Gamida Cell Ltd (fka GMDAQ)

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Gamida Cell Ltd. (GMDA) CEO Julian Adams on Q2 2020 Results - Earnings Call Transcript
Aug. 11, 2020 1:28 PM ET | About: Gamida Cell Ltd. (GMDA)

Gamida Cell Ltd (NASDAQ:GMDA) Q2 2020 Earnings Conference Call August 11, 2020 8:30 AM ET

Company Participants

Jaren Madden - Vice President, Investor Relations and Corporate Communications

Julian Adams - Chief Executive Officer

Ronit Simantov - Chief Medical Officer

Shai Lankry - Chief Financial Officer

Tracey Lodie - Chief Scientific Officer

Conference Call Participants

Ted Tenthoff - Piper Jaffray

Jonathan Mueller - Evercore

Mark Breidenbach - Oppenheimer

Gregory Renza - RBC Capital Markets

Jason Butler - JMP Securities

Chad Messer - Needham & Company

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Gamida Cell Conference Call for the Second Quarter 2020 Results. My name is Baxter, and I will your operator for today. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today’s call is being recorded at Gamida Cell’s request.

Now, I would like to introduce your host for today’s conference, Ms. Jaren Madden, Vice President of Investor Relations and Corporate Communications. Please go ahead, ma'am.

Jaren Madden

Thank you, Baxter, and good morning, everyone. Welcome to today’s call during which we will provide an update on the Company and review our financial results for the second quarter of 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.gamida-cell.com where you can find press release related to today's call.

Here with me on our call today is Julian Adams, Chief Executive Officer; Ronit Simantov, Chief Medical Officer; and Shai Lankry, Chief Financial Officer, and Tracey Lodie, our Chief Scientific Officer. Following our prepared remarks, we will open up the call for Q&A.

During this call, we may make forward looking statements about our future expectations and plans, including clinical development and commercial objectives, the therapeutic potential of our product candidates, our operational plans and strategies and projected operating expenses and cash runway.

Our actual results may differ materially from what we project today due to a number of important risk factors, including the considerations described in the risk factors section of our Form 20F and in other filings that Gamida Cell makes with the SEC from time-to-time. These forward-looking statements represent our views only as of today and we caution you that we may not update them in the future, whether as a result of new information, future events, or otherwise.

And now I'd like to turn the call over to Julian Adams.

Julian Adams

Thank you, Jaren. And thanks to everyone for joining us this morning. At Gamida Cell, we are 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 COVID-19. We have made important progress across the business, while protecting the health and safety of our employees. Earlier this year, we reported positive top-line data from our global randomized Phase III study of Omidubicel, which could be the first FDA approved graft source for bone marrow transplant. We are also making progress with our second cell therapy candidate GDA-201, a natural killer cell or NK cell therapy, which has the potential in both hematologic malignancies and solid tumors. Additionally, we completed a follow-on offering that provides cash runway into the second half of 2021.

And we've added new talent to our executive team. Today, we'll review our clinical programs and highlight our anticipated milestones over the next few months. Starting first with Omidubicel; in May, we reported positive highly significant top-line data from our Phase III clinical study of Omidubicel in patients with high-risk hemologic malignancies in need of a bone marrow transplant. We are continuing to generate data from this study, and expect to report the secondary endpoints in the fourth quarter of this year. We are on track to initiate the BLA submission on a rolling basis in the fourth quarter, which positions us for a potential launch in the second half of 2021.

We are also making good progress with other key activities required to bring Omidubicel 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, our 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. Omidubicel validated our cell expansion platform which also led to the generation of GDA-201. NK cell therapies offered tremendous potential for transforming the care of hematologic malignancy. We are pleased to be pioneering a novel approach that harnesses the power of our cell expansion technology, which uniquely improves the antibody dependent cytotoxicity known as ADCC cytotoxic killing and the in viva homing of potential of GDA-201 to address potential limitations of NK cells.

With GDA-201, our goal is to develop an off-the-shelf allogeneic cell therapy with response rates similar to the cartese in lymphoma, while potentially offering a more favorable safety profile. Data from our ongoing Phase I study have demonstrated striking early results of efficacy with multiple complete responses in patients with advanced lymphoma. We are planning to initiate a Phase I to multicentered 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 for a registration trial through an accelerated approval pathway.

The timeline for our IND submission has been impacted by COVID-19 and we expect to submit the IND in the first half of 2021. This shift is a result of implementing additional safety measures including shift work in our labs as second waves of Covid emerged. As we advance both of our clinical programs and prepare for a potential launch next year, we've expanded our leadership team. In July, Michele Korfin was appointed to the role of Chief Operating and Chief Commercial Officer. Ms Korfin brings over 20 years of experience in oncology focused on business operations and 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 Gamida Cell, we have appointed

Matthew Metivier, 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 teams.

