DiaMedica Therapeutics (DMAC) Status Update summary

Clinical expansion and program updates

• DM199 is expanding into preeclampsia with a Phase II investigator-sponsored trial starting in Q4 2024, aiming for rapid proof of concept by H1 2025 and enrolling up to 120 participants at Tygerberg Hospital, South Africa.

• Collaborations with leading academic centers and maternal/fetal medicine experts support the trial, which is divided into parts focusing on dose-finding, pregnancy prolongation, and fetal growth restriction.

• The phase II study is capital efficient, with a total cost of up to $1.5 million and initial proof of concept at $600,000.

• A key opinion leader event and white paper release are scheduled for July 2024 to present more details.

• Recent $12 million capital raise extends cash runway into Q3 2026, supporting both stroke and preeclampsia programs.

Unmet medical need and mechanism of action

• Preeclampsia affects 5-8% of pregnancies in the US and up to 8% worldwide, with high maternal mortality and no FDA-approved treatments.

• Current antihypertensives only temporarily control blood pressure and do not halt disease progression, often leading to premature delivery.

• DM199, a recombinant KLK1 protein, targets the Bradykinin B2 receptor to lower blood pressure, dilate intrauterine arteries, and improve placental perfusion without fetal exposure.

• Preclinical and clinical data show DM199 can significantly reduce blood pressure and does not cross the placental barrier in animal studies.

• The therapy may also benefit fetal growth restriction, another area with no approved treatments.

Phase II clinical trial design and objectives

• The trial at Tygerberg Hospital is in multiple parts: Part 1 for dose-finding and safety, Part 2 for pregnancy prolongation, and Part 3 for fetal growth restriction, with up to 120 participants.

• Part 1A will escalate DM199 doses to identify a safe, effective dose; Part 1B will treat additional patients at this dose.

• Endpoints include safety, blood pressure reduction, intrauterine artery dilation, kidney function, and confirmation of no placental transfer.

• Part 2 focuses on prolonging pregnancy, blood pressure control, and maternal/fetal safety, with subcutaneous DM199 every three days until delivery.

• Part 3 will assess effects on fetal growth restriction in up to 30 women, contingent on positive findings from Part 1.