Q2 2020 Gamida Cell Ltd Earnings Call
[music].
Thank you breakeven so my name's Dexter and I'll be your property before to be at this time, all participants will be single people. After the speakers presentation. There will be a question and answer session.
Last question Judy the session you will lead the press star one on your telephone.
Anytime during the call French you need to beach and operating lease breast started zero.
We had last at the these Cogs being recorded I gave me the settlement with.
No I would like to reduce your hosts for todays Conference Me, John and then Vice President Investor Relations and corporate Communications. Please go ahead.
Thank you Dexter and good morning, everyone welcome to todays call during which we will provide an update on the company and review our financial results kind of second quarter 2020.
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 Gemino gosh, South Dotcom, where you can find the press release related to today's call here with me on our call today is Julian Adams, Chief Executive Officer, when it comes on top.
Chief Medical Officer Child, angry Chief Financial Officer, and Tracy Muddy, our Chief Scientific Officer.
Following our prepared remarks, well open the call for Q and <unk>.
During this call we may make forward looking statements about our future expectations and plan, including clinical development and commercial objective.
<unk> potential of our product candidate or operational plans and strategies and projected operating expenses on cash runway actual results may differ materially from what we project today due to a number of important risk factors include a consideration described in the risk factor section of our form 20-F, and then other filings that to me to fund makes it 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 update then in the future whether as a result of new information future events or otherwise now, let's turn the call ever to Julien.
Thank you Jeremy and thanks, everyone for joining us this morning.
It can be to Phil we're committed to developing cell therapies with the potential to provide cures for patients with blood cancers and rare serious hematologic diseases.
We have continued to navigate through the challenges of Covidien 19, we have made.
Important progress across the business.
While protecting the health and safety bar employees.
Earlier this year, we reported positive topline data from a global randomized phase three study of on would do b cell, which could be the first ft approved graft source for bone marrow transplant.
We're also making progress with our second cell therapy candidate G.D.A. tool, one and natural killer cells or NK cell therapy, which has the potential in both hematologic malignancies in solid tumors.
Additionally, we completed a follow on offering provides cash runway into the second half of 2021 and.
We've added new talent to our executive team.
Today will review, our clinical programs and highlight our anticipated milestones over the next few months.
[noise], starting first with omen do Brasil in May we reported positive highly significant topline data from our phase three clinical study of woman do so in patients with high risk hematologic malignancies, neither bone marrow transplant.
We are continuing to generate data from this study and expect to report secondary endpoints in the fourth quarter of this year.
We are on track to initiate the be allay submission on a rolling basis in the fourth quarter.
Which positions us for a potential launch in the second half of 2021.
We're also making good progress.
The key activities required to bring on the due to sell to patients following potential FDA approval, including developing comprehensive hospital services and patient assistance programs.
Regarding manufacturing readiness, we completed the tech transfer to Lonza her contract manufacturer.
And have finished the build out of our own facility. We are now entering the validation phase, which we expect to be finished by the end of this year.
On the due to sell validated our cell expansion platform, which also led to the generation of G.D.A. to a one.
NK cell therapies offer tremendous potential the transforming the care of hematologic malignancy.
We're pleased to be pioneering a novel approach that harness.
Harnesses the power of our cell expansion technology, which uniquely improves the antibody dependent cytotoxicity known as ADCC cytotoxic, killing and that in vivo home and the potential.
Oh, Gee D.A. to a one to address potential limitations NK cells.
With GBA to a one our goal is to develop an off the shelf allogeneic cell therapy with response rates similar to the card teas in lymphoma, well potentially offering a more favorable safety profile.
Data from our ongoing phase one study demonstrated striking early results of efficacy with multiple complete responses in patients with advanced lymphoma.
We are planning to initiate a phase one two multi center study in patients with lymphoma, using a cryopreserved formulation in 2021.
Our hope is that if the data are compelling this study could serve as the basis.
Hey registration trial through an accelerated approval pathway.
The timeline for our I.M.D. submission has been impacted by coded 19, and we expect to submit the I M. B in the first half of 2021.
This shift is a result of implementing additional safety measures, including shift work in our labs, a second waves of Kobin emerged.
As we advance both of our clinical programs and prepare for potential launch next year, we've expanded our leadership team.
In July and Michelle course, and was appointed to the role of Chief operating and Chief Commercial Officer.
News Corp, and brings over 20 years of experience in oncology focused on business operations and <unk> commercialization of novel therapies.
She has worked at several highly regarded companies, including Celgene and kite, where she served most recently as president of market access.
As we look to attract additional talent and bring new capabilities into me to sell we've appointed magnitude BA to the role of Vice President of human resources.
And that also brings more than 20 years of human resources experience and in particular building out our commercial.
Building out commercial teams.
Both Michelle and Matt officially start next week, and we look forward to their contributions.
I'll now turn the call over to relieve some until our chief Medical officer to provide further update on them would do epicel in G.D.A. two or one.
So neat.
Thank you Julien and good morning, everyone.
This morning, our view I program and highlight our upcoming milestones beginning with omitted itself.
It's really noted in May we reported positive topline data from our global Phase three study of only to the south and 125 patients with high risk hematologic malignancy.
We're very proud of that rigorous well executed trial and we truly appreciate the support of our collaborators and the transplant community or working with us to help move the fuel filler.
The primary endpoint at times, and you're just going back now a key milestone in recovery from bone marrow transplant.
Define how quickly to stem cells. The patient seed became established and began to make helping you sell.
And he intends to treat analysis and heating times and you're just on grappling with 12 days and patients randomized to own the dermacell compared to 22 days of patients in the comparative glip randomized to a standard cord blood transplant.
The P value was less than their point here and there are one.
This is a clinically significant difference because faster and graphic is associated with fewer infections and shorter hospitalization, which is meaningful for patients physicians and hospitals.
These data were consistent with our phase one two study and also compare favorably to the timing it took on Graton, but had been previously reported other studies for other transplant modality, well, we've seen data ranging from 16 to 21 days.
Additionally, I would do the cell was generally well tolerated.
Among patients what transplanted per protocol, 96% of patients who received on the deal to sell a chief successful neutrophil engraftment compared to 88% of patient a comparative growth.
Our team is continuing to work closely with the clinical study sites as we continue patient follow up in a blinded fashion.
Our next data read out will include at least six months a follow up post transplantation for all patients.
Typically we'll be validating the incidence of infection as well as Dave alive out at a hospital for on the do the cell patients compared to patients and the comparative grip.
