Q4 2022 Brainstorm Cell Therapeutics Inc Earnings Call
Greetings and welcome to the Brainstorm cell Therapeutics fourth quarter 2022 earnings call.
At this time all participants are in a listen only mode.
As a reminder, this call is being recorded and I will now like to introduce your host for today's call Michael Wood of life Science Pfizer's. Mr. Wood, you may begin.
Good morning, and thank you for joining us.
Earlier today Brainstorm issued a press release with its financial results for the full year two.
2022, including a corporate update.
Before passing it off the company management for prepared remarks, I'd like to remind listeners that this conference call and webcast will contain numerous statements descriptions forecasts and projections regarding brainstorm cell therapeutics and its potential future business operations and performance.
Regarding the market potential for the treatment of Neurodegenerative disorders, such as they lap the sufficiency of the company's existing capital resources for continuing operations into 2023 and beyond the safety and clinical effectiveness of the New York Technology platform clinical trials, a neuron unrelated clinical development programs on the companys ability to develop.
Strategic collaborations and partnerships to support its business planning efforts.
Forward looking statements are subject to numerous risks and uncertainties many of which are beyond brain trucks control, including the risks and uncertainties described from time to time in the company's SEC filings.
The company's results may differ materially from those projected on todays conference call and the company undertakes no obligation to publicly update any forward looking statements.
Joining us on the call today will be Mr. Hyde Leibowitz, President and CEO of Brainstorm, Dr. JT Lindbergh co Chief Executive Executive Officer, an Arab Populists interim Chief Financial Officer.
David set born executive VP and Chief operating Officer are also on the call and will be available to answer your questions. During the Q&A session.
I'd now like to turn the call over to Mr. Li.
Please go ahead.
Yeah.
Good morning, Thank you Michael.
I want to thank all of you that joined us to discuss our 2022 financial results and.
And recent developments.
Throughout 2022.
<unk> had a number of important clinical and operational achievements.
Which we believe position the company for further success in the year ahead.
Our priority in 2023 years to advanced neuron through the regulatory process as expeditiously as possible.
We were very excited to announce earlier this week at the <unk>.
Do you intend to hold an advisory Committee meeting.
Thus, our BLA seeking <unk> approval as achievements for Atlas.
We held a conference call on Monday to discuss the planned outcome.
But given the importance of this news as well as some of the follow up questions. We have received since then I think it's worthwhile to summarize the course content and emphasize a few key points.
First.
The information we communicated on Monday is that neurons BLA is back under review.
The FDA has committed to an advisory committee meeting.
The date of the AD Com is unknown at this time, but we know the FDA is actively working on it.
We will share it with you once we receive it from the FDA.
I want to emphasize a few additional points from our investor call from Monday.
Point number one relates to the review process for neurons filed the BLA.
Now that the BLA is under review.
Review process should be the same as any other regulatory mechanism, we could've utilized to get to this point.
The regulatory response.
There will be an app some guided by an agenda and a set of questions put forward by the FDA.
These questions or question will allow experts at FDA and brainstorm to frame, the efficacy and safety of neuro and any of us.
Independent medical and statistical experts members of the ILS community and all the other key stake holders will then have the opportunity to participate in an open discussion on the prospect of shared by the FDA and brainstorm as well as the need for new therapies.
The agency will then render a decision on the BLA by specified the stupidity.
We anticipate that we will have the date of that come soon.
And when we receive that that will also have clarity on that particular day.
Yes.
The next point I'll emphasize relates to the regulatory mechanism, we utilized which is formerly known as the pilot where protests pathway.
Despite its name this mechanism is a standard regulatory procedure and is not inherently agonistic. In fact, we collaborated constructively with the FDA before the agency provided us with several regulatory options that would reactivate the BLA in order to allow neurons to be discussed at half time.
As mentioned on our call on Monday. This pathway was ultimately chosen over the other options because this allows the fastest regulatory path to an outcome.
This was the driving factor in our decision, making we recognize the urgency that patients deserves.
Next I'd like to remind those listening to the contents of the refusal to file letter we received from FDA late last year.
