Brainstorm Cell Therapeutics Inc.
Q2 2019 Earnings Call Transcript

Published: 13 Aug 2019

[Operator:]

Good day and welcome to BrainStorm Cell Therapeutics' Second Quarter 2019 Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] As a reminder, this call is being recorded.I would now like to introduce your host for today's conference, Sean Leous from ICR Westwicke. Thank you. You may begin.

[Sean Leous:]

Thank you for joining the BrainStorm Cell Therapeutics' second quarter financial results conference call. Before we begin opening remarks we would like to remind listeners that this conference call contains numerous statements, descriptions, forecasts, and projections regarding BrainStorm Cell Therapeutics Inc. and Nasdaq BCLI and its potential future business operations and performance. Statements regarding the market potential for treatment of our neurodegenerative disorders such as ALS and MS, the sufficiency of our existing capital resources for continuing operations in 2019 and beyond, the safety and clinical effectiveness of our NurOwn technology platform, our clinical trials of NurOwn and related clinical development programs, and our ability to develop strategic collaborations and partnerships to support our business planning efforts.Forward-looking statements are subject to numerous needs to develop strategic collaborations and partnerships to support our business planning efforts. Forward-looking statements are subject to numerous risks and uncertainties. Our results may differ materially from those projected here on today's call. We undertake no obligation to publicly update any forward-looking statements.Joining me on the call today will be Chaim Lebovits, President and CEO of BrainStorm; Dr. Ralph Kern, Chief Operating and Chief Medical Officer; and Eyal Rubin, our Chief Financial Officer. We will be available to answer your questions during the Q&A session.

[Chaim Lebovits:]

Thank you, very much, Sean. Good morning and good afternoon to everyone on the second quarter earnings call. Let me begin by thanking everyone for participating in today's call and for all of those that sent their questions prior to our call. We will address many of your pre-submitted questions in the opening remarks. I will look forward to addressing any additional questions or comments you may have in the Q&A session.On behalf of management, I want to express our thanks on for the ongoing and continued support of so many. Firstly, I would like to thank patients, their families, caregivers, and all those who are helping us advance the Phase 3 ALS and Phase 2 progressive MS studies, the dedicated clinical professionals at all our investigational sites continued to provide top tier patient care and the highest quality clinical trial expertise. I also want to thank our wonderful team here at BrainStorm, who fully devoted themselves to advancing best in class and potentially life altering therapies. And finally I want to thank our shareholders, both new and long-term for their continued ongoing support and our collective journey to FDA approval.Many of you have asked about the progress of our Phase 3 ALS trial, which I'm happy to say is nearing the end of patient recruitment. Today, we have enrolled a total of 170 patients, 85% enrollment. Based on our current projection, we plan to enroll a total of 200 patients by the end of September or depending on the still [ph] failure rate latest by the second week of October.Top line data results are expected approximately 11, 12 months after the last patient is enrolled. While we expected to have completed enrollment by July of this year, by now it has taken two to three months longer due to study logistics as may be expected in a stem cell therapy trial. That said, all six sites continue to advance patient enrollment and the level of interest in our Phase 3 Study from ALS patients has remained as strong as ever. In summary, we should see study enrollment completed by end of September latest the second week of October.In July, we were invited to a special or high-level meeting with FDA Senior Management, coordinated by I AM ALS, a grass roots ALS advocacy group advocating for an ALS cure. The meeting included Dr. Peter Marks, the Director of CBER; Dr. Janet Woodcock, the Director of CDER, the FDA Chief of Staff, and other senior officials of the Commissioner's Office. In this highly productive meeting, we gained further support for our Phase 3 clinical trial design and endpoints and explored various options to bring NurOwn to patients with ALS as quick as possible.All in the meeting felt the urgency. Unfortunately I cannot share too many more details of the conversation. What I can say is, that we were very happy with open dialogue, the questions, and the suggestions that were exchanged. We look forward to continue closely our conversations with the FDA to bring a much needed innovative therapy to patients with ALS as soon as possible.We had previously scheduled a meeting in September, rather more than one meeting in September with the FDA. During the last quarter, we also held a meeting with the CEO and Senior Management at the ALS Association, ALSA. On the agenda was a discussion of how we could better collectively communicate the importance of seeking a cure for ALS and how we can mutually support one another and foster ongoing relationships with the ALS community, their families and their advocates. We intend to continue our mutually respectful dialogue, leverage our individual organizational strength to better the entire ALS community in the long run.Another important pipeline advancement was the announcement that two additional sites were contracted to enroll patients in our Phase 2 Open Label, Multicenter Study of Repeated Intrathecal Administration of NurOwn in participants with progressive multiple sclerosis. In addition to the Cleveland Clinic, the Stanford School of Medicine and the Keck School of Medicine of the University of Southern California, USC will be enrolling patients. These Phase 2 study will evaluate validated [indiscernible] efficacy outcome measures and sophisticated CSF and certain biomarkers. We expect the study to be fully enrolled by the fourth quarter of 2019 and we should see top line data by the middle of 2020.As announced previously, we are also advancing the development of NurOwn drug exosomes for a broad range of CNS disorders including Alzheimer's and Parkinson's disease, two devastating diseases that continue to affect countless lives of patients and families around the world. Exosomes have practical advantages including their ability to cross the blood-brain barrier through high [indiscernible] and [indiscernible] and low immunogenicity moreover exosomes have the potential to serve as nano carriers for delivering therapeutic molecules and to the damaged tissue sites. We expect to complete additional preclinical studies in the second half of this year and plan to present additional data at upcoming scientific congresses.BrainStorm's incredible research team is also looking at ways to optimize and validate neuron cell culture processes in closed system bioactors to create a simpler, and far lower cost manufacturing process that will greatly increase access to our innovative cellular therapies. We intend to present such data to the FDA in our upcoming meetings. We expect to share further details about this important and often unrecognized wonderful technical capabilities of our CNC [ph] team over the next few months.I'd like to hand over the call to Eyal Rubin, our CFO to discuss our financials.

