Q2 2020 Brainstorm Cell Therapeutics Inc Earnings and Corporate Update Call
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It is now my pleasure to introduce your host Michael Wood.
So I advisors, Sir you may begin.
Thank you operator, thank you all for joining the brainstorm cell therapeutics calls today.
Before we begin the opening remarks I'd like to remind listeners that this conference call contains no my statements descriptions forecasts and projections regarding brainstorm cell therapeutics and its future business operations are performing statements regarding the market potential for the treatment of nearer to garner disorders, such as <unk>.
Yes.
Efficiency of the company's existing capital resources for continuing operations in 2020 out beyond the safety of clinical effectiveness.
Technology platform clinical trials of New York and related clinical development programs as was the only the company's devops strategic collaborations and partnerships to support the business planning efforts.
Forward looking statements are subject to numerous risks and uncertainties many of which.
I'll be on the company's control acuity the risks and uncertainties described from time to time and it's actually see filings.
<unk> may differ materially for those projects on todays call. The company undertakes no obligation to publicly update any forward looking statements.
Joining me on the call today will be hard Liebowitz C O Brainstorm Dr., Ralph current President Chief Medical Officer, Dr., rather tell a richer VP of research development.
After preach I'm shocked SVP and Chief Financial Officer.
There will be available to answer your questions as well as with additional members of the management team during the Q and recession, which follows the prepared remarks.
Now I'd like to try to call over to Mr. Liebowitz. Please go ahead.
Thank you Mike.
Welcome to bring some second quarter 2020 earnings call.
Okay. Thank you everyone for joining us.
At the onset of this call.
I'm, so proud to share with you.
Our cash on hand is by far a record for brainstorm.
We have never been in such a strong financial position.
We have no that's no convertibles old alike.
The day after close to $35 million cash on hand.
Well again, this morning's call with some introductory remarks.
In general corporate updates.
Brainstorm.
Next I'll, President and Chief Medical Officer Dr. Oscar.
Well update you on our clinical programs, including our pivotal Aeolus trial.
Our recently announced.
I used to old timers do this program in our phase two progressive MS trial following robs comments.
There are with all our Utah or the R&D will walk you through our development program for nor on the REIT index is on treatment recovered 19 arts.
Our Chief Financial Officer, Dr. Prelims Shaw.
Then provide updates on our financial results.
Turning it back to me for concluding remarks.
We will of course address your questions the combination.
We are proud of the continued dedication and focus from our team members. During these challenging times of the current of our spend that make our mission or brainstorm the leverage our proprietary nurown technology into the clinical development, new treatments for Neurodegenerative disease patients with high unmet medical needs.
This is an extremely important done worthy mission in normal times, and <unk> and it requires an even greater level of commitment of creativity collaboration doing them with them.
So grateful to our <unk> community partners, which includes patients their families doctors regulatory bodies.
So many more for helping US continued to move forward over the past few months.
This morning, I would like but also recognize two new additions to our senior management team the second quarter.
Let's just say, but said no.
No. It doesn't they fell 2020 and serves as executive Vice President and Chief operating Officer.
You said one has extensive experience in the biopharmaceutical industry.
During key leadership roles and commercial development and product launches at the margin.
Most recently served as VP corporate development strategy and business.
Life Sciences, where he was instrumental in the development a virus critical commercial operating and funding milestones.
Thrilled that David the joined our team unexpectedly <unk> role in the potential commercial launch of Nurown in the next couple of years.
Dr. Stacy Lindbergh joined doesn't June 2020.
The role of executive Vice President and head of global clinical research.
Okay, Lynbrook isn't experienced health care executive globally recognized medical statistician with over two decades, a multinational experience in R&D regulatory strategy development analytics, and big data Lilly and Biogen.
Most recently talked a number of spent eight years merger, which held several leadership positions.
Moving Vice President of an Olympics and data fives.
See I stayed she's a great addition to our team are deep experience will be highly valued in many areas advanced.
I will now I'll turn the call over to Dr., all firm, who will provide updates on our major clinical developments broadens Ralph.
Thank you crime and thank you everyone for joining us today on the earnings call.
