Q3 2020 Brainstorm Cell Therapeutics Inc Earnings and Corporate Update Call
Ladies and gentlemen, thank you for standing by please continue to hold brainstorm cell therapeutics call will begin momentarily. Once again. Thank you for standing by please continue to hold.
Paul will begin momentarily.
[music].
Greetings and welcome to the Brainstorm cell Therapeutics third quarter 2020 conference call. At this time all participants are in a listen only mode. As a reminder, this call is recorded.
I would now like to introduce your host for today's conference Michael Ward from lifestyle Advisors Mr., what you may begin.
Well. Thank you everyone for joining the brainstorm cell therapeutics earnings call before we begin the opening remarks.
I remind listeners that this conference call contains numerous statements descriptions forecasts and projections regarding brainstorm.
Actual future business operations performance statements regarding the market potential for the treatment of Neurodegenerative diseases, such as Latin and that's.
The sufficiency of the company's existing capital resources for continuing operations in 2020 and beyond the safety and clinical effectiveness of the New York Technology platform clinical trials of neurons I laid it kinda <unk> programs and the company's ability to develop strategic collaborations and partnerships to support its business planning efforts.
Forward looking statements are subject to numerous risks and uncertainties many of which are beyond brain stops control, including the risks and uncertainties described from time to time in the Companys SEC filings.
Cost may differ materially from those projects projected on todays call. The company undertakes no obligation to publicly update any forward looking statements.
Joining us on the call today will be tightly with President C. O Brainstorm, Dr. wildcard, President and Chief Medical Officer, Dr., Stacy Lindbergh Executive VP and head of research at three times Shaw Executive VP and CFO.
They will be available to answer your questions. During the culmination session I'd now like to turn the call over to Mr. Lieberman.
Please go ahead.
Thanks, Michael.
Welcome to Brainstorm third quarter 20, Twond earnings call and thank you everyone for joining us.
So far 2020 and being very productive for brainstorm.
As we advance the woman several neurological diseases.
Continued to build out our operating infrastructure to go up he's had expanded our senior management team.
We're focused on the upcoming topline read out for the neural interface the trial and they are less.
Which we expect to happen by the end of November.
We believe that a successful outcome for this trial will.
Well I hope so they have less community.
And we will be a transformative moment for <unk>.
So I think that's on a path to filling.
Hi, sorry to filing.
Ladies and supporting our transition to a commercial stage company.
The phase three trial is being conducted the checks for all these centers of excellence in the United States.
I'd like to once again, thank all the investigators and their staff.
At the participating sites for their dedication.
Especially if we're unable to get this trial to complete on time, the middle of an ongoing coordinating pandemic.
I also want to express my complete gratitude to the trial participants and their loved ones. So fully devoted themselves to the challenges are bringing in an investigational therapeutic forward.
Joining me on the call today are president and Chief Medical Officer Dr. else card.
We will update you on our clinical program, including our pivotal trial.
As well as recent news relating to our progressive and that's an old timers that these programs.
I've also has dr. stays at Lindbergh Executive Vice President and head of global clinical research to join the call today.
He'll talk for a few minutes about the design of the phase to the airlift trial.
Our CFO Dr., Jim Shaw will then provide updates on our financial results for 10.
Before turning it back to me for some.
What are your mark.
Well then address your questions into Q and a session.
For that session.
I would like to.
Also invite to.
Two recent additions to our senior team.
In September we appointed Dr., Tony will fall, well Hauske as executive Vice President Global regulatory.
Regulatory affairs.
Tony is a recognized leader regulatory affairs and brings years of multinational experience you spend 35 years of Bristol Myers Squibb.
On his experience that spans a broad range of regulatory capabilities across multiple therapeutic areas and geographies.
Yeah, the track record.
Having success of Liberty interactions.
Publishing.
And executing a successful global regulatory strategies.
What was appointed Bill White senior Vice President of a market access and pricing.
But it was also very accomplished senior executive with more than 25 years experience, leading product commercialization and securing market access for innovative new medicines.
His experience will help us develop market access patient service into this business strategies that will.
[noise] stuff will be important to the time that official market entry of neural frail, that's assuming its approval by the FDA.
