Q1 2025 Brainstorm Cell Therapeutics Inc Earnings Call

Speaker Change: [music].

Greetings and welcome to the Brainstorm cell Therapeutics first quarter 2025 conference call. At this time, all participants are in a listen only mode as.

Operator: Greetings and welcome to the Brainstorm Cell Therapeutics first quarter 2025. At this time, all participants are in a As a reminder, this call is being I would now like to introduce your host for today's call, Joyce Lonergan of Life Sciad Joyce, you may.

As a reminder, this call is being recorded I would now like to introduce your host for today's call Joyce Lonergan of lifestyle advisers choice you may begin.

Joyce Lonergan: Thank you Holly.

Joyce Lonergan: Thank you Holly good morning, and thank you for joining us today.

Joyce Lonergan: Good morning and thank you for joining us today. Before passing the call to company management for prepared remarks, I would like to remind listeners that this conference call 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 for the treatment of neurodegenerative disorders such as ALS, the sufficiency of the company's existing capital resources for continuing operations in 2025 and beyond, the safety and clinical effectiveness of the Neuron technology platform, clinical trials of Neuron and related clinical development programs, and the company's ability to develop strategic collaborations and partnerships to support their business planning efforts.

Joyce Lonergan: Before passing the call to company management for prepared remarks, I would like to remind listeners that this conference call will contain 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 kit.

Joyce Lonergan: Neuro degenerative disorders, such as a L. S. The sufficiency of the company's existing capital resources for continuing operations in 2025 and beyond the safety and clinical effectiveness of the neuron technology platform clinical trials of neuron and related clinical development.

Joyce Lonergan: Programs and the Companys ability to develop strategic collaborations and partnerships to support their business planning efforts.

Joyce Lonergan: Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond Brainstorm's control, including the risks and uncertainties described from time to time in its SEC filings. The company's results may differ materially from those projected on today's call.

Joyce Lonergan: Forward looking statements are subject to numerous risks and uncertainties many of which are beyond <unk> control, including the risks and uncertainties described from time to time in our SEC filings.

Joyce Lonergan: The company's results may differ materially from those projected on today's call. The company undertakes no obligation.

Joyce Lonergan: The company undertakes no obligation to publicly update any forward-looking statements.

Joyce Lonergan: Quickly update any forward looking statements.

Joyce Lonergan: Joining us on the call today will be Chaim Lebovits, President and Chief Executive Officer of Brainstorm, Dr. Hara Hartounian, Executive Vice President and Chief Operating Officer, Dr. Bob Dagher, Executive Vice President and Chief Medical Officer, and Dr. Netta Blondheim Schrage, Senior Vice President of Research and Development. I would now like to turn the call over to Mr. Lebovits. Please go ahead. Thank you, Joyce. Good morning or good afternoon, everyone. Thank you for joining us today. We appreciate your continued interest and support.

Speaker Change: Joining us on the call today will be <unk>, President and Chief Executive Officer of Brainstorm, Dr. Hart Sounion, Executive Vice President and Chief Operating Officer, Dr. Backpacker Executive Vice President and Chief Medical Officer, and Dr. <unk> <unk> Senior Vice President of research and development.

Speaker Change: I would now like to turn the call over to Mr. <unk>. Please go ahead.

Speaker Change: Thank you Joyce.

Speaker Change: Good morning, or good afternoon, everyone.

Speaker Change: Thank you for joining us today.

Speaker Change: We appreciate your continued interest and support and brainstorm.

Speaker Change: We published our Q1 2025 earnings release.

Chaim Lebovits: Republish our Q1 2025 earnings After the market closed last And colleagues and I are pleased to provide a corporate update. Our unwavering primary focus remains The Execution of the Clinical Development Plan for Neurons and the Initiation of our Pivotal Phase IIIb Trial designed to confirm its therapeutic benefits for individuals in the early stages of ALS. Hopefully you will have seen the press release released this morning announcing that USFDA has cleared us to initiate This follows the amendments we submitted to our Investigational New Drug application. Included Comprehensive Technical Transfer Documents. Robust Quality Assurance. This regulatory clearance marks a significant milestone, bringing us closer to commencing As previously disclosed, the trial design has been carefully agreed upon with the FDA under a Special Protocol Assessment, or SPA.

Speaker Change: After the market closed last Thursday, and then colleagues and I are pleased to provide a corporate update today.

Speaker Change: Our olive wavering primary focus remains the execution of the clinical development plan for neuro and the initiation of our pivotal phase III trial designed to confirm its therapeutic benefit for individuals in the early stages of Atlas.

Speaker Change: Hopefully.

Speaker Change: You will have seen the press release released this morning announcing that U S. F D. A.

Speaker Change: Has cleared us to initiate the trial.

Speaker Change: This follows the amendments we submitted an investigational new drug application.

Speaker Change: Which included comprehensive technical transfer documentation.

Robust quality assurance and stringent quality control processes.

Speaker Change: This regulatory clearance marks a significant milestone, bringing us closer to commencing patient enrollment.

Speaker Change: As previously disclosed the trial design has been carefully agreed upon with the FDA under a special protocol assessment or spa.

Chaim Lebovits: This spa is a crucial element, as we believe it substantially de-risks the regulatory path We provide confirmation that the trial's endpoints and our statistical analysis are deemed appropriate for the FDA to potentially support approval contingent upon the trial meeting. We also announced previous that in a face-to-face type-C meeting, we had achieved alignment with the FDA and CNN.

Speaker Change: This spa is a crucial element as we believe it's substantially de risks are real good.

