Q4 2019 Earnings Call

Ladies and gentlemen, thank you for standing by and welcome to the terminus sell financial results Conference call for the full year 2019. My name is Sylvia and I will be your operator for today's call.

At this time all participants are in a listen only mode. After the speakers presentation, there will be a question and answer session.

Asking question during the session you will need to press star one on your telephone. Please be advised that today's call is being recorded at Kamada sales request.

Now I will like to introduce your host for today's conference Ms. Gerons Madden, Vice President of Investor Relations and corporate Communications. Please go ahead.

Thank you Silvia and good morning, everyone. Welcome to today's call during which will provide an update on to me the South and review our financial results for 2019th.

Earlier. This morning, we issued a press release summarizing our financial results and progress across the company, which is available on our website at Www Dot me to sell Uh huh.

With me on our call. This morning is Julian Adams, Chief Executive Officer, or any Kinda talk Chief Medical Officer shy light Gray, Chief Financial Officer, and Tom Klema, Chief Commercial officer, following our remarks, well open up the call for QNX.

During the call me may make forward looking statements about our future expectations and plans, including clinical development objectives. The therapeutic potential of our product candidates are operational plans and strategies projected operating expenses and cashman like our actual results may differ materially from what we project today due to a number of it.

We're in factors, including a consideration society and the rest risk factor section of our form 20-F, and then other filings that to me that makes with the FCC from time to time. These forward looking statements represent our views only as of today and we caution you that we may not updates I'm in the future. What are the result of new information future events or otherwise.

Now I'd like to turn the call over to Joanne.

Thank you John and thanks, everyone for taking the time to join US This morning.

I'd give me to sell we're committed to finding cures for patients with blood cancers, and rare seriously middle logic diseases through the development of next generation cell therapies.

Our most advanced product candidate Omid do Brasil is in phase three development could offer a lifesaving treatment option for patients in need of the bone marrow transplant.

We're also developing G.D.A. tool one our investigation expanded natural killer or NK cell therapy.

With potential in both humid logic malignancies and solid tumors.

2019 was an important executionally here for the me to sell and today I will highlight the substantial progress we have made advancing our programs and building our team.

Turning first to on the do Brasil in December we completed patient enrollment in our phase three study in patients with high risk hematologic malignancies.

As we are nearly two months into this year, we're narrowing our guidance to expect to report topline data from the phase three study in the second quarter of 2020.

Positive data will enable us to submit a B.L.A. for home would do so with the FDA in the fourth quarter of Twentytwenty.

And position us for potential approval and launch in 2021.

We will use a common technical document for our regulatory filing which enables us to streamline the work required to file a marketing authorization application or EMEA for home would do muscle in the EU next year.

Oh, we do sell has orphan drug designation in the U.S. and Europe.

And is the first bone marrow transplant product to received breakthrough therapy designation from the FDIC.

The ability to bring on when do we sell to patients broadly would represent a significant advancement in the field stem cell transplant.

We're also investing key activities required to bring on would do the sell to patients following potential FDA approval.

Work is ongoing to build out the manufacturing infrastructure, both at Lonza and our own facility to help ensure that we will have sufficient and reliable commercial supply.

We're also working to develop comprehensible comprehensive hospital services.

And patient assistance programs designed to seamlessly, bringing all the good the cells the patients.

Turning to GBA to a one we continued to be very pleased with the data from the phase one investigator sponsored study.

In patients with non Hodgkin lymphoma in multiple myeloma.

Last December we reported data at the American Society for Hematology or Ash annual meeting.

And we'll provide a further update on GBA tool one at a medical meetings in the first half of this year.

Based on multiple complete responses observed heavily pretreated patients non hodgkin lymphoma, we are focused on the activities required to submit an investigational new drug application to the FDA and the fourth quarter of this year.

The I, Andy will enable us to initiate a multicenter multi dose phase one two clinical study in patients with non Hodgkin lymphoma next year.

Using our Cryopreserved formulation.

Both on the due to sell and G.D.A. tool, one we're creating using using our proprietary NAND technology platform.

