Q2 2024 Brainstorm Cell Therapeutics Inc Earnings Call
Operator: And Ibrahim Dagher, Ibrahim Dagher, Ibrahim Dagher, Ibrahim Dagher, Ibrahim Dagher, Ladies and gentlemen, thank you for your patience. This conference will begin momentarily. Once again, thank you for your patience, and this conference will begin momentarily. FamilyMediaAdventures.blogspot.com, Greetings and welcome to the Brainstorm Cell Therapeutics second quarter 2024 conference call. At this time, the participants are in a listen-only mode.
Speaker Change: Ladies and gentlemen, thank you for your patience. This conference will begin momentarily. Once again, thank you for your patience, and this conference will begin momentarily.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Greetings and welcome to the Brainstorm cell Therapeutics second quarter 2024 conference call.
Speaker Change: At this time participants are I know the slowly mode.
Michael Wood: As 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 Change: As a reminder, this call is being recorded.
Speaker Change: And I would now like to introduce your host for today's call Michael Wood of lifestyle advisors. Mr. Wood you may begin.
Michael Wood: Good 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, and the safety and clinical effectiveness of the Neuron technology platform.
Speaker Change: Good morning, everyone and thank you for joining us today.
Michael Wood: Clinical Trials of Neuron and related clinical development programs and the company's ability to develop strategic collaborations and partnerships. Report, It's Business Planning Up 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 FCC filing. 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.
Speaker Change: Before passing it off to accompany management's prepared remarks, I would like to remind listeners that this conference call contains numerous statements descriptions forecast and projections regarding brainstorm cell therapeutics and its potential future business operations and performance statements regarding the market potential for the treatment of neuro degenerative disorders, such as <unk>.
Speaker Change: Oh, that's it.
Speaker Change: Sufficiency of the company's existing capital resources for continuing operations in 2024 and beyond the safety and clinical effectiveness of the neuro and technology platform.
Speaker Change: Nickel trials of neuron unrelated clinical development programs and the company's ability to develop strategic collaborations and partnerships to support this business planning efforts.
Speaker Change: Forward looking statements are subject to numerous risks and uncertainties and many of these are beyond brand stores control, including the risks and uncertainties described from time to time in the Companys SEC filings.
Speaker Change: These results may differ materially from those projected on today's call and the company undertakes no obligation to publicly update any forward looking statements.
Chaim Lebovits: Joining us on the call this morning will be Chaim Lebovits, President and CEO of Brainstorm, and Alla Patlis, Interim Chief Financial Officer. In addition, Dr. Hartounian, Chief Operating Officer, and Dr. Bob Dagher, Chief Medical Officer, are also on the line and will be available to answer questions during the Q&A. So I'd now like to turn the call over to Mr. Lebovits. Please go ahead. All right. Thank you, Mike. Good morning and afternoon to everyone.
Speaker Change: Joining us on the call. This morning will be Frank Leto, President and CEO, Brainstorm and I'll, let partlet interim Chief Financial Officer.
Speaker Change: In addition, Dr Ottonian, Chief operating officer, Dr. Bob <unk>, our Chief Medical Officer are also on the line I won't be available to answer questions. During the Q&A session.
Speaker Change: So I'd now like to turn the call over to Mr. Li Please.
Speaker Change: Please go ahead.
Frank Leto: Alright, Thank you Mike.
Chaim Lebovits: Thank you for joining us today. We appreciate your continued interest and support in Brainstorm. We're making substantial progress in our preparations for the Phase 3b trial for neurons in ALS. Importantly... Neuron is now a de-risked asset, having secured a written SBA agreement from the FDA. The 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.
Mr. Li: Hey, good morning, and good afternoon to everyone.
Speaker Change: You for joining us today.
Speaker Change: We appreciate your continued interest and support in brand store.
Speaker Change: We're making substantial progress in our preparations for the phase III trial for neuron and E. L F.
Speaker Change: Yes.
Speaker Change: Importantly.
Speaker Change: So we're almost now a derisked asset having secured a written SBA agreement from the FDA.
Speaker Change: This significant milestone, which we announced earlier in the year underscores the agency's recognition.
Speaker Change: The unmet need that exists in a L. S.
Speaker Change: <unk> continues to be supportive and we are grateful for their input and advice.
Speaker Change: Yeah.
Chaim Lebovits: In addition to the SBA, during the second quarter, we reached alignment with FDA on CMC aspects of the phase three trial. In June, we participated in a very constructive face-to-face type C meeting, and have now resolved previously outstanding CMC questions. Teletherapy 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 febrile trial.
