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.

Financial Data and Key Metrics Changes - DiaMedica Therapeutics is in a pivotal phase two/three for ischemic stroke and simultaneously conducting a phase two study for preeclampsia, with key data expected in the next sixty days [3][34] - The company estimates a market opportunity of about 30,000 patients for early onset preeclampsia in the U.S., with a focus on severe cases that require hospitalization [13][14] Business Line Data and Key Metrics Changes - The primary asset, DM199, is a recombinant human tissue kallikrein-1 enzyme aimed at treating ischemic diseases, specifically targeting preeclampsia and ischemic stroke [1][3] - Current treatment options for preeclampsia are described as antiquated and ineffective, highlighting the potential for DM199 to fill a significant unmet need [14][19] Market Data and Key Metrics Changes - In the U.S., early onset preeclampsia occurs in up to 1% of pregnancies, translating to approximately 30,000 patients annually [13] - The company anticipates a high penetration rate for DM199 in the market due to the lack of effective current treatments [13][15] Company Strategy and Development Direction - DiaMedica aims to position DM199 as a disease-modifying therapy that is endothelial protective and lowers blood pressure, addressing the underlying dysfunction in preeclampsia [19][30] - The company is also exploring the acute ischemic stroke market, targeting patients who are not eligible for existing treatments like mechanical thrombectomy or tPA [43][49] Management's Comments on Operating Environment and Future Outlook - Management emphasizes the critical need for effective treatments in preeclampsia, noting that current medications often fail to manage symptoms effectively [19][54] - The company believes that the unique properties of DM199, such as its large molecular size, will provide a safety advantage by not crossing the placental barrier [15][30] Other Important Information - The clinical trial for preeclampsia is being conducted in South Africa due to high rates of the condition and access to experienced investigators [21][23] - Upcoming key opinion leader (KOL) event scheduled for May 28, 2025, to discuss the unmet need in preeclampsia and the trial design [58][60] Q&A Session Summary Question: Can you discuss the clinical development of DM199 for preeclampsia? - The company is in a pivotal phase two/three for ischemic stroke and a phase two for preeclampsia, with data expected in the next sixty days [3][34] Question: What is the market opportunity for DM199? - The estimated market opportunity for early onset preeclampsia in the U.S. is about 30,000 patients, with a focus on severe cases [13][14] Question: Why was South Africa chosen for the preeclampsia trial? - South Africa was selected due to high rates of preeclampsia and access to leading investigators who can conduct rigorous clinical trials [21][23] Question: How does DM199 differ from current treatments? - DM199 is a large molecule that does not cross the placental barrier, providing a safety advantage over current small molecule treatments [15][30] Question: What are the next steps for the company? - The company is preparing for a KOL event to discuss the unmet need in preeclampsia and the trial design, with data readouts expected in late June to early July [58][60]