Q1 2020 Earnings Call
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Therapeutics, NASDAQ Bcl lie and its potential future business operations and performance statements regarding the market potential for the treatment <unk> disorders, such as L.S. and M.S.
Efficiency of our existing capital resources for continuing operations in 2020 and beyond the safety and clinical effectiveness of on their own technology platform are clinical trials looking around and unrelated clinical development programs and our ability to develop strategic collaboration and.
Partnerships to support our business planning efforts.
We're looking statements are subject to numerous risks and uncertainties many of which are beyond our control, including the risks and uncertainties described from time to time in R.S. using filings our results may differ material from those projected here on today's call. We undertake no obligation to publicly update.
Forward looking statements.
Any me on the call today will behind Liebowitz C.E.O. Brainstorm, Dr. Ralph current President and Chief Medical Officer, David set them Chief operating officer.
Shock.
Financial officer, they will be available to answer your questions during the Q. and a session.
Like usual.
Good morning, a good afternoon to everyone on the first quarter. It's one of these ones during school.
I would like to begin by thanking everyone for participating this call.
For all those <unk> questions prior to our goal.
We will address many of your you submitted to question the opening remarks.
Well look forward to addressing any additional questions were common.
You may have during during the session.
Although the global markets and the thrown a virus pandemic has impacted.
<unk>.
First quarter of 2020 have been adopted for baseball.
As we continue to execute on our goal of bringing much needed treatment.
It was all suffering from those are generated disease.
On behalf of <unk> management team.
<unk> insert association was ongoing that occasion.
<unk>.
We have received from patients their families caregivers and all those are hoping goes advantage <unk> clinical trial.
I also want to think our team is brainstorm a fully devote themselves.
To advance.
I think last potentially life altering therapies.
Finally, I would like to think Oh shareholders for their continuous ongoing support on our collective journey over potential of the approval so neural net <unk>.
We're happy to share with you that are fully enrolled face to the left one of the trial remains on Ontrack or two for 2020, Pup blind date or read.
Ooh, that's been done me go partner healthcare institutions prioritized investigation <unk> therapies.
<unk> well, we've been able to continue to deliver most federal treatment with occasional schedule changes only.
Yeah, well, so aligned with the F.D.A. guidance and enabled non treatments visits to be conducted drum, mostly by phone to optimize patient safety.
As you previously mentioned the clinical trial primary outcome measure.
<unk> R. rating scale is fully validated for telephone administration.
We have train timely and certified all of our clinical trials like to support this effort.
Regarding to face to progressive in this trial.
We faced unexpected delays and new patients enrollment.
Due to the site closes for clinical trials.
Related to the global cope with 19 pandemic.
Therefore, the schedule March and April 2020 treatments that new enrollments. We're the first two may and June 2020.
Despite all efforts from our principal investigators.
We stay in close contact with all of these centers.
Clinical trial active with these new patients there almost will recommend soon.
The impact of covert 19 diminishes.
The company, partly collecting all clinical environment the data from three to the station.
[noise] with tool blasted performing in term Alice's have to 50% for patients have received all is that he's probably treatment.
I would like to now provide an update on the Israeli hospital exemption program.
I'm happy to announce the the Ministry of Health has improved extension of the ongoing study, which will enable us to enroll the full 13 patients.
In addition.
The Ministry of Health is also proves an expansion of the hospitals program to lose additional 13 fish.
Well currently the company has not completed treatments of all patients.
The first 13 it proposed vision.
As non Israeli patients.
We're not able to B.S.S.
Or further treated at the hospital from the end of March to this day due to imposed travel ban between Israel and other countries.
The company is currently collecting hospitals and clinical data for the patients already three that that <unk>.
The full data set for the first 13 patient just collected we will perform a detailed analysts.
I should also mentioned depending on when such travel ban would be lifted.
And as we get closer to them dissipated B.L.A. filing.
We may elect not to make public statements about the hospitals outcomes, so not too interfor without interactions that communication with the F.D.A. and other regulatory agencies.
As it were mentioned previously you have d. would likely look at the totality over the data.
Meeting face to the data and the hospital exemption outcomes.
That'd be announced yesterday.
We have license that can help them facility, yeah, Yeah, Hello Hospital in Israel to support them manufacture of Nurown for Israel Other European Union.