Speaker Change: In addition to the SBA.
Speaker Change: During the second quarter, we reached alignment F D a.
Speaker Change: CMC aspects of the phase III trial.
Speaker Change: In June.
Speaker Change: We participated in a very constructive face to face type C meeting.
Speaker Change: Now resolved previously outstanding CMC questions.
Speaker Change: Cell therapy products have certain additional complexities in their manufacturing process.
Speaker Change: Therefore, it's important.
Speaker Change: He is involved at various steps during the regulatory process.
Speaker Change: <unk>, probably prior to initiating a pivotal trial.
Chaim Lebovits: 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 that spans diverse geographic regions to ensure broad patient access and representation. The manufacturing processes are well advanced, and I believe we are on track to meet production time.
Speaker Change: Our collaboration with the CLO has been instrumental in advancing key trial protocols.
Speaker Change: We have selected a leading zero and are diligently building a network of over 12, leading clinical centers across diverse geography regions to ensure broad patient access and representation.
Speaker Change: The manufacturing processes.
Speaker Change: Advanced <unk>.
Speaker Change: Believe on track to meet production time.
Chaim Lebovits: We remain committed to initiating the trial by the end of 2024 or in the first year of 2024, to bolster our financial position. We're actively pursuing non-dilutive funding, including a promising grant application with the potential to secure up to $15 million. ALS is a devastating disease with limited treatment options.
Speaker Change: We remain committed to initiating the trial by the end of 'twenty 'twenty four or.
Speaker Change: The first year of 2025.
Speaker Change: To bolster our financial position.
Speaker Change: We're actively pursuing non dilutive funding, including get promising grant application.
Speaker Change: Potential to secure up to $15 million.
Speaker Change: AOS is a devastating disease with limited treatment options.
Chaim Lebovits: The potential impact of a successful Phase IIIb trial cannot be overstated. It could represent a significant breakthrough for patients and their families. We 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 28th or face a risk of delisting.
Speaker Change: The potential impact of a successful phase II b trial cannot be overstated.
Speaker Change: It could represent a significant breakthrough for patients and their families.
Speaker Change: We are committed to transparency communication.
Speaker Change: In providing regular updates about our progress.
Speaker Change: We are grateful for the support and collaboration of the edge.
Speaker Change: Anti L. S community as we continue this important work.
Chaim Lebovits: Additionally, we need to achieve a 35 million market cap to address these challenges and provide the company with maximum flexibility, with Schedule, an earlier than usual annual shareholder meeting. A key item on the agenda is seeking shareholder approval to authorize the Board of Directors to effect a reverse tax split if deemed necessary to maintain our NASDAQ. It's important to understand that approving this proposal does not automatically trigger a risk-fit. It simply grants the board the discretion to implement. If it becomes necessary to comply with now, that's one less thing to require. Why will exhaust all possibilities to avoid a reversal?
Speaker Change: I wanted I want to address the items in our proxy statement and the upcoming shareholder meeting.
Speaker Change: NASDAQ has notified us that we must maintain a $1 share price for 10 consecutive trading days.
Speaker Change: October 28th or risk to listening.
Speaker Change: Additionally, we need to achieve a 35 billion market cap.
The address these challenges and provide the company with maximum flexibility.
Speaker Change: We've scheduled an earlier than usual annual shareholders' meeting.
Speaker Change: A key item on the agenda is seeking shareholder approval to all.
Speaker Change: Authorize the board of directors to effect, the reverse stock split if deemed necessary to maintain our NASDAQ listing.
Speaker Change: It's important to understand that are proving this proposal does not automatically trigger a risk of that.
Speaker Change: It simply grant the board the discretion to implement.
Speaker Change: If it becomes necessary to comply with nasdaq's listing requirements.
Speaker Change: While we will exhaust all possibilities to avoid a reverse split.
Chaim Lebovits: 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 nasvec image. The Board will carefully consider all options, including a potential reverse split or transition to the OTCQB. If we opt for the O2CQB, we'll work diligently to regain that compliance without resorting to a resplit.
Speaker Change: Including driving up the share price, but the good news we believe it's essential to have this option available to protect shareholder value and maintain our NASDAQ listing.
Speaker Change: The board will carefully consider all options, including a potential reverse split origin just into the ultra secure b if.
Speaker Change: If we opt for the ultras at QB will work diligently to regain NASDAQ compliance without resorting to Arista.
