Q1 2020 Earnings Call
Ladies and gentlemen, this is the operator today's conference is scheduled to begin momentarily until that time your lines will again be placed on musicals. Thank you for your patience.
[music].
In France call to discuss the topline results from diabetic as remedy phase two clinical studies and acute ischemic stroke in first quarter results and audio recording of the webcast and a copy of the slide presentation will be available shortly after the call today I'm dying Amedicas website at Www Dot die Amedica.
Calm in the Investor section I would now like to hand, the call over to Rick polls, 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 that the company will be making forward looking statements on today's call. These statements are a participant to risks and uncertainties that could cause actual results to differ materially from those projected in these statements more information, including the factors.
I 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 diabetic as previously filed annual report on form 10-K Diamond because as you see filings are available at www.
The FCC dot Gov and on our website.
It also note that any comments made on todays call speak only as of today May 14, 2020, it may no longer be accurate at the tons any replay or transcript rereading <unk> medical <unk> disclaims any duty to update as forward looking statements.
[noise], we're very excited say to share with you the topline results from a remedy phase two study of do your money nine in participant suffering in acute exclaiming stroke and to provide some additional color on our plans to continue moving forward with 29 for acute ischemic stroke Stoke.
Yesterday, we issued a press release summarizing the topline results from the remedies study and also filed a copy of today's presentation, what the Stacey.
Both of these documents can be found in investor section ever website at Www Dot died Amedica dotcom I'm joined today by our Chief Medical Officer, Dr., Harry I'll, Gordon and Chief Financial Officer, Scott, killing.
As we previously discussed we're positioning do your money nine.
Page recombinant or synthetic form other key okay, one protein as a treatment for several very important diseases. Kilkeel. One is up does a protein which is produced primarily in the kidneys pancreas and salivary glands Kilkeel wouldn't plays a critical role in a regulation of local blood flow and be able dilation, which really.
Thanks 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 do you want to nine has the potential to treat a variety of diseases, where healthy function requires sufficient activity. Okay. Okay, one and its system, the calibrin kind and system.
I'd like to begin todays call by reviewing the topline results from our remedies study remedy was a double blind placebo controlled study in participants who have experienced an acute scheming stroke. During this call. When we use the term stroke, we mean acute excuse me stroke, the primary endpoint for safety and Tolerability well also.
Looking for Epicel, because he signals consistent with the approved calibrating the year in drive form of Kale K. One currently used to treat acute ischemic stroke in China.
Turning to slide deck on your screen slide three.
[noise] summarizes the key takeaways that we're going to share with you today remedy demonstrated that do you. Many now and was safe and well tolerated with no do your money nine related serious adverse events do you have many nine has now been administered to over 200 participants building a strong base of data supporting its positive safety profile. This is very important does.
After you evaluate potential patient benefits against any treatment related risks, having an excellent safety profile should help the FDA is analysis and allow us to move forward with further clinical studies.
We believe that this de risks regulatory hurdles that could lengthen or delay our path forward.
Certainly and looking at efficacy signals, the 29 significantly outperformed the placebo in stroke participants, who most closely resembled the target patient population of Duminy nine the approximately 90% of stroke participants that do not receive mechanical thrombectomy.
In the group of 46 participants who did not receive turn back to me. We reserve we observed that significantly more participants treated with do your money nine 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 do you money nine can be administered up to 24 hours post stroke. The only currently approved drug in the U.S. as ultra place recombinant <unk>.
Which can only be administered in carefully selected patients within four and a half hours after a stroke.
You also talk about do your money on results compared to <unk> and Keller caring for human here and drive karaoke when protein improved 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 two kidney study. We're pleased to know that participants who had chronic kidney disease and were treated with do you have money nine showed a significant improvements in kidney function. This is why rather excited to be sharing these topline results with you today.
Turning to slide four.
