DiaMedica Therapeutics Inc.
Q4 2020 Earnings Call Transcript

Published: 11 Mar 2021

[Operator:]

Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics Fourth Quarter 2020 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 Relation 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 including factors that cause actual results. 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 from Form 10-K.

[Rick Pauls:]

Thank you, operator. Good morning, everyone. We hope you're all well and we'd like to welcome you to the year 2020 earnings and business update call. We issued a press release with a business update and summary of our financial results for 2020 yesterday after the markets closed. At that time, we also filed our annual reports on Form 10-K. Both documents can be found in the Investors Relation section of our website at diamedica.com. I'm joined this morning by our Chief Financial Officer, Scott Kellen and our Chief Medical Officer, Dr. Harry Alcorn. Let me begin this morning with a few comments on our Acute Ischemic Stroke program. As you recall, we were very pleased with the FDA accepted our request for a pre-IND meeting for our Stroke Development program and are encouraged by their written responses to our questions. Their responses indicated acceptance of key elements of our plan Phase 2/3 trial for DM199 in Acute Ischemic Stroke patients. Specifically, we proposed an adaptive trial design, which will allow us to conduct an interim check. The interim check will evaluate the performance of DM199. Specifically, an independent data monitoring committee will evaluate whether DM199 is having a positive effect that is consistent with our statistical analysis plan assumptions and allow for adjustments in the patient size if necessary. In short, we believe that the guidance received from the FDA provides a clear path forward for our Stroke program. We are currently finalizing the investigational new drug application for our proposed Phase 2/3 study and expect to be submitting this application later this month. In parallel with this process, we are taking steps to organize the supporting vendors to run the study. We still anticipate initiating the enrollment in the study later this summer. The results of our ReMEDy Phase 2 study in Acute Ischemic Stroke will be the subject of an oral presentation at the upcoming International Stroke Conference 2021 being held virtually on March 17th to 19th 2021.

[Scott Kellen:]

Thank you, Rick. Good morning, everyone. As Rick mentioned, we didn't release our full year 2020 financial results and filed our 10-K yesterday afternoon. If you haven't had a chance to review these documents, they are both available on either the DiaMedica or sec websites. Our net loss for the full year of 2020 was $12.3 million or $0.78 per share. This compares to a net loss of $10.6 million or$0.89 per share for the prior year. Our research and development expenses were $8.3 million for the year ended December 31, 2020, and this compares to $7.9 million for the year ended December 31, 2019, an increase of point $0.4 million. Now the increase was primarily due to a combination of costs incurred for our REDUX Phase 2 CKD study, which initiated in late 2019, and of course driven in particular by the addition of the third cohort, targeting the DKD patients, which fully enrolled during the fourth quarter of 2020. We also incurred increased non-cash share-based compensation costs. And these costs were partially offset by decreases related to clinical study costs incurred for a ReMEDy Stroke study, which wound down in the first half of 2020 and the non-recurring costs of the Phase 1b CKD study, which was started and completed during 2019. Additionally, there was a year-over-year net decrease in drug manufacturing and development costs. Our general and administrative expenses were $4.4 million and $3.7 million for the years ended December 31, 2020 and 2019, respectively. This $0.7 million increase was primarily due to increased non-cash share-based compensation costs, increased outside professional services and increased directors and officers’ liability insurance. And the increase in 2020 was partially offset by reduced travel and meeting costs, driven by restrictions instituted as countermeasures to the COVID-19 pandemic.

[Rick Pauls:]

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

[Operator:]

Sure. Your first question comes from Alex Nowak from Craig-Hallum. Your line is open.

[Alex Nowak:]

Great. Good morning, everyone. Maybe could you speak to on the label expansion to include stroke reoccurrence, just how would that work, do you anticipate that the single pivotal Phase 2/3 study would support that label alone for stroke recurrence? And, frankly, is there enough powering in that 350 patients to get an indication. What you’ve being hearing from the FDA?

