Financial Data and Key Metrics Changes - As of December 31, 2025, cash equivalents and short-term investments increased to $59.9 million from $44.1 million in 2024, while current liabilities decreased slightly to $5.1 million from $5.4 million [16] - Net cash used in operating activities rose to $29.1 million in 2025 from $22.1 million in 2024, primarily due to an increase in net loss [17] - Research and development expenses increased to $24.6 million in 2025 from $19.1 million in 2024, driven by the continuation and global expansion of the ReMEDy2 clinical trial [17][18] Business Line Data and Key Metrics Changes - The preeclampsia program showed significant progress with positive interim results from a phase II trial, indicating DM199's potential to reduce blood pressure and improve blood flow to the placenta [5][6] - The stroke program, ReMEDy2, achieved nearly 70% enrollment of the required 200 participants for interim analysis, with 61 active sites globally [12][13] Market Data and Key Metrics Changes - The company is expanding its clinical trials into the U.K. and Europe, indicating a broader market reach for DM199 [13][10] - Regulatory clearance from Health Canada for a global phase II clinical trial of DM199 in early onset preeclampsia marks a significant milestone for the company [9] Company Strategy and Development Direction - The company aims to position DM199 as a first-in-class disease-modifying therapy for preeclampsia and other vascular-related conditions, focusing on improving patient outcomes through innovative treatment approaches [5][7] - Plans to initiate a global phase II study for early onset preeclampsia are underway, with a focus on patient safety and efficacy [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the cash position, anticipating it will fund clinical studies and operations through the end of 2027 [16] - The management highlighted the importance of DM199's safety profile, which is expected to facilitate broader use in community hospitals and academic centers upon approval [48] Other Important Information - The company is evaluating alternative animal models for reproductive toxicology studies in response to FDA requests, indicating ongoing regulatory engagement [11][26] - A recent publication in the Journal of Hypertension underscores the need for new treatment approaches for resistant hypertension, further validating DM199's potential [14] Q&A Session Summary Question: Update on rabbit preclinical trials for U.S. IND approval - Management is in discussions with the FDA regarding appropriate preclinical models and will provide updates once discussions are finalized [21][26] Question: Key learnings for early onset preeclampsia cohort - Management plans to use subcutaneous administration for early onset studies and is focused on selecting sites experienced in managing preeclampsia [27][28] Question: Risk of DM199 crossing the placental barrier - Management believes DM199 will not cross the placental barrier based on previous studies, with the protein size being significantly larger than the threshold for crossing [33] Question: Enrollment challenges in the ReMEDy2 trial - Enrollment has been slower due to staffing challenges at certain sites, but recent support and hiring are expected to accelerate enrollment [40] Question: Commercialization access for DM199 - Management believes the safety profile of DM199 will facilitate broad use in both small community hospitals and large academic centers [48]