DiaMedica Therapeutics(DMAC) - 2025 FY - Earnings Call Transcript

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]