We believe that this will secure O.G.M.P. compliant manufacturing capacity and enable <unk> Kayla production to provide <unk> after regulatory approval not only in Israel, but across the European Union has this little further support our pipeline activities.
<unk> degenerative disease.
We're very pleased to be able to expand our ongoing collaboration with a little one of the world's most innovative respective medical centers.
In addition, we have recently engaged.
Services of experience.
Yeah me, a regulatory expert as we plan to approach the M.B.A. regarding.
To advance Nurown N.L.S.
And potentially engage with the U.M.A. across other pipeline indications.
Finally <unk>.
<unk> These transcend dollar management team and board.
I'm pleased to announce the duct throughout the current as being promoted to president and Chief Medical officer or Brainstorm.
I'm also happy that today, David set bone is joining earnings cold David it onto the Chief operating Officer I.
I want to extend the David at warm welcome to the company.
Save it as an experience international pharmaceutical executive was erected commercial development business strategy and product launches for two decades.
Major by pharmaceutical companies.
David's will play a critical role in our business development and partnering efforts.
I'm also very happy to announce.
<unk> board has to be strengthened by the <unk> <unk> wished economists professor <unk> cool.
The chairman of our board of directors and additional we are pleased to add to our board Mr sank to shabby.
Festival healthcare entrepreneur.
<unk> and Investor.
As brainstorm advances Oh corporate objectives over the next few months, we believe that today. Our board has the right mix of expertise and experience from or the R. and D., new product commercialization strategic partnerships and financial managements needed to advance the company's objective.
On the financial from.
Imprudent and disciplined and hour to fusion strategy.
Have a strong balance sheet through such as the use of R.H.T.M. and and the register direct offering from Abby capital.
<unk> Nondilutive grants from CIRM and from this really innovative association.
Well position.
To efficiently run our business through upcoming product life cycle events.
Was that I went to hand over to call to adopt for freedom shower, Chief financial officer to discuss our first quarter financial results.
Thank you mine, it's my pleasure now to walk into our fourth quarter 2020 financial performance.
Research and development expensive net for the three month on mid March 31, 2024, 5.95 million compacted 3.46 million <unk> ended March 31 2019.
Excluding participation from I am term onto the grandson proceeds received from the hospital exemption regulatory pathway research and development expanded increase by 1.94 million from 5.20 million end up first quarter of 2019 87.14 million in the first quarter of 2020.
<unk> near already or what's primarily due to an increase in expensive in connection with our ongoing airlines pay three and progressive M. at Spain, who clinical trial.
Decreasing participation of I A.M.M.M.T. 120, 20 on the various born in Grand and partially offset by post P. three theme ponder the hospital exemption regulatory pathway.
Handle and administrative expenses for the <unk> ended March 31, 2020, what two points 26 million compared to 1.47 million in that field microphone did March 31, 2019, that's been Queen <unk>, primarily <unk>, increasing payroll Doc based compensation.
P.R. and I are caught rank consultants on travel.
Lost for the three months ended March 31, 2021, 8.1 million or negative 32 cents per share as compared to a net loss of 5.3 million or negative 24 cents a share for the three months did Mark 31 2019.
Back in Cleveland, including short term bank deposits were approximately 14.5 million.
31, 2020 compared to approximately 6.2 million at March 31 coin 19, our total of <unk> available funding as of March 31, 2020, which includes cash on hand, as well as remaining Nondilutive term and I Ain't grind amounts to approximately 17.5 no.
<unk>.
What part are details on our financial please report to our form 10, Q. files would be anything you today.
The line.
Things are pretty dumb.
Looking at the 2020 rising focus on generating top find results.
Let's face reprogramming will make all necessary efforts to deliver progressive M.S. space to try result in the fourth quarter of 2020, unless there are further unexpected delays due to the covert 19 disruption, we look forward to work towards potential approval and initiating the regulatory submission and eventual commercialization of nor on an L.S.
Further advancing proprietary in an innovative.
Allergies and enhance our manufacturing capabilities.
We're actively working on additional preclinical and clinical opportunities to expand our pipeline to address that's neat and to grow as it by X.M.L.G. Company does is an exciting here for us as you work towards executing on behalf of patients and shareholders.
Lastly, we are old trying to adjust our lives implants was doing all we Kansas, they've got public health and wellbeing of our patients caregivers principal investigators and employees I would personally thanks, everyone for working together and your continued support I. Thank you all for your ongoing support to bring some souls or <unk>.
