Q1 2022 Brainstorm Cell Therapeutics Inc Earnings Call

Speaker 1: Greetings and welcome to the brain storm cell therapeutics: first quarter 2022 conference call. At this time, participants are in a listcent-only mode as a reminder. This call is being recorded and I would now like to introduce your host for today's conference, Tom galazi of lifesyle invide if visor. Mr galazy, you may begin.

Speaker 2: Good morning and thank you for joining us. Before we begin the opening remarks, we would like to remind listeners that this conference call contains numerous statements descriptions, forecasts and projections regarding Brainstorm cell therapeutics as potential future operations and.

Speaker 2: Performance statements regarding the market potential for the treatment of neuroagendves orders such as alalsms. The sufficiency of the company's existing capital resources for continuing operations in 2022 and beyond. The safety and clinical effectiveness for the neurural technology platform, clinical trials of neuron and related clinical development programs. And the company's ability to develop jutic up collaborations and partnerships to support their business planning efforts.

Speaker 2: Forward-looking statements are subject to numerous risks uncertainties, many of which are beyond brings some's control, including the risks and uncertainties described from time to time, and SEC filings, the company's results may differ materially from those projected. On today's call, the company undertakes no obligation to publicly update any forward-looking statements.

Speaker 2: Joining me on the call today will be highly eberit CEO Brainstorm anala polis, interim Chief financi Officer. In addition, DR Stacy lenberg, Executive Vice President and Chief developmentofficer, DR Ralph kt, President and Chief Medical Officer, and DR David seppon, Executive Vice President and Chief oating Officer, are also onthe call and will be avaableto wer your questions during the curity session. Now I'd like to turn the call over to MR ebez. Please go ahead.

Speaker 3: Thanks Tom. Thank you to all listening for joining us to discuss our first quarter financial results and corporate highlightsgiven that we provided a detailed update on our clinical programs during our year-end call only about six weeks ago, I'll keep my prepared remarks briefed. Today, as is our usual practice, will follow up our prepared remarks that addressing questions we received from investors in advance.

Speaker 4: As well as taken live questions from those of you listening on the call today.

Speaker 4: I want to emphasize the brainsome's highest priority of pursuing the optimal path forward to provide broad access to neuron for patients with ALS.

Speaker 4: Our continued efforts toward this goal are moving forward and have been advanced in many ways, including ongoing interactions with alx experts, world general trestiticians and leaders from the clinical and patient communities.

Speaker 4: As I previously stated, valuable feedback and insight gain from these interactions.

Speaker 4: Critical in are guiding the specific steps we will take to move norm forward.

Speaker 4: Our dedicated team has continuously received expert feedback on the neural cheinical data set since our Phase of trials initial top line readout. However, the insights provided to us throughout the first quarter have been particularly insightsful, given that we have published our full results near the end of 2000 and twenty-onethe availability of the Phase publication enabled us to provide Alf expertin community with a full and transparent view of our randomized, for ical controled trhase trial data that have been validated through the rigorous peer review process. As a reminder, although the Phase trial did not reach ceratificically significant and primary or secondary endpoints pre specified in POC, analystis showed neuron delivering robust clinical benefit: trailless patients with less adgrant disease.

Speaker 4: These clinical findings are further supported by byommarket data showing significant neural-driven changes across important data disease pathways, such as those related to neuural protection, ural informammation. Since the publication of our paper, we have had the pportunity to present data from our FAC, the trial at the scientific conferences, including them the annual meeting and the American Academy analogy.

Speaker 4: And we will deliver an additional biommarket presentation, coming up with the first airlet joug development from it later this month. We have been highly encouraged by the feedback received to date, which we are incorporating into our business and regulatory strategy as we move forward.

Speaker 4: Given the sensitive and confidential nature of our ongoing communications with the regulatory authorities, we are not in a position today to disflowse the specifics of these interactions. I'll thress however, that we continue to make tangible progress.

Speaker 4: Behind the scenes, and I look forward to whenther we can share a comprehensive update.

Speaker 4: We appreciate the urgency of the needs facing dalily communteity and I ensure you all that our entire team is working diligently through a coordinatedor effort to address these needs as expectitively as possible.

Speaker 4: In parallel with our efforts to Trans the room down, it's optimal pathforward. We will extended prayer for antparticipated growthby adding talented and dedicated individual to our leadership team. Just this past week we announced appointment of DR natab lonam shraga as VP of research and development and untal per loner to the newly created position of chie legal counsel, where ther to welcome both antal and that other brands.

