Q1 2021 Beyond Air Inc Earnings Call
[music].
Good day and welcome to the beyond Air first quarter 2021 earnings call. Today's conference is being recorded at this time I would like to turn the conference over to Corey Davis. Please go ahead Sir.
Thank you here good morning, everyone. Thanks for participating in todays conference calls for the company's first quarter School 2021.
Usually see Trimble before right Chief Executive officer beyond their Jordan Kim.
Chief Financial Officer and.
President and Chief operating Officer. This morning beyond Air issued a press release announcing the financial results for this first quarter fiscal 21, the GAAP either one of these can be found in the Investor Relations section of the company's website.
To begin I'd like to remind everyone that college and various remarks.
Expectations plans and prospects Constitution [laughter] she's in the Safe Harbor provisions under the private Securities Litigation Reform Act of much.
Yeah on their cautions that these forward looking statements are subject to risks and uncertainties that could cause actual results could differ materially from wasn't the case.
There are urges you to review the probably filings with the FCC, including without limitation that somebody's form 10-K, which identify specific factors that may cause actual results or does it differ materially when those described.
As a reminder, this conference will be recorded.
I'll be available for audio we bought yes, well yeah there.
Furthermore, Chicago It was conference call contains time sensitive information is accurate.
Yes.
Okay.
Okay last August 620, 20, you on their undertakes no obligation to revise or update any statements to reflect the done sports circumstances.
This conference call.
Doug.
I would now like turn the call overseas, we see chairman of the Borden Chief Executive Officer beyond there Steve.
Thanks, Corey good morning, everyone that can be joining us today.
Considering we just had a fourth quarter call six weeks ago I'll be brief.
They will provide an update or provenge upcoming milestones after which I will hand, the colder Doug will then review our financial results.
Oh start todays call discussing the concept that is beyond air.
Across our development pipeline I see so many reasons to be excited about the benefits for patients like health care providers.
That's what was the opportunity for us to build shareholder value.
At the core of our story he starts system's ability to generate nitric oxide for maybe a bear.
On demand, it's just the power from stand or what's your topic.
Capability to generate you know for maybe there you need to start device used to have a number of practical features that allow us to address your broad number of complex indications and also have a number of potential advantages in real world shut ins compared to show in the based legacy systems currently in the market.
The reason I want to start today's call highlighting this point just to emphasize the importance of her guidance today, but we expect to file you watch premarket approval to younger people along fifth ph to treat persisted pulmonary hypertension of a newborn we'll keep you tried to the FDA at the end of next month.
This pmeight will set us up what we expect to be Oh first after the approval and subsequent commercial launch.
Thanks, Good platform technology.
As I've mentioned in the past we believe our system has the potential to disrupt the current got no supply chain to hospitals and it actually make the shoulder based delivery system I feel the cost.
[noise], we've got sick.
Good specific programs, starting with lung fit ph.
As a reminder.
The lungs, P.H. ventilator compatible system.
Is currently being developed to dress P. PHN.
And also for certain cardiac surgery patients outside the United States.
This continues to be our lead program. It consumes the vast majority of our engineering regulatory and quality team's focus.
I just mentioned during the process of pairing up here makes submission.
I'm certain that many of you follows closely where that's be it makes a mission times, it's been going back several months due to the corporate 19 pandemic impacting supply chains and logistics for testing.
Well, we are confident filing guidance based on current situation. We are not me complete control of this kinda give me overall macro environment in New York City.
Emphasize that under the current circumstances, because they've only a few months you're not standing colpatria for the got their cheap.
Given the FDA guidelines for 180 gig review period for P., having we anticipated U.S. commercial launch could occur in the second quarter.
2021.
Commercial watches outside the U.S. will be dependent or ongoing partnering discussions approval time lunch each jurisdiction.
I'd like to briefly highlight again, the operational safety cost advantages of our lungs with each system, we're showing the big systems.
Eliminating cylinders watch the hospital instant savings on space inventory requirements training employee Todd patient time, we actually do you.