[Eyal Rubin:]

Thank you, Chaim. Research and development expenses net for the three months ended June 30, 2019 were $3.55 million compared to $1.5 million net for the three months ended June 30, 2018. Excluding the participation from the Israel Innovation Authority's CIRM under the grants and the proceeds received under the hospital exemption regulatory pathway research and development expenses increased by $3.23 million from $3.3 million in the second quarter of 2018 to $6.53 million in the second quarter of 2019. The increase year-over-year was primarily due to expenses in connection with our ongoing ALS Phase 3 and progressive MS Phase 2 clinical trials.General and administrative expenses for the three months ended June 30, 2019 were $1.3 million compared to $1.6 million in the three months ended June 30, 2018. Net loss for the three months ended June 30, 2019 was $4.9 million or $0.23 per share as compared to a net loss of $3.1 million or $0.16 per share for the three months ended June 30, 2018.Cash, cash equivalents and short-term bank deposits were $2.7 million at June 30, 2019 compared to $6.23 million at March 31, 2019. Our total available funding, which includes cash on hand, as well as remaining non-dilutive CIRM and the Israel Innovation Authority's grants amounts to over approximately $6.5 million. In addition, we are still expecting further hospital exemption proceeds in the upcoming quarters.For further details on our financials please refer to our Form 10-Q filed with the SEC earlier this morning. On a personal note, and since this is my last earnings call with BrainStorm, I would like to thank our loyal investors and express complete faith in the future of BrainStorm, the company's science, the management team and the researchers, who continue to explore the future applications of NurOwn in a wide variety of indications.Back to you Chaim.

[Chaim Lebovits:]

Thank you, very much Eyal and on behalf of the management, I would like to thank you for all of your contributions to BrainStorm over the last few years and wish you much success in your future career and whole – any endeavors you may take.As you all know, we do receive proceeds from the hospital grant pathway from a business standpoint as we approach the full enrollment of our Phase 3 ALS clinical trial, the management team continues to hold high level conversation with some of the leading global pharmaceutical and biotechnology companies. We are actively engaged in strategic partnering and collaboration discussions and although we cannot disclose the details of our conversations, due to NDAs we file with them, we are exploring several opportunities with key interested parties, to advance opportunities for NurOwn development and commercialization.We understand the urgency in unmet need and our sole focus is to quickly advance NurOwn to FDA approval. The promise of NurOwn is clear to so many lives and the management team and every BrainStorm employee continues to work tirelessly to meet the unmet clinical need in ALS and progressive MS and in other neurodegenerative life altering diseases. I thank you all for your ongoing support and continuing interest in BrainStorm Cell Therapeutics and I look forward to your questions. I hope this time we will hear all of your questions loud and clear.As mentioned at the start of this call, Dr. Ralph Kern and Eyal Rubin will also join me answering your questions. But before we open the lines for the Qs we would like to first answer the questions we got online from those that took their time and really sent in very long detailed questions. We'll summarize them into a few questions, some were redundant, and I would ask Sean, please if you can read out the questions.

