DiaMedica Therapeutics Inc.
Q2 2023 Earnings Call Transcript

Published: 15 Aug 2023

[Operator:]

Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics Second 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 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. 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, August 15, 2023, 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. 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, Paul. Hello, everyone, and welcome to our second quarter conference call. I'm joined this morning by Scott Kellen, our Chief Financial Officer. Before we begin this morning, I want to take a moment to welcome Dr. Richard Kuntz to our Board of Directors. Dr. Kuntz recently retired from Medtronic, where he was the Chief Medical Officer, Chief Scientific Officer and a member of the Executive Committee. Prior to that, he served as a Senior Vice President and President, Neuromodulation at Medtronic. Before Medtronic, he was the Founder and Chief Scientific Officer of the Harvard Clinical Research Institute in Boston. He also served as an Associate Professor of Medicine at Harvard Medical School, Chief of the Division of Clinical Biometrics and as an Interventional Cardiologist in the division of cardiovascular diseases at the Brigham and Women's Hospital in Boston. He also served as an adviser to multiple national and regional committees in the National Academy of Medicine and National Institutes of Health. Dr. Kuntz has directed numerous multi-center clinical trials and has authored over 200 original publications. We are grateful to have Rick join our Board. His experience complements and broadens the knowledge and skill set of our Board. Turning back to our update. The second quarter saw two important milestones for DiaMedica and our shareholders

[Scott Kellen:]

Thanks, Rick, and good morning, everyone. As Rick mentioned, we strengthened our balance sheet considerably in June with the completion of a $37.5 million private placement with accredited investors. Net proceeds from the transaction were approximately $36.1 million. And also, when David Wambeke joined us as our Chief Business Officer in April, he invested $750,000. As a result, our June 30, 2023, total cash, cash equivalents and marketable securities increased to $60.6 million, up from $33.5 million at the end of 2022. Our cash usage was $10.1 million for the six months ended June 30, 2023, compared to $6.4 million in the prior year period. The increase in our cash usage was due primarily to a combination of factors, including the completion of the in-use and the Phase 1C studies, ongoing manufacturing development work, our expanded management and clinical team to support the ReMEDy2 trial and our lawsuit with PRA. Now we believe that our current capital will support the clinical development of DM199 and our operations into 2026. Our research and development expenses increased to $2.5 million for the three months ended June 30, 2023, up from $2 million in the prior year period. R&D expenses increased to $6.2 million for the six months ended June 30, 2023, compared to $3.9 million for the six months ended June 30, 2022. The increase for the six-month comparison was due primarily to costs incurred for the in-use study performed to address the recently lifted clinical hold on our ReMEDy2 trial and costs incurred for the Phase 1C study, determining the DM199 blood concentration levels achieved with the new IV dose of DM199. Also contributing to the increase were increased manufacturing and process development costs, costs incurred to finalize the clinical data and perform the related analyses for the REDUX trial and increased personnel costs associated with expanding our clinical team. These increases were partially offset by decreased costs incurred for the ReMEDy2 trial, which until late June had been on clinical hold. Our general and administrative expenses were $2.2 million for the three months ended June 30, 2023, up from $1.4 million for the three months ended June 30, 2022. G&A expenses were $4.1 million for the six months ended June 30, 2023, and this was up from $3 million for the six months ended June 30, 2022. The increase for the six-month comparison was primarily due to increased legal fees incurred in connection with our lawsuit against PRA Netherlands and increased personnel costs associated with expanding our management team. Increased professional service fees and noncash share-based compensation also contributed to this increase. Now before I turn you back over to Rick, let me also provide a brief update on our ongoing lawsuit against PRA Netherlands. As many of you will recall, in December of 2022, the Netherlands court at our request seized our study records from PRA. Then in April 2023, following a March 2023 hearing, the Netherlands court issued a ruling affirming our ownership of the study data and importantly, stating that PRA had no legal basis for withholding the study data. Now PRA appealed this decision in June, and while this appeal may take nine to 12 months to resolve, it is not holding up our main damages lawsuit. This hearing is currently scheduled for December 7 of this year, and we look forward to presenting our case against the PRA and providing our analysis of the damages caused by PRA's actions. It's also interesting to note that the same three judge panel that oversaw the hearing on our ownership of the study data is scheduled to oversee the hearing for the main lawsuit. For more information regarding the background to this lawsuit, please see our SEC filings. Now let me turn the call back over to Rick.