Its safety for book species and medical stuff.
Obviously, we since we do not require nitric oxide manufacturing facility.
Sure sure.
It seems you're having some technical difficulties please hold.
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Sorry, everyone Theyll all right.
Sure everyone for that you'd go ahead.
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Chart, one for that but we can be seen call.
The problem with that issue here, so bear with us and Subleases not happening in Madison, Wisconsin, We're doing RPM may work. So it's a good thing.
So.
Get back to where we were.
You are saying don't require nitric oxide manufacturing facility, which certainly is usually infrastructure.
And these advantages will position beyond air to make significant take significant share this market, which is estimated to be more than 300 million U.S. another 600 million worldwide.
Turning to recover 19 program.
As we previously announced the U.S. Covidien team study start enrolling patients in June.
To date study has shown an excellent safety profile the patients treated with nitric oxide. We anticipate the completion of this study within the next 60 days.
As a reminder, U.S. trials, an open label study of up to 20 adult patients hospitalized with Covance 18.
Subject to being randomized one to one and treated with intermittent dosing using 80 parts per million nitric oxide emissions over 40 minutes for time today. In addition to stand in support of therapy will try to withstand a supportive therapy alone.
This low dose of 80 parts per million is designed to prove the safety of this concentration before moving to a higher concentration that we expect is going to have a more optimal efficacy profile.
Primary endpoint, it's time to clinical deterioration or the endpoints include reduction viral load safety and various biomarkers.
We see significant opportunity to use along for system in mild to moderate patients diagnosed with cobot 19 caused by scobey too.
Considering the data compiled to date with high concentration I know most notably the three completed pilot clinical studies in bronchitis, where things were hospitalized due to viral infections. We believe that this system could do significant tool in the battle against the score of ours.
Staying with the viral lung infection team are talking about us program is pretty stellar efficacy and safety data to date.
As I previously mentioned this program is on hold until the pandemic subsides.
Give a quick review of the data presented to date, which lends support for our chances of success in probably thinking patients.
Last quarter, we announced positive top line results for my third and final powered study in Buckhead of stations.
Which showed on an intent to treat basis that 150 parts per million nitric oxide statistically significant when compared to both the 85, plus really nitric oxide and to control arms on both the primary end point of time to fit for discharge.
And on the key secondary endpoint of hospital length of stay.
In all cases, the P values were below point on five with hazard ratio is north of two.
It's important to note that the result far exceeded expectations. Given this was a small study with just 87 evaluable patients across the three arms.
There were no serious adverse events associated with metric oxide.
It's important to emphasize but a low dose of 85 parts per million Ano.
Had no effect when compared to placebo.
We look forward to publishing these data just as the previous two pilot studies have been published.
Now long fit home program, we are progressing rapidly towards initiating a multicenter 12 weeks of administered at home pilot study in 20 patients with non tuberculosis mycobacteria lung infection, we expect to begin enrollment in the fourth quarter of 2020.
In order to be enrolled in the study a patient maybe diagnosed with Ida Mike of axiom obsesses complex or NSS on back of Acxiom Avium complex or Mac.
Patients will be titrated up to 250 parts per million metric oxide.
The study will evaluate safety quality of life physical function and bacterial load.
The FDA has emphasized the importance of quality of life improvement because were function as well as and improved safety profile as markers of success versus so Asia the bacteria.
Based on our current expectations, we expect to report interim data from the at home study around the end of the first half of calendar 2021.
As many of you are aware, we have a high confidence level for success in this study given our previously generated data.
We're also quite encouraged by the simplicity of our loan fit system functionality.
So simple fact step process.
First put this isnt any standard orchard outfit.
Turn on the power switch.
Insert the smart filter into the system.
Most of bidding mask on the face and press the star.
This is a very straightforward system, our smart filters have an archived chip that communicates with the system and will dictate the dosing parameters. So patient does not have much to be concerned with.
As a reminder, lung fit automatically staffs generating nitric oxide wants to time on the filter runs out.