[Sean Leous:]

First question is, do you have a target date or timeline to release Phase 3 data?

[Chaim Lebovits:]

Yes, about one year after last patient enrolled we will have the top line data.

[Sean Leous:]

Your second question is, the Phase 3 ALS trial, is the trial fully enrolled?

[Chaim Lebovits:]

So we discussed in the opening comments that if somebody asked a question, we are asking it again, so we have enrolled 170 patients and expect to fully enroll latest by the second week of October, hopefully by the end of September.

[Sean Leous:]

What was discussed at the meeting with the FDA Directors and I AM ALS? Are all parties pursuing a path to early approval of NurOwn to treat ALS?

[Chaim Lebovits:]

It was a very productive meeting. All parties involved understand the urgency. We are exploring opportunities with the FDA. We're looking at various potential regulatory pathways to advance the development and the timelines to get NurOwn to patients as quickly as possible. As I mentioned in my opening comments, I cannot disclose at this time more details. I have to say that we look forward to our next scheduled meetings with the FDA in September.

[Sean Leous:]

Has BrainStorm Cell Therapeutics submitted interim data from NurOwn's Phase 3 trial in ALS to the FDA to apply for early FDA approval? If endpoints is the main issue, why would the company expect results to be different at end of this study than for patients that have completed all three doses of treatment to this point?

[Chaim Lebovits:]

Dr. Kern your turn.

[Ralph Kern:]

Thank you. So at this point, we don’t have a planned interim analysis and as you know, interim analysis do come at a cost of impairing statistical outcomes, and potentially could decrease the likelihood of an approval. The second part of the question about endpoints, the study endpoints are the same at an interim analysis and at the end. However, when the full length of followup is included in the full study followup it would be much greater, the statistical power of the study will be much greater at the end of the study and we will be much better able to demonstrate efficacy.

[Sean Leous:]

And has BrainStorm been in communication with the Trump Administration about an executive order approving NurOwn for ALS?

[Chaim Lebovits:]

Fake news, no.

[Sean Leous:]

What were the conclusions of the Data and Safety Monitoring Board? Can that organization recommend approval of NurOwn to the FDA?

[Ralph Kern:]

Thank you. So the DSMB is meeting in October, so they don’t have a conclusion yet. The date of the meeting is determined by the number of patients who have had sufficient followup and as Chaim mentioned, we're about two months behind. So I know people had expected an earlier DSMB, but consistent with our finishing completing enrollment a couple of months later the DSMB will also be two month too late. They are being asked to review safety as per their charter. So currently there is no plan to make efficacy conclusions at that time.

[Sean Leous:]

How many patients are currently enrolled in the Phase 2 trial for MS? Since it's an open-label trial, when will updates and progress reports be made public?

[Chaim Lebovits:]

Ralph?

[Ralph Kern:]

Thank you. So to date we've enrolled seven patients, so the planned totaled - a total of 20. And no decision has been made yet regarding an interim analysis. So we will be meeting with the study principal investigators at the [indiscernible] meeting in Stockholm in a few weeks and at that time we're going to review our options with our principal investigators.

[Sean Leous:]

When will the company provide updates about enrollment and progress of the patients in the hospital exemption program in Israel? Is that program recruiting additional patients?

[Chaim Lebovits:]

Enrollment is ongoing. We're still recruiting additional patients. We will provide additional details in the next quarter which will include the proceeds that we got from hospital exempt. We expect a few more million dollars and also on patient enrollment. In collaboration with the Tel Aviv Medical Center we may or may not provide program updates or the actual patient results.

[Sean Leous:]

How will the company use the $20 million of newly available funds obtained through the sale of additional stock? I would like to enquire in regards to why the warrants with the investors were renegotiated down to $3.90? If BCLI believes the current share price is substantially undervalued, then why raise dollars from investors at lower share price, it's too sweet a deal especially when they already agreed to the original warrants?