Alla Patlis: Our ultimate goal is to maximize shareholder value, and we are confident in our ability to navigate these challenges and deliver value to our shareholders. Your support in approving the proxy is crucial to ensuring we have the flexibility to make the best decisions for the company. Thank you for your continued support. Thank you, Chaim. Cash, cash equivalents, and restricted cash were approximately $3.65 million as of June 30, 2024, compared to $0.75 million as of June 30, 2023.
Speaker Change: Our ultimate goal is to maximize shareholder value.
Speaker Change: But we are confident in our ability to navigate these challenges and delivered value to shareholders.
Speaker Change: Our support and are proving their proxy a truthful to ensuring we have the flexibility to make the best decisions for the company.
Speaker Change: Thank you for your continued support.
Speaker Change: Hello.
Speaker Change: Okay.
Speaker Change: Thank you hi.
Alla Patlis: Research and development expenses for the three months and June 30, 2024, and 2023 were approximately $0.9 million and $2.8 million, respectively. General and Administrative expenses for the three months and June 30, 2024, and 2023 were approximately $2 million and 2.7 million, respectively. Net loss for the three months and June 30, 2024 was approximately 2.5 million as compared to a net loss of approximately 5.3 million for the three months and June 30, 2023. Net loss per share for the three months at June 30, 2024 and 2023 was $0.0413, respectively.
Speaker Change: Cash cash equivalents and the restricted cash was approximately 365 million as of June 32024, compared to zero point 75 million as of June 30 centers in Q3.
Speaker Change: Right.
Gary Laurie: Research and development expenses for the three months ended June 30, 'twenty 'twenty four and thank you. Thank you Gary Laurie proximity of 0.9 million and 2.8 million respectively.
Gary Laurie: General and administrative expenses for the three months ended June 30 of 'twenty, 'twenty, four and 'twenty to 'twenty three or trucks in the two 2 million and $2 7 million respectively.
Larry: Net loss for the three months ended June 30 to 24 was approximately $2 5 million as compared to a net loss of approximately $5 3 million for the three months ended June 30th when do you think it's Larry.
Larry: Net loss per share for the three months ended June 30, 'twenty 'twenty, four and 'twenty to 'twenty three.
Larry: For.
Larry: 13 cents respectively.
Chaim Lebovits: I'll turn it back to Chaim to close the call. Thank you so much, Alla. We'll now open the call for written questions. Please.
Speaker Change: Turning back to crime to close the call.
Speaker Change: Thank you so much I'll, we'll now open the call for the written questions. Please.
Speaker Change: Please.
Michael Wood: Mike, can you please go forward with the written question? Yes, first question. Can you please elaborate on the key milestones that investors should be looking forward to in the near term? Thank you.
Speaker Change: Can you. Please go forward with the written questions.
Speaker Change: Yes first question can you. Please elaborate on the key milestones that investors should be looking forward to in the near term.
Speaker Change: Yeah.
Mike: Thank you Mike.
Chaim Lebovits: Absolute, We're very enthusiastic about the potential catalysts that should drive significant shareholder value. In the near term, we are focused on several key milestones. Firstly, Securing the first few trial site agreements is a crucial step.
Mike: Absolutely.
Speaker Change: We're very enthusiastic about the potential catalysts that should drive significant shareholder value.
Speaker Change: And then near term we are focused on several key milestones.
Speaker Change: Firstly, securing the first two trials side agreements is a crucial step.
Chaim Lebovits: This demonstrates our ability to execute on the clinical trial timeline efficiently. We're actively pursuing additional non-diluted funding through grants and strategic partnerships. The successful acquisition of these funds will significantly strengthen our financial position and accelerate our development time, 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 models and deliver substantial value for our show. Thank you. Next question. With a proposed increase in the authorized shares from 100 million to 250 million, there is a possibility that existing shareholders will be significantly diluted.
This demonstrates our ability to execute on the clinical trial timeline of fitness recently.
Speaker Change: Secondly, we're actively pursuing additional non dilutive funding through grants and strategic partnerships.
Successful acquisition of these funds will significantly strengthen our financial position and accelerate our development timeline.
Speaker Change: And of course trial initiation and enrolling the first patient in the story.
Our major milestones that will mark significant progress.
Speaker Change: We believe we can successfully successfully execute on these milestones.
Speaker Change: We deliver substantial value for our shareholders.
Speaker Change: Thank you next question.
Speaker Change: With a proposed increase in the authorized shares from 100 million to 250 million. There is a possibility that existing shareholders would be significantly dilutive.