With the successful study, we believe our lump at home system, both as a global very significant underserved market for chronic severe lung infections that can be treated in the home.
This market includes CLP patients with severe exacerbations that are frequently precipitated by infectious agent.
There are over 1 million hospitalizations annually in United States do exacerbations caused by lung infections in 70 patients.
And we would look to avoid rehospitalization in these patients clearly this is quite a large unmet medical need.
Finally, we turn to our solid tumor program.
In June we presented early very promising data on coal in breast tumors in vitro and cold tumors in either.
The data demonstrated very potent anti tumor activity with eradication in vitro and anti tumor immunity in vivo.
Pretty very encouraged by this invivo anti tumor immunity, which was demonstrated with 25000 200000 parts per million nitric oxide in six months versus setting control nice.
Two is grew in all seven control mice, while none of the six months previously treated with nitric oxide for an initial tumor has secondary tumor present.
We anticipate presenting more in vivo preclinical data before the end of this calendar year.
With that.
I'll now turn the call over to Doug for the financial review Doug.
Thank you see is a brief review of our financial results for the third quarter fiscal year 2021 of which ended on June Thirtyth.
Our 2020, let me for the quarter with 229000 compared to 627000 from the three month ended June Thirtyth 2019.
While revenue related to the accounting for the payment made to beyond there in the now terminated commercial agreement for the ones that ph.
Research and development expenses for the quarter were 4.3 million compared to 2.3 million for the three month ended June Thirtyth 2019.
General and administrative expenses for the quarter with 2.5 million compared to 2.2 million for the three month period June 32019.
For the quarter the company had a net loss of $6.7 million or 40 cents per share compared to a net loss of 6.2 million or 67 cents per share for the same period last year.
As of June Thirtyth 2020, the company had cash cash equivalents unrestricted cash of 24.4 million. This cash is sufficient to fund operations well beyond 12 months from today I'll now hand, it back to Steve.
Thanks.
Before we go to acuity.
I just want to point out that we have signed our commercial supply agreement with spot Tronics formally Spartan.
For the long fit and Lowfat Peach systems. This is a critical step as we prepare to submit rpms now onto questions operator.
Alright, Thank you very nights.
Well go ahead and take the first question from Sunrise Command with Oppenheimer Company.
Good morning, Steve go ahead.
Yeah pace Rush Korea.
I hope everyone is safe and healthy.
So Steve lot of information provided in the call, let me start out with that Pmeight submission dossier.
Between now and September Thirtyth bordered remains to be done.
Facilitate this timeline, obviously with the caveat that Colin it's still some wonderful myocardial.
Yes, so slash there's there's testing to be done we're we're wrapping up all different kinds of tests and as you know in a PNM has an enormous amount of documentation.
So that's that's what's going on for the next week.
Roughly eight each year.
And.
It's it's a lot of work and when gasket people, who can do it and that's the common or so there are still some outside.
Vendors, who are working with us and they're doing.
Fantastic job with us and yes.
Backlog with no no no impact from Covidien, and we'll hit our timelines.
Died.
Steve one of things you mentioned in the core.
Which even rest mad was talking about yesterday.
These potential long term down and lung damage with proven.
And you also mentioned about CRPD no home day setting the potential for iron ore use I guess.
Maybe.
You can help us understand.
What safety do you believe needs to be demonstrating a home setting for this potential long term use versus a PHN knowing that the latter London's ventilator compatible to the form factor is different but just from a safety perspective at home setting what additional hurdles do you anticipate forced them.
Longer term opportunity.
So our study that will bring in non tuberculosis mycobacteria patients will be self administration at home. So we're going to get a good idea of what profile.
It is about nine to 12 months, when we share that data already CDP interim look of that data.
So.
I think that the main hurdles or.
One item.
To safety, we don't need nitrogen dioxide.
Flooding someone's home.
Obviously, our system has alarms shutdown mechanisms.
