NASDAQ:BCLI Brainstorm Cell Therapeutics Q2 2024 Earnings Report $0.98 +0.06 (+5.98%) Closing price 04:00 PM EasternExtended Trading$0.99 +0.02 (+1.54%) As of 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-$0.60Consensus EPS -$0.60Beat/MissMet ExpectationsOne Year Ago EPS-$4.05Brainstorm Cell Therapeutics Revenue ResultsActual RevenueN/AExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/ABrainstorm Cell Therapeutics Announcement DetailsQuarterQ2 2024Date8/14/2024TimeBefore Market OpensConference Call DateWednesday, August 14, 2024Conference 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 Q2 2024 Earnings Call TranscriptProvided by QuartrAugust 14, 2024 ShareLink copied to clipboard.There are 8 speakers on the call. Operator00:00:00Greetings, and welcome to the Brainstorm Cell Therapeutics Second Quarter 2024 Conference Call. At this time, participants are in a listen only mode. Operator00:00:11As a reminder, this call is being recorded. And I would now like to introduce your host for today's call, Michael Wood of LifeSci Advisors. Mr. Wood, you may begin. Speaker 100:00:23Good morning, everyone, and thank you for joining us today. Before passing it off to company management for prepared remarks, I would like to remind listeners that this conference call contains numerous statements, descriptions, forecasts and projections regarding Brainstorm Cell Therapeutics and its potential future business operations and performance statements regarding the market potential for the treatment of neurodegenerative disorders such as ALS the sufficiency of the company's existing capital resources for continuing operations in 2024 and beyond, the safety and clinical effectiveness of the Neuron Technology Platform, clinical trials of Neuron and related clinical development programs and the company's ability to develop strategic collaborations and partnerships to support its business planning efforts. Forward looking statements are subject to numerous risks and uncertainties, and many of these 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 this morning will be Chaim Levowitz, President and CEO of Brainstorm and Alain Patlitz, Interim Chief Financial Officer. Speaker 100:01:42In addition, Doctor. Harounian, Chief Operating Officer and Doctor. Bob Daugher, Chief Medical Officer are also on the line and will be available to answer questions during the Q and A session. Speaker 200:01:53So I'd now like to Speaker 100:01:54turn the call over to Mr. Leibowitz. Please go ahead. Speaker 300:02:00Hi. Thank you, Mike. Good morning and afternoon to everyone. Thank you for joining us today. We appreciate your continued interest and support in BRAINSTORM. Speaker 300:02:14We're making substantial progress in our preparations for the Phase 3b trial for Neuron in ALS. Importantly, Neuron is now a derisked asset having secured a written SPA agreement from the FDA. This significant milestone, which we announced earlier in the year, underscores the agency's recognition of the unmet need that exists in ALS. The FDA continues to be supportive and we are grateful for their input and advice. In addition to the SBA, during the Q2, we reached alignment with the FDA on CMC aspects of the Phase 3 trial. Speaker 300:02:58In June, we participated in a very constructive Phase to Phase Type C meeting and have now resolved previously outstanding CMC questions. Cell therapy products have certain additional complexities in the manufacturing process. Therefore, it's important that the FDA is involved at various steps during the regulatory process, including prior to initiating a pivotal trial. Our collaboration with the CRO has been instrumental in advancing key trial protocols. We have selected a leading CRO and are diligently building a network of over 12 leading clinical centers across diverse geographic regions to ensure broad patient access and representation. Speaker 300:03:53The manufacturing processes are well advanced and I believe on track to meet production timelines. We remain committed to initiating the trial by the end of 2024 or the Q1 of 2025. To bolster our financial position, we are actively pursuing non diluted funding, including a promising grant application with the potential to secure up to $15,000,000 ALS is a devastating disease with limited treatment options. The potential impact of a successful Phase IIIb trial cannot be overstated. It could represent a significant breakthrough for patients and their families. Speaker 300:04:40We are committed to transparent communication and providing regular updates about our progress. We are grateful for the support and collaboration of the entire ALS community as we continue this important work. I want to address the items in our proxy statement and the upcoming shareholder meeting. NASDAQ has notified us that we must maintain a $1 share price for 10 consecutive trading days by October 28 for a risk delisting. Additionally, we need to achieve a $35,000,000 market cap. Speaker 300:05:17To address these challenges and provide the company with maximum flexibility, with scheduled and earlier than usual annual shareholders meeting. A key item on the agenda is seeking shareholder approval to authorize the Board of Directors to affect the reverse tax split if deemed necessary to maintain our NASDAQ listing. It's important to understand that approving this proposal does not automatically trigger a risk split. It simply grants the Board the discretion to implement if it becomes necessary to comply with NatWest listing requirements. While we'll exhaust all possibilities to avoid a reverse split, including driving up the share