Now speaking about how we plan to address these points.
The idea of letter included one item one item related to the trial not meeting the standard for substantial evidence of effectiveness.
Or.
The primary end point missing statistical significance and the remaining items related to chemistry manufacturing and controls and short CMC.
Given our exemplary record of high quality manufacturing.
We have full confidence that we will be able to remediate each of these points in a straightforward manner in fact.
We already have conducted much of the necessary work in a short timeframe and submitted an amendment to the BLA on March seven 2023, which response to the majority of the manufacturing items raised in the letter.
Work to respond to the few remaining Mexican manufacturing items is ongoing and would be conclude fleet in due time.
The remaining the remaining item Doctor letter and the only item related to our clinical data.
That will be the focus that will be the key points of discussion with our upcoming got to come.
We view the opportunity to discuss neurons full dataset in a public forum offered by the Optum as an extremely positive development for brainstorm and the entire AOS community. At this forum offers an open conversation among agencies of yours grandson's experts clinical program investigators and all other relevant.
All this can take place each of these groups has its own expertise experience some points of view to contribute and it's critical that all voices are heard given the complex scientific and policy issues at hand.
Finally.
I want to once again, thank the EBITDA for the calibration throughout this process that led them to this decision.
Given our datasets and incredibly urgent need for novel therapies that can improve the lives of individuals living with Atlas.
Leave an advisory Committee meeting is the most prudent and appropriate next step in their own regulatory paths.
With this I will now turn the call over to my colleague Dr Student Lindbergh.
Thank you.
Once again I want to make the point that the carrying an AD com has been central to our strategy, because we have a robust and compelling data set.
That will benefit from a deepened thoughtful discussion at this public meeting.
While our phase II trial of neuro and analysts did not reach statistical significance on the primary endpoint.
Firmly believe that the totality of evidence from the trial will ultimately support approval.
This belief has only grown as we've continued to analyze the trial results and discuss our learnings with leading experts in the analyst community.
Along these lines I would like to highlight a presentation that was made at the annual <unk> muscular Dystrophy Association clinical and scientific meeting.
It was held in Dallas last week.
I believe as we've explained before we now understand that the results from our phase II trial.
Were influenced by participants who entered the trial with advanced Atlas and yourself victim to the floor effect of the L. S functional rating scale.
A floor effect as observed when scale items reached zero and ongoing progression cannot be measured on the queried items.
The rate of the Ala separate Saar decline appears to slow and plateau in many patients.
Despite further deterioration of the participants function and health.
While the floor effect is certainly a limitation of the illness functional rating scale the.
Good news is its presence can be objectively measured demonstrated and accounted for.
This is what we've done with various techniques, including with the new analyses presented at M. B a last week.
This analysis focused on trial participants who were not impacted by the floor effect at baseline or in other words participants who did not have a.
Zero on any item of the AOS functional rating scale at baseline.
Which means that the scale was able to measure decline that occurred in participants across the entire scale.
The number of participants with no evidence of a floor effect at baseline in this trial with 106 out of 189.
Just over half the participants in the trial.
When looking at these participants there was a significantly higher response rate with neuron.
Impaired to placebo on the primary endpoint.
With 41% of neuro and participants reaching this substantial definition of clinical response.
23% on placebo or a difference of 18%.
And this had a significant P value of 0.03 pipes.
Additionally, in these participants with no evidence of a floor effect, we see significantly less disease progression on the endpoint average change from baseline and the Atlas <unk>.
Our two week 28.
There was a difference of two points to three one with a P value of 0.04.
A copy of this presentation is on the events and presentation section of our website and I would encourage those interested to read that.
These important findings not only gave us more confidence in our clinical data, but also address an area where there appears to be a misconception among some observers.
There's a perception that the phase III trial had a higher than expected placebo effect with approximately 28%.
Let's see bow participants responding on the primary endpoint at week 28.
Well, it's true that we expected only 15% of placebo participants.
To be classified as responders on the primary endpoint, which.
Which is based on based on numerous post hoc sensitivity analyses. We can objectively say that this was a floor effect that impacted the primary end point and not a placebo effect.