Speaker Change: That's already passed me a final rule.

Speaker Change: It provides confirmation that the child's endpoints and statistical analysis plan are deemed appropriate for the FDA to potentially support approval.

Speaker Change: Finjan upon the trial meeting its pre specified expectations.

Speaker Change: We also announced previously.

Speaker Change: It doesn't the face to face type C meeting, we had achieved alignment with the FDA on C. M C.

Chaim Lebovits: a particularly vital as. Aspect of for an advanced cell therapy Our CMC team. is always advancing its development and continues to work as regulatory guide.

Speaker Change: Particular revivalist back aspect.

Speaker Change: Aspect of sport and advanced cell therapy like neuro.

Speaker Change: Our CMC team.

Speaker Change: As always advancing its development that continues to work as regulatory guidance directs.

Speaker Change: To provide further detail on our operational readiness for the upcoming trial.

Chaim Lebovits: to provide further detail on our operational readiness for the upcoming trial.

Hara Hartounian: I'd like to turn the call over to our Chief Operating Officer, Dr. Harold Artunio. Thank you, Chaim. As previously discussed, we plan to initiate our initial manufacturing for the phase 3b trial at the Tel Aviv Swarovski Medical Center. to scale up our manufacturing capabilities. We'll then proceed with a technology transfer to Plurie, which will provide additional clean room facilities. We have signed a letter of intent with Plurie and anticipate moving forward to a definitive contract soon.

Speaker Change: Like to turn the call over to our Chief operating Officer, Dr. O'hara 20 O.

Speaker Change: Carol.

Speaker Change: Thank you.

Speaker Change: As previously discussed we plan to initiate our initial manufacturing for the phase III trial at the Tel Aviv source Good Medical Center.

Speaker Change: To scale up our manufacturing capabilities will then proceed with the technology transfer to glory, which would provide additional clean room facilities.

Speaker Change: We have signed a letter of intent with Fleury and anticipate moving forward to a definitive contract. So.

Hara Hartounian: Further. team and I have secured a leading U.S. clinical site that has successfully passed FDA inspection. We are in the process of finalizing an LOI, and we'll be announcing the details of this important site shortly. We are all very excited about the progress and remain hopeful that we can begin treating patients soon.

Speaker Change: Furthermore.

Speaker Change: The team and I have secured a leading U S clinical sites that has successfully passed FDA inspection.

Speaker Change: We are in the process of finalizing an LOI and we'll be announcing the details of this important sites shortly.

Speaker Change: We are all very excited about the progress and remain hopeful that we can begin treating patients soon.

Chaim Lebovits: Back to you, Chaim. Thank you, Harold. for that important update on our manufacturing and site selection progress. Currently, we're actively engaged in negotiations for the clinical trial agreement. with approximately 15 leading clinical centers across the United States. Each points to serve as a site for a Phase 3b trial. The strong interest we are getting from numerous renowned ALS clinicians and researchers underscores their conviction in the potential of neurons. We will make announcements regarding these agreements as they are finalized. As noted in our earnings press release, the details of the trial, which we are calling Endurance have now been posted on clinicaltrials.gov.

Speaker Change: Back to you.

IRA: Thank you IRA.

Speaker Change: Well that important update on our manufacturing and site selection progress.

Speaker Change: Currently we're actively engaged in negotiations for the clinical trial agreements with approximately 15, leading clinical centers across the United States.

Speaker Change: Each poised to serve as a site for a phase III trial.

Speaker Change: The strong interest we are getting from numerous Renault clinicians and researchers on the scores that our conviction in the potential of neurons.

Speaker Change: We will make announcements regarding these agreements as they are finalized.

Speaker Change: As noted in our earnings specialties, the details of the trial.

Speaker Change: Which we're calling endurance.

Speaker Change: I have now been posted a clinical trials Gov.

Chaim Lebovits: On this website, you will see the study plan, including primary and secondary endpoints. as well as a list of clinical sites that we expect will participate. Publication of these details is important for transparency and allows the medical community and mainly ALS patients who are interested in participating, as well as caregivers, to review the structure of the study. We fully recognize the urgency felt by patients and clinicians for innovative therapeutic options in ALS. Our commitment is absolute in executing this trial with the highest level of scientific rigor. with a limited treatment options currently available for ALS patients.

Speaker Change: This website you will see the study plan.

Speaker Change: Including primary and secondary endpoints.

Speaker Change: As well as a list of clinical sites that we expect will participate.

Speaker Change: Publication of these detail it's important for transparency and allows the medical community and mainly if patients are interested in participating as well as caregivers to review the structure of the study.

Speaker Change: We fully recognize the urgency felt by patients.

Speaker Change: Clinicians for innovative therapeutic options in a L. S.

Speaker Change: Our commitment is absolute and executing this trial was the highest level of scientific rigor.

Speaker Change: With the limited treatment options currently available for Ebola patients.

Chaim Lebovits: We firmly believe that Neuron is successful in the study and subsequently approved, holds the promise of becoming a significant and valuable treatment.

Speaker Change: Firmly believe the new rule is successful in this study and subsequently approved holds the promise of becoming a significant and valuable treatment.

Speaker Change: In parallel with our dedicated in their own development efforts.

Chaim Lebovits: in parallel with our dedicated neuron development efforts. Our scientific team remains actively engaged. with the academic community and our industry peers, sharing the latest data.

Speaker Change: Scientific team remains actively engaged with.

Speaker Change: With the academic community and our industry peers shading, the latest data and insights.

