Brainstorm Cell Therapeutics Inc (BCLI) 2020 Q2 法說會逐字稿

Greetings, everyone, and welcome to the Brainstorm Cell Therapeutics financial results for the second quarter of 2020 and corporate updates conference call. (Operator Instructions) As a reminder, today's conference call is being recorded.

It is now my pleasure to introduce your host, Michael Woodof LifeSci Advisors. Sir, you may begin.

Thank you, operator, and thank you all for joining the Brainstorm Cell Therapeutics call today. And before we begin the opening remarks, I'd like to remind listeners that this conference call contains numerous statements, descriptions, forecasts, and projections regarding Brainstorm Cell Therapeutics, and its future business operations and performance, statements regarding the market potential for the treatment of neurodegenerative disorders such as ALS and MS, the sufficiency of the company's existing capital resources for continuing operations in 2020 and beyond, the safety and clinical effectiveness of newer technology platforms, clinical trials of NurOwn, and related clinical development programs, as well as the ability of the company to develop strategic collaborations and partnerships to support the business planning efforts.

Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond the company's control, including the risks and uncertainties described from time to time in its SEC filings. Results may differ materially from those projected on today's call. The company undertakes no obligation to publicly update any forward-looking statements.

Joining me on the call today will be Chaim Lebovits, CEO of Brainstorm; Dr. Ralph Kern, President and Chief Medical Officer; Dr. Revital Aricha, VP of Research Development; and Dr. Preetam Shah, EVP and Chief Financial Officer. They will be available to answer your questions as well as with additional members of the management team during the Q&A session which follows the prepared remarks.

So, now I'd like to turn the call over to Mr. Lebovitz. Chaim, please go ahead.

Thank you, Mike, and welcome to Brainstorm's second quarter 2020 earnings call. And thank you, everyone, for joining us.

At the onset of this call, I'm so proud to share with you that our cash on hand is by far a record for Brainstorm. We have never been in such a strong financial position. We have no debt, no convertibles or the like. We today are close to $35 million of cash on hand.

I'll begin this morning's call with some introductory remarks and general corporate updates at Brainstorm. Next, our President and Chief Medical Officer, Dr. Ralph Kernwill update you on our clinical programs including our pivotal ALS trial, our recently announced Phase 2 Alzheimer's disease program, and our Phase 2 progressive MS trial. Following Ralph's comments, Dr. Revital Aricha, our VP R&D, will walk you through our development program for neuron derived (inaudible) treatment for COVID-19. Our Chief Financial Officer, Dr. Preetam Shah, will then provide updates on our financial results before turning it back to me for concluding remarks. We will, of course, address questions in the Q&A session.

We are proud of the continued dedication and focus from our team members during these challenging times of the coronavirus pandemic. Our mission of brainstorm is to leverage our proprietary NurOwn technology into clinical development, new treatments for neurodegenerative disease patients with high unmet medical needs. This is an extremely important and worthy mission during normal times. And it requires an even greater level of commitment, creativity, and collaboration [within]. We are grateful to our community partners, which includes patients, the families, doctors, regulatory bodies, and so many more for helping us continue to move forward over the past few months.

This morning, I would like to also recognize two new additions to our senior management team for the second quarter. Dr. David Setboun joined us in April 2020 and serves as Executive Vice President and Chief Operating Officer. Dr. Setboun has extensive experience in the biopharmaceutical industry. He's going to have key leadership roles in commercial development and product launches at the margin. Most recently, he served as VP Corporate Development - Strategy and Business at Life Biosciences, where he was instrumental in the development of various critical commercial operating and funding milestones. We are thrilled that David has joined our team and expect him to play a key role in the potential commercial launch of NurOwn in the next couple of years.

Dr. Stacey Lindborg joined us in June 2020 and the role of Executive Vice President and Head of Global Clinical Research. Dr. Lindborg is an experienced healthcare executive and globally recognized medical statistician with over to that is a multinational experience in R&D, regulatory strategy development, analytics, and big data at Lilly and Biogen. Most recently, Dr. Lindborg spent eight years at Biogen, where she held several leadership positions including Vice President of Analytics and Data Science. Stacey is a great addition to our team, and her deep experience will be highly valued in many areas of Brainstorm.

