NASDAQ:BCLI Brainstorm Cell Therapeutics Q3 2023 Earnings Report $0.98 +0.06 (+5.98%) Closing price 04/25/2025 04:00 PM EasternExtended Trading$0.99 +0.02 (+1.54%) As of 04/25/2025 07:08 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Brainstorm Cell Therapeutics EPS ResultsActual EPS-$2.10Consensus EPS -$2.10Beat/MissMet ExpectationsOne Year Ago EPS-$2.85Brainstorm Cell Therapeutics Revenue ResultsActual RevenueN/AExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/ABrainstorm Cell Therapeutics Announcement DetailsQuarterQ3 2023Date11/14/2023TimeBefore Market OpensConference Call DateTuesday, November 14, 2023Conference Call Time8:30AM ETUpcoming EarningsBrainstorm Cell Therapeutics' Q1 2025 earnings is scheduled for Tuesday, May 13, 2025, with a conference call scheduled at 7:00 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Brainstorm Cell Therapeutics Q3 2023 Earnings Call TranscriptProvided by QuartrNovember 14, 2023 ShareLink copied to clipboard.There are 8 speakers on the call. Operator00:00:00Greetings, and welcome to the Brainstorm Cell Therapeutics Third Quarter 2023 Earnings Call. At this time, participants are in a listen only mode. As a reminder, this call is being recorded. And I would now like to Your host for today's call, Michael Wood of LifeSci Advisors. Mitra Wood, you may begin. Speaker 100:00:22Good morning and thank you everybody for joining us. Earlier today Brainstorm issued a press release with its financial results for the Q3 of 2023, including a corporate update. Before passing it off to the company management for prepared remarks, I'd like to remind listeners on this conference call, will contain Numerous statements, descriptions, forecasts, projections regarding Brainstorm Cell Therapeutics and its potential future business operation and performance, Statements regarding the market potential, the treatment of neurodegenerative disorders such as ALS, the sufficiency of the company's existing Capital resources for continuing operations in 2023 and beyond, the safety and clinical effectiveness of the neurotechnology platform, clinical trials of Neuron and related Forward looking statements are subject to numerous risks and uncertainties, many of which are beyond Brainstorm's control, including the risks and uncertainties described from time to time in the company's SEC filings. The company's results may differ materially from those projected on today's call and the company undertakes no obligation to publicly update any forward looking statements. Joining us on the call today will be Mr. Speaker 100:01:42Chaim Lebowitz, President and CEO of Brainstorm Doctor. Stacey Lindbergh, Co Chief Executive Officer and Alipatlas, Interim Financial Officer. So I'd now like to turn the call over to Mr. Lebowitz. Please go ahead, Ryan. Speaker 200:01:59Thank you, Michael. Thanks to all who have joined us to discuss our Q3 2023 financial results and ongoing progress. We are committed to our goal of making NUURAN available to the ALS community. Our priority now is to work with the FDA And do everything in our power to align on a path forward. As announced previously, we made the decision To withdraw the BLA for Neuron from FDA review. Speaker 200:02:35This decision was made following the outcome of the advisory committee We took place to review Neuron in September. This action was coordinated with the FDA and is viewed by the FDA as a withdrawal without prejudice. The next important step will be for us to conduct a meeting with the FDA. We submitted the official request just a few days ago. We will use the opportunity to discuss next steps, including the design for a confirmatory Phase 3b study in ALS, which we intend to conduct at such meetings. Speaker 200:03:18As part of our regulatory strategy, We intend to seek a special protocol assessment with the FDA before continuing with the planned registration trial. A spa indicates agreement with the agency on the adequacy and the stability of critical elements of the trial design, including items such as patient entry criteria, endpoints and planned analysis. We believe that having a spa in place will de risk the regulatory aspect of our ALS program. We believe the process will likely take 1 or 2 meetings With the FDA, we'll provide an update once we have clarity on the path forward. In parallel with these regulatory activities, our management team and Board are giving serious thoughts How to finance the company and to ensure we have the resources to fund the planned Phase 3 trial and position ourselves for success in the future. Speaker 200:04:33We're actively exploring various options to raise capital, including non dilutive grants as well as capitalizing on certain non core assets such as our exosome technology. In October, we announced a strategic realignment to prioritize and conserve resources. This involved a number of steps, including streamlining our genome operations as well as a targeted reduction headcount of approximately 30%. Importantly, those positions that are most critical to managing the planned Phase 3b trial and regulatory submission will be retained. We estimate that overall the strategic realignment will cut total resource consumption by approximately 50%. Speaker 200:05:25Many of us, including all senior management, Took a 30% cut in their wages. As for myself, I took over an 80% cut from now. These were difficult but necessary decisions. We are very thankful for the hard work and commitment Of all our colleagues that are brainstormed for the contributions in advancing Neurom. I'll now turn the call over To Doctor. Speaker 200:05:53Stacey Lindbergh for additional comments. Speaker 300:05:57Thank you, Haim. There remains an urgent need for new treatments for ALS, treatments that are safe and effective. Every day, patients and their families confront the harrowing reality of this terrible disease. We've assembled a considerable body of data on your own in A List participants. And we continue to believe that if approved, this product has the potential to be a valuable new treatment option for people living with this disease. Speaker 300:06:29We are motivated by the courage of Ayla's patients And we're driven