DiaMedica Therapeutics Inc (DMAC) 2020 Q1 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics conference call to discuss the top line results from DiaMedica's REMEDY Phase II clinical study in 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 participant 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 report 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 rereading. DiaMedica's disclaims any duty to update its forward-looking statements.

We're very excited today to share with you the top line results from our REMEDY Phase II study of DM199 in participants suffering an acute ischemic stroke, and to provide some additional color on our plans to continue moving forward with DM199 for acute ischemic stroke.

Yesterday, we issued a press release summarizing the top line 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.diamedica.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 and salivary glands. KLK1 plays a critical role in the regulation of local blood flow and vasodilation, which relates to the widening of blood vessels and decreasing the vascular resistance in the body. It also plays an important role in managing inflammation and oxidative stress. We believe DM199 has the potential to treat a variety of diseases where healthy function requires sufficient activity of KLK1 and its system, the kallikrein-kinin system.

I'd like to begin today's call by reviewing the top line results from our REMEDY study. REMEDY was a double blinded placebo-controlled study in participants who have experienced an acute ischemic stroke. During this call, when we use the term stroke, we mean acute ischemic stroke. The primary endpoints were safety and tolerability, while also looking for efficacy signals consistent with the approved Kailikang, the urine-derived form of KLK1 currently used to treat acute ischemic stroke in China.

Turning to the slide deck on your screen, on Slide 3, summarizes the key takeaways that we're going to share with you today. REMEDY demonstrated that DM199 was safe and well-tolerated with no DM199-related serious adverse events. DM199 has now been administered to over 200 participants, building a strong base of data supporting its positive safety profile. This is very important as the FDA evaluates potential patient benefits against any treatment-related risks. Having an excellent safety profile should help the FDA's analysis and allow us to move forward with further clinical studies. We believe that this derisks regulatory hurdles that could lengthen or delay our path forward.

Secondly, in looking at efficacy signals, DM199 significantly outperformed the placebo in stroke participants who most closely resembled the target patient population of DM199, the approximately 90% of stroke participants that do not receive mechanical thrombectomy. In the group of 46 participants who did not receive thrombectomy, we observed that significantly more participants treated with DM199 progressed to a full or near full recovery than those in the placebo group. This means that people who are able to resume independent normal daily function. This is particularly exciting in that DM199 can be administered up to 24 hours post stroke. The only currently approved drug in the U.S. is alteplase, recombinant TPA, which can only be administered in carefully selected patients within 4.5 hours after a stroke. We'll also talk about DM199 results compared to TPA and Kailikang, the human urine-derived KLK1 protein approved in China for stroke.

In addition, we'll review the reductions in recurrent strokes and inflammatory biomarkers C-reactive protein. And of course, because of our interest in chronic kidney disease, and our ongoing Phase II kidney study, we are pleased to note that participants who had chronic kidney disease and were treated with DM199 showed a significant improvements in kidney function. This is why we're rather excited to be sharing these top line results with you today.

Turning to Slide 4. We have a series of charts providing a high level visual overview of the encouraging outcomes that were observed in the REMEDY study. In total, although these results are based on small numbers, we believe these show that DM199 is a biologically active protein and acts in a manner consistent with this mechanism of action. To summarize quickly, starting on the left, top left corner, this chart shows the 22% improvement in stroke recoveries in participants that most closely resembled our target patient population, those that are excluding mechanical thrombectomy. The next chart, to the right, shows the lower level of recurrent strokes in the DM199 treatment group and note that this is based upon all participants that received at least 1 dose of the study drug.

For the subset of participants, which had chronic kidney disease, based upon eGFR levels below 70 mL, DM199-treated participants showed a significant increase in their eGFR levels after 3 weeks of treatment. The second row starts with C-reactive protein, or CRP. This is a measure of inflammation in the body, and the DM199-treated participants showed a meaningful reduction over 90 days. The last 2 charts show the improvements in Prostaglandin E2 and nitric oxide levels after 3 weeks of treatment. These are 2 important biomarkers, which we believe show levels of activity consistent with DM199's mechanism of action.