Chaim Lebovits: What is your plan for equity raises over the next several quarters? Thank you for this question. Very good
Speaker Change: What is your plan for equity raises over the next several quarters.
Speaker Change: Thank you for this question very good so we can clarify this.
Chaim Lebovits: So we can clarify. Of course, we understand the concern regarding potential dilution. What's important to emphasize is that an increase in authorized shares (inaudible) does not equate to immediate dilution. This action only provides us with the flexibility to pursue strategic opportunities without resorting to diluted finance.
Speaker Change: Of course, we understand the concern regarding potential dilution.
Speaker Change: What's important to emphasize.
Speaker Change: That an increase in authorized shares.
Speaker Change: Does not equate to immediate dilution.
Speaker Change: This action only provides us with the flexibility to pursue strategic opportunities without resorting to dilutive financing.
Chaim Lebovits: Our primary focus is Nanda Lurifunding Source. Such as Grant and other calibrators, strategic calibrators. We have a successful track record of securing non-dilutive funding, demonstrating our ability to execute on the strategy. BCLI has a 15-year history of efficient capital management, issuing less than 100 million shares while raising close to 200 million dollars.
Our primary focus is non dilutive funding sources such as grants.
Speaker Change: And other calibers strategic collaborations we have successful track record of securing non dilutive funding demonstrating our ability to execute on the strategy.
Speaker Change: Okay.
Do you see ally has a 15 year history of efficient capital management.
Speaker Change: Issuing less than 100 million shares, while raising close to $200 million.
Chaim Lebovits: 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 We will continue to explore all avenues to optimize capital allocation and minimize the, Thanks, Chaim. 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 Change: This demonstrates our commitment to maximizing shareholder value.
Speaker Change: Both increase in authorized shares is a strategic long term decision to ensure we have the flexibility to capitalize on future growth opportunities.
Speaker Change: Without unnecessary dilution.
Speaker Change: We will continue to floor, all avenues to optimize capital allocation and minimize dilution.
Speaker Change: Okay.
Speaker Change: And a related question what non equity funding sources are currently have a good probability of transacting.
For initiation of the phase III trial can you speak to grant partnerships are the potential outsourcing of intellectual property.
Chaim Lebovits: Thank you. So we're actively pursuing multiple non-equity funding revenue streams. Our previous grant award from CIRM, the California Institute for Regenerative Medicine, was a good example of our. It was a $16 million non-dilutive grant that supported our Phase 3 trial. We're also exploring partnerships with pharmaceutical companies and other industry stakeholders. Discollaboration can provide both financial support and strategic advantage, outsourcing of intellectual property not currently at the table. However, we believe that maintaining control over our record technology is essential for long-term success.
Speaker Change: Thank you. So we are actively pursuing multiple non equity funding revenues.
Speaker Change: Our previous Grant award from <unk>, The California Institute for Regenerative Medicine was a good example of our efforts it was a $16 million non dilutive grant that supported our phase III trial.
Speaker Change: We're also exploring partnerships with pharmaceutical companies and other industry stakeholders.
Speaker Change: These collaborations can provide both financial support our strategic advantages.
Speaker Change: Outsourcing of intellectual property is not currently on the table.
Speaker Change: Believes that maintaining control over our record technology is essential for long term success.
Chaim Lebovits: However, we're open to strategic partnerships that involve technology sharing or licensing on mutually beneficial terms. The next question regarding the planned clinical trial, is there a take-to-peak provision that would allow inter-analysis of early signs of efficacy over reported? So thank you. So an independent data safety monitoring board is being established for the basically be trial design. The board members and the charter are currently under finalization, but the DSMP will be responsible for periodic safety evaluations to monitor patients' safety and well-being.
Speaker Change: However, we are open to strategic partnerships that involve technology sharing or licensing on the mutually beneficial terms.
Speaker Change: Okay.
Speaker Change: The next question regarding the planned clinical trial is there a take a peek provision that would allow interim analysis, the early signs of efficacy or reported.
Speaker Change: So thank you so an independent data safety monitoring board is being established for the basically be trial design.
The board members and their charter are currently under Finalization.
But then some people will be responsible for periodic safety evaluations to monitor patient safety and wellbeing.
Speaker Change: Thank you.
Speaker Change: Okay.
Dr. Bob Dagher: Thank you. The next question is whether the ALS, FRS, or enrollments are higher than in the prior phase three studies? Thanks, Bob. Do you want to take that question, please? Yes, thanks, Chaim. Based on properly conducted simulation, the total score of the LSFRS is expected to be higher than in the previous trial.
