Company: DMAC
Filing Date: 2025-12-18
Form Type: 8-K
Source: 0001437749-25-038211
Chunk: 1

Company: DiaMedica Therapeutics Inc.
Filing Date: 2025-12-18
Form: 8-K
Item: Item 8.01
Chunk 1
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Item 8.01

Other Events.

As previously announced, DiaMedica requested and completed an in-person pre-IND meeting with the FDA for a planned study evaluating DM199 in pre-eclampsia. Minutes from the meeting have affirmed the FDA’s request for one additional non-clinical, 10-day modified embryo-fetal development (EFD) and pre and postnatal Development (PPND) study in a rabbit model. Preparations for this study have commenced and results are expected to be available by the second quarter of 2026.

Cautionary Note Regarding Forward-Looking Statements

This report contains forward-looking statements within the meaning of the U. S. Private Securities Litigation Reform Act of 1995 and forward-looking information that are based on the beliefs of management and reflect management’s current expectations. When used in report, the words “anticipates,” “believes,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” or “will,” the negative of these words or such variations thereon or comparable terminology and the use of future dates are intended to identify forward-looking statements and information. The forward-looking statements and information in this report include statements regarding expectations regarding the timing for a rabbit treatment study and the preeclampsia Phase 2 investigator-sponsored trial; anticipated clinical benefits and success of DM199 for the treatment of preeclampsia and acute ischemic stroke; and future regulatory requirements. Such statements and information reflect management’s current view and DiaMedica undertakes no obligation to update or revise any of these statements or information. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Applicable risks and uncertainties include, among others, risks and uncertainties related to the timing and outcomes of non-clinical studies; risks and uncertainties relating to the timing of studies and trials; risks and uncertainties relating to the clinical expansion into preeclampsia and associated trials; the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; DiaMedica’s plans to develop, obtain regulatory approval for and commercialize its DM199 product candidate for the treatment of preeclampsia and acute ischemic stroke and its expectations regarding the benefits of DM