She is designed to enhance the number and functionality of our generic donor cells.

This represents an important advance because preserving therapeutic functionality has been a key limitation, though prior approaches.

Last week, the transplantation and cellular therapy or TCT meeting, we presented preclinical data that reinforce our understanding of the mechanism of action.

Underlying garden and platform.

The data suggests that Nan mimics the hypoxic environment in the bone marrow nish to preserve the function and long term engraft mint ability of set of stem cells.

These data provide scientific rationale for favorable engraftment and patient outcomes observed in the previously reported phase one two clinical study of and do so.

We're continuing to study the Nam mechanism of action for on the due to sell to characterize the biochemical events during the expansion process.

We are initiating similar mechanism of action studies with GDH worldwide.

Over the past year, we made key several appointments.

Several key appointments with the management team to add depth and expertise as well as to establish new functions.

2019, Tom Klema joined Us as Chief commercial officer, and Tracy load he joined as Chief Scientific Officer.

Last month, we appointed jazz Kupol, as chief regulatory and quality officer.

She previously worked at Ipsen, Karyopharm, and Biogen and has been instrumental in developing and executing.

Global regulatory strategy for multiple products in oncology in rare diseases.

Experience is already making the positive impact on our plan B.L.A. submission.

I'll now turn the call over to need someone tells our chief Medical officer, providing further updates on the Dubis, though and G eight two or one well need.

Thank you Julian and good morning, everyone.

Our most important clinical milestone this year is reporting data from our phase three study of omitted the so.

As a reminder, this trial designed to evaluate the safety and efficacy of on the do it yourself compared to standard umbilical cord blood the allogeneic bone marrow transplants in approximately 120 patients.

The me to sell the first company to conduct a global randomized phase three study for novel bone marrow transplant graft.

And the completion of patient enrollment in this study was a significant accomplishments for us and for the bone marrow transplant community.

We truly appreciate the participation and support from the patients and from the investigators who are helping to move the field forward.

Julian mentioned, we expect to report top line data via press release in the second quarter of this year.

The first read out will be focused on the primary endpoint comparing the time to neutrophil engraftment in the two arms.

The study is well powered to detect a difference of seven days, which would be a clinically meaningful treatment effect.

Additional study endpoints will read out after the neutrophil Engraftment analysis.

Therefore, we anticipate reporting the study results at a medical meeting in the second half will be here.

Hi, good of data from this study will reinforce our belief that on the Juba. So can provide a potentially curative treatment option to patients who currently have no available donor and potentially improve outcomes for any patient who needs a transplant.

We're also evaluating or would you be sell in an investigator sponsored phase one two study in patients with severe a classic anemia, a rare and life threatening blood disorder.

Last year, we completed the first cohort of the study which showed that all three patients treated successfully underwent a bone marrow transplant consisting of on budget itself plus hapless identical stem cell graph.

Currently patients are being enrolled into the second cohort, which is designed to evaluate ahmadullah sell as a standalone graft.

We expect to report additional data from this study in the second half of the year.

We're also continuing to advance our second cell therapy program GDP to a one and natural killer based therapy.

Natural killer or NK cells have potent anti tumor properties the tumor killing activity of NK cells is greatly enhanced by antibodies that recognize tumor cells, which trigger antibody dependent cellular cytotoxicity or ADCC.

The binding of an antibody to a sell marks it for destruction by activated NK cells.

In the past a key limitation to the therapeutic utility of NK cells has been the ability to generate sufficient numbers of highly functional cells and culture.

We are using our NAND technology to potentially overcome this limitation.

The ongoing phase one study was designed to assess the safety of three increasing doses of GDP to a one in combination with monoclonal antibody and to determine the recommended phase two dose.

The trial being conducted by Dr. Veronica Bakken over at the University of Minnesota.

We've already achieved our phase one objective.

And as additional patients are enrolled we continue to be very encouraged by the safety and activity observed.

The most recently reported data from this study in an all presentation at the American Society, Hematology or Ash meeting, which included data from 22 patients nine patients with non Hodgkin lymphoma in 13 patients with multiple myeloma.