Do you still most frequent important appointments are the latest in a series of key senior hires we made throughout 2020.
The reason I'm mentioning them now is that they are part of a strategic initiative to build a senior team with proven development the global commercial capabilities as rental makes the transition to a commercial organization.
Other appointments this year that were reviewed previously announced.
The doctors, taking Lindbergh as executive Vice President and head of Global clinical research on David <unk> Executive Vice President and Chief operating officer and profit subject sprinkle. It distinguish that kinda <unk> Thomas and thank her joined US as the chairman of our board earlier in the year.
And it isn't all preparations for the upcoming data read out.
We've been busy planning and executing.
There's a cheating another breed deal activities.
Well our focus is to expedite this process.
I want to be able to submit.
Yeah. They would you have D.A. as soon as possible after topline data is available.
At the same times, all clinical trial activities and data profit fairness, the drawing, whereas the dancing or CMC activities in preparation for the BLE and subsequent launch.
With respect to the deal they plan on there.
Understanding the urgency of the islands.
We are in full dialogue with the FDA.
We are actively exploring with them opportunities to expedite the information flow to they have to do with.
With the ultimate goal of enabling to determine you process itself.
I'll now turn the call to Dr., Ralf turn for a clinical and R&D updates Ralph.
Thank you, Brian and welcome everyone.
I'm just stated the immediate priority and focus for everyone here at Brainstorm is that.
The completion and preparation of topline data read outs in.
In the phase three or less trial for Nurown.
Oh, we completed dosing of all patients at the beginning of July as we previously announced and we intend to announce top line results by the end of November.
There are several important clinical trial activities remaining that are being completed at this time to support a high quality database lock him.
I'm very happy to announce that these are all proceeding as planned.
This double blind placebo controlled trial will provide data that hopefully can support registration of nurown for LLS.
A lot of very thoughtful planning.
Went into the phase three clinical trial design, including careful selection of clinical and biomarker outcomes.
And the detailed statistical analysis plan that will be used to analyze the data.
We've incorporated all that we have learned about the neuron treatments.
Including lessons learned from our prior phase two randomized placebo controlled clinical trial.
Help you understand our thinking about the phase three clinical trial design.
And particularly how the primary endpoint is calculated I'm going to turn the call over to Dr. Stacy Lindbergh.
Stacy in addition to her experience in global commercialization and regulatory strategy has a long and deep experience in clinical trial design and bio statistics.
It's really great to have Stacy here today to share our thinking with you Stacey.
Thank you Ralph.
To begin I want to emphasize the critical role that trial design plays in determining the success of the product.
Throughout my career I've been involved in a different numerous innovative therapies through the development and the regulatory process leading to approval.
Well the underlying clinical activity and the safety of a new product will always be the most important factors in determining if it meets the standards for approval very often it's a dot design and the execution of the supporting clinical trials that become the overriding factor and one that a company can influence for success.
The phase three you're in trouble with obviously well underway before I arrived at Brainstorm earlier. This year. However, I can say that from the beginning I've been impressed by the very careful planning he pitching the detail in execution and sophisticated analysis that went into that setting up at this trial and ultimately his prepared us for the readout that means.
Sure.
The phase two trial enrolled approximately 200 patients randomized one to one to receive three doses of nurown or placebo administered over four months.
It incorporates an 18 to 20 week running period.
Allows us to ensure that the trial only involves airlift patients defined as rapid progressors.
This is important as we observed a greater benefit in reference to the pressures from your own treatment in our phase two study.
Additionally, this trials run in period allows us to quantify the Atlas to claim for each patient prior to treatment.
Very important for a disease like they list that has great heterogeneity.
He brings precision to our estimates for the treatment effect like counting for inter patient variability.
The primary endpoint of this trial is a responder analysis based on the change in the rate of decline of a piece of ellipse functional rating score or the LSW suppress our score across 20 weeks exposed.
Specifically the way. This works is by comparing the rate of decline for each patients in the pre versus post treatment period.
Each patient endless separates our data or if that was a model provide.
Provide providing an estimate of the disease progression over time and the format, which is expressed in terms of the rate of unless I press, our score either the decline or improvement per month.