We have a series of charts, providing a high level visual overview of encouraging outcomes that were observed in the remedy study in total. Although these results are based on small numbers. We believe these show that do you want to nine is a biologic biologically active protein and accident manner consistent with this mechanism of action.
To summarize quickly starting the left top left corner. This chart shows the 22% improvement in stroke recoveries.
Participants that most closely resembled our target patient population those that are excluding mechanical thrombectomy. The next chart to the right shows a lower level recurrent strokes in that do your money nine treatment group and know that this is based upon all participants that received at least one dose of the study drug.
For the subset of participants, which had chronic kidney disease based upon EG, if our levels below 70, M.L.D. 29 treated participant showed a significant increase in their EG apart levels. After three weeks it's treatments.
The second real starts with C reactive protein or CRP. This as a measure of inflammation in the body and the D. and one in nine treaty participant in showed a meaningful reduction over 90 days. The last two charts show the improvements in prostate gland too and nitric oxide levels. After three weeks of treatment. These are two important biomarkers, which we believe show level.
<unk> of activity consistent with DMD nines mechanism of action.
Moving to slide six.
Real quickly I, just want to remind everyone how serious unmet need acute ischemic stroke represents and our health care system. It's estimated that globally 15 million strokes occur each year in the U.S. that number is 800000, approximately 690000, which our acute ischemic strokes or is the seriousness of this unmet.
It is due primarily the fact that 90% of patients hovering suffering in AI S have no direct treatment option. This has referred to as palliative care.
On slide seven.
We have a summary of the design of four remedy our goal is safety assessment, while searching for potential efficacy signals.
In this study DM, winning nine was administered to participants, but the first dose of one microgram per kg I'd.
Followed by three microgram per kg dose of DMD nine and then every third day for a total treatment period of 22 days. The primary endpoints were measured at day 90.
Turning to slide eight.
We present on the baseline characteristics for a study participants ages genders and average severity of stroke broken down by cohort a total of 91 participants were evenly split between the DM money nine 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 ta or both I'll speak more about these participants in a moment.
Moving to slide nine.
We present, a summary of the safety and Tolerability results, our primary endpoint for remedy the absence of any deal money now and 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 for pretty mild.
This is very important for us as the FDA and other regulatory bodies evaluate drops for clinical study an approval based upon the potential benefits versus risk to patients.
And we believe that provides discontinued and future studies do you want to nine safety profile should simplify any regulatory devaluation of DMD nine and further de risk a 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 and different people and are often worse when it's a recurrence stroke the NIH assess scale.
Where the higher the score is the more impaired patient is the skills use to attempt to quantify the degree of impact on the participant much of this assessment centers around the activity of daily living kind of person dressbarn themselves can feed themselves can use the bathroom et cetera, ideally, we'd like to see all individuals achieve the post.
Stroke score of zero, or one which means that the a fully or near fully recovered their ability to live independently.
Unfortunately, many of individuals do not fully recover and the shift analysis is performed to evaluate the improvements across the entire range of impacts the book and fully recovery and H score absorbed one.
On the right.
Now on on the left and then on the right the deaths.
Now the least amount subjectivity and most important to regulatory authorities there was more subs activity in the scores in between.
Slide 11, just for reference to show you the improvements and for recoveries.
And I HSS score UBS your one in the dark blue and the reduction in patient deaths TPH study used for FDA approval, TCPA demonstrated and 11% improvement in participants achieving a full recovery.
That being an Eni HSS score as zero or a one and I'd point out that TPH can also have some serious side effects.
Slide 12, we presented the comparison the NIH us score for both cohorts using 91 participants in the remedies study.
One participant is not the valuable as they withdrew before first dose which is the requirements for inclusion in the safety analysis at this level, we don't see large portion participants in a placebo group achieving full recovery. This is due to the large number of participants receiving thrombectomy proud to enrollment in remedy just to remind everyone is there.
