Brainstorm Cell Therapeutics Inc.

Greetings, everyone, and welcome to the Brainstorm Cell Therapeutics financial results for the second quarter of 2020 and corporate update conference call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star and zero on your telephone keypads. As a reminder, today's conference call is being recorded. It is now my pleasure to introduce your host, Michael Wood of LifeSciAdvisors. Sir, you may begin.

Thank you, operator, and thank you all for joining the Brainstorm Cell Therapeutics Call today. 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 neuro and technology platform, clinical trials of neuron 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 Hein Liebowitz, CEO of Brainstorm, Dr. Ralph Curran, President and Chief Medical Officer, Dr. Revital Arisha, VP of Research and Development, and Dr. Pritam Shah, EVP and Chief Financial Officer. They will be available to answer 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. Leibowitz. At that time, please go ahead.

Thank you, Mike. 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 have close to $35 million 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 Kern, will update you on our clinical programs, including our pivotal ALS trial, a recently announced phase two Alzheimer's disease program and our phase two progressive MS trial. Following Ralph's comments, Dr. Ravital Arija, our VP R&D, will walk you through our development program for neuron-derived exosome treatment for COVID-19 ARDS. Our chief financial officer, Dr. Pridham Shah, will then provide updates on our financial results before turning it back to me for concluding remarks. We will, of course, address your 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 at Brainstorm is to leverage our proprietary neuron technology into the clinical development of 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 with them. We are grateful to our community partners, which includes patients, their families, doctors, regulatory bodies, and so many more for helping us to continue to move forward over the past few months. This morning, I would like to also recognize two new addition to our senior management team in the second quarter, Dr. Seved Sedman, joined us in April 2020 and serves as Executive Vice President and Chief Operating Officer. Dr. Sedbon has extensive experience in the biopharmaceutical industry, including key leadership roles in commercial development and product launches at Biogen. 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 Neuron in the next couple of years. Dr. Stacey Lindbergh joined us in June 2020 in the role of Executive Vice President and Head of Global Clinical Research. Dr. Lindbergh is an experienced healthcare executive and globally recognized medical statistician with over two decades of multinational experience in R&D, regulatory strategies development, analytics, and big data at Lilly and Biogen. Most recently, Dr. Lindbergh spent eight years at Biogen, where she held several leadership positions, including vice president of analytics and data science. Stacy is a great addition to our team, and her deep experience will be highly valued in many areas at Brainstorm. I will now turn the call over to Dr. Ralph Kern, who will provide updates on our major clinical development programs. Ralph?

