Brainstorm Cell Therapeutics Inc (BCLI) 2019 Q4 法說會逐字稿

Greetings and welcome to the BrainStorm Cell Therapeutics fourth quarter 2019 earnings conference call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. (Operator Instructions) As a reminder, this conference is being recorded. It is my pleasure to introduce your host, Sean Leous with ICR. Please go ahead.

Thank you for joining the BrainStorm Cell Therapeutics fourth quarter and full year 2019 financial results conference.

Before we begin the prepared remarks, we would like to remind listeners that this conference contains numerous statements, descriptions, forecasts, and projections regarding BrainStorm Cell Therapeutics, Inc., Nasdaq: BCLI, and it's potential future business operations and performance statements regarding the market potential for treatment of neurodegenerative disorders such as ALS and MS, 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 effort.

Forward-looking statements are subject to numerous risks and uncertainties, many of which 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 today on the call will be Chaim Lebovits, President and CEO of BrainStorm; Dr. Ralph Kern, Chief Operating and Chief Medical Officer; and Preetam Shah, our Chief Financial Officer will be available to answer your questions during the Q&A session.

And now it is my pleasure to introduce Mr. Chaim Lebovits, Chief Executive Officer of BrainStorm. Mr. Lebovits, you may begin.

Good morning. Let me begin by thanking everyone for joining today's call.

2019 was an exceptional year for BrainStorm. We continue to achieve milestone after milestone. And we're holding this call to remind our shareholders of all that have been accomplished during this past exceptional year and what we expect for 2020. We remain fully committed to bring much-needed innovative cellular therapies to individuals with neurodegenerative disease, to remain patient focused, and to advance our business objectives through scientific excellence.

Before I begin discussing 2019, I would like to first give you a more detailed update of our recent meeting with the FDA. This meeting was very important and was a watershed moment for our ALS development program. The Director of the Center for Biologics and Research, in short CBER, proposed this meeting and senior leaders of CBER all [the official] were present. From our side, in addition to myself and Dr. Ralph Kern, we were accompanied by some of the principal investigators of our trial. We were also fortunate to have other world-renowned leading ALS experts join us at this meeting.

Brian Wallach, a person living with ALS and co-founder of I AM ALS, attended and represented the patient voice because of (inaudible) for every step of the development process for NurOwn. Objectives of this meeting were to confirm that there is a clear regulatory path forward for NurOwn and ALS that it leverages all available regulatory options and to confirm our strategy commitment with senior FDA leadership to quickly advance the development and subsequent regulatory review of NurOwn with a view towards a biological license application, BLA submission and hopefully approval.

Early last year, the FDA published guidelines that recognize the terrible burden of ALS and there is a feel to quickly advance the development and approval of much needed therapies. Dr. Peter Marks, the Director of CBER, and Dr. Janet Woodcock, the Director of CDER, said in a joint statement that the goal of every interaction with FDA is to allow the agency to advise and propose development program and the efficient design of trials produce the data needed for FDA approval.

Therefore, we felt it was important to hear the FDA's views on ALS drug development at an official meeting where the views of experts and the patients were combined. We had a wonderful discussion. What was most important to BrainStorm was to confirm that the data we are collecting, and this Phase 3 trial are aligned with current FDA views when considering a BLA for approval.

At the meeting, the FDA confirmed that the fully enrolled Phase 3 trial is collecting relevant data critical to the assessment of NurOwn's efficacy. [There they] also commented that this is a well-designed trial. They further indicated that they would like to have additional discussions with BrainStorm on how to expedite statistical review of data from the Phase 3 trial in a manner similar to that being piloted by the Oncology Center of Excellence.

Now to move on to 2019 achievements. One of our proudest moments of 2019 was announcement that we fully enrolled our Phase 3 trial of ALS. All 200 patients were enrolled at [six] of the leading US centers for ALS research. Each center [ran our] clinical trial with excellence.

