Q4 2024 Brainstorm Cell Therapeutics Inc Earnings Call
Good morning, everyone and welcome to Brainstorm cell Therapeutics fourth quarter 2024 earnings call.
Operator: Good morning, everyone, and welcome to Brainstorm Cell Therapeutics fourth quarter 2024. At this time all participants are in a listen only mode. And if anyone should require operator assistance during this conference, please press star zero on your. This conference is being recorded.
Speaker Change: At this time all participants are in a listen only mode and if anyone should require operator assistance. During this conference. Please press star zero on your phone keypad. Please note. This conference is being recorded I will now turn the conference over to your host Michael but Michael the floor is yours.
Michael Wood: I will now turn the conference over to your host Michael Wood. Michael, the floor is yours. Thank you, Operator.
Michael: Thank you operator, good morning, and thank you for joining us before passing it all the company management for our prepared remarks, I'd like to remind listeners on this conference call.
Michael Wood: Good morning, and thank you. Therapeutics.
Michael Wood: Before passing it off to company management for prepared remarks, I'd like to remind listeners on this conference call that it will contain numerous statements, descriptions, forecasts, and projections regarding Brainstorm Cell Therapeutics and its potential Operations and Performance Statements regarding the market potential of the treatment for neurodegenerative disorders such as ALS. and Capital Resources for Continuing Operations. The Safety and Clinical Effectiveness of the Neuron Technology Platform, Clinical Trials of Neuron, and Related Clinical Development Programs. Abilities to Develop Strategic Collaborations and Partnerships to Support.
Michael: That it will contain numerous statements descriptions forecasts and projections regarding brainstorm cell therapeutics and its potential future business operations and performance statements regarding the market potential as a treatment for neuro degenerative disorders, such as the sufficiency of the company's existing capital resources.
Michael: For continuing operations into 'twenty 200 in 2025 and beyond.
Michael: Safety and clinical effectiveness of the neuron technology platform clinical trials of neuron unrelated clinical development programs and the company's ability to develop strategic collaborations and partnerships to support their business planning efforts.
Michael Wood: Forelooking statements are subject to risks and uncertainties, many of which are beyond the brainstorms control, including the risks and uncertainties described from time to time in the company. The company's results may differ materially from those projected on today's call and they undertake no obligation to publicly update any of these forward-looking statements.
Michael: Forward looking statements are subject to numerous risks and uncertainties many of which are beyond the brainstorms control, including the risks and uncertainties described from time to time in the company's SEC filings.
Michael: The company's results may differ materially from those projected on today's call.
Speaker Change: <unk> undertakes no obligation to publicly update any of these forward looking statements joining us on the call today will be Mr. <unk>, <unk>, President and C. O brainstorm on Ala populist interim Chief Financial Officer, and in addition, Dr. Halle hard Tony <unk>, EVP and Chief operating Officer, Dr. Bob.
Michael Wood: Joining us on the call today will be Mr. Chaim Lebovits, President and CEO of Brainstorm, and Alla Patlis, Interim Chief Financial Officer, and in addition, Dr. Haro Hartounian, EVP Operating Officer, and Dr. Bob Dagher. Medical Officer are also on the line and they will be available.
Speaker Change: Dogger EVP and Chief Medical Officer are also on the line and they will be available for the Q&A.
Chaim Lebovits: So with that, I'd like to turn the call over to Mr. Lebovits, please go ahead. Thank you, Michael. Good morning. Good afternoon. to everyone. Thank you for joining us today. We appreciate your continued interest and support in Brainstorm.
Mr. Lee: So with that I'd like to turn the call over to Mr. Lee, but please go ahead.
Lee: Thank you Michael.
Mr. Lee: Good morning, good afternoon.
Lee: Hello, everyone.
Lee: Thank you for joining us today.
Lee: We appreciate your continued interest and support and brainstorm.
Lee: Only 24 was a year of foundational work.
Chaim Lebovits: 2024 was a year of foundational work. positioning us for the critical phase 3b trial of Neuron, our investigational treatment for ALS. Our team, in close collaboration with leading ALS experts. and Regulatory Authority. Carefully designed a trial aimed at confirming neurons potential. A Significantly Slow Disease Progression in Early-Stage Patients. thus generating the robust data necessary for successful biologic license applications.
Lee: But is there something else for the critical phase II B trial of neuro, one our investigational treatment for a L. S.
Lee: Our team in close collaboration with leading Gail Les experts.
Lee: And regulatory authorities.
Lee: That's carefully designed that trial aimed at confirming neurons potential.
Significantly slow disease progression and early stage patients.
Lee: Thus generating the robust data necessary for successful biologic license application.
Speaker Change: Oh, Brian refocus or 2025 as well.
Chaim Lebovits: Our primary focus for 2025 is We're Unwavering Execution. We're now advancing preparation. to initiate the trial and begin patient enrollment driven by our strong belief that Neuron, if approved, can make a meaningful difference in the lives of ALS patients.
Lee: Claire.
Lee: Wavering execution.
Lee: We're now advancing preparations to initiate the trial and begin patient enrollment.
Lee: Driven by our strong beliefs.
Ron: Ron you've been through.
Speaker Change: And make a meaningful difference in the lives of patients.
Lee: <unk>.
Lee: I want to address the day three key areas.
Chaim Lebovits: I want to address today three key areas. Seutical... Regulatory, Clinical, and Trial Execution and Manufacturing.
Lee: Solid progress.
Lee: Regulatory clinical and solid execution in manufacturing.
Lee: Regulatory we maintain a strong collaborative relationship with the F D. A.