Thank you, Chaim, and thank you, everyone, for joining us today on the earnings call. Let me start with an update on our phase three pivotal trial of Neuron and 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 Neuron 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 2nd, very pleased to restate that all participants in the pivotal ALS Phase 3 trial have received all scheduled doses of Neuron. 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 three 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 readouts and all pre-LA, 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 as 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 the 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 Brainstorm 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 three clinical trial of neuron treatment 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 neuron can be of great value to the ALS population. In late June, we announced a new clinical program focused on the development of neuron as a treatment for prodromal to mild Alzheimer's disease. We hosted a key opinion leader call and webcast on July 8th 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 neuron in Alzheimer's disease and why we're hopeful in the potential of neurons 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 Neuron 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 a 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 data set, and that is our current plan. In addition to the steady progress made across all of the clinical programs and brainstorm that I have just described, We're supporting a small, compassionate MSC program for COVID ARDS in Israel, as we've previously announced. We've 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've conducted a proof of biology study of neuron-derived exosomes in a mouse model of ARDS, which my colleague, Dr. Revital Arisha, will 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 racism-based 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 treatment to prevent or reverse ARDS. ARDS is a type of respiratory failure associated with widespread inflammation and lung damage caused by a cytokine storm in most severely affected patients. The Xanthimoxample-derived exosomes have been suggested as a potential treatment for ARDS, due to their ability to penetrate into deep tissues, effectively deliver bioactive molecules to target cells, and decrease the inflammatory response. MSC exosomes may be delivered intravenously or directly into the lungs via intratracheal administration, and have several practical advantages, including ease of storage, stability, and low immunogenicity. Therefore, Brinson decided to evaluate MSC and neuron-derived exosomes in an art mouse model relevant to the severe acute lung injury. In this trial, the animals were treated with either neuron exosomes or exosomes derived from the e-MSCs from the same donor and compared to placebo treatment and to host mice. Treatment was given either intravenously or directly to the lungs. Analysis was conducted on lung cystopathology, daily assessment of oxygen saturation and heart rate, and measurement of pro-inflammatory cytokines and chemokines in the bronchoalveolar lavage fluid and serum. The study demonstrated several key observations. We demonstrated that animals treated with neuroderived exosomes showed superior results compared to naive MCs. The results showed statistically significant improvement of neuron-derived exosomes in multiple parameters, including functional lung recovery reflected by increase of oxygen saturation to normal levels, reduction in pro-inflammatory cytokines, and most importantly, attenuation of lung damage. Secondly, we observed the direct administration of neuron-derived exosomes directly into the lungs through the interstitial roots showed advantages over the intravenous force of administration. We plan to submit these important results to a peer-reviewed medical journal, and we are actively evaluating our next steps to determine how best to proceed. Thank you, and I turn to Pritam 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 the decrease in participation of IIA and CIRM under various awarded grants and proceeds received under the hospital exemption program. Excluding participation from IIA 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 25 cents per share as compared to a net loss of 4.9 million or 23 cents per share for the three months ended June 30, 2019. Cash, cash equivalents including short-term bank deposits were 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 excise of warrants from certain warrant holders and also received a non-dilutive bonus payment of $700,000 from CIRM for treating more California patients than originally proposed in our Phase III 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, Heinz.

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

Thank you, Heinz. So the first question that we have from Investor is, Would you please provide a timeline for the ALS Phase III data readouts and application for FDA approval of Neuron? And then as a follow-up to that, when would the company plan to submit a BLA, and do you expect Neuron to get priority review?

Very good question. We have consistently communicated that our Phase III 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 is because of the hard work and talent within Brainstorm that has achieved operational excellence in this trial and through the commitment of our investigators and trial participants. We are 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 the DLA 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 treatment 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 Neuron for ALS, what are the company's manufacturing plans, and does Brainstorm intend to operate its own facility to produce Neuron?

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 III trial and the production of commercial cell products. This process has spanned many years as we have sought to reduce the time required to manufacture a neuron for each patient. Throughout the neuron clinical development, we have streamlined manufacturing process and have consistently demonstrated we can efficiently deliver a high-quality autologous product. Following your DLA approval, we anticipate the scale of production of our high-quality cell product to support a commercial launch to treat patients in need. Next question.

Thanks. So when do you anticipate automation of the neuron 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.

Thanks. So the next question relates to the multiple sclerosis program. When do you intend to provide an update on the Phase II 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?

Tom was already in the opening comments, but Ralph, do you want to take this one?

Yeah, absolutely. So per our press release on August 4th, and after a brief pause in clinical trial enrollment due to COVID hospital restrictions, all clinical trial sites reopened, and the Phase II progressive MS trial is now fully enrolled. with the 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'll focus on the full data set as we described in our opening comments. Thank you.

Next question, please. The company has previously announced that it has received SME status in Europe. How do you plan to leverage this SME status in bringing Neuron to ALS patients? What are the regulatory pathways to be considered here? And how is the hired EMA regular consultant helping you in this process?

Paul, please.

Absolutely. We're really happy that engagements have begun with regulatory institutions to map out the regulatory pathways to enable Neuron to be an available treatment option for ALS patients in the European Union. We're obviously leveraging the SME office, and we have an EMA regulatory consultant 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. And the next question relates to the Alzheimer's program. This program was announced on July 8th, but can you please provide an update on any new developments that have happened in the interim period?

