DiaMedica Therapeutics Inc. (NASDAQ:DMAC) Q1 2023 Earnings Conference Call May 16, 2023 8:00 AM ET
Company Participants
Rick Pauls - President and Chief Executive Officer
Scott Kellen - Chief Financial Officer
Conference Call Participants
Thomas Flaten - Lake Street Capital
Alex Nowak - Craig-Hallum
Daniel Hultberg - Oppenheimer
Operator
Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics First Quarter 2023 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 and subsequent quarterly report on Form 10-Q.
DiaMedica's SEC filings are available at SECs website www.sec.gov and on its website. Please also note that any comments made on today's call speak only as of today, May 16th, 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
Thank you, operator. Hello, everyone, and welcome to our Q1 2023 conference call. I am joined this morning with Dr. Kirsten Gruis, our Chief Medical Officer and Scott Kellen, our Chief Financial Officer. I am happy to report this morning that our complete response requesting the lifting of our clinical hold is being finalized as we speak and we plan to submit to the FDA this week. Much hard work has been performed to get us here.
The FDA requested a new study was completed in April. This was performed at an independent laboratory and consisted of two parts. Part one simulated actual use in the hospital of drug being administered. And part two evaluated worst case scenarios such as varying storage durations, temperature and light exposure. We believe that the data from part one confirmed our conclusions that the effects of the change in the IV bag material was the cause of the hypotensive events leading to our halting of enrollment in the study.