Chaim Lebovits: Regulatory. We maintain a strong collaborative relationship with the In 2024, we secured a special protocol assessment. Significantly de-risking the regulatory path. We're also aligned with the FDA. Chemistry, Manufacturing, and Controls, a Crucial Aspect for a Complex Cell Therapy like Neuroscience. I want to emphasize. that we have been diligently updating and submitting models to our IND. application including detailed technical transfer documentation, quality assurance, and quality control process.
Lee: And it's 124, we secured a special protocol assessment.
Lee: Difficultly Derisking the regulatory pathway.
Lee: We're also aligned with the F D a.
Lee: On chemistry manufacturing and controls it.
Lee: A crucial aspect for complex cell therapy like the wrong.
Lee: I want to emphasize.
Lee: So we have been diligently updating and submitting modules to all R&D.
Lee: Application, including detailed technical transfer type of communication.
Lee: Quality assurance and quality control processes.
Chaim Lebovits: One of these problems... require attention and time. They are essential for regulatory compliance and trial integrity. We anticipate announcing the submission of these models shortly.
Lee: A lot of these processes.
Lee: Acquire attention and time.
Lee: They are essential for regulatory compliance and trial integrity.
Lee: We anticipate announcing the submission of these models spoke to it.
Lee: Political.
Chaim Lebovits: Clinical. We are in active negotiations for clinical trial agreement with approximately 15 leading clinical centers across the United States, leveraging our established relationship with many of these institutions. The strong interest from renowned ALS clinicians and researchers. underscore their belief in neurons. We will announce these agreements as they are final.
Lee: We are in active negotiations for clinical trial agreements.
Lee: It was approximately 15, leading clinical centers across the United States.
Lee: Leveraging our established relationship with many of these institutions.
Lee: The strong interest from the known ALS clinicians and researchers.
Lee: Underscore their beliefs in the rooms potential.
Lee: We will announce these agreements as they are finalized.
Lee: The trial execution in manufacturing to ensure the efficient execution.
Chaim Lebovits: The Trial Execution and Manufacturing to Ensure the Efficient Execution.
Chaim Lebovits: of our Phase 3B trial, we have partnered with Equivia, a leading clinical research organization. Specializing in Cell and Gene Therapy Trials. with previous expertise in ALS trials, regulatory compliance.
Lee: Of our phase III B trial, we have partnered with <unk>, a leading clinical research organization.
Lee: Realizing and cell and gene therapy trials.
Lee: Excuse me this expertise in the L. S trials regulatory compliance and comprehensive capabilities will be crucial in managing key aspects of the clinical trial.
Chaim Lebovits: and Comprehensive Capabilities will be crucial in managing key aspects of the clinical For the clinical manufacturing of Neuron, we have contracted with Blu-ray Inc., leveraging their expertise in GMP-compliant products. This arrangement complements our leased facility at Swarovski Medical Center in Tel Aviv.
Lee: Well the clinical manufacturing of neurons, we have contracted with Fleury, Inc. Leveraging their expertise in GMP compliant production.
Lee: This arrangement complements our leased facility, that's you're asking medical center until abuse. Furthermore.
Chaim Lebovits: Furthermore, we're planning to bring an additional U.S.-based manufacturing center online to support broader production needs as we advance through clinical trials.
Lee: We're planning to bring in additional U S based manufacturing center online.
Lee: Or broader production needs as we advance through clinical trial.
Lee: Our financial position that strategic outlook.
Chaim Lebovits: Our Financial Position and Strategic Outlook. I want to address the financial realities and strategic direction of brainstorm direction. We are committed to securing the necessary funding to execute the Phase 3B trial and build a sustainable future. We're actively pursuing multiple funding avenues, including what we announced today, including licensing non-core assets for near-term capital and exploring non-dilutive financing opportunities, such as grant funding. I understand. and Vectors. and even more so the patient community. are eager for rapid progress. We are acutely aware of the urgent I want to acknowledge. The extraordinary dedication of our staff. who worked tirelessly under significant financial constraints.
Lee: I want to address the financial realities as a future direction that brings them directly.
Lee: We are committed to securing the necessary funding.
Lee: The phase III trial, and build a sustainable future.
Lee: We are actively pursuing multiple folding funding avenues.
Lee: <unk>, what we announced today.
Lee: <unk> licensing noncore assets for near term capital and exploring non dilutive financing opportunities.
Lee: This is grant funding.
Lee: I understand that.
Lee: Investors.
Lee: And even more so the patient community.
Lee: Eager for rapid progress.
Lee: We are acutely aware of the urgency.
Lee: I want to acknowledge.
Lee: The extraordinary dedication of our staff.
Lee: Well work tirelessly under significant financial constraints.
Lee: Including salary reductions.
Chaim Lebovits: Including salaries of to advance this trial. The time required for regulatory submissions, including the intricate technical transfer and QA QC processes inherent in a pioneering stem cell therapy. is not indicative of financial delay.
Lee: The advanced this trial.
Lee: The time required for regulatory submissions, including the intricate technical transfer and QA QC processes and her.
Lee: And a pioneer in stem cell therapy.
Lee: It's not indicated all financial delays.
Lee: I also want to address the expectations regarding immediate financial and I have to get announcements in trial milestones.
