Q3 2021 Brainstorm Cell Therapeutics Inc Earnings Call

Good morning, ladies and gentlemen, thank you for dialing in to the Brainstorm Conference call. Your conference will begin in just a couple of minutes. Please stay on the line to your conference will begin in just a couple of minutes.

[music].

Good day, ladies and gentlemen, and welcome to the Brainstorm cell Therapeutics third quarter 2021 earnings call at.

At this time, all participants have been placed on listen only mode and the floor will be opened for questions and comments. After the presentation. It is now my pleasure to turn the floor over to your host Michael Ward of lifestyle advisors, Sir the floor is yours.

Good morning, and thank you for joining us.

Before we begin the opening remarks I'd like to remind listeners that this conference call contains numerous statements descriptions forecast and projections regarding brainstorm cell therapeutics.

Potential future business operations and performance.

Regarding the market potential for the treatment of neuro degenerative diseases, such as Alison I Miss this.

You can see at the company's existing capital resources for continuing operations in 2021 and beyond the safety and clinical effectiveness of the new web technology platform clinical trials of neurons and related clinical development programs and the company's ability to develop a strategic collaborations and partnerships to support the business planning efforts.

Forward looking statements are subject to numerous risks and uncertainties many of which are beyond the brainstorms control, including the risks and uncertainties described from time to time in its filings with the SEC.

Company's results may differ materially from those projected on today's call. The company undertakes no obligation to publicly update any forward looking statements.

Joining me on the call today will be hired Leibowitz, president and CEO of Brainstorm on a populous interim chief financial officer.

Dr. Stacy Lindbergh executive VP, and Chief Development Officer, Dr. Ralph current President and Chief Medical Officer, Dr. David Sandberg Executive VP and Chief operating Officer will also be on the call and will be available to answer your questions. During the Q&A session.

Now I'd like to turn the call over to Mr. Leibowitz. Please go ahead.

Thanks, Michael.

Thanks to all listening for joining us to discuss our third quarter financial results.

And corporate highlights.

Our updates on new role in both the L F and progressive I must programs that I want to cover today.

As well as some important additions to our management team.

First with regard to our lead program in the world in AOS.

We remain committed to advancing this program and pursuing the best and most of that production.

Forward to enable patient access.

Patients and advocates.

Changing the landscape of E L F.

To match the urgency of their disease.

Given the important changes.

We are in active dialogue with regulators.

All of the regulatory plan.

And we will share that as soon as appropriate.

We recently presented important new biomarker data from our phase III trial in their life.

The poster session at the northeast consortium.

Neil in October.

The presenter was Dr. James <unk>, the principal investigator of the trial.

And the director of the Massachusetts General Hospital.

Multi.

As Linda.

Got it.

Biomarker analysis as a reminder were prespecified in the statistical analysis plan.

Was completed and submitted to the FDA prior Tom blinding of the trial.

These involve collecting CSF samples from all participants in <unk>.

Pre specified biomarkers at certain time points from baseline through week 20.

The results of these animals this shows the.

The neuro treatment resulted in significant changes occur.

Across many biomarkers pertaining to neuro degeneration, neuro inflammation and neuro protection.

While our levels of these biomarkers remains stable then unchanged following treatment with placebo.

Another important dialysis that was pre specified was designed to help us understand.

How's the observed changes in Biomarkers related to clinical response observed in the trial.

As shared in the Nielsen patient Dr. Berger presented.

<unk> from a stepwise regression model, which identified identified a set of biomarkers.

Think of the pathways of neuro protection or Oh, there's an annual degeneration biomarkers.

But accurately predicted clinical response.

In the trial with over 80% accuracy.

And not only because we have no significant changes in biomarkers, both for AOS with neuro, but they.

There are meaningful in helping us understand who responded to treatment and disposal.

Further our understanding of the mechanism of action to nail that.

Which target multiple pathways and provide additional evidence linking the mechanism of action for New Orleans impact on any other disease progression.

The future of this information.