We have all kinds of safety precautions in place we have timers on our system that shutdown automatically so for patient fall sleep, while taking a dose.
It will stop manufacturing producing nitric oxide on by itself.
Sales safes in placing safeguards in place.
Obviously, if any to filtration.
So there is no one or two that's at levels of harmful I think thats really the main issue or is there to levels and Daryl we've taken extreme.
Measures to make sure that it's safe not just in the home, but in the hospital as well for for the long fit and for the long CPH systems.
That's really probably the biggest total inherent in my opinion I missed the are too.
And then of course, it the user with a patient or so it will to understand how use the system as I described earlier in my prepared remarks.
It's extremely simple the filter runs to system. So.
I really our team here you've got over this.
I don't know couple of hundred times. A question you asked about what a niche due to get home use and it really comes back to.
And on two levels.
So just to breakfast is question up.
On our system is not in use.
Our there's absolutely no danger them too.
We don't store nitric oxide, we can't slip on by itself.
So when your system is that being used even if its pardon.
It's not being used there's no danger.
The only time theoretically there would be any concern as wing systems in operation and the only way collaborated with a filter in place. So the filter is.
The purpose of the filters to stop and two from from reaching levels that are dangerous.
And like I said earlier, we have a launch we have fell six in place to assist them shuts down automatically and so forth. So I think the bottom line as an old too.
Is probably the biggest hurdle and we don't really see it as a hurdle given our system, but I think the hurdles, let's demonstrated in a number of patients in their homes.
To regulatory regulatory authorities around the world that it is safe.
So maybe a long winded answer I put it just it through but I want to give it to focus your.
Fair enough and finally, Stephen I'll hop back in queue, all use partnership discussions for lung for P. edge, what does the current status.
The timelines you can provide any any and thresholds you're looking to to get over just some some parameters and what ifs and what we could expect for at the edge. Thanks for taking my questions.
Thanks, Josh.
There's really no timelines outside the U.S. that that we want to get specific on at this time.
I think.
Europe being.
The big market outside the U.S. I think there's still some uncertainty about when the changes.
Within the rules will will take place that's obviously been delayed because of the pandemic.
So there may be a window for us to get an approval.
Before the exchanges are made but we agree they have no visibility on on that economic so it's still fairly chaotic so.
I'm going to stay away from any kind of timing of partnerships ex us at this time.
Okay.
Alright. Thank you very nice if he would like to ask a question. Please press star one and if you find your question asked and answered in they remove yourself from the Q by pressing Star. Kim next question is from Scott Henry with Roth capital.
Please go ahead.
Thank you and good morning.
I guess, starting with the covert 19 program.
[music].
When should we expect data from the Canadian trial.
Well.
Thanks Scott.
I think data from Canadian trials going there will be well after anything from the restaurants, so I wouldn't.
I wouldn't count on seeing.
150 ppm data from the Canadian trial.
In the next 60 days like we've we've been.
Targeting to get the restaurant wrapped up so maybe little bit longer than that.
For obvious reasons that people have as many cases as the rest us so it's not very prevalent which is picked for for Canada.
So just not the volume of patients there to be able to get that down as quickly as we like.
Okay. Thank you for the color there.
And then with regards to the at home NTM trial, I mean, I guess you described the data as interim by the end of or by the middle of 2021.
One over the long term data there would be I assume all the interim data would recover the fold that data set with the primary endpoint and we're looking at longer term safety or just trying to get a hanson.
How how we should think about that total packaging data.
Yes. So the study is a 12 week treatment period with a 12 week follow up period. So.
Thanks again.
Well, it's open label Scott, So, we'll see how the data or.
Our coming in but the one would think that we'd like to show.
Data on our interim look with patients who have completed the be treatment phase show once take the treated 12 weeks of treatment.
I'd like to show something and depending on how enrollment goes.
If we can get a bunch patients that are well beyond that 12 week treatment period get some follow up.
We'll decide when we want to put out that interim look since it is open label leasing the data on a fairly regular basis, but again the full data set would be after the last patient has completed the 12 weeks hour period. So.