I must thank the principal investigators and their staff who made this happen, as well as the courageous trial participants who returned to these medical centers for screening, treatment, and follow ups required for data assessment for the regulatory authorities. At the same [moment], we were making additional progress when the Data and Safety Monitoring Board concluded our trials with continuous plan without any protocol change.

Another milestone was achieved in late October when we proudly announced the publication of NurOwn ALS Phase 2 randomized clinical trial data in Neurology, one of the most widely respected and highly cited peer-reviewed neurology journals. Our Phase 2 data was published for the benefit of researchers now and in the future who will continue the [path to ALS]. In 2019, we also extended our clinical pipeline into another neurodegenerative disease, multiple sclerosis. Currently, we are enrolling patients with progressive MS.

And as you know, there is no US FDA approved therapy addressing more than one progressive form of MS. We enrolled our first patient in March at a clinical investigational site. We received a grand award of about $0.5 million from the National Multiple Sclerosis Society through its Fast Forward Program.

Once again, due to the clinical team and BrainStorm and the principal investigators of the Cleveland Clinic, the Stanford University School of Medicine, the Keck School of Medicine at the University of Southern California, and the Mount Sinai School of Medicine, this phase of the trial has already enrolled 10 patients to date. And for this trial too, the Data and Safety Monitoring Board unanimously found that the study should continue as planned without any protocol change.

Throughout the year, BrainStorm's management team traveled to conference after conference, meeting after meeting, bringing our story to the many audiences that need to hear this, whether it was Dr. Kern presenting at NEALS [or in Perth] at the International [MND] Symposium; Dr. Susan Ward overseeing a workshop at the Neuromuscular Drug Development Summit; Dr. Preetam Shah, our CFO, presenting at the Dawson James Securities Conference; Medicaid Center convening a panel [filled with] advocates and key members of the US government together [with] shared goals that [BrainStorm] is [doing] to meet critical unmet medical need. And we do it every single day to make sure the [medical] story is being heard around the world.

We're a company with a mission to make a difference. And I again, take the time to express my sincere gratitude to everyone at BrainStorm who brought us to where we are today.

These clinical milestones and ongoing success [I attribute] to the outstanding work of our senior management and their teams, namely our Chief Operating Officer and Chief Medical Officer, Dr. Kern; our VP for Scientific and Regulatory Affairs, Dr. Yael Gothelf; our VP for [CMC], Dr. Yossef Levy and his team; our VP for Patient Advocacy and Government Affairs, Mary Kay Turner; our Head of Clinical Operations, Dr. Susan Ward; Uri Yablonka, our Executive Vice President and Chief Business Officer.

All we do is the result of a wonderful teamwork effort from all our colleagues here at BrainStorm. So, thank you to all for all your tireless efforts to get us where we are now.

Before I turn the call over to Preetam to discuss the financials, I want to again thank the ALS and MS communities, their families, their friends, the advocates, and everyone who continues to support and believe in what BrainStorm does and will continue to do. We continue to collaborate with ALS advocacy organizations to ensure that patient perspective is incorporated in all we do.

We are grateful for the support from I AM ALS; National ALS Association ALSA; many chapters of ALSA, including Golden West, Arizona, Greater Philadelphia; Les Turner; Team Gleason; ALS Hope Foundation. These are just to name a few of the many who share our common goal of bringing forward a clinically meaningful treatment for ALS. We will keep up our commitment to you to advance science and maintain our focus on the development of highly impactful and innovative cellular therapies, and we can never thank you enough for your ongoing support of BrainStorm's mission.

With that, I'll turn the call over to Dr. Shah, our Chief Financial Officer.

Thank you, Chaim. It's my pleasure now to walk you through our 2019 financial performance. Research and development expenses net for the year ended December 31, 2019, was $17.2 million compared to $8.3 million net for the year ended December 31, 2018. Included in these amounts are R&D grants from the Israel Innovation Authority or IIA and California Institute of Regenerative Medicine or CIRM, as well as proceeds received from the Israeli Hospital Exemption pathway that are recorded as an offset to the expense.

