Q2 2023 Brainstorm Cell Therapeutics Inc Earnings Call
Speaker 1: And.
Speaker 2: Greetings and welcome to the Brainstorm Cell Therapeutics second quarter 2023 earnings call.
Speaker 2: At this time, all participants are in a listen-only mode. As a reminder, this call is being recorded. And I would now like to introduce your host for today's call, Mr. Michael Wood of LifeSci Advisors. Mr. Wood, you may begin.
Speaker 3: Good morning and thank you for joining us this morning. Earlier today, BrainStorm issued a press release with its financial results for the second quarter of 2023, including a corporate update.
Speaker 3: Before passing it off to the company for prepared remarks, I'd like to remind listeners that this conference call will contain numerous statements, descriptions, and interviews.
Speaker 3: forecasts and projections regarding brainstorming cell therapeutics and its potential future business operations and performance. Statements regarding the market potential for the treatment of neurodegenerative diseases such as ALS.
Speaker 3: the sufficiency of the company's existing capital resources for continued operations in 2023 and beyond, the safety and clinical effectiveness of Neuron technology platform, clinical trials of Neuron, and related clinical development programs, and the company's ability to develop strategic collaborations and partnerships.
Speaker 3: to support its business planning efforts. Poor looking statements are subject to numerous risks and uncertainties, many of which are beyond brainstorm control including the risks and uncertainties described from time to time in the company's SEC findings.
Speaker 3: The company's results may differ materially from those projected on today's call, and the company undertakes no obligation to publicly update any forward-looking statement.
Speaker 3: Joining us on the call this morning will be Kayne Leibovitz, President and CEO of Brainstorm, Dr. Stacey Lindberg, Co-Chief Executive Officer and Alapatlis, Interim Chief Financial Officer.
Speaker 3: In addition, Brainstorm's Executive VP and Chief Medical Officer, Dr. Kirk Taylor, is also on the call and will be available to answer questions during the Q&A session.
Speaker 3: So I'd like to turn the call now to Mr. Liebowitz. Please go ahead.
Speaker 4: Thank you Michael.
Speaker 4: Thank you all who have joined us to discuss our Q2 2023 financial results.
Speaker 4: and recent progress.
Speaker 4: Our main priorities right now are to prepare for the forthcoming advisory committee for neuron.
Speaker 4: our investigational therapy for the treatment of ALS.
Speaker 4: and to make sure the company is prepared to make Neuron available to patients.
Speaker 4: As announced in June , the FDA will convene a meeting of the Cellular Tissue and Genotherapies Advisory Committee.
Speaker 4: to review our BLA for Neuron on September 27th.
Speaker 4: In addition, the BLA has been assigned a PDUPA action date of December 8, 2023.
Speaker 4: Neurons regulatory process.
Speaker 4: as we have mentioned previously.
Speaker 4: will be the same as it is for any other investigational therapy.
Speaker 4: subject of a filed BLA.
Speaker 4: The upcoming outcome will be guided by an agenda that includes detailed presentations.
Speaker 4: by BrainStorm and the FDA.
Speaker 4: which will allow our team and the agency
Speaker 4: to discuss
Speaker 4: the clinical evidence supporting neurons safety and efficacy as an ALS therapy.
Speaker 4: Other key stakeholders including independent medical experts.
Speaker 4: including independent medical experts, statisticians.
Speaker 4: and patient advocates.
Speaker 4: will then have the opportunity to provide their own unique perspective on Neuron's clinical data set as well as the unmet needs of people living with ALS. Members of the outcome will then have the opportunity to vote on the response to the question set forth by the FDA.
Speaker 4: as well as the preceding discussions at the meeting under advisement when coming to a decision on the BLA which will be made by the December 8th PDUFA date. Given the strength of the clinical evidence we have generated on neuron, we remain confident in our ability to achieve a successful outcome from the outcome and are preparing for success to ensure we can make neuron available to patients as quickly as possible if approved later this year.