Oh look forward to your question as mentioned at the beginning of this cold duct Akorn, David check on and off the shot well also join me to answer your question well before Reopens Alliance with you.
The questions and to reply to those already received I would not please Sean if u. Penn.
You can you you will be readings <unk>, but before was taught that David Justin introduce yourself to the investor or community, Let's say a few words about your business brainstorm before we handover for the hearing aid to Sean.
David Thank you, Yeah, I think today and that's fine.
Good morning, I'm extremely hundred to reinforce <unk> mm.
In Texas thrown out in it.
Yeah, but obviously been following brain darn.
And you're on technology.
Greenco given up thing we've been lots of things right.
Right.
East Coast burn.
It could change the treatment will scare patients suffering from there that.
And no there's no getting like <unk>.
Indeed, the cause of web.
But I can see an I.D. scrutiny.
During the last month.
I hope so.
Mm two critical Freaky development.
Or companions alright.
<unk>.
Yeah.
Yeah I'm track.
Right right.
And be like.
<unk>.
<unk> do I'm very impressed by <unk>, <unk> <unk> <unk> <unk> Hmm.
That we hide behind me around.
Which words demonstrated again recently.
Mmm, the new data published.
You mean the modulation.
I can tell you that I'm, putting all my energy need my heart, Mike varying.
There are a union station.
My first objective.
Yeah, they rate argument plan education.
Try to you and commercial partners across you know correctly.
Yeah, I've outpatient into their bridge.
So you know technology.
Thank you okay.
Thank you very much David.
<unk>.
Let's have yes the.
Please. Thank you your purse question for the team.
Can you please elaborate on the impact of covert 19 on the A.S.A.L.S. trial.
Approximately was the timeline up the last patient isn't it.
When when you get the top line data.
When it will it be presented and what is your timing for the B.L.A. process.
Thank you so since our last call in March March as happens due to the coping 19, which forced us to adopt in response, but.
Oh primary focus was and is to complete their less space the clinical trial by the end of the year.
Preparing for a be other submission and ensuring commercial preparedness.
Building manufacturing capacity and expanding our human resources kept it capabilities.
As you can see in today's news.
Even despite.
The impact of Corona, we are advancing got all of these from not everything was and.
Today, we announced that we are maintaining the <unk> pays the phase three activity to complete all study treatment.
<unk> by the end of the year.
This is the man that's our focus unresolved working closely with all six United States investigations sites.
At a time when most clinical trials in the U.S. have seized operation.
We are very fortunate that are basically clinical trial, what's fully enrolled before this pandemic.
As we were able to continue the treatments through this.
<unk> 19 restrictions.
Oh commitment to the left community drive our results and those of our face that he partners.
We have kept that commitment.
All of our manufacturing facilities are operating and growing in this period without delay.
As you know Oh.
<unk> program have been.
Really impacted by the international travel ban I know many of your disappointed you want to tear some of the exciting results I was talking to the previous call.
We don't control the <unk> that mic and at that Cold, we didn't think that this program would've been delayed.
Just a little bit more detailed from the 13 patient.
Eight hours radio five and not as raised.
And three of those five patients did not finish their treatment.
Also one of those radio patients are still has to get through treatment.
Therefore, the center is not comfortable to share result.
Bits and pieces, it's not professional another seven to call when we get closer to that.
Unblinding, we may not be able to share this with investor community, we will share the data with the F.D.A. as you have day, we'll look at the totality of ourselves.
The same goes with the M.S. trials.
We did anticipate that we'll we'll be able to do the same as we did with L.S., but M.S. Unfortunately, even though the principal investigators up these wonderful sensors were supporting our view to continue with the trial the censorship like Mount Sinai. It just shuts down anything that doesn't have to do with colder than not life saving.
Not agreed to allow or M.S. patients to come in for treatment. Unfortunately, we as a company, but we're ready to manufacture and treats all of those station.
I'm again, so thankful that we were able to do that in the most important trials. The company you know hailed.
Next question <unk>.
So you're next question is why is this study design with a placebo bar.
Why is the trial salon.
Huh.
So the truth is I guess.
And all of US get these questions on a daily basis to our Twitter accounts and to our emails.