The IIA grant included to offset was approximately $732,000 in 2019 and approximately $1.8 million in 2018, while the CIRM grant included to offset was approximately $4.1 million in 2019 and approximately $6.3 million in 2018. Proceeds from the Israel Hospital Exemption regulatory pathway in 2019 was approximately $2.5 million compared to zero in 2018.

Excluding these grants by both the IIA and CIRM and proceeds from the Israeli Hospital Exemption regulatory pathway, R&D expenses increased by approximately $8.4 million from $16.3 million in 2018 to $24.7 million in 2019. This year-over-year increase was primarily due to expenses in connection with our Phase 3 ALS clinical trial and Phase 2 progressive MS trial.

General and administrative expenses for the years ended December 31, 2019, and 2018 were approximately $5.79 million and $5.77 million, respectively. Net loss for the year ended December 31, 2019, was $23.2 million or $1.06 per share as compared to a net loss of $13.9 million or negative $0.70 per share for the year ended December 31, 2018.

As of December 31, 2019, cash equivalents and short-term bank deposits were approximately $0.6 million. As of December 31, 2019, our total available funding, which includes cash on hand as well as remaining nondilutive CIRM and IIA grants were approximately $4 million.

On June 11, 2019, the company filed and entered into a $20 million at-the-market or ATM program for the purpose of issuing shares of our common stock into the open market from time to time. The ATM product provides the company the flexibility to issue shares at its discretion with the aim of exercising that discretion in favorable market conditions.

The company chose not to activate the ATM from June to November 2019 as the price and the volume was not too favorable for the company and too delusional. From November 20, 2019 to February 14, 2020, the company issued approximately 3.91 million shares of common stock through the ATM program at an average price of $4.75 per share for gross proceeds of approximately $18.6 million.

The company aims to leverage the sale of stock into periods of higher liquidity and price strength. During the execution period, shares of BrainStorm appreciated approximately 38%. Raymond James & Associates, Inc., acted as the sales agent for the offering. We chose this financing structure because it was least dilutive, most cost efficient, and cost-effective option that we evaluated.

With a significantly strengthened balance sheet, we are now laser focused on getting through significant near-term milestones, including the Phase 3 ALS pivotal trial data and BLA filing of NurOwn. As of today, cash equivalents and short-term bank deposits are approximately $11.1 million. For further details on BrainStorm's financials, including financial results for year ended December 31, 2019, refer to Form 10-K filed with the SEC this morning. Back to you, Chaim.

Thank you, Preetam. Prior to this call, we asked for questions to be submitted online. We received many questions in advance. We have consolidated the most frequently asked question that the BrainStorm team will respond to after Sean reads them. Sean?

Thank you. Your first question is, I saw the press release and the FDA meeting. Can you provide more detail to everyone on the call today, please?

Yes, so I addressed this in my opening statement, but I will ask Ralph to summarize the meeting in his words. Ralph?

Of course. Thank you. In follow up to what Chaim had said, I'll just make a few brief comments. First of all, we're very reassured at the working relationship we have with the FDA at this time. And they are working collaboratively with BrainStorm to advance the development of ALS therapies as quickly as possible. And we must say that they do share our urgency and magnitude of the unmet need in ALS.

And I think that was well understood at our meeting. The most important outcome of the discussion, of course, was that they confirmed that we're completing a well-run study. It's a very high-quality study. And the data that will be collected at the end of the study is relevant and critical to the assessment of NurOwn efficacy. It's an important confirmation for us.

Of course, as is usually the case, they'll look at the totality of our data. And that means data from all sources. And they're committed to work with us going forward. And they do have some options in-house to do a statistical assessment of data more quickly than has been done historically in the past. And of course, they're going to make those options available to us.

We obviously were very reassured by their position. And I think that the success of the meeting was in large part to the level of urgency that the FDA has for the situation. The fact that they are very patient focused, and I think that Brian Wallach's presence at the meeting really had a important impact on getting us all to understand what we're really trying to accomplish together, and we're all on the same team.