Moving to Slide 6. Real quickly, I just want to remind everyone how serious an unmet need acute ischemic stroke represents in our healthcare system. It's estimated that, globally, 15 million strokes occur each year. In the U.S., that number is 800,000, approximately 690,000 of which are acute ischemic strokes, or AIS. The seriousness of this unmet need is due primarily the fact that 90% of patients suffering an AIS have no direct treatment option. This is referred to as palliative care.

On Slide 7, we have a summary of the design of REMEDY. Our goal of safety assessment was searching for potential efficacy signals. In this study, DM199 was administered to participants with the first dose of 1 microgram per kg IV, followed by 3-microgram per kg dose of DM199 and then every third day for a total treatment period of 22 days. The primary endpoints were measured at day 90.

Turning to Slide 8. We present some of the baseline characteristics for study participants, ages, genders and average severity of stroke broken down by cohort. A total of 91 participants were evenly split between the DM199 and placebo groups. You'll note that we had a large number of participants enrolled after they had received treatment with either mechanical thrombectomy or TPA or both. I'll speak more about these participants in a moment.

Moving to Slide 9. We present a summary of the safety and tolerability results, our primary endpoint for REMEDY. The absence of any DM199-related serious adverse events, as determined by the Independent Data Safety Monitoring Board, was very encouraging and consistent with our prior studies. In addition, the adverse events were pretty mild. This is very important for us as the FDA and other regulatory bodies evaluate drugs for clinical study and approval based upon the potential benefits versus risk to patients. And we believe that it provides -- this continued and future studies, DM199's safety profile should simplify any regulatory evaluation of DM199 and further derisk our regulatory pathway.

Turning to Slide 10. Before we look at the REMEDY results, let me walk you through the NIH stroke scoring system. Strokes cause different degrees of damage in different people and are often worst when it's a recurrent stroke. The NIHSS scale, where the higher the score is, the more impaired the patient is. The scale is used to attempt to quantify the degree of impact on the participant. Much of this assessment centers around the activities of daily living. Can a person dress by themselves? Can they feed themselves, can they use the bathroom, et cetera? Ideally, we'd like to see all individuals achieve a post-stroke score of 0 or 1, which means that they have fully or near fully recovered their ability to live independently.

Unfortunately, many individuals do not fully recover and the shift analysis is performed to evaluate the improvements across the entire range of impacts. The bookends, fully recovery, an NIH score of 0 to 1 on the right -- on the left, and then on the right, the deaths have the least amount of subjectivity, and most important, to regulatory authorities, there's more subjectivity in the scores in between.

Slide 11 is just for reference to show you the improvements in full recoveries, NIHSS score of 0 to 1 in the dark blue, and the reduction in patient deaths in the TPA study used for FDA approval. TPA demonstrated an 11% improvement in participants achieving a full recovery, that being an NIHSS score of 0 or 1. And I'd point out that TPA can also have some serious side effects.

On Slide 12, we presented the comparison of the NIHSS score for both cohorts using the 91 participants in the REMEDY study. One participant is not evaluable as they withdrew before first dose, which is the requirements for inclusion in the safety analysis. At this level, we don't see a large proportion of participants in the placebo group achieving full recovery. This is due to the large number of participants receiving thrombectomy prior to enrollment in REMEDY. Just to remind everyone, a thrombectomy is a procedure, in which a mechanical device known as the catheter is inserted into the participant's arterial system, navigated up to the clot with the intent to immediately remove the clot. The procedure is limited to only those patients whose blockage is in the large vessel, which presents at the hospital generally within 6 hours, but in some cases, it can be 12 or more. In addition, an experienced and skilled physician is needed to perform the procedure. Because of these limitations in the U.S. today, only about 6% of stroke victims receive thrombectomy.

