DiaMedica Therapeutics Inc. (NASDAQ:DMAC) Q4 2022 Earnings Conference Call March 29, 2023 8:00 AM ET

Company Participants

Rick Pauls - President and Chief Executive Officer

Scott Kellen - Chief Financial Officer

Kirsten Gruis - Chief Medical Officer

Conference Call Participants

Thomas Flaten - Lake Street Capital Markets

Alexander Nowak - Craig-Hallum Capital Group

Daniel Hultberg - Oppenheimer

Operator

Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics ReMEDy2 Update 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 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.

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, March 29th, 2023, 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, sir.

Rick Pauls

Thanks, Paul. Hello, everyone, and welcome to our fourth quarter conference call. I'm joined this morning by Kirsten Gruis, our Chief medical officer, and Scott Kellen, our Chief Financial Officer.

I'd like to start off today this call by updating everyone on the status of our work to remove the clinical hold on our ReMEDy2 Phase 2/3 pivotal trial and our communications with the FDA as we approach what we believe will be the final resolution of the clinical hold.

Recall that the hold was not caused by any issue with our drug product candidate DM199, but was caused by the effects of switching to a new IV bag formulation in our ReMEDy2 trial. In our prior ReMEDy1 Phase 2 trial, the IV bag made from polyolefin retained up to half of the DM199 drug.