DiaMedica Therapeutics reports Q1 EPS (14c), consensus (16c)

“We are diligently working to involve and mobilize top-tier stroke centers, laying a solid groundwork for patient participation,” stated Dr. Lorianne Masuoka, DiaMedica’s Chief Medical Officer. “The enthusiasm from premier research sites is uplifting, and we remain dedicated to bringing DM199 to stroke patients.” The company added: “DiaMedica, as recently announced, enrolled its first participant in the continuation of its ReMEDy2 trial of DM199 in participants with acute ischemic stroke, AIS. The first clinical sites were opened in December 2023 and as of the date of this press release, eight sites have now been opened. The majority of the U.S. sites are expected to be activated by the end of the third quarter of 2024. Progress is also being made outside of the United States. With the support of the Canadian Stroke Consortium, the required Senior Medical Officer, who will serve as the national physician investigator for Canada, has been engaged and six quality sites have been identified for inclusion in the trial. DiaMedica currently expects to submit its regulatory filings to Health Canada this month and expects a response by the end of June. The activation of study sites in Canada is expected to begin in the fourth quarter of 2024. The Australian Stroke Trials Network has completed its endorsement of DiaMedica’s protocol and DiaMedica is currently selecting study sites. The Company plans to work with many of the same highly-engaged centers it worked with in the ReMEDy1 trial. Australian site activation remains on track to commence before the end of 2024. The company currently believes that, barring any unforeseen circumstances, full enrollment for the 144 patients for the interim analysis will be completed in the first quarter of 2025.”