Speaker 4: And expect their complementary SK sets and experience working with in this indust leaders such as GE capital and type of Pharmaceuticals respectively, to be the port health to drive our continued cross progress inical to our pipeline. We continue to make progress developing our priority, exison based platform and technology which has a which has implicated the multiple disease areas, DR factor are: seniorvice, presid of medical affa, ical innovation, presented new preclicaldata from this program at the international Society of cel GE therapy conference early this month and branisco. These data look bum prior clical parties that demonstrated the superior as acy of neuralon derived excism in a model of a long jur when compared with accism that had been posced from naive and the hand of pencils.

Speaker 4: With a new data, but that the I. we gained important insights into the biologic mechanisms underlying this superior efficacy of ne under on to preappeares to be linked to their anti lammeory effects on macrorid populations. We look forward to discussing our accon program further during an upcomingic presentation at the high V 2022 annual meetings which is taking place on the on France and may two and 26. I will now turn all over. proplease will review our financialsthank you, heim. It is my pleasure now to discuss our financial results for the first quarter and it merged thirsurfirst 2020 two brand on cash cash equivalence and sh. Then bank deposits were approximately 18.4 million as of merged surfirst 2020 two This compares with approximately two twenty two point one million on thedetemmber surfirst 2021 . Our research and development expenditures.

Speaker 5: Net in the first quarter of 2022 were two point six million compared to with four point three million for the comparable period in 2021. general and administrative expenses for the first quarter: two point eight million compared to two point six million in the comparable period of 2021. net loss for the first quarter was five pointing four million, or 15 cents per share, as compared to net loss of six point seven million, or 19 cents per share for the comparable period in 2021. back to you H. Thank you all. vulable job comp back when now read the questions we received from investors: com.

Speaker 2: Thanks iam. Our first question asked if you could provide an update on the regulatory status of neurons and aals. You want to. The goodour time mentioned in his prepared comments. We continue to leverage expert feedback as we work collaboratively with regulators to enable neuron devancement. Our aim is to seek the most editious path forward to enable patient access and, at this time, at the same time, create value for our stakeholders. Thank you.

Speaker 2: Okay for our second question we have: what are you gaining from recent presentations to scientific conferencesthe? I ll have to do that. I'm just hearing with the shareholders and other people living again that I think at the first time in a long time, since corona, that we're doing to call in the same room in our officers about mem berlichton and ralare ticket.

Speaker 6: Thanks K. as we mentioned, we continue to broaden our understanding of neuron's mechanism action, in's and then progressive's, while at the same time providing key scientific insights into the enhanced immunoomoddulation in, or protection of, our platform technology.

Speaker 6: These really important scientific insights that we will share over the next few months will support a few activities: first of all, regulatory activities. Secondly, they'll definitely increase scientific credibility with the broad scientific community. And finally, they'll provide support for both internal and external discussions related to strategic partnershipsthank you.

Speaker 2: Our next question asked: can you provide an update on your progressive MS program? Let's wrote.

Speaker 6: Thank you. As we mentioned, we've completed additional analyses of the Phase I study and we plan to share these insights at the upcoming CMSC meeting in June in DC and at the exrom meeting in the fall, which will be in the Netherlands.

Speaker 6: These scientific presentations will support continued development of neuron and progressive MS in our view, but we've also received valuable feedback from scientific experts and regulators over the last two months.

Speaker 6: andonce the Phase I study is publisheding in the peer-review Journal will provide a further update.

Speaker 3: Thank you all.

Speaker 2: Okay and the last presubmitted question as: can you provide an update on your ALS expanded access program?

Speaker 4: Yes sureort. Thank you, Tom. We continue to provide additionally AP treatments to the intermediate sized P protocol that they have as approved.

Speaker 4: We continue to actively collect clinical and biommarke Ata from this program and hope to provide further update as they become available and wish the best success to all the patients getting treatments these weeks.

Speaker 7: jeny, I would like you to please open the call for questions from people on the callall.

Speaker 1: No problem at all, Ladies and gentlemen. The floor is now open for questions. If you have any questions or comments, please press star one on your phone. At this time. We ask that while opposing your question, you please pick up your handset. If listening on a speakerof phone to provide optimum sound quality, Please hold while we pull for question.

Speaker 8: Okay your first question is coming from David boutts of Zach smallcap research. David, over to you. Hey, good morning everybody.

Speaker 9: Well I know you CAn't go into the details. I'm just curious if you've had any further meetings with the FDA, or if you guys do decide to go down the path of filing a BA, would you plan on having additional meetings with the FDA before you do that?