price with good news, we believe it's essential to have this option available to protect shareholder value and maintain our NASDAQ listing. Speaker 300:06:15The Board will carefully consider all options including a potential reverse split or transition to the OTCQB. If we opt for the OTCQB, we'll work diligently to regain NASDAQ compliance without resorting to a reverse split. Our ultimate goal is to maximize shareholder value. We are confident in our ability to navigate these challenges and deliver value to shareholders. Your support in approving the proxy is crucial to ensuring we have the flexibility to make the best decisions for the company. Speaker 300:06:52Thank you for your continued support. Ella? Speaker 400:06:58Thank you, Raim. Cash, cash equivalents and restricted cash were approximately 3,650,000 dollars as of June 30, 2024, compared to $750,000 as of June 30, 2023. Research and development expenses for the 3 months ended June 30, 2024, 2023 were approximately 900,000 dollars and $2,800,000 respectively. General and administrative expenses for the 3 months ended June 30, 2024, 2023 were approximately $2,000,000 $2,700,000 respectively. Net loss for the 3 months ended June 30, 2024 was approximately $2,500,000 as compared to a net loss of approximately $5,300,000 for the 3 months ended June 30, 2023. Speaker 400:07:51Net loss per share for the 3 months at the June 30, 20242023 was $0.04 and $0.13 respectively. I'll turn it back to Chaim to close the call. Speaker 300:08:07Thank you so much, Alaa. We'll now open the call for the written questions. Please, Mike, can you please go forward with the written questions? Speaker 100:08:19Yes. First question, can you please elaborate on the key milestones that investors should be looking forward to in the near term? Speaker 300:08:31Thank you, Mike. Absolutely, we're very enthusiastic about the potential catalysts that should drive significant shareholders value. In the near term, we are focused on several key milestones. Firstly, securing the first few trial site agreements is a crucial step. This demonstrates our ability to execute on the clinical trial timeline efficiently. Speaker 300:09:00Secondly, we're actively pursuing additional non diluted funding through grants and strategic partnerships. Successful acquisition of these funds will significantly strengthen our financial position and accelerate our development timeline. And of course, trial initiation and enrolling the first patient in the story are major milestones that will mark significant progress. We believe we can successfully execute on these milestones and deliver substantial value for our shareholders. Speaker 100:09:36Thank you. Next question. With the proposed increase in the authorized shares from $100,000,000 to $250,000,000 there's a possibility that existing shareholders would be significantly diluted. What is your plan for equity raises over the next several quarters? Speaker 300:09:55Thank you for this question. Very good so we can clarify this. Of course, we understand the concern regarding potential dilution. What's important to emphasize that an increase in authorized shares does not equate to immediate dilution. This action only provides us with the flexibility to pursue strategic opportunities without resorting to diluted financing. Speaker 300:10:20Our primary focus is non diluted funding sources, such as grants and other strategic collaborations. We have a successful track record of securing non diluted funding, demonstrating our ability to execute on the strategy. BCLI has a 15 year history of efficient capital management, issuing less than 100,000,000 shares while raising close to $200,000,000 This demonstrates our commitment to maximizing shareholder value. The proposed increase in authorized shares is a strategic long term decision to ensure we have the flexibility to capitalize on future growth opportunities without unnecessary dilution. We will continue to explore all avenues to optimize capital allocation and minimize dilution. Speaker 100:11:12Thanks, Tayne. And a related question, what non equity funding sources currently have a good probability of transacting before initiation of the Phase 3b trial? Can you speak to grants partnerships or the potential outsourcing of intellectual property? Speaker 300:11:30Thank you. So we're actively pursuing multiple non equity funding revenues. Our previous grant award from CIRM, the California Institute For Regenerative Medicine was a good example of our efforts. It was a $16,000,000 non dilutive grant that supported our Phase 3 trial. We're also exploring partnerships with pharmaceutical companies and other industry stakeholders. Speaker 300:11:54These collaborations can provide both financial support and strategic advantages. Outsourcing of intellectual property is not currently on the table. We believe that maintaining control over our core technology is essential for long term success. However, we're open to strategic partnerships that involve technology sharing or licensing on a mutually beneficial terms. Thanks. Speaker 100:12:21The next question regarding the planned clinical trial. Is there a take the peak provision that would allow interim analysis of early signs of efficacy or reported? Speaker 300:12:34So, thank you. So an independent data safety monitoring board is being established for the Phase 3b trial design. The Board members and their charter are currently under finalization. But the DSMP will be responsible for periodic safety evaluations to monitor patients' safety and well-being. Thank you. Speaker 100:12:57Next question. Is the ALS, IFRS or at