To me as a procedure in which a mechanical device known as the catheter is inserted into the participants arterial system navigated after the clots within 10 to immediately remove the clot procedures limited only those patients whose blockage isn't large vessel, which presents at the hospital generally within six hours, but.
In some cases, it can be 12 or more.
Addition, and experience and skilled physician is needed to perform the procedure because of these limitations in the U.S. today, only about 6% of stroke victims received thrombectomy.
The 29 is not an alternative to turn back to me. If you have a stroke caused by a large vessel inclusion and you can get to the right hospital in time thrombectomy can immediately restore blood flow personally I would want this procedure for myself or my family if any of US we're in that position 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 the 29.
There was a much larger than expect thrombectomy component that was not anticipated in China. It is our understanding that urinary kill Q1 is not prescribed on top of mechanical thrombectomy. That's the patient is treated with from back to me. They do not receive urinary kill Q1, we do not plans include thrombectomy and our target patient population our focus is on the.
90% of stroke victims that do not receive from back to meet procedure.
Turning to slide 13.
Here are the NHS scores for remedy participants that did not receive thrombectomy prior to enrollment. This group. Most closely represents the target patient population that do you want to nine is intended to treat and we have a total of four to six participants in this analysis, although small number visually the differences are quite compelling in the deal.
29 grew 36% to participants achieved a full or near full recovery as compared to the 14% in a placebo group a 22% positive difference the P value was less than zero point to.
The results also showed a 50% reduction in the number of participants death in the DMD nine group compared to the civil group.
I can't stress enough that the results occurred with DMD nine being first dose within a 24 24 hour treatment window dramatically longer therapeutic window compared to TPH that must be administered within four and a half hours of a stroke and only to those patients selectively selected.
We believe that 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 ta 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 do you. Many nine phase two results and the studies for activates recommit Ta and calibrating the urinary kill Q1, the approved pharma urinary kill Q1 in Asia. The key message here is that.
You are seeing comparable results in the Kelly King and improved results compared to TCPA, while offering a much longer therapeutic window and what we believe will be a much improved safety profile compared to ta.
Slide 15 place the only improvements in participant functional abilities were also very encouraged by other observations from the study data on this slide.
We're showing the reduced we occurred and severe recurrent strokes from one in DMD nine group to seven at the Siebel with four resulting in participant deaths in the foreseeable 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.
Our consistent with the published studies with your NK. Okay. One set of shows significant reductions in stroke recurrence as an aside. These results are a key reason why we believe DMD nine has a potential to be adjuvant neoadjuvant therapy for thrombectomy patients in the future.
On slide 16, we showed a decrease in CRP, an important blood marker of inflammation observed in the DNA nine group. We believe that this is also considered consistent with your money nines mechanism of action.
With our interest in CKD. We're also interested in looking at the effects of the 29.
Participants with CKD at the time of their stroke, although the relationship between stroke in 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 Kale K one.
On slide 18.
We look to changes in the estimated glomerular filtration rate or EG afar for any steady participant with an easier far below 70 M.L. at entry into the study EG as far as a primary measure of kidney function. These patients had an average baseline EG if our in the mid Fiftys range.
With respect to 28 participants at day, 22, and 24 participants at a 56.
We're pleased to see that after 22 days of dosing participants receiving do your money nine showed a seven and a half AML average increase in Egypt bar. This a significantly better than the participants in the placebo group.
Equally encouraging we observe that participants in the deal 29 group retained a higher EG if our level a day 50 634 days after treatment discontinued this could be in early sign of potential retain benefits associated with the use of dealers 29 note that this is a small number of participants but this is a very positive.
Of signal.
Slide 19, we broke down the proportion of patients who had an increase in Egypt bar compared to placebo to look at that in a slightly different way here at the results show that 77% of the DM on 99 participants experience at least it to AML increase in EG. If our this shows that the effects of occurred broad.
Okay.
And the average wasn't driven by a small number of outliers.
On slide 20.