I will now turn the call over to Dr. Ralph Stern who will provide updates on our major clinical development programs. Ralph?

Thanks you, Chaim, and thank you, everyone, for joining us today on the earnings call. Let me start with an update on our Phase 3 pivotal trial of NurOwn in ALS. As a reminder, the trial is being conducted at six ALS centers of excellence in the US. It has enrolled approximately 200 participants, randomized one to one to receive three doses of NurOwn or placebo. These are administered over four months, and then participants in the trial are followed for a total of 28 weeks. As we announced on July 2, very pleased to announce -- pleased to restate that all participants in the pivotal ALS Phase 3 trial have received all scheduled doses of NurOwn.

We were able to achieve this important milestone as a result of the relentless dedication of trial participants, their loved ones, our investigators, and the outstanding team here at Brainstorm. On behalf of all of us at Brainstorm, I again want to thank everyone for their commitment during a very unique and challenging time. As previously announced, following completion of all study visits, data collection, and database lock, we expect Phase 3 top-line data by the end of November of this year.

At Brainstorm, we are staffing up a highly experienced team, and we're very busy on a day-to-day basis planning and executing to support data readout in all pre-BLA activities. Our clear focus is to expedite this process. We want to be able to submit a biologic license application, or BLA, with the FDA as soon as possible after the top line data is available. At the same time, our clinical trial activities and data preparedness is growing and advancing. We're proceeding with all CMC activities that are needed for the preparation of a BLA.

Finally, with respect to BLA planning, and understanding the urgency of the ALS community, and also in full dialogue with the FDA, we're actively exploring opportunities to expedite information flow and the review process itself. In June, we announced that the ALS Association and IMALS awarded grants from a combined grant of $500,000 to fund an ALS. biomarker study. The grant will be used to draw insights from data and samples collected from patients enrolled in Brainstorm's ongoing Phase 3 clinical trial of neuron treatments, and to further understand critical biomarkers associated with treatment response for people with ALS. The study involves one of the largest and most robust clinical trial collections of CSF and serum biomarkers to date. And we're very excited that this will advance ALS understanding and also contribute to our understanding of how NurOwn can be of great value to the ALS population.

In late June, we announced a new clinical program focused on the development of NurOwn as a treatment for prodromal to mild Alzheimer's disease. We hosted a key opinion leader call and webcast on July 8, that we would encourage you to listen to if you have a chance. The call included professors Philip Shelton and Bruno Dubois, who provided a great overview of why we made the decision to study NurOwn in Alzheimer's disease, and why we are hopeful in the potential of NurOwn to address the great unmet need in Alzheimer's disease. The study will be conducted at two leading centers of excellence in the Netherlands and France. We plan to treat the first Alzheimer's clinical trial participant with NurOwn before the end of this year.

I'm also happy to report that our progressive MS trial is now fully enrolled. Despite facing severe COVID-19 hospital restrictions in the spring, we still expect all study treatments to be completed by the end of this year. Due to the rapid enrollment in the last month, the time difference between the potential interim analysis later this year and full data analysis is much shorter than anticipated. Therefore, it is most practical and informative for us to present an analysis of the full dataset. And that is our current plan.

In addition to the steady progress made across all of the clinical programs in Brainstorm that I have just described, we're supporting a small compassionate MSC program for COVID ARDS in Israel as we previously announced. We have examined strategic opportunities around COVID ARDS, and we have identified the advantages of using exosomes as a treatment platform. And by leveraging our strong capabilities in exosome manufacturing and IP, we have conducted a proof of biology study of NurOwn derived exosomes in a mouse model of ARDS, which my colleague, Dr. Revital Arichawill now share. Revital?

Thank you, Ralph. And let me join my colleagues in thanking you all for joining us today. We recently announced that Brainstorm successfully completed its first milestone in developing an innovative vessels on [today's] platform technology for the treatment of severe COVID-19. As you are aware, COVID-19-induced pneumonia has been associated with acute respiratory distress syndrome or ARDS. Currently, there is no effective treatments to prevent or reverse ARDS. ARDS is that type of respiratory failure associated with widespread inflammation and lung damage caused by a cytokine storm in the most severely affected patients.