It will also help future studies that Youll CSF Biomarkers the advance AOS science, we do of course plan to share them with the FDA and other regulatory authorities.

Hyperlinked to this poster was included in the press release, which is available on the publications section.

Painful flip side.

We encourage investors to review it.

Turning now to our progressive multiple sclerosis program.

The results of our phase two study of her own in Progressive I met were featured in an oral presentation as a citizen Congress of the European Committee of the research in multiple sclerosis correction.

We announced positive topline results from the study in March of this year and this was our first opportunity to share the results the broader neurology community at a major international in this meeting.

The presentation was given by Dr. Jeffrey Cohen.

The director of experimental Therapeutics at the Cleveland Clinic Medical Center for a medicine principles. After you get into the new one M S phase II trial.

That's the color sure sure.

Study achieved its primary endpoint of safety and Tolerability. In addition, we demonstrated a reduction.

A little inflammatory biomarkers and an increase neuroprotective biomarkers in Vienna.

In addition, we observed assistance improvement across functional outcome measures, including walking upper extremity function vision in cognition.

Based on what was the main sponsor for the study, but we had additional financial support for the biomarker analysis from the National multiple Sclerosis Society path forward program.

They're actively.

Working on a development plan in order to advance the progressive Ms program.

So the decision on approval.

Currently holding discussions with BMS experts and.

Seeking guidance from the FDA to determine next steps.

We have submitted the manuscript summarizing the final results for publication.

Based on the developing an innovative access on basic platform technology, which utilizes exosomes derived from neurons.

We have been exploring acute respiratory distress syndrome or ards.

Is it potential first indication.

Clinical data from this program will publish and adult Samsung just therapy at the beginning of the year and Dr. Patel, Our retail Vice President of R&D had an opportunity to present. This data at the New York Pencil Foundation of 2021 virtual meeting which took place in October.

The results showed that <unk> zones, we're capable of increasing but just aspiration and reducing loss pathology inflammatory infiltrates.

And levels of pro inflammatory cytokines in two animal models of Ards.

We showed that <unk> was superior to uneven.

Exosomes and all examined parameters.

Finally, I want to mention some important additions to the management team and to the board of directors.

Last week, we had appointed Dr detector Senior Vice President of Global strategy, and Medical Affairs, and African factors Senior Vice President of Medical Affairs and clinical innovation.

Our perspective was most recently a clinical associate professor of Neurology at University of Arizona College of Medicine, and the work with the industry developing drugs.

At Novartis, La Palma and Pfizer.

<unk> brings more than 20 years of experience in the pharma and biotech medical.

Medical Affairs.

Origin and previously at Sanofi Aventis.

Pfizer Roche among others.

Both Dr. Spector and that's the fact actually will work together to create a formal global medical affairs function.

As we prepare for our anticipated growth.

In addition, we expanded the responsibilities of that particular member executor.

Executive Vice President and name it hurts us the new position of Chief Development Officer.

In this role she will build the leadership team for development regulatory affairs to support clinical development in multiple disease areas and technology.

We also recently announced that Dr. Tomatoes viral was appointed to the board of directors in October the battle with the physician entrepreneur business executive editor author and philanthropist.

As founder.

Chairman and CEO.

Venture partners, which provides capital management in excess of global network of vectors companies in late preclinical and early stage clinical development devices.

He's also chairman and CEO of virus and international Medical Education and market Research organization focused on Africa, and the Middle East.

At this critical juncture in the history of Brainstorm cell therapeutics visa.

These appointments will expand the leadership team with capabilities that complement our already strong team to help us as we advanced our development portfolio of innovative treatment.

I want to formally welcome Sidney came in language to brainstorm and congratulate spacing on our new responsibilities.

I will now turn the call over to our police.

He will review our financials.

Thank you.

It's my pleasure now to walk you through our third. Thank you. Thank you one financial results.

<unk> cash cash equivalents and projects.

Approximately 58 million as of December 31, and this compare proximately $35 million.

Thank you thank you Juan.

Search and development expenses for the three months ended September 30.