Speaker 4: Our team is focused on being fully prepared in advance of the upcoming outcome. These preparations began months ago and continue today as we work with our expert consultants to ensure we can present and respond to all questions that the FDA and outcome members might raise. We are grateful to the FDA for its cooperation throughout the review process and recognize that the agency is taking our application very seriously.
Speaker 4: I'll now turn the call over to my colleague, Dr. Stacy Klimber, for additional comments. Stacy? I'll now turn the call over to Dr. Stacy Klimber for additional comments.
Speaker 4: I'll now turn the call over to my colleague, Dr. Stacy Klimberg, for additional comments. Stacy? Thank you, Haim.
Speaker 5: We are looking forward to the outcome in September and cannot overstate the importance of this meeting in neurons' regulatory path, given the scientific and policy issues that need to be understood. First deck Check
Speaker 5: The FDA has rightly shown a willingness to apply regulatory flexibility when evaluating investigational ALIS therapies over the last year.
Speaker 5: And we look forward to having Neurons full dataset discussed in the context of the need for new ALS therapies in the public forum offered by NADCOM.
Speaker 5: As we move towards the FDA's decision, we continue to have full confidence in our data and believe that a comprehensive analysis of our results strongly supports neurons' clinical efficacy and safety.
Speaker 5: We remain committed to the scientific and regulatory process, which includes continuing research to confirm the results of the Neuron Clinical Program.
Speaker 5: We also remain committed to ongoing learning about the safety and the clinical effectiveness of neurons.
Speaker 5: For this reason, we have assembled a steering committee to gather input on goals and the core design elements of a confirmatory trial.
Speaker 5: We look forward to providing an update prior to the outcome.
Speaker 5: We continue to be active with the ALIS community at scientific conferences.
Speaker 5: We delivered an important presentation featuring new biomarker data at the recent 2023 Gordon Research Conference for ALAS and related motor neuron diseases.
Speaker 5: as we described previously.
Speaker 5: During the Neuron-Faster trial, we collected CSF fluid from all trial participants.
Speaker 5: and examined biomarkers spanning three pathways important to ALS pathology.
Speaker 5: Neuroimplimation, neurodegeneration, and neuroprotection.
Speaker 5: The study is the most robust PSF biomarker study conducted in people living with ALF.
Speaker 5: And the new data presented at the Gordon Conference features analysis of a biomarker known as neurofilament light. Today's Perhaps
Speaker 5: In addition to more broadly providing evidence of the importance of using baseline disease characteristics, in the analysis of biomarker data.
Speaker 5: which I'll provide the rationale for.
Speaker 5: I believe we all appreciate how heterogeneous AELIS is as a disease.
Speaker 5: Because of this, it is common practice to include ALIS disease characteristics of cut-a-variant in the analysis of clinical data, which we also did in our case through trial.
Speaker 5: The goal is to include information that could influence an individual's prognosis in addition to therapy. The goal is to include information that could influence an individual's prognosis in addition to therapy.
Speaker 5: so that you're drawing the appropriate conclusion relative to the treatment effects in a trial.
Speaker 5: When we decided to include these scovariants in our by-marker analyses.
Speaker 5: We drew on the ALS literature and the final guidance released in 2023 by the FDA on adjusting for covariates and randomized clinical trials for drugs and biologic products.
Speaker 5: Portugal is exploring the importance of A-Lis disease characteristics in our bi-murkered data, run Phase 3.
Speaker 5: We employed five disease covariates that were pre-specified and used in the primary efficacy model in the trial. Okay, let's give it up and we'll start the issue. We shall fine as doitis.
Speaker 5: These covariates, which include baseline ALS-EPRS-R score.
Speaker 5: The baseline rate of decline, use of release all, fight of ALF disease onset, and time since symptom onset to treatment are well supported in the literature. As highlighted in our poster presentation, all five disease covariates in addition to biomarker data had a significant impact on clinical outcome.
Speaker 5: Therefore, the analysis of biomarker data can reflect the treatment effect more accurately when accounting for the baseline heterogeneity of participants.