[Chaim Lebovits:]

Yes, we do believe we are undervalued, but the market doesn’t behave as we believe, but I do have to make order right? I've seen many shareholders often wrote to me directly about the $20 million we raised. We did not raise $20 million. We filed an ATM with Raymond James that allows us to raise through the ATM tool up to $20 million within the F3 registration. Just like you'd file an F3 shelf [ph] for the opportunity within the next ex years you are able to use that shelf [ph] whenever the opportunity comes for a follow on or a private placement, the same result due to previous very good high volume days has this opportunity would come and we will see the volume and mainly we will see the price which we believe is not undervalued or not too undervalued, we may then activate the ATM or we may activate the $1 million, $5 million, $10 million $20 or nothing. Up to date we didn’t activate the ATM. We did not reach the prices that we are happy with. I hope that clarifies the questions we got on this matter.

[Sean Leous:]

I would like to ask about Matt Bellina if it does not violate his privacy, can you tell us how you plan to proceed with Matt's treatment? Will treatments continued for a prolonged period, at what intervals will he receive NurOwn, the number of cells per treatment, any biomarker info? The only updates we are getting on Matt Bellina are from his social media. Why isn’t the company capitalizing on his apparent progress by broadcasting it to the investor community?

[Chaim Lebovits:]

The company has refrained and will refrain from commenting on clinical outcomes inside or outside the trial. NurOwn is an investigational therapy in Phase 3. While Matt has commented on his progress, we chose to be very conservative and not to comment. As to other patients in the trial, you all know we are blinded to our location of study participants and cannot comment about the progress of any study subject in keeping with FDA guidelines. We can disclose however, that Matt the first patient to have received four treatments of NurOwn and may receive more treatments. We can also say that we are very hopeful that NurOwn will continue to have a positive impact on him and hopefully we will see very positive result of our Phase 3 trial.

[Sean Leous:]

Please address your cash position, cash outflow through Q2 2020 and cash inflows? There is concern about the outflow due to your ramp up for MS.

[Chaim Lebovits:]

First I would like to address the ramp up of MS. The truth is that manufacturing cost of the MS trial which is a major cost of the trial is already embedded in the ALS trial costs, because you know, when you have such a complex product and trial and patients traveling to sites, we miss here and there slots that we were able to provide manufacturing product, and what we do is, we use - utilize those “slots” for the progressive MS trials. So, in no way are we paying additional money up till now for the manufacturing of the MS trial.The detail of the cash and cash equivalent you just have heard more or less from Eyal Rubin, so we have on hand around $4.5 million and we are still going to have additional funds coming in from CIRM and the Israeli scientific officer was now called, The Israeli Innovation Authority and also we see additional funding from the – and not procedures we say right, that's a professional word for tax returns. So if you put additional proceeds from hospital exempts for the next quarter.So I would also share with you some just broader numbers you just - for the understanding of the shareholders, that want to understand how tough it is for us, well, it’s not so tough, even though we’re quite low on cash and - as I said we have different pathways to bring in enough money to finalize both trials. Adjust and expenses, direct expenses for ALS in 2018 broadly cost around $8 million for the ALS trials the direct expenses for the trial and the manufacturing cost. In 2019 it was about $16 million including to the end of the year of course. In 2020 it’s going to be only around $5 million or $6 million. So just you understand more or less where we are at.

[Sean Leous:]

When are the next quarterly financial results and can guidance be given on revenue?

[Eyal Rubin:]

So the financial results are expected by November 15, and with regards to our revenues as we wrote in our current 10-Q the company doesn’t have revenues. We do have the proceeds that we’re getting under the hospital exemption regulatory pathway.

[Sean Leous:]

Thank you, Eyal. Do you have any comments on the nationally broadcast ABC Nightline ALS ice bucket challenge segment that aired last week?

[Chaim Lebovits:]

Yes, thank you. ABC Nightline proactively reached out to BrainStorm for the recent segment on ALS to be on the bucket. Juju Chang and ABC Nightline have been covering ALS for five years now. We applaud her work and the entire ABC team for continuing to raise awareness concerning the disease, burden of ALS, and for highlighting the unmet medical need and the urgency of devoting a clinically meaningful therapy. We were honored that ABC Nightline and Juju Chang recognized our commitment and hopes that our investigational therapy, NurOwn brings to the entire ALS community. We of course look forward to see the full segment of ABC which will air in the next few months.

