Brainstorm Cell Therapeutics Inc (BCLI) 2020 Q1 法說會逐字稿

Good day and welcome to the Brainstorm Cell Therapeutics first-quarter 2020 conference call. At this time, all participants are in a 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.

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 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, CEO of Brainstorm; Dr. Ralph Kern, President and Chief Medical Officer; David Setboun, Chief Operating Officer; Preetam Shah, Chief Financial Officer. They will be available to answer your questions during the Q&A session.

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 have during the Q&A session.

Although the global markets and the coronavirus pandemic has impacted all of us, the first quarter of 2020 has been productive for Brainstorm as we continued 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 express my sincere appreciation for the ongoing dedication and support we have received from patients, their families, caregivers, and all 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 and potentially life-altering therapies. And finally, I would like to thank our shareholders for their continued ongoing support on our collective journey to a potential FDA approval of NurOwn in ALS.

We're happy to share with you that our fully-enrolled Phase 3 ALS clinical trial remains on track for Q4 2020 topline data readout. Through the pandemic, our partner health care institutions have prioritized investigational ALS therapies despite severe COVID access restrictions. And we've been able to continue to deliver most [scheduled] treatments 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 ALSFRS-R rating scale is fully validated for telephone administration, and we have trained timely and certified all of our clinical trial sites to support this effort.

Regarding the Phase 2 progressive MS trial, we faced unexpected delays in new patient enrollment due to site closures for clinical trials related to the global COVID-19 pandemic. Therefore, the scheduled March and April 2020 treatments 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 hear that clinical and trial activities and new patient enrollments will recommence soon as the impact of COVID-19 diminishes. The company's currently collecting all clinical and biomarker data from treated patients with plan to perform an interim analysis after 50% of patients have received [all of these study] treatments.

I would like to now provide an update on the Israeli Hospital Exemption Program. I'm happy to announce that the Ministry of Health has approved the 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 hospitals on program to include additional 13 patients.

But currently, the company has 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 bans between Israel and other countries. The company is currently collecting hospital exempt clinical data for the patients already treated at Ichilov. Once the full dataset for 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 hospitals and outcomes so as 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 the hospital exemption outcomes.

As we announced yesterday, we have licensed the 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 Israel but across the European Union. And this will further support our pipeline activities in neurodegenerative disease.

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 the 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 has been promoted to President and Chief Medical Officer of Brainstorm. I'm 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 financial pharmaceutical executive who has directed commercial 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'm also very happy to announce the Brainstorm Board has been strengthened by the addition of the renowned and 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 health care 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 through product commercialization, strategic partnerships and financial managements needed to advance the company's objectives.

On the financial front, we have 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 innovatives 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 result.

Thank you, Chaim. It's 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 from 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 under 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, rent 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 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-Q filed with the SEC today. Back to you, Chaim.

Thank you, Preetam. Looking at the 2020, we're highly focused on generating topline results for ALS Phase 3 program. We will make all necessary efforts to deliver progressive MS Phase 2 trial results 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 proprietary and innovative cellular technologies and enhance our manufacturing capabilities.

We're actively working on additional preclinical and clinical opportunities to expand our pipeline to address unmet need 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. I look forward to your question.

As mentioned at the beginning of the call, Dr. Kern, David Setboun and Dr. Shah will also join me to answer your questions. Before we open the lines for Q -- for the questions and to reply to those already received, I would ask please, Sean, if you can -- you will be reading the Q and A.

But before we start that, David, just introduce yourself to the investor community and say a few words about your vision of Brainstorm before we hand over for the Q&A to Sean. David.

Thank you. Yes, thank you very much, Chaim.

Good morning. I'm extremely honored to reinforce such a senior executive team and such a strong governance. I have obviously been following Brainstorm NurOwn technology and its clinical development with a lot of interest for a while. [If confirmed], it could change the treatment of care for patients suffering from ALS and other neurodegenerative diseases [and this across the world].

What I can say in addition is during the last month, I [looked] the first -- two critical interesting development 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'm very impressed by the deep scientific and technical expertise that we had behind NurOwn, which was demonstrated again, recently, in the new data published in immunomodulation.

I can tell you that I'm putting all my energy, my heart, my experience [to steer] our unique patient-centric mission. My first objective is to accelerate our engagement plan and discussion with strategy and commercial partners across geographies to serve our patients and to leverage the potential of NurOwn technology. Thank you. Chaim?

Thank you very much, David. Sean, let's have the -- please.

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 topline data? When will it be presented? And what is your timing for the BLA process?

Thank you. Since our last call in March, much has happened due to the COVID-19, which forced us to adapt and respond. But our primary focus was 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 treatments and assessment by the end of the year. This has demanded our focus and resolve working closely with all six United States investigation sites at a time when most clinical trials in the US have ceased operations.