Both Michele and Matt officially start next week, and we look forward to their contributions.

I'll now turn the call over to Ronit Simantov, our Chief Medical Officer to provide a further update on Omidubicel GDA-201. Ronit?

Ronit Simantov

Thank you, Julian, and good morning, everyone. This morning I'll review our program and highlight our upcoming milestones beginning with Omidubicel. As Julian noted in May, we reported positive top-line data from our global Phase III study of Omidubicel in 125 patients with high-risk hematologic malignancies. We are very proud of this rigorous, well-executed trial, and we truly appreciate the support of our collaborators in the transplant community who are working with us to help move the field forward. The primary endpoint is time to neutrophil engraftment, a key milestone in recovery from bone marrow transplant signifying how quickly the stem cells the patient received became established and began to make healthy new cells. In the intent to treat analysis the median time to neutrophil engraftment was 12 days in patients randomized to Omidubicel compared to 22 days for patients in the comparative group randomized to a standard cord blood transplant. The p-value was less than 0.001. This is a clinically significant difference because faster engraftment is associated with fewer infections and shorter hospitalizations, which is meaningful for patients, physicians and hospitals.

These data were consistent with our Phase 1/2 study and also compared favorably to the time to neutrophil engraftment that has been previously reported in other studies for other transplant modalities, where we've seen data ranging from 16 to 21 days. Additionally, Omidubicel was generally well tolerated; among patients who were transplanted per protocol 96% of patients who received Omidubicel achieved successful neutrophil engraftment compared to 88% of patients in the comparator 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 of follow-up post-transplantation for all patients. Specifically, we will be evaluating the incidence of infections, as well as days alive and out of the hospital for Omidubicel patients compared to patients in the comparator group.

Another secondary endpoint, we will evaluate is platelet engraftment which takes longer to achieve than neutrophil engraftment. We expect to make a top line announcement via press release but will preserve the details for presentation in a peer-review forum by the end of the year. Importantly, based on our primary endpoint data, we are confident that Omidubicel could serve as a graft for any patient in need of a bone marrow transplant. By providing a readily available bone marrow transplant graft, we can potentially reduce the time patients currently spend waiting for a donor match. Omidubicel can also make transplant more accessible to the 40% of patients who are today eligible for transplant, but unable to find a matched donor.

As we work to complete our Phase III study, we have recently initiated an open-label single arm study to provide access to Omidubicel for people with high risk hematologic malignancies, who are in need of a bone marrow transplant and meet protocol criteria. This study is currently open at three sites in the US and additional sites are expected to open in the coming months. We are also collecting data to further understanding of how Omidubicel fits 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 CIBMTR to collect and analyze real world health outcomes in patients with hematologic malignancies, who receive an allogeneic bone marrow transplant from various donor sources.

The observational study includes data contemporaneous with our Phase III study. Next month the initial data from this study will be reported in a poster presentation at the virtual Cord Blood Connect meeting. This research underscores our commitment to improving outcomes for patients. We believe Omidubicel has potential beyond hematologic malignancies, and we are continuing to evaluate Omidubicel in an investigator sponsored Phase 1/2 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 Omidubicel, we're advancing our NK program GDA-201, natural killer cells or innate immune cells that have held tremendous promise for treating cancer. However, the field to face several development challenges including the ability to expand NK cells in culture while preserving their functionality. Our technology addresses this challenge and our initial Phase I data provide proof-of-concept. The ongoing study in patients with non-Hodgkin's lymphoma and multiple myeloma is designed to assess the safety of GDA-201 in combination with monoclonal antibodies and to determine the recommended Phase 2 dose. We have previously reported that among the 11 patients with non-Hodgkin lymphoma, 7 achieved the complete response and 1 patient achieved a partial response. While this is a small data set from a single site, the activity observed in heavily pretreated patients including those with diffuse large B-cell lymphoma compares favorably with responses observed in early studies of CAR-T therapy.

We also continued to be impressed with the safety profile of GDA-201. In 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 are taking the opportunity to evaluate the duration of response and to ask additional questions to inform future development plans. For example, we successfully re-treated patients with GDA-201 without lymphodepletion. We expect to report updated data from this study in the fourth quarter of this year.

I am very proud of our team and their commitment to advancing our clinical studies during the COVID pandemic, and I look forward to sharing data from both programs with you in just a few months.

