Brainstorm Cell Therapeutics Inc.
Q1 2020 Earnings Call Transcript

Published: 10 May 2020

[Operator:]

Greetings and welcome to the BrainStorm Cell Therapeutics First Quarter 2020 Conference Call. At this time, all participants are in listen-only mode. As a reminder, this call is recorded and I would now like to introduce your host for today’s conference, Mr. Sean Leous from ICR Westwicke. Mr. Leous you may begin.

[Sean Leous:]

Thank you for joining the BrainStorm Cell Therapeutics call. Before we begin the opening remarks, we would like to remind listeners that this conference call contains numerous statements, descriptions, forecasts, and projections regarding BrainStorm Cell Therapeutics, NASDAQ BCLI and its potential future business operations and performance, statements regarding the market potential for the treatment of neurodegenerative disorders such as ALS and MS, the sufficiency of our existing capital resources for continuing operations in 2020 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 risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time-to-time in our SEC filings. Our results may differ material 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, President and Chief Medical Officer; David Setboun, Chief Operating Officer, Preetam Shah, Chief Financial Officer, they be available to answer your questions during the Q&A session.

[Chaim Lebovits:]

Thank you, Sean. Good morning and good afternoon to everyone on the first quarter 2020 earnings call. I would like to begin by thanking everyone for participating in today's call and for all those that sent the questions prior to our call. We will address many of your pre-submitted questions in the opening remarks and we look forward to addressing any additional questions or comments you may during the Question-And-Answer Session.Overall, the global markets and the Coronavirus pandemic has impacted all of us. The first quarter of 2020 has been the doctrine for Brainstorm. As we continue to execute on our goal of bringing much needed treatment to those suffering from neurodegenerative disease.On behalf of the entire Brainstorm management team, I would like to spread my sincere appreciation for the ongoing dedication and support we have received from patients, their families, caregivers, and all of those who are helping us advance the Phase 3 ALS clinical trial.I also want to thank our team at Brainstorm who fully devote themselves to advance best-in-class, potentially life-altering therapies. And finally, I would like to thank our shareholders for their continued ongoing support on our collective journey towards potential FDA approval of NurOwn and ALS.We are happy to share with you that our fully enrolled, Phase 3 ALS clinical trial remains on track with our Q4 2020 top-line data readout. Due to the pandemic, our partnered healthcare institutions have prioritized investigational ALS therapies, despite severe COVID actions we are taking and we have been able to continue to deliver most scheduled treatment with occasional schedule changes only.We have also aligned with the FDA guidance and enabled non-treatment visits to be conducted remotely by phone to optimize patient safety. As we previously mentioned, the clinical trial primary outcome measure, the ALS refers to our rating scale is fully validated through telephone administration and we have trained timely and certified all of our clinical trial sites to support with this effort.Regarding the Phase 2 progressive MS trial, we faced unexpected delays in new patient enrollment, due to site closures from clinical trials related to the global COVID-19 pandemic. Therefore, the scheduled March and April 2020 treatment and new enrollments were deferred to May and June of 2020 despite all efforts from our principal investigators.We stay in close contact with all of these centers to have the clinical and trial activities and new patient enrollments we will recommend soon and the impact of COVID-19 diminishes. The company is carefully collecting all clinical and biomarker data from treated patients which we’ll plan to perform an internal analysis after 50% of patients have received all three study treatments.I would like to now provide an update on the Israeli Hospital Exemption Program. I am happy to announce that the Ministry of Health has approved extension of the ongoing study which will enable us to enroll the full 13 patients. In addition, the Ministry of Health has also approved an expansion of the Hospital Exempt program to include additional 13 patients.While currently the company have not completed treatment of all patients for the first 13 approved patients, as non-Israeli patients were not able to be assessed and/or further treated at the hospital from the end of March to this date, due to imposed travel ban between Israel and other countries.The company is currently collecting Hospital Exempt clinical for the patients already treated with ALS, once the full datasets of the first 13 patients is collected, we will perform a detailed analysis.I should also mention, depending on when such travel bans would be lifted, and as we get closer to the anticipated BLA filing date, we may elect not to make public statements about the Hospital Exempt outcomes, so that not to interfere with our interactions and communications with the FDA and other regulatory agencies.As we mentioned previously, the FDA would likely look at the totality of the data, including Phase 2 data and hospital exemption outcomes.As we announced yesterday, we have licensed a cleanroom facility at the Ichilov Hospital in Israel to support the manufacture of NurOwn for Israel and the European Union.We believe that this will secure our GMP compliant manufacturing capacity and enable Brainstorm to rapidly scale up production to provide NurOwn to patients after regulatory approval, not only in the Israel, but across the European Union, as this will further support our pipeline activities and neurodegenerative diseases.We are very pleased to be able to expand our ongoing collaboration with the hospital, one of the world’s most innovative and respected medical centers. In addition, we have recently engaged the services of an experienced EMEA regulatory expert as we plan to approach EMEA regarding to advance NurOwn in ALS and potentially engage with the EMEA across other pipeline indications.Finally, we recently strengthened our management team and Board. I am pleased to announce that Dr. Ralph Kern is being promoted to President and Chief Medical Officer of Brainstorm. I am also happy that today, David Setboun is joining our earnings call. David is our new Chief Operating Officer.I want to extend David a warm welcome to the company. David is an experienced international pharmaceutical executive with direct customers and development, business strategy and product launches for two decades at three major biopharmaceutical companies. David will play a critical role in our business development and partnering efforts.I am also very happy to announce the Brainstorm Board has been strengthened by the addition of the renowned distinguished economist, Professor Jacob Frenkel as Chairman of our Board of Directors.In addition we are pleased to add to our Board, Mr. Sankesh Abbhi a successful healthcare entrepreneur, executive and investor as Brainstorm advances our corporate objectives over the next few months, we believe that today our Board has the right mix of expertise and experience from early R&D, new product commercialization, contingent partnerships and financial management needed to advance the company’s objectives.On the financial front, we’ve been prudent and disciplined in our execution strategy. We have a strong balance sheet through strategic use of our ATM and the registered direct offering from Abbhi Capital, successful receipt of non-dilutive grants from CIRM and from the Israeli Innovative Association, we remain well positioned to efficiently run our business through upcoming product lifecycle events.With that, I will now hand over the call to Dr. Preetam Shah, our Chief Financial Officer to discuss our first quarter financial results.