We define a responder or the participant whose analysts FSR post treatment scores at least 1.25 points greater than his or her pretreatment slip.
Those patients who don't see at least a 1.25 points per month improvement in their airlift superstar slope. After treatment are defined as non responders.
The response data are then analyzed using a statistical model with <unk> with important disease could vary.
There are a number of.
A secondary efficacy analyses, including the percentage of trial participants are patients with disease progression that halted or improved.
The analyst I first start change from baseline.
The combined analysis, a function and survival.
Slow vital capacity as well as survival analysis.
And another critical element of our trial is the collection of CSF biomarker D that seven different time points across the study in all patients.
This data will further our understanding that their biological effect in English station.
And safety remains Paramount in our trials and will be central to our planned data with you.
Altogether, we believe that these primary and secondary endpoints will generate the evidence we need to assess your and efficacy and safety.
And for more details on the trial design and how the primary endpoint is calculated I gave a presentation at the annual North East L.S. before Neil's meeting on September Thirtyth, you can find a poster from this event as well as an audio recording of my presentation on Brainstorms corporate web site.
I'll now turn the call back to Ralph to complete the review of our clinical and regulatory activities.
Thank you Stacy for that great discussion.
I want to touch on a few other issues now the other news Ah relating to our LSW program.
During last quarter was a very important publication in the journal amyotrophic lateral sclerosis, and Frontotemporal degeneration.
In this publication, we described the results through the series of preclinical experiments that.
As demonstrated the ability of nurown to induce T.N.B. regulatory cells and Upregulates, a molecule called I El pen.
Oh. This is very important because we know that decrease t. and be regulatory function.
Appear to play a role in disease progression nail last and then other neuro inflammatory diseases that are currently under study. These.
These novel observations.
Greatly extend our understanding of how nurown modulation overactive immune system.
Coupled with its ability to deliver neurotrophic factors helped months helps advance our understanding of neurons mechanism of action.
We believe that neurons ability to simultaneously targets. These pathways is an important contributor to the proposed mechanism of action we hope.
We hope to extend these observations in the planned phase three biomarker analysis.
We also announced honor.
On our last quarterly call that our trial of Nurown in progressive and mass was fully enrolled and were.
And we're pleased to report today that we expect all study treatments to be completed by the end of the year.
In September we also presented a scientific poster at the M.S. virtual 2020 meeting.
This scientific presentation was given by Dr. can do chestnuts, who is a professor of neurology at Harvard Medical School, and senior neurologists that the Brigham and women's hospital in Boston.
The study evaluated 48 participants in the Cline registry, which is a large scale long term prospective natural history study are then that's all.
Our colleagues conducted an analysis of patients who matched exactly the inclusion criteria of our ongoing phase two progressive MSK trial and serves as an important natural history comparator.
What was unique about this presentation is that dr. fitness demonstrated a correlation between specific brain and spinal cord quantitative Emery matchers that we're performing in our clinical trial and she correlated them with the observer functional improvements and progressive en masse patients.
We believe that these results are very important as they will help us in the analysis and greatly advanced the ability to understand the results from our phase two clinical trial in progress that mass.
Also as discussed in the last quarterly call.
We are in the process of initiating an innovative clinical program focused on the development of Nurown as a potential treatment for Alzheimer's disease.
Part of this program, we're planning a multinational phase two clinical trial in Europe to evaluate the safety and preliminary efficacy of nurown treatment in patients with prodromal mild Alzheimer's disease, who are biomarker and clinically selected.
This will be conducted at the Vu University Medical Center in Amsterdam, P.T. cell Cat, Seattle Hospital, and other clinical trial sites in the Netherlands, and France, where.
We are currently engaged with the relevant regulatory agencies to finalize the design and conduct of this clinical trial and we will begin clinical trial enrollment once we receive final regulatory and logistical approvals.
Lastly in July we.
We announced results from a groundbreaking preclinical study of Nurown derived exosomes as a potential treatment for COVID-19, a rds that we studied in an L.P.S.A. Rds mouse model.