Presenting on samples derived exosomes, again suggested as a potential treatment for ARDS, due to their ability to penetrate into deep tissue, effectively deliver bioactive molecules to target cells, and decrease the inflammatory response.

MSC exosomes may be delivered intravenously or directly into the lungs via [in total TL] administration and have several practical advantages, including ease of storage, stability, and low immunogenicity. Therefore, Brainstorm decided to evaluate MSC and NurOwn derived exosomes in an ARDS mouse model where its relevant to the severe acute lung injury.

In this trial, the animals were treated with either NurOwn exosome or exosome derived from (inaudible) from the same donor, and comparison to placebo treatment and the host mice. Treatments were given either intravenously or directly to the lungs. Analysis was conducted on lungs histopathology, data assessment of oxygen saturation and heart rate, and measurement of pro-inflammatory cytokine and chemokine in the (inaudible) and so on.

This study demonstrated several key observations. We demonstrated that animals treated with NurOwn derived exosomes showed superior results comparised to [agencies]. Their results showed statistically significant improvement of NurOwn derived exosomes in multiple parameters, including functional [lagging] recovery reflected by increase of oxygen situation to normal levels, reduction in (inaudible) cykotines, and most importantly, attenuation of [flank] damage.

Secondly, we observed that the direct administration of NurOwn derived exosomes directly into the lung through the (inaudible) would show the advantages over the intravenous route of administration. We plan to submit these important results to a peer-reviewed medical journal, and we are actively evaluating our next test to determine how best to proceed.

Thank you, and I'm going to Preetam Shah, our CFO, for Q2 financial updates.

Thank you, Revital. It is my pleasure now to walk you through our second quarter 2020 financial results. Research and development expenses net for the three months ended June 30, 2020, were $5.69 million compared to $3.55 million net for the three months ended June 30, 2019. This increase year-over-year was primarily due to increase in expenses due to materials and other costs, payroll and stock-based compensation, and a decrease in participation of IIA and CIRM under various audit grants and proceeds received under the hospital exemption program.

Excluding participation from IAA and CIRM under the grants and proceeds received from the hospital exemption regulatory pathway, research and development expenses decreased by $520,000 from $6.54 million in the second quarter of 2019, to $6.02 million in the second quarter of 2020.

General and administrative expenses for the three months ended June 30, 2020 were $1.71 million compared to $1.3 million in the three months ended June 30, 2019. This increase year-over-year was primarily due to increase in payroll, stock-based compensation, rent, and other costs, partially offset by decrease in PR costs, consultants, and travel expenses.

Net loss for the three months ended June 30, 2020 was $7.4 million or $0.25 per share as compared to a net loss of $4.9 million or $0.23 per share for the three months ended June 30, 2019. Cash, cash equivalents, including short-term bank deposits, were up approximately $16.2 million as of June 30, 2020, compared to approximately $2.7 million as of June 30, 2019.

In the month of July 2020, we further strengthened our balance sheet. We raised approximately $13.6 million from our ATM facility at an average price of $14.48 per share. And an additional $6.3 million from exercise of warrants from certain warrant holders, and also received a non-dilutive bonus payments of $700,000 from CIRM for treating more California patients than originally proposed in our Phase 3 ALS trial.

With these activities, our total available funding as of July 31, 2020, which includes cash on hand of approximately $34.7 million, as well as remaining non-dilutive funding from CIRM, IIA, and other grants amounts to approximately $37.5 million.

For further details on our financials, please refer to our Form 10-Q filed with the SEC today.

Back to you, Chaim.

Michael Woodfrom LifeSci, please will now read the questions we have received. And after that, we will take live questions as well. Mike?

Thank you, Chaim.

And so the first question that we have from investor is, would you please provide a timeline for the ALS Phase 3 data readouts and application for FDA approval of NurOwn? And then as a follow-up to that, when will the company plan to submit a BLA, and do you expect NurOwn to get priority review?