Speaker 5: including these coverings in the analysis across all by mothers.
Speaker 5: simply adds precision to the results.
Speaker 5: In the poster we highlighted the longitudinal trajectory of four by markers, including your filament light.
Speaker 5: As examples of the improvement observed in biomarkers following treatment with neurons, compared to placebo across all participants in the trial.
Speaker 5: Nerflement Light has been getting a lot of attention in the scientific community.
Speaker 5: and with drug developers as evidenced by the exponential growth in publications and recent years.
Speaker 5: And Neuronant Treated Participants.
Speaker 5: We observed an 11% decrease from baseline to week 20 in Neurokalmit light.
Speaker 5: with the change over around 1% with placebo.
Speaker 5: and a significant treatment difference of a P less than 0.05.
Speaker 5: The other biomarkers highlighted in the poster also showed significant treatment differences with decreases in pro-inflammatory biomarker in CP1.
Speaker 5: and large increases in near protected biomarkers that just and collect in one.
Speaker 5: I also presented two other results in the poster.
Speaker 5: First, neurofimate light baseline levels appear to be prognostic of A-List disease progression.
Speaker 5: This means that participants with higher baseline near-efficient light values had greater decline from baseline to week 28 as measured by the ALF Everest R.
Speaker 5: This finding confirms results seen in other ALS trials, which is promising for the field.
Speaker 5: The last analysis we presented was motivated by the literature and has been used in the review and approval products by the FDA and diseases, such as pulmonary, arterial, hypertension, and triple-class refractory multiple-minimum. In addition to ALS through the review of traversing.
Speaker 5: And while neurons mechanism of action is very different from to person,
Speaker 5: As we have a broad, multi-modal mechanism faction, simultaneously targeting biological deficiencies associated with ALS.
Speaker 5: We felt these analyses were important to conduct and understand the insights derived into our data based on their relationship between neurofilament light and clinical outcome.
Speaker 5: The analysis used an approach called causal inference, sometimes referred to as outcomes regression.
Speaker 5: And it allows us to explore the relationship between the change in neuroplomant light and the change in aylis of rsar.
Speaker 5: Do ten your own alone.
Speaker 5: by adjusting the observed outcome with the change we would have expected due to the natural progression of the disease.
Speaker 5: The analysis presented confirmed that neuron-driven reductions in neurofilament light are associated with less decline in the ALS separate star from baseline to week 28.
Speaker 5: Taken together, data from the literature, and the neurom phase through trial.
Speaker 5: The porthole hypothesis, but treatment driven reductions in neurofilmot light, are reasonably likely to be associated with clinical benefit in ALF.
Speaker 5: We believe these results are timely given the regulatory precedent that was set in ALF this year.
Speaker 5: In April , the FDA granted accelerated approval to biogen and IONUS's drug to person.
Speaker 5: to treat the genetic form of ALAS known as SOD1 ALAS.
Speaker 5: which represents approximately 2% of ALIS patients.
Speaker 5: The approval decision was based in part onto first responsibility to lower plasma levels of near-fimate light.
Speaker 5: Establishing the view that reductions in near-front light are reasonably likely to be associated with clinical benefit in ALF.
Speaker 5: Specifically, when the adcom that reviewed to person was asked, whether the available evidence supported the reduction in plasma neurofilament concentration was reasonably likely to predict clinical benefit, the committee voted unanimously nine to zero.
Speaker 5: This is the first time an ALIS drug was approved by the FDA based on bi-mercord data.
Speaker 5: I'll now turn the call back to Hein for some additional comments.
Speaker 4: Thank you, Stacey.
Speaker 4: Our second main priority, as I mentioned earlier,
Speaker 4: is to ensure commercial preparedness and execute on the various activities that we need to complete.
Speaker 4: in order to make neuron available to patients if approved.
Speaker 4: These include activities across manufacturing.
Speaker 4: commercial and medical affairs to engage with the physicians.
Speaker 4: three-day loss.
