ReMEDy2 Stroke Trial Enrollment Surpassed 70%
Enrollment in the global ReMEDy2 acute ischemic stroke trial has surpassed 70% of the target required for the interim analysis; approximately 70 sites are activated across the U.S., Canada, U.K. and six additional European countries. Company reiterates intention to complete interim analysis by end of 2026.
Strong Phase II ReMEDy1 Efficacy Signals Informing ReMEDy2
Prior Phase II (ReMEDy1) data showed clinically meaningful improvements: a 15% absolute increase over placebo in favorable recovery (mRS 0–1) in non-thrombectomy patients; a 19% absolute improvement in the moderate NIHSS (5–15) subgroup; a 50% reduction in deaths and a 13.3% reduction in recurrent strokes versus placebo. These results are being used to power and design ReMEDy2.
Preeclampsia Program: IST Progress and Planned Cohorts
Investigator-sponsored Phase II IST: Part 1a extension (12 additional late-onset patients) near completion with a data update expected later this quarter. Company plans concurrent Part 1b (up to 30 late-onset patients) and Part 2 (up to 30 early-onset patients) to establish dosing for Phase III; first patient expected in the fetal growth restriction cohort this quarter.
Regulatory Progress Outside U.S.: Health Canada Approval
Received Health Canada approval (March 2026) to initiate the global Phase II early-onset preeclampsia study; sites selected and enrollment in Canada targeted by year-end 2026; U.K. clinical trial application expected this quarter.
Cash Runway Through 2027
Cash, cash equivalents and short-term investments of $51.3 million as of March 31, 2026 (from $59.9M on Dec 31, 2025). Management expects current cash and investments will be sufficient to fund planned clinical studies and operations through 2027.
Operational Momentum and Site Activation Support
Recent investigator meeting in Europe was well attended and productive, supporting enrollment momentum. Company added European countries and leveraged existing site relationships (e.g., Canadian sites active in stroke trial) to expedite activation for PE and stroke programs.
Defined Interim Analysis Decision Framework for Stroke
Interim analysis will include a futility assessment (terminate if no drug effect) or a resample/upsizing decision; potential resample size range of 300–700 patients and clear timeline guidance (interim by end-2026; potential full enrollment completion in Q1 2027 if effect consistent with Phase II).