Very good question. We have consistently communicated that our Phase 3 trial readout would occur in Q4 2020. We are thrilled to confirm that this plan remains unchanged even in the presence of the COVID-19 pandemic. This because of the hard work and [sounds] within Brainstorm. It has achieved operational excellence in this trial through the commitment of our investigators and trial participants. We're completing the remaining study visits and actively working through the data management steps to ensure high quality data, which will enable a timely database lock and readout of the story. We plan to have top-line data by the end of November.

Obviously, the company will be able to advise on our intentions and dates to file a BLA only after database lock and unblinding the data. We are happy to share with you that like Brainstorm, the FDA appreciates the urgency required to find effective treatments for ALS, and therefore is in close contact with Brainstorm to expedite the review process.

Next question, please.

Thanks. So next question. Assuming the FDA approves NurOwn for ALS, what are the company's manufacturing plans and does Brainstorm intend to operate its own facility to produce NurOwn?

Another good question. So Brainstorm has been proactively and aggressively working with potential partners and commercial manufacturing sites. We are prepared in all facets for a positive readout of our Phase 3 trial and the production of commercial cell product. This process has spanned many years as we have sought to reduce the time required to manufacture NurOwn for each patient. Throughout the NurOwn clinical development, we have streamlined manufacturing process and have consistently demonstrated we can efficiently deliver a high-quality autologous product.

Following the BLA approval, we anticipate to scale up production of our high quality cell product to support the a commercial launch to treat patients in need.

Next question.

Thanks. So, when do you anticipate automation of the NurOwn production process, in other words, with some kind of bioreactors?

So we have automated part of the manufacturing process. We'll share feedback after we get CMC feedback from the FDA on this process.

Next question.

So the next question relates to the multiple sclerosis program. When do you intend to provide an update on the Phase 2 progressive MS trial? And as a follow-up to that, how many patients are enrolled? And when do you expect the interim data to be shared?

This one was addressed already in the opening comments. But Ralph, you want to take this one?

Yes. Absolutely. So per our press release on August 4 and after a brief pause in clinical trial enrollment due to COVID hospital restrictions, all clinical trial sites reopened. And the Phase 2 progressive MS trial is now fully enrolled with a planned number of 20 patients. And we expect the trial to be completed by the end of this year with all doses administered. Because of the short timeline between what would have been an interim and full data. We're no longer planning to do an interim analysis and we're focussed on the full data set as we described in our opening comments.

Thank you.

Next question, please.

Company has previously announced that it has received SME status in Europe. How do you plan to leverage this SME status in bringing NurOwn to ALS patients? Whether there are regulatory pathways to be considered here? And how is the hired EMA regulatory consultants helping you in this process?

Ralph, please?

Absolutely. So, we're really happy that engagements have begun with regulatory institutions to map out the regulatory pathways to enable NurOwn to be an available treatment option for ALS patients in the European Union. We're obviously leveraging the SME office. And we have many EMA regulatory consultants who's helped us guide our processes and next steps. I want to emphasize that this is a top priority for the company, both from a business perspective, but also to address the enormous unmet need in the ALS population. Thank you.

Thanks. The next question relates to the Alzheimer's program. This program was announced on July 8. Can you please provide an update on any new developments that have happened in the interim period?

Ralph, this is for you too. Please.

Okay. No problem. So as we announced on July 8, we've expanded our clinical pipeline to evaluate NurOwn for the treatment of Alzheimer's disease. I think we provided fairly convincing biologic and clinical rationale for that program. I'm happy to provide an update on our efforts related to this.

Since our since our press release of July 8, we have finalized our clinical trial protocol. We have submitted this protocol along with accompanying documentation to the regulatory bodies in Europe. We're also interacting with local European authorities during the summer. And our intent is to dose the first patient before the end of this calendar year. Thank you.

The next investor who sent in a question wanted to congratulate you simply on the preclinical work that's been conducted so far in ARDS caused by COVID-19. The question though is, what are the company's plans for clinical trials with the exosome based technology? And also what advantages does NurOwn bring to this, what's now become a crowded competitive landscape?