Speaker 7: I'll launch on the second part of the question and.

Speaker 4: There are different ways how you can talk to regulators. There are official meetings and if there is sometimes the important programs to the agency, they have ways to talk to us. So we keep on saying that we have an ongoing conversation with regulatory and that's true. It continues to be true. That's as far as I can go this morning. David, I know we justdiscuss it also offline and both with other investors. Everyone wants to know where we are. We'll share as soon as we can. We are doing the best for shareholderss of of not yet sharing where we are, but everything is on courseto your question: yes.

Speaker 3: Okay now regarding exooms. I'm curious what potential other indications you could look at for that platform outside of say acute long injury which you've already sho dat for preclinical data for us so.

Speaker 4: This is a wonderful question. Again, I can share too much. What I will share with you that we just shared, that we just appointed a new V P R and D and she has a lot of expertise in that exactly to drive from the scientific good indication to drive to OK, where this going, what are the diseases, who are the right partners. That's what she has done in tlaw with huge consortium and bring things from academic to company development. So of course we are not academic but our R and D team was is more academic driven, is going to be more business focused and also to try to figure out to with who the partnner what, what different indications. It's a very good question. So we're looking at the whole of the whole broad possibilities and she's very professional with a team and she may bring out more people to sister to exactly be able to outline the company to move very fast in the right direction. So while we are already focused and long disease in different ways.

Speaker 4: There will be an add on this year, AC on to becoming very, very hot in our industry, as you knowyes, all right sounds good. Thanks for taking the questions this morningthank you, Ion. Next question is coming from Michelle lourerenz, of voices for as overt.

Speaker 10: Good morning everybody. I have four questions about biomarkers and two about patient reported outcomes. The first biomarker question relates to your C's F biomarkers. At the recent AD com Cedars, DR Billy done talked about the importance of neurofilament light trending in the right direction, and earlier last year or at the end of last year, DR Brown said that N F? L in the neuron trial was trending. I think his quote was iye popping. So I'm curious if you can comment on which of the C's F biomarkers you found the most compelling, and did you see a larger magnitude difference in the higher L's F, R's R scores, just as you did in the clinical trial data with the that was published in? Must wonder.

Speaker 11: Thank you so much. So the answer for that is that we are not claiming a single biomarker support only. We don't think ls and none of our rescientces or neurologists think that ls will be driven only by a single biomarker. We do know and, as you mentioned, ductibly done on on the has come for analytics has mentioned that you would like to see the NFL are going in the right direction as an additional credibility to ls R SR results. We can say that we have that and not only with NL. We have many biomarkers supporting our ls R SR score story that we are claiming. That shows that our trial as that, our treatment division.

Speaker 4: We did lay out part of the biomarker story in our manuscript, but there's still for months to share and we are working in an additional manuscript that we lay out actually a lot of what you were asking in more detail.

Speaker 10: But you may not be able to answer the second one then I noticed that DR skovage presented at the M N D talking about U N C 13 a and about- I think the data was about- 65% of the people with the a C Le met the primary endpoint and that was roughly about five times P value. So given that U N C 13 a snip is a misplplacicing error, do you hypothesizee that neuron may show efficacy on the other genes that have misspling errors that were identified in Aaron gitler's paper in naturethat you think a very good question and Dr. whatever would be able to be shared at the time. It doesn't mean that we have.

Speaker 4: That we say that only a versus C works it. It is far more complex, as you know. I think first of all the COUR to see you really follow all our presentations very good, a lot of detail, are happy to see that and our scientists are very excited that we are paving the way first in biomarkers. Someone following many ls trials, I know that you know with the first with the largest biomarker data set to bring forward in an trial and now, Thank God, all of the trials are now understanding that biomarers has to be part of trial collection and even though you know and other CF tap again and again in which we were rather ue to patients, but patients are very happy that they know that whatever happening in the trial, they are really, really giving a lot of support for science going forward, understanding ls better and I think our data set of bomarkers brings that into the generics.

Speaker 4: We just- and it's just on a surface, So we are opening the door there. We are showing very interesting datdata. As you mentioned, we can, of course, inclu that now biommarket paper will have the generetic section, but it's only the beginning. I think our biomome data will be far more helpful at this moment than the generic data, but the etic data is very supportive of what we're saying definitely.

Speaker 10: To that end. I've also a believer that the patient reported outcomes are compelling and, as you know, sadly the the COVID-19 halted the collection of breathing data in the Phase three trial. But it appears from the people in E a p- both the last E a p- that some people having significant improvements in F C, C.

