DiaMedica Therapeutics Inc.

Good morning, ladies and gentlemen, and welcome to the Diomedica Therapeutics first quarter 2024 conference call. An audio recording of the webcast will be available shortly after the call today on Diomedica's website at www.diomedica.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 risk 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 Diomedica's most recent annual report on Form 10-K and current year quarterly reports on Form 10-Q. Diomedica's SEC filings are available at www.sec.gov and its website. Please also note that any comments made on today's call speak only as of today, May 9, 2024, and may no longer be accurate at the time of annual replay or transcript rereading. Diomedica 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, Diomedica's President and Chief Executive Officer. Mr. Pauls, you may begin.

Thank you, Operator. Hello, everyone, and welcome to our first quarter conference call. I'm joined this morning by Dr. Loriane Masuoka, our Chief Medical Officer, and Scott Kellan, our Chief Financial Officer. Well, it has been only six weeks since our last discussion. We have been diligently working to ramp up site activation and participant enrollment. We've also strengthened our clinical team with the addition of three experienced clinical operations personnel, to further support the significant number of new site activations we expect over the next six months and the global expansion of the trial. We're also encouraged to recently learn that the momentum of Calicang usage in China continues to build. We now understand that upwards of 1 million patients were treated with Calicang, the human urine-derived form of KLK1 in China in 2023. For perspective, This is more than all the stroke events in the United States in 2023. Sites considering participation in our trial can be reassured of the safety of KLK1 therapy by the large usage of human-derived KLK1. I would like to now invite Loriane to provide an update on our Remedy 2 trial. Loriane?

Good morning, everyone. I'm pleased with our recent announcement that we have dosed the first participant since the restart of our Remedy 2 trial. Enrolling the first participant is particularly challenging and a crucial milestone when coming off a clinical hold for a safety event. Although the hypotension we previously observed with the inadvertent higher dose was transient and resolved quickly, and despite the results of our Phase 1 CTRAW clearly demonstrating that the appropriate IV dose of DM-199 does not cause hypotension, we recognize there is often some reluctance to be the first to enroll on restart. The feedback from the investigator who dosed this participant was very positive, with no observed hypotension. However, we do not know whether the participant received drug or placebo. Success begets success, and we are optimistic that other investigators will have a similar positive safety experience dosing their first participant with DM-199, encouraging them to enroll more participants. I want to emphasize that these stroke patients have no treatment alternative and are not eligible to receive any standard of care treatment, either TPA or mechanical thrombectomy. Investigators want to see a future where every patient has a treatment option. So as we accrue more safety data, we expect momentum to build quickly. From discussion with sites, we believe a key inflection point will be enrolling the first 10 participants. To them, this represents a meaningful sample size. We will keep our active sites abreast of our participant enrollments, and in the future, we will also send out a monthly newsletter in an attempt to facilitate some friendly competition between study sites. Now let me discuss some specifics of site activation. We currently have eight sites activated. Two of these sites are large sites, the University of Pennsylvania, associated with our national principal investigator, Dr. Scott Kasner, and Tampa General Hospital, a major stroke center. In activating these two sites, we learned of a common software coordination issue which we had to work through to enable the processing of pharmacy orders through the individual site's investigational drug management platform. We worked closely with these two sites to resolve the issue, and both are now positioned to screen for potential participants. We are actively working closely with all other sites in the queue for site activation to avoid similar delays and ensure that their internal systems, like their pharmacy investigational drug management platforms, are fully operational prior to site activation so they can immediately begin screening participants without interruption. This is just one example of how we apply best practices learned from experience to enhance operations at all sites going forward. While we are slightly behind our short-term activation targets, we still anticipate that the majority of sites will be activated this year with a major bolus of U.S. sites in Q2 and Q3. With the current level of interest from high-quality stroke sites, we are considering increasing the target number of U.S. sites beyond the 40 initially planned. The key is now focusing only on quality sites that are considered high enrollers. Importantly, many of the largest U.S. stroke enrolling hospitals are now in the startup stage and are working to join our trial in the coming months. These sites have been major contributors to recent stroke trials, which is encouraging for our study. We anticipate that their involvement could also drive competition among study sites and also contribute to a higher per-site enrollment rate. We also believe their endorsement speaks to the potential of DM-199 and, in particular, our differentiated mechanism of action of selectively increasing cerebral blood flow. Outside of the U.S., things are progressing well. In Canada, with official support from the Canadian Stroke Consortium, we have identified six quality sites and are finalizing our regulatory submissions for Health Canada. We expect a response around the end of June. The Australian Stroke Alliance has recently provided its formal endorsement of our protocol, and we are in the process of selecting study sites and initiating regulatory filing activities. We plan to work with many of the same highly engaged centers we work with in our RemedyOne trial, as well as new sites recommended by the network. I am also excited to report that we continue to strengthen our clinical operations team. Earlier this year, we announced the addition of Rebecca Fries as our VP of Clinical Operations. This is the third company at which Rebecca has joined me to execute on clinical trials. Rebecca initially joined Diomedica as a consultant in January and has already made substantial progress in streamlining our operations both internally and externally with our multiple vendors, which we believe will lead to momentum building and site activations. The additional experienced clinical operations personnel mentioned earlier also previously worked with both Rebecca and I at two prior companies. These are important additions to support our global expansion of the trial. I will now turn the call back over to Rick.