Chaim Lebovits: Last week, we participated in the annual ALF Drug Development Summit in Boston. and Crucial Gatherings that brought together over 200 scientific leaders to address the most pressing challenges in the therapeutic development for this devastating The discussions at this year's meeting were centered on critical areas, such as target validation. Effective Utilization of Biomarkers and the Optimization of Clinical Trials .

Speaker Change: Last week, we participated in the annual elite drug development summit in Boston.

Speaker Change: A crucial gatherings are brought together over 200 scientific leaders to address the most pressing challenges in the therapeutic development for this devastating disease.

Speaker Change: The discussions at this year's meeting were centered all critical areas such as target validation.

Speaker Change: The effective utilization of my Biomarkers and optimization of clinical trial design.

Speaker Change: I wanted to take a moment to speak about our incredible team at Redstone.

Chaim Lebovits: I want to take a moment to speak about our incredible team at NASA. despite facing significant financial constraints. A reality for many small biotech companies in the current environment. Their dedication and tireless efforts are truly remarkable.

Speaker Change: Despite facing significant financial constraints.

Speaker Change: Our reality for many small biotech companies in the current environment.

Speaker Change: Their dedication and tireless efforts are truly remarkable.

Speaker Change: We heard a very powerful message at the L. A summit from Wendy.

Chaim Lebovits: We heard a very powerful message at the ALS Summit from Wendy. a courageous individual living with ALS. who eloquently referred to every ALS patient as a warrior. At Brainstorm, we see it as part of our mission to join the ranks of these warriors. working every single day to advance preparations for the critical trial. We are succeeding in making substantial progress. with the limited financial resources we currently have.

Speaker Change: Courageous individuals living with Atlas.

Speaker Change: Oh, I love liter firms. So every patient as it were.

Speaker Change: Warrior.

Speaker Change: At Brainstorm, we see it as part of our mission to join the ranks of these warriors.

Speaker Change: Working every single day.

Speaker Change: To advanced preparations for the critical trial.

Speaker Change: We are succeeding in making substantial progress with the limited financial resources. We currently have.

Chaim Lebovits: Thanks a lot. to the outstanding support of our dedicated partners. This positions us to move forward with significant agility once we secure a strategic funding deal, which remains our key priority. We understand that members of the investment community and the ALF community are eager to know precisely when the first patient will be enrolled. Please know that our focus remains squarely on diligently completing the necessary steps, including securing adequate funding as we are working to advance various funding opportunities that include potential strategic investments and non-dilutive grants. We're simultaneously proceeding on many fronts to be able to initiate the trial as swiftly, as responsibly as possible.

Speaker Change: So large.

Speaker Change: So the outstanding support of our dedicated partners.

Speaker Change: This positions us to move forward with significant they're guilty.

Speaker Change: Once we secure a strategic funding deal which remain.

Speaker Change: Priority.

Speaker Change: We understand that members of the investment community community are eager to know precisely when the first patient will be enrolled.

Speaker Change: Please know that our focus remains squarely on diligently completing the necessary steps.

Speaker Change: Clothing, securing adequate funding as we are working to advance various funding opportunities that include potential strategic investments and non dilutive grants.

Speaker Change: We are simultaneously preceding on many fronts to be able to initiate the trial as swiftly as responsibly as possible.

Speaker Change: We are deeply committed to this endeavor endeavor and we will continue to provide updates as they become available.

Chaim Lebovits: We are deeply committed to this endeavor, and we will continue to provide updates as they become available.

Bob Dagher: I'll now turn the call over to Dr. Bob Dagher, Brainstorm's Chief Medical Officer, who will give a brief summary of his presentation at the ALS Summit last week. Thank you. Hi. Hi, everyone. As part of my presentation last week, I provided a detailed overview of the design of our planned phase 3B trial and explained the significant changes we made versus our prior phase 3 trial in order to increase the probability of success. As we have previously disclosed, the new trial will be conducted in two parts. Part A is a 24-week double-blind period, which will be followed by Part B, a 24-week open-label extension designed to evaluate long-term effects on survival and biomarkers.

Speaker Change: I'll now turn the call over to Dr. Bob Dagger, Greenfields, Chief Medical Officer, who will give you a brief summary of his presentation.

Speaker Change: Summit last week Bob.

Speaker Change: Yeah.

Speaker Change: Thank you hi, everyone.

Speaker Change: The bulk of my presentation last week I provided a detailed overview of the design of our planned phase <unk> trial.

Speaker Change: Explain the significant changes we made this adult trial phase III trial in order to increase the probability of success.

Speaker Change: As we have previously disclosed the new trial will be conducted in two parts.

Speaker Change: He is a 24 week double blind period, which will be followed by part B.

Speaker Change: Four week open label extension designed to evaluate both during the cycle survival in Biomarkers.

Bob Dagher: We have set the entry criteria to enroll patients who have early stage ALS, in other words, those with less advanced level of functional decline. The primary endpoint will be the change from baseline to week 24, so at the end of part A, in the ALS FRSR total score, which is now considered the gold standard in recent registrational trials. The results from Part A at 24 weeks, if they meet our expectations, should be sufficient to support a new BLA. This is covered specifically in our SPA agreement with the FDA. In the phase 3b trial, we eliminated the three-month run-in period from the previous study.

Speaker Change: We have set the entry criteria to enroll patients who have early stage a yellow.

Speaker Change: Other words, those with less advanced level functional big lawyer.

Speaker Change: The primary endpoint will be the change from baseline to week 24, so at the end of.

Speaker Change: And the a lot of Florida, all total score, which is now considered the gold standard and the reason I'm sort of inspirational trials.