Let me start with an update on our phase three pivotal trial of Nurown to nail outs.
As a reminder.
The trial is being conducted at six Ala centers of excellence in the U.S.
It has enrolled approximately 200 participants.
Randomized one to one to receive three doses of nurown or placebo.
These are administered over four months.
And then participants in the trial or followed for a total of 28 weeks.
As we announced on July 2nd.
I'm very pleased to announce we used to restate that all participants in the pivotal.
Phase three trial have received all scheduled doses of neuron.
We were able to achieve this important milestone.
As a result of the relentless dedication of trial participants.
Their loved ones, our investigators and the outstanding team here at Brainstorm.
On behalf of all of Us and Brainstorm I again want to thank everyone for their commitment during a very unique in challenging times.
As previously announced following completion of all study visits.
Data collection and database lock, we expect phase three top line data by the end of November of this year.
And brainstorm, we're staffing up a highly experienced team.
And we're very busy on a day to day basis planning and executing to support data read outs and all pre L.A.P.B.L.A. activities.
Our clear focus is to expedite this process.
We want to be able to submit a biologic license application or B.L.A. with the FDA as soon as possible.
After the topline data is available.
At the same time as our clinical trial activities and data preparedness is growing and advancing.
We're.
Proceeding with all CMC activities that are needed for the preparation of the B.L.A.
Finally, with respect to be L.A. planning.
And understanding the urgency I'd be a less community.
And also when full dialogue with the F.D.A., we're actively exploring opportunities to expedite information flow.
And the review process itself.
In June we announced that the L.S. Association.
And I am MLS awarded Brainstorm, a combined grant of $500000 to find an L.S. biomarker study.
The grants will be used to draw insights from data and samples collected from patients enrolled in brainstorms ongoing phase three clinical trial of Nurown treatments.
And to further understand critical biomarkers associated with treatment response for people, where they allow us.
The study involves one of the largest and most robust clinical trial collections of CSF in serum Biomarkers to date and we're very excited that this will advance LSW understanding.
And also contributed to our understanding of how Nurown can.
He is a great value to the L.S. population.
In late June we announced a new clinical program.
Focused on the development of Nurown as a treatment for prodromal to mild Alzheimer's disease.
We hosted a key opinion leader call and webcast on July eight.
We would encourage you to listen to if you have a chance.
The call included professors, Philip Shelton's and Bruno Du Bois, we provided a great overview of why we made the decision to study nurown in Alzheimer's disease.
And why we're hopeful and the potential of Nurown to address the great unmet need in Alzheimer's disease.
The study will be conducted at two leading centers of excellence in the Netherlands in France, We plan to treat the first Alzheimer's clinical trial participant with Nurown.
For the end of this year.
I'm also happy to report that our progressive M.S. Charles is now fully enrolled.
Despite facing severe cold good 19 hospital restrictions in the spring.
We still expect all study treatments to be completed by the end of this year.
Due to the rapid enrollment in the last month, the time difference between it potential interim analysis later this year.
And full data analysis is much shorter than anticipated.
Therefore, it is most practical informative for.
For us to present.
An analysis of the full dataset and that is our current plan.
In addition to the steady progress made across all of the clinical programs and breaks darn. Good I have just described.
We're supporting a small compassionate M. A C program for Kobe Rds in Israel as we previously announced.
We had examine strategic opportunities around Kobe, Rds and we have identified the advantages of using exosomes as a treatment platform.
And by leveraging our strong capabilities, an extra so manufacturing.
And IP, we've conducted a proof of biology study of Nurown derived exosomes in a mouse model of a Rds, which my colleague Dr. Reddy child Irish I will now share Rev itself.
Thank you I'll, let me join my colleagues in thanking you all for joining us today.
We recently announced that bring successfully completed its first milestone in developing and nobody innovative sexism based platform technology for the treatment of severe Toby 19.
C. O work can be maintained you do no money has been associated with if you do spirits carried these tourette syndrome or eight or so.
Currently the even though you treatment to prevent or we heard as art.
Yeah, Hi, Spiritthree cellular associated with wide screen inflammation and lung damage caused by a side of things Tom the most of the are you most severely affected patients.