With that, I will turn the call over to Shai to review our financial results. Shai?

Shai Lankry

Thank you, Ronit, and good morning, everyone. Today, I will summarize our financial results for the second quarter of 2020. As of June 30, 2020, we have total cash and cash equivalents and available for sale security of $88.6 million compared to $55.4 million as of December 31, 2019. The June 30, 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 GDA-201 and decreasing grants received from the Israel Innovation Authority.

Commercial expenses in the quarter were $1 million compared to $1.1 million for the same period last year. The decrease was mainly attributed to non-cash compensation income offset by Omidubicel 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 was $2.2 million for the quarter compared to finance income net of $16.8 million in the same period in 2019. The increase was primarily due to non-cash expenses resulting from revaluation of warrants 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 use for ongoing operating activities this year to range from $60 million to $70 million. We anticipated 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 that may be received for business development activities that may be undertaken.

With that, I will turn the call back over to Julian.

Julian Adams

Thanks, Shai. Thanks, Shai. We’re in a strong positive and excited about the opportunities ahead. With Omidubicel, we are months away from reporting the secondary endpoints and initiating our BLA filing. With GDA-201, we have a very compelling dataset in lymphoma and are working hard to initiate our own study, which could transition to a registrational trial if the data are consistent with our ongoing Phase 1 study. I'd like to conclude by thanking all the Gamida Cell 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?

Question-and-Answer Session

Operator

[Operator Instructions]

And your first question comes from the line of Ted Tenthoff from Piper Jaffray. Your line is open.

TedTenthoff

Congrats on all the progress. I agree it's a really difficult time and you guys just -- breaking out as a company. A high level question and congrats on the new hires. How would you say as you know the Phase III data are being digested by the community? I mean clearly a pretty impressive win for patients. What would you say KOL feedback has been as you've started to kind of run these datasets by opinion leaders and as you've started to do the prep not just for regulatory filings but ultimately commercial launch. Thanks so much.

JulianAdams

Ronit, would you take that and thanks Ted for your question.

RonitSimantov

Thanks. Thank you, Ted and the KOL 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 interactions with large number of KOLs in the transplant community both in the US and globally, and the general response is overwhelmingly positive; so there's a lot of enthusiasm going forward as we bring this to BLA submission and ultimately to potential approval.

JulianAdams

And if I may add to that. We've also shared the data with FDA and have also received very positive feedback from the agency as well.

TedTenthoff

Okay. That’s great. Looking forward to more data in the back half.

Operator

And our next question comes from the line of Jonathan Mueller from Evercore. Your line is open.

JonathanMueller

Thanks so much for taking the question. I guess two quick ones. First, the NK program looks much more active at least in 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 antibody that goes along with the indication and whichever the answer is there -- which if the characteristics of the indication or MAB that you expect to be most successful as we look forward towards the NHL's trials starting next year? And then secondly, I wanted to ask a question about the internal manufacturing capacity that you've been building out. 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 Omidubicel?

JulianAdams

So let me invite Tracey to answer the first question on GDA-201, and I’ll cover the manufacturing, second part of your question.

Tracey Lodie

Sure. Thank you, Jonathan for your question. And then I’ll turn it over to Ronit 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 we're seeing in the patients, and the overall response rate that we see in non-Hodgkin's lymphoma. As you pointed out there is a distinct difference that we’ve seen with multiple myeloma, and we really do believe that is due to the antibody combination that we’re seeing. And those patients as you recall are receiving elotuzumab, which is humanized monoclonal antibody to anti SLAMF7 which is also an antigen present on all NK cell including GDA-201. So we have laboratory in animal data suggesting that this is the combination of these -- this antibody with these cells is actually causing fratricide or causing the NK cells to obviously recognize 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, it’s known that elotuzumab is not approved for multi brand moment in and of itself as a single agent. And we think that it’s just not as effective as ADCC as rituximab and even in multiple MMR as a single agent, it’s just not as effective and even in multiple myeloma as a single agent, and it's just not as effective. In order to address this we are working with a research program and 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 in non-Hodgkin lymphoma that is where we're focusing for our future IND and for that clinical trial. So I think I'll turn it over to Ronit to comment on those patients and what we're hoping to see in our IND next year.

RonitSimantov

Yes. We’ve seen enough in our Phase I study to make the decision and to initiate plans for a global multi-center study in lymphoma, and we expect to include patients with both indolent and aggressive lymphoma because we've seen results in both of those types of patients obviously analyzed differently and separately. But we believe that there will be benefit to each of those patient cohorts.