Speaker Change: The results from part a 24 week, if they meet our expectations should be sufficient to support a BLA.

Speaker Change: Specifically in our Spa agreement with the FDA.

Speaker Change: In this phase the beats, while we eliminated three months run in period from the previous study.

Bob Dagher: and also shorten the screening period from 20 weeks to now nine weeks to minimize changes between screening and baseline.

Speaker Change: And also shortened the screening period from 'twenty, we do now nine week Dominion might change it between screening and baseline.

Speaker Change: I will now turn the call over to my colleague Dr. Longtime Chicago.

Netta Blondheim: I will now turn the call over to my colleague, Dr. Blondheim-Schwager, to discuss the ALS biomarkers analysis. Netta? Thank you, Bob. My presentation at the ALS Summit focused on biomarkers in ALS and specifically how the experiments we have conducted with biomarkers support the potential multimodal mechanism of action of neurons.

Speaker Change: The biomarker analysis.

Speaker Change: Yes.

Speaker Change: Thank you Bob.

Speaker Change: My presentation at the analyst on it focused on Biomarkers and Atlas and specifically how the experiments we have conducted with Biomarkers support the potential multimodal mechanism of action of neuron.

Netta Blondheim: There is currently no established universal marker for ALS, as it is a complex disease that may require combinations of biomarkers for accurate assessment. We hypothesize that neuron exerts its biological effects across multiple pathways. Analysis of CSF samples from patients who participated in the prior phase 3B, phase 3A study provided us with valuable insight into how neuron may be exerting its effect. CSF samples were collected at seven time points from all participants in the study, and analysis of these samples showed significant changes in biomarkers that are relevant to ALS pathology. Treatment with neuron was associated with a reduction in neuroinflammatory and neurodegenerative biomarkers and with increase in anti-inflammatory and neuroprotective biomarkers.

Speaker Change: There is currently no established universal marker for Atlas as it is a complex disease may require combinations of biomarkers for accurate assessment.

Speaker Change: We have prophesized that neuron exerts its biological effects across multiple pathways.

Speaker Change: Now is this a CSF samples from patients who participated in the prior phase III B phase III study provided us with valuable insight into how narrow and maybe exerting its effect.

Speaker Change: He has had samples were collected at seven points from all participants in the study and the analysis of these samples showed significant changes in biomarkers that are relevant to Atlas pathology.

Speaker Change: Treatment with neuron was associated with a reduction in non inflammatory and neuro degenerative borrowing that Chris and with increase in anti inflammatory and Neuroprotective biomarkers.

Netta Blondheim: At the ALS Summit, we presented the results from three sets of preclinical experiments to investigate the immunomodulation, neuroprotectant, and neurodegenerative properties of neurons. The first of these was an in vitro experimental model of immune-activated peripheral blood mononuclear cells, or PBMCs, that were co-cultured with neuron cells. We demonstrated that neuron inhibits the secretion of pro-inflammatory cytokines and decrease the proliferation of certain types of T cells, CD4 cells, and CD8 cells that are involved in the inflammatory process. The second was an in vitro hypoxia model that examined the effect of neuron on a motor neuron cell line that had been subjected to hypoxic stress in a low oxygen environment and resulted in about one in three cells dying.

Speaker Change: At the Ada that suddenly we presented the results from three sets of preclinical experiments to investigate the immuno modulation neuroprotectant and neurodegenerative properties of neuron.

Speaker Change: First of these was there any vitro experimental models of immune activated peripheral blood mononuclear cells or P. P. M sees that we're co cultured with neuron cells.

Speaker Change: We demonstrated that neuron inhibits the secretion of pro inflammatory cytokines and decrease the proliferation of certain types of T cells C. D. Four cells and CD eight cells that are involved in the inflammatory process.

Speaker Change: The second was an in vitro hypoxia model that examines the effect of neuron on a motor neuron cell lines that had been subjected to hypoxic stress in a low oxygen environment and resulted in about one in 3000 died.

Netta Blondheim: We showed here that when these cells were co-cultured with conditioned media collected from neuron cell cultures, viability was restored to 96.5% of normoxic conditions or 96.5 of normal. providing evidence of a neuroprotective effect. Finally, we studied an experimental neurite outgrowth model in which human neuroblastoma cells were co-cultured in a no-contact transwill system with neuron cells. We showed that neurons enhance growth of neurites, supporting a neuroregenerative role for neurons.

Speaker Change: We showed here that when these cells were co culture with condition media collected from their own cell cultures.

Speaker Change: Liability was restored to 96, 5% of normal conditions or 90, 596 months type of normal.

Speaker Change: Providing evidence of a neuroprotective effect.

Speaker Change: Finally, we studied and experimental Neurite outgrowth model in which human neural stem cells were co cultured in a no contact transwell system with neuron cells.

Speaker Change: We showed that neuron enhanced growth of them know right. So.

Speaker Change: <unk> and Mero regenerative real for now.

Speaker Change: As disclosed previously we reviewed the clinical utility of nerve filament light or NFL as a biomarker of disease progression and treatment monitoring in AOS.

Netta Blondheim: As disclosed previously, we review the clinical utility of neurofilament light, or NFL, as a biomarker of disease progression and treatment monitoring in ALS. Ten patients who completed the prior Phase 3 trial enrolled in an open-label expanded access program that spanned two 28-week periods. We showed that early treatment with Neuron resulted in greater reductions in NFL levels. Among the six participants who received Neuron in both Phase 3 and the EAP, a continual group level reduction in NFL was observed. In contrast, for the four patients who received placebo in the Phase 3, the group median NSL change was higher at the end of the study, indicating a worsening neurodegeneration.

