Brainstorm Cell Therapeutics Q1 2025 Earnings Report

Brainstorm Cell Therapeutics EPS Results

• Actual EPS: -$0.45
• Consensus EPS: -$0.38
• Beat/Miss: Missed by -$0.07
• One Year Ago EPS: N/A

Brainstorm Cell Therapeutics Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Brainstorm Cell Therapeutics Announcement Details

• Quarter: Q1 2025
• Date: 5/15/2025
• Time: Before Market Opens
• Conference Call Date: Monday, May 19, 2025
• Conference Call Time: 8:30AM ET

Brainstorm Cell Therapeutics (NASDAQ:BCLI), a biotechnology company, engages in the development and commercialization of autologous cellular therapies for the treatment of neurodegenerative diseases. The company, through its NurOwn proprietary cell therapy platform, leverages cell culture methods to induce autologous bone marrow-derived mesenchymal stem cells to secrete high levels of neurotrophic factors, modulate neuroinflammatory and neurodegenerative disease processes, promote neuronal survival, and enhance neurological function. It is developing NurOwn, which has completed Phase III clinical trial for the treatment of amyotrophic lateral sclerosis; Phase II clinical trial for the treatment of progressive multiple sclerosis; and for the treatment of alzheimer's disease, as well as for other neurodegenerative diseases. Brainstorm Cell Therapeutics Inc. was incorporated in 2000 and is headquartered in New York, New York.

Brainstorm Cell Therapeutics Q1 2025 Earnings Call Transcript

Key Takeaways

• Our FDA clearance to initiate the Phase 3b “Endurance” trial confirms BrainStorm can begin patient enrollment under its amended IND application.
• A Special Protocol Assessment agreement with the FDA derisks the regulatory pathway by confirming the trial endpoints and statistical analysis plan are acceptable for potential approval.
• The company has secured initial manufacturing at Tel Aviv’s Sorsky Medical Center with a planned technology transfer to Pluri and a forthcoming US facility letter of intent for future commercialization.
• BrainStorm’s ability to commence the trial hinges on securing adequate funding, as current cash resources require supplementation through strategic partnerships and a pending $15 million non-dilutive grant.
• The proprietary allogeneic exosome program delivered promising preclinical results in lung inflammation and fibrosis models, with strategic collaborations and expanded IP filings in progress.

Presentation

[Operator]

Greetings, and welcome to the BrainStorm Cell Therapeutics Therapeutics first quarter twenty twenty five conference call. At this time, all participants are in a listen only mode. As a reminder, this call is being recorded. I would now like to introduce your host for today's call, Joyce Lonergan of Life Advisors. Joyce, you may begin.

[Joyce Lonergan, Managing Director at LifeSci Advisors, LLC]

Thank you, Holly. 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 NurOwn technology platform, clinical trials of NurOwn and related clinical development programs and the company's ability to develop strategic collaborations and partnerships to support their business planning efforts. 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.

[Joyce Lonergan, Managing Director at LifeSci Advisors, LLC]

The company's results may differ materially from those projected on today's call. The company undertakes no obligation to publicly update any forward looking statements. Joining us on the call today will be Chaim Leivovitz, President and Chief Executive Officer of BrainStorm Doctor. Hara Hartunian, Executive Vice President and Chief Operating Officer Doctor. Bob Dagger, Executive Vice President and Chief Medical Officer and Doctor.

[Joyce Lonergan, Managing Director at LifeSci Advisors, LLC]

Neta Blantyme Sraga, Senior Vice President of Research and Development. I would now like to turn the call over to Mr. Leibowitz. Please go ahead.

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

Thank you, Joyce. Good morning or good afternoon, everyone. Thank you for joining us today. We appreciate your continued interest and support in BrainStorm. We published our Q1 twenty twenty five earnings release after the market closed last Thursday, and colleagues and I are pleased to provide a corporate update today.