by the opportunity to bring a product to market that we believe can improve their lives. We look forward to continuing to engage with the FDA and conducting a confirmatory Phase 3b trial as efficiently as Speaker 400:06:47possible. Chaim? Speaker 200:06:53Thank you so much, Speaker 400:07:01Thank you, Chaim. Cash, cash equivalents and short term VIN deposits were approximately $1,400,000 as of September 30, 2023 compared to $3,000,000 as of December 31, 2022. In July 2023, The company raised net proceeds of approximately $7,000,000 in the registered direct offering. Research and development expenses for the 3 months Ended September 30, 2023, 2022 were approximately $3,300,000 $3,800,000 respectively. General and administrative expenses for the 3 months ended September 30, 2023, 2022 were approximately $2,700,000 and $3,100,000 respectively. Speaker 400:07:45Net loss for the 3 months ended September 30, 2023 was approximately $1,200,000 or $0.03 per share as compared to a net loss of approximately $6,900,000 or $0.19 per share for the 3 months ended September 30, 2022. I'll turn it back to Chaim. Speaker 200:08:03Thank you very much, Alaa. Michael Wood from LifeSci will now read some questions we have received from investors. Michael, are you there? Speaker 100:08:21Yes. Sorry, I was on mute. Yes. Thank you, Kai. Is it possible that Even with the AdCom decision around the FDA could grant limited approval for early stage ALS patients Where there has been an observable positive response. Speaker 500:08:38Stacy, you want to take this? Speaker 300:08:40Sure. We firmly believe that generating additional data in the form of the Phase 3b trial that we've been discussing is the only path forward That will gain regulatory approval of Neurone. We would have never withdrawn the BLA if we weren't convinced that we would not be successful with the current data alone. Therefore, it's in our best interest to move forward as quickly as we can to get the trial started. Speaker 100:09:08Thanks, Stacy. Next question, how long before you know more about your funding plans? And as a follow-up to that, when are you hoping to start the Phase 3b? And are you waiting for funding or grants to come in before you can commence the study? Speaker 200:09:24Thank you. We're working with banks who have been successful, including very recently raising funds for biotech companies like Brainstorm, And they are confident in our ability to raise the funds needed to run this trial. We'll first work to As we shared in our prepared remarks, we're exploring a variety of avenues, including partnerships and grants. Although there is always the chance of a larger infusion of funds, we expect to raise money for the trial in stages. We also do not intend to wait to start the trial until we have raised the full amount needed. Speaker 200:10:09We'll be thoughtful about starting the trial, but patients deserve more urgency than this. Speaker 100:10:17Thank you. Next question. Are you working on the new trial parameters with the FDA? Speaker 200:10:26Stacy? Speaker 300:10:28Yes, that's correct. As Chaim mentioned in the prepared remarks, we've requested an But I did face to face meeting very recently. And this meeting will allow us to discuss the next steps for Neuron, which will focus on the core design elements of the Phase trial that we've been working on with a scientific advisory panel and a panel of people from the ALS community, including those living with the disease. We intend to seek a special protocol assessment from the FDA, which as many of you will know is an opportunity to reach an agreement With the FDA before the study starts on the design of a clinical trial, and this trial, of course, is intended to serve as the primary basis We view this as beneficial and a valuable tool to accelerate the Phase The trial for Neurone and potentially derisk the regulatory aspects of the program. Speaker 100:11:28Thank you. And one final question. Why don't you partner with Big Pharma? Speaker 200:11:35Thank you. So we are seeking to partner. In fact, we're in contact with a few companies. Although ALS is a relatively rare disease, the commercial opportunity is still compelling and we know there is interest from companies who would like to have a successful product in this area and to be able to serve patients. You have to remember though that cell therapy is still an emerging modality, especially in neurodegeneration. Speaker 200:12:04There are very few approved cell therapy products And R and D products are largely focused on oncology and genetic disease. Presumably, a major approval in the cell therapy space We'll bring investments and until then some will remain cautious. As you may know, It took many years to develop CAR T cell therapy for various cancer treatments and innovation came from within smaller companies before developing partnerships. Just a few examples, Kite Pharma went alone until after approval and then was bought out by Gilead. Junopharma did the same and was also acquired after FDA approval by Celgene, while Bluebird wasn't acquired and remains independent today. Speaker 200:12:53We have a derisked Phase 3 asset, which will have an attractive upside for the right company. So we will pursue a partnership as a promising avenue. Neurone as a technology represents a strategic approach and therefore we would welcome a partnership, but until that comes we are willing to do all we can to proceed Jenny, would you like to open the call for any additional questions? Operator00:13:53Thank you. Your first question is coming from David Bautz of Zacks SmallCap Research. David, your line is live. Speaker 600:14:01Hey, good morning, everyone. Thanks for the update this morning. So Chaim or Stacy, I was wondering if you could talk a little bit more about the SPA. And basically, what differentiates that from saying just coming to an agreement with the FDA about a trial design? Speaker 200:14:23Tracey? Speaker 300:14:25Yes. David, I think that the SPA pathway and the opportunity to formally recognize and use a pathway that the FDA Offers really just gives the platform to come together and to align, but to have a formal agreement That's