Business
DiaMedica Therapeutics Provides a Business Update and Announces Second Quarter 2023 Financial Results
Conference Call and Webcast August 15 at 8:00 am Eastern Time / 7:00 am Central Time Company Resumes ReMEDy2 Clinical Trial after Clinical Hold Lifted
About this update from Diamedica Therapeutics Inc.
[{"type":"text","content":"\nConference Call and Webcast August 15 at 8:00 am Eastern Time / 7:00 am Central Time\n\n\n\nCompany Resumes ReMEDy2 Clinical Trial after Clinical Hold Lifted\n\n\n\nCompany Completed a $37.5M “At-The-Market” Private Placement, Cash Runway Into 2026\n\n\n\nCompany Completed an Additional Safety Cohort of ACEi Patients in its Phase 1C Healthy Volunteer Study\n\n\n\n MINNEAPOLIS--(BUSINESS WIRE)--\nDiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and cardio-renal disease, today provided a business update and financial results for the quarter ended June 30, 2023. Management will host a conference call Tuesday, August 15, 2023, at 7:00AM Central Time/8:00AM Eastern Time to discuss its business update and second quarter 2023 financial results.\n\n\nClinical Developments\n\n\nClinical Hold Lifted on ReMEDy2 Phase 2/3 Trial for Acute Ischemic Stroke\n\n\nOn June 21, 2023, the Company announced that the U.S. Food and Drug Administration (FDA) fully lifted the clinical hold on DiaMedica’s investigational new drug application for its ReMEDy2 clinical trial of DM199 in acute ischemic stroke (AIS) patients. The Company has rapidly re-engaged with its study support vendors and brought on a new contract research organization (CRO) with strong stroke experience, to assist with the planning and preparations for resuming the ReMEDy2 trial with a focus on ensuring that the right resources are in place to attract high quality study sites and ensure smooth and efficient clinical operations as patient enrollment resumes. The enrollment timeline projections and site selection are being finalized in collaboration with the new CRO. In addition, the Company is planning for the inclusion of study sites outside of the United States to increase the enrollment rate for both the interim analysis and the overall study. At this time, based upon enrollment rates in recent stroke trials and discussions with multiple CROs, the Company believes that full enrollment for the interim analysis can be completed in 2024.\n\n\n“With the lifting of the clinical hold, we are thrilled to reengage with doctors and hospitals to work towards developing DM199 as a significant advance for the treatment of ischemic stroke patients,” commented Rick Pauls, DiaMedica’s Chief Exec...