[Preetam Shah:]

Thank you, Chaim. It is my pleasure now to walk you through our first quarter 2020 financial performance. Research and development expenses, net, for the three months ended March 31, 2020 were $5.95 million, compared to $3.46 million, net for the three months ended March 31, 2019.Excluding participation from IIA and CIRM under the grants and proceeds received under the Hospital Exemption regulatory pathway, research and development expenses increased by $1.94 million from $5.20 million in the first quarter of 2019 to $7.14 million in the first quarter of 2020.This increase year-over-year was primarily due to an increase in expenses in connection with our ongoing ALS Phase 3 and progressive MS Phase 2 clinical trials, a decrease in participation of IIA and CIRM in Q1 2020 and the various awarded grants and partially offset by proceeds received under the Hospital Exemption Regulatory pathway.General and administrative expenses for the three months ended March 31, 2020 were $2.36 million, compared to $1.47 million in the three months ended March 31, 2019. This increase year-over-year was primarily due to increase in payroll, stock-based compensation, PR and IR costs, rents, consultants and travel.Net loss for the three months ended March 31, 2020 was $8.1 million, or negative $0.32 per share, as compared to a net loss of $5.03 million, or negative $0.24 per share for the three months ended March 31, 2019.Cash, cash equivalents, including and short-term bank deposits were approximately $14.5 million at March 31, 2020, compared to approximately $6.2 million at March 31, 2019. Our total available funding as of March 31, 2020, which includes cash on hand, as well as remaining non-dilutive CIRM and IIA grants amounts to approximately $17.5 million.For further details on our financials, please refer to our Form 10-K filed with the SEC today.Back to you Chaim.