documented. And I think it's a constructive way to approach this and it's something that I think We'll be positive for BRAINSTORM, but also really ensure that the discussion and the work that we do ahead ultimately is It nets out with the successful trial really what we expect, which should be an approval. So it really is about a formal engagement And it's a pathway that's well established and leveraged. Speaker 600:15:15Okay. And as far as Go ahead. Sorry. Speaker 200:15:20I was just going to add on that. Of course, I just want to emphasize what FDA is discussing with us an expedited pathway for us path. So that's just additional answer to your question. What we're looking for expedited SPAs, you know that if those companies that are able to have a SPA with the FDA, There is a far higher chance from the pool at the end of the day. But many choose not to do that because usually it can take a year or 2 years just to get to an agreed upon SPA. Speaker 200:15:48This past we're talking about expedited SPA process and we're looking forward for that. Go on and David, another question please. Speaker 600:15:59Yes, actually I was going to key off of what you just said and basically kind of looking at the timeline. So would normally that process would be a year or 2, you're looking at less than a year probably then for an expedited spa? Speaker 200:16:12Well, I don't want to put any words into FDA It's Khotsam here. So I want to be very cautious, but I do see a first meeting very fast. And I think after that meeting, we'll be We'll share that by the way. We'll share what happened at the meetings with the investor community because this is our number one priority just now To see if we can come to an agreed upon spot. And we'll learn from this meeting that, that should be very soon and we'll be announcing when that meeting is. Speaker 600:16:42Okay. Now I understand you probably won't be able to get into specifics, but do you foresee The primary outcome for the next Phase 3 trial being the same as it was for the previous one? Speaker 200:16:58We're going to have to have a discussion with the agency at that meeting. So let's keep it for that. We will share once those meetings are done, we come to an agreement. We'll share what the trial design looks like. Speaker 600:17:11Okay. All right. Thanks for taking the questions. Sure. Operator00:17:16Thank you very much. Your next question is coming from William Barr from Tivam Adventures. William, your line is live. Speaker 500:17:26Thank you. Thank you, Chaim, and thank you, Stacy, and thanks to everyone at Brainstorm. We've been following and we've been investors in the company for many years. So My question is, why is this time going to be different? There's like those of us who know you guys have been fighting, how hard you've been working and all of us Many of us are really so beyond grateful for everything that you've done and continue to do for ALS patients. Speaker 500:17:52We're finally starting to see That the AMALYX treatment is maybe not what some people thought it was. And we're finally starting to see that some ALS chapters are Maybe recognizing the issues at Alsa and their start is to break away. And we all saw what happened at the AdCom and many of us believe that it was Extraordinarily unfair. A lot of investors want Brainstorm to sue the FDA. And instead, you guys are basically embracing the FDA. Speaker 500:18:21And we know you want a treatment for ALS as quickly as possible. And we know that you guys have really done everything in your power to try to effectuate that. So Why is this time going to be different? Speaker 200:18:33Thank you. It's a very good question. So first, allow me, I can't I don't want to comment on other treatment For the organizations, we are looking to have everyone supporting us, all the organizations and all the advocates, and we're going to work on that as well. We're going to reach out once we have a trial design and share it with them, listen to their inputs going forward. What I think will be different, as you have heard in our opening statements, we're trying to come to an agreement with the spine and I want to share with you it is Proposed by the FDA to do that, to have an expedited path. Speaker 200:19:07So again, we should see how they will treat a difference going forward. We should acknowledge that even though some see the outcome as being overly negative To Neuron, but what we are being explained and I want to be cautious what I'm saying that many don't disagree with what we are saying. They just To provide that data and therefore that discussion together with them is very important to see what are they thinking in addition to what we provided. So we should align on what should be provided, what should be sufficient for an approval. That's what Asta means. Speaker 200:19:55So going into that meeting, I think we are going to get an expedited meeting. We are getting the indication from the agency That they want to have this meeting very fast. So they're showing interest and supporting us being able to have another trial very soon, To start another driver issue, I'll ask Stacy also to comment. Stacy? Speaker 300:20:18Yes. William, thank you for the Comment and your question. And I think when we step back and we look at what we have before us, Certainly, when we brought forward our product, we believe and we still believe in our data and we believe that there was a discussion That should happen around the efficacy and safety and the appropriateness given regulatory flexibility. But at the end of the day, when we look forward, one of the strongest positions and the things that we can do is we can execute on a trial design, Leveraging the learnings that have occurred and we can read out a trial that meets its endpoints. And so what you see us doing It's really doubling down. Speaker 300:21:07We understand our product. We have a lot of information that we believe gives us a lot Confidence in our ability to deliver this trial. And so what we're focused on is bringing forward a product that's straightforward in this next trial That makes the regulatory process certainly more conventional And the next time around certainly much