Late to the I think we are bombarded with.
Huge campaign from European patients and we appreciate it.
And we read every email.
And we're listening to it and it's important tool.
And I think this is a very good at paternity to address.
Some of this question and explain our strategy.
More than we explained up until now but please you must appreciate that we have to be very sensitive even when we have <unk>.
Tends to completion of our face to trial.
<unk> don't work diligently to find the best path forward that would enable us to provide access to patients.
While collecting the data necessary for an F.D. a pool.
Even though we tried we tried.
We found that such a pathway to access.
No wrong for patients that as credible and economically feasible.
Not exist in the current U.S. regulatory system.
The clinical development program for <unk> have to follow the only available F.D.A. pathway for possible approval.
The cards pays three trials design is based upon the F.D.A. guidance for therapy development.
Time of the pace three trial initiation.
Efforts to minimize the placebo.
Degree if the total number of patients and the trial, allowing an open label extension where advised against that because they would decrease the chance of success.
Ooh It was weekend the statistical power and therefore, the try I mean, not have been power to demonstrate substantial evidence for effectiveness for an F.D.A. approval.
Definitely at this time.
Just a few months before the thought of completion.
It would be even responsible the during the term analysts this because it will decrease statistical power and May jeopardize the path approval.
We have consulted with experts are beehive touch sufficient and other L.S. experts.
Strongly advised us not to go on that path way not to reflect the outcome.
We are fully focused.
We'll have the best support we can.
Free B.L.A. submission.
<unk> addicted upon a successful completion.
And positive outcome from the face to the trial.
<unk>.
So you're next question. He just went another company announced a new indication printer round.
And what will be your indication for exercise.
Thank you.
So we plan to announce a tourist clinical indication.
In June of 2020.
We just need a bit more time to finalize the details and the regulatory interactions.
But in logistics.
But we already know and the boards already approved Oh next indication.
What center, we are going to do who are P.I.s et cetera.
We <unk> we are constantly reviewing the data of our brief clinical studies using opera <unk> to them.
If it's true that outlet from technology has potential across several indications.
What is important for me to say again that why we are planning to pursue these additional education.
I would like to be clear that our number one priority.
Complete finally, they are less paste the trial.
Symbols that data necessary to submit there'd be L.A. package and gain approval in this syndication that in our commitment.
<unk>.
In the next question on what action says brainstorm taken taken to treat coated in 19 in Israel.
An announcement seeking bone marrow donation, what exactly does that mean have patience and treated and if so what were the result.
Ralph.
Well if you want the question.
Yeah of course, thank you [noise].
So as you know we are closely follow several other companies that have an off the shelf.
M.F.C. product that is being conducted in clinical trials in the U.S. another country.
You know, we don't have a ready off the shelf product.
I can tell you that our team has look very carefully oh, good 19, including.
Pre clinical and clinical components and regulatory aspect.
And we've decided to proceed with small compassionate treatment program in Israel.
The outcome of that passionate program and we'll see if a later wave appropriate 19 could benefit from our in house product that were manufacturing.
To to summarize for the first code that way.
[noise] excuse me, which we see right now we decided to not shift our resources away from a a laugh and it's high mentioned our focus is on completing the A.L.S. trial in a timely fashion.
But we do have great expertise in the expansion of M.S.B.'s and we're certainly ready to support manufacturing of these bells should they be down to be effective begin games go get 19, so more to comment a later date.
That's a question please.
Your next question concerns the hospital exemption when no.
13 in the initial cohort between it when we open new cohort be started when when we have the data.
And.
<unk>.
<unk> data overlap with the P.L.A. process and limits the ability to communicate.
[laughter].
Think I just cut it in the opening statement, but I wouldn't answer again because.
I see many investors.
Are asking that question before the call.
Oh like to not address.
These question.
As I stated in the opening remarks, the minister of L.
Drove extension of the ongoing study, which will enable us and roll. The full 13 patients. We had a date when we have to finish it due to cope with that Dave was not map of course, and they extended that because they're the ones that don't allow patients the visitors.
In addition, the minutes you have L. also approved an expansion of the hospitals and program to glued additional 13 patients.
Again, depending on when we will be able to allow more patients to visit the sensor here in Israel rule decide if we will move forward with this expansion.
For the status, we've not to have completed.
13 patient.