Another secondary endpoint and they will evaluate it platelet engraftment, which takes longer to achieve and you're just going back next.
We expect to make a topline announcement via press release, but will preserve the detail for presentation in appears informed by the end of year.
Importantly, based on our primary endpoint data, we are confident that I would do the cell conservative graft for any patient I need a bone marrow transplant by providing a readily available bone marrow transplant graph, we can potentially reduce the time patients currently spend waiting for doing a match.
On the Dermacell can also make transplant more accessible to the 40% of patients who are today eligible for transplant, but unable to find a match Donna.
As we work to complete our phase three study. We've recently initiated an open label single arm study to provide access to under the cells for people with high risking the logic malignancies, who are in need of a bone marrow transplant and the protocol criteria.
Study currently open three sites in the U.S. and additional sites are expected to open in the coming month.
We're also collecting data to further our understanding of how long do itself fit into the bone marrow transplant treatment paradigm.
Last year, we established a research agreement with the center for International Blood and marrow transplant research or the C. I'd be MTR to collect and analyze real world health outcomes in patients with hematologic malignancies, who is Stephen allogeneic bone marrow transplant very donor sources.
The observation of study includes data contemporaneous with our phase three study next month. The initial data from this study will be recorded in the poster presentation at the virtual cord blood connects meeting this research underscores our commitment to improving outcomes for patients.
We believe on the due to sell have potential beyond human logic malignancies, and we're continuing to evaluate on the diversity in an investigator sponsored phase one study in patients with severe aplastic anemia, a rare and life threatening blood disorder.
We expect to report additional data from this study in the fourth quarter.
In addition to only do the so were advancing our NK program DTA to a one.
Natural killer cells innate immune cells that have helped tremendous promise for treating cancer.
However, the field to say several development challenges, including the ability to expand NK cells and culture, while preserving their functionality.
Our technology addresses this challenge and our initial phase one data provide proof of concept.
The ongoing study in patients with non Hodgkin lymphoma, and multiple myeloma is designed to assess the safety of GE day to a one in combination with monoclonal antibody and to determine the recommended phase two dose.
We have previously reported that among the 11 patients with non Hodgkin lymphoma, seven achieved a complete response and one patient achieved partial response.
While this is a small dataset from a single site the activity observed and heavily pretreated patients, including those with diffuse large b cell lymphoma compares favourably with responses observed and early studies of car T therapy.
We also continued to be impressed with the safety profile of GDP to align.
And 25 patients there were no dose limiting toxicities and no gvhd and importantly, no neurotoxicity observed.
With the primary objectives of the study complete we're taking the opportunity to evaluate the duration of response and to add additional questions to inform future development plan. For example, we've successfully me treated patients, which he day to a one without lymphodepletion.
We expect to report updated data from this study in the fourth quarter of this year.
Hi, I'm very proud of our team and their commitment to advancing our clinical studies during the cold pandemic and it looks forward to sharing data from both programs with you in just a few months.
I will turn the call over to shy to review our financial results.
Thank you are in eight and good morning, everyone. Today, I will summarize our financial results for the second quarter 2020.
As of June Thirtyth 2020, we had total cash cash equivalents and available for sale securities was $88.6 million compared to $55.4 billion as of December 31st 2019.
The June Thirtyth 2020 cash position includes the aggregate net proceeds from our recent public follow on offering which were approximately $64 million.
Research and development expenses for the quarter were $9.3 million compared to $7.3 million for the same period in 2019. The increase was mainly due to clinical activities related to the advancement of GDP to one and decreasing grants received from these rarely innovation authority.
Commercial expenses during the quarter were 1 million dollar compared to $1.1 million for the same period last year.
The decrease was mainly attributed to non cash compensation income offset by only do be so commercial readiness activities.
General and administrative expenses were $2.5 million for both the second quarter of 2020.
And for the same period in 2019.
Finance expenses net.
Two candidates for the quarter compared to finance income net of $16.8 million into same period into any 19.
The increase was primarily due to non cash accomplish expenses, resulting for revaluation of four inch owned by shareholders.
Net loss for the quarter was $15.1 million compared to a net income of $6 million for the same period last year.
We continue to expect cash used for ongoing operating activities. This year to range from $60 million to $70 million, we anticipate at our current total cash position will support our ongoing operating activities into the second half of next year.
This cash runway guidance is based on our current operational plans and excludes any additional funding to maybe received or business development activities that maybe undertaken we debt I will turn to call back over to Julien.
Thanks shy.
The strong position I'm excited about the opportunities ahead.
With on the do it so we're months away from reporting the secondary endpoints and initiating our be away filing.
We Judy a to a one we have a very compelling data.
Said in lymphoma and are working hard to initiate our own study, which could transitioning to a registrational trial. If the data are consistent with our ongoing phase one study.
I'd like to conclude by thanking all the give me the fellow employees, who have shown tremendous commitment and resilience. During this global pandemic as we work to advance the company and bring new cell therapies to patients.
Now we will open the call for questions operator.
And controlling for reminder to ask your question you will need to press star one corner telephone three daughter question breast abound.
That's fair wants to ask the question.
And your first question comps are the line or says that hall from Barclays. Your line is open.
And congrats Moreover, progress I agree it's really difficult Herman you've got six is breaking up at the company.
Hi, Little question and congrats overview hires how would you say as you know the.
Hey, free data or being digested, but as a community.
Clearly a pretty impressive win for patient what would you say cotwo feedback has been as you've started to kind of run. These data sets by her opinion leaders said as you've started to do the crop, let's just for regulatory filings for ultimately commercial launch. Thanks, so much.
[noise] resonate when you take rather impressive harder question.
Thanks. Thank you had an end up the Kalo response has been very positive first for.
The execution of.
Such a high quality study.
And second for the primary endpoint results, which are incredibly significant and meaningful from a clinical standpoint as well.
So we've had interaction with a large number of caylloma transplant community both in the U.S. and globally and the general responses overwhelmingly positive. So there's a lot of enthusiasm going forward as we bring that to be allay submission and.
Ultimately to potential approval.
Great and if I may not occur.
If I may add to that we've also showed the data with FDA and have also received very positive feedback from the agency as well.
That's correct reported them, where they come back half.
So yes, so are we [laughter] <unk>.
<unk>.
All right and our next question comes from the line of Jonathan Rose from Evercore. Your line is open.
So much for taking the question.
I guess two quick ones.
First the NK program looks much more active leasing this initial data in NHL versus in my alumina and I guess my question is is the driver of these differences.