And thank you, Michael. Very good question again. So there's a strong rationale in the scientific literature for cell-based clinical trials and COVID ARDS. Therefore, many cell therapy companies are pursuing such cell-based clinical trials. Our clinical team have stayed highly focused on our lead indications of ALS and other CNS diseases to ensure that there would be no delay in our key clinical milestones.

We were able though, through our preclinical discovery team, to show the potential benefits of NurOwn derived exosomes in a proof of concept preclinical trial in an animal model of ARDS. Based on this proven manufacturing capabilities and MSCs and exosomes, we have demonstrated the biology of NurOwn and NurOwn derived exosomes, providing the opportunity to explore this preclinical study. As presented by our VP R&D, Revital, we demonstrated that NurOwn derived exosomes delivered superior efficacy in ARDS compared to [naive] MSC exosomes. This was very important for all our programs.

Our CMC team is able to manufacture all generic MSCs now. The Ministry of Health has already granted approval for Brainstorm to conduct a [compassionate] study of all generic MSC in COVID ARDS at the Sourasky Medical Center in Tel Aviv. Based on the positive results of the preclinical study presented, Brainstorm will also seek approval for a compassionate use of NurOwn derived exosomes in patients for COVID ARDS.

So, to sum this up, as you can see, while we are following the data, our commitment to the ALS community is to continue to prioritize our efforts, focus, and energy for their ALS trial.

This concludes the pre-submitted questions. Operator, I would like to ask if you can open the lines for additional questions. Jamie?

Thank you. We will now be conducting a question and answer session. (Operator Instructions)

Jason McCarthy, Maxim Group.

Hi everyone, it's Dave on the line for Jason. Thanks for taking my question. So just regarding the Phase 2 proof-of-concept Alzheimer's study. I just wanted to see if (inaudible) plan on opening any sites in the US? And if you could shed some color on when you expect to complete enrollment? Thanks.

Ralph?

Thanks for the question. At the present time, we don't have plans to expand that particular study into the US. We will start treating participants at the end of this year. We expect somewhere in the order of a 6 month to 9 month enrollment period. And then obviously, the study is a one year trial from beginning to end. So you can do the math, and we would end up completing the last patient last visits probably in the first half of 2022. That would be our timeline at this time.

All right. Great. Thanks for the color.

Jamie, next question?

David Bautz, Zacks Small-Cap Research.

Hey, good morning, everybody. So I'm curious if you report positive ALS data, how quickly talks with payers could occur as I imagine that could be an issue for some ALS patients?

A very good question. Well, we have a plan, but we're not ready to lay it out yet. But we are seriously planning for already having some discussions with payers.

Could those discussions also include maybe ALS advocacy groups?

We are in direct discussions with ALS advocacy groups about this matter already.

Thank you. It was a very good question. Very thoughtful for you to think about the patients, how to guide the treatment after an approval immediately. And that our aim. We want to make sure that if and when we get an approval, we're able to get this into patients as fast as possible.

Ralph, you want to add something, please?

No, I think that we're very focused on everything leading up to database lock and then on top line data. And then, we're going to work in parallel. Obviously these are not done one after the other. And as Chaim said, you know, we're already having interactions both internally and externally to address the question that you posed.

Okay, great. And then for the MS trial, do you anticipate positive results allowing you to move directly into a Phase 3 trial?

Ralph?

Well, we'd love to anticipate results. I think that's hard to do. What I like to say is that there are really two components of the study that we'll be looking at very carefully. One are the clinical outcomes that are quite quite reproducible and validated. And then, in partnership with the clinical outcomes, we have a very ambitious biomarker program. As you recall, we've received the grant from the National MS Society to advance those analyses. So we believe that a combination of clinical and biomarker outcomes will inform a subsequent Phase 3 trial. But obviously, we'd want to look at the data first to know exactly what next steps are needed.

All right. Great. Thanks for taking the questions.

Thanks, David.

Next question please, Jamie.

Jason Kolbert, Dawson James.