Approved and only once that will happen, we will be able to gather data and at least presented to the F.D.A., which is very important.
She also mentioned, but depending on its ups travel bands would be lifted as what gets closer to dissipate it'd be L.A. filing data, we may elect not to make public statements about these outcome as I said previously the truth is slip.
In the previous call sad that I'm excited and the data and real shirt.
I still would love to sure, but I do have to follow professional advice.
From the team working on the <unk> <unk> package, that's what's more most important I believe for on investors and even more so for our illustration.
For the company, we want to make sure that we don't take any risk not needed for the <unk> package the vehicle.
That's a question.
So you're next question concerns the progressive M.S. clinical trial.
His coded back to the trial when well the company have interim and final data.
Will be a L.S. data shorten the timeline progressive M.S. and how many patients our current or have 10 enrolled.
Wow.
Oh.
Yeah. Thank you very much for that question regarding the page two progressive M.S. trial.
Main delay we've found in in new patients enrollment, obviously, we had already enrolled eight participants in this trial.
And because of the site closures, we weren't able to bring new patients injuring the second half with March and the entire month of April and as I mentioned possible such as Mount Sinai in New York, where essentially locked down because of the terrible situation I think that is lifting wearing very close contact with all the.
Beginners, we expect the situation to improve.
So we we did.
Noticed that.
We are able to get biomarker data and clinical data from those who've already been treated and we do plan to perform an interim analysis after 50% of the patients have received all three study treatments.
We still feel that we may be able to complete the clinical trial by the end of the year. It depends on when covered restrictions are black and obviously, we monitor that on a day by day basis and as I mentioned were in very close contact with all the site and with all the principal investigators the second part of the question relate to B.A.L.S. data.
And how that might support C.M. out.
Program progress I think that clearly there is an opportunity there I think safety and advocacy for an L.S. patients.
Would be very important in interpreting <unk> or progressive takes too data and also next steps with the agency and we think perhaps more importantly, the biomarker data confirming the mechanism of action of neurons in a laugh at progressive in mass and other nerd degenerative diseases will be self supporting.
We we anticipate that the data from our progressive M.S. interim analysis will be helpful for a laugh and we also believe that our final data.
We'll be helpful and advancing milestones in or Progressive M.S. program. Thank you.
[noise] [noise] take yourself.
<unk>.
[noise] next question are what are the company's plan in the European Union, the United Kingdom and <unk>.
And how would David <unk> really expanding outside the U.S. markets.
Thank you very much on the rather than be discussing David <unk> plans Oh.
David These can you.
That question.
Alright, thank acclaim.
Right credit card and then in the on.
Dropping and things and U.W. state.
<unk> midnight and the regulatory.
And we we recently hired.
Very strong your finger or something.
That's going to like borders indeed that you're getting very good at three or four.
We we are anyhow.
<unk> you.
Yeah.
<unk>.
International market opportunity.
Only reinforced however that how immediate priority you way.
Where we have come to eat our 12.
<unk> then we are getting getting ready to be good at three pack way.
<unk> <unk> your own any.
<unk>.
Obviously, I, how I believe we can enter.
Depending on the next D.V.D. in response to that they're relevant national and regulatory authority.
Thank you.
Thank you David.
It's a question please.
The next question concerning <unk> commercialization asks how many patients will brainstorm B.A. tree and when will you be seeking a joint venture or a strategic partnership.
And <unk> no round, what's the what's the entire what's the situation with Medicare and the pairs.
I think there's you'll pick this one also.
Chores that I Wonder enforcer Hines said, we we're committed to the patient.
And <unk> or <unk>.
Can be able to treat the ready, but but that Asian that though.
We obviously as well accelerating our engagement and an hour discussion.
Potential studies you can <unk>.
Oh, Joe Buffy.
He is obviously an important question but.
<unk>.
The pre segmented right now.
But I can tell you now.
Our manufacturing cost today as a potential to be yeah rapidly using a combination.
And we already neck discussion, we keep buyers.
And.
We do not want to read those negotiation.
Excuse thing then too early.
Thanks.
Thank you David next question please.
The next question concerns manufacturing in the last Turnings call. It was mentioned that brainstorm is preparing for commercial sensation I building internal and external production capacity, enabling the companies that bridge early to map.
That demand exists today, what is the status of these plans.