enrollment higher than in the prior Phase 3 study? Speaker 300:13:06Thanks. Bob, you want to take that question, please? Yes. Thanks, Haim. Speaker 500:13:15Based on properly conducted simulation, the total score of the ALSFRS is expected to be higher than in the previous trial. And we're looking forward to executing the trial based on those assumptions. Thank you. Speaker 100:13:36And also on the trial, will there be more trial sites than in the prior Phase 3, thus allowing the trial slots to be filled more quickly? Speaker 300:13:45Thank you. That's for Bob too. Speaker 500:13:49Yes, thanks. I'll take that question as well. Yes, we are planning to add a higher number of sites for the Phase IIIb trial than it was conducted in Phase III for the same roughly number of patients, about 200 patients in the trial. We expect that this will increase the rate of enrollment and will also speed the timelines of the trial. Thank you. Speaker 100:14:17And has a commercial manufacturing partner being locked down at this point? Speaker 300:14:24Harold, please take that one. Thank you, Caim for the question. We're planning for multiple manufacturing sites for this trial and simultaneously are engaged in advanced discussions with highly qualified potential commercial manufacturing partners. While we cannot disclose specific detail until a contract is signed, we are confident in our ability to secure a suitable partner in a timely manner to support the commercial launch of our product if and when approved. Thank you. Speaker 300:15:04Is Speaker 100:15:04the Phase 3b inclusion criteria more stringent than the prior Phase 3 study, thus ensuring a healthier pool of patients or trial participants? Speaker 300:15:18Thank you. Bob, you want to take that? Speaker 500:15:23Yes, sure. Thanks for the question as well. Yes, we designed the Phase the inclusion criteria for the Phase IIIb trial being informed by the Phase III, but they are more refined to focus on patients that are earlier in the disease than they are in the course of their disease. The goal is to enroll patients with a higher likelihood of showing benefits from our treatment, which we believe will be also strengthened by having an overall robust data. Thank you. Speaker 300:16:00Thank you very much. I think that concludes the written questions we received. Ali, would you open the call for any additional questions from any investors on the line? Operator00:16:13Thank you, sir. Ladies and gentlemen, the floor is now open for questions. Thank you. Our first question is coming from Jason McCarthy with Maxim Group. Your line is live. Speaker 200:16:44Hi. This is Joanne Lee on Speaker 600:16:45the call for Jason McCarthy. Just regarding the CMC alignment, does the company need to implement any new actions or adjustments on the CMC front to reach the alignment with the FDA? Speaker 300:17:05Thank you very much. We did. We reached alignment to be able to initialize the trial That was very important. Thank you for that clarifying question. Speaker 600:17:15Got it. And just regarding the upcoming study, could you briefly remind us of the changes made to the ALSFRS entry criteria? And how these adjustments may impact the upcoming Phase 3b? And just as a follow-up, if you could provide a mechanistic rationale for why an effect might be more easily identifiable under the new ALSFRS criteria? Speaker 300:17:38Thank you. Bob, you want to take this question? Speaker 500:17:43Sure. I'm happy to do that. Thank you for your question. So basically, there are a number of differences from the previous trial. We the main criteria regarding to the ALSFRF is number 1, to make sure that every item the score is made out of 12 items. Speaker 500:18:01Every item on the score is scored at a 2, 3 or 4. Recall, each item can be scored from 0 to 4, 0 being the worst. So we are not allowing any 0 or any one answer on each one of the 12 items. That's number 1. Number 2, we are also not allowing the LS total score to be either 45 sorry, not 45, 46 or 47 or 48. Speaker 500:18:3448 is the maximum, but once you start your first symptom, you drop from 48 typically to 47 or lower. The reason for that is we didn't want an allowance of a 2 years since first symptom for someone 2 years later to remain without really showing signs of progression by more than 1 or 2 points. So the score allows people to enter the trial at 45 or less. Number 3, we are looking basically at associated entry criteria, such as the typical 2 years from symptom onset, looking very carefully at first symptom with a documented evidence of that and making sure that we get patients quickly after they get diagnosed with ALS. And we're also looking to get their respiratory function to be relatively paired with looking at low vital capacity to be about 65%, which is in the healthy side. Speaker 500:19:35Combining all of those together and simulating those entry criteria I mentioned on large databases, one of them is the ProAct database, we got a score, a total score that puts us at a confidence higher than what was conducted in the previous Phase 3 and in line with the modern ALS clinical trials that were conducted in recent years. So we have high confidence with these criteria together to get the population of target for that will benefit more from Neuron, which is the population that earlier in the disease. I hope this answers your question. Speaker 300:20:15Thank you so much, Bob. Thank you for the questions. Speaker 600:20:19Yes. That was very helpful. Thanks again. Looking forward to further updates on the launch of the study. Thank you. Speaker 300:20:25Thank you so much for being on the