And finally, it was important opportunity for CBER to hear the voice and the experience and the wisdom of the experts that we brought to the table. I think that was really a critical factor in the outcome. Thanks for the opportunity to answer that.

So the next question would be, in light of the meeting with the FDA, what is the updated timing for the data readout and the BLA and even approval?

Ralph?

Thank you again. So, our plan at this time as Chaim said is laser focused, where our goal is to complete the Phase 3 data readout in the fourth quarter of this year. And so, everybody understands the BLA application is made after FDA Phase 3 data review.

And based on the BLA application, the FDA will then review all the data supporting materials and then they will make a decision to approve or disapprove the application. And of course, we can't speculate on the outcome of that review, but we're very confident that we have a package that will meet the data requirements. Thanks for the opportunity to answer that.

The next question that came in is what is the current status of the clinical trial for MS?

Well, Ralph?

Thank you again. Yeah, thanks. That's a great question. As you know, we're very excited about this program and as are the experts in the field -- I should say that the MS scientific community is equally excited about our prospect in progressive MS given the unmet need. Currently our Phase 2 clinical trial is more than half enrolled and currently, it's at four MS Center of Excellence in the United States.

And we are examining opportunities to look at an interim analysis where we would look at both the clinical and biomarker data. Just to ground us back on the study outline, the study will evaluate as is the case in ALS, repeated dosing of NurOwn. And we are looking at clinical outcomes that are well established for MS in terms of function and disability. And there's been a lot of scientific work on MS biomarkers, both tissue biomarkers and the CSF and imaging biomarkers, we're going to be looking at those.

And we've -- because it's an open-label study, we have matched the outcomes to contemporary prospective data set of 100 progressive MS patients who match our clinical trial characteristics. I think that's going to be an important comparator.

Finally, the last thing I'm going to say about our MS program is, we're deeply appreciative of our collaboration with the National MS Society, who has provided about $0.5 million funding to advance the sophisticated biomarker analyses we're going to undertake in this study. And again, very excited to have to look at data later this year. Thanks a lot.

And your next question is on exosome. You have mentioned in prior press releases and conference calls that you are exploring exosome. What is the update on this project?

Thanks to our wonderful research and development team, led by Dr. Revital Aricha, we were successful in developing in-house, the know-how for exosome production. We'll share with you more once we choose an indication to proceed with this novel approach. For now, I'll ask Ralph, please elaborate a bit on our general thoughts with our way forward with exosome. Ralph?

Absolutely. And I just want to second the motion and commend Revital and Haggai and [Yoni], who we work with very closely on a day-to-day basis, who made tremendous progress on this project. We know that exosomes are showing great promises and means of cell-to-cell communication and particularly as a delivery vehicle for biological therapeutics as similar to how we are viewing the cell therapy technology.

We've developed significant technical expertise in exosome development, in the characterization of exosomes, and also in their function and their impact on nervous tissue. And finally, on manufacturing. I think we're in a unique league in terms of our technical capabilities in exosomes. So where do we go from there?

Well, currently, we have advanced preclinical programs using exosomes as a therapeutic modality. And we will share results on this clinical opportunity later this year. Look forward to some announcements from us.

Your next question is would you provide an update on the financing of the company? Have you used the ATM? If so, what are the details?

Thank you. So obviously as we just heard from Preetam, we did use the ATM. And I would like to take this opportunity to discuss our strategy on this matter. So, during December, we had various options to go the traditional route to financing, various bankers proposed deals, for example, $5 [billion] to $7 billion as a discount to the market price like similar biotech companies did over the last few years, and even at the market price that we usually are [stubborn] to do, it comes in addition to some warrants and additional expenses, the bank commissions.

So those deals would have had probably a price of around [390] when we started our ATM and that will be discounted and very delusional with additional warrants. The other option was to use ATM and try to make better than the price and not only not [at] a discount, but rather running up the price. So, I think that [probably] in hindsight, definitely that was the right decision to take. And we were very careful in the way we ran this ATM.