It's mostly the responses observed to date are in patients with lymphoma I'll focus my comments on those patients.

And actually reported clinical activity at all doses evaluated which is particularly encouraging to see in a population of heavily pretreated patients with advanced disease.

Among nine patients with non Hodgkin lymphoma, there were five complete responses among patients who were treated with a single dose of GDP to a one.

There was also a patient with partial response after one dose would reach treated with an additional infusion without lymphodepletion.

This patient subsequently achieved a complete response.

So in all there were six complete responses out of nine patients.

Well they trust one of these patients with a history of CLL and Richter transformation had a tumor that continue to shrink over approximately 10 months post therapy before becoming a complete response.

This is clinically insane typically very interesting because it suggests that GDP to a one elicits an adaptive immune response.

We also continued to be pleased with the safety profile of GBP, two or one there were no dose limiting toxicities and arts barium no gvhd, no tumor lysis syndrome, and strikingly no no no no neurotoxicity has been observed.

In summary, we think this is highly compelling data for first in human study.

We are focused on the activities required to enable and I'd submission in the fourth quarter, which includes GMP scale up of our Cryopreserved formulation.

Simultaneously, we're working on key strategic and operational activities to enable the initiation of a multicenter multi dose phase one two study in patients with lymphoma next year.

With that I will turn the call over to shy to review our financial results.

Thank you Randy and good morning, everyone. This morning, I will review our between 19 full year financial results.

As of December 31st 2019, we had total cash cash equivalents and available for sale securities or $55.4 million compared to $60.7 million It'll December 31st when you do.

As a reminder, we completed the follow on offering that you like we don't have gross proceeds were $40.3 million.

Research and development expenses for the year were $31.5 million compared to $22 million, but the same period between your team.

The increase was mainly due to clinical activities related to the advancement of Ami Doobie. So in junior to a one program is whether the additional headcount we can get R&D organization.

The commercial organization was established in 2019 and the total commercial expenses for the year were $4.7 million.

These expenses were mainly due to a $2.4 million <unk> and non cash expenses related to hiring in establishing the commercial organization, it's really $2.3 million related to professional services and other expenses.

General and administrative expenses were $12.1 million for the year compared to $11.6 million drinking.

The increase was mainly due to 1.3 million dollar increasing rent and other expenses as well as 1 million dollar increase in professional services expenses associated with being a publicly traded company offered by 1.8 million dollar decrease we like a good publishing the commercial expenses line item in our opinion.

Net finance income were $13.8 million for the year compared to net finance expense was $19.2 million into anything.

The increase was primarily due to noncash income, resulting from revaluation of warrants offset by non cash expenses from the Israeli innovation authority royalty bearing grant liability and implementation of the new I first 16 accounting standard.

Net loss for the you were $34.4 million compared to a net loss of $52.9 billion into anything.

As you know we expect to report topline data from the phase three study are probably to be selling to second quarter.

All the data would trigger additional activities into second half of your including additional clinical studies to board into potential if I mean do b cells in activities to support a commercial readiness. There for today, we are providing financial guidance for the operating expenses for the first six months would view, which expect ranged from $30 million to $35 million inhibition, we until.

To date with our current total cash position will support our ongoing operating activities into the fourth quarter of these here.

These cash run rate guidance based on our current operational plans, including the assumption, but we'll continue to advance boat or commercial readiness and all our clinical programs and exclude any additional funding. It may be received or business development activities that maybe undertaken with that I will turn the call back over to Julien.

I will conclude thanks, Shai I will conclude by reviewing our anticipated milestones for 2020, which are as follows.

One report topline omen due to sell data from the second.

For me.

In this second quarter.

To present, the phase three on the do B cell data at a medical meeting in the second half a year.

Three assuming positive data submitted to be away from it due to sell in the fourth quarter.

For report additional woman due to sell data from the phase one two study in patients with severe a plastic anemia in the second half of the year.

Five present additional GBA to a one data in the first half of the year.

And finally six.

Finally, I Nd for G.D.A. to a one in the fourth quarter.

2020 has the potential to be a transformable transformational year for the company.