[Chaim Lebovits:]

Thank you, Preetam. Looking ahead to 2020, we are highly focused on generating top-line results. For our ALS Phase 3 program, we will make all necessary efforts to deliver progressive MS Phase 2 trials out in the fourth quarter of 2020 unless there are further unexpected delays due to the COVID-19 disruption.We look forward to working towards potential approval and initiating the regulatory submission and eventual commercialization of NurOwn and ALS and to further advancing propriety and innovative cellular technologies and enhance our manufacturing capabilities.We are actively working on additional preclinical and clinical opportunities to expand our pipeline to address unmet needs and to grow as a biotechnology company. This is an exciting year for us as we work towards executing on behalf of patients and shareholders.Lastly, we are all trying to adjust our lives and plans while doing all we can to safeguard public health and the well-being of our patients, caregivers, principal investigators and employees. I would personally thank everyone for working together and your continued support. And thank you all for your ongoing support of Brainstorm Cell Therapeutics and I look forward to your questions.As mentioned, at the beginning of this call, Dr. Kern, David Setboun, and Dr. Shah will also join me to answer your questions. And before we open the lines to queue for the questions and to reply to those already received, I would ask please Sean if you can – you will be reading the Q&A.But before we start out, David, just introduce yourself to the investor community and say a few words about your vision at Brainstorm before we hand over for the Q&A to Sean. David?

[David Setboun:]

Thank you. Yes, thank you very much, Chaim. So, good morning. I am extremely honored to reinforce the existing executive team and such a strong governance. I have obviously been following Brainstorm in NurOwn technology and its clinical development with a lot of interest for a while.This confirms it could change the treatment of care of patients suffering from ALS and other neurodegenerative diseases and it is across the world.What I can say in addition is, during the last months, I observed first-hand two critical impressive developments for a company of this size. Number one, the ability to stay on track for the ALS Phase 3 study and this despite COVID-19; number two, I am very impressed by the deep scientific and technical expertise that we have behind NurOwn, which was demonstrated again recently in the new data published in immunomodulation.I can tell you that I am putting all of my energy, my heart, my experience to spur our unique patient-centric mission. My first objective is to accelerate our engagement plan and discussion with strategy and commercial partners across geographies to stand our patients and to leverage the potential of NurOwn technology.Thank you. Chaim?

[Chaim Lebovits:]

Thank you very much, David. Sean, let’s start.

[Sean Leous:]

Yes, sir. Thank you. Your first question for the team is, can you please elaborate on the impact of COVID-19 on the ALS trial? What approximately was the timeline of the last patient visit? When will you get the top-line data? When it will be presented? And what is your timing for the BLA process?

[Chaim Lebovits:]

Thank you. So, since our last call in March, much have happened due to the COVID-19 which forced us to adapt in response, but our primary focus and is to complete the ALS Phase 3 clinical trial by the end of the year, preparing for a BLA submission and ensuring commercial preparedness including building manufacturing capacity, and expanding our human resources capabilities.As you can see in today’s news, even despite the impact of corona, we are advancing on all of these fronts, not everything was announced. Today we announced that we are maintaining the pace of Phase 3 activity to complete all study treatment and assessment by the end of the year.This has demanded our focus and resolved working closely with all six United States investigation sites at a time when most clinical trials in the U.S. have ceased operations. We are very fortunate that our Phase 3 clinical trial was fully enrolled before this pandemic as we were to able to continue the treatment through this COVID-19 restrictions, our commitments to the ALS community drives our results in those of our Phase 3 partners.We have kept that commitment. All of our manufacturing facilities are operating and growing in this period without delay. As you know, the Hospital Exemption program has been adversely impacted by the international travel ban. I know many of you are disappointed. You want to hear of the exciting results I was talking in the previous calls.We don’t control the COVID-19 pandemic and at that call we didn’t think that this program would have been delayed. So, a little bit more details from the 13 patients, eight are Israeli and five are not Israeli. And three of those five patients did not finish the treatment. Also one of the Israeli patients are still have to get to treatment and therefore, the center is not comfortable to share results of different pieces.It’s not professional and as I said in the call, when we get closer to the underlying date, we may not be able to share this with the investor community. We will share the data with the FDA as the FDA will look at the totality of our results. The same goes with the MS trial. We did anticipate that we will be able to do the same as we did with ALS with MS.Unfortunately, even though the principal investigators of these wonderful centers were supporting our view to continue with the trial. The centers like Mount Sinai Center, they just shut down anything that was going to have to do with COVID and it’s not life-saving. They did not agreed to allow our MS patients to come in for treatment.Unfortunately, we as a company, but we are ready to manufacture and treat all of those patients and again, so thankful that we were so thankful that we were able to do that in the most important trial of the company now ALS.Next question, Sean?