[Rick Pauls:]

Thanks, Scott. With that, we would like to open the call for questions. Paul, if you could please open the line for questions.

[Operator:]

[Operator Instructions] And our first question comes from Thomas Flaten from Lake Street Capital. Your line is open.

[Thomas Flaten:]

Hey, good morning. Thank you. Good morning, guys. Appreciate taking the questions. Hey, Rick, with respect to the patients that were enrolled in the study prior to the clinical hold, I don't know if you've told us how many there were, but will they be kept in the efficacy analysis set or will they be censored out?

[Rick Pauls:]

Yeah, Thomas. So we haven't disclosed that number, but we do plan to have those included in the analysis.

[Thomas Flaten:]

Got it. And then for the interim analysis, given the change to the endpoint, is the number of patients still the same for the interim analysis?

[Rick Pauls:]

Yeah, we're still planning for 144 patients for the interim analysis.

[Thomas Flaten:]

Got it. Got it. And then you're still shooting for a total of 75 sites. Is that right?

[Rick Pauls:]

So the current plan is currently being revised kind of live as we move ahead. Currently, we're working towards 40 sites in the US, 10 sites in Australia. And then as I mentioned on the prepared remarks, with the additional capital that came in, we're also looking at going further ex-US. We're looking at Canada and Europe. There's some work right now just making -- seeing what it's going to take in terms of timelines to add. But I think it's important for us if we can expand internationally to increase the enrollment rate for the trial.

[Thomas Flaten:]

Excellent. Appreciate you taking the questions. Thank you.

[Rick Pauls:]

Thanks, Thomas.

[Operator:]

And our next question comes from Alex Nowak of Craig-Hallum Capital Group. Your line is open. One moment, we seemed to have lost him from the queue. And I apologize for the technical difficulty. [Operator Instructions] All right, and Mr. Nowak, your line is open.

[Alex Nowak:]

Okay. Hopefully, you can hear me this time. I'm not sure what you could hear, what you couldn't hear, Rick. But just with regards to getting the clinical hold lifted and searching for the new CRO, what were some of the new requirements that you had this time when searching for a CRO compared to when ReMEDy2 was initially started? It sounds like maybe some more international exposure was a new requirement, but anything in addition?

[Rick Pauls:]

Yeah. So Alex, so that -- we're in a different environment today, so we're, a year plus now past COVID. So it was important for us to take the learnings we had previously. And then we were looking for a global CRO that could really help us with expanding outside of the US as well but also importantly, having a CRO that could -- has recent experience with stroke trial. So that was an important piece. So the CRO we've selected has extensive experience with a number of more recent trials, better understanding I’d say, of a, good understanding of sites that could ideally be strong enrollers for this trial.

[Alex Nowak:]

Okay. Understood. And then maybe expand on the expected international uptake at DM199 and the clinical study versus domestic uptake. Why would international necessarily go faster just from your conversations? What are you thinking there?

[Rick Pauls:]

Yeah. So as we -- we're looking at enrollment rates of past trials. What we did see in particular in Europe, that the enrollment rates per site per month was a fair bit higher than what were -- than what's been seen for US trials. And part of that may be associated with socialized healthcare. But based upon this, we think it'd be as important if we seriously can look at ex-US expansion.

[Alex Nowak:]

Okay. Understood. And then do you need a specific number of patients in the US versus OUS to meet that statistical analysis plan? Or is that kind of getting baked in with the 40 sites US and then remainder amount OUS?

[Rick Pauls:]

There's not. And the context here also is the timelines to get sites set up in Europe will be longer than they are in the US. So in particular for the interim analysis, we still think it's going to be driven by the US sites. And then the other ex-US sites will be supplementary.