While the AOS suppressor tourist act impacts all analyses that leverage the analysts at our scale data and.
The primary endpoint when the floor effect occurs it results in a misclassification of clinical response.
The plateau also occurs due to the inability to measure further decline on impacted items.
Results and also resulted in a difference from the pre treatment rate of decline.
And participants meeting the definition of a response.
Thus.
This is a scale phenomenon and not a halting of clinical symptoms.
In fact in the same trial participants who had the highest rate a floor effect in this study.
Driving their Alice efforts, our scores to meet the criteria on the primary endpoint.
That's a clinical response these same participants had the lowest SBC scores.
Our highest rates of pre treatment decline.
And the lowest baseline Atlas up our star scores.
And while I'm focusing on these analyses that controls of the floor effects, which include these new analyses presented last week, let's not forget that in a prespecified group of participants with the L. A superstar score about 35.
There was a larger treatment effect across all endpoints with neuron compared to placebo with a statistically significant difference on a key endpoint the average change from baseline in the L. A separate Saar.
Lastly, in addition to this pre specified and sensitivity analyses by any macro data collected during the trial also demonstrate the importance of accounting for the analyst surfers hard floor effects when evaluating clinical endpoints.
These data showed in your own positively affected multiple pathways and.
And are intimately involved in a loss.
Including those related to neuro degeneration, neuro inflammation and neuro protection.
Importantly, the changes observed were consistent regardless of participants levels of disease progression that baseline with positive effects seen in trial participants with less advanced Atlas.
And with those with more advanced.
Disease at baseline.
One of the reasons, we've been able to drive such valuable learnings from our trials biomarker data is because we employed an extensive specimen collection protocol in the study.
This protocol, which called for the matched collection of up to seven Sir I'm in CSF samples from trial participants.
Over a 20 week period is to the best of our knowledge the largest longitudinal specimen collection protocol ever employed in an Atlas trial.
To maximize the value of these samples for the analyst community. We partnered earlier this year with meals to provide the public with access to samples from placebo treated trial participants.
This was done in connection with a 500000 dollar grant previously awarded to Brainstorm by the ALS Association and I M E. L. F to support biomarker research in this phase II trial.
By providing the analyst community with access to this clinical samples, we hope to drive additional research that will facilitate the discovery of new breakthroughs.
For patients with ALS.
I'll now turn the call over to Oliver to discuss our financials.
So.
Thank you Stacey it is my pleasure now to walk you through our full year 2022 financial results Brainstorms cash cash equivalents and short term bank deposits were approximately 3 million.
Remember, they're supposed to 'twenty to 'twenty. Two this compares to approximately 22 million on December 31st 2021.
Research and development expenditures net in the year ended December 31st 'twenty, 'twenty, two or 14 million compared to $15 2 million for the year ended December surface 2021 Jim.
General and administrative expenses for the years 'twenty to 'twenty, two and 2021 respectively.
$10 9 million and $9 3 million net.
Net loss for the year ended December 31st 2022 was $24 3 million or 66 cents per share as compared to a net loss of $24 5 million or 68 cents per share for the year ended December 31st 2021.
Now I'll turn back the time to close the call.
Most of what you enable thank you very much Ala and Michael Woods. Please can you read the.
Please specify the questions we have.
Before we will Nicole Port Colas journey.
Michael.
First question.
Can you tell us about the biomarker response of the trial versus what happened in the expanded access program.
Yeah very good question Stacy that's for you.
Sure, let me start by summarizing what we've collected and the expanded access program.
Program. So we collected the clinical data and CSF samples.
And collected them on a schedule that was similar to the phase III randomized clinical trial.
As a as a matter of update the second period of the E. P has been completed which now completes the EAP and we've begun to analyze the clinical data.
The final biomarker samples need need to be collected from the sites and then samples from all of the EAP participants will be sent to labs. The same labs that were used in the phase III.
While for analysis.
And we will present the data in a scientific forum like we do with with all the data.
As a follow up question to that have you submitted your biomarker data to.
We are public.
Academic journal yet.
Yes.
But the maintenance script is fully written and its in its final stages of review with authors prior to submission.