Speaker 4: and also early discussions with payers.
Speaker 4: In terms of how neuron would actually be delivered to ALS patients.
Speaker 4: The first step is to collect bone marrow from the patient.
Speaker 4: and this is then shipped to our manufacturing facility.
Speaker 4: Where the MSCs would undergo a series of steps to create the therapeutic product.
Speaker 4: We're currently in discussions.
Speaker 4: to be able to sign contracts.
Speaker 4: with centers of excellence across the United States.
Speaker 4: so that they will be set up to collect boomerow from patients.
Speaker 4: and we can initiate the manufacturing process for each person.
Speaker 4: personalized treatment.
Speaker 4: We'll begin with 8 to 10 centers and then move to broader engagement with more centers.
Speaker 4: As we have outlined before, we are in the process of a targeted capability build.
Speaker 4: to expand our team in preparation for this as a bit of growth.
Speaker 4: be able to move quickly so that if we are successful in achieving approval for neuron.
Speaker 4: We will have the infrastructure in place, and the wait for patients and families to gain access.
Speaker 4: will be as short as possible.
Speaker 4: We have made a number of hires and management changes so far in 2023.
Speaker 4: At the beginning of the year, Dr. Stasellinberg was promoted to COCO.
Speaker 4: Then early in the second quarter, we appointed Dr. Kirk Taylor as executive vice president and chief medical officer.
Speaker 4: Curricle lead the global medical affairs function and launch activities.
Speaker 4: including plant product launches.
Speaker 4: More recently
Speaker 4: In July , we appointed Dr. Bob Dagger.
Speaker 4: as executive vice president and chief development officer.
Speaker 4: Bob will be responsible for the portfolio strategy and advancement of clinical development plans towards regulatory approval, including the expansion of neuron into new diseases.
Speaker 4: and the translation of preclinical research into first-in-human trials.
Speaker 4: He brings approximately 20 years of industry expertise in the development and approval of treatments for challenging neurological and rare diseases.
Speaker 4: He began his career at GSK.
Speaker 4: and have served in leadership positions of science and medicine at companies such as Sanofi Genzaim and LabCorp Covent.
Speaker 4: We also made an important addition to our board with the appointment of Nir Noor as a board member.
Speaker 4: and the Chairman of the Audit Committee and member of the Governance, Domination and Composition Committee.
Speaker 4: Nearbrings over 20 years of global work experience as a CFO and senior finance leader.
Speaker 4: He has a broad background that includes large pharma and viatac and has overseen organizations with up to 2.5 billion in sales and one billion dollars in annual spend.
Speaker 4: We are excited to expand our team with these and other talented individuals and I know they share our vision and excitement around neurons prospects.
Speaker 4: This expanded team is fully focused to prepare brainstorm for the exciting future ahead.
Speaker 4: I'll now turn the call over to Alla to discuss our financials.
Speaker 6: Allah
Speaker 7: Thank you, Hiem.
Speaker 7: Cash, cash equivalence and sharon 10 bank deposits were approximately 0.75 million dollars as at the end of June 2023, compared to approximately 3 million as at the end of December 2022. In July ,
Speaker 7: 2023 subsequent to the end of the quarter, the company raised net proceeds of approximately $7 million in a registered direct offering.
Speaker 7: Research and development expenses for the three months and June 30, 2023 and 2022, were approximately 2.8 million and 5.1 million respectively. General and administrative expenses for the three months and June 30, 2023 and 2022.
Speaker 7: were approximately 2.7 million and 2.5 million, respectively. Net loss for the three months and June 30, 2023 was approximately 5.3 million or the 13 cents per share as compared to a net loss of approximately 7 million or 19 cents per share.
Speaker 7: for the three months and June 30th, 2022. I'll turn it back to Haim. Haim.
Speaker 4: Thank you, Aala. I'll ask Michael Wood from Lifesci to read the questions we have received from investors, Michael.
Speaker 3: Thanks, time. The first question is the minute BLA for neuron.