[Sean Leous:]

And the last submitted question. We have seen patients that claim they can stand up after being bound two years in a wheel chair, or just driving a motorbike they couldn’t do for a year or so. I understand these are anecdotes and you can’t come into the individual results of patients, but in general, do you expect dramatic reversal effects for all those responding to treatment, if so why? Is that what we hear from only a few patients with such a dramatic result or how do you qualify a responder?

[Chaim Lebovits:]

Ralph?

[Ralph Kern:]

Yes thank you. So I think we’ll just back track a bit. You know, ALS patients have many areas of function that could potentially change after treatment and that change could occur for varying periods of time. And well, what you hear about in terms of these reversals of the function are the most obvious type of treatment response, there are other less talked about, but more prevalent types of responses where specific areas of function can stabilize or progress more slowly, we think those are more common. And at the end of the day in an individual patient and also across the group of treated people in our study, it’s the sum of all these functional changes that contribute to the overall responder outcome that we’re capturing in our Phase 3 trial.And in fact, specifically we’re looking at a 1.25 point per month improvement in the ALS functional scale and that could be at the end of the day the 1.25 could be composed of many different areas of function that can move together or differently. And we’re looking at both these individual responses, but also the overall average group change. And I think these are all very meaningful and very important. So, that’s what we’re focused on in the Phase 3 trial. I think these highlighted stories you hear about, are anecdotes are - contribute to the overall results, but they're not the most common type of response.

[Chaim Lebovits:]

Thank you. Operator, you want to open for question and answers please?

[Operator:]

Thank you, yes. [Operator Instructions] Our first question comes from line of Jason McCarthy with Maxim Group. Please proceed with your question.

[Unidentified Analyst:]

Hi, good morning. This is Joanne on the line for Jason. So my first question is, while we are awaiting data for the Phase 3 trial in ALS which is a pivotal turn [ph] for the company, how can we look at NurOwn from a platform perspective?

[Chaim Lebovits:]

Ralph?

[Ralph Kern:]

Thank you, thank you for the question. Yes, I think a way to look at NurOwn is that it’s a cell delivery that delivers biologically relevant molecules to areas of damage and inflammation. And it corrects the underlying disease through two mechanisms; one is by reducing inflammation which is becoming a very important common threat in ALS, progressive MS obviously, Alzheimer's and Parkinson's disease, so that’s one mechanism. The other is that the molecules that are being delivered have very important function in both, the disease course, and also the repair processes in many of these diseases. And it's really the combination of reducing inflammation, delivering repair factors that is what is unique about NurOwn.And it plays out differently in different diseases and some of the repair factors are more important in ALS and in progressive MS and in Alzheimer's disease, but there's a lot of overlap. And I think that the stable technology platform and the manufacturing expertise that Chaim had alluded to earlier really plays well across different diseases. And we’re seeing that some of biomarkers for example in progressive MS overlap quite well with what we’re measuring in ALS.So we’re very optimistic that it will be slightly different than the different diseases but there are some commonalities and it allows us to play the platform across different diseases because the outcomes may vary as you can imagine and we may see better results in one disease or another and the fact that we have many opportunities is important for us.

[Unidentified Analyst:]

Great, thank you for that. And my last question, the trial progressive, the trial of progressive MS that’s ongoing, what about the other indications like Parkinson’s disease or even a very neurological condition like Alzheimer’s where we see an entire drug development stage shift towards approaches other than beta-amyloid, like I know you briefly mentioned exosomes, could you expand on that?

[Chaim Lebovits:]

Ralph?