And then he must since it was derived it deserves a guess suggests it has the potential treatment for you to their ability to penetrate into deep you.
If you really de lever my active molecule targeting children and decreasing cemeteries on.
Let me see XOMA, maybe to lever the intravenously or nicely the into the long.
Yeah, yeah that needs to Asian.
You know several party go advantages, including her age ability and blowing managing the city.
No for bring some decided to evaluate M. A C and neuron derived sexism yen.
Well I know what wells on the severe acute luggage injury.
The trial the animals treated with either no an excellent excellent derived from the even see either from the thing done.
When compared to placebo treatment.
And well nice.
Treated wasn't even either intravenously are directly to the lungs.
And that as these was conducted amongst the pathology they assessment of oxygen saturation inherits right and the meter Amanda inflammatory cytokine <unk> in the Broncos.
Ladies and.
The study demonstrated cyberark utilization.
We demonstrated that the animals treated with new on derived sexism showed superior results compared to an even see.
The results showed statistically significant lieberman's, nor on derived exosomes in liquid parameters, including Ensenada <unk> recovery reflected an increase of oxygen situation to normal level reduction for inflammatory cytokine.
And most importantly, I mean, you Asian lung damage.
Secondly, we observed that Varick administration of no on derived sexism directly into the line.
<unk> yeah.
Showed advantages over the intravenous worth it needs to Asian.
Well I just have made is important who's also be reviewed medical journal and we're actively evaluating go next I've never mind, how best to proceed.
Thank you and I'm going to freedom show and see how hard you do financial update.
Thank you rather tell it it's my pleasure now to walk you through our second quarter 2020 financial result.
Research and development expenses net what a three month ended June 30, 2020 were 5.69 million compared to 3.55 million net for the three month ended June 32019.
Increased year over year was primarily due to increases in expenses due to material and auto call payroll and stock based compensation and a decrease in participation of I am sorry, I'm, a very important Graham.
Proceeds received under the hospital exemption program.
Excluding participation from I am sorry under the ground and proceeds received from the hospital exemption regulatory pathway.
Research and development expenses decreased by 500 Duane.
Allison from 6.54 million in the second quarter of 2019 to 6.2 million in the second quarter of 2020.
General and administrative expenses for the three months ended June 30, 20, 21.71 million compared to 1.3 million in a three month ended June 32019.
This increase year over year was primarily due to increasing payroll stock based compensation rent and other costs, partially offset by decrease in PR caught consultants and travel expenses.
Net loss for the three month ended June 30, 20, tiny what 7.4 million or 25 cents per share that's compared to a net loss of 4.9 million or 23 cents per share for the three months ended June 32019.
Gotcha, Gotcha equivalence, including short term bank deposits.
Approximately 16.2 million as of June 30, 2020.
Compared to approximately 2.7 million as of June 32019.
In the month of July 2020, we further strengthened our balance sheet.
We raised approximately 13.6 million from our ATM facility at an average price of $14.48 per share.
An additional 6.3 million exercise of warrants from second warrant holders and ultra received a long dilutive bonus mavens 700000 from CIRM, what treating more California patients.
Originally proposed in our phase three yeah that's trial.
With these activities our total available funding as of July 31, 2020, which includes cash on hand of approximately 34.7 million as well as remaining non dilutive funding from sorry.
Hey, and other grant amounts to approximately 37.5 million.
For further details on our financial please refer to our form 10-Q filed with the FTC today.
Back to your line.
Yeah, Michael Wood from life's I. These will now read the questions we have received.
After that we will take lots of questions as well Mike.
Okay. So the first question that we have from Investor is that would you. Please provide a timeline for the <unk> phase three data read outs application for FDA approval of neuro and then as a follow up to that what would the company plans at summit A.B.L.A. and do you expect neuron to get priority review.
Very good question.
We have consistently communicated.
Our phase three trial result would occur in Q4 2020.
We are thrilled to confirm the discipline remains unchanged even in the presence of the covert nine him to them.
Because of the hard work on Tom's within brainstorming has achieved.
That has achieved operational excellence in this trial it was a commitment of our investigators and trial participants.