In efficacy the indication or is it the combo antibody that goes along with the education and whatever the answer is there what should the characteristics of the indication or map that you expect to be most successful as we look forward towards.
The NHL trial, starting next year.
And then secondly.
I wanted to ask a question about the internal manufacturing capacity that you've been building out Oh, how much manufacturing capacity do you expect to be building out and how much of the commercial demand do you think you'd be able to meet with that and is that infrastructure also available for other programs beyond government itself.
So let me invite Tracy to answer your first question on Judea to a one and I'll cover the manufacturing.
The second part of your question.
Sure. Thank you Jonathan for your question.
In inter and then I'll turn it over to or need to afterwards, if she has more comments on the indication and where we're going obviously first we're really excited about the complete remission high rate that were seen in the patients and the overall response rate that we see in non Hodgkin's lymphoma as you as you pointed.
No. There there is a distinct difference that we've seen with multiple myeloma and we really do believe that that is due to the antibody combination that we're seeing and do those patient does your call are receiving either choosing.
Which is humanized monoclonal antibody to Andy slamming seven which is also.
And antigen present on all NK cells, <unk> coating Gd two or one so we have laboratory in animal data, suggesting that this is the combination of lease. This antibody with these cells is actually causing fratricide, causing the NK cells, obviously recognize them.
Solved and auto killing suicide. So we think we're not being as efficient as we would with using a different target antibody and in addition, it knowing that either to them and it is not you know approve them up and while I'm on my end in of itself as a single agent and we think that it's just not as a.
Effective in ADCC as your talks a map and even in multiple I'm Omar I just single agent. It's just not as effective in order to address this.
No. We are working with a research program and you don't modifying our NK cells to actually have successful combination with different antibodies in the future, but given that we see such a high rate of complete remission and non Hodgkin's lymphoma that is where we're focusing for us.
Our future I envy and for that clinical trial.
So I think I'll turn it over to or need to comment on on those patients and what we're hoping to see.
In our eye in the next year.
Yeah, we seen enough in our phase one study to make the decision and to initiate plans for a global multicenter study in lymphoma, and we expect to include patients with both indolent and aggressive lymphoma, because we seeing results and both of those type of patients obviously analyze.
Differently and separately, but we believe that they'll be benefit to each of those patient cohort.
And.
Your question on manufacturing first I'd like to.
Say that we've had this longstanding contract manufacturing relationship with Lonza that supplied.
All of our clinical studies.
And so that relationship continues and has being morphed into a commercial agreement commercial supply agreement.
In addition, we've built out our own facility.
And Ah so for business redundancy, we will have two sides of manufacturing.
We are continuously I'm doing a market research.
To enable us to project of the forecast and.
Build out our manufacturing capacity to be able to serve the community that we are intending to treat both its launch and in subsequent years.
Okay. Thank you very much I guess, then one follow up to that first question. A one thing that you mentioned in your prepared remarks that I didn't hear you guys talk about just now is solid tumor plans for that to a one program can you talk about when we might start to see direct motion in that direction.
So to do you want to talk about our our early lab results.
Sure sure I I can talk about that.
We have an active research program right now obviously as we we said because we have unique ability to combine you know G.D.A. to a one with different antibody, we haven't a research setting.
Machine very good activity with herceptin and and other antibodies. So we're now actually performing studies preclinical studies to actually guide us into which will be the that solid tumor antibody G. D to a one combination for that.
As well as other research activities that we have ongoing around gene editing, which we're not disclosing that targets right now well, which will actually make our NK cells amenable to solid tumors. So it's definitely an area that we're focusing on and when we have more this preclinical.
Work will allow that to guide us into which area that we think will be the most beneficial.
Her I'm solid tumors with G.H. over one.
Hi, Thanks, very much bigger.
Thank you John Thank you for the question.
Your next question comes from the line of Mark Breidenbach from organizes your line is open.
Hey, good morning, and thanks for taking my questions.
I I was wondering if you could just give us a little bit of guidance in terms of numbers of patients to expect for the DTA two on update presumably at Ash and maybe you could remind us about the mean differences between the version of GE a tool one that's in the clinic now and the version that you'll be advancing into your own study next year.
I'll talk about so I'll turn it over to Yeah, Oh, sorry go ahead garnered over to trade all over the urgent found that that will that sounds perfect [laughter].
So things like in terms of the phase one study at the University of Minnesota again, we have we were.
Really.
Raised by what we've seen for a study that was the first in human study, where we expected a safety outcome and we've seen enough from an efficacy side to already moved forward with our plans for development of the product in lymphoma.
There have been a an incremental increase in number of patients throughout this entire time I'm, even despite coded they've been able to continue to enroll patients over the months since the last update what shall and the last updated you remember was supposed to be at the European.
Bone marrow transplant meeting, but that was postponed and cancelled and ultimately.
We decided to hold off until a meeting later this year in order to give an update on the larger number of patients.
[noise], but suffice it to say the data continue to look encouraging and consistent with the responses we've seen in the first 11 patients.
Okay and in terms of differences between your Youre version of it through one of the one but that's okay. Yeah. Yeah. She could you markup cover that I can again. Thank you yeah. So I hear aware and I'll remind you that diversion of Judy to a one that you drive.
Now in the patient is being manufactured at Minnesota.
Did you the direction in after tech transfer from Gamete itself. So this product is a fresh product, which still is or is that our 14 day manufacturing timeline and its haplo product that's given fresh to the patients. The team has worked Trump.
Endlessly hard through the back half of last year in the first two quarters of this year now to come up with some of Cryopreserved formulation. So we're really excited I'm now that our goal is to have a completely allogeneic off the shelf cryopreserved formulation of GE.
To a one.
We have completed that cryo formulation.
Even through this pandemic and shift working we have maintained been able to get a formulation that has maintained the activity of the sell post Doc.
That being said now we're working to you know implementing complete the validation of that process and then scale up for clinical manufacturing and the GMP facility. So the main differences are that this will be completely allo and off the shelf and cryopreserved.
Okay. That's helpful.
And a follow up with respect to the initial data from the see I'd be MTR observational study are these data necessary or going to be included with I mean do consoles delay or is this completely separate from that process.
So this this real world dataset is one that were exploring in order to understand better what the transplant treatment paradigm is.
A with a variety of a transplant graph modality.
So to sort of understands the role of due to sell in the broader transplant paradigm.
And so were focusing that real world data on patients were treated.
Contemporaneously to those in the phase three study.