DM199 is not an alternative to thrombectomy. If you have a stroke caused by a large vessel occlusion and you can get to the right hospital in time, thrombectomy can immediately restore blood flow. Personally, I would want this procedure for myself, for my family if any of us were in the position and eligible for this procedure. These participants were included in the study, because we wanted to study a sampling of thrombectomy patients for safety and to evaluate whether there might be a beneficial clinical effect when combined with DM199. There was a much larger-than-expected thrombectomy component that was not anticipated. In China, it is our understanding that urinary KLK1 is not prescribed on top of mechanical thrombectomy, that's if a patient is treated with thrombectomy, they do not receive urinary KLK1. We do not plan to include thrombectomy in our target patient population. Our focus is on the 90% of stroke victims that do not receive a thrombectomy procedure.

Turning to Slide 13. Here are the NIHSS scores for REMEDY participants that did not receive thrombectomy prior to enrollment. This group most closely represents the target patient population that DM199 is intended to treat and we have a total of 46 participants in this analysis. Although a small number, visually, the differences are quite compelling. In the DM199 group, 36% of participants achieved a full or near full recovery as compared to the 14% in the placebo group, a 22% positive difference.

The p-value was less than 0.2. The results also showed a 50% reduction in the number of participants death in the DM199 group compared to the placebo group. I can't stress enough that the results occurred with DM199 being first dose within a 24-hour treatment window, a dramatically longer therapeutic window compared to TPA that must be administered within 4.5 hours of the stroke and only to those patients selectively -- selected. We believe that the most stroke victims can get to the hospital within 24 hours of a stroke and be eligible for our therapy.

Also to note that when we exclude participants receiving TPA prior to enrollment and limiting the placebo group to those participants receiving palliative care only, the results are similar. We also see similar results with the Modified Rankin score.

On Slide 14, we want to show you a comparison of DM199 Phase II results and the studies for Activase, the recombinant TPA; and Kailikang, the urinary KLK1, the approved form of urinary KLK1 in Asia. The key message here is that we are seeing comparable results in the Kailikang and improved results compared to TPA, while offering a much longer therapeutic window, and what we believe will be a much improved safety profile compared to TPA.

Slide 15, please. Beyond the improvements in participants' functional abilities, we are also very encouraged by other observations from the study data. On this slide, we're showing the reduced, recurrent and severe recurrent strokes from 1 in DM199 group to 7 in placebo, with 4 resulting in participant deaths in the placebo group. These results are based upon the 91 participants in the safety group, which include participants receiving thrombectomy. As you can see, a clear difference. These results are consistent with the published studies with urine KLK1 that have shown significant reductions in stroke recurrence.

As on the slide, these results are a key reason why we believe DM199 has the potential to be an adjuvant -- neoadjuvant therapy for thrombectomy patients in the future.

On Slide 16, we show the decrease in CRP, an important blood marker of inflammation observed in the DM199 group. We believe that this is also consistent with DM199's mechanism of action. With our interest in CKD, we're also interested in looking at the effects of DM199 on participants with CKD at the time of their stroke. Although the relationship between stroke and CKD is not well understood, many stroke patients do also have chronic kidney disease. We believe both diseases are also associated with low levels of KLK1.

On Slide 18, we looked at changes in the estimated glomerular filtration rate, or eGFR, for any study participant with an eGFR below 70 ml at entry into the study. eGFR is a primary measure of kidney function. These patients had an average baseline eGFR in the mid-50s range.

With respect to the 28 participants at day 22 and 24 participants at day 56, we are pleased to see that after 22 days of dosing, participants receiving DM199 showed a 7.5 ml average increase in eGFR. This is significantly better than the participants in the placebo group. Equally encouraging, we observed that participants in the DM199 group retained a higher eGFR level at day 56, 34 days after treatment discontinued. This could be an early sign of potential retained benefits associated with the use of DM199. Note that this is a small number of participants, but this is a very positive signal.

On Slide 19, we broke down the proportion of patients who had an increase in eGFR compared to placebo to look at it in a slightly different way. Here, the results show that 77% of the DM199 participants experienced at least a 2 ml increase in eGFR. This shows that the effects occurred broadly and the average wasn't driven by a small number of outliers.