[Sean Leous:]

So your next question is, why is the study design with a placebo arm? And why is the trial so long?

[Chaim Lebovits:]

So, it’s really what is I get and all of us get these questions on a daily basis to our Twitter accounts and to our emails. And lately, I think we are bombarded with huge campaigns from European patients and we appreciate it and we read every email and we are listening to you. And it’s important to us and I think this is a very good opportunity to address some of these questions and explain our strategy more than we try not to now.But please you must appreciate that we have to be very sensitive even when we frame our strategy. Since the completion of our Phase 2 trial, Brainstorm worked diligently to find the best path forward that will enable us to provide access to patient while collecting the data necessary for an FDA approval.Even though we try, we found that such a pathway to access NurOwn for patients that is credible and economically feasible does not exist in the current U.S. regulatory system.The clinical development program for NurOwn has to follow the only available FDA pathway for a possible approval. The current Phase 3 trial design is based upon the FDA guidance for therapy development at the time of the Phase 3 trial initiation.Efforts to minimize the placebo arm decreased the total number of patients in the trial allowing an open-label extension we are advised again because they would decrease the chance of success, to weaken the statistical power and therefore the trial may not have been powered to demonstrate substantial evidence for effectiveness for an FDA approval.Definitely, at this time, just a few months before the product completion, it would be irresponsible to do an interim analysis, because it will decrease statistical power and may jeopardize the path to approval. We have consulted with experts, our BIs, statisticians, and other ALS experts who have strongly advised us not to go on that pathway, not to risk the outcome.We are fully focused to have the best support we can pre-BLA submission. A BLA submission is predicted upon a successful completion and positive outcomes from the Phase 3 trial.Next question please, Sean?

[Sean Leous:]

So your next question is, when will the company announce a new indication for NurOwn? And what will be your indication for exosomes?

[Chaim Lebovits:]

Thank you. So, we plan to announce a third clinical indication in June of 2020. We just need a bit more time to finalize the details and the regulatory interactions and the study logistics. But we already know and the Board already approved our next indication, watch center we are going to do is, who our PI is, et cetera.Exosomes, we are currently reviewing the data of our preclinical studies using our proprietary exosome. It is true that our platform technology has the potential across several indications. But it’s important for me to say again that why we are planning to pursue these additional indications.I would like to be clear that our number one priority is to complete finally the ALS Phase 3 trial, assemble the data necessary to submit the BLA package and gain approval in this indication. That is our commitment.Next question please?

[Sean Leous:]

And the next question, what actions has Brainstorm taken to treat COVID-19 in Israel? There was an announcement seeking bone marrow donation. What exactly does that mean? Have patients been treated? And if so, what were the results?

[Chaim Lebovits:]

Ralph? Ralph, do you want to take the question?