With similar characteristics diseases disease risk et cetera.
That said, we we were using their to increase our understanding and to tough to explore the field, but we do not believe that these are necessary.
Or an aspect of the submission.
Which will be based on the clinical study of them into the though.
Okay. That's helpful and finally, just wondering if there's any then any recent progress would be editas collaboration in terms of developing next generation NK cell therapies.
And if we might see any preclinical presentations on a related to your collaboration with Editas. Thank you.
I believe in pretty good in previous calls.
We did announced that added cost is.
Done a restructuring.
And Reprioritized are there and Chris and that collaboration is no longer actors.
Okay understood. Thanks for clarifying.
But I'll just add to that <unk> that is correct, but we are still continuing work with an engineered program, which now it is at the R&D stage with a collaborator with the goal of the L., improving combinability with with other antibody, which we think we'll uniquely.
The enhance ADCC for Judy two or one.
We're not providing detailed on the targets at this time, but we hope that we will present. This work preclinical work out a research conference the latter half of 2021.
Got it.
Yeah. The question from Gregory Robbins them from RBC capital markets. Your line is open.
Hey, Good morning got Julian Tina Thanks for taking my question also congratulations on the continued progress.
I'm joined I, just wanted to start with respect to the homage himself program and you mentioned at the collection of the secondary endpoints. Just curious if you can perhaps help characterize the experience of that data collection over the next several weeks and months in light of some pandemic headwinds.
The trial.
Experiences and how we should think about <unk> question.
Its had excellent question I'll turn it over to really whose dealing with all of the challenges.
[laughter] collecting the secondary endpoints.
Absolutely yes.
Yeah, Yeah kind of clinical trials are definitely challenging during this time.
Both from the perspective of patients coming to sites as well as study das like research nurses being available to site and thirdly monitoring of data. So all those are offer challenge we are [noise].
We are aware of and facing these challenges and dealing with them.
With implementation of things like remote monitoring with a variety of ways that we can communicate with site.
And the data and monitor the data. So we believe that we will be able to report the secondary endpoints as as we have plans and that but these challenges will not impact our ability to to analyze and support the data.
Great. That's helpful. And then would be stated the gating for I'm starting.
Yes.
I'm supposed to be at least the mission and based on the clinical programs, so far and we believe that the.
The the phase three trial will the the basis of the BLM submission where phase three trial had primary endpoint has been met.
And we have regular meetings with the FDA in order to.
To understand how we can bring me be at least the mission.
All right so.
So we've already begun discussions and we've already begun that process.
To put together all of the report and submission package.
And as we get the Fuller dataset, we will fill those in and and bring those forward.
Any other pieces that.
That we want to talk about.
In terms I would just for my I was just remind Greg and others, we remain blinded to the the data sets. So it's to not influenced the secondary endpoints are.
And so were blinded for safety were blinded for activity and Ah with the collection of the secondary endpoints. We will then Unblind and then do perform all the statistical analysis required.
Yes.
For a clinical study report.
Bill I submission.
That's great I appreciate the color. Thanks for taking my question.
Our pleasure.
Okay.
You have the next question comes from Jason Butler from GMP Securities. Your line is open.
Hi, Thanks for taking the question just just one for me and drilling you mentioned that you received positive feedback on the data over the last couple of months the phase III pivotal data from from the the transplant community can you talk about work that you you've done in the interim and that you're you're continuing to do with payers to it to ensure access when when the.
When the drug comes to market. Thanks, Yes, we have we have ongoing discussion with we've talked to about a dozen of the.
Largest payers that cover about 80 million lives.
It's we have also received very favorable feedback on coverage.
And don't anticipate any reluctance.
To to cover the product.
Very similar to what.
The car T experiences and if I can just comment Michelle core from joining our team.
We wrote the playbook for quite a fully approval and.
Launch of U.S. Carter. So we're very very fortunate to have her joined the team because I think she knows to landscape extremely well and she joined said the time, where we have plenty of time to you know secure contracts and Ah Ah with.
With the major [laughter] inch insurers.
For the kind of launch next year.
Great. Thanks for the color.
[noise] my pleasure again.
If you like to ask the question breast phone then the number one when your telephone keypad that star one asked the question.
And you have a question from Chad Messer lead ankle realign Hilton.
Great. Thanks, Good morning, and thanks for taking my question I'm just for the upcoming read out of the secondary endpoints I was wondering ahead of that if you could just.
Maybe take a minute and sort of.
Texture lies the.
So the different endpoints, maybe sort of prioritize which ones we should be paying the most attention too.
Sure.
Yeah salaries mobile you again [laughter].
Sure.
So.
The first thing to note is that the secondary endpoint or our endpoint that I'm going to be analyzed.
After all patients Mitch about six months.
Post transplant. So obviously the earlier patients will have longer follow up but there are longer follow up for all the patients involved.
The main secondary endpoint that we believe our clinically significant.
Are the duration of hospitalization.
And the number of infection.
As well platelet in graph.
Those are all saying that are tied very closely with the duration neutrophil engraftment.
And that also quite important to the outcomes of patients.
Because they they impact directly the time that the patient capital spend in isolation and hospital the complications that the patients have post transplant and their overall clinical experience an outcome.
So those secondary endpoints will be endpoints that are really ally.
Once those patients hit that hundred 80 day.
Additionally, we will have a still set of safety data comparing the safety outcome in the two study arm.
And we will have other endpoints, including non relapse mortality, which is also called treatment related mortality.
As well as overall survival needs to be survival.
Which are important but are also stated what other factors, including the underlying disease and other than these characteristics and demographic, but we should have a full data that.
Two lot to now.
And.
And share with you for a full valuation of study.
That Chad I'll remind you that our phase two data also correlated very favourably with the secondary endpoints that really just mentioned.
Based on historical controls, but now we have a concurrent control so.
It'll be a much more robust.
Read out.
Obviously, a larger patient group and Ah you know very well controlled randomized.
In and intend to treat analysis, so I think I feel very confident that we'll be able to reproduce that.
We were able to reproduce the.
The primary endpoint.
With the same P value or as the open label Phase two study. So I think we we go forward with a lot of confidence that these secondary endpoints.
Not only clinically meaningful but also will provide a lot of economic benefit to the health care system.
Shortening the time of patients have to be oh tended to and hospitals.
Great. Thank you very helpful. I look forward to that data into the to the two and one update as well next quarter.
Thanks again.
There are no further questions at this time I would like during the conference back due June.
[noise]. Thank you.