more streamlined and smooth. Speaker 400:21:38So that's what I think of Speaker 300:21:40when I think about what's different. Next time and drug development is incredibly Complicated. We always learn things in our endeavors when we're tackling very tough diseases. And I think In the setting of this last Phase 3 program, certainly there were things that the community did not appreciate and did not understand and We now have those as learnings that we take forward to this next trial design. Speaker 500:22:11Thank you very much. For those of us that have ALS patients in our lives, have lost family and friends, I just wanted to say thank you to both of you and Thank you for fighting a good fight for us. Speaker 200:22:26Noah, thank you for your ongoing support many years. Really appreciate that. Operator00:22:33Thank you very much. Speaker 200:22:34Next question please, James. Operator00:22:36Your next question is Speaker 200:22:38We have time for one more. Yes, Operator00:22:39Daniel Walker is a Private Investor. Daniel, your line is live. Apologies there. Speaker 700:22:49Comment on manufacturing. You mentioned at the recent Brainstorm Town Hall meeting That Brainstorm has successfully manufactured 500 potent products. I think there have been some questions about Brainstorm's ability to manufacture. Can you just comment on that? And then also moving forward, How will the clean rooms be managed? Speaker 700:23:13Will it be Catalent? Will it be the academic centers? Maybe you could just comment a little bit on that. Speaker 200:23:21Thank you very much, Daniel, for this question. So we did I have quite a few centers where we already produced, as you know, for the Phase II and Phase III trials at different academic centers and the commercial centers only for the EAP. Going forward, it's first a financial question. The academic centers are cheaper than the commercial centers to operate. And on the other hand, you do want to have a site that once you're successful with the trial, you should have a commercial site ready. Speaker 200:23:53We're going to balance that timing wise to see maybe we'll start with academic and then for the second part of the trial do a commercial side, So we can gain from the cheaper cost earlier and then but simultaneously be able to have a commercial site ready once the trial is done. Does that answer your question? Speaker 700:24:13That does. And I guess with the SPA, I mean, how do you ensure that this go around because the FDA was quite critical of the manufacturing At the outcome, how do you ensure moving forward though that there is alignment not only on the SPA, but also in addition to the manufacturing so that at Time you resubmit the BLA, they feel confident in the manufacturing because obviously there's a difference between Manufacturing at the trial level compared to actually at the time of commercialization. Speaker 200:24:47Thank you. That's very helpful. You clarified the question even more. So the answer is FDA agreed to have discussions with us While we do the trial on the CMC issues to come to alignment. And as I've said previously, we have come to alignment on many of the CMC issues, if not most. Speaker 200:25:03With some of them, it takes longer to do those qualification tests, which we are continuing to do, those that are critical. But yes, FDA will have with us separate conversations With the CNC team and separately from the clinical team. Speaker 700:25:19Excellent. Thank you so much. And then just lastly, I was wondering if could just expand on the exosome technology, I know you're working on capitalizing that. Can you or Stacy just comment very briefly on what is that technology and Why that might be interesting and compelling to pharma or biotech? Speaker 200:25:39Yes, you mentioned Stacy, but I'll ask Stacy to talk to that of course and if I need to allow that. Stacy? Speaker 300:25:47Sure. Daniel, this is an additional technology that we have been developing and certainly have thought of As an interesting and exciting part of our portfolio and what's interesting about exosomes is, of course, that It allows us to move into and explore different diseases that can carry cargo and can penetrate different parts Of human bodies and therefore brings different advantages. But we've done a number of preclinical Some of which we published, and we think there's a lot of excitement in this technology platform, which again offers a wide array of diseases that there's a great unmet need and that these nanoscale particles really would be able to open Possible administration options that would be very effective for treatment. Speaker 700:26:54Excellent. Thank you both so much. I really appreciate it. Thank you. Operator00:27:00Thank you very much. That appears to be the end of our question and answer session. I will now hand back over to Haim for closing comments. Speaker 200:27:09Thank you very much and have Speaker 100:27:11a wonderful day. Thank you.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallBrainstorm Cell Therapeutics Q3 202300:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Brainstorm Cell Therapeutics Earnings HeadlinesBrainstorm Cell Therapeutics adjusts quorum requirementApril 23 at 8:11 AM | investing.comBrainStorm submits IND amendment to FDA for Phase 3b trial of NurOwn in ALSApril 10, 2025 | markets.businessinsider.com2025 could be "worse than the dot-com bust", says man who predicted 2008 banking crisisWhat's coming next to the U.S. market could be worse than anything we've ever seen before – worse than the dot-com bust, worse than the COVID crash, and even worse than the Great Depression. What's coming, he says, could soon crash the market by 50% or more – and keep it down for 10, 20, or even 30 years. April 26, 2025 | Stansberry Research (Ad)BrainStorm Cell Therapeutics Inc.: BrainStorm Cell Therapeutics Submits IND Amendment to FDA, Paving the Way for Phase 3b Trial of NurOwn in ALSApril 10, 2025 | finanznachrichten.deBrainStorm Cell Therapeutics Submits IND Amendment to FDA, Paving the Way for Phase 3b Trial of NurOwn® in ALSApril 10, 2025 | prnewswire.comAnalysts Are Bullish on These Healthcare Stocks: Nuvalent (NUVL), Brainstorm Cell Therapeutics (BCLI)April 10, 2025 | markets.businessinsider.comSee More Brainstorm Cell Therapeutics Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Brainstorm Cell Therapeutics? