DiaMedica Therapeutics Inc.

We are a clinical-stage biopharmaceutical company focused on developing therapies for severe ischemic disease. Our two main clinical programs target preeclampsia (PE) / fetal growth restriction (FGR) and acute ischemic stroke (AIS). Our lead candidate, DM199 (rinvecalinase alfa), is a recombinant form of the human tissue kallikrein-1 (rhKLK1) protein. DM199 has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of AIS. Kallikrein-1 (KLK1) from human urine and pig pancreas is an established treatment in Asia for AIS and cardio renal disease, including hypertension, respectively. We aim to advance DM199 through clinical trials for PE, FGR, and AIS. Our longer-term plan includes developing DM300, our patented recombinant human ulinastatin, as a potential therapy for severe acute pancreatitis. KLK1 is a serine protease enzyme that regulates physiological processes by enhancing endothelial health, microcirculatory blood flow, and tissue perfusion through increased production of nitric oxide (NO), prostacyclin (PGI 2 ), and endothelium-derived hyperpolarizing factor (EDHF). For PE and FGR, DM199 is designed to lower blood pressure, improve endothelial health, and enhance perfusion to maternal organs and the placenta. For AIS, DM199 aims to increase blood flow and neuronal survival in the ischemic penumbra by dilating arterioles and inhibiting apoptosis, while also promoting neuronal remodeling through angiogenesis. Our clinical development program for PE involves an investigator-sponsored Phase 2 study at Tygerberg Hospital in Cape Town, South Africa, assessing safety, tolerability, and pharmacodynamics.