[Alex Nowak:]

Okay. Understood. And then just a two-part question to end it out here is, first, I think the ReMEDy2 patients with ACE inhibitors would have been excluded. But will this be reversed based on the Phase 1C’s findings in that fourth cohort? And then the second part of the question is any other protocol changes to be aware of?

[Rick Pauls:]

Yeah. So if the patient was previously on an ACE inhibitor, there will be a 24-hour washout so that the drug will effectively be out of the system. And this is something -- actually it’s quite similar with the human urinary form of the protein in China. There's also a 24-hour washout. So all the patients will be included in the study. And just for context, again, in our Phase 2 trial for stroke, we had about 10 patients that were previously on ACE inhibitor. Of the 46 total patients on drug, there were no instances of hypertensive events. And then we made a couple of other protocol changes, learnings, I'll call it, from the hold. In particular, we're going to be starting off with a 15-minute slow infusion. And so if there are signs of large drops in blood pressure, then the dosing will be over three hours instead they prescribed one hour. And so we think the hypertensive event is really the result of overwhelming the system very rapidly when the dosing first starts. So that's going to be, again, an important aspect of it. We ran the Phase 1C trial and in particular, the ACE cohort that we just recently completed. I think just giving us and also importantly, to give the clinical sites some comfort here, that we feel that we've addressed the dosing and matching the dosing to what we had previously had in our Phase 2 trial, which was comparable to the drug exposure level with the human urinary form of the protein in China today.

[Alex Nowak:]

Okay. It makes sense. Well, I appreciate the update and congrats on getting the clinical hold lifted.

[Rick Pauls:]

Thanks, Alex.

[Operator:]

And our next question comes from Francois Brisebois from Oppenheimer. Your line is open.

[Dan Hultberg:]

Hi, this is Dan on for Franc. Thanks for taking my questions. In relation to the interim analysis, is the plan still to end the study if you see great efficacy in around the 140 patients? Any changes there?

[Rick Pauls:]

Yeah. So, similar to what we've discussed in the past. So at the interim analysis, there's really three scenarios. So the first is that we'll stop the study for futility. So if we're not seeing a positive drug effect, we'll stop the study for overwhelming efficacy, and that's based upon hitting a p value of less than approximately 0.0072. Or alternatively, we'll continue the study, and we'll do a resampling size where the total size will be somewhere between 240 and 728.

[Dan Hultberg:]

Great. Thanks. That makes sense. And just a quick one. Regarding the Phase 1C data in hypertensive patients, had any of the dozen sites from before requested to see additional data in patients or was this more of a proactive move as you target new sites?

[Rick Pauls:]

Yeah. This was completely proactive. First off, the FDA did not ask us to run this trial. So we did that proactively. And then none of the sites had asked. When we talk to sites, and we're talking about the hypotensive events, this is something that's manageable. By stopping the infusion, the blood pressure in the three patients that we had that were, this three serious adverse events, the blood pressure returned back to normal within minutes. But this was just another -- basically in the proactive way of providing additional comfort in case, in the future, any new sites that we talk to have any concerns about large drops in blood pressure. And keeping in context here is that these neurologists, many of them every day are dealing with treating patients with tPA and realizing that 5% to 6% of patients on tPA, it causes severe brain hemorrhage. So we think that the drop in blood pressure is manageable, but we just want to make sure we're comfortable and also for the sites as well with the dosing.

[Dan Hultberg:]

Okay. Thanks for taking my questions.

[Rick Pauls:]

Thank you, Dan.

[Operator:]

And I see no further questions in queue. I'll turn the call back over to our host for closing comments.

[Rick Pauls:]

All right. Again, we'd like to thank everyone for joining us this morning and for your continued support. Our goal is to bring this important treatment to stroke patients as quickly as possible. We appreciate your interest in DiaMedica and your continued support. With that, this concludes our call today. Thank you.

[Operator:]

The meeting has now concluded. Thank you for joining and have a pleasant day.