DiaMedica Therapeutics Inc.

Good morning, ladies and gentlemen, and welcome to the Diametica Therapeutics full year 2023 conference call. An audio recording of the webcast will be available shortly after the call on Diametica's website at www.diametica.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. Diomedica'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 20, 2024, and may no longer be accurate at the time of any replay or transcript rereading. Diametica 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, Diametica's President and Chief Executive Officer. Mr. Pauls, you may begin, sir.

Thank you, Paul. Hello, everyone, and welcome to our full-year 2023 conference call. I am joined this morning by Lorianne Masuoka, our Chief Medical Officer, and Scott Kellen, our CFO. To start off the call this morning, I would like to welcome Lorianne Masuoka as our new Chief Medical Officer. Dr. Masuoka has only been with us for a few short months but is already making an enormous impact with clinical sites and building strong momentum with current and potential physician investigators. Dr. Matsuoka is a board-certified neurologist with more than 25 years of experience building and expanding high-value pipelines in the biopharmaceutical industry. She has a history of building and leading high-performing teams in clinical development through all stages and the ultimate approval of new medicines. Her experience also includes playing a key role in developing strategic partnerships and acquisitions of multiple biotechnology companies. She has served as the Chief Medical Officer for Epigenetics Therapeutics, Marinus Pharmaceuticals, Cubist Pharmaceutical, now part of Merck, and Nectar Therapeutics. She was also an independent board member of Opiant Pharmaceuticals, which was acquired last year for an upfront premium of over 100% and the potential for an approximately 200% premium if the contingent value rights are achieved. The breadth of her experience includes managing teams in the areas of clinical research, pharmacovigilance, biostatistics, and data management, regulatory affairs, and clinical operations. We welcome Lorianne on the call today, and I am thrilled to have her as a key member of our team.

Thank you, Rick. I'm excited to join the management team at Diomedica for several reasons. First, DM-199 represents a potential breakthrough in the treatment of acute ischemic stroke, a serious and life-threatening condition for which no new approved medical therapy has emerged in over 25 years. On the basis of the subgroup analyses of the Remedy 1 study, DM-199 shows great promise in returning stroke patients back to baseline neurologic function and preventing recurrent stroke and death. Diomedica hosted a booth at the International Stroke Conference last month with follow-up requests to our Remedy 2 trial from over 80 stroke centers. Eleven of those have already requested participation in our trial. They were enthusiastic about DM-199's mechanism of action to increase collateral circulation in the area of ischemic damage after a stroke without increased risk of hemorrhage. They see DM-199 as more like revascularization strategies such as TPA and mechanical thrombectomy and considerably more promising than the many failed neuroprotective agents. Also at this year's International Stroke Conference, Dr. Scott Kasner, Diomedica's Global Principal Investigator for Remedy2, presented a poster in the main hall discussing the Remedy2 trial design. Second, the management team and the clinical functions, which I now lead, are among the savviest, hardest working, and collaborative with which I have worked. We've also made some strategic additions to the clinical team that have enhanced productivity and effectiveness. Finally, the Remedy2 trial is a thoughtfully conceived, well-designed study that is well-managed and I believe will provide definitive evidence of whether DM-199 can become an important addition to the treatment options for patients who have suffered an ischemic stroke. Now let me provide an update on the Remedy2 progress. As a reminder, our final clinical protocol went into effect in mid-November, and the first U.S. sites were activated in December 2023. The sites activated in December were our fast-track centers, who were open prior to our clinical hold, and we are now in the process of expanding to a total of 40 to 50 sites in the United States. Once a site expresses interest and we select them, it takes approximately three to six months for contracting and IRB approval. New site commitment was slow over the holidays, but beginning in mid-January and continuing through the ISC conference in February, we've had a surge of new site commitments. As of today, we have six sites activated with an additional 18 sites in the startup phase and a deep pipeline of 40 additional sites selected for pre-qualification visits in the U.S. It is also important to point out that some of the largest and most reputable stroke research hospitals in the country have decided to join our trial. These new centers have substantial patient volumes and clinical research infrastructure and consistently rank among the top enrolling stroke centers in AIF studies. As we move into Q2 and early summer, we expect a substantial ramp up in opening U.S. sites. Consistent with my past experience in recruiting sites for other studies, we don't expect linear growth in adding new sites and patient volumes and envision more of a hockey stick-like ramp up in the U.S. during the second half of 2024 and continuing into 2025. With respect to additional countries, in Canada, the Canadian Stroke Consortium has endorsed our protocol and made recommendations regarding qualified study sites. We have identified six Canadian hospitals to date to participate in Remedy 2 and can now make our application to Health Canada for approval of our trial. We expect Canadian sites to commence activation in Q3 of this year. In Australia, the Australian Stroke Trials Network has provisionally endorsed our protocol last week, and we are moving now to select study sites and initiate regulatory filing activities. We plan to work with many of the same highly engaged centers we work with in Remedy 1, as well as new sites recommended by the network. We expect Australian study sites to commence activating by the end of the year as well. In Europe, including the UK, we have to comply with new rules and requirements related to drug manufacturing quality audits. We have nearly completed the additional procedures and documentation required. This work needs to be completed prior to seeking European regulatory approval for this study. We plan to pursue sites in select European countries with experienced research teams and potential for significantly higher enrollment rates. We expect to commence site activations late this year. In summary, we expect to have 25 to 30 sites active in recruiting by the end of Q2 and most of the approximately 75 plus sites at the end of 2024. We have been in close contact with our first open sites and we know they are pre-screening patients as we are getting questions on eligibility and participant consenting processes. We anticipate the first post-hold participant will be enrolled soon and it can happen any day now. Then it's an issue of numbers. As we get more sites up and running, we expect to begin to see enrollment resume and then surge as the bulk of the sites are activated toward the end of the year. I would also point out that some competing trials are concluding in the near future, freeing up critical study center staff bandwidth and likely increasing the patients that can be approached. Given all of this, we are comfortable in now saying, barring any unexpected issues, that we anticipate the 144th participant for our interim analysis will be enrolled in Q1 2025. I will now turn the call back over to Rick.