Speaker 12: Some one person that obviously stopped using a trilogy and it's been two years. I checked with his UH, his family. They still aren't using the trilogy two years since his lastas tose. So I'm curious: is neuron up regulating the epidermal growth factor or is there another biomarker that you believe might be responsible for targeting the frrenic nerve that innovates the, the diaphragm?

Speaker 4: Michelle, I wish all the Investors will know what you know in detail, but you know that I CAn't comment on this app. Open program.

Speaker 4: While you follow everything. Nice Yeah, I CAn't really them another.

Speaker 13: Yes we, I can say, and I would say that we are very happy that we're able to vide course the AP that's, thats of course are given everyone of that we have done. This's not trivable all the companies to do. We small market cap company investing a lot of our money and resources to provide to these few patients at least, more and more treatments. We're very happy that the FDA is supporting this program in a very strong way. And then yes, So we see what you see in micshele, we see the same things. Of course you're not seeing wrong things, but we just can' comment on.

Speaker 12: Okay then the last quick question is again in E a P, a lot of people have reported that their facysculations have stopped immediately after getting their neuron injection. That's obviously nowhere reflected in the a, L's F's R. how is Brainstorm capturing this data to provide it to the F? D a in support of how a patient feels and functions?

Speaker 4: Again micshow is a very, very good question. The whole industry is discussing about the endpoint and about this coreter. Of course, this core is something that we have to hold up and the results that this core show are also, I think, very impressed with our trial.

Speaker 4: Outside of that you're asking a good question and there's a lot of answers but nonfinal answwer that we can really share here. I think the industry is going to come up with answers because you bring up veryty important. Points that this court does not of course cover every improvement where we know that it's well written in a literature. I'm sure you know that as well and we are talking to to many people including Ed itor's our authors of the srsr core and they want to know our data and you're looking at those things and and maybe they will share some of their thoughts. Very soon we are maybe but.

Speaker 4: It's not TR us to really edit, to score it for PS to BR. Forward our data and share as we can with the whole community to help everyone understand better how to measure.

Speaker 4: But you all a very good questionions. So even if you take up our time, quite a lot of time, very happy to answer these very professional questions, Thank you.

Speaker 12: Thank you for your time. Sure, Thank you. Your next question is coming from Daniel Walker of net industry. Daniel, please ask your question.

Speaker 14: Yes good morning. Neuron has a very broad mechanism of action in terms of its impact on multiple critical bimarkers. It seems like a lot of other therapies mechanism of action are much more narrow or end up targeting a subgroup. Maybe Conductor curren's comment on the advantages of neuron's mechanism of action relative to other therapies and development, both past and present, might do have a few other questions.

Speaker 11: Yes Hi, Daniel will let DR turn an answer your questions. I spoke too much this morning Thank, grimha. Yes Daniel, thanks. Thanks for that question. I think there's a couple of answers that would help.

Speaker 6: Shed some light on the point that you're raising. The first is that there's not a single neuroneuroprotective factor that has been shown to be effective, and in fact there's good reason for that, because there are different targets that the neuroprotective factors reach and in in the preclinical models there's pretty good evidence that targeting a single neuroprotective factor isn't as good as targeting multiple. So they have something called synergy, So they work together. So that's kind of the first cut that I would offerthe second is that is that offering Neuroprotection without managing the inflammation in the disease is probably not going to be effective. And there also is some evidence to suggest that combining- combining treatments that address both neuro-protection, in other words allowing the tissue to recover from the disease while at the same time reducing inflammation- are more likely to be effective. So we think that there's good scientific rationale for this.

Speaker 6: And then finally, the treatment technology platform that we're providing is a way of packaging both of those treatments into a single of delivering mechanism. So we think that we have we have a unique way of providing effective treatments across multiple pathways and I think, as high mentioned earlier, our biomarker data supports that scientific perspectivethank. Thank you so much. And non has shown a highly significant burden of proof in terms of's frs biomarkers, UNC 13 a and, most importantly, patient reported outcome. Maybe Conductor lindborg just provide some comment about how this compares to other therapies in development, both past and presentthank you for the question, diel. I don't think it's appropriate to comment relative to.