[Ralph Kern:]

Yes, of course. Thank you. So, as you know, we closely follow several other companies that have an off-the-shelf MSP product that is being conducted in clinical trials in the U.S. and other countries. As you know, we don’t have a ready off-the-shelf product. But I can tell you that, our team has looked very carefully at COVID-19, including the preclinical and clinical components and regulatory aspects.And we’ve decided to proceed with a small compassionate treatment program in Israel. We will review the outcomes of that compassionate program and we’ll see if the later of wave COVID-19 could benefit from our in-house product that we are manufacturing. So, to summarize, for the first COVID wave, excuse me, which we see right now, we decided to not shift our resources away from ALS.And as Chaim mentioned, our focus is on completing the ALS trial in a timely fashion. But we do have great expertise in the expansion of MSPs and we are certainly ready to support manufacturing of these should they be found to be effective against COVID-19. So, more to come at a later date.

[Chaim Lebovits:]

Next question please?

[Sean Leous:]

Your next question concerns the Hospital Exemption. When will 13 in the initial cohort be treated? When will the new cohort be started? When will we have the data? And will the delayed data overlap with the BLA process and limit the ability to communicate?

[Chaim Lebovits:]

I think, I discussed it in the opening statements, but I will answer it again, because, I see many investors are asking that question for the call. So, I would like not address these questions. As I stated in the opening remarks, the Ministry of Health has approved the extension of the ongoing study which will enable us to enroll the full 13 patients.We had a date when we have to finish it, due to COVID that date was not met, of course and they extended that because they are the ones that don’t allow patients to visit. In addition, the Ministry of Health have also approved an expansion of the hospital Exempt Program to include additional 13 patients.Again, depending on when we will be able to allow more patients to visit the center here in Israel, we will decide if we will move forward with this expansion. As per the status we have not yet completed all 13 patients approved and only ones that will happen we will be able to gather the data and at least present it to the FDA, which is very important.So, also mentioned, that depending on when such travel bans will be lifted, as we get closer to the anticipated BLA filing date, we may elect not to make public statements about these outcomes. As I said previously, this was a slip - I in the previous call said that I am excited in the data and we will share it.I still would love to share it, but I do have to follow professional advice from the team working on the pre-BLA package. That’s what’s most important I believe for our investors and even more so for our ALS patients and for the company. We want to make sure that we don’t take any risk not needed for the BLA package to be approved.Next question?

[Sean Leous:]

So your next question concerns the progressive MS clinical trial. How has COVID-19 affected the trial? When will the company have interim and final data? Will the ALS data shorten the timeline for progressive MS? And how many patients have been enrolled ?

[Chaim Lebovits:]

Ralph?

[Ralph Kern:]

Thank you very much for that question. So regarding the Phase 2 progressive MS trial, the main delay we found is in new patient enrollment. Obviously, we had already enrolled eight participants in this trial and because of the site closures, we weren’t able to bring new patients in during the second half of March and the entire month of April.And as Chaim mentioned, possible success now in Sinai in New York were essentially lockdown because of the terrible situation. I think that is lifting. We are in very close contact with all the investigators and we expect the situation to improve. So, we did noticed that, we are able to get biomarker data and clinical data from those who’ve already been treated and we do plan to perform an interim analysis after 50% of the patients have received all three study treatments.We still feel that we may be able to complete the clinical trial by the end of the year. It depends on when COVID restrictions are relaxed and obviously, we monitor that on a day-by-day basis. And as I mentioned, we are in very close contact with all the sites and with all the principal investigators. The second part of the question relates to the ALS data and how that might support the MS program progress.I think that, clearly, there is an opportunity there. I think safety and efficacy from ALS patients would be very important in interpreting our progressive Phase 2 data and also next steps with the agency and we think perhaps more importantly the biomarker data confirm the mechanism of action of NurOwn in ALS, progressive MS and other neurodegenerative diseases will be self-supporting.So, we anticipate that the data from our progressive MS, interim analysis will be helpful for ALS and we also believe that our final data for ALS will be helpful in advancing milestones in progressive MS program. Thank you.

[Chaim Lebovits:]

Thank you, Ralph. Next question please?