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

Our unwavering primary focus remains the execution of the clinical development plan for NurOwn, and the initiation of our pivotal Phase 3b trial designed to confirm its therapeutic benefit for individuals in the early stages of ALS. Hopefully, you will have seen the press release we released this morning announcing that the US FDA has cleared us to initiate the trial. This follows the amendments we submitted to our Investigational New Drug application, which included comprehensive technical transfer documentation, robust quality assurance and stringent quality control processes. This regulatory clearance marks a significant milestone, bringing us closer to commencing patient enrollment. As previously disclosed, the trial design has been carefully agreed upon with the FDA under a Special Protocol Assessment This SPA is a crucial element as we believe it substantially derisks the regulatory pathway for neurons.

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

It provides confirmation that the child's endpoints and our statistical analysis plan are deemed appropriate for the FDA to potentially support approval contingent upon the trial meeting its pre specified expectations. We also announced previously that in a face to face Type

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

C meeting, had achieved alignment with the FDA on CMC, a particularly vital aspect for an advanced cell therapy like NurOwn. Our CMC team is always advancing its development and continues to work as regulatory guidance directs. To provide further detail on our operational readiness for the upcoming trial, I'd like to turn the call over to our Chief Operating Officer, Doctor. Haro Artunio. Haro?

[Haro Hartounian, EVP & COO at Brainstorm Cell Therapeutics]

Thank you, Chaim. As previously discussed, we plan to initiate our initial manufacturing for the Phase IIIb trial at the Tel Aviv Sorsky Medical Center. To scale up our manufacturing capabilities, we'll then proceed with a technology transfer to Pluri, which would provide additional clean room facilities. We have signed a letter of intent with Cluri and anticipate moving forward to a definitive contract soon. Furthermore, the team and I have secured a leading US clinical site that has successfully passed FDA inspection.

[Haro Hartounian, EVP & COO at Brainstorm Cell Therapeutics]

We are in the process of finalizing an LOI and will 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. Back to you, Jaime.

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

Thank you, Harold, for that important update on our manufacturing and site selection progress. Currently, we are actively engaged in negotiations for the clinical trial agreements, with approximately 15 leading clinical centers across The United States. Each points to serve as a site for our Phase 3b trial. The strong interest we are getting from numerous renowned ALS clinicians and researchers underscores their conviction in the potential of NurOwn. We will make announcements regarding these agreements as they are finalized.

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

As noted in our earnings press release, the details of the trial, which we are calling Endurance, have now been posted on ClinicalTrials.gov. 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 limited treatment options currently available for ALS patients.

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

We firmly believe NurOwn, if successful in the study and subsequently approved, holds the promise of becoming a significant and valuable treatment. In parallel with our dedicated NurOwn development efforts, our scientific team remains actively engaged with the academic community and our industry peers, sharing the latest data and insights. Last week, we participated in the annual ALF Drug Development Summit in Boston, a crucial gathering that brought together over 200 scientific leaders to address the most pressing challenges in the therapeutic development for this devastating disease. The discussions at this year's meeting were centered on critical areas, such as target validation, effective utilization of biomarkers and optimization of clinical trial design. I want to take a moment to speak about our incredible team at BrainStorm.

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

Despite facing significant financial constraints, a reality for many small biotech companies in the current environment, their dedication and tireless efforts are truly remarkable. 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, thanks in large 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.

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

We understand that members of the investment community and the ELA community are eager to know precisely when the first patient will be enrolled. Please note 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 are simultaneously proceeding on many fronts be able to initiate the trial as swiftly and responsibly as possible. We are deeply committed to this endeavor, and we will continue to provide updates as they become available. I'll now turn the call over to Doctor.

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

Bob Dagger, BrainStorm's Chief Medical Officer, who will give a brief summary of his presentation at the ALS Summit last week. Bob?