Well, this is for you to please.

Okay, no problem. So as we announced on July 8th, we've expanded our clinical pipeline to evaluate neuron 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. So since our press release of July 8th, we have finalized our clinical trial protocol. We've 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.

And then the next investor sent in a question and wanted to congratulate you specifically on the pre-surgical work that's been conducted so far 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 Neuron bring to this, what's now become a crowded competitive landscape?

Thank you, Mike. Very good question again. So, there's a strong rationale in the scientific literature for cell-based clinical trials in COVID arts. Therefore, many cell therapy companies are pursuing such cell-based clinical trials. Our clinical team has 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 explore the potential benefits of neuron-derived exosomes in a proof-of-concept preclinical trial in an animal model of ARDS. Bainsom has proven manufacturing capabilities in MSCs and exosomes. We have demonstrated the biology of neuron and neuroderived exosomes, providing the opportunity to explore this preclinical study. As presented by our VP, R&D, Revital, we demonstrated that neuron-derived exosomes delivered superior efficacy in ARTS compared to naive MSC exosomes. This was very important for all our programs. Our CMC team is able to manufacture allogeneic MSCs now. The Ministry of Health has already granted approval for Benson to conduct a compassionate study of allogeneic MSC in COVID arts at the Swarovski Medical Center in Tel Aviv. Based on the positive results of the preclinical study presented, Benson will also seek approval for a compassionate use of neuron-derived exosomes in patients for COVID arts. But 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 the 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. If you would like to ask a question, please press star and 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star and 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the keys. One moment while we poll for questions. And our first question today comes from Jason McCarthy from Maxim Group. Please go ahead with your question.

Hi, everyone. It's Dave on the line for Jason. Thanks for taking my question. So just regarding the phase two for the concept Alzheimer's study, I just wanted to see if they plan on opening any sites in the U.S. and if you could shed some color on when you expect to complete enrollment. Thanks.

Thanks for the question. At the present time, we don't have plans to expand that particular study into the U.S. We will start treating participants at the end of this year. And we expect somewhere in the order of a six-month to nine-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, you know, completing the last patient, last visit probably in the first half of 2022. That would be our timeline at this time.

All right. Great. Thanks for being here.

Jamie, next question.

Our next question comes from David Bouts from Zacks Small Cap Research. Please go ahead with your question.

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 really 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 and very thoughtful for you to think about the patients, how they got the treatment after an approval immediately. And that's our aim. We want to make sure that even 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 top line data and then We're going to work in parallel, obviously, that these are not done one after the other. And as Hans said, you know, we're already having interactions both internally and externally to address the question that you posed.

Okay, great. And for the MS trial, do you anticipate positive results allowing you to move directly into a Phase III trial? No.

Well, we'd love to anticipate results. I think that's hard to do. What I'd 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 reproducible and validated. And then in partnership with the clinical outcomes, we have a very ambitious biomarker program. As you recall, we received a grant from the National MS Society to advance those analyses. We believe that a combination of clinical and biomarker outcomes will inform a subsequent Phase III 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.

Our next question comes from Jason Colbert from Lawson James. Please go ahead with your question.

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 two data that you've seen previously? That's my first question is, when I connect the dots between what you have now in the pivotal trial versus what you had in the phase two trials, do they line up precisely? Is it even better now that you're looking at multiple doses? Any insight that will help us gauge probabilities of success and outcomes? would be greatly appreciated.