We showed for the first time that intra trick he'll administration of Exosomes extracted from mesenchymal stem cells using our neurotechnology resulted in statistically significant improvements in multiple long parameters. We're in the process of publishing these findings in a peer reviewed scientific journal.
And we're actively considering next steps I will now turn the call over to precision to discuss the financials freedom.
Thank you Ralph.
My pleasure now to walk you through our third quarter 2020 financial performance.
Research and development expenses net for the three months ended September 30, 20, 21.87 million compared to 4.01 million net for the three months ended September 32019.
<unk> decreased year over year was primarily due to decrease in expenses related to the phase three and phase two clinical trial and increasing participation I am from under various awarded grant and a decrease in expenses in connection with passenger travel and other activity.
The decrease in expenses was partially offset by an increase in material costs payroll and stock based compensation expense and a decrease in proceeds received in connection to the treatment of patients under the hospital exemption regulatory pathway.
Excluding participation from I am sorry, I'm under the grandson proceeds received from the hospital exemption regulatory pathway.
Second development expenses decreased by 1.68 million from 5.66 million in the third quarter of 2019 to 3.9 million in the quarter up 2020.
General and administrative expenses for the three months ended September 32000, 22.62 million compared to 1.54 million in the three month and that ended September 32019.
Increased year over year was primarily due to an increase in payroll stock based compensation Yakov consultants and other costs, partially offset by decrease in travel expenses.
Net loss for the three months ended September 32000, 24.49 million or 40 cents per share as compared to a net loss of 5.63 million or 25 cents per share for the three months ended September 32019.
Cash cash equivalents, including short term bank deposits were approximately 28.8 million at September 32020, compared to 16.2 million at June 32020.
Our total available funding as of September 32020, which includes cash cash equivalents and short term bank deposits as well as the remaining non dilutive SARM I and other Gran amounts to approximately 31.4 million.
On March six 2020, we put in place a 50 million ATM facility.
During the quarter ended September 32020, we raised approximately 13.7 million at an average price of $14.40 per share utilizing the ATM facility.
As of September 24, 2020, we have utilized approximately 23 million up to 50 million ATM capacity with approximately 27 million of ATM capacity still available to us under the March six 2020 Eighthpm.
On September 25th 2020, we amended and restated the marks the ATM and increased our available capacity from approximately 27 million to 45.
Up to 45 million of our common stock under the ATM facility.
To clarify the aggregate amount of 45 million under the amended and restated ATM facility put in place on September 25th 2020, SVB Lincoln Raymond James in the amount of approximately 27 million I'm sold pursuant to the March six 2020 Eighthpm.
As of October 14, 2020, we raised an additional 5.1 million under the September 25, 2020, ATM facility at an average price of $17.21 per share.
With this additional capital our total available funding as of October 14, 2020, which includes cash cash equivalents and short term bank deposits of approximately 33.1 million as well as for meeting non dilutive funding from CIRM I and other grant.
I'll still approximately 36 million.
For further details on our financials. Please refer to our form 10-Q filed with the FCC to that.
Back to your line.
Thank you did a good job well done.
I will now turn over to Paul threat, you in a Michael Ward from life's I will read the questions. We have received Michael.
[laughter] thanks, guys.
The first question, we have relates to intellectual property.
And this investor says that the company website in various investor presentations indicate ER.
The intellectual property portfolio is robust revenue our platform and there is just to get a better understanding of the company's competitive advantage as it appears there are competitors and they are not able to stem cell space.
Would you. Please provide more details on what comprises the the IP portfolio the number of patents geographic area coverage.
Competitive differentiation of neurons Stephanie protected by your IP portfolio. I. For example are you the only autologous adult stem cell platform that has IP.
Yep.
Thank you so.
So rainfalls patent portfolio includes granted patents in the United States and Europe.
Additionally, we have numerous friends of patents and all the jurisdictions, including Canada, Israel, Japan and Hong.
In Hong Kong.
Just cover both sold compositions and methods of treating diseases.
We also have several pending patent applications, let's cover various aspects of the interim topology.
Platform.
The next question please.
Yeah. That's that's just a regulatory question, we'll brainstorm request the accelerated approval at the M&A in November 2021, when you had the results of the phase three it had.
David and please answer this question.