Speaker 3: Seventh May Sicking Full Approval are Accelerated Approval.
Speaker 4: The BLA filed is seeking full approval. Thank you.
Speaker 3: Thanks. And does the BLA include data collected from patients that have been treated under the expanded access program and from the Israeli H.E. pathway?
Speaker 4: Yes, that is correct. Data from both programs.
Speaker 4: We're included in the BLA.
Speaker 3: Do you still intend to publish your biomarker manuscript?
Speaker 4: Oh, absolutely. The biomarker data is a compelling part of our evidence, which provides strong support of the clinical data.
Speaker 4: And we can confirm the papers on the review at a highly regatta journal.
Speaker 4: The senior authors are Dr. Bob Brown and Dr. Meritz at Kuwitz.
Speaker 4: and the paper includes other leading researchers and scientists.
Speaker 3: Thanks to the next question relates to the Gordon conference. Why did you only recently decide to look at baseline characteristics of patients and make this presentation at Gordon?
Speaker 3: And did the results change substantially once you counted for the baseline characteristics?
Speaker 3: And then having listened to Stacy's discussion this morning, I have an additional question I'm going to add. And that is, we're intrigued by the word precision that Stacy used to do her for Perter Marks.
Speaker 3: Please explain what this means.
Speaker 4: Stay still, I'll have your answer this question.
Speaker 5: Okay, so to the first question, why adjust for baseline characteristics now? Basically, this is an example of emerging science.
Speaker 5: If you look at the public documents from TIFRSTON's adcom, you'll see that that FDA did a lot of work exploring the importance of disease co-curates, including all of the baseline disease co-curates that we pre-specified in our efficacy analyses that I actually spoke about in my prepared remarks. And they did this as they were analyzing TIFRSTON data.
Speaker 5: Also, as I referenced earlier, the FDA issued a final guidance on adjusting for covariates in randomized clinical trials, which was very timely and provided important perspectives.
Speaker 5: In fact, when we reviewed the guidance, which focused on prognostic baseline coverage, it's what stood out to us.
Speaker 5: was that sponsors should prospectively specify covariate adjusted analyses.
Speaker 5: Therefore, we thought it logical to use the covariate specified in our Phase III statistical analysis plan.
Speaker 5: The guideline also noted that covariate adjustment was acceptable even if baseline covariates were strongly associated with each other.
Speaker 5: So this guidance, combined with the importance the FDA placed on these covariates into a FDA's review, led us to explore the importance of these covariates in our data.
Speaker 5: As a side note,
Speaker 5: I note in analysis that we ran.
Speaker 5: We also used the model that FDA used with traversing data. And in the cases where this was done, the significant effects held across our data, so it's quite robust. Michael, if I understood the question at the end, you wanted to know what I meant by the word precision.
Speaker 5: Let me first recall the statement I made earlier. So I referenced that in the analysis of our biomarker data, we can reflect the true benefit more accurately when we account for baseline heterogeneity of patients.
Speaker 5: So in other words, by adding these characteristics, which really help identify ways that the disease is variable across patients, it brings precision to the estimate of treatment. So...
Speaker 5: Here, when I use this word precision, what I mean is that the model with disease covariates included in it, and these covariates can influence the rate of disease progression.
Speaker 5: This will have a better ability to capture very ability observed in the data.
Speaker 5: And the significance of these covariates tells us that this is the right way to analyze the data. Otherwise, you're ignoring important information in the analysis.
Speaker 5: The last part of the question was how the results compared across the model that had baseline covariates versus the model that did not.
Speaker 5: The biomarker results from the model, from both models, actually are very similar, with no conclusions changing substantially for any biomarker.
Speaker 5: There were two by markers that were already trending towards a significant treatment effect. One was neurofilement light. The other was neuroprotected by a marker HGS. The other was neurofilement light.
Speaker 5: And accounting for these disease characteristics resulted in the p-value dropping just below the conventional level of 0.05.