Speaker Change: Our next question is the ALS FRS or as enrollment higher than in the prior phase III study.
Speaker Change: Thanks, Bob you want to take that question. Please.
Bob: Yeah, Thanks, Hi.
Bob: The.
Speaker Change: Based on properly conducted simulation.
Speaker Change: <unk> total score of the electrical right.
Speaker Change: <unk> is.
Speaker Change: He is expected to be higher than in the previous trial and we're looking forward to doing the trial.
Speaker Change: Thank you.
Speaker Change: And also on the trial will there be more trial sites than in the prior phase III, thus, allowing the trial to be filled more quickly.
Bob: Thank you that's why Bob too.
Speaker Change: Yeah.
Dr. Bob Dagher: Yes, thanks, I'll take that question as well. Yeah, we are planning to add a higher number of sites for the phase 3B trials than was conducted in phase 3 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 timeline of the trial. Thank you, and has a commercial manufacturing partner locked down at this point.
Yeah. Thanks, I'll take that question as well yeah, we are planning to add.
Speaker Change: A higher number by.
Speaker Change: For the Phase <unk> trial, then conducting this phase three for the same.
Speaker Change: The number of patients about 200 patients in the trial, we expect that this will increase.
Speaker Change: The rate of enrollment and will also be the timelines of the trial. Thank you.
Speaker Change: And it has a commercial manufacturing partner being locked down at this point.
Harold: Harold, please take that. Thank you, Chaim, for the question. We're planning for multiple manufacturing sites. We'll just try, and simultaneously, we are engaged in advanced discussions with highly qualified potential commercial manufacturing partners. Why We Cannot Disclose Specific details 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.
Speaker Change: Oh, please take that one.
Speaker Change: Thank you Colin for the question.
Colin: We're planning for multiple manufacturing sites.
Speaker Change: Try it.
Speaker Change: Simultaneously our engaged in advanced discussions with highly qualified potential commercial manufacturing partners.
Speaker Change: While we cannot disclose the specific details until the 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.
Speaker Change: Thank you.
Dr. Bob Dagher: Is the Phase 3b inclusion criteria more stringent than the prior Phase 3 study, thus ensuring a healthier pool of patients or trial participants? Thank you, Bob. Do you want to take that? Cheshire, thanks for the question.
Speaker Change: Is the phase III b inclusion criteria more stringent than the prior phase III study thus ensuring.
Speaker Change: Our pool of patients our trial participants.
Speaker Change: Okay.
Speaker Change: Thank you Bob you want to take that.
Bob: Yeah sure. Thanks for the question as well.
Dr. Bob Dagher: Well, yeah, we designed the face, the inclusion criteria for the face DB trial were informed by phase three, but they are more refined to focus on patients that are earlier in the disease in the air and in the course of that disease. The goal is to enroll patients with a higher likelihood of showing benefits from our treatment, which we believe will also be strengthened by having overall robust data. Thank you. Thank you very much.
Bob: Yeah, we designed the phase Hum.
Bob: Criteria for the phase <unk> trial.
Being informed by the phase III, but they are more refined.
Speaker Change: Get on patients that are earlier in their disease.
Speaker Change: In the course of their disease. The goal is to enroll patients with a higher likelihood of.
Speaker Change: Showing benefits from our treatment.
Speaker Change: We believe we will be also strengthened.
Speaker Change: By having a overall robot data thank you.
Speaker Change: Thank you very much.
Operator: I think that concludes the written questions we received. Ali, would you open the call to any additional questions from any investors on the line? Thank you, sir.
Speaker Change: I think that this concludes the written questions we received.
Speaker Change: I'll leave with you open the call for any additional questions from any investors on the line.
Operator: Ladies and gentlemen, the floor is now open for questions. If you have any questions or comments, please press star one on your phone at this time. We ask that while asking your question you please pick up your handset if listening on speakerphone to provide optimum sound quality.
Speaker Change: Thank you, Sir ladies and gentlemen, the floor is now open for questions.
Speaker Change: If you have any questions or comments. Please press star one on your phone at this time.
Speaker Change: While posing your question you. Please pickup your handset if this thing on speaker phone to provide optimum sound policy.
Operator: Please hold while we poll for questions. Our first question is coming from Jason McCarthy with Maxim Group. Your line is:
Speaker Change: Please hold while we poll for questions.
Speaker Change: Thank you.
Speaker Change: Our first question is coming from Jason Mccarthy with Maxim Group. Your line is live.