It should be a.
No more than.
46 months after the interim look roughly should be the final look and again I caution you that.
We may have to shutdown sites in close them out and get reports written and so forth before show founded dataset show.
I would say looking towards more towards.
The next year in this calendar year you'd be looking at the full data showing that not too far beyond the interim look.
Okay. Thank you that's helpful.
And then just on the income statement.
Hi.
And we still bringing in the the co promote revenues that we should this be the last quarter on that.
And the income statement or is that some of that the lingering.
You know Scott I only.
It's an accounting.
You know anomaly of how we recorded that deal and it's not real cash so.
Lets say its GAAP accounting, so I want to refer that question, Doug I think there's one more quarter, but I honestly the nature that better Doug.
With that.
That's really going through the performance obligation over really the filing.
When we get at the approval so it trickles in ruled that performance obligation.
When we get close to two.
Approval.
Yeah, So Scott it could be two to two or three more quarters, then because were bigger saying.
If the numbers are small I mean, you're down part of the trend.
Okay and then.
Side.
Our R&D kind of jumped up in Q1.
Should we expect that to continue or is that kind of a timing related event.
Yeah, it's timing I mean in this in this quarter, we we completely changed our bronchitis programmed Colgate so.
There are some expenses to do that in.
I'm trying to get that that moving quickly and there's also timing of payments to.
To spark Tronics Ford for device manufacturing and so forth. So.
Its a.
Got it to 45 million per quarter.
I think that over the last quarter was or high I think that there was smoothed out in the next quarter.
The results are a lot of noncash charges this quarter in there of about 700000.
Okay last quarter.
Great. Thank you for taking my question.
Thanks Scott.
All right and then next question is from Matt Kaplan with Ladenburg chime in.
Please go ahead and good morning.
Thank you.
And even more than that.
Just on focusing on the Oh content ph.
In a filing on or specifically can you talk little about your commercial.
Preparations that you're putting in place and how how we should think about commercial launch.
The second quarter.
After you get approval.
Well Matt.
[music].
For keep saying we are we are preparing.
To launch this product on our own.
We are still in discussions for potential partnership.
So we will.
No well keep along those parallel paths because there's no guarantee that.
You know the partnership.
Crushes will end with.
There are a deal that satisfactory to us so.
We're preparing to launch the product that shows the impact.
We're ready to go I mean, I think now and any of you grew at our analyst day in early March.
You met our Chief commercial officer, he gave half the presentation is.
And is fantastic and we'll all be hunting and you know we can watch the product on our own without a problem but.
No there are factors that could.
Lead us to partner as well so.
By the way it will be launched in second quarter mixture pending a fair pool.
And.
Did you ask how we're going to one should I didn't catch second half my question, sorry, Yeah, and net how are you going to launch event for previously you described kind of a staggered our staged launch.
Plan within.
Thats failure your your objective here more.
Marty Hoffman.
Yeah, Matt.
I think this is pretty classic for for devices kicks.
Especially in the hospital pick thinking into kind of just going slowly with a with a small percentage of the hospitals that are useless nitric oxide and or couldn't get feedback.
And I think that's what we'll do I think it's the right.
Going out to.
1000, plus accounts at lunch is probably not the right method. So we will have that same strategy has spoken about in the past where it's a it's a slow controlled stepwise launch.
And just one other question and.
Relationship to the launch can you talk about the manufacturing capacity that will happen a number of devices you think youre having had in place as you prepare to launch the product this year.
Yeah, we'll have we'll have a.
Given the slow.
Trajectory in the first six to nine months of the launch.
We're going to have plenty of of of lung fit ph.
Systems too.
Products.
Within just a few weeks after we get approval.
Well, we're gonna have Oh, a handful of systems that are commercially viable once we.
Get through this pmeight process so.
No I don't think capacities and issue I think.
Yeah.
We can we can manufacture.
Thousands of these systems, a year and with the line we have set up right now show not.