Speaker 5: But even for these two biomarkers, the overall pattern in the treatment effect, as well as the percent change from baseline in both arms, is very similar to the results of the model that didn't adjust for the terms.
Speaker 5: The estimate of the treatment effect just had more precision because it could take into account important information that also influence clinical outcomes in addition to treatment.
Speaker 3: Thanks, facing. Next question. Do you intend to proceed with a confirmatory clinical trial?
Speaker 4: Oh yes, we have definite plans to proceed with the computer trial.
Speaker 4: It's for months now that we have been meeting with the Steering Committee of Leading Clinicians and Statisticians.
Speaker 4: We intend to share more after we get input from the FDA. In this regard, I would like to really share that...
Speaker 4: were thankful for the kind of for the institution for regenerative medicine and the term that reached out to us and they asked us
Speaker 4: that there would be an interest that we submit a application for such a trial.
Speaker 4: Thank you.
Speaker 3: Is there a reason that you're granted a different ADCOM from the ADCOM that oversaw the Amylix and Biogen drugs? Do you think this is a good or bad sign that you're being reviewed in a different ADCOM?
Speaker 4: Yeah, so the designation of the advisory committee that advises FDA for an application under review.
Speaker 4: is determined by the specific center of the FDA center that the application is filed with.
Speaker 4: The Leverio and Calcity were both submitted as new drug applications, NDA to Cedar, or the Center for Drug Evaluation and Research.
Speaker 4: while neuron, being a biological product...
Speaker 4: stem cell product was submitted as a biologic license application to CBER or the Center for Biologic Evaluation and Research.
Speaker 4: Each center has multiple outcomes.
Speaker 4: For example, Seabird has four.
Speaker 4: Neuroon will be reviewed by Seabird's cellular tissue and gene therapy's advisory committee.
Speaker 4: If anyone is interested.
Speaker 4: To look in deeper to this, there's a document called the Intercenter Agreement between the Cedar and the Ciber, it finds to each center jurisdiction for a regulation of drug and biological.
Speaker 4: products and combination of drugs and biological products.
Speaker 4: and it describes those product characteristics or medical indications that require a collaborative review of effort by the two centers.
Speaker 3: Thanks. The next question relates to clinical manufacturing controls or CMC. Have you been able to submit amendments to address the CMC items identified by the FDA in their initial RTF letter? And if so, or if not, you anticipate any impact on the updated avoid them.
Speaker 4: So yeah, definitely, as we have shared, and I'll confirm this again.
Speaker 4: The FDA has allowed us to submit amendments.
Speaker 4: and we have submitted those amendments, sure. Thank you.
Speaker 3: And have you been having any conversations directly with the FDA while the PLA has been under review?
Speaker 8: Yes.
Speaker 4: as a typical for a BLA under view.
Speaker 4: We have regularly occurring interactions with the FDA.
Speaker 4: We received quite a few requests for information.
Speaker 4: which we have responded to in a timely fashion.
Speaker 4: We also were able to share presentations and additions to other interactions.
Speaker 3: You reported that around 25% of patients in your face-free study had a baseline value below 25. And indeed patients further declined could not be measured because the items.
Speaker 3: reach zero. You're referring to this as the floor effect. Can you please expand on this floor effect and do you have any buyer market data for these participants?
Speaker 3: You refer to this as the floor effect. Can you please expand on this floor effect and do you have any buyer market data for these participants? Thank you, Steve. Please.
Speaker 5: Sure. I want to start by just reflecting on the fact that the AILA suffers or remains the best outcome measure that we have today.
Speaker 5: But like any bounded scale, it has limitations.
Speaker 5: And in the group of participants asked about in this question who were in the bottom half of the scale, there was a high rate of participants with ALIS-UPress-R items, specifically in the fine and gross motor subdomain, that started at zero, with approximately 40% of participants with ALIS-UPress-R items, which started at zero, with approximately 40% of participants with ALIS-UPress-R items,
Speaker 5: starting at zero across all six items.
Speaker 5: starting at zero across all six items. The rate of zero values of the number of items
Speaker 5: especially on the fine and gross motor is problematic.
