Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics Conference Call to discuss the topline results from DiaMedica's ReMEDy Phase 2 clinical study and Acute Ischemic Stroke and First Quarter Results. An audio recording of the webcast and a copy of the slide presentation will be available shortly after the call today on DiaMedica's website at www.diamedica.com in the Investors section. I would now like to hand the call over to Rick Pauls, President and CEO. Please go ahead, sir.

Thank you, Lisa and good morning everyone, and thank you for attending today's presentation. Before the company proceeds with our remarks, please note that the company will be making forward-looking statements on today's call. These statements are pursuant to risks and uncertainties that could cause actual results to differ materially from those projected in these statements. More information, including the factors that could cause actual results to differ from the projected results appear in the section entitled Cautionary Statement Note regarding forward-looking statements in the company's press release issued today and under the heading Risk Factors in DiaMedica's previously filed annual reports on Form 10-K. DiaMedica's SEC filings are available at www.sec.gov and on our website. Please also note that any comments made on today's call speak only as of today, May 14, 2020 and may no longer be accurate at the time of any replay or transcript re-reading. DiaMedica disclaims any duty to update its forward-looking statements. We are very excited today to share with you the topline results from our ReMEDy Phase 2 study of DM199 in participants suffering an acute ischemic stroke and to provide some additional color on our plans to continue moving forward with the DM199 for acute ischemic stroke. Yesterday we issued a press release summarizing the topline results from the ReMEDy study and also filed a copy of today's presentation with the SEC. Both of these documents can be found in the Investors section of our website at www.diabetic.com. I'm joined today by our Chief Medical Officer, Dr. Harry Alcorn and Chief Financial Officer, Scott Kellen. As we previously discussed, we are positioning DM199 as recombinant or synthetic form of the KLK1 protein as a treatment for several very important diseases. KLK1 is a protein which is produced primarily in the kidneys, pancreas…

Thank you, Rick. Good morning, everyone. As I'm sure you already know, our REDUX Phase 2 CKD, chronic kidney disease study, is enrolling a total of 60 participants in two equal cohorts. The first cohort is focused on hypertensive African Americans who are not diabetic, but have albuminuria. The second cohort is focused on participants with the IgA nephropathy, previously confirmed by biopsy and also having albuminuria. Participants will be treated with DM199 for approximately 13 weeks, at a dose level of either 2 mcg or 5 mcg/kg, which is administered subcutaneously two times per week. The primary efficacy endpoints for the overall study are eGFR and albuminuria. We are also tracking standard safety and tolerability markers. Participants' enrollment continues to be slow, while we technically have 12 sites in the current COVID environment, only approximately half are currently able to recruit and screen participants. As we discussed on our last call, our study design provides for registered nurses to make home visits for the majority of the participants' treatments. In April, we implemented additional changes to the protocol, including allowing participants' screening to be performed by registered nurse in the participants' home, which further reduced the level of participant contact. This approach is consistent with the principles of social distancing recommended by various governmental authorities. As of today, the safer at home policies enacted have not disrupted the treatment of any of our enrolled participants. I'm also pleased to report that the procedures implemented by our clinical team, study site and home nursing service providers as of today have been successful in that we have not had any reports of COVID-19 infections in any of our participants. We remain in close communication with all of our study sites. What we are currently hearing from the inactive sites is they are expected to be in a position to resume activities in the first half of June. We are optimistic that with this limited participation, contact and design of the REDUX study, sites will be able to progress more rapidly with the resuming recruitment and screening for the REDUX study in that time period. We will continue to monitor and evaluate the impact of COVID-19 on our study, but in light of the uncertainty surrounding COVID-19, we are not in a position to provide a projection for when we may have interim top line results. We will continue to provide additional information as conditions allow.

Thank you, Harry. I would now like to ask Scott Kellen to take us through the Q1 2020 financials.