As I said, the upside is that we had instant access to cash and the price certainty that comes from this special pool. At least we were able to optionally control the company stocks that were sold. And what we did is holding true to the patience approach of ATM offers. And we took the very conservative approach.

And the company did not exercise for example its right to raise capital through the ATM for the first five months at the initial filing. And once the company did enter the market in mid-November, management took every measure to avoid any pressure [for the ATM itself] could cause on the stock price. To elaborate on this fact, these were some of the measures taken: we scaled the order at higher prices than the prevailing market. The average execution price on our ATM orders was even or higher than the market we were at an 88% of the days we were in the market.

Sometimes we pulled the order entirely for a day or several days when the market conditions were not favorable. 100% of all shares issued were sold in line with market prices and at zero discount to the prevailing market. Shares of BCLI appreciated 38% during the execution period, and the average daily volume soared to 50% better than the average on the first day of execution. The zero-discounting equity financing allowed the company to significantly strengthen the company's balance sheet as we head into some significant near-term milestones such as pivotal Phase 3 trial data and the NurOwn 5.

So just to summarize, we have an option to raise $5 million in a single day, whether that will be relevant to the market price at the time for discount and dilution, [rather] to the ATM machine [we see] now -- we've finalized almost the whole tool at $18.6 million and the average price was for [475] far higher than what we were discussing then around the $4 market price.

So, I do want to thank our own team for working so close, and specifically the Raymond James that was wonderful through the whole process. And we felt like we have an [SDR] there. We may put up another ATM soon. It should be there for opportunistic possibilities. If this will in a few months from now, we may activate it again. We'll see -- we'll just have it there on the shelf. Next question, please.

Next question is what is the company's plan for commercialization as you move forward to an FDA approval?

Yes, I would like to introduce our Chief Commercial Officer and ask him to comment on this question as he is leading this effort. Arturo?

Thank you. Hi, and thanks for the opportunity to address this important question. What we are doing is that we're proceeding on three fronts. The first is process optimization. When you think about our process, you can see clearly that our process lends itself well to automation. So, we're proceeding down that front.

The second is internal and external build-out of our capacity. And the third is to bridge early demand by partnering with our existing manufacturers. All these discussions are ongoing. We are consistently holding discussions with potential partners that will assist us with our scale-up efforts to support our commercial launch. Our commitments is to scale as rapidly as possible so that every patient who needs our therapy can get it quickly.

And your next question is, you have been actively meeting with the FDA, congress, and advocacy groups. Where do things stand and what can you tell us about the legislative front?

Thank you. So, I will comment a few points. The ALS Congressional Caucus is a bipartisan group of champions on Capitol Hill for leading the federal fight to end ALS. Many have been personally impacted by the disease. All have been moved by the strength and energy of the ALS community. I AM ALS's important work to establish the [House caucus] has resulted in 125 House members joining and fighting to reimage ALS, another advocacy groups were involved in this process.

Second point, the reason we launched bipartisan Senate ASL Caucus will bring together senators from both sides of the aisle to share commitments to working collaboratively to advocate about ALS patients and their families. 12 founding members established this important caucus, [the ALS, where] the priorities are paramount with the support of the House and Senate caucuses. Quite outstanding [perceived] Senate caucuses. The other point is the recent legislation introduced in both the House and the Senate seeks to establish new pathways for diseases like ALS.

The value of unmet medical needs, specifically HR5480, which is called ALS Placebo No More bill, seeks to find alternate pathways [to step] outside the traditional [ones] while preserving the scientific integrity of ALS trials to give patients who don't have time to wait [access] investigational therapies. This is consistent with the FDA [ALS therapy] development guidance document issued by the FDA in December 2019.

Mary Kay Turner, the VP of Government Affairs and Advocacy for BrainStorm is a veteran public affairs professional and brings a 25 plus years of experience in biopharma credentials. She is the face of BrainStorm's (inaudible) important stakeholders. Mary Kay meets and collaborates with members of Congress and their staff, advocacy organizations, and grassroot advocates, and I really want to commend and thank her for her tireless work on all of these fronts. Next question.