Speaker 5: The measuring attrugment effect in a trial because it's expected that the fine and gross motor domains account for about 70% of decline observed in trials.
Speaker 5: This, therefore, confounds the ability to show a treatment effect, as the ALS suppressor can't measure for the decline once items reach zero.
Speaker 5: So the question about biomarker data and these participants, we have looked at biomarker data and these participants in fact at the Gordon conference we reported.
Speaker 5: First, that we observed significant improvements on ALIS biomarkers with neuron versus placebo in all trial participants, and this was important across the three important pathways that I referenced in my opening remarks, neuroinflammation, neurodegeneration, and neuroprotection.
Speaker 5: We infact see very similar treatment patterns in participants with baseline scores to 25 and below, and ALAS, a HR.
Speaker 5: And what this suggests is that Neuron is biologically active in the overall population that was studied in the trial, which includes participants with advanced a list disease where the scales, the a list of resource scale, demonstrated measurement challenges. And what this suggests is that Neuron is biologically active in the overall population that was studied in the overall population that was studied in the overall population
Speaker 3: Thanks, Stacey. Next question relates to your clinical pipeline. Rainstorm has said that it's working on the use of its product for other indications. Investors have been hearing about this now for years. Please provide some specificity with respect to what working on it means.
Speaker 4: Well, thank you all, as productive, to take this question, please.
Speaker 9: Great, Cyn. Thank you. Sure. Well, we completed a phase two study evaluating neuro and as a treatment for progressive MS and announced positive results in 2021. We have worked with neurologists and statisticians with deep expertise in MS to design the next trial and have a solid protocol concept prepared that builds on the completed phase two way study.
Speaker 9: We've also prepared a protocol concept designed to study the impact of neuron and Alzheimer's disease in the context of the unmet need that remains with approval of treatments that remove amyloid plaque, consulting with leading experts and that's neuron and Alzheimer's disease. Designed to the question addressed here is though
Speaker 9: In patients for MOA placards been removed, could neuro and increase cognitive function above baseline levels.
Speaker 9: Could neuro increase cognitive function above baseline levels? That's the question.
Speaker 9: Neurons mechanism of action supports our view that it may have broad applications in neurodegenerative disease. However,
Speaker 8: Sir?
Speaker 9: However, like many of our peers in biotech industry, we need to prioritize resources and focus those programs that potentially benefit patients in the near term and create value for our stakeholders.
Speaker 9: At this point, we're focused primarily on the ALS program and getting approval in that indication.
Speaker 9: We intend to move forward with other programs as resources allow.
Speaker 6: Thank you. Thank you.
Speaker 3: I have one final question. Did brainstorm finalize on the follow-on offering with maximum for $7.5 million? $7.5 million?
Speaker 4: Yeah, in addition to the PR on this matter, as is common practice, we did publish an 8K. Just to provide some more color on this.
Speaker 4: We will continue to explore the best ways for finance.
Speaker 4: will have multiple options to finance going forward.
Speaker 4: And the company will be quite opportunistic to utilize the most favorable opportunities.
Speaker 4: that comes our way at the time of need.
Speaker 6: Michael?
Speaker 3: And that's the final question.
Speaker 4: Thank you so much. Jenny would you open...
Speaker 4: for any additional questions.
Speaker 2: No problem. At this time we are opening the floor for questions. If you would like to ask a question, please 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 from the queue. For any participants using speaker equipment, it may be necessary to pick up your handset.
Speaker 2: Thank you. Your first question is coming from Jason McCarthy of Maxim Group. Jason, your line is live..
Speaker 10: Hi, all. Thanks for taking the questions really looking forward to that ad come in September . And about that ad come, do you expect based on your covariant analysis of the five covariance and what you've shown around?
Speaker 10: NFL particularly in that presentation in July do you expect the same questions that Biogen had gotten where there was the vote on NFL nine to zero but there was
Speaker 10: difference in the voting three F five no on the pillow approval I guess requiring a
Speaker 10: a confirmatory study. Do you expect a similar set of questions?