Speaker Change: 10 patients who completed the prior phase III trial enrolled in an open label expanded access program that spend to 28 week periods.

Speaker Change: We showed that early treatment with neuron resulted in greater reductions in NFL levels.

Speaker Change: Among the six participants who received neurons both both phase III and the EAP Kantar.

Speaker Change: Continual group level reduction and NFL was observed.

Speaker Change: In contrast for the four patients who received placebo in the phase III.

Speaker Change: The group mean, the group median NFL change was higher at the end of the study, indicating worsening or degeneration.

Netta Blondheim: After these patients switched to Neuron in the EAP, the majority showed a stabilization in NSL levels.

Speaker Change: After these patients switched neuron in the EAP. The majority showed a stability stabilization in NFL levels.

Netta Blondheim: As these results were from a very small group, we view them as hypothesis-generating and will continue to explore long-term effects of treatment in our upcoming Phase 3B study. at the conference.

Speaker Change: These results were from a very small group, we view them as hypothesis generating and will continue to explore long term effects of treatment in our upcoming upcoming phase III study.

Speaker Change: The conference. We also shared results from a genetic sub study conducted during our phase III study.

Netta Blondheim: We also shared results from a genetic substudy conducted during our phase three. We have examined the underlying genetics of ALS and how it may determine the clinical response to neurons. We are particularly interested in a gene called UNK13A, which has been widely studied in ALS. Patients who were enrolled in the prior Phase 3 trial had the option to participate in a genetic sub-study and 124 consented. We showed in these patients that the UNC13A genotype appeared to influence the response to neuron therapy. Patients who were heterozygous carriers of a risk allele had a statistically significant response rate to neuron treatment compared with placebo.

Speaker Change: We have examined the underlying genetics of Atlas and how it may determine the clinical response to neurons.

Speaker Change: We are particularly interested in a gene called on 13 eight.

Speaker Change: It has been widely studied in Atlas.

Speaker Change: Patients who were enrolled in a prior phase III trial have the option to participate in a genetic sub study and 124 consented.

Speaker Change: We showed in these patients that the UNC 13, eight I'm, sorry, teenage genotype appeared to influence the response to neuron therapy.

Speaker Change: Patients, who are heterozygous carriers of a risk <unk> had a statistically significant response rate in their own treatment compared with placebo.

Netta Blondheim: supporting further investigation of the uncertainty and other genetic factors and their correlation to treatment effect of Neuron in our next trial.

Speaker Change: Supporting further investigation of the 13, eight and other genetic sectors and their correlation to treatment effect of known in our next trial.

Chaim Lebovits: I will now turn the call back to Chaim for closing comments. Thank you, Netta. for the details on Brainstorm's financials for the quarter ended March 31, 2025. I would refer you to the press release we issued on Thursday. and also to our thank you file with this.

Speaker Change: I will now turn the call back to <unk> for closing comments.

Speaker Change: Thank goodness.

Speaker Change: For the details on <unk> financials for the quarter ended March 31 2025.

Speaker Change: I would refer you to the press release, we issued on Thursday.

Speaker Change: And also to our 10-Q filed with the FCC.

Speaker Change: We're now ready for the Q&A Joyce.

Joyce Lonergan: We're now ready for the Q&A, Joyce. Yes, thank you, Chaim. We have four written questions.

Joyce Lonergan: Yes. Thank you hi, we have for questions. The first one can you start the trial without proper funding.

Chaim Lebovits: The first one, can you start the trial without proper funding? Thank you. That's a very good question. While our financials over the past year and a half have reflected a very challenging environment. We have nonetheless been able to make significant strides in preparing for the trial. including technology transfer. FDA Regulatory Submission. site selection. and Ciaro Engage. However, initiating and successfully executing a clinical trial of this nature.

Joyce Lonergan: Thank you that's a very good question.

Joyce Lonergan: While our financials over the past year and a half have reflected.

Joyce Lonergan: A very challenging environment.

Joyce Lonergan: We are nonetheless being able to.

Joyce Lonergan: To make significant strides in preparing for the trial.

Joyce Lonergan: Including technology transfer.

Joyce Lonergan: FDA regulatory submissions.

Joyce Lonergan: Site selections and.

Joyce Lonergan: Zero engagements.

Joyce Lonergan: However, initiating it gets successfully executing a clinical trial of this nature nature.

Chaim Lebovits: Demands a robust and sustainable cash flow, therefore, while we have diligently progressed to this point with relatively limited resources, securing proper funding is essential to commence the trial. have communicated in our recent press... We are actively pursuing multiple funding avenues to ensure the timely commencement of the trial. These efforts are in various stages. encompassing a promising $15 million non-dilutive grant currently will be under review. alongside ongoing negotiations. for a strategic partner. We are focusing on strategic part.

Joyce Lonergan: Demand is robust and sustainable cash flow therefore, while.

Joyce Lonergan: While we are diligently progressed to this point was relative to limit themselves to securing proper funding is an essential to cameron's commence the trial.

Joyce Lonergan: As communicated in our recent press release, we are actively pursuing multiple funding avenues to ensure the timely commencement of the trial.

Joyce Lonergan: These efforts are in various stages.

Joyce Lonergan: Encompassing a promising $15 million non dilutive grant.

Joyce Lonergan: Currently will be under review.

Joyce Lonergan: Alongside ongoing negotiations for strategic partnerships.

Joyce Lonergan: We are focusing on strategic partnerships.