Sure. So on Percival Brainstorm knives benefited from the assistance, which is associated with the essence.
As to me.
Program and we've been holding.
We've been holding hole.
On direct status in Europe, sorry.
Bring some kinda speculate on the results of the phase three study buddies committing and engaging ways your regulators in order to seek approval in a timely manner.
Thank you and then question.
And how quickly do you think you have to be filed any less apt to the phase three results are announced.
Thanks Ralph.
Thank you and the team is actively preparing for the B.L.A. now as we mentioned in our opening comments, we do not intend to comment on the precise timing of our application, but I can tell you that we're doing all that we can see be ready should the phase three data support such an application.
Thanks next question.
So we'll never on Threed only specific hey that genetic sub types such as 71.
Well if you go again.
Nurown is being evaluated in a less patients irrespective of their genetic status as you know only 10% of bailout has a clear genetic factor identified of which about 20% are related to asset would be one.
Our investigational aeolus treatment is targeting a much broader population having.
He said that we are evaluating genetics into phase three clinical trial than we do plan to analyze any potential impact specific genes have on the last treatment outcomes.
Thanks, and then if approved how do you foresee positions utilizing your near on Friday last treatment will it just be administered every eight weeks for the rest of the patients life or how will that play out.
Well.
Oh, we're working on the assumption that physicians will initiate.
And continue to administer neuron based on their experience.
Obviously, a last patient preferences.
And an assessment of the benefit risk, which is a moving target does hasn't disease progressed is that is continually reevaluated. One thing that we are able to say is that a single bone marrow harvest.
Due to our cryopreservation technology should be able to support at least three years of therapy.
Thanks, Thanks, So they've seen an instance, where that another cell therapy company that recently announced a delay and there there would be other filings due to an inability to come to agreement with the FDA on a required potency assay.
I do think a similar type of assay is going to be required for near on being a filing.
What is the status of your App development up that's when I say.
Well.
Well, we can't comment on another companys interactions with the FDA, but here's what we do know about our delay filing first of all.
We are aware of the importance of the potency I'd say aspect and were addressing it internally and we.
We plan to discuss this in more detail with the FDA the appropriate time.
And secondly, Ah Brainstorms B.L., they will be based on a well designed and executed phase three clinical trial with a supportive evidence from phase two.
Hi, Thanks.
And then how many and I've patients and your estimate in your estimation could be treated in the first year following full of neuro.
Yeah, we're working towards treating get maximum number of patients.
Very quickly after an approval.
We're investing in advanced discussions concerning our.
The commercial production.
Partners, and we should be able to disclose more about this very soon.
The next question please.
Thanks, and then next question relates to the hospital exemption program. That's been ongoing in Israel do you have any additional information on the patients that were treated through this program and will they actually data that's been collected from those patients be presented or published at some point.
They see.
Sure happy to pick this all patients had been a role there are being treated per the protocol at brings.
At Brainstorm, we're committed to advancing science and we'll share the data as soon as we can.
But I can tell you is that our communication priorities will go in the following order first regulatory agencies and investigators in ongoing trials and then.
And then second to the scientific in the Investor community.
Thanks.
Thanks, Stacy then the next question relates to the upcoming as data release Ah first.
First of all what gives her team confidence that the data released what actually happened by the end of November or do you think this is an aggressive or conservative target date and then.
And then assuming the data stroke show strong advocacy is expected what's the estimated time lighting for submitting the B.L.A. FTC approval and commercial launch.
They see that goes to you soon.
Sure I mean, we do remain confident in our commitment to share top line data from our phase three trial by the end of November and a shirt shared earlier in this call. The team is actively been preparing for the FDA and are doing so now.
We will not comment on the precise timing of our filing that we are doing all that we can to be ready should that phase three data support the application.
Thanks, Stacy and then another question relating to the BLE filing besides the efficacy data that will be it will be generate into phase three trial, what other information or data will be needed.
To support the application.
Yeah, I would ask him told me to please answer this one it's only please introduce yourself before you answer the question pockets.
Thank you I'm and Hello, everyone.