Joanne Lee: Hi, this is Joanne Lee on the call for Jason McCarthy. Thanks for taking the question and congratulations on the progress made this quarter. Just regarding the CNC alignment, did the company need to implement any new actions or adjustments on the CMC front to reach alignment with the FDA? Thank you very much. We did.
Speaker Change: Hi, This is Joanne Lee on the call for Jason Mccarthy. Thanks for taking the question and congratulations on the progress made this quarter are.
Speaker Change: Just regarding the CNC alignment is.
Speaker Change: Does the company need to implement any new actions or adjustments on the CMC front, two which reached alignment with the FDA.
Unknown Executive: We reached alignment to be able to initialize the trial, and that was very, I got it. And just regarding the upcoming study, because you briefly remind us of the changes made to the ALS FRS entry criteria and how these adjustments may impact the upcoming phase 3B. And as a follow-up, if you could provide a mechanistic rationale for why an effect might be more easily identifiable under the new ALS FRS criteria.
Speaker Change: Thank you very much we did was reached alignment to be able to initialize the trial.
Speaker Change: Very important but thank you for the clarifying question.
Speaker Change: Oh got it and just regarding the upcoming study could you briefly remind us of the changes made to the ALS FRS entry criteria and how these adjustments may impact the upcoming phase three P. M and just as a follow up if you could provide a mechanistic rationale for wine and stacked it might be more easily identify.
Speaker Change: Under the new ALS FRS criteria.
Dr. Bob Dagher: Thank you, Bob. Do you want to take this question? I'm sure I'll be happy to do that.
Speaker Change: Thank you Bob do you want to take this question.
Dr. Bob Dagher: Thank you for your question. So basically, there are a number of differences from the previous trial. The main criteria regarding the ALS FRS are, number one, to make sure that every item, the score is made up of 12 items; every item on the score, it's scored at 2, 3 or 4. Recall that each item can be scored from 0 to 4, 0 being the worst. So we are not allowing any 0 or any 1, answers on each one of the 12 items.
Bob: Sure I'm happy to do that thank you for your question. So basically there are a number of this.
Speaker Change: From the previous Royal.
Dr. Bob Dagher: That's number one. Number two, we are also not allowing the LS total score to be either 40, 5, sorry, not 45, 46, or 47, or 48. 48 is the maximum, but once you start experiencing your first symptom, you drop from 48, typically to 47 or lower.
Speaker Change: We the main criteria regarding to the ILEC Buffalo that is number one two.
Speaker Change: Make sure that every item.
Speaker Change: Call is made up of wildlife and every item on the score.
Speaker Change: It's good that the key or whore recall, each item can be coke zero to four year it'll be the word.
Speaker Change: Not allowing any zero any one.
On each one of the 12 Iceland.
Speaker Change: That's number one number two.
Speaker Change: We are also not allowing the local school can be either.
Speaker Change: 40.
Speaker Change: Five.
Speaker Change: Not sorry, not 45 46 47.
Speaker Change: 48, 48, as the maximum but once you.
Speaker Change: You heard some of them you dropped from 48 47, a lowered reasoning for that is we didn't want.
Speaker Change: The allowance of two years.
Speaker Change: Or someone two years later remain without clearly showing.
Speaker Change: Progression by more than one or two point.
Speaker Change: The school allows people to answer that probably like 45 or less.
Speaker Change: Number three we're looking basically at.
Speaker Change: Well stated.
Speaker Change: Entry criteria.
Speaker Change: The difficulty is from symptom onset looking very carefully absolutely insane.
Speaker Change: Hey.
Speaker Change: With a documented evidence of that and making sure that we get patient.
Speaker Change: After they get diagnosed with a lot and we are also looking to get there a respiratory function and can be rapidly Edward.
Dr. Bob Dagher: And we're also looking to get their respiratory function to be relatively spared, looking for slow vital capacity to be above 65%, which is in the healthy zone. Combining all of those together and simulating those entry criteria I mentioned on large databases, one of them being the PROACT database, we got a score, a total score that puts us at a higher confidence level than what was conducted in phase three. And in line with more than a lot of clinical trials that have been conducted in recent years.
Speaker Change: Looking at like let's get back with you, but it would be about right.
Speaker Change: <unk>, which is which is in and be healthy.
Speaker Change: Combining all of those together.
Speaker Change: Simulating those antique rate theory are you mentioned, one large databases one of them is a neat little act reasonably well.
Speaker Change: We got a.
Speaker Change: Score a total score that puts us at a confidence high.