And your final question from online is, what is status of the Hospital Exemption in Israel? Are you making progress there?

Ralph?

Thank you. The hospital exemption program in Israel is proceeding very well. And several patients have received all three treatments. As you know, the Hospital Exemption for Advanced Medicinal Products is a pathway pioneered by the European Medicine Agency. And the Israel Ministry of Health recognizes the importance of this hospital exemption pathway as a way of patient access to treatments prior to full approval.

It's similar to accelerated approval, but the approval is to the medical facility and the approval is broad, but in a non-industrial capacity. So, under the hospital exemption program, we're now able to provide treatment to Israeli patients who have no alternative therapy to provide the financial resources required to treat these patients. And we're permitted to enroll foreign patients who will pay for their treatments.

In addition, we're collecting important clinical data in Israel in the hospital exemption program. Currently, we're looking at interim data results, which we may be able to publish in the spring of this year. And the FDA, as we mentioned, is open to the totality of the evidence. And we believe that we will benefit from pursuing the hospital exemption pathway for long term, both in terms of the ability to offer the treatments of patients, increase awareness of our therapy, and potentially the data that's produced in this program. Thank you.

Sean?

I have no more questions. I will turn it over to the operator to explain the process to ask questions.

(Operator Instructions) Jason Kolbert with Dawson James. Your line is now live.

Congratulations on all the progress. I just wanted to make sure I'm crystal clear on two things, how much cash was raised in the quarter using the ATM? I couldn't hear that number.

$18.6 million

Sorry, did you say 18?

0.6, yeah.

Okay, great. I mean that's -- by the way phenomenal job and it's great to see it. And what's the current share count or I guess (multiple speakers)

Shah, do you want to give -- Preetam do you want to give the exact share count we have today?

I don't have it in front of me, but it's 26,000 plus is the exact share count. It's in the cover of the 10-K (multiple speakers).

Okay. All right, perfect. Thank you. Last question, I understand you're working with the FDA. I understand, of course, the unmet medical need, God bless you. Help me understand the timing.

And I know you already had one question like this that you read, which I thought was very brilliant. But normally we would expect two pivotal trials. We may now see that because it's regenerative medicine and cell therapy. In the best-case scenario, could do you think it's possible you could be commercializing NurOwn in 2021, that look doable? And what are the plans for Europe?

I have a simple answer on that. On the first question, the answer is yes, but of course, dependent on the results of our trial. And that's why we are so excited that the FDA is having these very early conversations about the endpoint, and what they want to gather in the data.

And Europe, we will probably have to -- we're sure we have a lot of pressure from many European countries and governments. Some of them are open even, calling on us to come to their countries to do something. There are 50,000 patients in Western Europe only. We'll have to decide in the next quarter how we approach that before we finalize our pivotal trial here.

Fair enough. And Ralph, Dr. Kern, I understand when you talk about the totality of the data because for me, it means that there's no one single endpoint that you want to hang your hat on as a physician treating an ALS patient because there's a composite of multiple co-morbidities. But if there was any one single endpoint or if you were to focus in on your FDA discussions, are they looking at spasticity? Are they looking at forced vital capacity? What are the kinds of things that they want to see in terms of an endpoint that's reachable?

Sure. So Jason, I think that if you look at the direction the FDA is going, based on their ALS guidance documents that was put out at the end of September, which is one of the reasons why we needed to have a realignment, because the guidance the guidance has actually recently changed, is that the easiest thing to measure in a trial and not that anything is easy is function. And that there are -- there's a well enough appreciated scale called the ALS functional rating scale, which really forms the foundation for that.

There are different ways to evaluate that data. And different companies have looked at different aspects of it in terms of slope versus score. And I think that's a really good discussion that we had with the FDA. And finally, because there's sometimes missing data, there's statistical ways to deal with missing data.

And I think we had a very good comfortable discussion about that whole package in terms of what it looks like. And I think at its core, that's really what the totality of the data means. There are some other endpoints in ALS, as you mentioned, some breathing function. And I think that's a little bit more difficult to use as a clinical trial endpoint as has been recently evidenced by some other companies' efforts.