[Ralph Kern:]

Yes, sure, good question. I think if you had a couple of hours I could answer all of them, but I’ll do my best. So, yes, I think if you look in the last year, I don't think amyloid is being taken off the table. I think just the simple approaches of using bulk removal of amyloid is not going to be the answer. And it is a much more complex interaction of the various proteins that accumulate in different diseases in the clinical course. I think that, you know, what Chaim mentioned earlier in his opening comments that still holds true and that is that for some of the diseases such as Alzheimer’s and Parkinson's we've been looking in preclinical models that have exosomes might offer advantages. I think there’s a couple of reasons why that might be true. One is that, you know the exosomes still do what the cells do, but they do it in a more practical way by being easier to package, easier to deliver in many ways and crossing the blood-brain barrier.The other thing about exosomes is that because we have a well-defined cargo in the NurOwn, with exosomes we can take that cargo and it can be modified for specific diseases and now there isn’t one type of Alzheimer’s or one type of Parkinson’s and I think we’ve been looking at how we might adapt the exosome cargo to provide advantages over cell therapy. And we know that – we know that our capabilities in manufacturing would support either cell therapy or exosomes derived from the cells. So we are very confident that the options that we have are quite practical.

[Unidentified Analyst:]

Okay. Great. Thank you very much for that.

[Chaim Lebovits:]

Thank you. Operator, next question?

[Operator:]

Thank you. [Operator Instructions] Our next question comes from the line of David Bautz with Zacks Small Cap Research. Please proceed with your question.

[David Bautz:]

Hey, good morning, everyone. Could you remind us what is the follow up time period after patients complete treatment of NurOwn in the Phase 3 trial? And then is there any type of long term follow up, especially for the early enrollee in the trial?

[Chaim Lebovits:]

Thank you, David. So the follow up is 11 month after the last patient enrolled. As you can recall, the kind of trials in the three, four months running period where we follow is progression of the ALSFRS score and only then we take BMA and baseline and seven months following the baseline. And we’re only following up to seven months after treatment. David? Operator next question? Yes, David, you got off. You have another question, please?

[David Bautz:]

Yes, just so Dr. Kern, just to follow up on what you were discussing with the question about wheelchair bound ALS patients, can you point to maybe an example in the literature, what they discuss say dramatic reversals, spontaneous reversals of ALS patients?

[Ralph Kern:]

Yes, there’s not a lot -- thanks David for the question. There’s not a lot written about that. There are some suggestions that there could be plateaus or reversals and there's one look at that – they're not common in the backgrounds without treatment, without effective treatment and reversals mostly have been seen in people who are slow progressors.They haven't been seen in rapid progressors that often and also they tend to be short-lived. So they tend to last for three months or so. So I think with – if, you know again, we don't know what we’re going to see it in the Phase 3 trial because it's more blinded to allocation, but we think that there's a fairly good understanding of the natural history, so were these to be seen in our study we would be very pleasantly surprised as would everyone else.

[David Bautz:]

Okay. Great.

[Chaim Lebovits:]

Yes I would mention David…

[David Bautz:]

Go ahead.

[Chaim Lebovits:]

Yes, Dr. [indiscernible] has a paper a little bit about some people reversing, but as Dr. Kern just said, you don’t see it lasting more than a few months, so and therefore, we don't know of any other treatments that show or may show, you know, we've got to be very careful, such kind of reversal. But on the other hand it’s very important for us to educate investors and patient community that not everyone should look for the same response. We have patients complaining to their doctors that they are definitely on placebo because they are not standing up of the wheelchair. Not everyone will have that dramatic response. We would love to see that but we don’t think we are going to see that even those that we do see are very, very surprising. Thank you. Next question operator?

[Operator:]

Thank you. Our next question comes from the line of Jason Kolbert with Dawson James. Please proceed with your question.

[Jason Kolbert:]

Congratulations on all the progress, particularly the enrollment numbers. I have couple of accounting questions. I noticed in the cash flow statement that you show $4.2 million of an increase in accounts payable, can you help me understand what that is?

[Chaim Lebovits:]

Eyal?

[Eyal Rubin:]

Yes, so thank you for the question. The accounts payable are mainly the clinical sites obviously, some of them are sending the investigators last day of the quarter, so we weren't able to pay them.

[Jason Kolbert:]

Okay, I understand. And how should we be looking at the cash balance versus the grant income and so, how obviously, there's a need for capital. I understand you have the ATM in place. I also understand that you're talking in terms of business development. So, there are many factors, is there any way you can opine as to how they may all play out for you?

[Chaim Lebovits:]

For whom was that’s the question Jason?

[Jason Kolbert:]

I am sorry?

[Chaim Lebovits:]

To who did you address this question, to me or to Eyal?

[Jason Kolbert:]

Both of you really, I mean, I guess business development is the decision you're going to be making, but clearly there's a need for capital at the company.