[Sean Leous:]

Next questions are, what are the company’s plans in the European Union, in the United Kingdom and Canada? And how would David Setboun really expanding outside the U.S. markets?

[Chaim Lebovits:]

Thank you very much. And rather than me discussing David Setboun’s plans, I will ask David, please, can you answer that question?

[David Setboun:]

Sure. Thank you, Chaim. So, a critical element in the development and the expansion is obviously, I think the best advice in the regulatory side and we recently hired very strong European consultants and advisors that’s going to support us in this European regulatory efforts. We are expanding our footprint, not only in the EU, and we are as well, evaluating international market opportunity.I want to reinforce however that, our immediate priority is the U.S., because it is where we have conducted our trials. With the support of the consultants, we are investigating accelerated regulatory pathway that would support the variability of NurOwn in EU and in the UK.Obviously, how rapidly we can enter will depend on the flexibility and responsiveness of their relevant national and regulatory authorities. Thank you.

[Chaim Lebovits:]

Thank you, David. Next question please?

[Sean Leous:]

The next question concerning commercialization asks how many patients will Brainstorm be able to treat. And when will you be seeking a joint venture or strategic partnerships? And access to NurOwn, what’s the situation with Medicare and the payers?

[Chaim Lebovits:]

I think, David, you pick just one of them please?

[David Setboun:]

Sure. So, I want to reinforce what Chaim said, we are committed to the patients and our mission is to ramp up our possibility to be able to treat the relevant population at launch. We obviously, as well, accelerating our engagement plans and our discussions with potential strategic and commercial partners across all geographies.This is obviously an important question, but we cannot give a precise answer right now. What I can guide you now is, our manufacturing process has the potential to be scaled rapidly using automation and we are in active discussion with key suppliers. And we do not want to reach those negotiations by discussing them too early. Thanks.

[Chaim Lebovits:]

Thank you, David. Next question please?

[Sean Leous:]

The next question concerns manufacturing. In the last earnings call, it was mentioned that Brainstorm is preparing for commercialization by building internal and external product capacity enabling the company to bridge early demand. That demand exists today. What is the status of these plans?

[Chaim Lebovits:]

I think, I clear this and just then also, David, the new facilities in Israel that will support the EU as the first – which is the first step. We are also preparing other centers of course. We will announce when they will be ready. But it’s under working and also we are finalizing the automation agreement and that will have a great impact on the speed of this additional manufacturing capacity. And the next question please?

[Sean Leous:]

The question concerns financial. We received a question about the ATM. Can you provide more details and how are the proceeds be used?

[Chaim Lebovits:]

Preetam?

[Preetam Shah:]

Thanks, Chaim, and thanks for the question. So, during the quarter ended March 31, 2020, we raised approximately $19.6 million in total via ATM sales. We raised about $17.8 million via our previous ATM facility whose $20 million capacity be fully exhausted during the quarter and raised an additional $1.8 million from the new $50 million ATM facility, which we activated during this quarter.We plan to use our available capital prudently and we’ll deploy our funds to make progress on the following key business objectives. So we will use these funds successfully execute and complete our Phase 3 ALS clinical trial and filing of the BLA, which, as Chaim and David mentioned, is our first priority.We will be putting in place a pre-commercialization and launch strategy and plan and as we approach the filing and BLA, we will spend funds on continuing to advance our Phase 2 clinical trial. We’ll also advance our new pipeline indication, once it’s announced this summer. And then, we’ll be deploying these funds to scale-up manufacturing capability of NurOwn in Israel broadly EU and the UK.And then, finally, we will be – we will also be pursuing a regulatory approval of NurOwn in EU for ALS and advance EU regulatory strategy across pipeline indications and jurisdictions. It’s got different jurisdictions.Lastly, we will continue to advance our preclinical studies and data analysis for additional pipeline indications using MSP exosomes. So, I think these are the different areas where we want to prudently deploy our funds. With that, I will turn it back to Chaim.