Thank you everyone for joining us on todays call.
We're really excited about the opportunities that lie ahead and look forward to sharing data from both programs in the upcoming month.
Operator.
Compute that concludes today's call you may now disconnect.
[music].
[music].
[music].
[music].
Thank you Dexter and good morning, everyone welcome to today's call during which we will provide an update on the company and review our financial results.
Second quarter 2020.
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 Dot dot Dot com, where you can find the press release related to today's call here with me on our call today is Julian Adams, Chief Executive Officer.
And then talk Chief Medical Officer, Shine, a light Gray Chief Financial Officer, and Tracy Luddy, our Chief Scientific Officer.
Following our prepared remarks, well open the call for Q and I.
During this call we may make forward looking statements about our future expectations I'm glad what's going in clinical development and commercial objective.
Okay potential of our product candidate.
Our operational plans stoppages and projected operating expenses <unk> actual results may differ materially and what we project today due to a number of important risk factors include a consider just described in the risk factor section of our form 20-F, and then other filings I mean, it's fun makes with the FCC it from time to time.
These forward looking statements represent our views only as of today.
Caution you that we may not appear in the future whether as a result of new information future about or otherwise now, let's turn the call originally.
Thank you John and thanks, everyone for joining us this morning.
It could lead to Phil we're committed to developing cell therapies with the potential to provide cures for patients with blood cancers and rare serious hematologic diseases.
Continue to navigate through the challenges of Cobot 19.
Made.
Important progress across the business.
While protecting the health and safety of our employees.
Earlier this year, we recorded positive topline data from a global randomized phase three study on the do it yourself.
Which could be the first ft approved graft source for bone marrow transplant.
We're also making progress with our second cell therapy candidate G.D.A. tool, one and natural killer cells or NK cell therapy, which has the potential in both hematologic malignancies in solid tumors.
Additionally, we completed a follow on offering it provides cash runway into the second type of 2021.
And we've added new talent to our executive team.
Today will review, our clinical programs and highlight our anticipated milestones over the next few months.
[noise], starting first with only do muscle in May we reported positive highly significant topline data from our phase three clinical study of on the good Michelle in patients with high risk hematologic malignancies, neither bone marrow transplant.
Moving to generate data from this study and expect to report secondary endpoints in the fourth quarter of this year.
We are on track to initiate the be allay submission on a rolling basis in the fourth quarter.
Which positions us for a potential launch in the second half 2021.
We're also making good progress.
The key activities required to bring on the due to sell to patients following potential FDA approval, including developing comprehensive hospital services and patient assistance programs.
Regarding manufacturing readiness, we completed the tech transfer to launch on her contract manufacturer.
And have finished the build out of our own facility. We are now entering the validation phase, which we expect to be finished by the end of this year.
On the due to sell validated our cell expansion platform, which also led to the generation of G.D.A. to a one.
NK cell therapies offer tremendous potential the transforming the care hematologic malignancy.
We're pleased to be pioneering a novel approach that harness.
Harnesses the power of our cell expansion technology, which uniquely improves the antibody dependent cytotoxicity, knowing that has ADCC cytotoxic, killing and that in vivo home in the potential.
Oh, Gee D.A. to a one to address potential limitations NK cells.
With GDH well one our goal is to develop off the shelf allogeneic cell therapy with response rates similar to the car teas in lymphoma, well potentially offering a more favorable safety profile.
Data from our ongoing phase one study demonstrated striking early results of efficacy with multiple complete responses in patients with advanced lymphoma.
We are planning to initiate a phase one two multicenter study in patients with lymphoma, using a cryopreserved formulation in 2021.
Our hope is that if the data are compelling this study could serve as the basis.
Hey, registration trial truly an accelerated approval pathway.
The timeline for all right Andy submission has been impacted by cold It 90, and we expect to submit the eye in the in the first half 2021.
This shift is a result of implementing additional safety measures, including shift work in our labs, a second wage cobot emerged.
As we advance both about clinical programs and prepare for potential launch next year, we've expanded our leadership team.
In July and Michelle Corp, and was appointed to the role of Chief operating and Chief Commercial Officer.
MS Coffin brings over 20 years of experience in oncology focused on business operations and <unk> commercialization of novel therapies.
She is working several highly regarded companies, including Celgene and kite, where she served most recently as president of market access.
As we look to attract additional talent and bring new capabilities into give me the shell we've appointed mathematician to the role of Vice President of human resources.
Matt also brings more than 20 years of human resources experience and in particular building out our commercial.
Building out commercial teams.
Well, if Michelle and Matt officially start next week, and we look forward to their contributions.
I'll now turn the call over to needs and until our Chief Medical officer to provide further update when do the sell in G.D.A. to a one.
Right.
Thank you Julien and good morning, everyone.
This morning, our view I program and highlight our upcoming milestones beginning with almost itself.
As Julie noted in May we reported positive topline data from our global Phase three study of only did itself in 125 patients with high risk hematologic malignancy.
Part of that rigorous well executed trial and we truly appreciate the support of our collaborators and the transplant community or working with up to help moved to feel filler.
The primary endpoint is type thing, you're just going back now a key milestone in recovery from bone marrow transplant.
Hi, how quickly the stem cells. The patient receives became established and began to make helping yourself.
And he intends to treat analysis and meeting continued your phone grapple with 12 days and patients randomized to only due to sell compared to 22 days for patients comparative were randomized to a standard cord blood transplant.
The P value look lessons there a point there are there or what.
This is a clinically significant definitely because faster and graphic is associated with fewer inspections and shorter hospitalization, which is meaningful for patients physicians and hospitals.
These data were consistent with our phase one two study and also compare favorably to the times neutrophil engraftment, but it's been previously reported in other studies for other transplant modality, well, we've seen data ranging from 16 to 21 days.
Additionally, I would do the felt was generally well tolerated.
Among patients what transplanted per protocol, 96% of patients who received only deal with bell achieved successful neutrophil engraftment compared to 88% of patient a comparative group.
Our team is continuing to work closely with the clinical study sites as we continue patient follow up in a blinded fashion.
Our next data readout will include at least six months to follow up post transplantation for all patients.
Typically we'll be validating the incidence of infection as well as Dave alive out of the hospitals for all the beautiful patients compared to patients and the comparative grip.
Another secondary endpoints, we will evaluate it platelet engraftment, which takes longer to a cheap and you're just going back.
We expect to make a topline announcement via press release, well preserved the detailed for presentation in appears informed by the end of the here.