Congratulations, everybody. Really fantastic progress from the amount of cash on the balance sheet to the clinical timeline. I'd just like to ask a couple of quick questions.

In terms of ALS, we're at a point now where we really have to think very carefully about the probabilities of success, how much data you've seen from the current trial, and how well that data that you currently have and have released lines up with the Phase 2 data that you've seen previously. That's my first question is, when I connect the dots between what you have now and the pivotal trial versus what you had in the Phase 2 trials, do they line up precisely? Is it even better now that you're looking at multiple doses? Any insights that will help us gauge probabilities of success and outcome would be greatly appreciated.

Dr. Kern?

Yes. So thanks for the question. Obviously, we're blinded to the current Phase 3 trials. So we don't have visibility to the results. What I can tell you is that we've designed the Phase 3 trial to optimize our probability of success. A few things that we've done, clearly, the use of repeated dosing compared to a single dose we faced in the Phase 2 randomized trial. We've enriched the trial population to select a group of ALS participants who have a more predictable rate of decline in the run-in period. We think that that goes a long way to increasing the odds of success. I think in addition, the lessons we've learned from Phase 2, we've applied to Phase 3 in terms of which biomarkers to look at and how to proceed along those lines.

One big difference between Phase 2 and Phase 3 is that we have 7 serial CSF samples, which will, as we mentioned earlier, is a unique collection of biomarkers. And we believe that the confirmation of the clinical results through changes -- payment related changes and a biomarker will be very important in both the regulatory review and subsequently interactions with payers. Because we're trying to take neurology and use the oncology model where we have not just clinical outcomes, but we have verification of biological effects.

I think those are all the reasons why we believe that our Phase 3 trial has all the right ingredients success. And obviously, we're very anxious to get the top-line data. As we mentioned earlier, we've done a lot of work this year internally and with our sites so that we'll be ready on time. And we're looking forward to have the top-line data at the end of November.

Or in other words, Dr. Kern, the right stuff.

If we change gears and I think about Alzheimer's, when I think about ALS, I think about an inflammatory condition. When I think about Alzheimer's, I see a condition with multiple co-morbidities, and while inflammatory can be a component in the CNS and particularly on the brain, can you help me understand mechanistically how you're making that jump in terms of the mechanism of action that's impacting ALS patients versus what you hope will impact Alzheimer's patients?

Ralph?

Ralph, are you there?

Yes, hi, sorry, I just had to unmute my phone.

Yes, I'll be brief because I don't want to extend this too long. But I'll just give you a top-line view of why we think the mechanisms of NurOwn are applicable as a technology platform and across different diseases. As we demonstrated in ALS, we're able to both deliver cargo, which are repair molecules which help stabilize and restore the nerve tropihc support. And we saw very interesting results in inflammatory changes, 40% reduction of some key inflammatory markers.

It turns out that to our surprise and actually to our pleasure that in Alzheimer's disease, the same markers actually have even stronger correlations with the rate of cognitive decline. And it seems that in most neurodegenerative diseases, particularly the ones that we're studying right now, there's an inflection point in the disease where the neurodegeneration picks up pace. And along with that, the inflammatory component also keeps moves in parallel. And then we've seen in Alzheimer's disease, that the interaction between inflammatory markers such as MCP-1, amyloid and [tau] work together. So that's in the presence of those biomarkers that the disease is so is very different. And we believe this is a huge opportunity to test the potential of NurOwn. And we would expect that the impact on inflammation would not be disease specific, but would be platform attributive NurOwn.

And so that makes sense on why we were at long-term assets of that same group.

Thank you.

One last question on exosomes, which is, I can understand exactly why I would use kind of a NFC to trophically home to the lung to break the cytokine cascade and reduce inflammation. How do I make the jump from that homing capability along the gradients, whether it's SDF-1, (inaudible), versus an exosome, which is really kind of like the raw materials that I need to impact the localized environments. Where do I get the homing capability in terms of the delivery? And of course, this relates to your COVID project. Thank you.

Thank you very much. Ralph?

Yes, sure. Thanks again. You're going me all the hard questions.