[Chaim Lebovits:]

Thank you, very, very much and I think we have one more last question about the American Academy Abstract, Sean?

[Sean Leous:]

Yes. The final question is, what are the most import conclusions from the abstract that was presented at AAN 2020?

[Chaim Lebovits:]

Ralph?

[Ralph Kern:]

Thank you very much. So the abstract that was presented is critical in adding another layer of understanding to how we position the mechanism of action of NurOwn. In particular in this case immunomodulation, what we observed in our experiments was that NurOwn when combined with peripheral blood cells, increases B&T regulatory function in terms of the number of cells.And we found that this was mediated in part by the expression – induced expression of IL10. And for those who know this and those who don’t, IL10 is a very important molecule that’s known to be deficient in ALS. It correlates with the ALS functional decline.It also correlates with progressive MS disability and it maybe that increasing IL10 and B&T regulatory function are important therapeutic strategies to rebalance the immune system. So, we are very excited about this and we are continuing to do more biomarker work as we speak. Thank you.

[Chaim Lebovits:]

Well, thank you so much. Jerry, we are handing it back to you if other callers want to ask some questions please.

[Operator:]

[Operator Instructions] We have a question from Jason McCarthy, Maxim Group. Please go ahead sir.

[Unidentified Analyst:]

Hi, everyone. It’s Dave on the line for Jason. Thanks for taking my question. So, you mentioned earlier on the call that you plan perform an interim analysis once it’s – sort of patients have been treated for the Phase 2 MS trial. I was hoping you could shed some clarity on when we can – when roughly we can expect the interim data readout Thanks.

[Chaim Lebovits:]

Ralph, please?

[Ralph Kern:]

Yes, thanks for the question. At this point in time, we are hoping that over the next few weeks, the clinical trial sites will reopen. They will be able to bring patients back, do assessments, enroll new patients and continue their treatments. Unfortunately, this is a very fluid situation, as you are aware. We are still hoping that, later this month or early next month, that we’ll go back to our schedule.But at this point in time, I wouldn’t want to estimate a specific date or time, because there is a variable that we don’t have control over.

[Unidentified Analyst:]

Okay. Thanks for the additional clarity. Appreciate it.

[Chaim Lebovits:]

Next question, please?

[Operator:]

We have a question from Marcia Kaplan, Ameriprise Financial. Please go ahead.

[Marcia Kaplan:]

Hi, my question is, how is the – what is the longest period that any of the clinical trial participants have been in the NurOwn trial? And if any of the trial participants from stage 2 or stage 1 ever been brought back into the trial with part 3 to see how long somebody who is getting positive results can continue to get treatment of NurOwn?

[Chaim Lebovits:]

Very good question. Ralph?

[Ralph Kern:]

Yes, thanks for the question. The duration of the Phase 3 study for individual participants is 11.5 months. That includes seven months after the first treatments. So, that’s the duration of exposure that we have in the current population. Currently, the majority of patients in the Phase 3 trial have received all three treatments and a significant number have actually completed all study assessments.So we’ll have – that continues to grow by the month. We, obviously will be looking to a last patient, last visit in the fourth quarter and at that point in time I think we’ll have a good dataset. In terms of the other aspects of the question, whether Phase 2 patients came back for repeated treatments or other assessments, the answer to that is, no, because that was a Phase 2 study and it wasn’t designed for a long-term follow-up.So, thank you for the question.

[Marcia Kaplan:]

Is there any plan to look into a second set of treatments for any of the patients?

[Ralph Kern:]

So, not at this time. We obviously, receive a lot of questions about what happens at the end of the study and obviously we are looking at all options at this point in time, but we haven’t made any decisions and we haven’t announced any additional treatments that potentially could be offered. But we are thinking about it, obviously.So, thank you for the question.

[Marcia Kaplan:]

And I have a last part to this question. One of the things that I’ve been reading is the potential of, while the pre-treatment may have positive results for a certain percentage of the clinical trial participants that there is also a period of time, where it’s been very poor.Do you have any information on how long is the positive results it maintained in the participants before it’s variable – does that require any further treatment?