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Brainstorm Cell Therapeutics and other key companies, straight to your email. Email Address About Brainstorm Cell TherapeuticsBrainstorm Cell Therapeutics (NASDAQ:BCLI), a biotechnology company, engages in the development and commercialization of autologous cellular therapies for the treatment of neurodegenerative diseases. The company, through its NurOwn proprietary cell therapy platform, leverages cell culture methods to induce autologous bone marrow-derived mesenchymal stem cells to secrete high levels of neurotrophic factors, modulate neuroinflammatory and neurodegenerative disease processes, promote neuronal survival, and enhance neurological function. It is developing NurOwn, which has completed Phase III clinical trial for the treatment of amyotrophic lateral sclerosis; Phase II clinical trial for the treatment of progressive multiple sclerosis; and for the treatment of alzheimer's disease, as well as for other neurodegenerative diseases. Brainstorm Cell Therapeutics Inc. was incorporated in 2000 and is headquartered in New York, New York.View Brainstorm Cell Therapeutics ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Market Anticipation Builds: Joby Stock Climbs Ahead of EarningsIs Intuitive Surgical a Buy After Volatile Reaction to Earnings?Seismic Shift at Intel: Massive Layoffs Precede Crucial EarningsRocket Lab Lands New Contract, Builds Momentum Ahead of EarningsAmazon's Earnings Could Fuel a Rapid Breakout Tesla Earnings Miss, But Musk Refocuses and Bulls ReactQualcomm’s Range Narrows Ahead of Earnings as Bulls Step In Upcoming Earnings Cadence Design Systems (4/28/2025)Welltower (4/28/2025)Waste Management (4/28/2025)AstraZeneca (4/29/2025)Mondelez International (4/29/2025)PayPal (4/29/2025)Starbucks (4/29/2025)DoorDash (4/29/2025)Honeywell International (4/29/2025)Regeneron Pharmaceuticals (4/29/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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There are 8 speakers on the call. Operator00:00:00Greetings, and welcome to the Brainstorm Cell Therapeutics Third Quarter 2023 Earnings Call. At this time, participants are in a listen only mode. As a reminder, this call is being recorded. And I would now like to Your host for today's call, Michael Wood of LifeSci Advisors. Mitra Wood, you may begin. Speaker 100:00:22Good morning and thank you everybody for joining us. Earlier today Brainstorm issued a press release with its financial results for the Q3 of 2023, including a corporate update. Before passing it off to the company management for prepared remarks, I'd like to remind listeners on this conference call, will contain Numerous statements, descriptions, forecasts, projections regarding Brainstorm Cell Therapeutics and its potential future business operation and performance, Statements regarding the market potential, the treatment of neurodegenerative disorders such as ALS, the sufficiency of the company's existing Capital resources for continuing operations in 2023 and beyond, the safety and clinical effectiveness of the neurotechnology platform, clinical trials of Neuron and related Forward looking statements are subject to numerous risks and uncertainties, many of which are beyond Brainstorm's control, including the risks and uncertainties described from time to time in the company's SEC filings. The company's results may differ materially from those projected on today's call and the company undertakes no obligation to publicly update any forward looking statements. Joining us on the call today will be Mr. Speaker 100:01:42Chaim Lebowitz, President and CEO of Brainstorm Doctor. Stacey Lindbergh, Co Chief Executive Officer and Alipatlas, Interim Financial Officer. So I'd now like to turn the call over to Mr. Lebowitz. Please go ahead, Ryan. Speaker 200:01:59Thank you, Michael. Thanks to all who have joined us to discuss our Q3 2023 financial results and ongoing progress. We are committed to our goal of making NUURAN available to the ALS community. Our priority now is to work with the FDA And do everything in our power to align on a path forward. As announced previously, we made the decision To withdraw the BLA for Neuron from FDA review. Speaker 200:02:35This decision was made following the outcome of the advisory committee We took place to review Neuron in September. This action was coordinated with the FDA and is viewed by the FDA as a withdrawal without prejudice. The next important step will be for us to conduct a meeting with the FDA. We submitted the official request just a few days ago. We will use the opportunity to discuss next steps, including the design for a confirmatory Phase 3b study in ALS, which we intend to conduct at such meetings. Speaker 200:03:18As part of our regulatory strategy, We intend to seek a special protocol assessment with the FDA before continuing with the planned registration trial. A spa indicates agreement with the agency on the adequacy and the stability of critical elements of the trial design, including items such as patient entry criteria, endpoints and planned analysis. We believe that having a spa in place will de risk the regulatory aspect of our ALS program. We believe the process will likely take 1 or 2 meetings With the FDA, we'll provide an update once we have clarity on the path forward. In parallel with these regulatory activities, our management team and Board are giving serious thoughts How to finance the company and to ensure we have the resources to fund the planned Phase 3 trial and position ourselves for success in the future. Speaker 200:04:33We're actively exploring various options to raise capital, including non dilutive grants as well as capitalizing on certain non core assets such as our exosome technology. In October, we announced a strategic realignment to prioritize and conserve resources. This involved a number of steps, including streamlining our genome operations as well as a targeted reduction headcount of approximately 