Speaker Change: Higher than what was conducted in the C suite and in line with our more than a lot clinical Flyers that will come back to you.
Dr. Bob Dagher: So we have high confidence with these criteria together to get the population of target for that will benefit most from neuron, which is the population that's earlier in the disease. I hope this answers your question. Thank you very much, Bob. Thank you for the questions. Yeah.
Speaker Change: So we have high confidence these criteria together.
Speaker Change: The population.
Speaker Change: Target for that.
Speaker Change: Benefit more from neuron, which is the population that earlier in the disease course.
Speaker Change: I hope this answers it.
Speaker Change: Your question.
Speaker Change: Well, thank you for the questions yeah.
Unknown Attendee: Yeah, that was very helpful. Thanks again. Looking forward to further updates on the launch of the study. Thank you. Thank you so much for being on the call today. Thank you, Thank you. Our next question is coming from David Bautz with Vax Small Cup Research. Your line is... Hey, good morning, everybody.
Speaker Change: Yeah that was very helpful. Thanks, again looking forward to further updates on the launch of a study. Thank you.
Speaker Change: Thank you so much for being on the call today. Thank you.
Speaker Change: Thank you. Our next question is coming from David boats with Zacks small cap research your line is life.
David Bautz: So in regards to the upcoming phase three 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 Change: Yeah. Good morning, everybody. So in regards to the upcoming phase III trial. It looks like it's gonna 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 it be a lady filed SM.
Speaker Change: Actually immediately after that or will the data from the open label extension be required for the BLA.
Unknown Executive: No, we would be able to file the BLA after the first of the Double Blind Appeal. Thank you for that question. Okay, and um... 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 neuron. And you've already commented about potentially seeking non-dilutive funding, but I was going to ask about, you know, whether the patient advocacy groups would also potentially have any type of grants or funding available for the Phase III trial.
Speaker Change: No it won't be able to file the BLA after the first half.
Speaker Change: The double blind period.
Speaker Change: Thank you for that question.
Speaker Change: Okay and.
Speaker Change: I was wondering if you could comment just on the a general sense of how a patient advocacy groups and maybe even ah patients or physicians also.
Speaker Change: Their enthusiasm still for neuro, one and you've already commented about potentially seeking non dilutive funding, but I was going to ask about you know whether the patient advocacy groups.
Speaker Change: Oh would also potentially have any type of grants our order funding available for the phase III trial.
Unknown Executive: Thank 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 with the previous trial. Hopefully, we will see that publicly and also in ways of grand [inaudible]. But I can tell you across the board, patient advocacy groups are very supportive of this Phase 3B trial. As you know, some of them felt that we didn't have sufficient data in Phase 3, but they're very supportive of the Phase 3B trial. They won't have an answer on their own, a clear answer.
Speaker Change: Thank you very much for the question, we're working diligently with many patient advocacy groups and I can tell you that we're seeing even more excitement in the previous trial.
Speaker Change: Hopefully, we will see that publicly and also in ways of grants.
Speaker Change: But I can tell you across the board patient advocacy are very supportive of this phase III trial as you know some of them felt that we didn't have sufficient data on the phase III, but they're very supportive of the phase three trial that won't have an answer a neuron.
Speaker Change: 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.
Speaker Change: Our stronger support from different groups.
Speaker Change: Wasn't there in the past.
Speaker Change: Alright, well, that's great to hear and thanks for taking the questions.
Operator: Operator, we have time for one more question, please. Understand sir, we have a question from Christopher Nicholson, who is a private investor. Your line- Hi, it's a good morning, everybody. I'm not a private investor.
Speaker Change: Yeah, Okay. Operator, we have time for one more question. Please.
Speaker Change: Understood. Sir we have a question from Christopher Nicholson, who is a private investor Your line is life.
Christopher Nicholson: 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 head basis or overall. And as a follow-up, are you able to give us any further color on the light costs of production of each course of treatment at the Thank 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 of that cost for the trial.
Speaker Change: Hi.
Speaker Change: Good morning, everybody I'm, not a private investor.
Christopher Nicholson: Research analysts that ACF equity research.
Christopher Nicholson: I Wonder 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 and as a follow up are you able to give us any further color.
Speaker Change: On the lightly costs of production of each course of treatment at this time.
Speaker Change: Thank you so much for these questions. So the answer is that we are still not in a position now and we will share of course.
Speaker Change: In the near future more exact cost for the trial. The reason for that is that the main cost of the trial the manufacturing costs.