We're completing the remaining study visits and actively working through the data management steps to ensure high quality data, which will enable a timely data base lock I read although the story.
We plan to topline data by the end of November.
Obviously, the company will be able to advice to advise on our intentions and they.
If I look really only after the database lock and Unblinding the data.
We are happy to share with you know like brainstorm, the F.D.A. appreciates the urgency required.
To find effective treatments were less.
And therefore is in close contact with Brainstorm <unk> expedite the review process next question. Please.
Thanks. So next question, assuming the FDA approved Nurown for Alas, one of the company's manufacturing plans and does brainstorming tend to operate its own facility to produce neuron.
Another good question.
So brand so much deeper actively and aggressively working with potential partners on commercial manufacturing sites.
We are prepared in all facets for a positive read out of our phase three trial and the production of commercial cell product.
This process find many years as we have sought to reduce the time required someone infection or on for each patient.
Throughout.
The Nurown clinical development, we have streamline manufacturing process.
And have consistently demonstrated we can efficiently deliver a high quality autologous product.
Hello, and good BLE approval anticipates kilo production of our high quality sell brought up to support the come or commercial launch to treat patients in the.
Next question.
Thanks, So when do you anticipate automated automation of and the around production process and in other words with some kind of buyer actors.
So we have automated part of the manufacturing process.
Well sure feedback after we get CMC, if he's got from their view on this process.
Next question. Thanks for the next question relates to the multiple sclerosis program. When do you intend to provide an update on the phase two progressive that trial.
<unk>, how many patients are enrolled and when do you expect the interim data to be shared.
Some of that I've, just sort of readying the opening comments, but <unk> Ralph you want to fix is one.
Yeah, absolutely so per our press release on August sports.
And after a brief pause in clinical trial enrollment you to Oh, good possible restrictions.
Oh, all clinical trial sites reopened.
And the phase two progressive M.S. Charles is now fully enrolled.
With the plan number of 20 patients.
We expect the trial to be completed by the end of this year with all doses administered because of the short timeline between but would have been an interim and full data we're no longer planning to do an interim analysis and we'll focus on the pull data set as we described in our opening comments. Thank you.
Next question please.
Companies previously announced that it has received a semi status in Europe, how do you plan to leverage this SMB stated status and bringing neuron to analyze patients.
One of the regulatory pathways to be considered here.
And how is the hired M. A regular consultants, helping you in this process.
Well please.
That's absolutely so I'm.
We're really happy that engagement could be gone with regulatory institutions to map out the regulatory pathways to enable a nurown should be.
And available treatment option trail less patients in the European Union.
We're obviously leveraging the EPS to me office and we haven't yet yeah may regulatory consultants, who has helped US gaidar process season next steps.
I want to emphasize the this is a top priority for the company both from a business perspective, but also to address the enormous unmet need in the last population. Thank you.
The next question relates to the Alzheimer's program.
As part of it was announced on July eight but can you. Please provide an update on any new developments that have happened in the interim period.
Well this 42 please.
Okay No no problem.
So as we announced on July eight we've expanded our clinical pipeline to evaluate nurown for the treatment of Alzheimer's disease. I think we brought we provided.
Fairly convincing biologic and critical rationale for that program.
Oh I'm happy to provide an update on our efforts are related to this since our.
Since our press release of July eight.
We have finalized our clinical trial protocol.
We've submitted this protocol along with accompanying documentation to the regulatory bodies in Europe.
We're also interacting with local European authorities during the summer.
And our intent is to dosed the first patient before the end of this calendar year.
Thank you.
And then the next investor instead of the question wanted to congratulate you separately on the preclinical work that's been conducted so far in.
Yeah, Hey, Rds caused by October 19.
Question, though is one of the company's plans for clinical trials with the access on based technology and also what what advantages that neuron bring to this what's now become a crowded competitive landscape.
Thank you my can very good question again.
So there's a strong rationale the scientific literature for so this clinical trials and Cobra darts.
For many cell therapy companies are pursuing thought cellbased.
Clinical trials.
Our clinical team Ive stayed highly focused on our lead indications of Pls.
And other CNS diseases, so I'm sure that there would be no delay now keep clinical milestones.