30%. Importantly, those positions that are most critical to managing the planned Phase 3b trial and regulatory submission will be retained. We estimate that overall the strategic realignment will cut total resource consumption by approximately 50%. Speaker 200:05:25Many of us, including all senior management, Took a 30% cut in their wages. As for myself, I took over an 80% cut from now. These were difficult but necessary decisions. We are very thankful for the hard work and commitment Of all our colleagues that are brainstormed for the contributions in advancing Neurom. I'll now turn the call over To Doctor. Speaker 200:05:53Stacey Lindbergh for additional comments. Speaker 300:05:57Thank you, Haim. There remains an urgent need for new treatments for ALS, treatments that are safe and effective. Every day, patients and their families confront the harrowing reality of this terrible disease. We've assembled a considerable body of data on your own in A List participants. And we continue to believe that if approved, this product has the potential to be a valuable new treatment option for people living with this disease. Speaker 300:06:29We are motivated by the courage of Ayla's patients And we're driven by the opportunity to bring a product to market that we believe can improve their lives. We look forward to continuing to engage with the FDA and conducting a confirmatory Phase 3b trial as efficiently as Speaker 400:06:47possible. Chaim? Speaker 200:06:53Thank you so much, Speaker 400:07:01Thank you, Chaim. Cash, cash equivalents and short term VIN deposits were approximately $1,400,000 as of September 30, 2023 compared to $3,000,000 as of December 31, 2022. In July 2023, The company raised net proceeds of approximately $7,000,000 in the registered direct offering. Research and development expenses for the 3 months Ended September 30, 2023, 2022 were approximately $3,300,000 $3,800,000 respectively. General and administrative expenses for the 3 months ended September 30, 2023, 2022 were approximately $2,700,000 and $3,100,000 respectively. Speaker 400:07:45Net loss for the 3 months ended September 30, 2023 was approximately $1,200,000 or $0.03 per share as compared to a net loss of approximately $6,900,000 or $0.19 per share for the 3 months ended September 30, 2022. I'll turn it back to Chaim. Speaker 200:08:03Thank you very much, Alaa. Michael Wood from LifeSci will now read some questions we have received from investors. Michael, are you there? Speaker 100:08:21Yes. Sorry, I was on mute. Yes. Thank you, Kai. Is it possible that Even with the AdCom decision around the FDA could grant limited approval for early stage ALS patients Where there has been an observable positive response. Speaker 500:08:38Stacy, you want to take this? Speaker 300:08:40Sure. We firmly believe that generating additional data in the form of the Phase 3b trial that we've been discussing is the only path forward That will gain regulatory approval of Neurone. We would have never withdrawn the BLA if we weren't convinced that we would not be successful with the current data alone. Therefore, it's in our best interest to move forward as quickly as we can to get the trial started. Speaker 100:09:08Thanks, Stacy. Next question, how long before you know more about your funding plans? And as a follow-up to that, when are you hoping to start the Phase 3b? And are you waiting for funding or grants to come in before you can commence the study? Speaker 200:09:24Thank you. We're working with banks who have been successful, including very recently raising funds for biotech companies like Brainstorm, And they are confident in our ability to raise the funds needed to run this trial. We'll first work to As we shared in our prepared remarks, we're exploring a variety of avenues, including partnerships and grants. Although there is always the chance of a larger infusion of funds, we expect to raise money for the trial in stages. We also do not intend to wait to start the trial until we have raised the full amount needed. Speaker 200:10:09We'll be thoughtful about starting the trial, but patients deserve more urgency than this. Speaker 100:10:17Thank you. Next question. Are you working on the new trial parameters with the FDA? Speaker 200:10:26Stacy? Speaker 300:10:28Yes, that's correct. As Chaim mentioned in the prepared remarks, we've requested an But I did face to face meeting very recently. And this meeting will allow us to discuss the next steps for Neuron, which will focus on the core design elements of the Phase trial that we've been working on with a scientific advisory panel and a panel of people from the ALS community, including those living with the disease. We intend to seek a special protocol assessment from the FDA, which as many of you will know is an opportunity to reach an agreement With the FDA before the study starts on the design of a clinical trial, and this trial, of course, is intended to serve as the primary basis We view this as beneficial and a valuable tool to accelerate the Phase The trial for Neurone and potentially derisk the regulatory aspects of the program. Speaker 100:11:28Thank you. And one final question. Why don't you partner with Big Pharma? Speaker 200:11:35Thank you. So we are seeking to partner. In fact, we're in contact with a few companies. Although ALS is a relatively rare disease, the commercial opportunity is still compelling and we know there is interest from companies who would like to have a successful product in this area and to be able to serve patients. You have to remember though that cell therapy is still an emerging modality, especially in neurodegeneration. Speaker 200:12:04There are very few approved cell therapy products And R and D products are largely focused on oncology and genetic disease. Presumably, a major approval in the cell therapy space We'll bring investments and until then some will remain cautious. As you may know, It took many years to develop CAR T cell therapy for various cancer treatments and innovation came from within smaller companies before developing partnerships. Just a few examples, Kite Pharma went alone until after approval and then was bought out by Gilead. Junopharma