call today. Thank you. Operator00:20:30Thank you. Our next question is coming from David Boats with Zacks Small Cap Research. Your line is live. Speaker 700:20:38Hey, good morning, everybody. So in regards to the upcoming Phase III trial, it looks like it's going to have a 24 week double blind period and a 24 week open label extension. So in regards to potentially filing the BLA, assuming positive results from the double blind portion, Could the BLA be filed essentially immediately after that or will the data from the open label extension be required for the BLA? Speaker 300:21:07No, we would be able to file the BLA after the first half of the double blinded period. Thank you for that question. Speaker 700:21:15Okay. And I was wondering if you could comment just on the general sense of how patient advocacy groups, maybe even patients or physicians also, their enthusiasm still for Neurone and you've already commented about potentially seeking a non dilutive funding, but I was going to ask about whether the patient advocacy groups would also potentially have any type of grants or funding available for the Phase 3 trial? Speaker 300:21:49Thank you very much for that question. We are working diligently with many patient advocacy groups and I can tell you that we're seeing even more excitement than the previous trial. Hopefully, we'll see that publicly and also in ways of grants. But I can tell you across the board, patient advocacy are very supportive of this Phase 3b trial. As you know, some of them felt that we didn't have sufficient data in the Phase 3, but they're very supportive of the Phase 3b trial. Speaker 300:22:16They won't have an answer on neuron, a clear answer and they think that the patient population that we are now focusing on, as Bob described again and again, is the patient population that has the best chance to show efficacy. So we're getting a lot of support and I think we are getting far stronger support from different groups that wasn't there in the past. Speaker 700:22:40All right. Well, that's great to hear and thanks for taking the questions. Speaker 300:22:45Yes. Okay. Operator, we have time for one more question, please. Operator00:22:50Understood, sir. We have a question from Nicholson, who is a private investor. Your line is live. Speaker 200:22:58Hi. Good morning, everybody. I'm not a private investor. I'm a research analyst at ACF Equity Research. I wondered if you are in a position to give any color on the cost of the trial at this point either on a per head basis or overall? Speaker 200:23:16And as a follow-up, are you able to give us any further color on the likely costs of production of each course of treatment at this time? Speaker 300:23:31Thank you so much for these questions. So the answer is that we are still not in a position and we will share of course in the near future more exact costs for the trial. The reason for that is that the main cost of the trial, the manufacturing costs and we're still in the phase of finalizing contracts with different manufacturing centers from different geographies that will be different prices and it's not just a small difference. So therefore, we're not able to the previous trial cost us about $50,000,000 and with 200 patients only for 6 months and this time it's for 7 months, sorry, and this time it's for a longer period. But we will provide numbers in a later stage and definitely not able to give you a reduction also versus a manual process and maybe we'll be able to implement automatic process, which significantly would change prices for the product costs. Speaker 300:24:32We are really focused to try to bring down the product costs. So while we are doing this huge undertaking of initiating this trial, we're still at the same time working very hard with R and D to get our processes cheaper as well. It's very important in gene and cell therapy and we're very focused on that. But thank you very much for these questions. Speaker 200:24:54Thank you. If I could just follow-up slightly on that one. Is it your experience that the current technological innovations that are going on in manufacturing and therapy development, do they play well into your space? Is it the expectation that you could see costs reducing? Or is it somewhat the other way around because you're very innovative? Speaker 300:25:20Thank you very much for that question. So if we can get a validated automated product, definitely will be dramatically decreased. But even in the manual product, we are having many good developments to get the price cheaper. I think even in this trial, we may have a dramatic cheaper price per product than previously, hopefully, and if you look on the whole thing. So but we are still wearing out those exactly you're touching on things that we're working on now very hard. Speaker 300:25:52And hopefully, in the next quarters, you will see different updates on this. Speaker 200:25:57Thank you very much indeed. Speaker 300:26:00Thank you very much. So I want to thank again everyone for being on the call today. We are finishing just on time for the 9 a. M. We wanted to finish this call. Speaker 300:26:09Thank you very, very much for everyone joining us and thank you all for your continued support and we're looking in the next quarter to have additional exciting updates in line to what we discussed today. We hope everything will fall in place and we'll be in a better place when we speak in the next quarter, hopefully even after initiating a trial. Thank you very, very much. Operator00:26:32Thank you, ladies and gentlemen. This does conclude today's conference call. You may disconnect your lines at this time and have a wonderful day. And we thank you for your participation.