JulianAdams

And a 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 been morphed into a commercial agreement, the commercial supply agreement. In addition, we've built out our own facility and so for business redundancy we will have two sites of manufacturing. We are continuously doing market research to enable us to project 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.

JonathanMueller

Okay. Thank you very much. I guess then one follow up to that first question. 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 the 201 program. Can you talk about when we might start to see a motion in that direction?

JulianAdams

Tracey, do you want to talk about our early lab results?

Tracey Lodie

Sure. I can talk about that. We have an active research program right now. Obviously, as we said because we have a unique ability to combine GDA-201 with different antibodies. We have in a research setting seen very good activity with Herceptin and other antibodies. So we are now actually performing studies, preclinical studies to actually guide us into which will be the best solid tumor antibody GDA-201 combination for that as well as other research activities that we have ongoing around gene editing, which we're not disclosing the target right now 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 this preclinical work will allow that could guide us into which area that we think will be the most beneficial for solid tumors with GDA-201.

Operator

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

MarkBreidenbach

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 GDA-201 update presumably at ASH and maybe you could remind us about the main differences between the version of GDA-201 that’s in the clinic now and the version that you'll be advancing into your own study next year?

RonitSimantov

I'll talk about that and then I'll hand it over -- turn over to Tracey for the version. Sound good?

JulianAdams

Yes. That sounds perfect.

RonitSimantov

So, thanks Mark. In terms of the Phase 1 study at the University of Minnesota, again we have -- we're really pleased by what we've seen for a study that was the first in human study where we expect safety outcome, and we've seen enough from an efficacy side to already move forward with our plans for development of the product in lymphoma. There have been an incremental increase in number of patients throughout this entire time even despite COVID; they've been able to continue to enroll patients over the months since the last update was shown. The last update as you remember was supposed to be at the European Bone Marrow Transplant meeting, but that was postponed and canceled 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.

JulianAdams

But suffice it to say that the data continue to look encouraging and consistent with the responses we've seen in the first 11 patients.

MarkBreidenbach

Okay. And in terms of differences between your version of GDA-201 that -- [Multiple Speakers]

JulianAdams

Yes, Shai, could you cover that?

ShaiLankry

I can. Thank you. Yes. So, as you're aware and I'll remind you that the version of GDA-201 that’s used right now in the patient is being manufactured at Minnesota under the direction and after tech transfer from Gamida Cell. So this product is a fresh product, which still is at our 14 day manufacturing timeline and it's haplo product that’s given fresh to the patients. The team has worked tremendously hard through the back half of last year and the first two quarters of this year now to come up with a cryopreserved formulation. So we're really excited now that our goal is to have a completely allogeneic off the shelf cryopreserved formulation of GDA-201. So we have completed that cryo formulation even through this pandemic in shift working. We have maintained -- been able to get a formulation that has maintained the activity of the cell post op. That being said, now we're working to 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 and off-the-shelf and cryopreserved.

MarkBreidenbach

Okay. That’s helpful. And a follow-up, with respect to the initial data from the CIB and TR observational study, are these data necessary or are going to be included with Omidubicel BLA or is this completely separate from that process?

RonitSimantov

So this real world dataset is one that we're exploring in order to understand better what the transplant treatment paradigm is with a variety of transplant graft modalities and to sort of understand the role of Omidubicel in the broader transplant paradigm. And so we're focusing that real world data on patients who are treated contemporaneously to those in the Phase 3 study with similar characteristic diseases, disease risks et cetera. That said we’re using this to increase our understanding, and 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 studies of Omidubicel.

MarkBreidenbach

Okay. That's helpful. And finally just wondering if there has been any recent progress with Editas collaboration in terms of developing next generation NK cell therapies? And if we might see any preclinical presentations related to your collaboration with Editas? Thank you.

JulianAdams

I believe in previous calls we did announce that Editas has done a restructuring and reprioritized their interests and that collaboration is no longer active.

Tracey Lodie

But I'll just add to that, that is correct, but we are still continuing to work with an engineered program, which now is at the R&D stage with a collaborator with a goal of improving combinability with other antibodies, which we think will uniquely enhance ADCC for GDA-201. We're not providing details on the targets at this time, but we hope that we will present this work, pre-clinical work at a research conference in the latter half of 2021.

Operator

We have a question from Gregory Renza from RBC Capital Markets. Your line is open.

GregoryRenza

Hey. Good morning, Julian team. Thanks for taking my question. Also congratulations on the continued progress. Julian, I just wanted to start with respect to the Omidubicel program and mention of 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 to just a month in light of some of the pandemic headwinds that some trials have been experiencing and how we should think about? That’s the question. Thank you.