Chaim Lebovits: I also want to address the expectations regarding immediate financial financing announcements and trial analysis. who's committed to transparency. But we must adhere to rigorous regulatory processes. We are pioneering in a space where we know there is capacity. and we must provide robust data to validate neurons. The PHASE-3B trial involves rolling enrollment based on manufacturing capabilities for an autologous stem cell. We anticipate needing approximately $20-30 million annually to see the trial to its conclusion. Given our current market capitalization and the challenging market for non-revenue biotech, raising this amount of cash up front is not practical. But we believe that as we achieve keynote.
Lee: We've committed to transparency.
Lee: But we must adhere the rigorous regulatory processes.
Lee: We are pioneering in a space, where we know there's skepticism.
Lee: We must provide robust data validate neurons.
Lee: The phase II B trial involves rolling enrollment based on manufacturing capabilities for an autologous stem cell therapy.
Lee: We anticipate needing approximately 20 to.
Lee: $30 million annually to see the trial to its conclusion.
Lee: Given our current market capitalization and the challenging market for non revenue biotech.
Lee: Raising this amount of cash a prompt is not practical but.
Lee: But we believe.
Lee: As we achieved key milestones.
Chaim Lebovits: IND model submission, FDA clearance to proceed, signing CTAs and enrolling the first patient, we will see a corresponding increase in our market value. especially when combined with strategic partnership and non-dilutive. We are fully committed to the Microsoft. Our Chief Medical Officer, our Chief Operating Officer, our Chief Business Officer. and Aldous C. Nero. are at times working without your numeracy. and most of all the other employees have taken significant reductions in compensation. Many of our talented team members have also made sacrifices. They are driven by a shared commitment. Proving Neurons' Potential. and ultimately helping ALS patients and for other neurodegenerative diseases.
Lee: I am the model submission FDA clearance to proceed finding C T H and enrolling the first patient we will see a corresponding increase in our market valuation, especially.
Lee: Especially when combined with strategic partnership and non dilutive grants.
Lee: We are fully committed to this mission.
Lee: Myself.
Speaker Change: Our Chief Medical Officer, our Chief operating Officer, our Chief business Officer.
Lee: And the other senior officers.
Lee: Our times working with Alger numeration.
Lee: And most of all the all of the employees have taken significant reductions in compensation.
Lee: Many of our talented team members have also made sacrifices.
Lee: They are driven by a shared commitment.
Lee: The proving neurons potential.
Lee: And ultimately helping.
Lee: A L S patients and we're all done the neuro degenerative disease.
Lee: We are deeply grateful for their dedication.
Chaim Lebovits: We are deeply grateful for their dedication.
Chaim Lebovits: I want to ensure they are recognized and rewarded for their contributions. ALS is a devastating We are committed to providing a therapeutic solution. We are confident in the foundation we have built. and the progress we are making. We will continue to provide updates as we advance through the PACE-DB trial. We are committed to doing all we can to make this happen.
Lee: I want to sure Theyre recognized and rewarded for their contributions.
Lee: ALS is a devastating disease.
Lee: We are committed to providing a therapeutic solution.
Lee: We are confident in the foundation, we have built.
Lee: And the progress we're making.
Lee: We will continue to provide updates as we advance through the phase <unk> trial.
Lee: We are committed to doing all we can to make this happen.
Lee: Thank you for your continued support.
Chaim Lebovits: Thank you for your continued support.
Alla Patlis: I'll now turn the call over to Alla to review the financials. Thank you, Chaim. Research and Development Expenditures Net for the year ended December 31, 2024 were $4.7 million. This compared to $10.7 million for the year ended December 31, 2023. General and Administrative Expenses for the 12 months ended December 31, 2024 were approximately $7 million, compared with $10.7 million in 2023. Net loss for the 12 months ended December 31, 2024 was approximately $11.6 million or $2.31 per share. This compares with a net loss of approximately $17.2 million or $6 per share for the 12 months ended December 31, 2023.
al: I'll now turn the call over to Al to review the financials.
Lee: Sure.
al: Thank you Ed.
al: Everybody starts and development expenditures net for the year ended December 31st. Thank you. Thank you for what.
al: Corporate incentive.
al: This compares to $10 7 million for the year ended December 31st 2023.
al: General and administrative expenses for the month.
al: And at December 31st. Thank you. Thank you for or interruption that you said a million compared with $10 7 million invented right next door.
al: Months ended December 31st. Thank you. Thank you for what approximately $11 6 million or $2.31 per share.
al: This compares with a net loss of approximately $17 2 million.
al: $6 per share.
al: Months ended December 31st when do you think that's right.
Alla Patlis: Cash, Cash Equivalents, and Retrieved Cash were approximately $0.4 million as of the end of December 2024, compared to $1.5 million as of the end of December 2023.
al: Cash cash equivalents and restricted cash or approximately 0.5 4 million.
al: At the end of December 2024, compared to $1 5 million at the end of September 23.
Alla Patlis: The company is announcing today that they have entered into a Warm Inducement Agreement, to which they expect to raise approximately $1.64 million in gross proceeds. This agreement is expected to close on or about April 1st, 2025.
al: The company is announcing today that they had entered into one investment agreement pursuant to which you expect to raise approximately $164 million and growth perspective.
al: This agreement is expected to close Don already about 10 to 25.
Chaim Lebovits: I will now turn the call back to Chaim. Thank you.
al: I will now turn the call back to him.
al: Thank you all are Michael.
Michael Wood: Michael, do you want to read the questions, the prepared questions? Yes, first question here. Some investors are concerned about the delays. the Phase 3b trial. Provide more clarity on the timeline and the resources.
al: Michael do you want to read the questions to prepare question.
al: Yes.
al: First question here.
Speaker Change: Some investors are concerned about the delays in initiating the phase III trial can you. Please provide more clarity on the timeline of the reasons for the perceived delays.