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallBrainstorm Cell Therapeutics Q2 202400:00 / 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.comCrypto’s crashing…but we’re still profitingMost traders are panicking right now. Bitcoin’s dropping. Altcoins are bleeding. The stock market’s a mess. The news is screaming fear. But while most traders watch their portfolios tank…April 25, 2025 | Crypto Swap Profits (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)Booking (4/29/2025)DoorDash (4/29/2025)Honeywell International (4/29/2025)Mondelez International (4/29/2025)PayPal (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 Second Quarter 2024 Conference Call. At this time, participants are in a listen only mode. Operator00:00:11As a reminder, this call is being recorded. And I would now like to introduce your host for today's call, Michael Wood of LifeSci Advisors. Mr. Wood, you may begin. Speaker 100:00:23Good morning, everyone, and thank you for joining us today. Before passing it off to company management for prepared remarks, I would like to remind listeners that this conference call contains numerous statements, descriptions, forecasts and projections regarding Brainstorm Cell Therapeutics and its potential future business operations and performance statements regarding the market potential for the treatment of neurodegenerative disorders such as ALS the sufficiency of the company's existing capital resources for continuing operations in 2024 and beyond, the safety and clinical effectiveness of the Neuron Technology Platform, clinical trials of Neuron and related clinical development programs and the company's ability to develop strategic collaborations and partnerships to support its business planning efforts. Forward looking statements are subject to numerous risks and uncertainties, and many of these 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 this morning will be Chaim Levowitz, President and CEO of Brainstorm and Alain Patlitz, Interim Chief Financial Officer. Speaker 100:01:42In addition, Doctor. Harounian, Chief Operating Officer and Doctor. Bob Daugher, Chief Medical Officer are also on the line and will be available to answer questions during the Q and A session. Speaker 200:01:53So I'd now like to Speaker 100:01:54turn the call over to Mr. Leibowitz. Please go ahead. Speaker 300:02:00Hi. Thank you, Mike. Good morning and afternoon to everyone. Thank you for joining us today. We appreciate your continued interest and support in BRAINSTORM. Speaker 300:02:14We're making substantial progress in our preparations for the Phase 3b trial for Neuron in ALS. Importantly, Neuron is now a derisked asset having secured a written SPA agreement from the FDA. This significant milestone, which we announced earlier in the year, underscores the agency's recognition of the unmet need that exists in ALS. The FDA continues to be supportive and we are grateful for their input and advice. In addition to the SBA, during the Q2, we reached alignment with the FDA on CMC aspects of the Phase 3 trial. Speaker 300:02:58In June, we participated in a very constructive Phase to Phase Type C meeting and have now resolved previously outstanding CMC questions. Cell therapy products have certain additional complexities in the manufacturing process. Therefore, it's important that the FDA is involved at various steps during the regulatory process, including prior to initiating a pivotal trial. Our collaboration with the CRO has been instrumental in advancing key trial protocols. We have selected a leading CRO and are diligently building a network of over 12 leading clinical centers across diverse geographic regions to ensure broad patient access and representation. Speaker 300:03:53The manufacturing processes are well advanced and I believe on track to meet production timelines. We remain committed to initiating the trial by the end of 2024 or the Q1 of 2025. To bolster our financial position, we are actively pursuing non diluted funding, including a promising grant application with the potential to secure up to $15,000,000 ALS is a devastating disease with limited treatment options. The potential impact of a successful Phase IIIb trial cannot be overstated. It could represent a significant breakthrough for patients and their families. Speaker 300:04:40We are committed to transparent communication and providing regular updates about our progress. We are grateful for the support and collaboration of the entire ALS community as we continue this important work. I want to address the items in our proxy statement and the upcoming shareholder meeting. NASDAQ has notified us that we must maintain a $1 share price for 10 consecutive trading days by October 28 for a risk delisting. Additionally, we need to achieve a $35,000,000 market cap. Speaker 300:05:17To address these challenges and provide the company with maximum flexibility, with scheduled and earlier than usual annual shareholders meeting. A key item on the agenda is seeking shareholder approval to authorize the Board of Directors to affect the reverse tax split if deemed necessary to maintain our NASDAQ listing. It's important to understand that approving this proposal does not automatically trigger a risk split. It simply grants the Board the discretion to implement if it becomes necessary to comply with NatWest listing requirements. While we'll exhaust all possibilities to avoid a reverse split, including driving up the share price with good news, we believe it's essential to have this option available to protect shareholder