We were able though through our preclinical discovery team before the potential benefits of Nurown derived exosomes no proof of concept pre clinical trial in and then an animal model of out.
Based on this proven manufacturing capabilities and I'm a season next zones. We've demonstrated the biology of number on a neural derived actually zones, providing the opportunity to explore this preclinical study.
That's presented by our VP are indeed, or if it's all the demonstrated that nurown derived exosomes delivered superior efficacy in her arts compare to naive M. A C. Excellence. This was very important for all our programs.
Oh CMC team was able to manufacture looking at it kind of seasonal.
The Ministry of Health has already granted approval for brands from depends on.
Hey, good passionate study villa genetic M. A C and Cobra darts at the Serowski Medical center until it is.
Based on the positive results of the preclinical study design that based on will also seek approval for a compassionate use of neuron derived.
Zones in patients for Cobra Dart, but the sum this up as you can see.
Why do we are following the data.
Our commitment to they left community is.
We continue the prioritize our efforts focus in energy for the rail as trial.
This concludes the pre submitted questions.
Operator, I would like to ask if you can open the lines for additional question.
Jamie.
Thank you well now be conducting a question answer session. If you would like to ask a question. Please press star and one on your telephone keypad.
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One moment, while we pull for questions.
And our first question today comes from Jason Mccarthy from Maxim Group. Please go ahead with your question.
Hi, everyone. Its they bought a line for Jason Thanks for taking my question Oh, So just regarding the assays to caught Alzheimer study I just wanted to see it if you plan on opening any sites you away and if you could shed some color on when you expect to complete.
Thanks.
Ralph.
Yeah, so that the thanks for the question at the present time, we don't have plans to expand that particular study into the U.S.
We we will start treating.
Participants that the ended this year.
And we expect a somewhere in the order of its six month or two nine month enrollment period.
And then obviously the studies a one year trial.
From beginning to and so you can you can do the math and we would end up or.
No completing the or the last patient last visits.
Probably a.
In the first half.
Oh 20 or 22.
I would be our timeline at this time.
Hi, everybody. Thanks, Yeah color.
Jamie next question.
Our next question comes from David bouts from Zacks Smallcap Research. Please go with your question.
Hey, good morning, everybody.
So I'm curious.
If you ever for positive Aeolus data, how quickly talks with payers could occur as a as I imagine that could be a and an issue for some AOL patients.
[noise], they're very good question, well, we have a plan, but we're not really lay it out yet, but we are seriously.
For a really having some cousins with with Payors.
Could those discussions also include maybe aeolus advocacy groups.
We are in direct discussions with LSW advocacy groups about this matter.
Already.
Thank you. It was very good question very thoughtful for you to think about the patients how they've got the treatment after an approval immediately and that's already him.
Want to make sure that if and when we got an approval and were able to get us into patients as fast as possible Ralph you want to add something please.
No I I think that we're we're very focused on everything leading up to two database lock and then topline data and then we're going to work in parallel obviously that these are not done one after the other and and as I said you know we're already having.
Interactions that both internally and externally to address that question that you just.
Okay great.
And then for the and that's the trial do you anticipate positive results, allowing you to move directly into a phase three trial.
Ralph.
Well, we'd love to anticipate results I think that's that's hard to do what what I'd like to say is that.
It really two components of the study that would be looking at very carefully what are the clinical outcomes that are quite quite reproducible invalidated.
And then in partnership with the clinical outcomes, we have a very ambitious biomarker program. If you recall, we received the grant from the National M.S. Society to advance those.
Those analyses, we believe that a combination of clinical and biomarker outcomes will inform a case subsequent phase three trial, but obviously, we'd want to look at the data first too.
To know to know exactly what next steps are needed.
Alright, great. Thanks for taking the questions.
Thanks, David next question please Jamie.
Our next question comes from Jason Kolbert from Washington, James. Please go ahead with your question.
Hi, congratulations everybody really fantastic progress from cash on the balance sheet to the clinical pipeline I just like the foot ask a couple of quick questions.
In terms of the Hell last word to point now where are we really have to think very carefully about the probabilities of success how much data you've seen from the current trial and how well that data that you currently have been have released lined up with the.