[Rick Pauls:]

Yeah. Thanks, Alex. So our plan is surely after filing our IND for the plan Phase 2/3, we plan to reach out to the FDA and request a meeting to discuss the clinical paths and the powering. We do believe that, you know, based upon the profile of our therapy for stroke recurrence there is truly a real potential. And this is something that we want to go get clarity with the FDA first.

[Alex Nowak:]

Okay. Got it. That makes sense. So that decision will come later. It sounds like, okay. And maybe from the feedback - okay, and maybe from the feedback you got from the FDA back in December, what did they say around fast track or breakthrough designation? And when would you plan to submit for those two - those two labels?

[Rick Pauls:]

Yeah, so our plan is shortly after filing our IND that we will be filing for fast track designation. And then based upon our discussions with the FDA, we'll look at other pathways for expedited approval.

[Alex Nowak:]

Okay, got it. And then any update on the timing to run the pivotal stroke study? Just how long would that take? And what sort of costs all in for 350 patients? And has there been any discussion about partnering on stroke to include participants outside the US?

[Rick Pauls:]

Yeah. So the - based upon the powering on a 90% powering, we're anticipating approximately 350 patients overall. That study will start this summer. And we're planning to have an interim analysis after about halfway through. And right now we're planning for that to happen next year in 2022, and then ideally to finish the study in 2023. The overall cost of that study will be, you know, close to $30 million for the 350 patients. And then what's - in terms of partnering, yeah, we're always having discussions, ongoing discussions right now. Our real focus, though, is getting this IND filed, getting the chronic kidney disease cohorts completed. And I think after that point in time, I think we'll be in a much better position, both looking for a partner in Asia and globally.

[Alex Nowak:]

Understood. That makes sense. And then you mentioned in the press release that you do intend to take the drug forward in IgA Nephropathy. And that's even before seeing the data, just am I my reading that correctly and perhaps speak to why you picked this syndication now, before you’ve even seen the three cohorts of data. And I guess how closely should the upcoming DKD results correlate to the IgA population?

[Rick Pauls:]

Yeah. So as we look at the clinical, the regulatory path for these different cohorts, we see a very clear path for IgA Nephropathy, rare form. There are a number of other recent compounds that are moving into pivotal studies for IgA Nephropathy. So we think this is the clearest path for us moving forward. And so how we see the potential for DM199 for kidney disease is, you know, the potential to start off in the rare and then longer term, us – we’re partner moving into the overall CKD, or diabetic kidney disease. And part of that just comes to today, the size and the cost of running a pivotal study for diabetic kidney disease is much larger.

[Alex Nowak:]

Okay, got it. And then just a correlation of DKD results to IgA?

[Rick Pauls:]

Yeah, I mean, we believe that ultimately, you know, DM199 will improve kidney function amongst different causes. And really, the purpose of the study is to get clarity and clarity on that to see, I think, ultimately, one of the differences between, you know, DKD into IgA is that we feel after the IgA there's a potential immune modulating effect. But again, I think we're optimistic for all three cohorts and, you know, we plan to follow the data.

[Alex Nowak:]

That makes sense. Appreciate the update. Thank you.

[Operator:]

Your next question comes from Etzer Darout from Guggenheim. Your line is open.

[Etzer Darout:]

Thanks for taking the questions. Just the first one on stroke. Just wanted to know if you had any further color on which mechanisms or sorry, which medications won't be allowed on beyond call to place in the stroke of Phase 2/3 study?

[Rick Pauls:]

Sure. The protocol is currently being developed and finalized in the inclusion exclusion criteria, which we've delineated being they will not be allowed to be on tPA or receive tPA or mechanical thrombectomy. Beyond that, we will look at each patient individually. But that's the only two exclusions as point for this patient population.

[Etzer Darout:]

Got it. Thank you. And then just quickly on kidney, so IgA Nephropathy, diabetic kidney disease seems to be pretty clearly defined populations Just wondered, you know, do regulators view the hypertensive African American with CKD cohort the same way as other sort of CDK indications and trends of UACR and eGFR gets, you know, either decline or the improvements that would be needed by new therapies in that particular indication?