I think quite clear that just announced today that clean them facilities and Israel that will support you. It's the first it's a good first that.
We're also preparing other centres of course.
<unk> they'll be ready.
But to told the workings and also we were finalizing is automation agreement.
And that would have a greater impact on the speed of this additional manufacturing capacity.
<unk>.
The question.
Concerns financial we received a question.
About the H.T.M.
Can you provide more details and how well the proceeds bees.
Yeah.
Time time and hang for the question so during the quarter and good Mark 31st 2020, we raised approximately 19.6 million in total by H.T.M. sale, we raised about 17.8 million by or previous 18 to 2020.
A million dollar capacity be fully exhausted during the quarter and raised an additional 1.8 million from the new 50 million 18 facility. They can be activated during this quarter.
Planting use are available capital prudently.
They are fun to make progress on the falling see business objectives.
We will use these fon du, it's definitely an incomplete are paid clean.
Yeah, what clinical trial and falling off the B.L.A., which as climbing David mentioned is our first priority little than putting in place Precommercialization N. <unk> and plan and as we approach the filing M.B.L.A.
We'll spend funds on continuing to advance our faith to clinical trial will also advance or new pipeline indication one it's a one could announce this summer.
And then we'll need to <unk> fun to scale up manufacturing capability of from your own in Israel brought in the U.N.B.U.K.
And then finally, we'll be pursuing <unk> will also be pursuing a regulatory approval of noodle in new for A.L.S. and in advance new regulatory started coming across pipeline indication anger addiction.
I get from jurisdiction.
Lastly will continue to advance R.P. clinical studies and data and out this additional pipeline indication using an N.T.X. or something so I I think these are the different areas, where we want to prudently deploy are fun would that I'll turn back time.
Okay. Thank you very much and I think about one one last question about the American Academy asked abstract to Sean.
Yes.
The final question is what are the most important conclusions from the abstract that was presented at A.N.
2020.
Oh.
Yeah. Thank you very much so the abstract that was presented is a critical and adding another layer of understanding to how we how we are we position the mechanism of action of neurons in particular in this case immunomodulation, what we observed.
In our experiments was that.
<unk> when combined with peripheral blood cells increases D.N.T. regulatory function in terms of the number of cells and we found that this was mediated in part by the expression.
Induced expression of I.L. 10, and for those who no this and those who don't I. All 10 is a very important molecule, it's known to be deficient in A.L.S. It correlates with the L.S. functional decline. It also correlates with progressive M.S. disability and it may be that increasing aisles.
And and being T. regulatory function are important therapeutic strategies to rebalance the immune system. So we're very excited about this and we're continuing to do more biomarker work as we speak thank you.
Well. Thank you so much Jerry.
<unk> other colors when asked some questions. Please.
Thank you well now they get into question and answer, especially for the audio topic.
Anyone who wishes to ask a question.
Star one of your telephone keypad.
If you wish to remove yourself from the question to you May press start to.
Well now wait poor.
Professionals.
We have a question from Jason Mccarthy Maxim Group, whose go ahead Sir.
Hi, everyone at a day on the line for a good thanks to take my question Oh. So you mentioned earlier on the call that you plan to warm up now.
I don't have tasted been treated or the phase two N.S. trial I was hoping you could set some clarity on Monday, you can when brought back the entering data read that thing.
<unk>.
Yeah. Thanks for the question you know at this point in time, we're hoping that over the next few weeks the clinical trials by school reopened there'll be able to bring patients back do assessments enroll new patients and continue their treatments. Unfortunately, we you know this is a very fluid situation.
You are aware, we are still hoping that later this month or early next month. So we'll go back to our schedule, but this point in time I wouldn't want to estimate a specific date or time, because there's a variable that we we don't have control over.
Okay. Thanks to any additional inquiry shit.
<unk>.
They have a question for Marcia Caplin Ameriprise financial please go ahead.
Hi, My question is.
How are we to what is the lowest period that any of the n.
Critical trial participants in in the new around well and if any of the trials could just depends.
Me too boy page one ever been brought back into the trial, but like three [laughter] see how long somebody who is getting positive results.
Can continue to get treatment.
<unk>.
Very good question <unk>.
Yeah. Thanks to the question the duration of the Phase three study for individual participants is 11 and a half months that includes seven months. After the first treatment. So that that's the duration of exposure that that we have in the current population currently the mud.