We're really looking forward to getting it under review and generating what we believe will be an important publication for the analyst community in the near future.
Thanks, Karen regarding the time line on what to do for data and the Advisory Committee.
Sure.
RBC six month priority review.
Thank you we were waiting for the FDA to provide us this information and upset who communicated when we have this information.
But regardless, if you're on a six or a 10 month review timeline.
Can you clarify when the clock started running add to this happened at the time of the refusal to file data or is it running a new as of last Wednesday notice regarding from the FDA.
Good question. Thank you so the BLA is back under review it.
It has to be back under review for the FDA to grant an outcome.
The timeline read the data part Jeff is as follows.
February 20th February six 2023.
We have notified the FDA of the decision to request to FDA.
To file.
To file a new one.
For all of you on this.
Yes.
The following day on February seven we received confirmation from FDA that the BLA has been filed.
Therefore February seven.
To date, the review timeline became active again.
So we made this point during the prepared remarks, but it's worth reiterating.
We chose the procedure a file a protest because it allows for the quickest path to an outcome in this part of the block again.
The only other regulatory path, we would seriously consider was to revive the BLA and resubmit.
And we did not select this pathway could present substantial delays in the overall regulatory path.
But the journeys of other sponsors we experienced unexpected illnesses Denise.
Individuals living with Atlas, there's the urgency that comes with the regulatory clock associated with it.
Their findings.
And after them.
So again on February seven it was reactivated the file meaning the first two months already happened from the first day when we.
At September 9th.
It's paused after the ought to you a letter and then the clock started to tick again interpreter to seven.
Thank you.
And one last question is just financial question has the company been active with its ATM in the last few days and then what is the capacity of that ATM.
Thank you for that so no no. We're not active of course at these prices, we have confidence that we'll be able to activate them.
And for better better returns and less dilution.
We have disposed of course, we do have an ATM in place sponsors Barry James Raymond James I'm Living Inc.
But we did do a single Cros.
Investments made by a single institutional investor, we're not activating and we don't attempt to activate the ATM on these current prices.
Thank you for that.
And the capacity of the a T M.
$100 million.
Okay. That's the final question.
Thank you Holly would you open the call for any questions from callers.
Certainly at this time, we will be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad.
Confirmation tone will indicate your line is in the question queue. You May Press Star two if you would like to remove your question from the queue.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys, one moment, while we poll for questions.
Your first question for today is coming from Jason Mccarthy at Maxim Group.
Sure.
Hi, all thanks for taking the questions system.
Oh focus questions first did the.
Did the floor effect.
Impact the biomarker changes in the total phase III trial population and if not can the biomarkers be used to show that while the floor effect.
Impacted the ALS FRS score in the total population can you still see the impact of neuron just through the Biomarkers in particular, the NFL biomarker, which came up as a big deal during the Biogen.
<unk> com as a therapeutic marker.
Jason Thanks, so much the short answer is yes, but I wouldn't let stacy elaborate.
Yeah, Jason It's a great question and it is a really important point every time, we've talked about our biomarker data every presentation, we'd given in the public domain and is focusing on all trial participants. So its everybody that was in the trial, we see the same biological response with known across all patients.
In the trial and importantly, we also see no changes as we would expect in these same biomarkers, where participants treated with placebo.
So there is a very important finding that has brought to this overall study that.
That comes out in the biomarker data.
And it allows us to have even more confidence that the the impact that we're seeing in the Arab functional rating scale is in fact due to a limitation of the scale and does not reflect on something further about these these participants in the trial, we simply can't measure the decline in participants that <unk>.
Yes.
The advance of the stage of disease and to where the scale has heroes I can't measure can't measure differences. So that that's a very important point and we did very specifically look at the participants data the biomarker data.
From the thresholds that define participants that have a floor of the scale.
Those that don't and we see the same patterns across all of our Biomarkers. So that will become very clear in our manuscript.
That will describe our partner did a very fully.
The second question about <unk>.
No no I'm sorry.
To interrupt.
