DiaMedica Therapeutics Inc.

What they do

DiaMedica develops DM199, a recombinant form of human tissue kallikrein-1 protein, which it describes as the first pharmaceutically active recombinant KLK1 to be clinically studied in patients; it holds FDA Fast Track Designation for acute ischemic stroke. Clinical work spans an investigator-sponsored Phase 2 preeclampsia study in South Africa (Parts 1a, 1b, 2) with a fetal growth restriction arm (Part 3), a planned North American/UK early-onset preeclampsia Phase 2, and the Phase 2/3 ReMEDy2 trial in acute ischemic stroke. A longer-term program, DM300 (patented recombinant human ulinastatin), is described as a potential therapy for severe acute pancreatitis. The company reported only $500,000 of annual revenue in 2018 and no commercial products, so operations are funded by equity rather than product sales.

Revenue drivers

• DM199 in preeclampsia (PE) / fetal growth restriction (FGR) — Lead program; no revenue today. Phase 2 Part 1a enrolled up to approximately 100 PE women plus potentially 30 FGR subjects at Tygerberg Hospital, Cape Town, and a North American/UK Phase 2 in early-onset preeclampsia is being prepared.
• DM199 in acute ischemic stroke (AIS) — ReMEDy2 — Phase 2/3 trial (NCT05065216) targeting 200 participants; the company said enrollment has surpassed 85% of the 200-participant target, with interim analysis anticipated in Q1 2027.
• DM300 (recombinant human ulinastatin) — Earlier-stage, patented asset described as a broad-spectrum serine protease inhibitor for severe acute pancreatitis; no trials or revenue reported in the excerpts.
• Future out-licensing / partnership revenue — The 10-K risk disclosure states the business model assumes revenue will come from marketing or out-licensing product candidates; none has been generated to date.

Recent performance

The company reported no product revenue; its most recent reported annual revenue figure in the data is $500,000 in 2018. Net losses widened each year from $13.6M in 2021 to $32.8M in 2025, with operating cash use rising from $12.3M in 2021 to $29.1M in 2025. Diluted EPS was -$0.70 in 2025 versus -$0.60 in 2024. As of June 30, 2026, total assets were $45.0M and shareholder equity $38.3M; the company reported $43.5M in cash, cash equivalents and investments in its August 10, 2026 earnings release and said runway extends through 2027. As of August 3, 2026, there were 53,925,697 voting common shares outstanding.

Strategy

Advance DM199 through clinical trials in preeclampsia, fetal growth restriction and acute ischemic stroke, with the stated aim of establishing clinical and commercial potential and ultimately creating value through marketing or out-licensing. In preeclampsia, Part 1a topline results are intended to identify a dose for Parts 1b, 2 and 3, and the mid-dose range (Cohorts 4-8) is being carried forward into early-onset preeclampsia and FGR studies. The company plans an open-label, three-dose Phase 2 in early-onset preeclampsia in North America and the UK, having received Health Canada approval in March 2026 and expecting to file a UK clinical trial application in Q2 2026. It is also continuing ReMEDy2 enrollment and longer-term development of DM300 for severe acute pancreatitis.

Risks

• Pre-revenue, no approved products — The company has no products approved for commercialization and its business model depends on future marketing or out-licensing, leaving investors little operating history to evaluate.
• Rising cash burn and losses — Net loss grew from $13.6M in 2021 to $32.8M in 2025 and operating cash use from $12.3M to $29.1M, with cash and investments of $43.5M as of the latest release financing a runway the company says extends through 2027.
• US preeclampsia trial gating issue — The FDA requested a 10-day modified ePPND rabbit study, but preliminary results suggest the animals developed an antibody response to DM199, preventing completion of the requested study.
• Clinical enrollment and trial design risk — The 10-K cites past and possible future difficulty enrolling the ReMEDy2 trial and notes the adaptive design could require enrolling more patients than anticipated, increasing time and cost.

Outlook

Management expects to initiate subsequent FGR and early-onset preeclampsia studies in the second half of 2026, with site activation planned and a UK clinical trial application anticipated. Topline results from the first FGR cohort (6 participants at the 5 g/kg dose) and a KOL call are scheduled for September 2026. For acute ischemic stroke, enrollment has surpassed 85% of the 200-participant ReMEDy2 target, with interim analysis anticipated in Q1 2027. The company states it has $43.5M in cash, cash equivalents and investments and an anticipated runway through 2027.