You already have the patience into pastry trial have received all three treatments and this and a significant number have actually completed all study assessments. So you'll have that continues to grow by the month.
We obviously, we'll be looking to last patient last is that in the fourth quarter.
And at that point in time, I think we'll have a a good data set in terms of the other aspects of the question whether phase two patients came back for repeated treatments or other assessment the answer too bad. It's no. Good that was it pays to study and it wasn't designed for a long term follow up.
Thank you for the question.
Is there any plan to look into it.
Second set of treatments for any of the patient.
<unk> not at this time, we we obviously receive a lot of questions about.
You know about what happens at the end of this study and obviously, we're looking at all options at this point in time, but we haven't made any decisions and we haven't been down they need additional treatments that potentially could be offered but we're we are thinking about it.
For the question.
And then the last quite to this question.
One of the things that I've been reading his potential well this tweak treatment may have hi, <unk> certain percentage.
But the clinical trial participants.
There's also to eat a time, where Ben wears off.
You have any information on how long it yeah it depends it without.
Maintained in the picture.
What were so.
Yeah, well, that's that's a good question anyway.
Yeah.
Yeah. Thank you for that that's a very good question all treatments were off.
And ours ours is no different what we saw on our face to trial was that the the median duration of affect was.
Roughly you know within the range of two to three months and that's how we chose a two month dosing interval. There's also some pre clinical data suggest that the persistence with M.S.C.'s.
In in animal models, there's about three months. So we think that as long as the cells through there and continuing to deliver their cargo which was the mechanism of action that we can expect to treatment effect and obviously, we wouldn't expect to treatment effect beyond the persistence of the transplant itself so as as our treatment.
As a drug sales or a drug delivery system. We would think that you know repeated repeated dosing is needed and that an interval of two months in our case three trial is the best option at this time, Thank you pretty question.
Thank you operator that any other questions at this time.
It's a sign so there are no for their questions.
You want to insert once again, all people going to ask questions.
Okay. We do have someone has just registered.
But John Evans from Raymond James.
Of course, it's go ahead so.
Good morning, everybody couple quick questions in the N.S. base to study.
Remind me is it one injection or are we doing three injection and the reason I ask is that.
We stopped at her only patients it could be starting to 10 months until we get that magic number of temptation.
Well.
Yeah. Thanks, John Nice to hear your voice John out you know get question again I'll forgive me.
He does [laughter] that but it's good and we appreciate we're we appreciate the questions. The phase defaced to M.S. trial is as you say a three doses obviously, if the situation in the hospitals per se is.
With without resolution, we would have to make a decision what we hear from the various sites and we've been in.
Actually daily contact with the the experts at all those sites is that they're planning to open up soon and I think that the best course of action for US is to keep the protocol as is provide three treatments to each individual in the trial and then have a very strong data set I think that anything that diminishes the quality of the data.
Or the amount of data I think is not in the best interests to brainstorm to patients or investors at this time. So our plan is to continue with the schedule, but we had originally said and we'll see if we can get back to business as usual as soon as possible. Thank you. Okay. Thank you next question back to everybody.
His favorite tough topic, the hospital exemption program I seem to tend to you've received 3.4 million.
From the H.G. to date, who pays that.
Only the non is really patients paid the whole reason why.
Israeli government wanted us to treat a is really patients, which kind of afford anything so they're paying zero.
Okay. So it's really medical tourism.
Opportunity allows us to treat a few patients and Israel for free that wasn't a return of not having you know oh the trial in Israel.
<unk> probably with close.
<unk> the medical authority in Israel does not pay for the Israelis, It's it's done for free and it's supported by the international patience, but if you have done exactly five patients support <unk>.
Wow, so five patients paid over $3 million, that's not going to be the cost of Nurown. That's just not over there I would imagine.
100% nothing these patients are very good hata people not only is they want to get possibility of treatment. You really are very happy that other people also getting doesn't pretend to.
And to the right time to thing.
Okay, but that's all a text gentleness.
Thank you and other question.
Once again, if you wish to ask a question on the teleconference piece first star one on your telephone keypad styles.
Gentleman, we have no for the questions registered.
Thank you very much.
Operation go, but she to the closing comment.
This <unk> <unk> <unk> teleconference me <unk>, thanks for calling.
Thank you very much or anything.
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