[Eyal Rubin:]

So, we think that with the grant and with what we know is coming in the next quarter and hospital exempt, we’re not under urgency to raise, and you don’t want to raise when you are under urgency to raise. We’re looking for a good opportunity and that’s why ATM was indeed another tool we want to have in place.

[Jason Kolbert:]

Yes, of course, and it makes perfect sense by the way. Last question…

[Chaim Lebovits:]

3.3 million we could have from the warrant activation, so it’s a very cheap way to bring in money yes.

[Jason Kolbert:]

No brainer. So my last question is, it sounds like the meeting with the FDA was very impressive. Janet Woodcock does typically attend these meetings, so clearly there's an interest and a focus. Where does RMAT designation play and where does the opportunity to do one pivotal trial and potentially file on one trial become a reality?

[Chaim Lebovits:]

Let me be careful how I answer this. So these issues were discussed and I think we had a very good exchange. I hope we will be able to update more in September.

[Jason Kolbert:]

Okay, very exciting stuff, really thank you for the update. Look forward to kind of just hearing about how the patients are doing as time progresses. Thanks.

[Chaim Lebovits:]

Thank you very much. Operator?

[Operator:]

Thank you. Our next question comes from the line of Sean Martin, private investor. Please proceed with your question.

[Unidentified Analyst:]

Hi, yes. Good morning. Thank you for taking my questions. Can you tell me, in the rest of the world you have patents in Japan, European Union and Canada, is there any progress being made there. Now that another ALS drug has been approved that hasn’t progressed like NurOwn in its six country?

[Chaim Lebovits:]

Well, the patents in Japan allows us, without going into details to have additional serious partnership conversations. We had decided at the time not to do our own trials, simultaneously together with the same level of trials we are doing in the states.We think and strongly believe that, if this trial will be successful we will not have to do full-fledged trials in Europe or in Japan to get an approval because it's ALS. So therefore we focus rather to go with an additional disease in our pipeline which was progressive MS, which as you know was a very -- it's a huge unmet need and a very huge market, capabilities of course it’s 500,000 patients, of progressive MS patients only in the U.S.

[Unidentified Analyst:]

Thank you.

[Chaim Lebovits:]

Very welcome. Operator, next question please?

[Operator:]

Thank you. [Operator Instructions] Our next question comes from the line of John Rice with Wells Fargo. Please proceed with your question.

[John Rice:]

Good morning and thanks for the conference call. On Friday, August 9, with about 20 minutes left to go in trading, a very odd thing happened. First [ph] would eventually show that in that last 20 minutes about 150,000 shares traded each minute and over 1.7 million shares were traded all in the space of that time. The stock closed at 4

[Chaim Lebovits:]

Thank you, Mr. Rice. So we did announce in a tweet that there is going to be an ABC story that evening and that’s when we saw a minute after the trades going up very high. And yes, it closed at $3.96 and the next day it closed down 10%. We have no good professional explanation, we can have the theories that we are discussing at the lunch table at BrainStorm, but no professional information to give you.And I'm told by many – that many small biotech stocks see similar things like that when uneducated investors see something and they think it’s a huge news and they come and buy and then the next morning then don't see additional strong volume as they dump, but I don’t know this a theoretical only. Maybe you have – why do you have any idea? You are from Wells Fargo, you are more professional in managing stock prices, my focus is more managing a company.

[John Rice:]

I understand, but let me leave you with one last question Chaim, and thank you for giving the opportunity to enforce [ph] with you. Share with me what feelings do you have about the fact that there were so many biotechs who have wonderful things going on, and the at the top of the class in my mind is BCLI and NurOwn and all the work you guys are doing in ALS and MS and now Parkinson's and new Alzheimer's. How can we not crack the $100 million net worth barrier that we seem to be below forever? Do you have any comment about that, so strange it seems to me?