As DM Onenine initial development was in diabetes, we're pleased to see you reductions and elevated blood glucose levels in the DM wondering group, but not in the placebo group.
This chart summarizes blood glucose levels change and those participants who had elevated glucose levels that base.
At the 22, DMD nine lowered blood glucose by almost two millimoles per liter with continued benefit a day 56.
Lastly on slide 21, the mechanism of the only nine or Kale K. One is to restore normal levels of Brady kind in which releases to critical hormones nitric oxide in prostate gland and as you can see here the DM money nine groups demonstrated significant improvements versus baseline much better than the placebo group again to us.
These are encouraging signals of DM wanting nine activity.
Slide 23 please.
To recap today's presentation, we've seen a deal when I was safe well tolerated with no deal money nine related serious adverse events and Thats building a positive safety profile is very important to make our path to commercialization as smooth and predictable as possible. We've also seen that the DMD nine group significantly outperformed the.
Well group in stroke patients when excluding mechanical thrombectomy, who most closely resemble the target patient population per diem onenine, the approximately 90% of stroke patients that do not receive direct treatment for their stroke.
Further that these results are based upon DM wanting nine being administered up to 24 hours post stroke, which is approximately six times longer than Ta the only drug approved in the U.S.
We also reviewed DMD nines phase two results compared to the data from the approved studies for older players the recommit TCPA in the U.S. in calibrating product in China.
Lastly for stroke. We also review of the positive data related to reductions and severe recurrent strokes a critical factor in the treatment of stroke patients.
And of course, because of our concurrent development of Duminy nine for chronic kidney disease participants with chronic kidney disease that retreated. Good morning, nine showed significant improvement in kidney function.
I also want to highlight that we have not seen any negative data in this study results. We believe this topline data fairly represents the results of a remedy study.
Turning to slide 24, so briefly here's what's next for do you. Many nine in the treatment of stroke, we plan to request a meeting with the regulators discuss remedy results future stroke study requirements and potential for breakthrough therapy and accelerated review designations, we intend to further engage stroke advisors health.
Condiments and payers design and prepare for phase two slashed three study, we intend to evaluate potential strategic partnerships in parallel we intend to also do this while continuing to maintain tight fiscal discipline and are focused on completing the redux phase two study for chronic kidney disease.
Now, let me turn the call over to Dr., Harry I'll corn for a brief update on the Redux trial.
Thank you Rick good morning, everyone as I'm sure you already know our redux phase two CKD.
Chronic kidney disease study is enrolling a total 60 participants in two week will cohorts first cohort is focused on hypertensive African Americans, who are not diabetic.
That have camping area.
Second cohort is focused on participants with the idea in property previously confirmed by biopsy and also having commentary on.
Participants will be treated with deal 199 for approximately 13 weeks at a dose level of either two or five micrograms per kilogram, which is administered subcutaneously two times per week.
The primary efficacy endpoints for the overall study are fr and helping area.
We're also tracking standard safety and Tolerability markers.
Participants enrollment continues to be slow why we technically have 12 sites in the current cobot 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 performed by registered users in the participants home, which further reduced level participant context.
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 at Cobiz 19 infections in any of our participants.
We remain in close communication with all of our study sites, where 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 would just limited participation.
Contact in design of the reader 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 cold in 19 on our study, but in light of the uncertain surroundings coping 19, we're not in a position to provide a projection for when we may have interim topline results.
We will continue to provide additional information as conditions allow.
Thank you Gary.
I'd 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 2020 and filed our 10-Q yesterday. After the market's close if you haven't had a chance to review. These documents. They are both available on either the die amedica or the FCC web sites.
Our net loss for the first quarter 2020 was 2.4 million or 19 cents per share. This compares to a net loss of $3.3 million or 27 cents per share for the first quarter of 2019.
Our research and development expenses decreased to 1.4 million for the first quarter of 2020.