Thank you, Rick. Good morning everyone. As Rick mentioned, we released our financial results for the first quarter of 2020 and filed our 10-Q yesterday after the markets closed. If you haven't had a chance to review these documents, they are both available on either the DiaMedica or the SEC websites. Our net loss for the first quarter of 2020 was $2.4 million or $0.19 per share. This compares to a net loss of $3.3 million or $0.27 per share for the first quarter of 2019. Our research and development expenses decreased to $1.4 million for the first quarter of 2020, a decrease of $1.2 million from $2.6 million incurred in the first quarter of 2019. This year-over-year decrease was due to costs incurred during the first quarter of 2019, which did not reoccur during the first quarter of 2020. Primarily the costs for a production run of the DM199 drug substance and our Phase 1b pharmacokinetic study in CKD patients. Declining costs for the remedy study in the current year as compared with the prior year period also contributed to this decrease. Now, these decreases were partially offset by the costs incurred for our REDUX Phase 2 CKD study, which began enrollment in December of 2019 and increased non-cash share based compensation costs. Our general and administrative expenses were $1 million for the first quarter of 2020, compared to $814,000 for the first quarter of 2019. This increase resulted primarily from increased non-cash share based compensation costs. Now our total other income or expense for the first quarter of 2020 was a net expense of $12,000. This compares with a net income of $178,000 for the first quarter of 2019. This change was primarily caused by foreign currency transaction losses associated with funds held in non-functional currency or non-U.S.…

Thank you, Scott. We'd like to open the call for questions. Operator, if you could please introduce the first analyst?

Thank you. [Operator Instructions] And our first question comes from the line of Alex Nowak - Craig-Hallum Capital Markets. Your line is open.

Great, good morning, everyone and congrats on getting the Phase 2 stroke study across the finish line here. Rick, you mentioned this earlier, but could you provide a bit more detail and insight why mechanical thrombectomy was included in the study in the first place? At that time, it sounds like it was more of a safety aspect, but can you just confirm it was pre-specified that the true intent to treat population really did exclude mechanical thrombectomy?

Yes, thank you, Alex. So the first protocol when it was designed now a couple years ago, initially it was excluded. We later decided with our advisory board to include patients that had mechanical thrombectomy. And so we wanted a sampling of mechanical thrombectomy patients for safety and to determine if there's any possible clinical benefits. In the end, if we look at it that approximately 20% of patients are eligible for thrombectomy, where in the U.S. about 6% actually received. And so we really just wanted to get a sense here whether or not it's something we should consider for Phase 3. The human urine form of KLK1 in China, there is some pretty clear synergistic data with tPA, but there really wasn't anything with mechanical thrombectomy. So we want to get a sense of whether or not as something we want to include or not for Phase 3. From a mechanism perspective, there is some clear differences that we believe our drug is targeting microvascular circulation, whereas those patients who had an eligible for thrombectomy are targeting more large vessel occlusion. So it's something that we wanted to research.

That's helpful. What are the primary physicians in the study say about the high rate of mechanical thrombectomy enrollment that you saw, and when you showed your stroke advisory board the data, what was their overall response to the results?

Yes, so overall, we were anticipating 10%, 15% maybe that would have thrombectomy. We were all surprised including our advisors that the level was so high. Our advisors perspective, you can see the quote from Dr. Campbell. You know, this was first a safety study, I mean, stroke is a severe condition. I mean, first and foremost, making sure that it is safe, it was very encouraging that we saw the reductions in stroke recurrences. And it seems that - we've got some signals here that are consistent with the results with the human urine form of KLK1.

That's good. And, as we spoke over the years, I know you and the team have spoken with larger pharma, large strategics, about your work on KLK1. From your discussions that you've had with them on stroke in the past, what do they want to see in stroke, and does the data from the intend to treat population really check all the boxes there?

I guess to be determined, we'll have to go out and talk to them. We do believe that they're from a partnering perspective there will be a lot more interest for chronic kidney disease. But I think that the data we have here, and it's not just the NIHs scores, it's the safety, it’s the mechanism, it's the whole, it's all the pieces kind of together on a relatively small study, that's all pointing to a biologically active protein that we absolutely believe has a place now for stroke in addition to kidney disease.

Yes, no, I would agree. And actually switching gears over to CKD, Harry, the CKD data that you put out here with eGFR, that appears to be - looks to be a pretty big deal. Is there anything with the physiology or the condition state of stroke that would make it difficult to use the data here as a direct proxy to your Phase 2 kidney study? And have you shown your Kidney Advisory Board this data yet?