Michael: Thank you Michael as I said.
Chaim Lebovits: Thank you, Michael. As I said, we understand the urgency and frustration regarding the trial time. We share that frustration, but while we are moving as quickly as possible. Pioneering a complex cell therapy like Neuron requires stringent adherence to regulatory processes. The perceived delays are primarily due to the intricate and time-consuming nature of updating and submitting the necessary models to the IND. that includes technical transfer, quality assurance, quality control, document. These are not simply administrative tasks. They involve complex scientific and manufacturing processes. require rigorous validation.
Michael: We understand the urgency and frustration regarding the trial timeline.
Michael: Sure that frustration, but it's while we're moving as quickly as possible.
Michael: Pioneering get complex cell therapy like neuron requires stringent adherence the regulatory process.
Michael: The perceived the delays are primarily due to the interest interested and time consuming nature of updating and submitting the necessary models.
Michael: R&D.
Michael: That includes technical transfer quality assurance quality control documentation.
Michael: These are not simply administrative staff.
Michael: They involve complex scientific.
Michael: Manifests manufacturing processes require rigorous validation.
Michael: Additionally.
Chaim Lebovits: Additionally. The Negotiators. and finalization of clinical trial agreements with multiple sites take time. The period between our NASDAQ non-compliance and our non-compliance. and the grant of the extension also created the challenging financial environment. We are now focused on finalizing this agreement. and initiating patient enrollment as quickly as possible. We anticipate announcing the IND model submission. Shortly, which will be an important month.
Michael: The negotiation.
Michael: And finalization of clinical trial agreements with multiple sites take time.
Michael: The period between our NASDAQ noncompliance and nonsense Andrew.
Michael: And the grant of the extension also created the challenging financial environment.
Michael: We're now focused on finalizing these agreements and initiating patient enrollment as quickly as possible.
Michael: We anticipate that I don't think the I N D model submission, shortly which will be an important milestone.
Speaker Change: Our next question can you elaborate on the financial situation and how you plan to secure the necessary funding for the trial.
Chaim Lebovits: Next question, can you elaborate on the financial situation and how you plan Necessary funding for the trial. Yes, thank you, Michael, for that one. We're actively pursuing multiple funding avenues to ensure the successful execution of our Phase 3B trial.
Michael: Yes. Thank you Michael for that one we were actively pursuing multiple folding I haven't used to ensure the successful execution of our phase two b trial.
Chaim Lebovits: This morning, we announced a significant step in bolstering our financial position raising approximately $1.64 million through warranty. Demonstrating investor confidence in our strategy, as mentioned. We're also exploring. The Licensing of Non-Core Assets for Near-Term Capital. We're also focusing on securing non-dilutive financing through grant opportunities, a strategy that has proven successful for us in the past. Notably, we received a CIRM grant of approximately $60 million for our Phase III trial. We anticipate needing approximately $20-30 million annually for the trial, given the current market conditions, particularly for non-revenue-viable companies. As I said in my remarks, raising all forms of trust.
Michael: This morning, we announced a significant step in bolstering golf and that's a position raising.
Michael: Approximately 164 million through warrant inducement.
Michael: Demonstrating investor confidence in our strategy as mentioned.
Michael: We're also exploring.
Michael: And think of non core assets for near term capital.
Michael: We're also focusing on securing non dilutive financing through grants a person as a strategy.
Michael: Proven successful for us in the past.
Michael: Notably.
Michael: We received a serum grant of approximately $60 million or a phase III trial.
Michael: We anticipate needing approximately 23 million annually for the trial.
Michael: Given the current market conditions, particularly for non revenue by other companies.
Michael: As I said in my remarks reasonable old phones upfront.
Chaim Lebovits: is not realistic. We are confident that as we achieve scheme outcomes. such as the IND model submissions, CTA signings, and enrollment of the first. Our market valuation will improve, making it easier to secure additional funding. We're also open.
Michael: He is not realistic we're confident that as we achieved key milestones.
Michael: Just the I in the models submissions Cta signings and they're all rolled into the first patient our market valuation will improve.
Michael: Looking at easier to secure additional funding.
Michael: We're also open.
Michael: Preceding strategic partnerships that can provide financial and operational support.
Chaim Lebovits: Proceeding Strategic Partnerships that can provide financial and operational support.
Michael: Thank you.
Michael: Next question, some analysts and investors are skeptical about the ethics efficacy of neurons. How do you plan to address these concerns.
Unknown Executive: Next question. Some analysts and investors are skeptical about the efficacy of neurons. How do you plan to address this?
Bob: Yeah. Thank you Bob would you take this question.
Dr. Bob Dagher: Yeah, thank you, Bob. Would you take? Sure, thank you for the question. As we all know, as we all know, there has been a lot of thought and progress and design changes and agreements with FDA on the next path for neuron under the special protocol assessment agreement. We have made it clear that we are pursuing the right population that is target for our therapy with the most success and data generated from previous trials. The choice of the endpoints, the duration of the trial, the critical design elements of this have de-risked our program significantly, and hence we feel strongly about our.
Michael: Sure. Thank you for the question.
Michael: As we all know as we all know there has been a lot of.
Michael: Salt in progress and well design changes and agreements with FDA on the next possible neuron.
Michael: Under the special Protocol assessment agreement.
Michael: We have made it clear that we are pursuing.
Michael: The life population, that's as targets for our therapy was the most success and data generated from previous trials.
Michael: The choice of the endpoints the duration of the trial.