Yeah, so thanks for the question. Obviously, we're blinded to the current phase three trials, so we don't have visibility to the results. What I can tell you is that we've designed the phase three trial to optimize our probability of success. A few things that we've done are clearly the use of repeated dosing compared to a single dose in the Phase II 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. I think that that goes a long way to increasing the odds of success. I think, in addition, the Lessons we've learned from phase two, we've applied to phase three in terms of which biomarkers to look at and how to proceed along those lines. One big difference between phase two and phase three is that we have seven serial CSF samples, which will, as we mentioned earlier, is a unique collection of biomarkers. And we believe that the confirmation of a clinical result through changes, treatment-related changes in a biomarker will be very important in both the regulatory review and subsequently interactions with payers because we're trying to take a neurology and use the oncology model where we have not just clinical outcomes, but we have verification of biological effects. So, I think those are all the reasons why we believe that our phase three trial has all the right ingredients for 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. Kearns, the right stuff. If we... changed 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 comorbidities and while inflammatory can be a component in the CNS and particularly in 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? Hello?

Hello?

Yeah, hi. Sorry, I just had to unmute my phone. Yeah, 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, you know, the mechanisms of neuron are applicable as a technology platform and across different diseases. You know, as we demonstrated in ALS, we're able to both deliver cargo, which are repair molecules, which help stabilize and restore the neurotrophic support, We saw very interesting results in inflammatory changes, a 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 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 that where the neurodegeneration picks up pace, and along with that, the inflammatory component also keeps, moves in parallel. And then we've seen, you know, in Alzheimer's disease that the interaction between inflammatory markers such as MCP1, amyloid, and tau work together. so that in the presence of those biomarkers that the disease is very different. And we believe this is a huge opportunity to test the potential of Neuron. And we would expect that the impact on inflammation would not be disease-specific, but would be a platform attribute of Neuron.

And so that makes sense on why we would lump our masks into that same group. Thank you. Thank you very much. One last question on exosomes, which is I can understand exactly why I would use kind of a NFC to trophically home to the lungs to break the cytokine cascade and reduce inflammation. How do I make the jump from that homing capability along the gradients, whether it's SDF1, HIP, HIF, versus an exosome, which is really kind of like the raw materials that I need to impact a localized environment. 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, Raul.

Yeah, sure. Thanks again. You're giving me all the hard questions. Yeah, no, I think there's a couple of ways to look at it. One is that, you know, we've confirmed, we've shared this in scientific meetings, that a lot of the attributes of neuron are actually mediated through exosomes. Exosomes deliver cargo. They produce immunomodulation. They also deliver microRNA. 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 exosomes is a very unique opportunity in this case. We had demonstrated that delivery into the endotracheal tube or intratracheal administration produce superior results compared to IV. And we know that 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 that the neuron administered in, 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 preclinical studies before we make a final decision.

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

Thank you, Jason. Next question, please, Jamie.

Our next question comes from John Nevins from Raymond James. Please go ahead with your question.

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 a sales force in the U.S. 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 self-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 treatment to patients in need. Read the bills in the Congress. It is not an effort led by brainstorm. It's an effort led by many advocacy groups. We commend the ALS advocacy groups on their wonderful work for the awareness and everything else they're trying to promote, but we're not taking any active positions or any active items that we are doing under the bills. And therefore, please allow me not to further comment on this. Any other question? I believe John left the line too. No, I'm here. Thank you. Appreciate it. Yeah. You're very welcome. And Jamie, any other questions?

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

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

Once again, if you would like to ask a question, please press star and 1. We do have an additional question from Robert McCann. Please go ahead with your question.

I am just curious if you have any updated guidance given all the positive news that appears to be around your company.

Well, I'm sorry. Guidance on which specific terms? Earnings. On earnings? Earnings. Maybe Chaim I'll pass that back to you.

Yeah, so I'm not sure. I thought you meant guidance for the VDI guidance for ALS. What guidance on earnings are you asking for? Senator? Robert? Senator, our queue was filed, and you can read anything you would like via our financial position. I started this call with the comment that this is our best financial position ever with about $35 million cash on hand, and we're very proud of that. We're going into the last two quarters of the year 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.

Yeah, no, 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 an Alzheimer's trial in Europe at the top Alzheimer's centers, and we have completed enrollment of our phase two progressive MS trial. We have, you know, commitments 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. We hope to have more news for you in the near future.

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

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