And thank you Sandy.

$3 6 million and $4 1 million respectively.

As such in development expenses.

1021.

One 9 million.

Blue's participation from IAA category.

General and administrative expenses for the three months ended December 31.

Approximately $1 7 million and $2 6 million.

Okay.

Net loss for the three months ended December 31.

But the breadth of the decline.

$5 3 million or <unk> 15 per share as compared to a net loss of approximately $1 5 million.

14th sensors, yet for the <unk>.

Three months ended September 32000 claims.

Hi.

Thank you so much ala.

Mike would you please.

Yeah.

Reading all of the questions we have received from investors.

I guess the first question.

Directly or do you find that what do you say to those who state that you have ethical obligation to make neuro and available now for.

For AML patients or do you feel that the phase III trial met high ethical standards.

I think most patients with AOS would agree with you.

Thank you Michael.

We hear and understand the urgency expressed in this question.

Because we arent urgency everyday directly from patients and through social media for access to neurons.

This is a complicated question with lots of dimensions.

Let me start by acknowledging that broad access to maneuver on at this point in the development cycle can only come through a regulatory approval.

However.

We engage with regulators regulators and took action to establish a small E&P.

Funded access program.

Demonstrates our urgency to make newer and available beyond the completion of the phase III trial.

We treated the maximum number of patients we were able to do with.

The Companys resource limited.

The FDA gave its full support for the ERP and the dosing for this protocol has now been completed.

This will provide additional data into the effect of new room based on a longer treatment period.

And while we haven't released any data from this program.

Customers towards testified at the recent congressional hearing again I quote.

There are reports from people in the neuron trial, an expanded access program.

Improvements in function and not something we typically see or hear an analyst.

In the fourth.

We are excited to see what we will learn from this program.

So turning to the components of your question that inquired about bring some ethical obligation.

There's no question of our minds that this trial meets an extremely high ethical standards.

Even though we're rolling up a delusion more representative of the analyst community then most AOS trials made.

<unk> made it more challenging to conduct the study.

We truly believe in the effectiveness of neuro.

And we're working diligently to provided to those who could benefit even as we continue our research to learn more as.

As we noted in our earlier remarks.

We have submitted the full data set for publication in a peer reviewed journal.

I would expect to be able to share these results widely upon publication.

We sincerely hope the people and families living with LLS no.

Their best interest and our.

Next question please.

So what is the status of the neuro and application to the FDA and will be application being submitted are considered early.

Thank you would you take this one.

Sure.

Been clear in our communications every time that before we would make a decision around the filing of the BLA application of Iran. That we intended to first published the results from our trial in a peer reviewed journal and second can meet with important members of the analyst community, who were not involved in the conduct of our phase III trial.

I'm just shared on this call we've made great progress with these goals and immediately after the publication is in print we will be prepared to speak to our plans for BLA filing.

Thank you.

Our next question. Please provide an update on the identification of AOS Biomarkers.

Hey, CCR soon.

Sure.

In the phase III trial, we generated a unique set of biomarker data to the collection and analysis and seven CSF samples every time going from baseline to 20 weeks in all study participants and as Tim just reflected we observed significant improvements in multiple CFO.

Workers your inflammation neuro degeneration, and you're a terrific factors support with your treatment, while placebo remained unchanged and stable.

A few examples so pretty.

All of these are at week 20, which is the final time point that we collected by Mercury deal.

With that job, which is a marker and important Margaret neuro protection, we observed a twofold increase and with euro and treated patients while placebo remained unchanged with MCP, one and Mark correct neural inflammation.

The values, where 74% with neuron treated patients on placebo.

Right.

A remarkable reduction over the placebo values finally, north on that light a marker of neuro degeneration with 84% of placebo values in your own treated patients at that time period.

As we shared in our prepared remarks, Dr. James Perry principal investigator from mass General recently presented the results of a.

Stepwise regression model at Niels.

Identified a set of biomarkers spanning these really important pathways of neuro protection neural inflammation in neuro degeneration.