[Bob Dagher, EVP & Chief Medical Officer at Brainstorm Cell Therapeutics]

Thank you, Chaim. Hi everyone. As part of my presentation last week, I provided a detailed overview of the design of our planned Phase IIIb trial and explain the significant changes we made versus our trial Phase three 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 twenty four week double blind period, which will be followed by Part B, a twenty four week open label extension designed to evaluate long term effects on survival and biomarkers.

[Bob Dagher, EVP & Chief Medical Officer at Brainstorm Cell Therapeutics]

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 twenty four, so at the end of Part A, in the ALSFRS R total score, which is now considered the gold standard in recent registrational trials. The results from Part A at twenty four weeks, if they meet our expectations should be sufficient to support a new BLA. This is covered specifically in our spy agreement with the FDA.

[Bob Dagher, EVP & Chief Medical Officer at Brainstorm Cell Therapeutics]

In the phase 3b trial, we eliminated the three months run-in period from the previous study, and also shortened the screening period from twenty weeks to now nine weeks to minimize changes between screening and baseline. I will now turn the call over to my colleague, Doctor. Blondheim Swagya, to discuss the ALS biomarkers analysis. Nata?

[Netta Blondheim-Shraga, SVP - Research & Development at Brainstorm Cell Therapeutics]

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 neuron. 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 phase 3a study provided us with valuable insight into how neuron may be exerting its effect.

[Netta Blondheim-Shraga, SVP - Research & Development at Brainstorm Cell Therapeutics]

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 NurOwn was associated with a reduction in neuroinflammatory and neurodegenerative biomarkers, and with increase in anti inflammatory and neuroprotective biomarkers. At the ALS Summit, we presented the results from three sets of preclinical experiments to investigate the immunomodulation, neuroprotectant, and neuroriginative 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 NurOwn cells. We demonstrated that NurOwn inhibits the secretion of pro inflammatory cytokines and decreased the proliferation of certain types of T cells, CD4 cells and CD8 cells, that are involved in the inflammatory process.

[Netta Blondheim-Shraga, SVP - Research & Development at Brainstorm Cell Therapeutics]

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. We showed here that when these cells were co cultured with conditioned media collected from their own cell cultures, viability was restored to ninety six point five percent of normoxic conditions, or ninety six point five percent abnormal, 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 transwell system with neuron cells. We showed that neuron enhanced growth of neurites, supporting a neuroregenerative role for neuron. As disclosed previously, we reviewed the clinical utility of neurofilament light, or NfL, as a biomarker of disease progression and treatment monitoring in ALS.

[Netta Blondheim-Shraga, SVP - Research & Development at Brainstorm Cell Therapeutics]

Ten patients who completed the prior Phase III trial enrolled in an open label expanded access program that spanned two twenty eight week periods. We showed that early treatment with NurOwn resulted in greater reductions in Nf L levels. Among the six participants who received NurOwn in both Phase III and the EAP, a continual group level reduction in NfL was observed. In contrast, for the four patients who received placebo in the phase three, the group median NfL change was higher at the end of the study, indicating worsening neurodegeneration. After these patients switched to NurONA in the EAP, the majority showed a stabilization in NSL levels.

[Netta Blondheim-Shraga, SVP - Research & Development at Brainstorm Cell Therapeutics]

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 IIIb study. At the conference, we also shared results from a genetic sub study conducted during our Phase III study. 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 Unc13A, which has been widely studied in ALS. Patients who were enrolled in the prior Phase III trial had the option to participate in a genetic substudy, and 124 consented.

[Netta Blondheim-Shraga, SVP - Research & Development at Brainstorm Cell Therapeutics]

We showed in these patients that the UNC13A, the UNC13A genotype appeared to influence the response to neurone therapy. Patients who were heterozygous carriers of ORISCLL had a statistically significant response rate to neurone treatment compared with placebo, supporting further investigation of UNG13A and other genetic factors and their correlation to treatment effect of NurOwn in our next trial. I will now turn the call back to Chaim for closing comments.