Phase two data that you've seen previously so that's my first question is when I connect the dots between what you have now when the pivotal trial versus what you had in the phase two trials did they line up precisely is it even better now that you're looking at multiple doses.
Any insights that will help blocky age probabilities.
Ups access an outcome would be greatly appreciate it.
The upturn.
Yes. Thanks for the question, obviously were blinded to the current a phase three trials. So we don't have we don't have visibility to the results.
What I can tell you is that we we designed the phase three trial to optimize our probability of success few things that we've done here.
Clearly the use of repeated dosing compared to a single dose and faced in the phase two randomized trial.
Weve enrich the trial population.
You are to select a group of.
Yes, I participants who have a more predictable rate of decline in the run in period like that that goes a long way too or increasing the odds of success.
I think in addition, the lessons we've learned from phase two we've applied to phase three in terms of which biomarkers to look at.
And how how to proceed along those lines one big difference between a phase two in phase three is that we have seven cereal CSF samples, which will as we mentioned earlier is a unique collection of Biomarkers and we believe that the confirmation of a clinical.
All three.
Through changes treatment related changes in a biomarker will be very important and both the regulatory review and subsequently interactions with payers because we're trying to take a neurology and use the oncology model, where we have not just clinical outcomes, but we have verification compiler.
Trickle effect. So I think those are all the reasons why we believed that our phase three trial.
Has has all the right ingredients for success and obviously, we're very anxious to to get the topline data as we mentioned earlier, we've done a lot of work this year internally and with our sites. So that will be ready on time, and we're looking forward to have the topline data.
On November.
Or in other words like the current the rights stuff [laughter], if we change gears and I think about all climbers one I think about ale last I think about and then lime at Torrey condition. When I think about old timers, I see a condition with multiple co morbidities and while inflammatory could be a camp.
Pulling it then the CNS and particularly on the brain can you help me understand mechanistically, how you're making that jump in terms of the mechanism of action that's impacting aeolus patients versus what you hope will impact all timers patience.
Oh.
So I'll figure there.
Yeah, Hi, sorry, I just had to on my phone.
Yeah, I'll be brief because I don't want to I don't want to extend those too long, but I'll just give you a topline view of why we think you know the mechanisms of Nurown are applicable as a technology platform and across different diseases. We demonstrated the nail asked were able to both delivered cargo which are repair molecules, which are help.
Helps stabilize and restore a dinner tropic support we saw very interesting results in inflammatory changes at 40% reduction in some key inflammatory markers it turns out that to our surprising actually to our to our pleasure that a in Alzheimer's disease. The same markers actually have even.
Stronger correlations with a rate of cognitive decline and it seems that in most neurodegenerative diseases, particularly the ones that were studying right now there's an inflection point in the disease, where the nerve regeneration picks up pace and along with the inflammatory component also keeps.
Keeps up.
Moves in parallel and then we've seen a you know in Alzheimer's disease that the interaction between inflammatory markers such as MCP, one amyloid in child work together.
So that in the presence of those biomarkers that could disease is it's very different than we believe this is a huge opportunity to a two test the potential of nurown.
And we would expect that's the impact on inflammation would not be disease specific.
But would be a platform attribute of neuron.
And so that makes sense on why we would lump them assets about same for thank you last thank you very much.
One last question on Nexus arms, which as I can understand exactly why I would use kind of a NFC to trophic Lee home to the long to a break the cytokine cascade and reduce inflammation, how do I make the jumped from that whole.
I mean capability, along the gradients, whether its STS one hep yes.
Versus an accidents on which is really kind of like the raw materials that I need a to impact the localized environment, where do I get the homing capability in terms of the delivery and of course this relates to your coated project. Thank you.
Thank you very much at all.
Yeah sure. Thanks, Thanks, again, you're giving me all the hard questions. Yeah, No I think I think there's a couple of ways to look at it. One is that you know we've confirmed so we've shared this at scientific meetings that a lot of the attributes nurown are actually mediated through exercise.
Actually it sounds deliver cargo.
Hey, produced or they produce immunomodulation.