We're very focused on the activities required to deliver on our milestones, which we hope will drive value for shareholders. We have a strong team in place committed to delivering to the next generation of cell therapies to patients and we look forward to providing updates on our progress.

Now we will open the call for questions operator.

Thank you, ladies and gentlemen, if he would like to ask a question. Please press Star then the number one on your telephone keypad again to ask a question. Please press star one on your telephone keypad, we'll pause for just a moment to compile the Q1 day roster.

Your first question comes from the line, Jason Butler from JMP Securities.

Hi, Thanks for taking the questions and congrats on the progress.

Just a couple on them and do the self phase three read out I just wanted to clarify.

You mentioned earlier that the topline relief will focus on the primary endpoint what will we get any secondary endpoints in the top frame release, a and safety data will all that we'll just see the primary endpoint and then from.

The L.A. submission perspective.

On the clinical section of the B.L.A. are there any other high end gating item to other components for example, C.M.C.

Set that we should be aware of and then I have a follow up on the commercial readiness.

Okay, Let me direct the first part of your question to run eight.

To talk about the endpoints.

Sure.

Thanks for the question.

So the topline data the primary endpoint resolved is the time to neutrophil Engraftment, which is an objective and rapidly reading out endpoint and and we built that analysis in so that we could report data from this study quickly and get a real read on on what's important.

So that announcement will have that top line data well have some basic demographic.

And you know sort of study numbers, but won't contain any of the other endpoints, which will take longer to mature and read out and you know at the time that we presented the full dataset will have those other endpoints and the rest of it.

And Jason with regards to the B.L.A. its important maybe too.

No that there are three important sections to the BLM.

What is the clinical section, which is of course ongoing.

And we need to finals clinical study reports to submit to the B.L.A.

That will happen or in the fourth quarter or the Nonclinical section is virtually complete.

And finally the CMC.

Section of the BLM is ongoing and Ah.

The expectation is that we will be pre approval inspection ready Oh contemporaneously with filing the BLE. So the FDA will need to Oh, inspect the site and Ah the manufacturing site.

For the believed to be.

Accepted.

Great. That's very helpful. Thanks, Julien and then just from a commercial side can you talk about where you believe awareness today in key transplant centers. It in the U.S. is those on the do be selling and the company and be the work you're doing to continue to build awareness throughout 2020 in.

Anticipation of a launch.

I'll ask Tom to answer that question, Yeah, Hey, good morning, Jason Thompson tumor they the I think we've we've discussed this before but the opportunity for on the due to sell patience is relatively concentrated to about 70 transplant centers in the United States. So just to remind you about 80% of the opportunity is concerned.

Ladies and 70 transplant centers, we were in a good portion of those into clinical trials. So we already have existing relationships and awareness.

We are also working on and disease state and unmet need educational campaigns as well as expanding our awareness throughout 2020.

In addition to completing some of the foundational market research. So that we continue to fine tune, our understanding and fine tune our internal projections.

Great. Thanks for taking my question.

Your next question comes from the line of Gregory Renova from RBC capital markets.

Hey, Julian team congrats on the progress and thanks for taking my question.

Our pleasure I just thank you I just wanted to turn Julian just back to.

The endpoints and expectations on them on the comedy muscle topline read out in perhaps run it you could just perhaps for ride out just additional contacts in color I'm on the clinical meaningfulness. The translation of time to neutrophil on grass graph and how that how that conveys benefit and perhaps any.

Specific benchmark.

In the marketplace that you're looking at or that we should keep in mind and I think if I heard correctly that you are mentioning protect against a different the seven days without read out. Thank you.

Let me I'll go having just yep. Thanks, I'll go ahead and do that.

So yes, it's one grafman represents the time, it take or neutrophils or the infection fighting cells to grow again or to be back in a circulation after they've been obliterated by the very harsh conditioning chemotherapy that patients get to cure, though the kimi our lymphoma.

And every day that a patient has very very low neutrophils is a day that they can get.

Serious life threatening infection and other complication.

And so every day that they have where they're not neutropenia <unk> or were there cellcom going back as is another day that they can have a healthier immune system as potentially lead the hospital.