Christopher Nicholson: The reason for that is that the main cost of the trial, the manufacturing cost, and we're still in the phase of finalizing contracts with different manufacturing centers from different geographies that will be a different product. It's not just a small but...
Speaker Change: And we're still in the phase of finalizing contracts with different manufacturing centers.
Speaker Change: From the 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 $60 million and was 200 patients on the first six months at this time its worth.
Chaim Lebovits: So therefore, we're not able to. The previous trial cost us about $50 million and with 200 patients for only six months at this time, for seven months, sorry, and this time it's for a longer period. But we will provide numbers at a later stage and definitely not be able to give you a reduction in cost of what it will be in a few years from now because the whole industry is changing with the CDMOs and also versus, All right, bye-bye, trial to bring down the product cost.
Speaker Change: Seven months already at 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 production costs what it will be in a few years from now because the whole industry is changing with the C. D M O and also versus.
Speaker Change: And manual process and maybe it will be able to implement automatic process with significantly with change prices to the product cost. We are really focused to try to bring down the protocol. So while we are doing.
Chaim Lebovits: So while we are doing this huge undertaking of initiating this trial, we're still, at the same time, working very hard with R&D to get our processes cheaper as well. It's very important in gene and cell therapy, and we're very focused.
Speaker Change: This huge undertaking of initiating the trial, we're still at the same time working very hard with R&D to get our processes cheaper as well, it's very important in gene and cell therapy, and we're very focused for that.
Chaim Lebovits: Thank you very much for the opportunity. Thank 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 in your space? Is the expectation that you could see costs reducing? Or is it somewhat the other way around because you're very innovative?
Speaker Change: Well, thank you very much for the questions.
Speaker Change: Thank you if I could just follow up slightly on that one is.
Speaker Change: Is it is it your experience that the.
Speaker Change: 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 cost reducing or is it somewhat the other way around because you are very innovative.
Chaim Lebovits: Thank you very much for that question. So, if we can get a validated automated product, the cost will definitely be dramatically decreased. And but even in the manual product, we are having many good developments to get the price sheet. I think even in this trial, we may have a dramatic... A cheaper price per product than previously, hopefully, if you look at the whole thing.
Speaker Change: Thank you very much for that question. So if we can if we can get a validated automated automated product definitely will be dramatically decreased.
But even though the mono product we are having many good developments to get the price cheaper.
Speaker Change: Even in this trial, we may have a dramatic cheaper.
Speaker Change: Cheaper price per product from previously hopefully.
Speaker Change: If you look on the whole thing of it so but we are still wearing golf goes exactly as you're touching on things that we're working on now very hard and hopefully in the next quarters, you will see different updates on this.
Chaim Lebovits: So, but we are still working out those, exactly, you're touching on things that we're working on now very hard. And hopefully, in the next quarters, you will see different updates. Thank you very much. Thank 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 want to finish this call.
Speaker Change: Yeah.
Speaker Change #100: Thank you very much indeed.
Chaim Lebovits: Thank you very, very much for everyone joining us. And thank you all for your continued support. And we're looking forward to the next quarter to have additional exciting updates in line with what we discussed today. We hope everything will fall in place and will be in a better place when we speak the next quarter. Hope to leave after initiating a try.
Speaker Change #100: Thank you very much so I want to thank again, everyone for being on the call today.
Speaker Change #101: We're finishing just in time for the nine a M. We wanted to finish this call. Thank you very very much for everyone joining us.
Speaker Change #101: 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 almost speak in the next quarter hopefully even after initiating its rob. Thank you very very much.
Operator: Thank you very, very much. Thank 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.
Speaker Change #102: Thank you ladies and gentlemen, this does conclude today's conference call. You may disconnect. Your lines at this time and have a wonderful day, we thank you for your participation.
Dr. Bob Dagher: The reason for that is we didn't want any allowance of the two years in the first symptom for someone two years later to remain without really showing time of progression by more than one or two points. So the score allows people to enter the trial at 45 or less. Number three, we are looking basically at associated entry criteria, such as the typical two years from symptom onset, looking very carefully at the first symptom with documented evidence of that, and making sure that we get patients quickly after they are diagnosed with ALS.
Dr. Bob Dagher: And we're looking forward to keeping the trial based on those assumptions. Thank you, and also on the trial. Will there be more trial sites than in the prior phase three, thus allowing the trial plot to be filled more quickly? Thank you, that's for Bautz, too.
Chaim Lebovits: 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 weren't there. Alright, well that's great to hear, and thanks for taking the questions. Yeah, okay.