Company: DMAC
Filing Date: 2025-08-01
Form Type: S-3
Source: 0001437749-25-024290
Chunk: 16

Company: DiaMedica Therapeutics Inc.
Filing Date: 2025-08-01
Form: S-3
Chunk 16
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 are more likely to be sites in our trial; and competition for research staff and trial subjects due to other pending stroke and neurological clinical trials; |

| ● | the success of the actions we are taking to mitigate the impact of the factors adversely affecting our ReMEDy2 trial site activations and enrollment rate, including significantly expanding our internal clinical team and bringing in-house certain trial activities, such as study site identification, qualification and activation, clinical site monitoring and overall program management; globally expanding the trial; and making additional changes to the study protocol; and risks associated with these mitigation actions; |

| ● | uncertainties relating to regulatory applications and related filing and approval timelines, especially in light of recent changes in funding and staffing levels for the FDA and other government agencies; |

| ● | the possibility of future adverse events associated with or unfavorable results from the Phase 2 investigator-sponsored PE trial or our ReMEDy2 trial; |

| ● | the adaptive design of our ReMEDy2 trial, which is intended to enroll approximately 300 patients at up to 100 sites globally, and the possibility that the final sample size, which will be determined based upon the results of an interim analysis of 200 participants, may be up to 728 patients, according to a pre-determined statistical plan, other possible changes in the trial, including as a result of input from the FDA, and the results of the interim analysis as determined by our independent data safety monitoring board; |

| ● | our expectations regarding the perceived benefits of our DM199 product candidate over existing treatment options for PE and AIS; |

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| ● | our ability to partner with and generate revenue from biopharmaceutical or pharmaceutical partners to develop, obtain regulatory approval for, and commercialize our DM199 product candidate for PE and AIS; |

| ● | the potential size of the markets for our DM199 product candidate for PE and AIS and our or any future partner’s ability to serve those markets, the rate and degree of market acceptance of and ability to obtain coverage and adequate reimbursement for, our DM199 product candidate for PE and AIS both in the United States and internationally; |

| ● | the success, cost and timing of our clinical trials, as well as our reliance on our key executives, clinical personnel, advisors and third parties in connection with our trials; |

| ● | our or any future partner’s ability to commercialize, market and manufacture DM199; |

| ● | expectations regarding U.S. federal, state and foreign regulatory requirements and developments