On Slide 20, as DM199's initial development was in diabetes, we are pleased to see reductions in elevated blood glucose levels in the DM199 group, but not in the placebo group. This chart summarizes blood glucose levels changed in those participants who had elevated glucose levels at baseline. At day 22, DM199 lowered blood glucose by almost 2-millimeter per liter, with continued benefit at day 56.

Lastly, on Slide 21, the mechanism of DM199, or KLK1, is to restore normal levels of bradykinin, which releases 2 critical hormones, nitric oxide and prostaglandins. As you can see here, the DM199 groups demonstrated significant improvements versus baseline, much better than the placebo group. Again, to us, these are encouraging signals of DM199 activity.

Slide 23, please. To recap today's presentation, we've seen that DM199 was safe and well-tolerated with no DM199-related serious adverse events. And that's building a positive safety profile is very, very important to make our path to commercialization as smooth and predictable as possible. We've also seen that the DM199 group significantly outperformed the placebo group in stroke patients when excluding mechanical thrombectomy, who most closely resemble the target patient population for DM199, the approximately 90% of stroke patients that do not receive direct treatment for their stroke.

Further, that these results are based upon DM199 being administered up to 24 hours post stroke, which is approximately 6x longer than TPA, the only drug approved in the U.S. We also reviewed how DM199's Phase II results compared to the data from the approved studies for alteplase, the recombinant TPA in the U.S. and Kailikang product in China.

Lastly, for stroke, we also reviewed the positive data related to reductions in severe recurrent strokes, a critical factor in the treatment of stroke patients. And of course, because of our concurrent development of DM199 for chronic kidney disease, participants with chronic kidney disease that were treated with DM199 showed significant improvements in kidney function. I also want to highlight that we have not seen any negative data in the study results. We believe this top line data fairly represents the results of our REMEDY study.

Turning to Slide 24. So briefly, here's what's next for DM199 in the treatment of stroke. We plan to request a meeting with the regulators to discuss REMEDY results, future stroke study requirements and potential for breakthrough therapy and accelerated review designations. We intend to further engage stroke advisers, health economists and payers to design and prepare for a Phase II/III study. We intend to evaluate potential strategic partnerships in parallel. We intend to also do this while continuing to maintain tight fiscal discipline and our focus on completing the REDUX Phase II study for chronic kidney disease.

Now let me turn the call over to Dr. Harry Alcorn for a brief update on the REDUX trial.

Thank you, Rick. Good morning, everyone. As I'm sure you already know, our REDUX Phase II CKD, chronic kidney disease, study is enrolling a total of 60 participants in 2 equal cohorts. The first cohort is focused on hypertensive African-Americans, who are not diabetic, but have albinuria. The second cohort is focused on participants with the IgA nephropathy, previously confirmed by biopsy and also having albinuria. Participants will be treated with DM199 for approximately 13 weeks at a dose level of either 2 or 5 micrograms per kilogram, which is administered subcutaneously 2 times per week.

The primary efficacy endpoints for the overall study are eGFR and albinuria. 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 perform 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 am 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 at 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 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 uncertain surroundings of 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 ask us -- 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 Ib pharmacokinetic study in CKD patients. Declining cost 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 II CKD study, which began enrollment in December of 2019, and increased noncash 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 noncash 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 nonfunctional currency or non-U.S. dollar accounts. For us, this was principally Australian dollars.

In addition, a decrease in our accrued R&D incentives associated with the decreased REMEDY study costs and reductions in interest income earned on our marketable securities during the first quarter of 2020 also contributed to this change.

Turning to the balance sheet. We finished the first quarter of 2020 with cash, cash equivalents and marketable securities of $12.6 million, current liabilities of $0.9 million and working capital of $13.2 million. This compares to $7.9 million in cash, cash equivalents and marketable securities, $1.3 million in current liabilities and $7.5 million in working capital as of the end of 2019.

These increases in the combined cash, cash equivalents and marketable securities, and in our working capital, are due to the February 2020 public offering of common shares. Let me remind you that on February 11, 2020, we completed a public offering of common shares, raising gross proceeds of $8.5 million and net proceeds of $7.7 million.