Decrease of 1.2 million from 2.6 million incurred in the first quarter 2019.
This year over year decrease was due to cost incurred during the first quarter 2019, which did not reoccur during the first quarter 2020.
Primarily the cost for a production run of the DM 199 drug substance and our phase one be 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.
These decreases were partially offset by the costs incurred for our redux phase two 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 2020.
Compared to 814000 for the first quarter 2019. This increase resulted primarily from increased noncash share based compensation costs.
Now our total other income or expense for the first quarter 2020 wasn't that expense of $12000. This compares with a net income of 178000 for the first quarter 2019.
This change was primarily caused by foreign currency transaction losses associated with funds held in non functional currency or non us dollar accounts for us This was principally Australian dollars.
In addition, a decrease in are 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 2020 also contributed to this change.
Turning to the balance sheet. We finished the first quarter 2020, with cash cash equivalents and marketable securities of $12.6 million current liabilities of point 9 million and working capital of 13.2 million. This compares to 7.9 million in cash cash equivalents and.
Purities 1.3 million in current liabilities and 7.5 billion working capital as at 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 2011th 2020, we completed the public offering of common shares raising gross proceeds 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.
Harry mentioned those caveat, however is that actions implemented to combat the novel strain of the Corona virus 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 cost 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.
Thank you as a reminder to ask a question you want me to press Star one on your telephone.
Draw your question pressed the founder hash key please standby, we come pilot Q and a roster.
And our first question comes from the line of Alex Nowak from Craig Hallum Capital markets. Your line is open.
Greg Good morning, everyone and congrats on getting the phase two stroke steady across the finish line here.
Rick you mentioned this earlier, but could you provide a bit more detailed insight why mechanical referring back to me was included in this day in the first place at the time it sounds like it was more of a safety aspects. So can you just confirm it wasn't it was pre specified that the true intend to treat population really did exclude mechanical thrombectomy.
Yes. Thank you Alex so the first approval when it was designed now a couple of years ago.
Initially it was excluded we later decided which 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 theres any possible clinical benefits.
In the end if you if you 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 three.
The human year in form of kill came on in China.
There's some pretty clear synergistic data with TPH, but there really wasn't anything with mechanical thrombectomy. So we want to get.
A sense of whether or not as something one to include or or not for phase three.
From a mechanism perspective theres some nuclear differences that we believe our drug is targeting microvascular circulation.
Whereas those patients who had an eligible for turn back to me are targeting more large vessel occlusion. So it's something that we wanted to we wanted to research.
That's helpful. What are the primary positions in the studies 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 of the results.
Yes, so overall we were anticipating.
10, 15%, maybe that Hasnt that would have turned back to me, we were all surprised including including our advisors that the level was so high.
Our advisors perspective, you can see the quote from Dr. Campbell.
This was this was first the safety study I mean stroke is a severe condition and when it first and foremost making sure that safe and it's very encouraging that we saw the reductions in stroke occurrences and it seems that we've got some signals here that are consistent with the results.
With the human yearned form of calculation.
No that's good and as we spoke over the years I know you in the team have spoken with larger pharma large strategics about your work on killed came one from your discussions that you've had with them myself in the past what do they want to see and stroke in and does the data from the intend to three population really check all the box.
Is there.
I guess to be determined well, we'll have to go out and and talk to them.
We do believe that there from a partnering perspective, there will be a lot more interest for chronic kidney disease.
But I think the data we have here and it's not just the NIH a scores hits. This at the safety as the mechanism. It's it's the whole once 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 for stroke. In addition to kidney disease.
Yes.
No I would agree and actually switching gears over to CKD Harry.
CKD data that you put us easier for our that appears to be.
Looks to be a pretty big deal is there anything with the physiology or the conditions data show that would make it difficult to use the data here as a direct proxy to your phase two kidney study and have you show on your kidney Advisory Board this data.
Thank you bring it up Alex.
