DiaMedica Therapeutics Inc

Current report

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

Current report

Our intended 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.

Current report

On June 26, 2024, we announced our plans to expand our DM199 clinical development program into PE. Pending required regulatory and other approvals, we intend to financially support the conduct a 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 the first subject anticipated to be 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.

Current report

Our plans to expand our DM199 clinical development program into PE may not occur on the anticipated timeline or at all, and we may not receive the required regulatory approvals 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 studies and the ability to recruit trial subjects than if we conducted these trials 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.

Current report

Our drug candidate, DM199, is in clinical development in two areas, AIS and PE. Data from our new PE clinical trial may adversely affect our ReMEDy2 clinical trial, which could adversely impact our business and results of operations.

Current report

We anticipate Part IA topline study results for our 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 IA of the study may not be consistent with the safety results from our prior ReMEDy1 trial or certain efficacy results note therein. If these results are inconsistent, inaccurate, incomplete or otherwise demonstrate that DM199 is not safe, does not lower blood pressure or dilate intrauterine arteries, our ReMEDy2 clinical trial 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 IA topline study also could adversely affect our ability to raise additional funding, if and when needed.

Previous report

As a smaller reporting company, we are not required to provide disclosure pursuant to this item.