Very worried about a U.S. launch and it's more so when we go internationally and second in accruals outside the U.S. and picking up there that.
They have to consider adding a second right but.
Before that.
One line that we had this.
More than sufficient.
For the rest market as you know there's this.
This is probably less than 10000 systems in the entire United States out there today nitric oxide delivery systems for further and on the players that are already in the market. So it's not a.
So intense on that side, it's the filter.
Correct.
We'll be the.
Key component that Skus used.
A lot more in our systems, obviously and so if there's a very small.
They are simply to produce.
Got more capacity than than we would need I think one one line can do.
Might even be onto the world I'm not sure yet with figure that out just for PPH and if we get into other indications. That's when we have to start adding lines for the for the filters so for PHN filter side its.
As to if im very easy to catch up if we get into a bind. They also have I got them mapping expenses means it's easy for us to keep inventory on hand, so I think the issue that you're thinking of with inventory and and putting things into a supply chain.
It's really a filter related question Where's the actual along with existing itself.
The last thing five plus years out in the market. So.
Let me a lot of them.
[music].
So once we kind of get our.
Footing the door, it's really about the filters and that's a.
Much much easier supply chain commencing systems.
[noise] statements. That's very helpful. Thanks, and then Oh Gee My question on that you mentioned he did say that that Canadian trial.
Has there as the patients in Canada to really get the how you're taking parts per million.
Trial going in data going have you thought about.
Initiating a 150 parts per million study outgrown alone and I know users on 21 point, Israel and now with the resurgence theirs is is there a chance you could watch that study in Israel.
[music].
Yeah, not Israel is probably the only place weeks, we should consider it because we can't send anybody anywhere.
Sure.
If we try to do a study in another country outside of the Usource, Canada, because we do have people in Canada or Israel.
We have nobody in most countries and we're not gonna be shipping.
Lung fits to countries, where we have no people, where they can't receiving from shipping and inspect them and.
Configure then it thing and train the people who are going to be using it and this is not.
As simple as you know shipping the drugs to country and saying here is you know just just do it by mounted due by the where everybody understands how to do those things here. This is a little bit different. So we are constrained to doing studies, where we have people on the ground for that 19.
And that really restrictions to just a few countries. So that's the difficulty I know there we get reports of coking around the world in some countries, where there's so much of it you would think it's just simple snap your fingers and go get a study done.
The great if we could send people to those countries and bring them back here, but.
That's an absolute nightmare to try to get your people to have a country and then actually bringing back in United States.
Show better.
Turning to restriction on us at this moment in time.
[music].
So we'll be working hard in the U.S. and hopefully Israel.
Unfold.
Oh, Thanks, and then.
How to program you announced the initial data.
Already this year, what should we expect to see you mentioned that there should be additional preclinical data.
For that program, which which we expect to see there later this year and then secondly on that on a solid tumor programs key keeping a little a picture for us in terms of the attack team I am I in game pack to the clinic in terms of Bob and in human studies.
[noise], so I'm going to have to wait to see the data that we show.
I think that ER.
We hope to show.
A different tumor than Colin in vivo and we'll see if we have that for you.
Then you know.
Could be some other data we have to.
We have to wait for some of these things to to be.
We completed in written up and.
And presented so I'm going to.
Wait on that Matt and see what we what we present.
But as for the pathway to.
First in man study.
We're looking for that to happen.
About 12 to 15 months from now so back half of next year, let's call. It Simon.
I don't know from September to December timeframe next year.
It looks like a reasonable target for us to do that so we have a few more things to do because you can imagine this distributors or.
Volume of animals needs to be tested.
We have to choose switch tumor type will be going with the optimal tumor type to go with Pfizer for in our first and then study.
That decision hasn't been made yet so we'll be doing some are testing on that.
And again, our like I mentioned too we do have our own.
A more house and that's been up and running after about a month so to take time to get defect built in and get all of those.