did the same and was also acquired after FDA approval by Celgene, while Bluebird wasn't acquired and remains independent today. Speaker 200:12:53We have a derisked Phase 3 asset, which will have an attractive upside for the right company. So we will pursue a partnership as a promising avenue. Neurone as a technology represents a strategic approach and therefore we would welcome a partnership, but until that comes we are willing to do all we can to proceed Jenny, would you like to open the call for any additional questions? Operator00:13:53Thank you. Your first question is coming from David Bautz of Zacks SmallCap Research. David, your line is live. Speaker 600:14:01Hey, good morning, everyone. Thanks for the update this morning. So Chaim or Stacy, I was wondering if you could talk a little bit more about the SPA. And basically, what differentiates that from saying just coming to an agreement with the FDA about a trial design? Speaker 200:14:23Tracey? Speaker 300:14:25Yes. David, I think that the SPA pathway and the opportunity to formally recognize and use a pathway that the FDA Offers really just gives the platform to come together and to align, but to have a formal agreement That's documented. And I think it's a constructive way to approach this and it's something that I think We'll be positive for BRAINSTORM, but also really ensure that the discussion and the work that we do ahead ultimately is It nets out with the successful trial really what we expect, which should be an approval. So it really is about a formal engagement And it's a pathway that's well established and leveraged. Speaker 600:15:15Okay. And as far as Go ahead. Sorry. Speaker 200:15:20I was just going to add on that. Of course, I just want to emphasize what FDA is discussing with us an expedited pathway for us path. So that's just additional answer to your question. What we're looking for expedited SPAs, you know that if those companies that are able to have a SPA with the FDA, There is a far higher chance from the pool at the end of the day. But many choose not to do that because usually it can take a year or 2 years just to get to an agreed upon SPA. Speaker 200:15:48This past we're talking about expedited SPA process and we're looking forward for that. Go on and David, another question please. Speaker 600:15:59Yes, actually I was going to key off of what you just said and basically kind of looking at the timeline. So would normally that process would be a year or 2, you're looking at less than a year probably then for an expedited spa? Speaker 200:16:12Well, I don't want to put any words into FDA It's Khotsam here. So I want to be very cautious, but I do see a first meeting very fast. And I think after that meeting, we'll be We'll share that by the way. We'll share what happened at the meetings with the investor community because this is our number one priority just now To see if we can come to an agreed upon spot. And we'll learn from this meeting that, that should be very soon and we'll be announcing when that meeting is. Speaker 600:16:42Okay. Now I understand you probably won't be able to get into specifics, but do you foresee The primary outcome for the next Phase 3 trial being the same as it was for the previous one? Speaker 200:16:58We're going to have to have a discussion with the agency at that meeting. So let's keep it for that. We will share once those meetings are done, we come to an agreement. We'll share what the trial design looks like. Speaker 600:17:11Okay. All right. Thanks for taking the questions. Sure. Operator00:17:16Thank you very much. Your next question is coming from William Barr from Tivam Adventures. William, your line is live. Speaker 500:17:26Thank you. Thank you, Chaim, and thank you, Stacy, and thanks to everyone at Brainstorm. We've been following and we've been investors in the company for many years. So My question is, why is this time going to be different? There's like those of us who know you guys have been fighting, how hard you've been working and all of us Many of us are really so beyond grateful for everything that you've done and continue to do for ALS patients. Speaker 500:17:52We're finally starting to see That the AMALYX treatment is maybe not what some people thought it was. And we're finally starting to see that some ALS chapters are Maybe recognizing the issues at Alsa and their start is to break away. And we all saw what happened at the AdCom and many of us believe that it was Extraordinarily unfair. A lot of investors want Brainstorm to sue the FDA. And instead, you guys are basically embracing the FDA. Speaker 500:18:21And we know you want a treatment for ALS as quickly as possible. And we know that you guys have really done everything in your power to try to effectuate that. So Why is this time going to be different? Speaker 200:18:33Thank you. It's a very good question. So first, allow me, I can't I don't want to comment on other treatment For the organizations, we are looking to have everyone supporting us, all the organizations and all the advocates, and we're going to work on that as well. We're going to reach out once we have a trial design and share it with them, listen to their inputs going forward. What I think will be different, as you have heard in our opening statements, we're trying to come to an agreement with the spine and I want to share with you it is Proposed by the FDA to do that, to have an expedited path. Speaker 200:19:07So again, we should see how they will treat a difference going forward. We should acknowledge that even though some see the outcome as being overly negative To Neuron, but what we are being explained and I want to be cautious what I'm saying that many don't disagree with what we are saying. They just To provide that data and therefore that discussion together with them is very important to see what are they thinking in addition to what we provided. So we should align on what should be provided, what should be sufficient for an approval. That's what Asta means. Speaker 200:19:55So going into that meeting, I think we are going to get an expedited meeting. We are getting the indication from the agency That they want to have this