And finally, when you look at the -- [pic at] large, the totality of the data really means all of our data from Phase 2 and Phase 3 and the FDA of also looks at other companies' data packages that are in the ALS space. So, they look at the context. And as you know, the most recent results in ALS have been not of large magnitude. So, I think that when they look at the clinical significance of data, they'll look at what the existing therapies can deliver and to look at how we compare to that. I think that's what the totality of the data really means.

With a dramatically different, more favorable dosing [NAE] profile, and I said it not you, but if I want to go to comp that's certainly a factor I'm going to consider.

Yeah, thank you for saying it instead of me.

Thank you, guys. I really appreciate it. And, you know, on behalf of all the patients that I'd say and the [investors], you know, people are excited. Thank you.

Thank you very much.

Dan Michael, a private investor. Your line is now live.

When are you eligible to get the balance on the CIRM grant?

There's a few milestones and [the one] milestone is (inaudible). And the latest milestone was after treating the first 80 Californian patients, which we met already. So, we will be receiving probably in this quarter, another $2.2 million out of the grant. Thank you.

Gary Bliss, a private investor. Your line is now live.

Thank you. Two questions. One, is there any thought to expanding the hospital exemption program to Canada or Europe? And the second question is, will you be submitting interim analysis to the FDA?

Ralph?

Yes. So, we're obviously looking at -- so as Chaim said, we have a lot of interest from many other countries, and we're actively looking at how we might address that need. But we don't have anything to announce today.

As far as interim analyses, we've announced, and we can reiterate today that we don't have a plan at this point to submit an interim analysis -- or sorry perform an interim analysis because of the short time between now and the end of the study. It really would not be in our interest or the interest of the patients necessarily. But again, it's something that we continually think about. But at this time, there is no planned interim analyses for Phase 3.

Christine Gomes, a private investor. Your line is now live.

Hi, good morning, and thank you for taking my call. First question is, has there been any discussions on any plans for trial participants in the interim? I know that 2021 as a possible date for availability is promising. It's not from any of the trial participants. And secondly, would they be eligible for the health exemption?

Yes. Thank you very much. We are discussing what our plan would be for the trial participants and we'll share the information once we have final policy. Obviously, funding is a major issue, but we'll announce once we have that. And there's no exemption program in the [States]. And as Dr. Kern explained before, this was only meant mainly for a few Israeli patients to be able to participate. And also, we're now hoping to see some nice data outside of the trial that may support the result. Thank you very much.

Thank you. We reached the end of our question-and-answer session. I'd like to turn the floor back over to management for any further or closing comments.

One second operator. I would like to -- if you can please advise how you can ask questions because from previous calls -- and even now we're getting messages. The investors are trying to ask and they're not [getting on]. So the instructions again on how to ask.

(Operator Instructions) [Annie Sworch], a private investor.

Hi and thank you for everything that you've done and will do for the communities that you serve. You had mentioned some other possible disease indication on a previous call. Is there any news on that?

Yes. So, we did mention also on this call that we will expand the additional product exosomes. And we will be announcing soon the indication for that.

Okay. That was it. Thank you.

(Operator Instructions) Dan Michael, a private investor. Please proceed with your follow-up.

under the Israel Hospital Exemption program, did you record any revenue in the last quarter? (Multiple Speakers)

Preetam, go ahead.

Yeah, for 2019, it was $2.5 million.

Do you have any projections for this calendar year in totality?

Yes, we expect the same, if not more.

Okay. Thank you.

(Operator Instructions) It appears there are no further questions at this time.

Thank you very much, Kevin. And thank you for joining us today. And thank you for your questions. We look forward to a very productive and transformational 2020. We look forward to our continued dialogue with the FDA and all stakeholders as we move our investigational therapy, NurOwn, out of the clinic and into those with incredible medical unmet need.

And this concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation. Kevin, that did your part. Thank you.

Thank you.