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

Thank you, Neta. For the details on BrainStone's financials for the quarter ended 03/31/2025, I would refer you to the press release we issued on Thursday and also to our 10 Q filed with the SEC. We are now ready for the Q and A. Joyce?

[Joyce Lonergan, Managing Director at LifeSci Advisors, LLC]

Yes. Thank you, Hyun. We have four written questions. The first one: Can you start the trial without proper funding?

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

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 submissions, site selections and CRO engagements. However, initiating and successfully executing a clinical trial of this nature 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 a trial. As communicated in our recent press release, we are actively pursuing multiple funding avenues to ensure the timely commencement of the trial.

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

These efforts are in various stages, encompassing a promising $15,000,000 nondilutive grant currently will be under review, alongside ongoing negotiations for strategic partnerships. We are focusing on strategic partnerships. Our priority is to secure the necessary capital through such partnerships to confidently initiate and complete this clinical study.

[Joyce Lonergan, Managing Director at LifeSci Advisors, LLC]

Thank you, Hanan. We have a second question. We see you called the trial Endurance. What's the meaning of that?

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

Thank you for that. The name Endurance was carefully chosen to deeply resonate with the ALS community. It stands as a tribute to the remarkable strength, tenacity and unwavering spirit demonstrated by individuals living with ALS and their families. For BrainStorm, endurance also underscores our steadfast commitment to persevere in our scientific endeavors and generate the robust data required for regulatory approval of NurOwn. We believe that this trial embodies the collective resilience of patients and our determined mission to deliver a potentially meaningful therapeutic option for ALS. Thank you.

[Joyce Lonergan, Managing Director at LifeSci Advisors, LLC]

Thank you for that, Hayim. The third question is: Will the company also be producing in The U. S?

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

Thank you. Haruo, you want to take that?

[Haro Hartounian, EVP & COO at Brainstorm Cell Therapeutics]

Sure. Thank you so much for the question. Absolutely, expanding our manufacturing footprint for The United States is a key strategic objective for us. We're pleased to share that we will be announcing a letter of intent in the coming days with a US 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.

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

Thank you.

[Joyce Lonergan, Managing Director at LifeSci Advisors, LLC]

Thank you for that. Question four is, can you update on any advances in the exosome program, or are you not proceeding with that at this time?

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

Thank you, Neta. Please take that one.

[Netta Blondheim-Shraga, SVP - Research & Development at Brainstorm Cell Therapeutics]

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, which would join our existing publication about the efficacy of exosomes in a model of ARDS.

[Netta Blondheim-Shraga, SVP - Research & Development at Brainstorm Cell Therapeutics]

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 as a chemotherapy agent 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 exosome program towards clinical development. 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.

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

Thank you, Neta. Holly, would you open the line for one or two questions, which we'll take before 09:00?

[Operator]

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. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue.

[Jason Mccarthy, Senior Managing Director & Head of Biotechnology Research at Maxim Group]

Good morning, everybody. Thanks for taking the questions. If you can go back to the Onc13 a discussion that you're having, have you had any communications with FDA in terms of being able to stratify by on 13 a in the upcoming Phase 3b or was that association that you've showed through the EAP more of an exploratory study? Kind of are you locked in with the spy? You don't really have a lot of wiggle room around the ALSFRS to go for onc13a stratification as well?

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

Thank you very much for that question, Jason. In general, the FDA is not yet approving any biomarker as a surrogate, but I would like Bob to elaborate more on that. Bob?

[Bob Dagher, EVP & Chief Medical Officer at Brainstorm Cell Therapeutics]

Oh, yeah, thank you. Thanks, Jason, for the question. So under the Special Protocol Assessment Agreement with FDA, the protocol, I wouldn't use the word locked, 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.