Importantly, based on our primary endpoint data, we are confident but I'm just sell could serve as the graph for any patient I need a bone marrow transplant.
Providing a readily available bone marrow transplant graph, we can potentially reduce the time patients currently spend waiting for doing a match.
On the Dermacell can also make transplant more accessible to the 40% of patients who are today eligible for transplant, but unable to find a match Donna.
As we work to complete a phase three study. We've recently initiated an open label single arm study to provide access to under the itself for people with high risk Kinga logic malignancies, who are in need of a bone marrow transplant and the protocol criteria. This study currently open recites in the U.S. and additional sites are expected to open in the coming back.
Were also collecting data to further our understanding of how often do itself fit into the bone marrow transplant treatment paradigm.
Last year, we established a research agreement with the center for International Blood and marrow transplant research or the C. I'd be MTR collected and analyzed real world health outcomes in patients with hematologic malignancy, but were Steven allogeneic bone marrow transplant, various daughter sources.
The observation of study includes data contemporaneous with our phase three study next month. The initial data from this study will be recorded in the poster presentations at the virtual cord blood connects meeting this research underscores our commitment to improving outcomes for patients.
We believe all much of the fell have potential beyond hematologic malignancies, and we're continuing to evaluate on the Dermacell and an investigator sponsored phase one study in patients with severe classic anemia, a rare in life threatening blood disorder.
We expect to report additional data from this study in the fourth quarter.
In addition to only do this though were advancing our NK program GTH all one.
Natural killer cells or innate immune cells that have helped tremendous promise for treating cancer.
However, the field to say several development challenges, including the ability to expand NK cells and culture, while preserving that functionality.
Our technology addresses this challenge and our initial phase one data provide proof of concept.
The ongoing study in patients with non Hodgkin lymphoma in multiple myeloma is designed to assess the safety of GTH World one in combination with monoclonal antibody and to determine the recommended phase two dose.
We have previously reported that among the 11 patients with non Hodgkin lymphoma, seven achieved a complete response, one patient achieved a partial response.
Well this is a small dataset from a single site activity observed heavily pretreated patients, including those with diffuse large b cell lymphoma compares favorably with responses observed and early study a car T therapy.
We also continue to be impressed with the safety profile of GDP to all one.
25 patients there were no dose limiting toxicities and no gvhd and importantly, no no toxicity observed.
But the primary objectives of the study complete we're taking the opportunity to evaluate the duration of response and the additional questions to inform future development plan. For example, we've said that believe me treated patients with GE day to a one without lymphodepletion.
We expect to report updated data from this study in the fourth quarter of it yeah.
I'm very proud of our team and their commitment to advancing our clinical studies during the cold pandemic.
And it looks forward to sharing data from both programs with you in just a feeling.
With that I will turn the call over just shy to review our financial results.
<unk>.
Thank you are in eight and good morning, everyone. Today, I will summarize our financial results for the second quarter of 2020.
As of June Thirtyth 2020, we had total cash cash equivalents and available for sale securities $88.6 million.
The $255.4 billion as of December 31st 2019.
The June Thirtyth 2020 cash position includes the aggregate net proceeds from our recent public follow on offering which were approximately $64 million.
Research and development expenses for the quarter were $9.3 million compared to $7.3 million for the same period in 2019. The increase was mainly due to clinical activities related to the advancement of Judy to a one and decreasing grants received from these really innovation authority.
Commercial expenses during the quarter were 1 million dollar compared to $1.1 million for the same period last year.
The decrease was mainly attributable to non cash compensation income offset by all means to be so commercial readiness activities.
General and administrative expenses were $2.5 million for both the second quarter of 2020.
And for the same period in 2019.
Finance expenses net.
2000 doors for the quarter compared to finance income net of $16.8 million into same period in 2019 <unk>.
The increase was primarily due to non cash accomplish expenses, resulting for revaluation of four inch owned by shareholders.
That's all for the quarter was $15.1 million compared to a net income of $6 million for the same period last year.
We continue to expect guess use for ongoing operating activities. This year to range from $60 million to $70 million, we anticipate that our current total cash position will support our ongoing operating activities into the second half of next year.
These cash runway guidance is based on our current operational plans and excludes any additional funding could maybe received well business development activities that maybe undertaken we get I will turn to call back over to Julien.
Thanks shy.
The strong position I'm excited about the opportunities ahead with on the do it. So we're months away from reporting the secondary endpoints and initiating our BLA filing.
GBA to a one we have a very compelling data.
Set in lymphoma and are working hard to initiate our own study, which could transitioning to a registrational trial. If the data are consistent with our ongoing phase one study.
I'd like to conclude by thanking all the give me to sell employees, who have shown tremendous commitment and resilience. During this global pandemic as we work to advance the company and bring new cell therapies to patients.
Now we will open the call for questions operator.
And to children as a reminder to ask your question you read the press star one corner telephone.
Daughter question breast their banking and that started wants to ask the question.
And your first question comps over the long enough that that hall from Barclays. Your line is open.
And congrats Moreover, progress I agree, it's really difficult arm and you've got six was breaking up at the company.
I was little question Congrats overview hires how would you say as you know the.
He did or being digested by as a community.
Clearly a pretty impressive win for patient.
What would you say coil feedback has been as you started to kind of run. These data sets by opinion leaders and as you've started to do the crop not just for regulatory filings, but ultimately commercial launch. Thanks. So much.
[noise] running it would you take rather impressive harder question.
Thanks.
Thank you had an end up the tail response has been very positive first for.
The execution of.
Such a high quality study.
And second for the primary endpoint results, which are incredibly significant and meaningful from a clinical standpoint as well.
So we've had interaction with a large number of caylloma transplant community both in the U.S. globally and the general responses overwhelmingly positive. So there's a lot of enthusiasm going forward as we bring that to be allay submission.
Ultimately to potential approval.
Great and if I mean.
Yes, if I may add to that we've also showed the data with FDA and have also received very positive feedback from the agency as well.
That's correct report them, where they live in back half.
So yes, so are we [laughter].
All right and our next question comes from the line of Jonathan Rose from Evercore. Your line is open.
So much for taking the question.
I guess two quick ones.
First the unpaid program looks much more active leasing this initial data in NHL versus in myeloma and I guess my question is is the driver of these differences.
In efficacy the indication or is it the combo anti body that goes along with the education and whichever the answer is there what should the characteristics of the indication or Matt that you expect to be most successful as we look forward towards.
The NHL trial, starting next year.