Yes. No, I think I think there's a couple of ways to look at it. One is that we've confirmed -- we've shared this at scientific meetings, that a lot of the attributes of NurOwns are actually mediated through exosomes, Exosomes deliver cargo. They produce immunomodulation. They also deliver micro-RNA. So we know that that's an important component of it.

The reason we're looking at exosomes, and I think Revital touched upon that earlier, is that there are practical advantages of exosomes in terms of storage stability formulation. We know that, in our hands and in other people's hands that, exosomes are very avidly taken up into tissues. We know that local administration of exosome is a very unique opportunity. In this case, we had demonstrated that delivery into the tracheal tube -- intratracheal administration produce superior results compared to IV. And we know that getting getting to the target is really important.

And then the last point you raised about homing that -- exosomes home as well to inflammatory signals. We know that -- we've shown in our preclinical studies of neuron administered. And for example, Parkinson's disease homes directly to the site of injury. So we expect that the homing function might also apply to exosomes. And there's growing evidence, in other people's hands and in ours, that this is a very important approach. There's still some unanswered questions and that's obviously why we're doing clinical studies before we make a final decision.

Thanks guys. All of your hard work really, really shows. So thank you.

Thank you, Jason. And next question please, Jamie.

John Evans, Raymond James.

Well, good morning, everybody. A couple of items. First of all, I'd like to know if you've decided any plans of whether to build the sales force in the US or Europe. Or are you currently planning to partner with a larger pharmaceutical to handle the sales. And anything you could add on what's going on with the partnering efforts that I'm sure Dr. David is spearheading.

And then my second question is, any updates on what's going on in Congress with the ALS bills that have been presented by the rapidly growing ALS caucus? Thank you.

Thank you very much. So we are looking at both options when it comes to the sales force, either internally or externally. And we can assure you, as we have said in my previous comments, that if and when we'll have an approval, we'll be ready either way to provide treatments to patients in need. Read the bills in the Congress. It is not an effort led by Brainstorm. It is an effort that many advocacy groups. We commend the ALS advocacy groups and their wonderful work and further awareness and everything else is trying to promote. But we're not taking any active positions or any active items that we are doing on those bills. And therefore, please allow me not to further comment in this.

Any other questions?

John left the line. (Multiple speakers)

Thank you. Appreciate it.

You're welcome. And Jamie, any other questions?

Sir, at this time, I'm showing no additional questions.

Do you want to poll once more? If anyone wants to ask a question, we are fine with it. We'll take one more question.

(Operator instructions)

Robert Macan

Hi. I'm just curious if you have any updated guidance given all the positive news appears to be around your company?

Ralph?

I'm sorry. Guidance on the specific earnings? On earnings? Maybe Chaim, I will pass that back to you.

Yes, I'm not sure -- I thought you meant guidance for the FDA guidance for ALS. So what guidance and earnings are you asking for?

Robert?

You can read anything you would like via our financial position. I started this call with the comments of this -- our net financial position after was about $35 million cash on hand. And we're very proud of that. And we're going into the last two quarters in a very good position.

And ladies and gentlemen, at this time, we will end today's question and answer session. I'd like to turn the conference call back over to management for any closing remarks.

I spoke so much today. So Ralph, I'll allow you to have the concluding remarks.

Yes. Thank you very much. And I just want to thank everybody for calling in today, for your ongoing support, for having confidence in our journey to find a solution for ALS. As we showed you today, we have continued to advance on all fronts. Our ALS program will have top-line data at the end of November. We're looking at options to advance ALS in Europe. We've initiated our Alzheimer's trials in Europe at the top Alzheimer centers. And we have completed enrollment of our Phase 2 progressive MS trial. We have commitment of the communities that we're hoping to serve, of the sites and investigators that we work with, and most importantly, the investor community. And obviously, our current position is really a testimonial to all the support you've given us. So thank you very much and we'll continue to deliver. And we hope to have more news for you in the near future.

Thank you. Thanks, Jamie and Mike, for handling this call for us.

Ladies and gentlemen, with that, we'll conclude today's conference call. We thank you for joining. You may now disconnect your lines.