Thank you for bringing it up, Alex. The CKD Scientific Advisory Board did receive the data. They did find it to be extremely impressive and very interesting, as it confirmed for them what our drug can do for kidney function. Obviously, this will be synergistic with our conversation with the agency and with other regulatory bodies as we move forward with stroke and eGFR, as eGFR is a fact that occurs with stroke patients. So they need to address total clinical care on these stroke patients, not only with obviously the clot, but also with their kidney function. So I hope this has been a wonderful conversation, as they've been supportive in total care of these patients for their disease state.

That’s good. Just last question from me. With COVID starting to fade here a bit and some of the states are on the reopen, do you have any timeline or a rough timeline for the CKD study read out the full 90 days, is it fair to say this should come before year end though?

Yes, it's - we do hope so. But right now, until we get clarity, I mean, what we're sensing from some of the sites that it seems that they're getting physicians, so that things can start ramping up in June. And a lot of our efforts right now have been to work with a site to identify participants, that when things do open up more, that we'll be in a position to get our enrollments really, really moving quickly.

Okay, excellent. Well, congrats on the really compelling data here.

Thanks, Alex.

Our next question comes from the line of Thomas Flaten from Lake Street Capital. Your line is open.

Good morning, guys. Thanks for taking the question. Just sticking with CKD for a second, would you - could you comment on how many patients are currently enrolled of the 60 total?

Thomas, we haven't provided guidance on that. I mean, we were anticipating to have results here in Q2, but with COVID, right now, we don't have any guidance. We will though when we get some clarity on COVID, hopefully here in the coming near-term.

And then flipping back to stroke, from an FDA perspective, given there might be a safety advantage and you certainly have the 24-hour window, do you think that the hurdle from an efficacy perspective will be to match tPA and then deliver better safety and a longer window? Will that be a sufficient hurdle for FDA or do you think they're going to be looking for both the safety advantage and an efficacy advantage from a design perspective?

So, first off, tPA has some clear safety issues, physicians really do have to weigh the pros and cons. I don't believe we'll see that same concern with our drug. We're really going to be targeting those patients, post four and a half hour window of tPA where there are no therapeutic window, where there are no therapeutic treatments today. So even if we see similar efficacy to tPA, that would be wonderful. And what we're seeing from our study here is that, again small number of patients, almost a doubling of the full recovery compared to tPA. So, we think because of that, because there are no other therapies in particular after that four and a half hour window, and with the strong safety profile, it gives us a very attractive clinical bar for us to hit.

So, just a follow-up on that. So would you specifically target post four and a half window or would that be a pre-specified subgroup that are post four and a half hour window?

Yes, so that's something that, the data is just in. We're getting it all just getting it out here now to the investment community. We plan to meet as soon as possible with the FDA. There is going to be a lot of things to talk to them about. So we're going to talk to them about with and without tPA. We do believe that we will see positive efficacy with tPA or without, and also, the safety profile including the reduced risk of recurrent strokes. Recurrent strokes are a problem, and so I think what we want to do is get the - show the data to the FDA, get the feedback, and then being in a position to looking at this point here with or without tPA. So we'll have some updates here in the coming months.

And then just one final question from me, you talked about a Phase 2/3 study going forward. Is that because you anticipated being adaptive or do you think – would that be pivotal design or I'm just curious why you label it a Phase 2/3, instead of just a Phase 3 or pivotal study more and more generically?

Yes, so one of the things we're looking at is again, this is now just initial internal discussions, advisors and so forth. A Phase 2 design would be a pathway would be adaptive. So one of the things we're considering is approximately 100 patients for the Phase 2 portion. And if we hit a minimum bar, call it a 10% full recovery, then we move into the Phase 3 portion. And we'll be allowed to do in a capital intensive way, allow us to get the study started. And then again on that first 100 patients, we see the signal that's needed going into the Phase 3 portion. So we'll be able to allow us to use the first 100 patients for the pivotal. Again, this is something that we're discussing, and again we'll be having that discussion further with the FDA.

Great, I appreciate you guys taking the question. Thanks so much.

Thank you, Thomas.

I would now like to turn the call back to Rick Paul's for closing remarks.

All right. Again, we'd like to thank everyone for joining us this morning. We're pleased to share the results of our Phase 2 study in acute ischemic stroke and we look forward to the upcoming plans for the Phase 2/3 study. We look forward to speaking with you again soon and reporting on our progress. We appreciate your interest and your continued support. Please stay safe in these challenging times. This concludes our call.

Ladies and gentlemen this concludes today’s conference call. Thank you for participating. You may now disconnect.