Summary of DiaMedica Therapeutics Conference Call Company Overview - DiaMedica Therapeutics focuses on developing a recombinant form of tissue kallikrein, a critical protein for treating conditions like preeclampsia and acute ischemic stroke [3][4] Industry Context - Preeclampsia is identified as a significant unmet medical need with a market opportunity exceeding $5 billion in the U.S. alone [5] - The company is also involved in a pivotal trial for acute ischemic stroke, another area with substantial unmet medical needs [5] Key Points on Preeclampsia - Preeclampsia is a hypertensive disorder occurring after 20 weeks of gestation, characterized by high blood pressure and organ dysfunction [13] - Current treatment options are limited, primarily involving alpha and beta blockers and calcium channel blockers, which only delay gestational age by about a week [14] - The root cause of preeclampsia is linked to inadequate remodeling of spiral arteries, leading to a hypoxic placenta [15][16] - The company aims to address the preeclampsia market, particularly focusing on patients diagnosed before 34 weeks of gestation, where the need is greatest [28] Clinical Data and Drug Mechanism - DiaMedica's drug, DM199, has shown promising results in lowering blood pressure, with a reported 25 mmHg drop in systolic blood pressure and a 13 mmHg drop in diastolic blood pressure during trials [46] - The drug was well tolerated, with no increase in fetal heart rates and no detection of DM199 in the placenta, indicating it does not cross the placental barrier [47] - A 13% reduction in the pulsatility index was observed, suggesting improved placental perfusion [48] Future Development Plans - The company is conducting ongoing studies in South Africa and plans to file a U.S. IND for a Phase II trial involving 30 patients [58] - A pivotal trial is anticipated, with a focus on extending gestational days by at least seven days, which could significantly reduce neonatal events [60] - Pricing strategy is expected to reflect orphan drug status, given the small patient population and potential cost savings from avoiding NICU admissions [68] Stroke Program Overview - The drug is also being studied for acute ischemic stroke, with an interim analysis of the pivotal trial expected in Q2 of the following year [72] - Pricing for stroke treatment is projected at $30,000 per patient, with higher dosing levels anticipated for preeclampsia [74] Conclusion - DiaMedica Therapeutics is positioned to address significant unmet medical needs in both preeclampsia and stroke, with promising clinical data supporting the efficacy and safety of DM199. The company is actively pursuing further trials and regulatory approvals to bring their treatments to market.