I'm so for our impression of the clinical significance of this is that saving patients. They have neutropenia will save them. They have infection save them days in the hospital save them. Other complications that are associated with neutropenia and this is something that supported by the bone marrow transplant community that for years and thin.

Fighting for improvement and I need to pay the time points for patients.

Well, there's just so engraftment, a with a therapy such as sibling or.

Unrelated donors.

Hey play a within a couple of weak.

After a transplant.

We've seen numbers like 16 to 18 days, a sometimes sooner in children.

But the the local core translate classically a and historically has had much longer times 20, twond graph and taking three weeks or more and that's been a a real source of.

Complications in patients who have cord blood graph.

And even improving upon the 16 to 18 days for patients with any transplant would be an opportunity to improve the time that the patient has.

With west complications such as infection less time needing very expensive medications and last time in the hospital at all.

In terms of what we're looking for for a difference where with 120 patients. There. So we are very well powered did pass the clinically meaningful difference, we think a clinically meaningful difference of about a week of would make a difference and the value proposition and and sort of.

The the the way that the patients clinically feel and do when the impact of the system I'm. So that's why I mentioned the seven day difference that's something that I think would be useful, but but really every single day of lessening Japan, yeah. It is important to patients and hot.

Central real.

Credibly meaningful.

Implication.

Great. Thank you that that's very helpful and just one more for me just with respect to bomb the phase three and how that's progressing certainly met all your timelines enrollment has been at a at a satisfactory pace I'm. Just curious if you have any commentary and what you've learned I'm sure obviously short of the [laughter], but.

The data read out that's pending but what you've learned.

About the potential commercial utility the commercial and practice and patient reception.

Product profile of such as I'm, a deep itself from the experiences with the pivotal that's been underway for sometime now thank you very much.

Roni, maybe you can start.

The beginning of that answer and then Tom I'd ask you. This also comment.

Absolutely so conducting clinical trials globally at over 50 sites really giving up the opportunity to engage with some fantastic transplant centers investigators and all of their staff.

On a very intense and personal basis, we've really been inside all of these centers.

Teaching them working with them going through things with them and and engaging with them over the past you're too.

So it's been a great opportunity to learn about the centers and to learn about the practices as well as to have them learn about.

Give me to sell and about on the do the south.

And that's really taught us a lot Tom.

Oh, sorry.

There are any of that Tiger you were done.

Greg just to add to that we've been doing market research is as we've shared in the past in the transplant centers, both in the United States and outside the United States and we're pleasantly continue to be pleasantly surprised that the response to the on the due to sell target product profile has been very well received and if you remember you know the transplant.

Community.

In the transport translates being done today, there's a significant amount of unmet need both in terms of patients you never make it to transplant for whatever reason, but also in some of the current existing modalities and some of the shortcoming. So when we show a target target product profile to physicians, they're telling us that they're excited about.

They're telling us that they'll use it and they are telling us that not only will they get more patients to transplant that they would use it in place if somebody other modalities.

In addition, I'd like to add that on the patient advocacy side, we've formed a strategic relationship with B. The match, which is the governing body that helps patients.

Get matched for transplant and so we're working very closely with them to.

To coordinate the ability to.

Source umbilical cord blood from which we expand the stem cells for patients. So at every level both from the physicians the patient advocates.

And other.

Work ongoing we're creating an enhanced awareness and obviously this will all be.

More poignant or when we have the primary endpoint.

Great. Thank you very much for taking the questions.

Your next question comes from the line of Matthew Luchini from B M O capital.

Hi, Good morning, guys. Thanks for taking my questions and congrats on a on the continued progress.

A couple from me so first.

You know I guess thinking about about the the target population, we've heard some color around awareness and target centers, but I guess you know what should we think about the the actual population who know we know the studies being run in the core about population, but there's also the potential for the.

The broader transcript transplant population, so I'm just wondering how from a.

How should we thinking about the label or and what might come out of that such that you could address that bigger population and then secondly on reimbursement you know I think probably the expectation is that this could be.