And then secondly.
I wanted to ask a question about the internal manufacturing capacity that you've been building out or how much manufacturing capacity do you expect to be building out and how much of the commercial demand do you think you'd be able to meet with that and is that infrastructure also available for other programs beyond the other good though.
So let me invite crazy to answer your first question on Judy It to a one and I'll I'll cover the manufacturing.
The second part of your question.
Sure. Thank you Jonathan for your question.
In inter and then I'll turn it over journey to afterwards, if she has more comments on the indication where we're going obviously first were really excited about the complete remission high rate that were seen in the patients in the overall response rate that we see in non Hodgkin's lymphoma as you as you pointed.
No. There there is a distinct difference that we've seen with multiple myeloma and we really do believe that that is due to the antibody combination that we're seeing and do those patient does your call are receiving either choosing though which is humanized monoclonal.
Antibody to Andy Slant up seven which is also.
And antigen present on all NK cells, <unk> coding GTH or one so we have laboratory animal data, suggesting that this is the combination of these this antibody with these cells is actually causing fratricide.
Causing the NK cells, obviously recognize them themselves and auto killing suicide. So we think we're not being as efficient as we would with using a different target antibody and in addition to knowing that either choose denied it is not you know to firm up Im glad I'm on my end enough.
Also the single agent and we think that it's just not as effective in HCC as your talks a mad and even in multiple and all more as a single agent. It's just not as affected.
In order to address this.
No. We are working with the research program and you don't modifying our NK cells, you actually have successful combination with different antibody in the future, but given that we see such a high rate of complete remission and non Hodgkin's lymphoma that is where we're focusing for us.
Our future I envy and for that clinical trial.
So I think I'll turn it over at your own need to comment on on those patients and what we're hoping to see.
In our I envy next year.
Yeah, we've seen enough in our phase one study to make the decision to initiate plans for Oh Global Multicenter study in lymphoma, and we expect to include patients with both indolent than aggressive lymphoma, because we've seen results in both of those subtype of patients obviously analyze.
Differently and separately, but we believe that they'll be benefit to each of those patient cohort.
And.
Your question on manufacturing.
First I'd like to.
Say that we've had this longstanding contract manufacturing relationship with Lonza that supplied.
All of our clinical studies.
And so that relationship continues and has.
Being morphed into a commercial agreement commercial supply agreement.
In addition, we've built out our own facility.
And Ah so for business redundancy, we will have two sides of manufacturer.
We are continuously I'm doing a market research.
To enable us to project of the forecast and.
Build out our manufacturing capacity to be able to serve the community that we are intending to treat both at launch and in subsequent years.
Okay. Thank you very much I guess, then one follow up to that first question. A one thing that you mentioned in your prepared remarks that I didn't hear you guys talk about just now is solid tumor plans for that to a one program can you talk about when we might start to see direct merchant in that direction.
[noise] because he want to talk about our early lab results.
Sure sure I I can talk about that.
We have an active research program right now obviously as we said because we have unique ability to combine you know GTH all one with different antibody, we haven't a research setting.
Machine very good activity with herceptin and and other antibody. So we're now actually performing studies preclinical studies to actually guide us into which will be the that solid tumor antibodies G. D to a one combination for that.
Well as other research activities that we have ongoing around gene editing, which we're not disclosing that targets right now well, which will actually make our NK cells amenable to solid tumors. So it's definitely an area that we're focusing on and when we have more of the preclinical work.
Well allow that to guide us into which area that we think will be the most beneficial for 'em solid tumors with G.H. over one.
Hi, Thanks very much here.
Thank you John Thank you for the question.
Your next question comes from design of Mark Breidenbach from all of them hardly your line is open.
Hey, good morning, and thanks for taking my questions.
I was wondering if you could just give us a little bit of guidance in terms of numbers of patients to expect for the DTA tool one update a presumably at ash and maybe you could remind us about the mean differences between the version of GDH. Your one that's in the clinic now and the version that you'll be advancing into your own starting next year.
I'll talk about Adam I'll turn it over yeah, Oh, sorry go ahead garnered over to train or the urgent found good well that's sounds perfect [laughter].
So thanks.
In terms of the phase one study at the University of Minnesota again, we have we were.
Really.
Raised by what we've seen for a study that was the first in human study, where we expect to safety outcomes and we've seen enough from an efficacy side to already moved forward with our plans for development of the product in lymphoma.
There have been a an incremental increase in number of patients throughout this entire time I'm, even despite coal bed they've been able to continue to enroll patients over the months since the last update what shell and the last update as you remember was supposed to be at the European.
Bone marrow transplant meeting, but that was postponing cancelled and ultimately.
We decided to hold off until a meeting later this year in order to give an update on the larger number of patients.
[noise], but suffice it to say the data continue to look encouraging and consistent with the responses we've seen in the first 11 patients.
Okay, and then in terms of differences between your version of it you're one of the one that that's fine yeah. Okay. Yeah, Yeah. So could you Mark I cant again, thank you yeah Joe.
You are aware and I'll remind you that diversion of Judy to a one that you do right now in the patient is being manufactured at Minnesota.
To do the direction and after tech transfer from give me. The show. So this product is a fresh product, which still is or is that our 14 day manufacturing timeline and its haplo product that's given fresh to the patients. The team has worked terms.
Endlessly hard to the back half of last year in the first two quarters of this year now to come up when some of Cryopreserved formulation. So we're really excited I'm now that our goal is to have a completely allogeneic off the shelf cryopreserved formulation of Judy.
To a one.
We have completed that cryo formulation.
Even through this pandemic and shift working we have maintained been able to get a formulation that is maintained the activity of the shell post Doc.
That being said now we're working to you know implementing complete the validation of that process and then scale up for clinical manufacturing in the GMP facility. So the main differences are that this will be completely allo and off the shelf and cryopreserved.
Okay. That's helpful.
And a follow up with respect to the initial data from the see I'd be MTR observational study are these data necessary or going to be included with Ami do because delay or this completely separate from that process.
So that's that's real world dataset is one that were exploring in order to understand better what the a transplant treatment paradigm is.
A with a variety of a transplant graph modality.
So to sort of understands the role of all due to sell in the broader transplant paradigm.
And so were focusing that real world data on patients were treated.
Contemporaneously to those in the phase three study.
With similar characteristics diseases disease risk that Oh.
That said we.
We were using their to increase our understanding and to tough to explore the field but.
We do not believe that these are necessary or oh, an aspect of the submission.