[Bob Dagher, EVP & Chief Medical Officer at Brainstorm Cell Therapeutics]

However, scientifically speaking, we're very excited with the larger ALS community about these new genetic discoveries and the ANK13A story is evolving. However, it remains exploratory and not definitive. At this stage in the game with the trial design innovations, etcetera, we are acutely aware of what's going on. I presented data on 15A two weeks ago in New Orleans at ISCT, it was very well received in oral presentation, it was chosen 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.

[Bob Dagher, EVP & Chief Medical Officer at Brainstorm Cell Therapeutics]

However, we're going to 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. Thank you for your question, really appreciate it.

[Jason Mccarthy, Senior Managing Director & Head of Biotechnology Research at Maxim Group]

Got it. And another, I guess somewhat technical question. You had talked a bit about the hypoxic stress cold culture with their own cells or the neuro media, if I caught that right. And did you say that it restored normoxic activity? And if so, can that mechanism of action be used as part of a data package when you refill or file the BLA the next time around?

[Jason Mccarthy, Senior Managing Director & Head of Biotechnology Research at Maxim Group]

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 NurOwn that would be supportive of the next BLA?

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

Very good question. Yes, Anatas can answer the first part and Tal can answer the second part.

[Netta Blondheim-Shraga, SVP - Research & Development at Brainstorm Cell Therapeutics]

Thank you. Yes, you're correct. What we saw was the media that was enriched by our cells had a protective effect and a rescue effect, really, on cells under hypoxic conditions, restored them back to almost one hundred percent of normoxic condition. So ninety six point five percent. This is a cell culture.

[Netta Blondheim-Shraga, SVP - Research & Development at Brainstorm Cell Therapeutics]

So it's a simplistic model. It's not a human, live model. It's not a clinical model. But it is supportive, I think, was included in our IND as well.

[Jason Mccarthy, Senior Managing Director & Head of Biotechnology Research at Maxim Group]

Got it. And just last question on the manufacturing. I know you're aiming to open up additional clean rooms, but currently the Tel Aviv facility, how many therapies can it handle or produce?

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

Yeah, it depends on how many rooms we're using. It will be a rolling enrollment, as you know, with the phases, taking off 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 US site also up and running.

[Jason Mccarthy, Senior Managing Director & Head of Biotechnology Research at Maxim Group]

Got it. Thanks for taking the question time.

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

You're very welcome. We have time for one more question, Holly.

[Operator]

Your next question is from David Bautz with Zacks Small Cap.

[David Bautz, Senior Analyst at Zacks Small Cap Research]

Hey, good morning, everyone. Thanks for the update this morning. So Jaime, 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 inside, 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?

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

Thank you very much for that question. On clinicaltrials.gov, you will see a listing of the sites. It's out there, but we didn't yet sign the CTAs. We will be announcing very soon, gradually after we sign CTAs. And as I just mentioned, we will start to grow site by site based on a GANT of patient population that we are going to be enrolling, based on the manufacturing.

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

So we are working on the final steps of that GANT, so I can't share exact numbers now. But the plan is, as you know, the 200 patient trial within two to three years, to have everyone enrolled and everyone treated the first part, and we'll be deep into the second part as well. I want to remind you that the BLA would be filed if we have statistical significant results of the first part of the trial.

[David Bautz, Senior Analyst at Zacks Small Cap Research]

Okay, great. Thanks for taking the question.

[Chaim Lebovits, President & CEO at Brainstorm Cell Therapeutics]

Thank you very much. Want to thank everyone for being on the call today. We're hoping to close this 09:00. I see it's exactly 09:00. So thank you very much. And have a wonderful day.

[Operator]

This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.

Participants

Executives

• Chaim Lebovits, President & CEO
• Haro Hartounian, EVP & COO
• Bob Dagher, EVP & Chief Medical Officer
• Netta Blondheim-Shraga, SVP - Research & Development

Analysts

• Joyce Lonergan, Managing Director at LifeSci Advisors, LLC
• Jason Mccarthy, Senior Managing Director & Head of Biotechnology Research at Maxim Group
• David Bautz, Senior Analyst at Zacks Small Cap Research