Michael: The critical design elements.
Michael: This.
Michael: Have to deal with the whole program significantly and hence we feel strongly about.
Michael: Probability of success. The next time around with this landmark phase <unk> trial that we are embarking on initiating and completing.
Dr. Bob Dagher: Probability of success this next time around with this landmark phase 3b trial that we are embarking on initiating and completing. This trial is designed to provide definitive evidence of neurons efficacy, and I emphasize definitive. That we are really focused on what it's gonna take to make sure that we demonstrate our, the therapeutic effects of neuron under the regulatory constraints and and and all the elements in place needed provided that the data comes positive that we will be filing our and and support approval for our therapy. It's also important to note that many of the leading key opinion leaders in ALS that we consult with them all the time.
Michael: This trial is designed to provide definitive evidence of nuance of secrecy and I emphasize definitively I'll really.
Michael: Our focus on what it's going to take to make sure that we demonstrate.
Speaker Change: Oh Oh.
Speaker Change: The particular sexual school on Unbilled, the regulatory constraints and and all the elements in place needed.
Speaker Change: Provided that the data comes positive that we will be filing our BLA.
Speaker Change: And support approval.
Speaker Change: Sarah.
Speaker Change: It's also important to note that many of the leading key opinion leaders and the loss that we consult with them. All the time it was going to stay in contact with them. Many has served as principal investigators all previous each while strongly believe in bluelinx potential having seen and have even been close to the data in and out.
Dr. Bob Dagher: We're constantly in contact with them. Many have served as principal investigators of previous phase 3 trials strongly believe in neurons potential, having seen and having been close to the data and and and worked with patients who who were given our therapy in the past. I particularly emphasize in the early stage of the patient population, this disease, we have to basically put put in place all the parameters to enroll the population that will benefit most from this treatment. And the evidence is there, so we feel very strong about. Also, we have received very strong support from many neurologists, scientists, advocacy groups, the patients themselves.
Speaker Change: <unk> worked with patients, who who will give them the whole set up in the past.
Speaker Change: Particularly with the size of the early stage of the patient population.
Speaker Change: We have to make.
Speaker Change: Italy.
Speaker Change: <unk> put in place all the parameters to enroll D. The population that will benefit most.
Speaker Change: From the street and the evidence is there so we.
Speaker Change: We feel very strong about that.
Speaker Change: Also we have very strong support from many neurologists scientist advocacy groups.
Speaker Change: <unk> themselves.
Dr. Bob Dagher: So yeah, this skepticism, we acknowledge it exists, but we are committed to providing the data, decisive data that will basically, you know, speak for itself at the end of the day.
Speaker Change: So yeah. The skepticism we acknowledged that exists, but we are committed to providing the data.
Speaker Change: The data that will basically.
Hum.
Speaker Change: Equal itself at the end of the day. Thank you Michael.
Michael Wood: Thank you, Michael.
Speaker Change: Yeah.
Speaker Change: Thank you Bob next question what is the status of the manufacturing facilities and how will you ensure a consistent supply of neurons.
Unknown Executive: Next question. What is the status of the manufacturing facilities? And how will you ensure a consistent supply?
Speaker Change: Thank you I will ask her to respond to the questions.
Unknown Executive: Thank you.
Dr. Haro Hartounian: I will ask Harold to respond. Thank you, Michael, for the question. As discussed in the prepared remarks, we have established a robust manufacturing strategy to support the Phase 3b trial and future commercialization. We have contracted with Plurink for clinical manufacturing, leveraging their expertise in GMP-compliant production. These complements our leased facility at Sorsky Medical Center in Tel Aviv. We are also planning to bring an additional U.S.-based manufacturing center online to support broader production needs. Our internal teams and partners remain focused on meeting all CMC requirements. This multifaceted approach will ensure a consistent and reliable supply of neurons for the trial and beyond.
Speaker Change: Thank you Michael for the question as discussed in the prepared remarks, we have established a robust manufacturing strategy to support the phase III trial and future commercialization.
Speaker Change: We have contracted with two rigs for clinical manufacturing leveraging their expertise in GMP compliant production. These.
Speaker Change: This complements our leased facility at <unk> Medical Center in Tel Aviv, you also planning to bring in additional U S. Based manufacturing center online to support broader production needs. Our internal teams and partners remain focused on meeting all CMC requirements.
Speaker Change: This multifaceted approach will ensure a consistent and reliable supply of new rolling for the trial and beyond.
Speaker Change: Thank you our next question given the current financial constraints.
Unknown Executive: tomorrow.
Chaim Lebovits: Next ques- given the current financial. How is the company ensuring operational continuity and maintaining its commitment to starting the Phase III trials? Thank you, Michael. We understand the importance of maintaining operational continuity and delivering on our commitment to the Phase 3B trial. Despite the financial challenges, our team remains deeply dedicated and focused. We've implemented strategic cost-saving measures, including salary reductions for many and periods during which members of our senior leadership have worked without compensation. to prioritize the trial's progress. Our task consists of highly skilled and experienced professionals who are passionate about bringing neurons to ALS patients.
Speaker Change: How is the company, ensuring operational continuity and maintaining its commitment to starting the phase III trial phase III trial.
Speaker Change: Thank you Michael we understand the importance of maintaining operational continuity and delivering on our commitment to the phase II B trial.
Speaker Change: Despite the financial challenges our team remains deeply dedicated and focused.
Speaker Change: We have implemented strategic cost savings measures, including salary reductions for many.
Speaker Change: And tourism, which members of our senior leadership have worked with all of the compensation.