Let me just how will be reimbursed similar to car T.

So just curious how we should be thinking about reimbursement dynamics here.

And then lastly on to a one.

You know we've talked about in the past about prior preservation being a key step to enabling the multi multi dose a multicenter study and I just was hoping to get a little bit more color on where things stand.

In terms of ability to crowd preserve product. Thank you.

Okay really can you comment on the real World data study were doing as well looking at other modalities of transplant.

Yeah, absolutely. So one of the way we can address the broader transplant population is through our collaboration with the sensor French national bone marrow transplant research he Ivy MTR, where we're doing a concurrent real world data study the concurrent to the population that in our phase three study.

In collecting data on other transplant modality, so that we can place our results in the context of patients another transplant would die so that'll help us I'm kind of.

Build the message around where I would give us all fits in terms of the broader transplant population.

And earlier Roni commented on this and this was also presented at the recent TCT meeting by cord blood connect and that.

All other modalities, whether its matched unrelated donors are halfway identical donors engraft between 16 to 19 days.

Cord blood itself is.

On average around 20 to 25 days so we.

Believes that on the do Purcell may be best in class in terms of a transplant graph again, we are awaiting the data to demonstrate that.

And then just this this is Tom just to add to answer your question around reimbursement.

There are some I think similarities to how we believe that omni do so we'll be reimbursed similar to car Ts and that it will likely be reimbursed the carve out mechanism. So payers would likely pay for not only the transplant, but then also pay for the product through a carve out mechanism.

The main difference to know between on the do this all in car Ts is that with I was just speak to Ahmadinejad. So.

Based on our patient demographics center in our study we believe that the payer mix will be about 70% commercial payers roughly and 30% all other.

One of the challenges that the car to use of faces that they had a much larger Medicare and Medicaid population.

And as you know the MTEP process takes a little bit longer than some of the commercial processes to do but we're confident that it will be reimbursed.

I believe it will reimburse you know carbone mechanism.

[noise] and lastly, let me comment on a G.D.A. to a one manufacturing we did it we have announced that we've successfully learned how to cryopreserved and saw the cells with very good recovery.

About 80% recovery, but we still need to optimize and get this into a GMP format and do both engineering runs and qualification runs prior to filing an eye in the so that's going to take us a much of the remainder of this year to to any.

Well in I Andy filing.

That will be an off the shelf cryopreserved.

Product.

To be able to have a multicenter multidose approach.

Great. Thanks, and just quickly yes, yes, no clarification question when the phase three data our press release in topline format are we going to be getting safety information as well or is it only going to either primary efficacy endpoint Ics.

For me can you reiterate what's going to what we're going to announce.

Sure, Yes, there'll be no detailed safety information there maybe a broad statement about safety based on filling in holes in the overall look but no detailed safety information.

That point.

And I would just remind you in the audience that we have had external data safety monitoring board throughout the study.

And they get data every month and they need.

By annual basis.

And we have had no safety signals.

Our concerning today.

Okay, great. Thank you for taking all the questions.

Mm.

Your next question comes from the line of Chad Messer from Needham and company.

Great Good morning, and thanks for taking my questions.

And just start with <unk> to a one in terms of the upcoming additional data that we're gonna get wondering if you can share what we should expect in terms of an amount of data obviously more follow up which is important but are there going to potentially be more NHL patients treated and he's the pro.

Total coal written in a way that it's possible, we would see additional patients with re treatment.

Really would you like to handle that he will happen.

Happy to take that.

Thanks, Chad so.

The additional there will be additional patients and additional follow up any.

The next data update.

And are there is yes. The protocol is has been a amended to allow for a week treatment under certain conditions and so there will be more data on patients who have been retreated as well.

Alright very exciting.

That and then maybe a couple on on the due to sell.

The sort of commercial preparedness I know youve made several comment on that already but do you have specific goals in terms of what throughput you'd like to habitat.

I'm a launch for manufacturing you know you back in house and Wanda and.

What's your view of the state of the availability I know you've got a partnership would be the match, but the availability of of getting cord blood stem that match for most of your patience.

