safety and pharmacologic activity signals.

• Management Tone on the Future:

  • Confidence: Management expresses high confidence ("feel very clearly," "very encouraging") in the drug's ability to control blood pressure and vascular function in preeclampsia and fetal growth restriction.
  • Optimism on Read-through: Positive FGR results are expected to generate significant optimism regarding preeclampsia prospects due to the shared vascular mechanism.
  • Cautious Timing: Uses conditional language ("subject to," "if," "expect") regarding enrollment start dates and regulatory approvals, acknowledging site-specific constraints and the need for specific data readouts before definitive conclusions.
  • Strategic Patience: Willing to adapt dosing strategies (IV vs. SC) and sample sizes based on interim data to optimize the likelihood of a successful pivotal trial.

• Miscellaneous:

  • Milestone Timeline: Next major milestones are the Nov 24, 2026 FGR KOL event and Q1 2027 Remedy 2 interim analysis completion.
  • Study Design: Remedy 2 is a randomized, double-blind, placebo-controlled trial assessing patients not candidates for thrombectomy, with functional recovery assessed at day 90.
  • Financial Context: Net loss for Q3 2026 was $11.3 million ($0.21/share); cash position $34.9 million as of Sept 30, 2026.