Speaker Change: But outside of the trials progress.
Our traffic staff consists of highly skilled.
Speaker Change: Experienced professionals, who are passionate about bringing neurons here left.
Speaker Change: Their dedication is a testament to their belief the potential of this therapy.
Chaim Lebovits: Their dedication is a testament to their belief in the potential of this therapy. We're confident in our ability to navigate these challenges and advance the child. We are committed to ensuring that the team's dedication.
Speaker Change: We're confident in our ability to navigate these challenges.
Speaker Change: The trial activity.
Speaker Change: We are.
Speaker Change: It.
Speaker Change: Sure.
Speaker Change: The team's dedication.
Chaim Lebovits: will be recognized and rewarded as we achieve our mark.
Speaker Change: We will be recognized and rewarded as we achieve our mouth.
Speaker Change: Thank you and one final submit a question here.
Chaim Lebovits: and one final submitted question. Why don't you just refile the original? Refiling the BLA at this time would not, in our best opinion, be the most strategic path forward.
Speaker Change: Why don't you just re file the original BLA.
Speaker Change: Okay.
Speaker Change: Huh.
Speaker Change: Finally, the BLA at this time would not in our best opinion would be the most strategic path forward.
Speaker Change: We are focused on generating robust data required.
Chaim Lebovits: We're focused on generating robust data required by the FDA through the Phase 3B trial, according to our SPA agreement with the FDA. This trial is designed to address Civic Concern. raised and provide the evidence necessary to support a new BLA and a successful path to approval. We believe this approach will ultimately lead to a more definitive and sustainable path to bringing the neuron to life. Thank you.
Speaker Change: By the FDA through the phase II B trial.
Speaker Change: To our Spa agreement with the FDA.
Speaker Change: This trial is designed.
Speaker Change: The address.
Speaker Change: Specific concerns.
Speaker Change: And provide the evidence necessary to support and new B L. A.
Speaker Change: And the successful path to approval.
Speaker Change: We believe this approach will ultimately lead to a more definite this a sustainable path to bringing in the world to patients.
Speaker Change: Thank you.
Speaker Change: Operator, Jenny do we have any.
Operator: Operator Jenny, do we have any questions on the line? Yes, we do.
Speaker Change: Questions on the line.
Speaker Change: Yes, we do I'm, just going to read the instructions to the audience. If anyone else would like Q up so will now be conducting a question answer session via the phone lines. If he would like to ask a question you can press star one on your phone keypad now a confirmation tone will indicate that your line is in the queue. You May press star two if you would like to remove your question.
Operator: I'm just going to read the instructions to the audience if anyone else would like to queue up. So we'll now be conducting our question and answer session via the phone lines if you Question, you can press star one on your. Now a confirmation. Thank you. You may press star 2 if you would like to remove.
Speaker Change: From the key so anyone using speaker equipment, it may be necessary to pick up your handset before pressing the keys. Please like mainland Maulsby poll for questions.
Operator: For anyone using speaker equipment, it may be necessary to pick up your handset.
Jason Mccarthy: Please wait a moment whilst Your first question is coming from Jason McCarthy of The Maxim Group. Jason, your line is open. Good morning, Chaim and team. Thanks for the update. Can you speak, I guess, broadly about your thoughts on the changing environment in the cell therapy space, particularly unmodified cells like neurons? They're not genetically manipulated in any way. Since we've seen one approval in January, we're probably going to see another. And while Brainstorm has done tremendous things in getting the spa in alignment with FDA, the whole environment seems to have changed towards being more favorable to exactly what you're doing.
Speaker Change: Thank you. Your first question is coming from Jason Mccarthy of Maxim Crane, Jason Your line is life.
Jason Mccarthy: Oh, good morning, Hi, and team. Thanks for the update can you speak I guess broadly about your thoughts on the changing environment in the cell therapy space, particularly.
Jason Mccarthy: Modified cells like neuro, and then that genetically manipulated or any way you could take it since we've seen one approval in January we're probably going to see another and while brainstorm is done.
Jason Mccarthy: Tremendous things and getting the spa and alignment with FDA the whole environment seems to have changed towards being more favorable to exactly what you're doing and I'm wondering if that opens up avenues of discussion with pharma partners or.
Jason Mccarthy: And I'm wondering if that opens up avenues of discussion with pharma partners or additional sources of non-dilutive capital through grants. Even, you know, we have an administration that, you know, in their prior administration. Put that right to try in place and now there's somebody at HHS that is a big believer in stem cells.
Jason Mccarthy: Additional sources of non dilutive capital through grants even.
Jason Mccarthy: We have an administration that you know in their prior administration.
Jason Mccarthy: Put that right to try in place and now Theres somebody at H H S that is a big believer in stem cells had all these things.
Chaim Lebovits: How do all these things shape the path forward for Brainstorm? Thank you, Jason. It's a very good question. And the truth is, we try to stay away from the political limelight. We want to stay very focused on the scientific data we want to provide. to be seen how these different staff changes will have an impact on how the FDA goes forward. But I believe that all parties would support good scientific results. I think we timely were able to lock down with the FDA a very strong special protocol assessment which really says that they see merit in our early patient population and they want us to replicate that.
Jason Mccarthy:
Jason Mccarthy: Shape the path forward for brainstorm have.
Jason Mccarthy: Thank you Jason is a very good question. The truth is we try to stay away from the political wildlife.
Jason Mccarthy: We want to stay very focused on the scientific data we want to provide.
Jason Mccarthy: To be seen how this different stuff changes will have an impact on how the vehicles forward, but I believe that all parties would support good scientific results.