We are very fortunate that our Phase 3 clinical trial was fully enrolled before this pandemic, and we were able to continue the treatment through this COVID-19 restrictions. Our commitment to the ALS community drives our resolve and 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 have been adversely impacted by the international travel ban. I know many of you are disappointed. You want to share some of the exciting results I was talking to 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.

Just a little bit more detail. From the 13 patient, 8 are Israeli and 5 are not Israeli. And 3 of those 5 patients did not finish their treatment. Also, one of the Israeli patient are still -- have to get to treatment. And therefore, the center is not comfortable to share results of bits and pieces. It's not professional.

And as I said in the call, when we get closer to the unblinding, we may not be able to share this with the investor community. We will share the data with the FDA and 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, they just shut down anything that doesn't have to do with COVID and is not life-saving. They did not agree 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. I'm, again, so thankful that we were able to do that in the most important trial of the company now -- ALS. Next question, Sean.

Your next question is, why is the study designed with a placebo arm? And why is the trial so long?

The truth is I get -- all of us get these questions on a daily basis to our Twitter accounts and to our emails. Lately, I think we are bombarded with a huge campaign from European patients and we appreciate it. 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 explained that till now. But please, you must appreciate that we have to be very sensitive even when we explain our strategy.

Since the completion of our Phase 2 trial, Brainstorm worked diligently to find the best path forward that would enable us to provide access to patients while collecting the data necessary for an FDA approval. Even though we tried, we found that's such a pathway to access NurOwn for a patient that is credible and economically feasible does not exist in the current US regulatory system.

The clinical development program for NurOwn have to follow the only available FDA pathway for 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're advised against because they would decrease the chance of success as it would 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 study 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 PIs, 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 and BLA submission is predicted upon a successful completion and positive outcome from the Phase 3 trial. Next question, please, Sean.

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

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, what center we are going to do it, who our PI is, et cetera.

[We], exosomes, we are constantly reviewing the data of our preclinical studies using our proprietary exosome. It is true that our platform technology has potential across several indications. But it's important for me to say again that while we are planning to pursue these additional indications, I would like to be clear that our number one priority is to complete, timely, 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.

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?

Ralph, you want to take the question?

Yes, of course. Thank you. 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 US 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'll review the outcomes of that compassionate program, and we'll see if a later wave of COVID-19 could benefit from our in-house product that we're manufacturing.

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're certainly ready to support manufacturing of these [sales] should they be found to be effective against COVID-19. So, more to come at a later date.

Next question, please.

Your next question concerns the Hospital Exemption. When will the 13 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?

I think I discussed it in the opening statement, but I will answer again because I see many investors are asking that question before the call. So, I'd like to now 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 had 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 has also approved an expansion of the Hospital Exemption 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 for the status, we have not yet completed all 13 patients approved. And only once 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, depending on when such travel bans would be lifted as we get closer to the anticipated BLA filing data, we may elect not to make public statements about these outcomes. As I said previously, the truth is it slipped. I, in the previous call, said that I am excited in the data and we'll 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 more 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 risks not needed for the BLA factors to be approved. Next question.

Your next question concerns the progressive MS clinical trial. How has COVID 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 are current or has been enrolled?

Ralph?

Yes, thank you very much for that question.

Regarding the Phase 2 progressive MS trial, the main delay we found is in new patient enrollments. 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 I mentioned, hospitals such as Mount Sinai in New York, were essentially locked down because of the terrible situation. I think that is lifting. We're in very close contact with all the investigators, and we expect the situation to improve.

We did notice 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're 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 confirming 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 the progressive MS program. Thank you.

Thank you, Ralph. Next question, please.

Next question are, what are the company's plan in the European Union, the United Kingdom and Canada? And how would David Setboun view expanding outside the US market?

Thank you very much. Rather than me discussing David Setboun's plans, I'll ask David. Please can you answer that question?

Sure. Thank you, Chaim. One critical element in the development and the expansion is obviously, I think, the best advice in the regulatory side. And we recently hired a very strong European consultant and adviser. That's going to support us in the European regulatory effort. We are expanding our footprint, notably in the EU, and we are as well evaluating international market opportunity.

I want to reinforce, however, that our immediate priority is the US because it is where we have conducted our trial. With the support of the consultants, we are investigating accelerated regulatory pathway that will [support] the availability of NurOwn in EU and in the UK. Obviously, how rapidly we can enter will depend on the flexibility and responsiveness of the relevant national and regulatory authorities. Thank you.

Thank you, David. Next question, please.

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 partnership? And access to NurOwn, what's the situation with Medicare and the payers?

I think, David, you'll take this one also, please?

Sure. I want to reinforce what Chaim said, we are committed to the patient. And our ambition is to ramp up our capability to be able to treat the relevant population at large. We are, obviously, as well accelerating our engagement plans and our discussions with potential strategic and commercial partners across all geography.

This is obviously an important questions, but we cannot give the precise answer right now. What I can tell you now, 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 negotiation by discussing them too early. Thanks.