value and maintain our NASDAQ listing. Speaker 300:06:15The Board will carefully consider all options including a potential reverse split or transition to the OTCQB. If we opt for the OTCQB, we'll work diligently to regain NASDAQ compliance without resorting to a reverse split. Our ultimate goal is to maximize shareholder value. We are confident in our ability to navigate these challenges and deliver value to shareholders. Your support in approving the proxy is crucial to ensuring we have the flexibility to make the best decisions for the company. Speaker 300:06:52Thank you for your continued support. Ella? Speaker 400:06:58Thank you, Raim. Cash, cash equivalents and restricted cash were approximately 3,650,000 dollars as of June 30, 2024, compared to $750,000 as of June 30, 2023. Research and development expenses for the 3 months ended June 30, 2024, 2023 were approximately 900,000 dollars and $2,800,000 respectively. General and administrative expenses for the 3 months ended June 30, 2024, 2023 were approximately $2,000,000 $2,700,000 respectively. Net loss for the 3 months ended June 30, 2024 was approximately $2,500,000 as compared to a net loss of approximately $5,300,000 for the 3 months ended June 30, 2023. Speaker 400:07:51Net loss per share for the 3 months at the June 30, 20242023 was $0.04 and $0.13 respectively. I'll turn it back to Chaim to close the call. Speaker 300:08:07Thank you so much, Alaa. We'll now open the call for the written questions. Please, Mike, can you please go forward with the written questions? Speaker 100:08:19Yes. First question, can you please elaborate on the key milestones that investors should be looking forward to in the near term? Speaker 300:08:31Thank you, Mike. Absolutely, we're very enthusiastic about the potential catalysts that should drive significant shareholders value. In the near term, we are focused on several key milestones. Firstly, securing the first few trial site agreements is a crucial step. This demonstrates our ability to execute on the clinical trial timeline efficiently. Speaker 300:09:00Secondly, we're actively pursuing additional non diluted funding through grants and strategic partnerships. Successful acquisition of these funds will significantly strengthen our financial position and accelerate our development timeline. And of course, trial initiation and enrolling the first patient in the story are major milestones that will mark significant progress. We believe we can successfully execute on these milestones and deliver substantial value for our shareholders. Speaker 100:09:36Thank you. Next question. With the proposed increase in the authorized shares from $100,000,000 to $250,000,000 there's a possibility that existing shareholders would be significantly diluted. What is your plan for equity raises over the next several quarters? Speaker 300:09:55Thank you for this question. Very good so we can clarify this. Of course, we understand the concern regarding potential dilution. What's important to emphasize that an increase in authorized shares does not equate to immediate dilution. This action only provides us with the flexibility to pursue strategic opportunities without resorting to diluted financing. Speaker 300:10:20Our primary focus is non diluted funding sources, such as grants and other strategic collaborations. We have a successful track record of securing non diluted funding, demonstrating our ability to execute on the strategy. BCLI has a 15 year history of efficient capital management, issuing less than 100,000,000 shares while raising close to $200,000,000 This demonstrates our commitment to maximizing shareholder value. The proposed increase in authorized shares is a strategic long term decision to ensure we have the flexibility to capitalize on future growth opportunities without unnecessary dilution. We will continue to explore all avenues to optimize capital allocation and minimize dilution. Speaker 100:11:12Thanks, Tayne. And a related question, what non equity funding sources currently have a good probability of transacting before initiation of the Phase 3b trial? Can you speak to grants partnerships or the potential outsourcing of intellectual property? Speaker 300:11:30Thank you. So we're actively pursuing multiple non equity funding revenues. Our previous grant award from CIRM, the California Institute For Regenerative Medicine was a good example of our efforts. It was a $16,000,000 non dilutive grant that supported our Phase 3 trial. We're also exploring partnerships with pharmaceutical companies and other industry stakeholders. Speaker 300:11:54These collaborations can provide both financial support and strategic advantages. Outsourcing of intellectual property is not currently on the table. We believe that maintaining control over our core technology is essential for long term success. However, we're open to strategic partnerships that involve technology sharing or licensing on a mutually beneficial terms. Thanks. Speaker 100:12:21The next question regarding the planned clinical trial. Is there a take the peak provision that would allow interim analysis of early signs of efficacy or reported? Speaker 300:12:34So, thank you. So an independent data safety monitoring board is being established for the Phase 3b trial design. The Board members and their charter are currently under finalization. But the DSMP will be responsible for periodic safety evaluations to monitor patients' safety and well-being. Thank you. Speaker 100:12:57Next question. Is the ALS, IFRS or at enrollment higher than in the prior Phase 3 study? Speaker 300:13:06Thanks. Bob, you want to take