Also deliver micro our name so we know that that's an important component of it. The reason, we're looking at Exosomes and I think.
Rich how Ah touched upon that earlier is that their practical advantages of excellence in terms of storage stability formulation, we know that a in our hands and in other people's hands that Exosomes are very avidly taken up into tissues. We know that local administration of exosomes. He's a very unique opportunity and it's a in this case.
So we had demonstrated that delivery into the younger tracheal too.
Sorry, intro trick he'll administration produce superior results compared to Ivy and we know that getting getting to the target is really important and in the last point you raised about homing that exosomes home as well to inflammatory signals. We know that we've shown in our preclinical studies that nurown administer.
Cured and for example, Parkinson's disease homes directly to the side of injuries. So we expect that the homing function might also apply to exosomes and ER and there's there's growing evidence and other people's hands and then ours. That's this is a very important approach there's still someone to answer your questions and that's obviously why were.
<unk> preclinical studies before we make a final decision.
Thanks, guys I get your all of your hard work is really really shows so thank you so much.
So next question please Jamie.
Our next question comes from Jon Evans from Raymond James. Please go ahead with your question.
Good morning, everybody a couple of items first of all I'd like to know.
If you've decided any plans of whether to build a sales force in the U.S. or Europe or are you currently planning to partner with a a larger pharmaceutical to handle the sales and anything you could add on and you know what's going on with the partnering efforts a that I'm sure Dr. David is.
Is spearheading and then my second question is any updates on what's going on in Congress with the LS bills that have been presented by the rapidly growing Kls caucus <unk>. Thank you.
Thank you very much.
So we're looking at those options when when it comes through the saleforce either internally or externally.
The we can assure you as I said in my previous comments.
But if and when will have an approval will be ready either way to provide treatments to patients in need.
Read a book to bills in Congress.
It's just not than effort led by brainstorm with an effort led by many advocacy groups.
Oh, we commenced the hey lets out because it groups on their wonderful work for the awareness and everything goes there trying to promote.
We're not taking an active positions or any active items that we are doing on the bills and therefore, please allow me not nothing further comment on this.
And the other question.
I believe John left a lot so no up here. Thank you appreciate so very welcome them Jamie any other questions.
So at this time I'm showing no additional questions.
But you want to belong once more if anyone wants to ask a question. We're fine with it will take one more question.
Once again, if he would like to ask a question. Please press star and one.
We do have an additional question from Robert Mccann. Please go ahead with your question.
Hi, I'm just curious if you have any updated guidance given all the positive news it appears to be around your company.
Ralph.
I'm, sorry, <unk> guidance on on which specific turnings on earnings.
Earnings maybe I'm all past that next year.
Yeah, So I'm not sure I told you women guidance for that guidance for L.S.. So what guidance on earnings are you asking for.
Sure.
Robert.
[noise] tender was out you was filed in there.
You can read anything you would like.
We are our financial position I started this call with the comments. If this is our best financial position I prefer was around 35 million cash on hand, and we're very proud of the we're going into the last quarters of two quarter, though they're very good position.
And ladies and gentlemen at this time, we will end today's question and answer session I'd like to turn the conference call back over to management for any closing remarks.
I spoke so much today, so Ralph I'll allow you to drive the can putting remark.
Yes, thank you very much and.
I just want to thank everybody for calling in today for your ongoing support.
Oh grabbing confidence in our journey to find a solution for L. S is we showed you today we have.
Continue to advance on all fronts, our SLS program.
Is it will have topline data at the end of November.
We're looking at options to advance sale last in Europe.
We've initiated a Alzheimer's trial in Europe at the top Alzheimer's centers.
And we have completed.
Enrollment of our age to progressive M.S. trial.
We have no commitment of the.
Communities that were hoping to serve a of the site's investigators that we work with and most importantly, the investor community and obviously, our current position is really testimonial to all the support you've given us. So thank you very much and we'll continue to deliver a and we hope to have more news for.
Are you in the near future.
Thank you thanks, Jamie.
And Mike for handling this cold but for us.
Ladies and gentlemen without.
Well conclude todays conference call. We do thank you for joining you may now disconnect your lines.
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