You you brought up near his home at night and I think you know there was a very broad and wonderful rich discussion at the two person AD com and a lot of confidence thing.
Displayed about the ability to it's important to have this marker and at worst diseases, specifically with Jefferson.
The mechanism of action with their product what I would say is that when we look at our biomarker data and we want to understand the relevant relevance of these very large changes that we see across markers of neuro degeneration.
Inflammation in addition to Merkerson their protection, we wanted to understand it.
I appreciate how important they were to the clinical response, that's observed and this is something as a company we certainly.
Thought about well in advance we knew it would be extremely important we don't want to just change biomarkers, we actually want to know that there's a direct effect on the clinical outcomes.
And so this was the subject of.
Second analysis plan that was submitted to the FDA before we have wind at our trial, where we outlined the proper ways to to actually explore these questions and these models that were that were pre specified identified three markers that the knowledge of the changes that were observed in a in.
The trial and where their participants were starting to be fine on that they were very important to predicting the clinical response that was observed in the trial and one of those markers actually was never saw that light. So that the changes in the knowledge based on values or are important to understanding the clinical responses are very relevant to clinic.
Response in addition to a marker of inflammation in Europe and protection. So it's.
It's very important we know that these three pathways are very central to our mechanism of action. We have also uncovered data that suggest that these are very critical the ability to modulate. These these pathways are very relevant in the clinical outcomes that we observe.
This trial.
Could you.
Yes also the floor effect drove in part the 28% or so.
<unk> group response rate and the total population in the phase three you had mentioned.
In the 106 patient data.
That was presented a couple of weeks ago at the muscular dystrophy conference where the.
If you remove the floor effect in the placebo response was 23% well neuroma.
I think you said, 40% or higher of the two.
22% was still above that 15%.
Statistical benchmark, how you designed the trial around that.
A function of something else or is that just the small in value and a subgroup that created some noise in it just looks a little bit higher than that 15%.
Yeah, I mean, I would say that that is within the ballpark of what we expected based on historical data.
So you know when we designed trials, we look at historical data and we really try to estimate based on other studies in other settings that natural history and also you know clinical trials.
And given the heterogeneity of the disease and the progression rate all of that can basically you know interpret and lead to to findings in trials and you really try to estimate what would you expect in a group of participants randomized to placebo.
The primary endpoint in the assumption that we'd see about a 15% response response rate on the placebo arm a 35% response rate on the on the neuron treated participant arm those were our assumptions going into it and in this sample of of Ah is about half of that data the neuron.
Responders were also about 5% higher than what we anticipated going into it was 40 or 41% and placebo of around 20%. So I mean these are.
We're expecting about a 20, 20% difference in the response rate and we see that in the sample.
And I would say that when you take small samples do you expect you expect some variability.
Oh aspect of the last question briefly can you just talk a little bit about the safety aspects of an autologous cell therapy being incredibly save I think it goes.
Relatively unnoticed when everyone's focused on efficacy.
Versus other types of therapies, and how something thats very safe like this.
Could really impact to the good you know an AD com decision.
Yeah, but that's also a great a great question with every single study, we take very seriously the safety. The trial participants can we monitor safety very closely.
We had a D V safety monitoring board monitoring.
Patient safety.
Across the study.
And we also go to great links to summarize what was observed in the trial. So we can certainly talk hypothetically as you're asking about the anticipated safety and I apologize.
A target cell therapy.
But what's important is to also come back to the evidence and what in what we generated.
We've summarized that theory completely very thoroughly and certainly that will be summarized them.
At our AD Com. This is a dimension that the physicians closest to our trial, including our data safety monitoring board.
Have have continued to express that there were no safety concerns.
Were existed in the trial or that emerged as a from a profile of Marin and that safety has been satisfied 222 there.
They're complete satisfaction.
Great. Thank you for taking all my questions.
Thank you Jason.
Question for your next question for today is coming from David bouts at small cat Zacks small cap research.
Hey, good morning, everybody.
So you're going to have a <unk>.
Outcome date soon a <unk> date soon so when does the company begin discussions with third party payers are in maybe discussions about patient access.
Want to get too far ahead of things, but at what point does the company begin to have those discussions.