that question, please? Yes. Thanks, Haim. Speaker 500:13:15Based on properly conducted simulation, the total score of the ALSFRS is expected to be higher than in the previous trial. And we're looking forward to executing the trial based on those assumptions. Thank you. Speaker 100:13:36And also on the trial, will there be more trial sites than in the prior Phase 3, thus allowing the trial slots to be filled more quickly? Speaker 300:13:45Thank you. That's for Bob too. Speaker 500:13:49Yes, thanks. I'll take that question as well. Yes, we are planning to add a higher number of sites for the Phase IIIb trial than it was conducted in Phase III for the same roughly number of patients, about 200 patients in the trial. We expect that this will increase the rate of enrollment and will also speed the timelines of the trial. Thank you. Speaker 100:14:17And has a commercial manufacturing partner being locked down at this point? Speaker 300:14:24Harold, please take that one. Thank you, Caim for the question. We're planning for multiple manufacturing sites for this trial and simultaneously are engaged in advanced discussions with highly qualified potential commercial manufacturing partners. While we cannot disclose specific detail until a contract is signed, we are confident in our ability to secure a suitable partner in a timely manner to support the commercial launch of our product if and when approved. Thank you. Speaker 300:15:04Is Speaker 100:15:04the Phase 3b inclusion criteria more stringent than the prior Phase 3 study, thus ensuring a healthier pool of patients or trial participants? Speaker 300:15:18Thank you. Bob, you want to take that? Speaker 500:15:23Yes, sure. Thanks for the question as well. Yes, we designed the Phase the inclusion criteria for the Phase IIIb trial being informed by the Phase III, but they are more refined to focus on patients that are earlier in the disease than they are in the course of their disease. The goal is to enroll patients with a higher likelihood of showing benefits from our treatment, which we believe will be also strengthened by having an overall robust data. Thank you. Speaker 300:16:00Thank you very much. I think that concludes the written questions we received. Ali, would you open the call for any additional questions from any investors on the line? Operator00:16:13Thank you, sir. Ladies and gentlemen, the floor is now open for questions. Thank you. Our first question is coming from Jason McCarthy with Maxim Group. Your line is live. Speaker 200:16:44Hi. This is Joanne Lee on Speaker 600:16:45the call for Jason McCarthy. Just regarding the CMC alignment, does the company need to implement any new actions or adjustments on the CMC front to reach the alignment with the FDA? Speaker 300:17:05Thank you very much. We did. We reached alignment to be able to initialize the trial That was very important. Thank you for that clarifying question. Speaker 600:17:15Got it. And just regarding the upcoming study, could you briefly remind us of the changes made to the ALSFRS entry criteria? And how these adjustments may impact the upcoming Phase 3b? And just as a follow-up, if you could provide a mechanistic rationale for why an effect might be more easily identifiable under the new ALSFRS criteria? Speaker 300:17:38Thank you. Bob, you want to take this question? Speaker 500:17:43Sure. I'm happy to do that. Thank you for your question. So basically, there are a number of differences from the previous trial. We the main criteria regarding to the ALSFRF is number 1, to make sure that every item the score is made out of 12 items. Speaker 500:18:01Every item on the score is scored at a 2, 3 or 4. Recall, each item can be scored from 0 to 4, 0 being the worst. So we are not allowing any 0 or any one answer on each one of the 12 items. That's number 1. Number 2, we are also not allowing the LS total score to be either 45 sorry, not 45, 46 or 47 or 48. Speaker 500:18:3448 is the maximum, but once you start your first symptom, you drop from 48 typically to 47 or lower. The reason for that is we didn't want an allowance of a 2 years since first symptom for someone 2 years later to remain without really showing signs of progression by more than 1 or 2 points. So the score allows people to enter the trial at 45 or less. Number 3, we are looking basically at associated entry criteria, such as the typical 2 years from symptom onset, looking very carefully at first symptom with a documented evidence of that and making sure that we get patients quickly after they get diagnosed with ALS. And we're also looking to get their respiratory function to be relatively paired with looking at low vital capacity to be about 65%, which is in the healthy side. Speaker 500:19:35Combining all of those together and simulating those entry criteria I mentioned on large databases, one of them is the ProAct database, we got a score, a total score that puts us at a confidence higher than what was conducted in the previous Phase 3 and in line with the modern ALS clinical trials that were conducted in recent years. So we have high confidence with these criteria together to get the population of target for that will benefit more from Neuron, which is the population that earlier in the disease. I hope this answers your question. Speaker 300:20:15Thank you so much, Bob. Thank you for the questions. Speaker 600:20:19Yes. That was very helpful. Thanks again. Looking forward to further updates on the launch of the study. Thank you. Speaker 300:20:25Thank you so much for being on the call today. Thank you. Operator00:20:30Thank you. Our next question is coming from David Boats