[Chaim Lebovits:]

Yes done, so I didn’t understand your comment when you say strange. It’s a question we ask ourselves, but what I can tell you generally not going into $100 million or $200 million or $50 million, we definitely, all of management thinks this is undervalued. By the way all of our bankers and advisors think the same. But let’s not forget that we're paving the way in so many ways with groundbreaking type of products.It has a huge upside. We are making it on the other hand there are credible questions. When you talk about ALF, we speak to many serious institutional investors, they just are very skeptical that anyone will be successful in ALF. Also stem cells, some of them had invested in the past in other companies which I will not name, well those companies were worth billions. And then they were not successful. There is yet to be seen a successful approved stem cell treatment.So we are paving the way in so many ways. I would – I think being an example, and I am very careful what I say, because I don’t want to say anything I should not say professionally. But if you would take a look just two years ago, at all of the major CAR-T companies, CAR-T cell for oncology, immunotherapy, they faced similar problems before their Phase 3 trials. They were also not getting the value they thought they should be getting at the time.Now I believe that the moment will come where this will be seen for what it is. When that moment will come, it’s hard to say. But we strongly believe in what we have and we are very focused in finalizing this trial. The data will have its day believe me. So while we are frustrated with the price sometimes how it is it doesn’t deter us even for a minute from what we are doing.

[John Rice:]

Well Chaim, thank you for taking my call and I wish you the very best going forward.

[Chaim Lebovits:]

Thank you very much Mr. Rice for your ongoing support for many years. Next question please operator?

[Operator:]

Thank you. Our next question comes from the line of Matthew Silver, Private Investor. Please proceed with your question.

[Chaim Lebovits:]

Hi Matthew.

[Unidentified Analyst:]

Thank you for taking my call. I was wondering if BrainStorm is considering being a long-term treatment for ALS. We’ve seen Matt Bellina has had four injections, is BrainStorm thinking of doing say 10 injections over a long period of time for people with ALS?

[Chaim Lebovits:]

Hey, very good questions, of course once approved this will not be only a three time treatment. It will be an ongoing treatment based on the response of the patients. Ralph, you want to add on this anything?

[Ralph Kern:]

Yes, so currently because we cryopreserve neuron we’re able to take a single bone barrow aspirate and provide treatment every two months for several years and that could even be longer. So, we do have the capacity to treat longer is there – obviously the data will be important to support such options. And then down the road, I mean it once an approval is achieved we hope so that we will be able to look at different dosing intervals and there will be some opportunities to see how often.And then the other thing that might support that is that we’re measuring very strong biomarkers in our clinical trials. We saw good results in our Phase 2 in terms of the biomarkers. And that may help determine how long people need to be treated for and also how often. So I think the answer is yes, it will be a long-term treatment, but the details will have to follow the data.

[Unidentified Analyst:]

Thank you very much.

[Chaim Lebovits:]

Operator, next question?

[Chaim Lebovits:]

Thank you and best of luck to you. Next question please operator?

[Operator:]

Thank you. Our next question is a follow-up from the line of Sean Martin, Private Investor. Please proceed with your question.

[Unidentified Analyst:]

Yes thank you again. And if for some reason the FDA gave you accelerated approval, do you have enough money to go to market or to roll out a large solution for people at ALS or even aggressive MS? Thank you.

[Chaim Lebovits:]

Well, if given an accelerated approval I don’t think we’ll have a problem with funding. You’re thinking good. Any other questions operator?

[Operator:]

No. Mr. Lebovits there are no further questions, I’ll turn the floor back to you for final comments.

[Chaim Lebovits:]

Please try. We have complaints in the past from investors that they couldn’t get their questions in. So let’s take another moment and give the rules again how they can ask questions as we are trying to ditch any question today. We never tried, but we were blamed that we are trying. I do want to comment on some that are blaming why we're so conservative, why we're not posting the details you read on Twitter and on Facebook, and why we are behaving like a few billion dollar company. Because we are taking the high road, it’s a very strict decision we have taken years ago and it will pay off in the end. So operator, if you want to give the rules again to anyone the instructions again to anyone that wants to ask a question, we’ll wait another minute.

[Operator:]

Of course. [Operator Instructions] Mr. Lebovits, there are no further questions at this time.

[Chaim Lebovits:]

I see that. So, hopefully we answered all of your questions. Again, I want to thank you all for your ongoing support and this maybe a good opportunity to invest in BrainStorm because it’s so undervalued. And we'll pray that we only are able to finalize the trial as its going up until now and hopefully we'll see the results we are all waiting for. Thank you very much for your ongoing support. Thank you from all my colleagues who being with me on the line. Thank you Sean, for helping us out with the question-and-answer session and then well, have a wonderful day. Thank you, operator.

[Operator:]

Thank you. This concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.