But we just thought it a bit and I would like to bring in our Chief operating officer. He was working on this over a year now.
We are preparing for success as you can imagine David do you want to answer this question.
Sure. So thank you for the question.
We obviously been working on it for it for quite some time, we have as well.
Market access and pricing capability and expertise in house. So we had been engaged with.
With Payors for quite some time now.
Okay, and I guess kind of as a follow up without holding you to any hard and fast numbers here, but how quickly would neuro and be available say if it was approved and then where does your manufacturing capabilities stand at this point for how many patients you can treat.
Say in the first year or so.
That's a wonderful question of course, we're not going to go into hard numbers, but I will generally tell you that we have.
An outstanding partner with Carlos and.
The principal fight is very dedicated to us and we have additional sites.
Here in Israel as well, so we will be able to treat patients.
Immediately after approval of course, we'll have to enroll those patients et cetera, but from the manufacturing capabilities. We are talking to they are able to treat more patients.
If it were to have an approval.
Thank you for that question.
Okay.
And thanks for taking the question.
Sure.
Your next question for today is coming from mirror Klingberg, a private investor.
Yeah good morning.
As you know my son Mt was in phase III.
Six doses in expanded access, but this whole cycle.
What's your name sorry.
Sorry, I don't mean to interrupt.
Yeah, that's breaking out.
Sorry, I didn't hear the name.
My name is mirrored a klingenberg.
Okay. Thank you.
You bet.
So I was wondering if you were my son, Matt was in phase III and in expanded access we are very pleased and thank you so much.
So Matt symptoms started over five years ago.
And he's still walking talking eating breathing all of that he has not been trait. So I was wondering is there any information.
Our people and expanded access or in the trial and whether or not they're tripped.
And how long they live.
And are you planning on really releasing any more information about this study like you have through manuscripts and presentation prior to the AD com.
Thank you very much that's a very good question.
Hum.
I'll just speak about it before but I will let Stacy follow up and give you more specifics. Thank you for the question.
Yes. Thank you very much for the question. We're really pleased to hear your son is still doing so well type yourself because it does he sits right quite remarkable.
And from the expanded access.
Program.
First in terms of in terms of <unk>, we did not have any tricks during the phase two trial.
We just brought the data in house and I actually haven't seen yet the.
The.
Rate of any tricks that we're getting during during the extended access programs I won't I won't comment there but.
But this data becomes important to ongoing learning and it will be something that we will want to present and not only scientific forums.
But also understand the body of evidence in how it relates to.
To the to the approval of a product. So we are working internally to to analyze the data and then we'll proceed with our discussions with regulators as well as on sharing data in the public domain.
Yes, just to add them again I'm also once of course commend the wonderful news youre shooting for boats or some very happy to hear that but.
Understood.
Our next managed group would be a biomarker manuscript.
As you just said, even though your son got probably treatments quite a few months ago, but we got the final data set just a few weeks ago and that's why we have to analyze them.
Know how fast this is able to be.
Published in a manuscript because it depends on as you know the journals. Although of course, we will try to have it all.
Possible in our comments was that in the opening Stacey said, but we will definitely find the platform to share the EAP data and hopefully even before an outcome.
Thank you so much.
Yeah.
Your next question for today is coming from Candy Simon's a private investor.
Hi, good morning, everyone.
I'm, calling in on behalf my son was also in the phase three trial he uh-huh.
With 21 at the time that the phase III trial, and probably one of your youngest Ah trial participants who.
He was diagnosed on December 10 2018.
And you couldn't printer family. He was prepared for this diagnosis are much less who knew anything about <unk>.
Any trial regarding Atlas.
We did not know that in your own was the treatment that everyone was speaking within the analyst community.
We knew nothing about the phase one conducted in Israel, we are thinking about the phase two conducted here in the U S. What we do know is that our 21 year old son is positive.
For him.
We witnessed the benefits with our own eyes as well as what he told us.
However, we have basically been called buyers like people, who can't seem to grasp that your room does work.
And despite having email brainstormed twice requesting to be unblinded.
