Strong Clinical Signal in Preeclampsia (Part 1a Interim)
Interim Part 1a investigator-sponsored Phase II results (Cohorts 6–9) showed statistically significant, dose-dependent sustained reductions in systolic and diastolic blood pressure and significant reductions in uterine artery pulsatility index (improved uteroplacental perfusion). DM199 did not cross the placental barrier and was not detected in breast milk in the reported patients, supporting a favorable maternal-only exposure/safety profile and potential for earlier/longer treatment to prolong pregnancy.
Regulatory and Trial Advancement for Early-Onset Preeclampsia
Received Health Canada clearance to initiate a global Phase II trial in early-onset preeclampsia (open-label, dose-finding, ~30 participants, 3 dose levels). Plans to finalize site activations in H2 2026 and expand to U.K. sites; Part 1b (up to 30 late-stage) and Part 2 (up to 30 early-onset) protocol amendments are being finalized. Part 1a expansion cohort (up to 12 additional patients) anticipated completion in H1 2026; fetal growth restriction cohort dosing expected in Q2 2026.
ReMEDy2 Stroke Trial Momentum and DSMB Clearance
Enrollment momentum increased with global site activations; trial has achieved almost 70% of the 200 participants required for the interim analysis (implying ~140/200). ~61 active sites (4 U.K., 12 Europe) with ~25 more expected to activate. An independent DSMB reviewed safety data after 100 patients and unanimously recommended continuation without modification. Company reiterated guidance to complete the interim analysis by H2 2026.
Publication and Supporting Data for Blood Pressure Indication
Paper published in Journal of Hypertension highlighting the 'Endothelial Triple Pathway' strategy and referencing prior Phase II REDUX results demonstrating DM199's ability to significantly reduce blood pressure over a 3-month period and lower serum potassium in patients with elevated potassium—supporting potential use in resistant hypertension and CKD populations.
Improved Cash Position and Runway
Cash, cash equivalents and short-term investments increased to $59.9M as of Dec 31, 2025 from $44.1M a year earlier, a $15.8M increase (≈+35.8%). Working capital rose to $55.5M from $39.2M (≈+41.6%). Company expects these funds to finance planned clinical studies and operations through the end of 2027. Net proceeds driven by July 2025 private placement and at-the-market program.