The.
CKD scientific Advisory Board did receive the data they did.
I find it to be extremely impressive and very interesting as it.
Confirm for them, what our drug can do for kidney function.
Obviously this will be synergistic with our conversation with the agency and with the other regulatory bodies as we move forward.
With stroke and as far as Egypt bar is a.
Effect that occurs with stroke patients so they need to address.
Total clinical care on these stroke patients not only with obviously the clock, but also with their kidney function. So this has been a wonderful conversation as had been supportive in total care of these patients for their disease state.
That's good just last question for me with Covance, starting to fade here a bit and some of the stays on the reopened given new timeline or rough timeline for for the CKD study readout of full 90 days is it fair to say that should come before year end, though.
Yes, if we do hope so.
Right now until we get clarity I mean, what we're sensing from some insights that it seems that they're they're getting positions. So that thing its can start ramping up in June.
And a lot of our FX rate now event to.
Work with us sites to identify participants that when things do open up more that will be in a position to get our enrollment I'm really really moving quickly.
Okay excellent or congrats on the really compelling data here.
Thanks, Alex.
Our next question comes from the line of Thomas Flatten from Lake Street Capital markets. Your line is open.
Good morning, guys. Thanks for taking the question just sticking with CKD for a second would you or could you comment on how many patients are currently enrolled of the 60 total.
I will tell us we haven't provide guidance on that I mean, we were anticipating to have results here in Q2.
But with coal that we right now we don't have any guidance, we will go and get some clarity on.
On on Corbett, hopefully here and then.
Near term.
And then flipping back to stroke from a 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 Ta and then deliver better safety and a longer window will that be sufficient hurdle for FDA or do you think are going to be looking for both the safety advantage and efficacy advantage from a design purposes.
So first off TP 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 concerned with our drug we're really going to be targeting those patients.
Post four and a half our window of Ta, where there are no therapeutic window, where the no therapeutic treatments today, so even if we see similar efficacy.
Two ta.
That would be that will be wonderful and what we're seeing from our study here is that.
Though again small and small number patients.
Just a doubling of the of the full recovery compared to TCPA. 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 and gives us a very attractive clinical bar for us to to hit.
So just a just a follow up on that so would you specifically target post four and a half window or would would that be a pre specified subgroup that are close four and a half window for half hour wins. So that's.
Yeah. So that's something that the data is just and we're getting at all just just getting it out here now today the investment community, we plan to meet as soon as possible with the FDA.
Theres going to be a lot of things to talk to them about so.
We're going to talk some about with and without PPA. We do believe that we will see positive efficacy with ta or without and also the safety profile, including be read reduce risk of recurrent strokes.
Recurrent strokes are no.
Our problem and so I think what we want to do is get to show the date of the FDA get the feedback and then being in a position to looking at at this point here with or without Ta. So we'll have some updates here in the coming months, Yes, and then just one final question for me you you talked about a phase two three study.
Going forward is that because you anticipated being adaptive word or do you think you go would that be pivotal design or I'm. Just curious why you label. The phase two three instead of just a phase III.
Pivotal study more and more generically.
Yes. So one of things were looking at is again. This is now just initial internal discussions advisors and so forth a phase two design will be a.
A half what would be adaptive so one of things were considering is approximately 100 patients for the phase two portion and if we hit a minimum bar call. It a 10% full recovery then we'd move into the phase three portion and well be able to do in the capital intensive way allow us to get the study started.
And then again on on that first 100 patients we see the signal that's needed going into the phase three portion. So bill does allow us to use.
The first first 100 patients for the for the pivotal.
Again this is something that we're discussing and get will be having that discussion further with the FDA.
Great I appreciate you 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.
Thanks.
All right.
Again, we'd like to thank everyone for joining us. This morning, we are pleased to share the results for phase two study and acute ischemic stroke and we look forward to the upcoming plans for the phase two specialty 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.
[music].