Which out will be based on the clinical study of them into the phone.
Okay. That's helpful.
And finally, just wondering if there's any than any recent progress with the editas calibration in terms of developing next generation NK cell therapy is and if we might see any preclinical presentations on a related to your collaboration with Editas. Thank you.
I believe in pre in previous calls or we did announce that added cost.
Done a restructuring.
And Reprioritized, ER and Chris and that collaboration is no longer active.
Okay understood. Thanks for clarifying.
But I'll just add to that that is correct, but we are still continuing work within engineered program, which now it is at the R&D stage with a collaborator with the goal of the L., improving combinability with with other antibody, which we think we'll uniquely.
Enhance ADCC for Judy Joel one.
We're not providing details on the targets at this time, but we hope that we will present. This work preclinical work out a research conference the latter half of 2021.
Got it.
Yeah. The question from revenue Relenza from RBC capital markets. Your line is open.
Hey, good morning, Julian team. Thanks for taking my question also congratulations continued progress.
I'm joined I, just wanted to start with respect to the homage himself program and you mentioned at the collection of the secondary endpoints. Just curious if you can perhaps help characterize the experience of that data collection over the next step several weeks and months in light of HM.
Ken.
Some trials have been experiencing and how we should think about.
Yeah.
Okay excellent question I'll turn it over to meet whose dealing with all of the challenges [laughter] collecting the secondary endpoints.
Absolutely yes.
Yeah, Yeah kind of clinical trials are definitely challenging during this time.
Both from the perspective of patients coming to sites as well as study das like research nurses being available by and thirdly monitoring of data. So all those are offer challenge we are.
We are aware of and facing these challenges and dealing with them with implementation of things like remote monitoring with a variety of ways that we can communicate with site obtain a data and monitor the data. So we believe that we will be able to report.
The secondary endpoints as as we have plans and that but these challenges will not impact our ability to to analyze them apart the data.
Great. That's helpful. And then was the state of the gating for starting up.
Yes.
I'm supposed to be at least the mission and based on the clinical program. So far in we believed that the.
The phase three trial.
So.
The the.
Oh, the BLE submission, where safety trial had primary endpoint has been met and we've had regular meetings with the FDA in order to.
To understand how we can bring me be at least the mission solar.
So we've already begun discussions and we've already begun the process.
To put together all the report and submission package.
And as we get though Fuller dataset, we will.
Fill those in and and bring though.
All work.
Any other pieces that.
That we want to talk about.
I would guess for my I was just remind Greg and others, we remain blinded to the.
The datasets source to not influenced the secondary endpoints are and so were blinded for safety were blinded for activity and Ah with fee collection of the secondary endpoints, we will run Unblind. The men do perform all the statistical analysis required.
<unk>.
For clinical study report.
And Bill I submission.
That's great I appreciate the color. Thanks for taking my question.
Our pleasure.
Okay.
Your next question comes from Jason Butler from GMP Securities. Your line is open.
Hi, Thanks for taking the question just just one for me drilling you mentioned that you received positive feedback on the data over the last couple of months the phase three amityville data from from the transplant community can you talk about the work that you've done in the interim and that you're you're continuing to do with payers to it to ensure access when when.
When the drug comes to market. Thanks, Yes, we have we have ongoing discussion with we've talked to about a dozen of the.
Largest payers that cover about 80 million lives.
It's we have also received very favorable feedback on coverage.
And don't anticipate any reluctance.
To to cover the product.
Very similar to what.
The car T experiences and if I can just comment Michelle Corp, and joining our team.
Basically wrote the playbook for quite a fully approval and launch.
Launch of U.S. Carda. So we're very very fortunate to have her joined the team because I think she knows landscape extremely well and she joined said the time, where we have plenty of time too.
You know secure contracts and Ah Ah with with the major [laughter] inch insurers.
For the kind of launch next year.
Great. Thanks for the color.
[noise] my pleasure again.
If you like to ask a question Breastbone then the number one on your telephone keypad that star one asset Christian.
And Gabbert question from Chad Messer Needham Cool realign Hilton.
Great. Thanks, Good morning, and thanks for taking my question I'm just for the upcoming read out of the secondary endpoints I was wondering well ahead of that if you could just.
Maybe take a minute and sort of.
Catch generalize the importance of the different endpoints, maybe sort of prioritize which ones we should be paying the most attention too.
Sure.
Yeah salaries mobile you again [laughter] [laughter] sure.
So.
The first thing to note is that the secondary endpoint.
Our endpoints that are going to be analyzed.
After all patients reach about six months.
Post transplant. So obviously the earlier patients will have longer follow up but there are longer follow up for all the patients involved.
The main secondary endpoint that we believe our clinically significant.
Are the duration of hospitalization.
And the number of infection.
Well platelet in Grafman.
Those are all things that are tied very closely with the duration of neutrophil engraftment.
And then also quite important to the outcomes of patients.
Because they they impact directly the time that the patient have to spend in isolation and hospital the complications that the patient have post transplant and their overall clinical experience in outcome.
So those secondary endpoints will be endpoints that are really ally.
Once those patients hit that hundred 80 day.
Additionally, we will have a full set of safety data comparing the safety outcomes.
And the two study arm.
And we will have other endpoints, including non relapse mortality, which is also called treatment related mortality.
As well as overall survival needs to be survival.
Which are important but are also stated what other factors, including the underlying disease and other disease characteristics and demographic, but we should have a full dataset.
Two lot to now.
And.
And share with you for a full valuation of study.
[noise] that try to I'll remind you that our phase two data also correlated very favourably with the secondary endpoints that let me just mentioned.
Based on historical controls, but now we have a concurrent control so.
It will be much more robust.
Read out.
Obviously, a larger patient group and Ah you know very well controlled randomized.
And then intend to treat analysis, so I think I feel very confident that we'll be able to reproduce that.
We were able to reproduce the.
The primary endpoint.
With the same P value or as the open label Phase two study. So I think we we go forward with a lot of confidence that these secondary endpoints.
Not only clinically meaningful but also will provide a lot of economic benefit to the health care system.
By shortening the time of patients have to be.
Tended to and hospitals.
Great. Thank you very helpful. I look forward to that data into the.
Well, one update as well much quarter.
Thanks again.
There are no further questions at this time are like during the conference back to June.
Thank you [noise].
Thank you everyone for joining us on todays call.
We're really excited about the opportunities that lie ahead and look forward to sharing data from both programs in the upcoming month.
Operator.
Thank you that concludes today's call you may now disconnect.