Chaim Lebovits: Our priority is to secure the necessary capital through subpart who confidentially initiate and complete this sort of study. Thank you.

Joyce Lonergan: Our priority is to secure the necessary capital through such partnerships to confidently initiate that complete this study.

Joyce Lonergan: Thank you.

Chaim Lebovits: We have a second question. We see you call the trial endurance.

Speaker Change: We have a second question, we see you called the trials endurance, what's the meaning of that.

Chaim Lebovits: What's the meaning of that? Thank. The name Endurance was carefully chosen. with ALS. It's 10. The Remarkable Strength, Tenef. and Aum Waverly. Spirit, demonstrated by individuals living with ALS and their families. for Brainstorm. Endurance also underscores. Our staff have committed persevere in our scientific endeavor. and generate the robust data required for regulatory approval. We believe that this trial embodies the collective resilience. patients and our determined mission to deliver a potentially meaningful therapeutic option for ALS.

Speaker Change: Thank you for that the name of endurance was carefully chosen.

Speaker Change: So deeply resonate with.

With ALS community.

Speaker Change: It stands.

Speaker Change: Attributes.

Speaker Change: The remarkable trends.

Speaker Change: Yeah.

Speaker Change: And all wavering spirit demonstrated by individuals living with ALS and their families.

Speaker Change: For brainstorm.

Speaker Change: Endurance also underscores.

Speaker Change: Our steadfast commitment.

Speaker Change: To persevere and our scientific endeavors and generate robust data required.

Speaker Change: For regulatory approval of neurons.

Speaker Change: We believe that this trialling bodies.

Speaker Change: Collective resilience Ah patients.

Speaker Change: We're determined mission to deliver a potentially meaningful therapeutic option for Atlas.

Speaker Change: Thank you.

Chaim Lebovits: Thank you for that, Chaim.

Speaker Change: Thank you for that high on the third question is will the company also be producing in the U S.

Hara Hartounian: The third question is, will the company also be producing in the U.S.? Thank you, Harold. You want to take that?

Speaker Change: Thank you I know you want to take that.

Speaker Change: Sure sure. Thank you so much for the question.

Hara Hartounian: Sure. Thank you so much for the question. Absolutely, expanding our manufacturing footprint to the United States is a key strategic objective for us.

Speaker Change: Absolutely.

Speaker Change: Spending or manufacturing footprint.

Speaker Change: In the United States is a key strategic objective for us.

Hara Hartounian: We're pleased to share that we will be announcing a letter of intent in the coming days with a U.S.-based facility that has a proven track record, having already successfully passed FDA inspection for the production of other products. This signifies an important step in our plans for future commercialization and supply chain security. Thank you for that.

Speaker Change: We're pleased to share that we will be announcing and literacy intent in the coming days with a U S. Based facility that has a proven track record track record having already successfully passed FDA inspection for the production of all their other products.

Speaker Change: It signifies an important step in our plans for future commercialization and supply chain security.

Speaker Change: Thank you.

Speaker Change: Thank you for that question for is can you update on any advances in the <unk>.

Netta Blondheim: Question four is, can you update on any advances in the exosome program, or are you not proceeding with that at this time? Thank you, Netta. Please take care. Sure. Thank you for this question. We are highly encouraged by the progress of our exosome program as the field of exosome-based therapeutics continues to show strong potential in the treatment of respiratory and inflammatory diseases. Our proprietary allogeneic exosome platform has yielded promising preclinical data demonstrating both therapeutic and preventative effects in models of lung disease. To support these findings, we are preparing a manuscript detailing the efficacy of our exosomes in a preclinical model of COPD.

Speaker Change: Exercise program or are you not proceeding with that at this time.

Speaker Change: Thank you and that's all please take that one.

Speaker Change: Sure. Thank you for this question we are highly encouraged by the progress of our Exosomes program as the field of extra zone based therapeutics continues to show strong potential in the treatment of respiratory and inflammatory diseases.

Speaker Change: Our proprietary allogenic Exosomes platform has yielded promising preclinical data demonstrating both therapeutic and preventative effect in models of lung disease.

Speaker Change: These findings we are preparing a manuscript detailing the efficacy of our exosomes in a preclinical model of COPD.

Netta Blondheim: which would join our existing publication about the efficacy of exosomes in the model of ARDS. Together, these works outline the wide potential of our allogeneic exosome technology, which is derived from neuron cells. Briefly, our new findings demonstrate that early treatment with exosomes significantly reduces lung inflammation in response to bleomycin, a chemotherapy agent with known lung toxicity, and significantly reduced lung fibrosis two weeks later compared to untreated control.

Speaker Change: Which would join our existing publication about the efficacy of Exosomes in a model of a R. D S.

Speaker Change: Together these work outlined the wide potential of our allogeneic excellent technology, which is derived from their own cells.

Speaker Change: Briefly our new findings demonstrate that early treatment with exosomes significantly reduces lung inflammation in response to bleomycin, that's chemotherapy agents with known lung toxicity and significantly reduced lung fibrosis, two weeks later compared to untreated controls.

In light of these exciting results, we are actively pursuing strategic partnerships to advance the <unk> program towards clinical development.

Netta Blondheim: In light of these exciting new results, we are actively pursuing strategic partnerships to advance the Exosome program towards clinical development.

Netta Blondheim: In parallel, we are expanding our global intellectual property portfolio and anticipate announcing the issuance of additional patents that will further strengthen the protection of our innovation. Thank you, Netta.

Speaker Change: In parallel we are expanding our global intellectual property portfolio and anticipate announcing the issuance of additional patents that will further strengthen the protection of our innovations.