[Ralph Kern:]

Yes, thank you for that. That’s a very good question. All treatments were off and ours is no different. What we saw in our Phase 2 trial was that the median duration of the fact was roughly within the range of two to three months. And that’s how we chose that two month dosing interval.There is also some preclinical data that suggest that the persistence with MSCs in animal model, there is about three months. So, we think that as long as the cells are there and continuing to deliver their cargo, which is the mechanism of action that we can expect a treatment effect. And obviously, we wouldn’t expect a treatment effect beyond the persistence of the transplanted cells.So, as our treatment is the drug cells or a drug delivery system, we would think that, repeated dosing is needed and that in interval of two months in our Phase 3 trial is the best option at this time. Thank you for the question.

[Chaim Lebovits:]

Thank you. Operator, are there any other questions at this time?

[Operator:]

At this time, sir, there are no further questions.

[Chaim Lebovits:]

Do you want instruct once again how people are going to ask questions?

[Operator:]

Okay. We do have – someone has just registered. We have John Evans from Raymond James. Please go ahead sir.

[John Evans:]

Good morning everybody. Couple of quick questions. In the MS Phase 2 study, remind me, is it one injection, or are we doing three injections? And the reason I ask is that, if we stop enrolling patients, it could be nine to ten months until we get that magic number of ten patients.

[Chaim Lebovits:]

Ralph?

[Ralph Kern:]

Yes. Thanks, John. Nice to hear your voice.

[Chaim Lebovits:]

John asked a tricky question…

[Ralph Kern:]

He does.

[Chaim Lebovits:]

But it’s good.

[Ralph Kern:]

And we appreciate the questions. The Phase 2 MS trial is, as you say, three doses. Obviously, if the situation in the hospitals persists without resolution, we would have to make a decision. What we hear from the various sites and we’ve been in potentially daily contact with the experts at all those sites who said, they are planning to open up soon.And I think that the best course of action for us is to keep a protocol as is, provide three treatments to each individual in the trial and then have a very strong dataset. I think that anything that diminishes the quality of the data or the amount of data, I think is not in the best interest of Brainstorm, the patients or investors at this time.So, our plan is to continue with the schedule that we had originally said and we’ll see if we can get back to business as usual as soon as possible. Thank you.

[John Evans:]

Okay. Thank you. Next question back to everybody’s favorite topic, the Hospital Exemption program. I see in the 10-Q, you’ve received $3.4 million based from the AG to-date. Who pays that?

[Chaim Lebovits:]

Only the non-Israeli patients pay. The whole – reason why, the Israeli government wanted us to treat Israeli patients which can’t afford anything. So they are paying zero.

[John Evans:]

Okay.

[Chaim Lebovits:]

And the Israeli Medical Tourism opportunity allows us to treat a few patients in Israel for free. That was in return of not having an arm of the trial in Israel. Both the trial would cost.

[John Evans:]

The Medical Authority in Israel does not pay for the Israelis. It’s done for free and it’s supported by the international patients.

[Chaim Lebovits:]

A few of them, exactly, five patients support the other eight.

[John Evans:]

Well, so five patients paid over $3 million, that’s not going to be the cost of NurOwn, that’s just for the program, I would imagine.

[Chaim Lebovits:]

100% and I think these patients are very good hearted people, not only as they want to get possibility of treatments, they really are very happy that other people are also getting this opportunity and so, the right time to thank them too.

[John Evans:]

Okay. That’s all I had. Thanks, gentlemen.

[Chaim Lebovits:]

Thank you. Any other questions?

[Operator:]

[Operator Instructions] Gentlemen, we have no further questions registered.

[Chaim Lebovits:]

Thank you very much. Operator, you can go and proceed to the closing comment.

[Operator:]

This concludes today’s teleconference. You may disconnect your telephones. Thanks for calling.