meeting very fast. So they're showing interest and supporting us being able to have another trial very soon, To start another driver issue, I'll ask Stacy also to comment. Stacy? Speaker 300:20:18Yes. William, thank you for the Comment and your question. And I think when we step back and we look at what we have before us, Certainly, when we brought forward our product, we believe and we still believe in our data and we believe that there was a discussion That should happen around the efficacy and safety and the appropriateness given regulatory flexibility. But at the end of the day, when we look forward, one of the strongest positions and the things that we can do is we can execute on a trial design, Leveraging the learnings that have occurred and we can read out a trial that meets its endpoints. And so what you see us doing It's really doubling down. Speaker 300:21:07We understand our product. We have a lot of information that we believe gives us a lot Confidence in our ability to deliver this trial. And so what we're focused on is bringing forward a product that's straightforward in this next trial That makes the regulatory process certainly more conventional And the next time around certainly much more streamlined and smooth. Speaker 400:21:38So that's what I think of Speaker 300:21:40when I think about what's different. Next time and drug development is incredibly Complicated. We always learn things in our endeavors when we're tackling very tough diseases. And I think In the setting of this last Phase 3 program, certainly there were things that the community did not appreciate and did not understand and We now have those as learnings that we take forward to this next trial design. Speaker 500:22:11Thank you very much. For those of us that have ALS patients in our lives, have lost family and friends, I just wanted to say thank you to both of you and Thank you for fighting a good fight for us. Speaker 200:22:26Noah, thank you for your ongoing support many years. Really appreciate that. Operator00:22:33Thank you very much. Speaker 200:22:34Next question please, James. Operator00:22:36Your next question is Speaker 200:22:38We have time for one more. Yes, Operator00:22:39Daniel Walker is a Private Investor. Daniel, your line is live. Apologies there. Speaker 700:22:49Comment on manufacturing. You mentioned at the recent Brainstorm Town Hall meeting That Brainstorm has successfully manufactured 500 potent products. I think there have been some questions about Brainstorm's ability to manufacture. Can you just comment on that? And then also moving forward, How will the clean rooms be managed? Speaker 700:23:13Will it be Catalent? Will it be the academic centers? Maybe you could just comment a little bit on that. Speaker 200:23:21Thank you very much, Daniel, for this question. So we did I have quite a few centers where we already produced, as you know, for the Phase II and Phase III trials at different academic centers and the commercial centers only for the EAP. Going forward, it's first a financial question. The academic centers are cheaper than the commercial centers to operate. And on the other hand, you do want to have a site that once you're successful with the trial, you should have a commercial site ready. Speaker 200:23:53We're going to balance that timing wise to see maybe we'll start with academic and then for the second part of the trial do a commercial side, So we can gain from the cheaper cost earlier and then but simultaneously be able to have a commercial site ready once the trial is done. Does that answer your question? Speaker 700:24:13That does. And I guess with the SPA, I mean, how do you ensure that this go around because the FDA was quite critical of the manufacturing At the outcome, how do you ensure moving forward though that there is alignment not only on the SPA, but also in addition to the manufacturing so that at Time you resubmit the BLA, they feel confident in the manufacturing because obviously there's a difference between Manufacturing at the trial level compared to actually at the time of commercialization. Speaker 200:24:47Thank you. That's very helpful. You clarified the question even more. So the answer is FDA agreed to have discussions with us While we do the trial on the CMC issues to come to alignment. And as I've said previously, we have come to alignment on many of the CMC issues, if not most. Speaker 200:25:03With some of them, it takes longer to do those qualification tests, which we are continuing to do, those that are critical. But yes, FDA will have with us separate conversations With the CNC team and separately from the clinical team. Speaker 700:25:19Excellent. Thank you so much. And then just lastly, I was wondering if could just expand on the exosome technology, I know you're working on capitalizing that. Can you or Stacy just comment very briefly on what is that technology and Why that might be interesting and compelling to pharma or biotech? Speaker 200:25:39Yes, you mentioned Stacy, but I'll ask Stacy to talk to that of course and if I need to allow that. Stacy? Speaker 300:25:47Sure. Daniel, this is an additional technology that we have been developing and certainly have thought of As an interesting and exciting part of our portfolio and what's interesting about exosomes is, of course, that It allows us to move into and explore different diseases that can carry cargo and can penetrate different parts Of human bodies and therefore brings different advantages. But we've done a number of preclinical Some of which we published, and we think there's a lot of excitement in this technology platform, which again offers a wide array of diseases that there's a great unmet need and that these nanoscale particles really would be able to open Possible administration options that would be very effective for treatment. Speaker 700:26:54Excellent. Thank you both so much. I really appreciate it. Thank you. Operator00:27:00Thank you very much. That appears to be the end of our question and answer session. I will now hand back over to Haim for closing comments. Speaker 200:27:09Thank you very much and have Speaker 100:27:11a wonderful day. Thank you.Read morePowered by