I'm, Tony Mccloskey I joined a rainstorm in September from Bristol Myers, Squibb, and I'll, just say Oh I'm. So excited to be here, joining a great team as the executive Vice President and head of Global regulatory Affairs. So again very excited to be here and do all I can to help with the therapy.
So with regard to when information is needed a biologics license application or be a laser request for an FDA approval to introduce the product into Interstate commerce and as such it will include a comprehensive summary of all of our data that can address the biologic product in question.
FDIC has extensive industry guidance regarding the content that's required for a BLE and that's what we're following.
The BLM BLE application for Nurown will contain product and manufacturing information along with the summary of non clinical and clinical studies.
Our overarching goal is to provide the FDA with the information that they need to make an informed regulatory decision and.
And we continue to have very productive engagement with the FDA.
Thank you.
Thanks, Toni next question relates to availability of revenue on once its approved I wasn't around trucking is available in the market doesn't require that patients to travel to specific countries in order to at box. It just stem cell therapy or will it be available or do you think in all countries.
Tony you want to take this one too.
Sure. Thank you all right.
Well like all therapies that require prior approval for marketing availability would be limited to where it is approved for commercialization by that relevant authority and although you asked is our first country targeted for regulatory approval.
We're not aware of any restriction that might prevent non U.S. patient to travel to the United States.
We will be working diligently to make the therapy available to patients in other countries.
Thank you.
So assuming FDA approval is granted how do you visiting a the commercial launch of.
No run rolling out or will the company manufacturing, Iran has its own facilities well be ready for large scale production using bio reactors.
The launch took place initially got than the U.S. and when do you plan to treat patients in Europe, Israel, Japan in other markets.
[laughter] so when it comes to David.
Sure So Uh huh.
We as we said before we are in advanced discussion concerning our commercial production.
And we should be able to disclose more about these very sorry.
We're we're engaging and we plan to work with regulators outside of the U.S. to seek approval for near on in different geographies.
Okay.
And the next Investor wanted to 70, welcome Mr. William Whites of the company and recognizing that his expertise will be very important to the commercial launch of neuron, but the question is how.
But the question is how far along is brain storming preparedness for the broad market access and reimbursement from private and public insurers at all.
These preparations happening just in the U.S., but also in the other target markets.
As you might guess I would the <unk> go wide to answer this question himself as he's getting some warm welcome from an investor built.
Bill. Please considers itself first and then answer the question.
Sure. Thank you I appreciate that my Bill White, a joint Brainstorm in late September following four years out of backlog now Novartis gene therapy.
Where we launched the second gene replacement therapy approved in the United States called Xeljanz about for spinal muscular atrophy.
So I'm very excited to to join Brainstorm and do a similar approach in bringing our novel Nurown therapy to market.
To answer the question and thank you for that question. It's a good one our goal is to partner with each of the commercial and public payers well in advance of the launch of Nurown in order.
In order to prepare the market for can we access.
Two our therapy.
Oh, we've just initiated early engagement with the top payers and the country, including United Health care all that much.
At Mount signal, and we expect to expand our outreach.
To the best.
Once the phase three readout had been completed.
Additionally, we expect to launch in the U.S. first.
Of course, and then followed by a similar approach in the E U five and some of the other key global markets.
Thank you.
And the next question relates to the progressive and that program. Please provide an update on the phase two trials on your own in progressive multiple sclerosis, or the south is the trial still on track to finish by the end of 2020. When do you expect to announce top line data are on a path for phase three.
And with strong efficacy and safety from.
Save you from Phase two is there a possibility that the company could apply for accelerated approval from the FDA.
Well.
Oh, Thanks, I'm happy to take that Ah. So just as an update as I mentioned previously the phase two progressive M.S. trial was fully enrolled.
And we expect that all patients enrolled in the trial will have received all the doses.
Nurown by the end of the year, our plan is to analyze the clinical and biomarker data.
And then decide on next steps and obviously, we'll be data driven.
Thanks.
And then regarding the Alzheimer's disease trial, how is enrollment proceeding into phase two trials in Alzheimer's disease in Europe. Many patients have been enrolled at this point I will the company began dosing patients by the end of 2020 and is there a possibility for interim data being announced at some point during the study.
Thanks, David.