So licenses in place for us to be able to start working on animal house in that it's a it's a big hurdle for us to get over this gives us a lot of flexibility in terms of what we want to do and how we want to do it and timing.
One things can get done I'm. So we really just started last month backup doing more in vivo studies. So.
I think thats all I can say at this moment in time.
Okay very helpful. Thanks, and congrats on the progress.
Thanks, Mike.
Alright, and I'll take them next question from Yale Jen with Laidlaw.
Please go ahead.
Good morning, the band.
Hi, guys, they're not I mean already so some of the thing you might have mentioned that but just wanted to follow up on that which is that the for the Cobiz 19 on the press release, you indicated that the safety as being established.
So my question to you at that that is the Canadian study.
For the audit and secondly, or can that progress in the faster and that jump to the 150.
Ppm for treating the patients so any update on there.
So are we have not enrolled a patient get there. So it has not begun.
And the.
What we put in release and what I said in prepared remarks was referring to the 80 parts per million study in the United States where weve.
Shape, which enrolled to date have seen a clean safety profile with respect to nitric oxide. So.
That's all we stated we do hope it thing imply anything about the Canadian study it doesn't matter too but.
We have not gotten that study started yet.
Maybe just bought up a little bit more in terms of the U.S. studied.
Are you seeing you could go to the entire cohort deployed in condom play or the next move or the data at this point they will be sufficient.
Two.
Other players.
Other sort of a future path of future.
Trials.
Well, yeah, we we've already contemplated our next move that's for sure. We're just kind of.
Waiting for sufficient supporting.
Data to move ahead so.
Like you stated that I don't have the answer for you.
Whether we need you know 10, and 15 or 20 patients to be completed dry study before we can.
Implement the next part of our strategy I I wish I knew the answer for you, but you're right. It's a it's a question that.
But.
Only time will tell what the answer is this a super.
Yeah.
Something that I guess I don't know if anybody can answer that question. So.
If we have to get to the full 20, then we'll get to the full 20 for if we get stop at 16 or 14, or we will but again.
It just depends on how that what the data look like and what our next step is with with Stx.
Two quick question here. The first one is that that is any updates in terms of that our data that for the you Ed.
Whatever that number it is and the second.
I believe when the Canadian study.
Going to start a lot of these kinds of though.
So.
With respect to the U.S. steady I mean.
Where we're.
We're probably going to be talking with Sta about the data in that study.
Before we have any kind of a press release on the data Center susser.
This is something that we we as a company want to work.
Work closely with FDA.
Not.
You know printing press releases out about every two or three patients that come into the study such that our goal of goes too.
You know use this information more closely with FDIC on how we can move forward. So I think you won't be seeing us putting out any pressure leases on any kind of data set for these patients until we share would have to your first so I don't take care the string and the Canadian question. It's a good question when will we start.
That's something we're debating internally when we were started or if we will.
At this point.
It's a matter of.
Is it worth our resources to push forward in Canada.
Given what we know over the last couple of months since we got approved from enough kind of through on the study.
Now we find work there.
And we're deciding whether it's worthwhile for us to even.
Entertain trying to do the study there and again you have to understand.
The progress you've made in the U.S., what's going on.
In Israel, and what we've learned in Canada, So weve to put all these things together and make a strategic decision. So.
I can't answer your question, because I don't know.
If we're going to try to stop the study and if we do try to start the study what that they would be one it would actually start to the first patient so.
I'm sorry to have it.
Exactly answer for you at the moment, but it's just not something that we made a decision on yet.
Okay, that's fine and I assume also about probably depending on the impact on rate in Canada or ended it particularly in the near future what their data will be assuming.
Well suitable for starting study there right.
Yep Yep package for sure.
Okay, great and Valerie Medicaid or congrats on the development.
Thanks you.
And it appears there no further questions at this time is Genesee I'd like to turn the conference back to you for any additional my closing remarks.
Alright, Thank you everyone for joining and can listen to our call today.
However have understood.
This concludes today's call. Thank you for your participation you may now disconnect.
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