Speaker 8: Thank you very much, Stacey.
Speaker 5: Hi Jason, great to hear from you. You know, my thinking about that is this is a different outcome, the different FDA center.
Speaker 5: Different application, very different mechanism of action. I think what each of the drug programs was presenting, is their evidence also is quite different. So we both bring interesting insights into neurofluent light and the association with ability to actually mention and show that reductions in neurofluent light.
Speaker 5: results in an association with the improved clinical outcomes, you know, is a strength. But I've learned over the course of my career to not assume anything with related regard to the regulators. We'll actually get the questions.
Speaker 5: very close to the time of the adcom, and I think the questions that were asked were relevant, but we'll know for certain what our questions are right before the adcom. During that adcom, as part of the presentation, will be made.
Speaker 10: more of a point on the safety aspects of Narone, given that it is an autologous cell therapy, it's not genetically manipulated, and that it is a far safer approach apparently than other drugs for ALS, including the Biogen drug.
Speaker 1: Stacy?
Speaker 5: Yeah, so we will present the full set of data, efficacy and safety, and Jason, we share your confidence in the safety of the neurons, not only in the data we've generated, but as a result of the way that our product is made and we will provide...
Speaker 10: a compelling overview of all data at our presentation. And just lastly, a brief question on the potential commercialization plan. From a, I know it's early, but from a pricing perspective to Faris in price at around 14.
Speaker 10: or so just north of that for treatment, but it's about 200,000 all told for a year. That's a similar pricing strategy that you could expect for a cell therapy. And just from a launch perspective, I am used to mentioned getting possibly 8 to 10 centers initially for bone marrow collection.
Speaker 10: How large of a sales force would you need to complete your initial commercialization plan?
Speaker 4: Thank you very much. You know many of these questions are premature for us to answer for regulatory reasons as you know.
Speaker 4: But I like the assumptions you're laying out. And I think what will be very important is to find the centers of excellence doing not only the bone marrow aspirations but the inter-fecal injections, which some of these like Sorepta treatments and Toprazone treatments really helps out. More and more centers have that expertise.
Speaker 4: And that's what we'll be focusing, and probably we'll start with the centers of the trial, which already have a lot of experience with our product, but we're also talking to many other geographical centers. Make sure that patients from other geographies have a center close nearby to where they are. Just to comment to a previous question you asked.
Speaker 4: and Stacey answered a little bit, is of course we believe that our clinical data set, even though the primary endpoint did not hit statistical significance, we think that the body of evidence we bring forward, we are able to show statistically significant results once we're able to show and dive into, more deeper into the data set.
Speaker 4: which you spent a lot of time and I don't want to repeat it for you. But therefore I think that the question will be more focused on clinical, why the biomarker data gives strong support to what we see in the clinical as it covers even for the part of the score where we think it's not sensitive in the more advanced patients. But when you're able to eliminate advanced patients we see both in the primary and secondary endpoints.
Speaker 4: statistical significant results. Of course, we're not gonna lay it out here. That's what we're gonna do at the outcome. But thank you very much for those questions Jason.
Speaker 10: Hi, I'm Stacy. Thank you.
Speaker 2: Sure. Thank you very much. Just a reminder, if you have any questions, please press star one on your phone keypad now.
Speaker 2: We don't appear to have any further questions in the queue. I can hand back over for closing comments.
Speaker 4: Thank you, I really appreciate that. It looks like Stacy did a wonderful job laying out
Speaker 4: the plan and there's no additional questions.
Speaker 4: So we had a long call this morning, so let's get back to time to everyone listening. We wanna thank you again for listening in, in August , mid of August , to have so many investors listen again. It shows the importance to our investors of our plan forward, and we really thank you for listening in today.
Speaker 2: Thank you very much, Jenny. Back to you. Thank you, Chaim. 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.
Speaker 2: Jenny, back to you. Thank you, Chaim. 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.