DiaMedica Therapeutics Inc. Common Stock

ITEM 1A. RISK FACTORS

Although Item 1A. is inapplicable to us as a smaller reporting company, we hereby disclose the following new risk factors in addition to those disclosed in our annual report on Form 10-K for the fiscal year ended December 31, 2023:

Our intendedThe expansion of our DM199 clinical development program into PE involves certain risks related to timing, regulatory approvals, costs and enrollment. Furthermore, because the proof-of-concept clinical trial will be investigator sponsored, we will have less control over the clinical trial and may face additional risks. Any such risks could adversely impact our business and results of operations.

On June 26, 2024, we announced  and financial position and harm our plansability to expand our DM199 clinical development program into PE. Pending required raise additional financing, if and when needed.

On October 9, 2024, we announced the receipt of regulatory and other approvals, we intend to  from SAHPRA to initiate an investigator-sponsored study of DM199 in PE. We are financially supporting the conduct a of the Phase 2 open-label, single center, single-arm, safety and pharmacodynamic, proof-of-concept, investigator-sponsored study of DM199 for the treatment of PE at the Tygerberg Hospital, Cape Town, South Africa. We anticipate that up to 90 women with PE and potentially an additional 30 subjects with fetal growth restriction will be evaluated, with th. The first subject anticipated to be ewas enrolled in the fourth quarter of 2024. Part 1A topline study results are intended to demonstrate initial proof-of-concept results including whether DM199 is safe, lowers blood pressure, and dilates intrauterine arteries to increase placental blood flow and are expected in the first half of 2025. We currently anticipate this Phase 2 trial to cost us approximately $1.5 million.

Our plans to expand

The expansion of our DM199 clinical development program into PE may not occur onand the progress of the anticipated timeline or at all, and we at program may not receive the required regulatory approvals ooccur on the anticipated timeline or at all. In addition, the Phase 2 trial may cost us more than we anticipate. Additionally, because the trial will be investigator-sponsored, we will have less control over the timing and costs of these studiesy and the ability to recruit trial subjects than if we conducted these trials study with our own personnel. There is no guarantee that our physician collaborators will devote adequate time and resources to perform this study and/or maintain adequate clinical trial information regarding our product candidate. If these third parties fail to meet expected deadlines, fail to transfer to us any regulatory information in a timely manner, fail to adhere to the study protocol or fail to act in accordance with regulatory requirements or our agreement with them, or if they otherwise perform in a substandard manner or in a way that compromises the quality or accuracy of their activities or the data they obtain, then our current or future clinical trials may be extended or delayed with additional costs incurred, or our data may be rejected by applicable regulatory agencies. Any of these risks could adversely impact our business, results of operations and financial position, including our ability to raise additional financing, if and when needed.

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Our drug candidate, DM199, is currently in clinical development in two areas, AIS and PE. Data from our new Pthe investigator-sponsored Phase 2 PE clinical trial may adversely affect our current ReMEDy2 clinical trial, which could adversely impact our business and , results of operations and financial position and harm our ability to raise additional financing, if and when needed.

We anticipate Part I1A topline study results for our Pthe Phase 2 PE clinical trial in the first half of 2025. Part 1A topline study results are intended to demonstrate whether DM199 is safe for PE patients, lowers blood pressure and/or dilates intrauterine arteries to increase placental blood flow. The results from Part I1A of the study may not be consistent with the safety results from our prior ReMEDy1 trial or cerf DM199 for the treatment of acute ischemic stroke or certain efficacy results notefrom thereinat trial. If these  Part 1A topline study results are inconsistent, inaccurate, incomplete or otherwise demonstrate that DM199 is not safe, does not lower blood pressure or dilate intrauterine arteries, our current ReMEDy2 clinical trial maof DM199 for the treatment of acute ischemic stroke may be adversely affected. Should this occur, we may be required to repeat clinical or non-clinical studies, our clinical development plans may be significantly delayed, and we may incur additional costs, which could adversely impact our business, results of operations and financial position. Adverse results from the Part I1A topline study also could adversely affect our ability to raise additional fundinancing, if and when needed.