And this model on.

Accurately predicted the primary clinical response, our primary endpoint in the trial with over 80% accuracy.

So not only are there changes observed in these important biomarkers for Atlas, but they're meaningful and helping us understand who responded to treatment in the study.

So in summary, our detailed biomarker analyses support the proposed mechanism of action and herein.

And provided additional evidence linking the mechanism of action to endurance impact on Atlas disease progression.

A thorough analysis of this data will be published separately in a peer reviewed manuscripts.

Thank you so much.

So the next question relates to the earlier clinical and preclinical programs. Please provide an update on the trials and data associated with MFS in Pakistan a disease.

Thank you Ralph.

Thank you for the question Michael.

I'll start with our Ms program.

As you recall in times prepared comments CNS phase two clinical trial was completed earlier this year.

And the data was recently presented at Ash in an oral presentation at the 37 spectrum Congress by Dr. Jeff come from the Cleveland Clinic.

The high level summary was that the study achieved the primary endpoints are safety and Tolerability. It also demonstrated a reduction of neuro inflammatory biomarkers and an increase of Neuroprotective biomarkers and distributors final fluid as well as consistent improvement across EMS functional outcome measures including measures.

Walking upper extremity function vision and cognition.

Now holding discussions with key experts and seeking guidance from the FDA to determine next steps.

As mentioned earlier.

<unk> also submitted a manuscript for peer review publication.

I'll now address the question about Parkinson's disease.

Now Parkinson's disease that we remain quite interested in we believe neurons demonstrated mechanism of action could motivate. This is the future clinical target, but for now we don't have an update on the syndication to date, our clinical priorities have been focused on first AOS.

And progressive Ms and third Alzheimer's disease, and given our size of the company and the resources, we can bring to bear on all our work, we're being very careful to not move too quickly with other indications.

Thank you.

And then regarding Alzheimer's and <unk> can you provide updates here. Please.

Absolutely.

So regarding Alzheimer's in the Q2 earnings call, we shared that with the recent approval of bad you're at home and with other advances in the Alzheimer's disease competitive landscape.

Wanted to step back and strategically consider our clinical goals before proceeding with clinical study in Alzheimer's disease with neuro.

Alzheimer's disease remains a prioritized indication and as such.

As we've already engaged with a few of the top Alzheimer's kols in the U S.

Sharing our data with them.

We've been consulting with them on our clinical plans and their feedback has been exciting and very helpful. We also expect to have an update to share publicly very shortly.

And finally regarding <unk>.

Hi made it Barry.

A full description of our results, but what I can add is that as we shared our prepared as we shared earlier, we've demonstrated the beneficial effects of.

Our derived exosomes in acute lung injury model. In addition to demonstrating a superior effect of these exosomes compared to naive MSC.

Access homes all of these results, including the publication in stem cell research in therapy Journal are available on our website.

We've continued to do further research using bleomycin model of lung injury.

Which is characterized by extensive inflammation fibrosis and injury to the lung tissue and we look forward to sharing new insights, including how they fit together with our priorities.

Going forward.

Thanks, so much.

And then finally with one question relating to a business development. Please provide an update on the plans for joint ventures or partnerships with other companies.

David.

Sure so.

Partnering easily integrated part of our strategy.

We are actively engaging with potential.

Potential partners.

Which includes.

Mid sized and leading pharmaceutical companies.

And we are engaging both.

Yeah less than that.

And as well a more recent exits on program. Thank.

Thank you.

Sure Paul would you open the lines for questions from.

And investors on the line.

Certainly ladies and gentlemen, the floor is now open for questions.

Have any questions or comments. Please press star one on your phone at this time.

He asked about posing your question you. Please pick up your handset if listening on speaker phone to provide optimum sound comedy once again. Please press star one if you have a question at this time and please hold while we poll for questions.

And the first question is coming from Jason Mccarthy from Maxim Group, Jason Your line is life.

Hey, Thanks for taking my question. This is Michael channel, which on the line for Jason.

So.