Thank you, David. Next question, please.

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

I think it's quite clear, that just announced today, the cleanroom facilities in Israel that will support the EU. It's the first -- it's a good first step. We are also preparing other centers, of course. We'll announce when they'll be ready, but it's on the workings. 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.

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

Preetam?

Thanks, Chaim, and thanks for the question. During the quarter ended March 31, 2020, we raised approximately $19.6 million in total via ATM sale. 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. We will use these funds to 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'll be putting in place a pre-commercialization and launch strategy and plan. And as we approach a filing and BLA, we'll 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. Finally, we'll also be pursuing a regulatory approval of NurOwn in EU for ALS and an advanced EU regulatory strategy across pipeline indications and jurisdictions -- different jurisdictions.

Lastly, we'll continue to advance our preclinical studies and data analysis for additional pipeline indications using MSC exosomes. So, I think these are of the different areas where we want to prudently deploy our funds.

With that, I'll turn it back to Chaim.

Thank you very, very much. And I think we have one more last question about the American Academy abstract? Sean?

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

Ralph?

Yes, thank you very much. The abstract that was presented is critical in adding another layer of understanding to how we position the mechanism of action of NurOwn and in particular, in this case, immunomodulation. What we observed in our experiments was that NurOwn, when combined with peripheral blood cells, increases B and 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 IL-10. And for those who know this and those who don't, IL-10 is a very important molecule. It's known to be deficient in ALS. It correlates with the ALS functional decline.

It also correlates with progressive MS disability, and it may be that increasing IL-10 and B and T regulatory function are important therapeutic strategies to rebalance the immune system. So, we're very excited about this, and we're continuing to do more biomarker work as we speak. Thank you.

Thank you so much. Jerry, we're handing this back to you if other callers want to ask some questions, please.

Thank you. (Operator Instructions)

We have a question from Jason McCarthy, Maxim Group. Please go ahead, sir.

Hi, everyone, it's [Dave] on the line for Jason, thanks for taking my question. You mentioned earlier on the call that you planned to perform an interim analysis about 1.6% 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.

Ralph, it's for you.

Yes, thanks for the question. At this point in time, we're hoping that over the next few weeks, the clinical trial sites will reopen. They'll be able to bring patients back to assessments, enroll new patients and continue their treatments. Unfortunately, we -- this is a very fluid situation, as you are aware.

We are still hoping that later this month, 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's a variable that we don't have control over.

Okay. Thanks for the additional clarity. Appreciate it.

Next question, please.

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

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 for part three to see how long somebody who is getting positive results can continue to get treatment of NurOwn?

Very good question. Ralph?

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 treatment. 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 some -- that continues to grow by the month. And 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 long-term follow-up. Well, thank you for the question.

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

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

And I have the last part to this question. One of the things that I've been reading is the potential of -- while the three treatments may have positive results for certain percentage of the clinical trial participants, but there's also a period of time where it then wears off. Do you have any information on how long, if there's a positive result, it maintains in the participants before it wears off?

Yes, well, that's very good question. (multiple speakers) Yes. Thank you for that. That's a very good question. All treatments wear off and ours is no different. What we saw in our Phase 2 trial was that the median duration of effect was roughly within the range of two months to three months. And that's how we chose the two-month dosing interval.

There's also some preclinical data to suggest that the persistence of MSCs in animal models 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 a drug -- cells are our drug delivery system, we would think that repeated dosing is needed and that an interval of two months in our Phase 3 trial is the best option at this time. Thank you for the question.

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

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

You want to insert, once again, how people can ask questions?

Okay. We do have -- someone has just registered. We have John Nevins from Raymond James. Please go ahead, sir.

Good morning, everybody. A 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 stopped enrolling patients, it could be 9 months to 10 months until we get that magic number of 10 patients.

Ralph?

Yes. Thanks, John. Nice to hear your voice. (multiple speakers) He does. 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 essentially daily contact with the experts at all those sites -- is that they're planning to open up soon.

And I think that the best course of action for us is to keep the protocol as is, provide three treatments to each individual in the trial and then have a very strong 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 set, and we'll see if we can get back to business as usual as soon as possible. Thank you.

Okay, thank you. Next question, back to everybody's favorite top 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?

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

So, it's really 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. A multinational trial would [cost] -- (multiple speakers).

So, the medical authority in Israel does not pay for the Israeli. It's done for free, and it's supported by the international patients?

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

Wow. So, five patients paid over $3 million, that's not going to be the cost of NurOwn, and that's just [for the program] I would imagine.

Absolutely not. 100%. And I think that these patients are very good-hearted people -- not only do they want to get possibility of treatment. They really are very happy that other people are also getting this opportunity. And [it's] the right time to thank them for it.

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

Thank you. Any other question?

(Operator Instructions) Gentlemen, we have no further questions registered.

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

(Operator Instructions)