Speaker Change: Thank goodness.

Operator: Holly, would you open the line for one or two questions which we'll take before nine o'clock? Certainly.

Speaker Change: Holly would you open the line for one or two questions.

Speaker Change: Before nine o'clock.

Operator: At this time, we will be conducting a question and answer. You would like to ask a question, please press star 1 on your telephone Information Tone will indicate your line is in the You may press star 2 if you would like to remove your.

Speaker Change: Certainly at this time, we will be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad.

Speaker Change: A confirmation tone will indicate your line is in the question queue.

Speaker Change: You May press Star two if you would like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys, one moment, please while we poll for questions.

Operator: For participants using speaker equipment, it may be necessary to pick up your handset before pressing. One moment, please, while we poll.

Speaker Change: Your first question for today is from Jason Mccarthy with Maxim Group.

Jason Mccarthy: Your first question for today is from Jason McCarthy with Mecca.

Jason Mccarthy: Good morning everybody. Thanks for taking the questions. If you can go back to the UNK13-A discussion that you're having, have you had any communications with FDA in terms of being able to stratify by UNK13-A in the upcoming phase 3B, or was that Association that you showed through the EAP, more of an exploratory study. Are you locked in with the spy? You don't really have a lot of wiggle room around the ALS FRS. to go for ONC13A stratification as well. Thank you very much for that question, Jason. In general, the FDA not yet approving any biomarker as a surrogate, but I would like Bob to elaborate more on that.

Jason Mccarthy: Good morning, everybody. Thanks for taking the questions.

Speaker Change: You can go back to the August 13.

Speaker Change: A discussion that you're having have you had any communications with FDA in terms of being able to stratify by all 13, a in the upcoming phase III V or was that.

Speaker Change: The association that you've showed through the EAP more of an exploratory study.

Speaker Change: Are you locked in with the spy, who don't really have a lot of wiggle room around the AOS F or S T.

Speaker Change: To go for all 13, a stratification as well.

Speaker Change: Thank you very much about that question, Jason in general the F D. A.

Speaker Change: He has not yet approved any biomarker as a surrogate, but I would like Bob to elaborate more on that Bob.

Speaker Change: Yeah.

Bob Dagher: Oh, yeah, thank you. Thanks, Jason, for the question. So under the Special Protocol Assessment Agreement, the FDA, the protocol. I wouldn't use the word lock, but... It's agreed on with all the details, including the population. It's not. impossible or difficult to go and add and make changes. It will require, obviously, discussions. However, scientifically speaking, and we're very excited with the larger ALS community about these new genetic discoveries and the uncertainty story is evolving. However, it remains exploratory and not definitive. At this stage in the game of the trial design innovations, et cetera, we are acutely aware of what's going on.

Oh, yeah. Thank you and thanks, Jason for the question.

Speaker Change: So under the special Protocol assessment agreement as SBA the protocol.

Speaker Change: Or they can use the word locked but.

Speaker Change: Agreed on with all the details.

Speaker Change: Including the population.

Speaker Change: It's not.

Impossible or difficult to go in and add a mix changes will require obviously you're discussing however.

Speaker Change: Scientifically speaking the.

Speaker Change: We are very excited with the.

Speaker Change: The larger community about these moves.

Speaker Change: And I think the discoveries and the answer would be in a story is evolving to however, it remains exploratory and not definitive.

Speaker Change: At this stage in the game with the.

Speaker Change: Trial design innovations et cetera.

Speaker Change: We are acutely aware of what's going on.

Bob Dagher: I presented data on 13A two weeks ago in New Orleans at ISCT. It was very well received in oral presentation. It was chosen for that for that target audience as well. So excitement is there, but not yet at the level where it will rise to become a stratification point.

I present, the data on all of them 15 a.

Speaker Change: Two weeks ago in New Orleans that audience C. D. It was very well received in an oral presentation was chosen for that.

Speaker Change: The target audience as well.

Speaker Change: Excitement is there, but not yet at the level, where it will rise to become a rectification works. However, we're gonna be obviously exploring.

Bob Dagher: However, we're gonna be obviously exploring, you know, we do post-hoc analyses and we'll cut the populations in however many ways we need to, to evaluate further the effect of neuron in the next study in the phase 3b.

Speaker Change: You know, we do post hoc analyses.

Speaker Change: It would put the populations.

Speaker Change: Although there are many ways, we need to do it and we'll evaluate further the neuron in the next probably interface TB. Thank you for your question really appreciate it.

Unknown Speaker: Thank you for your question, really. Another somewhat technical question. You had talked a bit about the hypoxic stress co-culture with neuron cells or the neuron media, if I caught that right. And did you say that it restored normoxic activity? And if so, can that...

Speaker Change: Got it and another I guess somewhat technical question, you had talked a bit about the.

Speaker Change: Hypoxic stress co culture with their own cells or the neuro and media if I caught that right and did you say that it would be stored Laura marks like activity and if so could that go.

Unknown Speaker: Mechanism of Action be used as part of a data package when you refile the BLA the next time around? Because I remember last time a lot of questions around Growth factors and levels of this and levels of that came up, but is this more defining of the mechanism of action for neuron that would be supportive of the next BLA?

Speaker Change: The mechanism of action be used as part of a data package when you read or file the BLA. The next time around.

Speaker Change: Because I remember last time, a lot of questions around.

Speaker Change: Growth factors and levels of this and levels of that came up but is this more the finding of the mechanism of action for neurology because that would be supportive of it the next BLA.

Speaker Change: Very good question.

Unknown Speaker: A very good question.