So in in the launch here, we have more than enough supply and this will be an ongoing education process.

Since cord blood supply is is critical to our success I will remind you that they're about 4 million babies born every year in the United States.

So I think cord blood supply will not be limiting.

And we're still doing market research to Oh.

Better quantify the uptake.

In the launch year, but Uh huh projections out too.

You know multiple thousands of transplants.

Between years three is three to five so we were scaling up accordingly.

Great. Thank you.

At this time I would like to remind everyone. If you will like to ask a question. Please press Star then the number one on your telephone keypad again for any questions. Please press star one on your telephone keypad.

Your next question comes from the line of Mark Breidenbach from Oppenheimer.

Hey, good morning, Thanks for taking your questions.

So over the weekend at TCT, we saw a fairly large.

Large trial results from a randomized study of double cord blood versus HATFA transplant, and and that's what they seem to favor the haplo transplant arm, especially in terms of overall survival.

So I'm I'm wondering if you can just you know give us an overview why you think <unk> they've become available on the do it yourself simply to reduce pure I'm enough to to erase any potential survival advantage for <unk> for weight when translating with no Medusa and I'm also wondering if you have any plans to do a.

Post approval randomize tribal versus versus Haplo, one from the dubious how is the fruit.

So let me just began the trial, you're referring to the city and 11, a one trial, which was a quantitative group study.

Used reduced intensity conditioning, so I think it's impossible to.

Compare.

Though those patients to the patients in our current study.

Rami do you have any further comments are analyzing these having.

So in this presentation.

Yeah, I think that's a key point just intensity conditioning, it's not any longer considered.

Appropriate oh conditioning for most robust healthy adults, who are are getting a transplant and maybe.

Maybe appropriate for the older or fail population, but not not for the group of adults that was included study. So for for that reason it is a bit hard to interpret. These results. These results also included double for transplant, the very different type of transplant and we're doing what you think.

You need of on the due to sell.

Rather than.

Our core transplants, all the patients. So I think I think the results were instructive in terms of you know sort of giving us some benchmarks about what but the issues are what what's interesting in terms of treatment related mortality and I think that yes. You are results of our phase two study did show that achievement related mortality.

Well decrease in patients who got on the do this all compared to historical controls who got standard court. So we anticipate that if the phase three results recapitulate. The phase. Two then then then we'll observed that as well and and that's certainly we'll have and important clinical impact on patients.

And we're looking forward to seeing the rest of the results and putting them into context with the though the that results that we see made no field.

We're not already you're not seeing a need to two to maybe run a randomized trial versus how quota.

So let me comment on that.

The.

There are.

First of all I think haplo are identical transplant is it perfectly legitimate.

Approach.

If you have a haplo donor.

However, about 25% of patients getting half would transplants are over the age of 50.

And they are suboptimal donors are we think there that at least that portion of the population should probably not get a haplo they have worse outcomes.

And with regard.

Doing additional randomized studies.

I think the real world data will teach us a lot about where on the do it yourself fits in the treatment paradigm.

So we.

Currently we do not have a a plan to do a a post approval a randomized trial with Apple.

Okay got it I'm just a quick one on GDP to one and your upcoming.

The company sponsored trial or would you can we safely assume that you'll be focusing on the same NHL sub types that were enrolling in dr. back into the study are we going to be seeing more.

Well like or lymphoma, and deal Bcl patients or will it be opened to other flavors of NHL and I'm curious, if you'll be allowing patients who respond to then go on to receive a transplant post response.

Well, 90% of patients with lymphoma are either of the follicular or deal Bcl. The largest population there are rare or types of lymphoma.

Molten and media steinle, and and mantle cell, we haven't designed the study yet and we will be meeting with.

Kolašin and will [laughter] as the year progresses, we will make those decisions.

At a future time.

Alright, Thank you for taking your question.

And at this time I show no further questions I will now turn the call back a Julien.

So thank you everyone for joining us on todays call. We're really excited about the opportunities that lie ahead and look forward to sharing updates on our progress throughout the year operator.

Ladies and gentlemen that concludes today's call you may now disconnect.

[music].