Oh, we actively engaged we are very relevant to regulatory authorities in Europe.
Regarding both the design and the conduct of the trial, we're we'd tend to start dosing patients.
As soon as it can go try to prove it.
Okay.
Thanks, and the next question relates to the expanded access program up there have been rumors or brain start providing expanded access artist participates in the phase three trials that the company has such plans or other external financial resources to help of costs.
And Mike the company provide expanded access to additional patients.
I also want to take a first shot on this.
Yeah. Thank you happy too.
So we appreciate the sensitivity and urgency in importance of this issue just to clarify.
Just to clarify a were not yet providing D.A.P. at this time. However, we have been very actively considering expanded access.
Has the potential pathway for L.S. patients.
As you know Nurown is not a conventional pharmaceutical product and there.
And there are certain logistical steps that are needed to be completed to make those treatments available.
We're very dependent on our partners and at this point some of them are working through logistical details needed to support such a program and they are not quite ready yet to participate we plan to.
We plan to continue this work.
And we will provide a further update when we have more information. So please stay tuned.
Yes. Thanks are often just to conclude on this matter. There was also a question about financing brainstorm is more than happy to finance. This program. It's only all parties will be ready so.
So we we didnt put aside money for this but again as Ralph just said.
Were dependent than if the the partners will be able to speed up.
Get ready will the finance will not withhold it Mike's next question. Please yeah, one more question from submitted from investors.
Investigational and that's treatments have been featured on a B C's Nightline show do you.
No when the next episode featuring progress since our last treatments, including your own may potentially be featured on nightlife.
Yeah. Some nice lines continued to follow and film they left community since the last segments there.
Vivus does that they are planning to do a full length documentary.
And are waiting for the results of our phase three trial for completion.
[noise] I think we're done with the written questions Melissa.
Melissa you want to reach out if there are any additional verbal questions.
We have time to take to the for more questions.
Yes, if you'd like to ask a question over the phone. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue.
The press star two if he'd 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 key one moment please poll for questions.
Thank you. Our first question comes from the line of John Mayer Private Investor. Please proceed with your question.
Hi, congratulations on that.
Congratulations on the progress.
With respect to the hospital collection program in Israel, I believe that the last time you spoke about it the status was that you had been able to treat the Israeli patients that you had been unable to treat the foreign patients.
And that you had gotten approval in Israel to treat additional patients.
Can you just update that part of it.
Yeah. So we did treat all 12 patients either with Covance Oh.
No we did not start to additional part of the patients.
We are focused.
For the phase three trial and elsewhere, we have a lot of pressure pumping stations to get.
No treatment and then turn them you know between now and the retail left to decide if we want to do it we have the for what to do with just a little.
And we will see thank you very good question John.
Do you have any other questions.
Not at this time thanks. Thank you.
Well. This is the next once again its star one to ask a question at this time. Our next question comes from the line and sports.
Private Investor. Please proceed with your question.
Oh, Yes is there any movement in Latin America.
You guys can talk about her.
What do mean movement, a lot of Latin America and unlike yeah is there any movement for are any any for brainstorming around for those folks.
If you're asking I'm, sorry, maybe part of this as I use campaign from a patient's of Latin America, asking us to.
Two or just.
Yes, they do provide treatment to Latin America and that was it.
Well as you sit here we have some questions before also on Europe, so with the European regulatory get ready and contact Latin America, We did file for a few buttons, but its taking them a lot of time to response, but.
We do know that there was a big.
Yes, Unfortunately, they gave us population.
Latin America, and once we get an approval.
If we will get an approval from the FDA, we will consider the up market, it's a very big big market.
Big patient population to really wants to make sure that we know about them. So we do know about them but.
Absolutely.
Can I ask one more question about the bear.
About the variance on SDMA P.L. last all the Aylesbury and well they'll be a time that you guys will maybe Walter can talk about that and since he said.
Since he was involved with us and they thought were just wondering about the variance trail off if they will be included.
Yes, many in our company were involved in this I mean, one of them is dr. off current Ralph you want to justice.
[laughter].
Yeah, I would say that the pls has much closer resemblance to a less from a disease perspective, So I would say that SDMA is a different disease and.