Your first question I'd like to gauge your thoughts on the Exosomes platform and how that might best be applied whether it could be thought of as a next gen <unk>.

Follow up in indications, where neuro and is already successful or.

If it's more targeted towards indications, which may have an increased benefit from using what is essentially a snapshot of the signaling activity of the cells.

Alright, Thanks, Michael Ralph wanted to take this question.

Yeah.

Yeah. Thank you for the question Yeah, we do extra sums as.

Potentially next generation, but I think that there are some unique advantages of exosomes that are worth mentioning first of all the ease of formulation.

And logistics.

Definitely an advantage, including potentially cost.

There are there are unique advantages of exosomes in terms of.

Delivery and certain unique situations for example in the lung.

Sending products through the through the Airways that are very small besides the size of viral particles like exosomes is very advantageous to reach the most distant parts of the lung. So there are some biophysical reasons why we have applied that in in the lung, particularly in the acute lung injury.

Model.

There are.

There are still questions around exosomes that we're working on and we intend to leverage the preclinical knowledge to make the best decision about the optimal application of Exosomes.

And lung disease and potentially in other diseases as well.

Alright, Thank you and then I like the.

Follow up on that just have you given any thought as to how you might.

Formulate the exosomes platform for delivery to the lungs.

Look we use mobilization or dry powder have you given any thoughts to that for what it eventually might move into humans.

Yes, so I will take that.

We gave a lot of thought and without looking at the different pathways and you mentioned those pathways and emulation is definitely something we're looking at them or interest.

Hey.

But yes, when we will get into humans will have to take that decision we're doing preclinical trials.

In order to confirm the best way.

Of targets.

Very good question.

He is one of the major questions on Mexico right.

And I'll just add that of course, whereas the CNS pace X is also may be beneficial for diseases like Parkinson's mentioned before.

You could probably can overcome the blood brain barrier.

Yes.

Thank you very much and then just one more on the.

Biomarker data I wanted to see if you could provide a bit more color on how you could leverage the biomarker data and its correlation to outcomes in your discussions with regulators and your further development within a L. S.

Thank you very much I'll, let you answer that.

Yeah, I'm happy to respond to that thank you and well I'm already described in his prepared remarks. These were pre specified analyses and we're sitting I did and to the FDA before we unblinded our trial so.

These kinds of models, which are really important.

Not that there are pre specified of course these will become part of.

Our discussions with regulators as we as we progressed either with informal discussions that were formal formal discussions I'd say Christine.

The important part of the model that the high.

I'm described to you is that it really leveraging the relationships that they work in the data.

And its machine learning in the sense that it's.

Doesn't involve our judgment or kind of preconceived belief about biomarker it doesn't a lot back to interfere so.

This model that that time was just speaking about.

Really is harnessing the information what we've observed about the treatment effects on these important biomarkers and they're selecting their selected into this model to help provide the most accurate explanation or predictions.

Patients that responded.

Thank you very much for taking my questions.

Yes, thanks, so much Michael.

Question. Please.

Thank you and the next question is coming from David <unk> from Zacks small cap research.

Your line is nice.

Hey, good morning, everybody.

So my first question is about M S.

So clearly theres a lot of M. S drugs that are out there right now and now that you've got some data in hand, I'm curious what your thoughts are on where neuro and might fit in that treatment landscape.

Okay.

Yes, David Thank you for that question I think it's I think it's worth just describing again the unmet need in progressive and masks as you know the most of the therapeutic success in MFS has been for relapsing remitting Ms. Since it's been remarkable over the past 20 years, how well that's gone there's still is a very large unmet need and.

They've got mass both clinically patients continue to deteriorate slowly despite the use of the optimal and most recent successful treatments and also theres, none that biologic in the you know we think that that's where we're what we're.

Targeting in terms of the compartmentalize inflammation in the brain delivering the treatment directly into the spinal fluid and changing the microenvironment and also delivering repair molecules of neurotrophic factors. We think that's what we saw in our phase II trial, we're very excited about the results.