Jason Mccarthy: With timely we're able to.
Jason Mccarthy: Lockdown with F D a very strong.
Jason Mccarthy: The protocol assessment, which really says that they.
Jason Mccarthy: They see merit in our early patient population that they want us to replicate that.
Chaim Lebovits: And that's where we are going. So while it's a very tough funding atmosphere, you know how the market is better than me, Chase, and you're an analyst, and biotech is not having it easy, I do believe that we are undervalued at the moment. I know many CEOs say that, but really, we are after the negative outcome we had. And people are skeptical if we're able to pull this off. But I think we're just now on the verge of pulling it off a few weeks later than we had announced and thought. But we're very close to signing for a CTA, getting all these models at the end and the feedback from them.
Jason Mccarthy: And that's where we're going so wildly.
Jason Mccarthy: A very tough.
Jason Mccarthy: The funding atmosphere, you know how the market is better than me chosen you're an analyst.
Jason Mccarthy: Biotech without having a D C I do believe that we're.
Jason Mccarthy: Undervalued at the moment I know many see you'll see that but really we are after the negative upcoming we have.
Jason Mccarthy: And people are skeptical, if we're able to pull this off but.
Jason Mccarthy: But I think we're just now on the verge of pulling it off a few weeks later than we have thought.
Jason Mccarthy: We're very close to finding for Cta.
Jason Mccarthy: Getting all of these models of the a and the feedback from them we are in contact.
Chaim Lebovits: We are in contact. with them on a daily basis when needed, and they wanted the trial to start as well. The rest we'll have to follow and see, but I do recognize the fact that the FDA in December approved the first-ever mesenchymal stem cells for GVHD, and that's very good because we are pioneering, and pioneering has many challenges, and so it was good that another company went through the challenge and got the first mesenchymal cell therapy approved, and I hope that we're going to be the second. Right, thank you. And, you know, prior To these approvals, I know Brainstorm, you know, the year before went through the adcom, went through a whole series of events.
Jason Mccarthy: With them in a daily basis when needed.
Jason Mccarthy: And they wanted us to trial to start as well.
Jason Mccarthy: The rest of it will have to follow and see.
Jason Mccarthy: But I do recognize the fact that the F. D. A N December approved the first ever mesenchymal stem cells for Gvhd and that's very good because we are pioneering and pioneering has.
Jason Mccarthy: And then the challenges. So it was good that another company went through the challenge and got to personalize the Carnival cell therapy approved and hope that we're going to be the second.
Right, Thank you and and you know prior.
Jason Mccarthy:
Jason Mccarthy: To these approvals I know brainstorm ear before went through the I call. It went through a whole series of events, but what's changed as you know.
Dr. Bob Dagher: But what's changed, as you know, between then and now, I think, is how FDA views data sets related to stem cells, obviously far more favorable. And I know the prior question that you had was, why don't you just resubmit the BLA? I understand that you can't, it's not the best path forward. But given FDA's view of these data sets now, from what we've seen, should the prior phase three data be used to support the phase 3B if you're able to complete that trial and file a BLA? Yeah, definitely will support. That's part of the pipeline that will take into consideration the previous data.
Jason Mccarthy: And now I think is how FDA views.
Jason Mccarthy: Data sets related to stem cells obvious save far more favorable I know the prior question that you had was why don't you just sit and resubmit the BLA Ah I understand that you can't it's thought that the best path forward, but given F. D. A's you of these data sets now from what we've seen.
Jason Mccarthy: Should the prior phase III data be used to support.
Jason Mccarthy: The phase three B, if you were able to complete that trial and file a BLA.
Jason Mccarthy: Yeah definitely it will support a that's part of the pipeline.
Jason Mccarthy: They will take in consideration the previous data as we said we want to replicate the early patient population as a result of the phase III trial.
Dr. Bob Dagher: As we said, we want to replicate the early patient population as a result of the Phase 3 trial. Bob, you may want to add some comments to that. Yeah, thanks, Keith. And this is a very important question for us, obviously. So I Everyone knows the main reason why we are all here today is because we believe in that data that was generated. specifically in the early disease population. There was a pre-specified analysis for the population that had a baseline score of about 35, panning out to be positive, as well as many post hoc analyses of early disease.
Jason Mccarthy: Bobby you may want to add some comments to that.
Bobby: Yeah. Thanks, Jason This is a very important question obviously.
Jason Mccarthy: Everyone knows.
Speaker Change: The main reason why we are all here today is because we believe in that data plus.
Jason Mccarthy: It was generated.
Jason Mccarthy: Specifically in the early disease population.
Jason Mccarthy: There was a pre specified analyses for the population that had the baseline school around about 35 banging out can be positive.
Jason Mccarthy: As well as many post talk analysis early disease and all of that data from the previous phase three trial.
Dr. Bob Dagher: And all of that data from the previous phase 3 trial will support the next phase 3b trial specifically in that population. So the pooling of data will be basically strong support We totally agree with you. This is the path that we are taking. Got it.
Jason Mccarthy: We will support the next phase <unk> trial, specifically in that population so the pooling of data basically.
Jason Mccarthy: Strong support.
Jason Mccarthy: We totally agree with you with.
Jason Mccarthy: This is the path that we're taking.
Speaker Change: Got it and last question.