We're also following very closely the success has been asked I mean really applaud.
The opportunity for patients and their families to get treatment Pls is a much slower disease.
More difficult to to identify and much lower frequency than traditionally a less we have had discussions with experts voted and are continuing to to think about pls, which has mostly an upper motor neuron.
Involvements. So it's it's on our radar screen, but nothing too.
Think to announce today cranes needed 'cause it's left out a lot. So thank you.
You're welcome.
Next question. Please thank you.
Thank you. Our next question comes from the line of Johnny bench with Raymond James. Please proceed with your question.
Well good morning, everybody. My question has to do is there any update you could provide particularly the David on the efforts to find a large commercial partner in any geography has the company decided whether to market the product themselves and I should say our.
Ourselves in a in the U.S., Europe, and potentially Japan, and one specific question would a Japanese study phase three study be required to get approval in Japan. Thank you.
Well.
Sure clients.
Yeah, [laughter], Hi, John Hope you're well.
Yeah, I think that I'll answer the second part and then I'll return it back to my colleagues about about partnerships.
Art art feeling in Japan is similar to other advanced therapies is that there are accelerated pathways such as the sakigake pathways that potential.
Potentially could could help accelerate efforts in that country.
Often a smaller.
Study in Japanese population is all that's needed.
If there's a large a large.
Scientifically valid or placebo controlled trial in the U.S. So so those are things that we are aware of but in terms of progress with other partners I'll return it to Mike My colleagues I mean, David who are closer to that.
Exactly David you want to talk about the partnerships the good opportunity okay.
David.
And maybe we lost it so yes, Dave is working very actively with many bodies is making sure that all the relevant bodies are up to date.
And well aware Oh.
Oh, where we are I'm.
I'm hesitant to what else I can share with you in.
Like debits fell off the line but.
Well, one we will have some things on the health of course, we will know.
Okay listen we have time for one more question. Please.
Thank you. Our next question comes from the line of David bouts with Zacks investment Research. Please proceed with your question.
Hey, good morning, everybody.
So I wanted to ask a quick follow up on a potential.
So the potency assay that may be required by the FDA basically what I'm curious to know is what would you be testing.
To say that okay. These sales are good to go.
Basically what do you think the FDIC is getting a specific we look for in that type of assay.
Very good question.
Ralph or Tony can Texas.
Yeah, I think I'll, let Tony starting and maybe I can I can add to his answer sure. Yeah. So I would I time, I wouldn't I would start with the observation that a there was guidance on the on potency assays in the United States and Europe also for that matter and there's lots of recent precedent that we've been studying and and we've had some.
Consultants help us understand the nature of this is a challenge we have the benefit of the measurement of many markers of characterization of the cells as well as the coming biomarkers in the CSF themselves. So I think you know we have that we have we have some framework in place and as was mentioned in the call already.
We are we will be discussing it with the FDA at the appropriate time it isn't it isn't important consideration in emerging.
Emerging as more and more important recently, so we're we're well aware of it and have some I think reasonable approaches to it.
Ralph.
Yeah, what I would I think thanks, Tony what I can add is that we've been very thoughtful and deliberate about linking.
The biological.
Biological parameters of our cellular product with a preclinical studies and then showing.
Showing consistent reflection of this biological activity in Biomarkers, which we have we spent a lot of effort linking to our our clinical results and we think that those efforts will bear fruit.
And that that obviously, a very thoughtful combination of biological properties of cells preclinical data and then biomarker data will be will be used to to address those questions in the future.
Thank you very very much Ah I think that's what's kind of food Melissa. Thank you very very much we're running just verbal session.
I want to thank everyone that asked questions previously that we were able to swap them out and to make sure.
Make sure that the.
Sure. The variety of these shows investors may have.
Many analysts that we didn't have them verbally today. They just some dumb question earlier. So it takes time for their time and hope that we answered the questions. So their satisfaction.
And I want to thank everyone for being with us today.
And we look forward to probably the next time, we'll speak to you after topline results. So thank you very much very exciting times.
Thank you. This concludes todays conference you may disconnect. Your lines at this time. Thank you for your participation.