Speaker 15: To other therapies But I will echo the comments that you're you're providing what is very exciting about our data which we have in the public domain. As we understand the participants that enrolled in the trial and we are accounting for floor effects in the from the study. We see very clinically meaningful events that are measured through the traditional scale of ALS. At's R we then also as DR krent. Just walked through have seen some incredibly exciting results large magnitudes and across a diverse set of biomarkers and our biomarker data and really as as would have been I guess hope for based on literature. We're also seeing participants that have that carry the risk of UN C 13 a having a differentiated response to treatment almost a ratio of nine nine times the response with the AC G a type. So we really see across a collection of of measures which.

Speaker 15: I think is one of the most important factors are really understanding what we believe about a product, and I think it paints. It paints a very important picture for what we believe about neurroonand that the last comment I would make is really intermingling these in points. So we have the ability- and we publish this in our muscle and nerve paper- to understand. Do the biomarkers help explain the clinical response that we see with the's F SR? In fact, as we published, they do, with very high predictive natureso I think that, counter to may be comparing to other therapies. Really what we're very excited about is the consistency of measures and really how everything. Ultimately, if we saw clinical response, we couldn't explain your bomarkers or vice versa, we would certainly be scratching our heads a little bit more. But what we actually see is, in fact, a very strong Ti that really give a very strong explanation for the effects observed. Thank you so much. And cancondoctor setbaron, based on his past experiences.

Speaker 14: Maybe just provides an insight into how he had seen companies in similar late stage development think about outside partnerships and collaborations. And then maybe H for you, how does brainsm thinking about ships particular issue and topicyou know then I thank you very much, know I spoke to this morning and I' really happ to be Al my colleagues of speak and I love they would take this question. Thank you.

Speaker 16: Thank you for the question. Your' you're right. There is not so many companies are very active in the seveng and, as you mentioned, exorm as well, very interesting and attractive technology partners and, as you said we are again, there is very few that are this level of development. 3, the potential to really bring treatment to patients. So, to your point, the three elements, the sel? Ng interest, the Exosome and the fact there is.

Speaker 17: Large set of data and a unique set of biomarker makes our company and our data interesting and attractive to other partners, So it has always been part of our strategy. We've always been in discussion with potential partners and we take that into account for the future. Thank you.

Speaker 14: Thank you so much, and he I don't know if you could comment about how Brainstorm is thinking about. Iti've going to only agree with viavid.

Speaker 4: I think he's great put it and just lastly given the amount of time that has now lapsed.

Speaker 14: And ever increasingly growing in patients amongst ALS patients and patient advocates. Some might question the motivations of brainstorment team. Just curious if anyone on the Brainstorm team or anyone from their family has ever personally been impacted by ALS and if So, would they be willing to share a little and how that experience affected their outlook and perspective on ALS and the urgency?

Speaker 7: That's a very personal question.

Speaker 4: More than one of the senior management to have family members that had a led can can tell you that.

Speaker 18: So the urgency is very highi think that's what I would sayit: hoing, I don't do my color wanting to talk to it of this cocaate great. Thank you so much time and thank you to that brandstorm team. I'll jump back in Q. Thank you so much.

Speaker 1: Thank you. Your next question is coming from Chris missoui. He's a private Investor. Chris, please ask your question. No, based upon the successful data from the Phase I progressive M MS trial, I just I guess my question is: is Brainstorm in preparation for a Phase three trial upon the upon, I guess, the publication of the Phase I dataand if So, are you able to give a timeline on that's? Thank you so much, Chris. All Ralph, your question.

Speaker 19: Hi Chris, thanks for the question. As, as I mentioned earlier, we are awaiting publication and peer-review Journal. I think that the peer review is the important next step, pivot step for us to make internal decisions, and once that happens, we'll discuss it. We obviously are. We've stated that our first priority is to advance your own ALS we continue to be fully focused on that.

Speaker 6: But we do have a lot of support from the scientific community in our MS project. We also plan to have very extensive scientific meetings in June , throughout the summer and then in the fall with the MS scientific community Brainstorm is part of the international progressive MS Alliance and the. The conversations are really quite rich and these will help us make a decision. But again, at until we get to the point where the Phase I study is published, we won't be able to make any further the public statements. Thanks for the question.

Speaker 7: Thank you so muchokay. We impai to have no more questions in the kid.

Speaker 1: So I will hand back to H M for closing remarks. Yes, Thank you so much, genuniie handling this call, and thank you every one to listen again and I'll see you soon have. The next queue is going to be- I'm sure that thankans have going to music week from now. It's going to be a longer T, technically and legally. Thank you very, very mucht. Thank you, Ladies and gentlemen. This does conclude today's conference call. You may now disconnect your phone lines and have a wonderful day. Thank you for your participation.