We have never wavered, and our epic advocacy for the approval of this treatment from day, one we have believed in it.
Paid was not offered in round one or two.
And I believe not being unblinded, we do not know with 100% certainty.
If you received it in the trial I do plan on testifying at the outcome, but it's been three and a half years since Covid received Pittsburgh and final trial injection.
With no ability to access more treatment.
Something that works for him. He has 25 years old now he is still breathing on his own despite being a lifelong asthmatic.
He's still eating him everything he chooses to eat.
Obviously, he has declined since being in the trial not being offered EAP one or two.
But it would be lovely to be able to speak with confidence and I'm curious if you are planning to unwind any of the trial participants so that.
The data that I presented them the outcome is more believable.
Feels like.
Bringing storm and I'm not trying to be rude has thrown us to the world.
Two.
Speak highly of other treatment that works, but didn't work called buyers because we are not unblinded.
People assume it's a placebo.
So my.
My question is is there any intention to unwind.
Thank you very much for this question can I.
Just a clarification first of all very very happy to hear about your son stability in this disease. This is wonderful news.
We didn't have to EAP programs, which was the same EAP program when twice for the same patient that had been concluded. So unfortunately, we couldn't include more efficient we'd love to have the possibilities. So so sorry, we couldn't include more patients.
We read all blinding policy, we know that some of you of that.
And of course, we are.
Very very strong and all of our policies.
What's the best interest for the trial.
Regulatory process to unwind.
The last piece, it's really to give you a detailed explanation of that which we already I think a pass through your doctors, who were very happy to have this proclivity to tell it to you directly but you should know we have the best interest of.
He left patients and what are the what's best to get this.
The product.
Access to patients yesterday, we understand the urgency.
And I heard you loud and clear that you want to be to talk even stronger.
I get that but we have this conflict of interest like what's the best interest of getting those products approved.
That's what we have to focus let's face. It. Please give those professional inside you have from your 25 years in the industry, what what old trials do usually there are of course some of the two was a little bit different way, but they're not enormous.
And thank you again for calling counted.
Thank you for taking my question.
Can be thank you very much for sharing the background of your son and.
We are encouraged every time, we hear updates in terms of the stability of patients. So I'm thrilled he's breathing on his own and able to eat.
But let me, let me step back and provide insights.
Insights into the conversations that we've had and really what drives our position right now.
So from the time that the trial the phase two trial completed we have learned and have received request from some participants requesting information about the randomization status.
In some instances as you're you're seeking to actually be able to describe with confidence the results that you've seen and with your son stability.
That that he has experience, which which is unusual in a disease like this for others. It's information that well offer peace of mind or closure on the trial and we have to say that our first and strongest inclination is to honor. These requests.
The dilemma that we must confront comes with a desire to provide this level of data has the potential to be detrimental to the overall community in the sense that it could interfere with the regulatory review.
We believe this would be the case, if we provided patient level randomization, while the regulatory review is underway.
And for this reason, we made the difficult decision to maintain confidentiality of randomization.
We have evaluated the merits of this decision it multiple times since the trial completed and we continue to believe that maintaining confidentially of randomization remains the best decision until the regulatory review process is complete as it facilitates discussion of the evidence at a treatment group level.
And we know this is an industry best practice and I know it perhaps is confusing.
From from the questions you're asking.
But fundamentally it.
When we look back to the forefront and even the two first one AD com from very recently there were important scientific benefits from preserving the confidentiality of treatment assignment as they did as well in the interpretation of future data as it reduces bias in the open label.
Period of their study these same parallels exist for us with the expanded access program. So I hope. This gives you. Some insight we are absolutely motivated by what is best and would be.
In the best interest of the entire set of people living with Atlas, who could benefit from an approval and that is at the forefront of our action.
Okay. Thank you I appreciate your explanation. Thank you.
Yeah.
Ali we have we have reached the end of our question and answer session and I will now turn the call over to management for any closing remarks.
No just thank you very much thanks, I'll leave us very well on this call and thanks for everyone for the questions and have a nice day.
This concludes today's conference and you may disconnect. Your lines at this time. Thank you for your participation.