There is huge potential and a lot of interest.

Among experts and also among international organizations to see what the next steps might be.

We're carefully considering all that we're very optimistic about.

Where we go next and we want to.

We want to consider that carefully received the feedback from the agency, obviously and other regulatory bodies and then make the best decision about what the next steps will be and we'll have an announcement once we've gotten there. So thanks for that question again.

Okay. Thanks for that and I just have one.

Question about the E. L F biomarker data I, just want to make sure that I understand so of those biomarkers that were identified was each of them correlated to outcome of neuron treatment or was it the.

Biomarkers as a group.

I know David.

Analysts will come up with a question understanding the correlation.

The group in the models.

We have an export tons of line Dr. Seuss at Lindbergh.

Yes. Thank you.

So can provide maybe a little bit more clarity into them into the methodology again so.

All biomarkers that were collected as part of the study where possible to be included in this model. So the methodology.

Allowed any any of these biomarkers that were contributing and at the explanatory value towards this prediction to enter the model N for any one marker.

Come into the model had to be statistically significant at a level.

P value less than 25 and to remain in the model. It after a hard touring and statistically significant with a P value is less than five. So these kinds of iterative models basically allowed terms to come and go in and then ultimately to to land on the optimal model that has this.

This prediction.

All of the terms of all of the Biomarkers that are a part of it which of course were reported in the poster.

Danielle meeting recently.

Contributing simultaneously significant information towards this prediction.

Hi, I'm spoke of the accuracy.

So what what we presented in this poster is an area under the curve, it's coming from a receiver.

Operating characteristic and it really gives us a wonderful metric the di diagnostic metric that allows us to evaluate how accurate predictions or or in this case. How good. These biomarkers are and discriminating participants that responded in the trial versus those that didn't.

And as a rule of thumb, if you'd have about 80%. This is quite high classification and in our model that we spoke that that won't be reported on it you know we had an area into the credit trends that we see for operating curve.

Of 82.5.

And we actually see this estimate increase when we focus on models that were predicted each therapy separately.

And this will be the focus of our biomarker.

That would be wrong.

Hopefully submitting in the near future.

Yeah, David I'm sure you would like some more I think on this we're going to have an offline conversation with Dr. Lindbergh I'm not sure of all of our social following these models.

Okay, No that's fine and then I have one more.

Last quarter, you mentioned that the the hospital exemption program was currently not ongoing in Israel and I'm just curious if there's a similar type programs being planned for other jurisdictions.

I'll give you a short answer yes kind of celebrities.

Okay.

Fair enough.

Thanks for taking my questions.

Sure.

Thank you, ladies and gentlemen, once again, if you wish to enter the queue to ask a question.

You can please press star one on your phone at any time in.

And the next question is coming from Paula Smith Paula Your line is live.

Good morning.

First as a mom I just wanted to express my gratitude to brainstorm.

So grateful that my son was given the opportunity to be in the trial and that.

Brainstorm is just giving us hope and access to treatment for AOS.

And that hopefully we can continue it.

I just wanted to say my son is 32 years old and he's been in the phase III trial and the expanded access trial.

He was in both stabilized he regained function.

And his AOS FRS score has improved.

So the biggest improvement for Josh.

His FCC had improved to over 40%.

To me, it's an amazing he's still able to walk it can still climb stairs. He can still get into is cheap. He can eat he has no problems swallowing.

And he's still able to use his hands and this is four years from his onset.

Or doctors here I'll believe that near one works.

And we are in close contact with other people that are receiving the EAP and their experiences and how they stabilized.

So my question is.

Can you speak about the results and EAP now that everyone has received a three doses and we'll brainstorm be using the EAP data to speak and seek approval for new round.

Yeah.

So Paulo.

Thank you for quest.

Question.

I wasn't expecting this talks a private investor.

As you know we are not yet and as we said in the comments.

At the beginning of the call we cannot see I talked to the a Pea result.

Very warming to hear what you are saying you're describing.

And I do hope that we should be able to share with you. Some good news there.