Our current capital position should allow us to complete the REDUX Phase II clinical study and fund our operations through 2021. As Rick -- as Harry mentioned, though, caveat, however, is that actions implemented to combat the novel strain of the coronavirus pandemic have caused a slowdown in the enrollment for the REDUX trial. We expect the impact of this to be a delay in the timing of the costs incurred, but not in a significant overall increase as we are managing this study internally.

However, we continue to assess the effect of the pandemic on our REDUX trial by monitoring the spread of the virus and the actions implemented to combat the virus, and we will continue to provide updates as we can.

Now let me turn the call back over to Rick.

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

(Operator Instructions) And our first question comes from the line of Alex Nowak from Craig-Hallum Capital Markets.

Congrats on getting the Phase II stroke study cross 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 the time, it sounds like it was more of a safety aspect. But can you just confirm, it wasn't a -- it was prespecified 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 of 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 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 III. The human urine form of KLK1 in China, there's some pretty clear synergistic data with TPA, but there really wasn't anything with mechanical thrombectomy. So we wanted to get a sense of whether or not it's something we want to include or not for Phase III.

From a mechanism perspective, there's some clear differences that we believe our drug is targeting microvascular circulation, whereas those patients who've had and eligible for thrombectomy, are targeting more large vessel occlusion. So it's something that we wanted to research.

That's helpful. What do 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 advisers that the level was so high. Our adviser's perspective, you can see the quote from Dr. Campbell. This was, first, a safety study. I mean, stroke is a severe condition. I mean, first and foremost, making sure that it's safe. It was very encouraging that we saw the reductions in stroke recurrences. And it seems like we've got some signals here that are consistent with the results with the human urine form of KLK1.

No that's good. And as we spoke over the years, I know you and the team have spoken with larger pharma, larger 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 intent-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 the data we have here, again, it's not just the NIHSS 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 for -- 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 II 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 an effect that occurs with stroke patients. So they need to address total clinical care in these stroke patients, not only with, obviously, the clot, but also with their kidney function. So this has been a wonderful conversation as it has been supportive in total care of these patients for their disease state.

That's good. Just last question for me. With COVID starting to fade here a bit and some of the states are starting to reopen. Given new time line, or a rough time line for the CKD study readout, the full 90 days. Is it fair to say this should come before year-end, now?

Yes. Alex, 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 the sites to identify participants that, when things do open up more, that we'll be in a position to get our enrollment really moving quickly.

Congrats on a really compelling data here.

Our next question comes from the line of Thomas Flaten from Lake Street Capital Markets.

Just sticking with CKD for a second, would you -- or 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're anticipating to have results here in Q2. But with COVID, we -- 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, and 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 4.5 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 and -- 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 4.5 hour window, and with the strong safety profile, it gives us a very attractive clinical bar for us to hit.

So just to follow-up on that. So would you specifically target post 4.5 window? Or would that be a prespecified subgroup that are post 4.5 window -- 4.5 hour window?

So that's -- 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's 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, at this point here, with or without TPA. So we'll have some updates here in the coming months.

Yes. And then just one final question for me. You talked about a Phase II/III study going forward. Is that because you anticipate it being adaptive? Or do you think you -- would that be a pivotal design? Or I'm just curious why you labeled it a Phase II/III instead of just a Phase III or pivotal study more generically?

Yes. So one of the things we're looking at is, again, this is now just initial internal discussions, advisers and so forth. A Phase II design would be a path where we would be adaptive. So one of the things we're considering is approximately 100 patients for the Phase II portion. And if we hit a minimum bar, call it a 10% full recovery, then we'd move into the Phase III portion. And what we'd love to do is 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 III portion. So we'll be able to allow us to use the first 100 patients for that pivotal. Again, this is something that we're discussing. And again, we'll be having that discussion further with the FDA.

I would now like to turn the call back to Rick Pauls for closing remarks.

All right. Again, we'd like to thank everyone for joining us this morning. We are pleased to share the results of our Phase II study in acute ischemic stroke, and we look forward to the upcoming plans for the Phase II/III 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.