JulianAdams

Yes. It’s an excellent question. I'll turn it over to Ronit who’s dealing with all of the challenges of collecting the secondary endpoints and with her team, yes.

RonitSimantov

Absolutely, yes. Clinical trials are definitely challenging during this time both from the perspective of patients coming to sites, as well as study staff like research nurses being available to sites, and thirdly monitoring of data. So all those are offered challenges. 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 sites, obtain the data and monitor the data. But we believe that we will be able to report the secondary endpoints as we have planned, and that these challenges will not impact our ability to analyze and report the data.

GregoryRenza

Great. That's helpful. And then would this data be gating for starting the BLA in the fourth quarter as well?

RonitSimantov

So the BLA submission is based on the clinical program so far. And we believe that the Phase III trial will be the basis of the BLA submission, where Phase III trial has primary endpoint has been met and we've had regular meetings with the FDA in order to understand how we can bring the BLA submission forward. So we've already begun discussions, and we've already begun the process to put together all of the reports and submission package. And as we get those fuller dataset, we will fill those in and bring those forward. Any other piece is that we want to talk about in terms of --

JulianAdams

I would just remind Greg and others, we remain blinded to the dataset so as to not influence the secondary endpoints or - and so we're blinded for safety, we're blinded for activity. And with the collection of the secondary endpoints, we went unblind and do perform all the statistical analysis required for a clinical study report and BLA submission.

Operator

We have your next question comes from Jason Butler from JMP Securities. Your line is now open.

JasonButler

Hi. Thanks for taking the question. Just one for me, Julian, you mentioned that you’d receive positive feedback on the data over the last couple of months, the Phase III Omidubicel data from the transplant community. Can you talk about the work that you've done in the interim? And that you're continuing to do with payers to ensure access when the drug comes to market? Thanks.

JulianAdams

Yes. We have ongoing discussions with -- we've talked to about a dozen of the largest payers to cover about 80 million lives, and so we have also received very favorable feedback on coverage. And I don't anticipate any reluctance to cover the product very similar to what the CAR-T experiences. And then if I can just comment Michele Korfin joining our team basically worked the playbook for Kite for the approval and launch of Yescarta. So we're very, very fortunate to have her join the team because I think she knows the landscape extremely well. And she joins at the time where we had plenty of time to secure contracts and with the major insurers for the time of launch next year.

Operator

And we have a question from Chad Messer from Needham & Co. Your line is open.

ChadMesser

Great. Thanks. Good morning and thanks for taking my questions. Just for the upcoming readout of the secondary endpoints. I was wondering ahead of that if you could just maybe take a minute and sort of contextualize the importance of the different endpoints maybe sort of prioritize, which ones we should be paying the most attention to?

JulianAdams

Yes. Ronit, over to you again.

RonitSimantov

Yes. Sure. So the first thing to note is that the secondary endpoints are 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 that there longer follow-up for all the patients involved. The main secondary endpoints that we believe are clinically significant are the duration of hospitalization and the number of infection as well as platelet engraftment. Those are all saying that are tied very closely with the duration of neutrophil engraftment and they're also quite important to the outcomes of patients because they impact directly the time that the patient has to spend in isolation in the hospital. The complications that the patients have post-transplant. And their overall clinical experience and outcome. So those secondary endpoints will be endpoints that are really analyzed once those patients hit 180 days.

Additionally, we will have a full set of safety data comparing the safety outcome in the two study arm, and we will have other endpoints including non-relapsed mortality, which is also called treatment-related mortality as well as overall survival, disease-free survival which are important but are also associated with other factors including the underlying disease, and other disease characteristics and demographic, but we should have a full dataset to announce and ensure with you for full evaluation of the study.

JulianAdams

Yes. Chad, I remind you that our Phase II data also correlated very favorably with the secondary endpoints that Ronit just mentioned based on historical controls, but now we have a concurrent control, so it’ll be a much more robust readout obviously a larger patient group and very well-controlled randomized in an intent to treat analysis. So I think I feel very confident that we'll be able to reproduce that. We were able to reproduce the primary endpoint with the same P value as the open-label Phase II study. So I think we go forward with a lot of confidence that these secondary endpoints are not only clinically meaningful, but also will provide a lot of economic benefit to the healthcare system by shortening the time the patients have to be attended to and hospitalized.

Operator

There are no further questions at this time. I would like to turn the conference back to you Julian.

Julian Adams

Thank you. Thank you everyone for joining us on today's call. We're really excited about the opportunities that lie ahead. And look forward to sharing data from both programs in the upcoming months. Operator?

Operator

Thank you. That concludes today's call. You may now disconnect.