Very soon.

That's all I can say for the time being and very happy.

That's your son is doing well and as being stable.

Or even better.

It is our hearts, it's amazing to me, it's a miracle and.

Just wanted to continue.

Well, we all want the same you know we're working very hard on them.

Thank you.

You're very welcome.

Thank you.

Yeah.

And the next question is coming from Michelle Laurens from voices for a L. S shall your line of lives.

Thank you.

Hard to follow up after Paula.

Last month at Akron. This win Dr. Cohen from Cleveland Clinic spoke about the results in Progressive M. S.

I found it quite profound because he used the words I'm getting her own repaired and restored function.

And he did that in an interview with urology live and it struck me that those words mirrored what the patients had been saying in the neuron trials since 2015 back in phase two.

So those words are subjective what I want to know if you can speak to any of the similarities and the biomarker data between the MF study and the E. L. F studies and if any of that biomarker data from wonder together helps validate the evidence of efficacy.

And the other disease.

Thank you very good question, though.

Throughout and Stacy to comment on this because there's different aspects to the tough question to answer.

Oh sure.

Sure I'll start and Handoffs to Stacy so thank you again for the really insightful question.

The answer is yes.

But I think it requires some explanation and we will start today and maybe we can take this offline.

There are two main areas, where we observed significant biomarker changes and Stacy gave a very clear and detailed description about a few minutes ago.

Just to highlight a couple of points one is that.

In the area of Neuro protection. This is something that is deficient in a L. S and also in progressive M. S. As it is and in many neurological diseases, where the repair mechanisms are failing.

And that's part of it part of the known disease processes, we believe that.

Repairing the nervous system requires restoring this neuro protection function and we know that the cells that we have primed in our technology platform.

Well to do that.

Better than on Prime M, a c's and certainly certainly better than other therapies, because that's the prime function of the cells is to deliver these molecules.

Second area is inflammation, we know that.

Literally every day, there's more there's more data, suggesting that all neurodegenerative diseases have inflammation. There are slight differences in terms of which sells participate in how it influences the outcomes, but we know that theres, a big commonality between LLS and progressive and that's regarding the inflammatory pathways and and again there.

We see consistent changes in inflammatory biomarkers the advantage of looking at CSF cerebrospinal fluid as we get a direct view of what's happening in the brain microenvironment. So so I'll pause there and I'll hand off to Stacy two to answer the other parts of the question.

Well I think you've covered this I think extremely well in terms of really linking not only what we believe about the dethlefs et cetera that are known across neuro degenerative diseases.

And known Biomarkers that more similarities of what we're observing with her and across these two these two devastating illnesses.

I think the point that I would add is that you know anytime we're looking at.

Why do we believe a treatment is working and of course biomarker data is critical across all diseases, and giving us insight into biologically what's happening.

One of the important aspects has been to understand also that treatment.

Relationship with clinical symptoms.

In your question about are we seeing similar repair and function restored.

Is also a component that is extremely important in.

In the progressive and that's triangle, we had responder criteria that.

Showed that patients were improving in their clinical function across many of.

The known.

Clinical measures, which which route and you heard that before.

Similarly, we can observe in our AOS data and of course the four.

Analyses that we've done really linking biomarkers and clinical data.

So show this important link that not only do we see important changes.

Either slowing down the decline or in some cases improving decline.

Decline, but we see similarly that the biomarkers are.

And in the direction that one would expect with an effective treatment. So we're seeing reductions in neural inflammation and we're seeing improvement in Europe protection.

I think it's a very insightful comment and.

Really great question for us to continue to consider.

Thank you.

Thank you.

And there were no more questions in queue at this time I would like to hand, the call back to the Brainstorm cell Therapeutics management team for any closing remarks.

Well. Thank you Paul no further remarks, thank you everyone for listening in.

Looking forward to a very exciting quarter look everyone.

Thank you ladies and gentlemen, this does conclude today's conference you may disconnect at this time and have a wonderful day. Thank you for your participation.

Yeah.