[Rick Pauls:]

Yes, that is correct. Especially with UACR, there was a meeting just last week on CKD 3, where the agency weighed in, in regards to the fact that they're looking at UACR directly as for kidney improvement, along with eGFR respectively.

[Etzer Darout:]

Got it. Thank you. Congrats on the progress.

[Rick Pauls:]

Thank you.

[Operator:]

Your next question comes from Elemer Piros from ROTH Capital Partners. Your line is open.

[Elemer Piros:]

Yes. Good morning, gentlemen. What I'd like to ask is, Rick, as you outlined that you would pursue IgA Nephropathy as an orphan indication. If then subsequently, there is a partner who would develop it for other kidney indications, how would you tackle the potential pricing differential in the different therapeutic indications?

[Rick Pauls:]

Yeah, so that's – so a great question. So how we see this and we actually recently have engaged a consulting company to help us to first answer the question is that can we co-position DM199 for both stroke and kidney disease, and you know, the bottom line, the feedback was that we feel those will be distinct products, they'll have different NDC numbers, from a prescribers perspective, the stroke product will be prescribed in a hospital setting, whereas the kidney disease and particularly the rare will be done from a nephrologist. So, ultimately, we feel that ideally, one partner for both indications and then that partner could manage. Right now our focuses, you know, getting as much data as we can and positioning ourselves here to find the right partner. We don't have intentions to commercialize ourselves. But we do can move this forward. And, again, find the right partner for both indications.

[Elemer Piros:]

And the next question would be, what new data do you anticipate to release at next week's Stroke Conference?

[Rick Pauls:]

There is some potential new data that could be coming, but we'll have to hold-off until that event. So it be great if you join in another call on March 19th.

[Elemer Piros:]

Okay, thank you very much.

[Rick Pauls:]

Thanks, Elemer.

[Operator:]

Your next question comes from Thomas Flaten from Lake Street Capital Markets. Your line is open.

[Thomas Flaten:]

Hey, guys. Thanks for taking the questions. Just a couple follow ups on stroke. Is our large vessel occlusion still part of the exclusion criteria?

[Rick Pauls:]

Large vessel occlusions will be excluded, which will automatically exclude mechanical thrombectomy.

[Thomas Flaten:]

Yeah. And then just going back to the sub-study on Stroke Recurrence. So if you're going to submit the protocol, you know, as part of the IND, obviously, how would you then re integrate a potential sub-study? Would that require an amendment? Would that potentially lead to a slowdown in enrollment or a pause? Can you help me just think through the mechanics of how that would work?

[Rick Pauls:]

Yeah. So we'll be filing the application with Stroke Recurrence as a key secondary endpoint. And then after we get clarity from the FDA, and based upon those discussions, we'll look at the potential for a sub-group study. But we don't - we do not anticipate this will slow down any aspects of the study.

[Harry Alcorn:]

Or pause it.

[Rick Pauls:]

Or pause, yeah.

[Thomas Flaten:]

Got it, Okay. Great. And then one for Scott, you know, with the, I guess, a bit of a slowdown on the CKD enrollment and then there was the pickup as you start the Stroke study, how should we think about spending pacing, you know, over the course of the year?

[Scott Kellen:]

Well, that a little, I guess, chunky, obviously. So as we wrap up the enrollment in the in REDUX, the spending will decline a little bit, of course, that's offset by start up on the Stroke study. So you probably see a slowdown mid-year and then a ramp back up towards the end of the year, as the site activations commence.

[Thomas Flaten:]

Excellent. Thanks, guys taking the questions.

[Rick Pauls:]

Thank you.

[Operator:]

There is no further question this time. I like to turn the call over back to Mr. Pauls.

[Rick Pauls:]

All right. Again, we would like to thank everyone for joining us this morning. We appreciate your interest and continued support. Please stay safe in these challenging times. And with this, this concludes our call today.