with Zacks Small Cap Research. Your line is live. Speaker 700:20:38Hey, good morning, everybody. So in regards to the upcoming Phase III trial, it looks like it's going to have a 24 week double blind period and a 24 week open label extension. So in regards to potentially filing the BLA, assuming positive results from the double blind portion, Could the BLA be filed essentially immediately after that or will the data from the open label extension be required for the BLA? Speaker 300:21:07No, we would be able to file the BLA after the first half of the double blinded period. Thank you for that question. Speaker 700:21:15Okay. And I was wondering if you could comment just on the general sense of how patient advocacy groups, maybe even patients or physicians also, their enthusiasm still for Neurone and you've already commented about potentially seeking a non dilutive funding, but I was going to ask about whether the patient advocacy groups would also potentially have any type of grants or funding available for the Phase 3 trial? Speaker 300:21:49Thank you very much for that question. We are working diligently with many patient advocacy groups and I can tell you that we're seeing even more excitement than the previous trial. Hopefully, we'll see that publicly and also in ways of grants. But I can tell you across the board, patient advocacy are very supportive of this Phase 3b trial. As you know, some of them felt that we didn't have sufficient data in the Phase 3, but they're very supportive of the Phase 3b trial. Speaker 300:22:16They won't have an answer on neuron, a clear answer and they think that the patient population that we are now focusing on, as Bob described again and again, is the patient population that has the best chance to show efficacy. So we're getting a lot of support and I think we are getting far stronger support from different groups that wasn't there in the past. Speaker 700:22:40All right. Well, that's great to hear and thanks for taking the questions. Speaker 300:22:45Yes. Okay. Operator, we have time for one more question, please. Operator00:22:50Understood, sir. We have a question from Nicholson, who is a private investor. Your line is live. Speaker 200:22:58Hi. Good morning, everybody. I'm not a private investor. I'm a research analyst at ACF Equity Research. I wondered if you are in a position to give any color on the cost of the trial at this point either on a per head basis or overall? Speaker 200:23:16And as a follow-up, are you able to give us any further color on the likely costs of production of each course of treatment at this time? Speaker 300:23:31Thank you so much for these questions. So the answer is that we are still not in a position and we will share of course in the near future more exact costs for the trial. The reason for that is that the main cost of the trial, the manufacturing costs and we're still in the phase of finalizing contracts with different manufacturing centers from different geographies that will be different prices and it's not just a small difference. So therefore, we're not able to the previous trial cost us about $50,000,000 and with 200 patients only for 6 months and this time it's for 7 months, sorry, and this time it's for a longer period. But we will provide numbers in a later stage and definitely not able to give you a reduction also versus a manual process and maybe we'll be able to implement automatic process, which significantly would change prices for the product costs. Speaker 300:24:32We are really focused to try to bring down the product costs. So while we are doing this huge undertaking of initiating this trial, we're still at the same time working very hard with R and D to get our processes cheaper as well. It's very important in gene and cell therapy and we're very focused on that. But thank you very much for these questions. Speaker 200:24:54Thank you. If I could just follow-up slightly on that one. Is it your experience that the current technological innovations that are going on in manufacturing and therapy development, do they play well into your space? Is it the expectation that you could see costs reducing? Or is it somewhat the other way around because you're very innovative? Speaker 300:25:20Thank you very much for that question. So if we can get a validated automated product, definitely will be dramatically decreased. But even in the manual product, we are having many good developments to get the price cheaper. I think even in this trial, we may have a dramatic cheaper price per product than previously, hopefully, and if you look on the whole thing. So but we are still wearing out those exactly you're touching on things that we're working on now very hard. Speaker 300:25:52And hopefully, in the next quarters, you will see different updates on this. Speaker 200:25:57Thank you very much indeed. Speaker 300:26:00Thank you very much. So I want to thank again everyone for being on the call today. We are finishing just on time for the 9 a. M. We wanted to finish this call. Speaker 300:26:09Thank you very, very much for everyone joining us and thank you all for your continued support and we're looking in the next quarter to have additional exciting updates in line to what we discussed today. We hope everything will fall in place and we'll be in a better place when we speak in the next quarter, hopefully even after initiating a trial. Thank you very, very much. Operator00:26:32Thank you, ladies and gentlemen. This does conclude today's conference call. You may disconnect your lines at this time and have a wonderful day. And we thank you for your participation.Read morePowered by