DiaMedica Therapeutics Inc. (NASDAQ:DMAC) Q2 2022 Earnings Conference Call August 11, 2022 8:00 AM ET

Company Participants

Rick Pauls - President and Chief Executive Officer

Kirsten Gruis - Chief Medical Officer

Scott Kellen - Chief Financial Officer

Conference Call Participants

Thomas Flaten - Lake Street Capital Markets

Alex Nowak - Craig-Hallum Capital Group

Elemer Piros - ROTH Capital Partners

Francois Brisebois - Oppenheimer

Operator

Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics Second Quarter 2022 Conference Call. An audio recording of the webcast will be available shortly after the call today on DiaMedica's website at www.diamedica.com in the Investor Relations section. Before the company proceeds with its remarks, please note that the company will be making forward-looking statements on today's call. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these statements. More information, including factors that could cause actual results to differ from projected results appears in the section entitled Cautionary Statement Note regarding forward-looking statements in the company's press release issued yesterday and under the heading Risk Factors in DiaMedica's most recent annual report on Form 10-K and Form 10-Qs. DiaMedica's SEC filings are available at www.sec.gov and on its website. Please also note that any comments made on today's call speak only as of today, August 11, 2022, and may no longer be accurate at the time of any replay or transcript rereading. DiaMedica disclaims any duty to update its forward-looking statements. Following the prepared remarks, we will open the phone lines for questions.

I would now like to introduce your host for today's call, Mr. Rick Pauls, DiaMedica's President and Chief Executive Officer. Mr. Pauls, you may begin.

Rick Pauls

Thank you, operator. Hello, everyone, and welcome to our second quarter 2022 conference call. We'd like to focus today on addressing the enrollment pause in our ReMEDy2 stroke trial. As you know, on July 6, we issued a press release in which we announced that the FDA posed a clinical hold on our trial. This came after we voluntarily paused enrollments in the ReMEDy2 trial to investigate three unexpected incidents of clinically significant hypotension or a decrease in blood pressure.

These incidents occurred shortly after initiating intravenous or IV infusion of DM199, which is the first administration of DM199 for each patient. I want to emphasize that in all three patients, the hypotension was transient, meaning their blood pressure returned to pre-dosing levels within a few minutes after stocking the IV dosing. And they did not experienced any further adverse events.