Chaim Lebovits: And last question. I think I heard earlier. There's an ongoing effort to open a manufacturing. Facility here in the U.S. Is that accurate? And two, you know, what would be the kind of the size and capacity of that center? And third part is the discussion with potential investors and their hang up on manufacturing that it's overseas versus not being here in the states. And if so, does this mitigate some of those concerns and reopen those discussions? Well, that was quite a few questions. Thank you for that, Jason. So the answer is that it's quite clear that towards the end of a trial, you want to have a site that's ready for inspection of DFD8 to get commercialized ASAP if you are successful in the primary results of the trial.
Harris: Harris earlier.
Harris: There is the ongoing effort to open a manufacturing.
Harris: <unk> here in the U S.
Harris: Is that accurate and end too.
Harris: What would be the kind of a size and capacity.
Harris: Of that center and third part is the discussion with potential investors and their hang up on manufacturing that its overseas versus not being here in the states.
Harris: And if so does this mitigate.
Harris: Some of those concerns and reopen those discussions.
Harris: Although it was quite a few questions.
Harris: Thank you for that Jason So the answer is that it's quite clear that towards the end of a trial you want to have a site that's ready for inspection of D. F D a to get commercialized SAP.
Harris: If you are successful in the primary results of the trial.
Chaim Lebovits: So, no, there's no concern from the FDA and the center that we are providing to start the trial. But on the other hand, we do want to have ready a stripe that's ready for inspection. So Harrow and the team are rigorously working, and we will be announcing something very soon. So the sites that we are looking forward to partner with in the United States. I hope that answers your question. Yes. Great. Thank you, Chaim. Thank you very much.
Jason Mccarthy: So no there's no concern from the FDA on the center, we are providing.
Jason Mccarthy: The trial, but on the other hand, we do want to have ready a strike that is ready for inspection.
Speaker Change: Heroines of team Ruger.
Jason Mccarthy: A rigorous who working again, we will be announcing something very soon.
Jason Mccarthy: The sites took me are.
Speaker Change: Looking forward to partner with them to the United States.
Speaker Change: I hope that answers your question, yes, great. Thank you hi.
Speaker Change: Thank you very much.
Speaker Change: You only have time for one multiple question. Thank.
Unknown Executive: We have time for one more question. Thank you.
Speaker Change: Thank you.
David Bautz: Yep, your next question is coming from David Bautz. David, your line Hey, good morning, everyone. Thanks for the overview this morning. I just got a couple of follow up financial questions.
Speaker Change: Your next question is coming from David Bautz, Zacks small cap David Your line is nice.
David Bautz: Hey, good morning, everyone. Thanks for the overview. This morning, I've just got a couple of follow up financial questions.
Chaim Lebovits: Chaim, what percentage, I don't know if you can quantitate completely, but what percentage of financing do you want to have in place before you're comfortable with getting the trial started? And then how quickly after that funding is in place do you think the first patient can be enrolled? That's a very good question. So the answer is, we are working very close with our partners. So we're having those discussions and the partners are giving us a lot of leeway. This is very outstanding and we are very grateful for those partners. That's not something that's difficult. I think our partners see the upside of this product.
Speaker Change: Hum what.
Speaker Change: Percentage I don't know if you can quantitate completely but what percentage of financing do you want to have in place before you're comfortable with getting trials started and then how quickly after that funding is in place do you think the first patient can be enrolled.
Speaker Change: That's a very good question. So the answer is we are working very close with our partner. So we're having those discussions and the partners are giving us a lot of leeway.
Speaker Change: Which is very outstanding and we're very grateful for those partners.
Speaker Change: It's not something that is typical I think our apartment see the upside of this product.
Chaim Lebovits: It's almost like a mission to get this product into patients. There's no one else that's going to do the trials, not Brainstorm. And those partners are really partnering with us in an outstanding way.
Speaker Change: It's almost like a mission to get this product into patients.
Speaker Change: Theres no one else is going to do the trials not brainstorm on both partners are really partnering with us.
Speaker Change: I'll start anyway, having said that.
Chaim Lebovits: Having said that, in addition to what we wrote in today is just to be able to start. finalize the preparations. We are having, of course, other funding in the pipeline, which we cannot discuss at this day, but I think once we announce that, everyone will be comfortable with our plan going forward. And that's in addition to Non-Delusional Grants, which is also in the pipeline for the fall. Okay, thanks for taking the question. Thank you very much. and that one now.
Speaker Change: In addition to what we wrote in two days just to be able to talk.
Speaker Change: Finalize preparations.
Speaker Change: We're having of course other fundings in the pipeline.
Speaker Change: Which we cannot disclose at this day, but.
Speaker Change: Once we announce that.
Speaker Change: Everyone will be comfortable with our plan going forward.
Speaker Change: And that's in addition to non dilutive grant.
Speaker Change: Which is also on the pipeline for the fall.
Speaker Change: Okay. Thanks for taking the question.
Speaker Change: Thank you very much.
Speaker Change: Lee.
Speaker Change: <unk> reached.
Speaker Change: And our final question and answer session I will now hand back over time for any closing comments.
Chaim Lebovits: Time for any I just want to thank everyone for joining us today. And we're looking forward to the next update. Hopefully it will be after the first patient in and in a different environment for our financial situation as well. Thank you very, very much. Thank you very much.
Speaker Change: I just wanted to thank everyone for joining us today and we're looking forward for the next update hopefully it will be after the first patient in and are in a different environment for our financial situation as well. Thank you very very much.
Speaker Change: Yeah.
Speaker Change: Thank you very much. This does conclude today's conference call. You may disconnect. Your phone lines at this time and have a wonderful day. Thank you for your participation.
Operator: This does conclude today's webinar. Phoneline.
Speaker Change: Okay.