Netta Blondheim: Yes, and Netta can answer the first part and Bob can answer the second part. Thank you. Yes, you're correct. What we saw was the media that was enriched by by ourselves had a protective effect and rescue effect really on cells under hypoxic conditions restored them back to almost 100% of normoxic condition. So 96.5%. And this is a cell culture. So it's a simplistic model. It's not a human, human, you know, live model. It's not a clinical model, but it is supportive, I think, of and was included in our ideas. Got it.

Speaker Change: Yes.

Speaker Change: She can answer the first part and Bob can answer the second part.

Speaker Change: Thank you, yes, you're correct.

Speaker Change: We saw was a D and media that wasn't reached by them by ourselves had a protective effect in a rescue the effect really on sells them under hypoxic conditions to restore them back to almost a 100% I've never amongst that condition. So 96, 5% and this is a cell culture.

Speaker Change: So it's a simplistic model, it's not a human my human lives that model, it's not a clinical model, but it is supportive I think of and and what's not included in our NDA.

Speaker Change: Got it and just last question another manufacturing I know you're aiming to open.

Unknown Speaker: And just last question on the manufacturing.

Hara Hartounian: I know you're aiming to open up additional clean rooms, but currently the Tel Aviv facility, how many, excuse me, therapies can it handle? Labour Produce. Yeah, it depends how many rules we're using. It will be a rolling enrollment, as you know, with the phases thing of the CTA. So it will serve us for the first few months. And then we'll start with Plurie as Harold specified before. And I believe that next year we'll have the U.S. site also up and running. Got it.

Speaker Change: Open up additional clean rooms, but currently the Tel Aviv facility how many.

Speaker Change: It gives me therapies can handle.

Speaker Change: Well I produce.

Speaker Change: Yes, it depends on how many rules, where you think it'll be a rolling enrollment as you know with the phases, taking up the Cta. So it will serve us for the first few months.

Speaker Change: And then we'll we'll we'll start with Fleury is hurdle at the specified before.

Speaker Change: I believe that next year, we'll have a V U S sites also up and running.

Speaker Change: Okay.

Speaker Change: Got it thanks for taking my questions I had.

Unknown Speaker: Thanks for taking the question, Chaim. Yo, very well.

Speaker Change: Youre very welcome.

Speaker Change: We have time for one more question Ali.

David Bautz: We have time for one more question, Holly. Your next question is from David Bautz with Zach Small. Hey, good morning, everyone. Thanks for the update this morning.

Speaker Change: Your next question is from David bouts with Zacks small cap.

David Bouts: Hey, good morning, everyone. Thanks for the update this morning. So I just wanted to make sure I heard correctly that you guys were looking to open up a is it 15 clinical trial sites and then for each of those sites, obviously, you're financing aside what needs to occur to try to get her to.

David Bautz: So Chaim, I just want to make sure I heard correctly that you guys are looking to open up, is it 15 clinical trial sites? And then for each of those sites, obviously, financing aside, what needs to occur to try to get or to get those sites up and running so that they can enroll patients? And then lastly, do you have any estimation of how many patients you can enroll, say per month, just based on Manufacturing Capacity. Yeah, so thank you very much for that question. So on clinicaltrials.gov, you will see a listing of the sites.

To get those sites up and running so that they can enroll patients and then lastly, do you have any estimation of how many patients you can enroll say per month, just based on manufacturing capacity.

Speaker Change: Yeah. So thank you very much without question. So on clinical trials Gov, you will see a listing of the sites.

Chaim Lebovits: It's out there, but we didn't yet sign the CTA. We'll be announcing very soon, gradually after we sign CTAs. And yeah, as I just mentioned, we'll start to grow site by site based on a Gantt of patient population that we're going to be enrolling based on the manufacturing. So we're working on the final steps of that Gantt. So I can't share exact numbers now. But the plan is, as you know, the 200 patient trial was included three years to have everyone enrolled and everyone treated. The first part will be deep into the second part as well.

Speaker Change: It's out there, but we didn't get signed the C T as well.

Speaker Change: We will be announcing very soon gradually after science Etfs and yeah. That's it just mentioned we will start to grow site by site based on again, a patient population that we're gonna be enrolling.

Speaker Change: Enrolling based on the manufacturing so we're working at the final stop so.

Speaker Change: Steps of those about Gan, so I can't share exact numbers now but.

Speaker Change: But the plan is as you know the 200 patient trial within two to three years to forever, one enrolled and everyone treated.

Speaker Change: The first part and will be deep into the second part as well and I want to remind you that the BLA would be filed.

Chaim Lebovits: I want to remind you that the BLA would be filed if we have a statistically significant result of the first part of the trial. Okay, great. Thanks. Thanks for taking the question. Yeah, so thank you very much.

Speaker Change: A statistical significant result over the first part of the trial.

Speaker Change: Yeah.

Speaker Change: Okay, great. Thanks, Thanks for taking the question.

Speaker Change: Yeah.

Speaker Change: Yeah. So thank you very much.

Chaim Lebovits: I want to thank everyone for being on the call today. We're hoping to close at nine o'clock. I think it's exactly nine o'clock.

I want to thank everyone for being on the call today.

Speaker Change: So we're hoping to close those nine o'clock I see exactly in a block. So thank you very much.

Operator: So thank you very much and have a wonderful day.

Speaker Change: Have a wonderful day.

Speaker Change: This concludes today's conference and you may disconnect. Your lines at this time. Thank you for your participation.

Operator: This concludes today's conference and you may disconnect your lines. Thank you for your.

Speaker Change: Okay.