Gamida Cell Ltd.
Q4 2019 Earnings Call Transcript

Published: 25 Feb 2020

[Operator:]

Ladies and gentlemen, thank you for standing by. And welcome to the Gamida Cell Financial Results Conference Call for the Full Year 2019. My name is Sylvia, and I will your operator for today’s call.At this time all participants are in a listen-only mode. After the speaker’s 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, Miss Jaren Madden, Vice President of Investor Relations and Corporate Communications.Please go ahead.

[Jaren Madden:]

Thank you, Sylvia and good morning everyone. Welcome to today’s call during which we will provide an update on Gamida Cell and review our financial results for 2019. 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.With me on our call this morning is Julian Adams, Chief Executive Officer, Ronit Simantov, Chief Medical Officer, Shai Lankry, Chief Financial Officer and Tom Klima, Chief Commercial Officer. Following our 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 objectives, the therapeutic potential of our product candidates, our operational plans and strategies, projected operating expenses and cash runway.Our actual results may differ materially from what we project today due to a number of important factors, including the considerations described in the risk factors section of our Form 20F and in other filings that Gamida 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.Now I'd like to turn the call over to Julian.

[Julian Adams:]

Thank you Jaren, and thanks to everyone for taking the time to join us this morning. At Gamida Cell, we are committed to finding cures for patients with blood cancers, and rare serious hematologic diseases through the development of next-generation cell therapies.Our most advanced product candidate, omidubicel is in phase 3 development and could offer a lifesaving treatment option for patients in need of a bone marrow transplant. We are also developing GDA-201 our investigational, expanded natural killer or NK cell therapy with potential in both hematologic malignancies and solid tumors. 2019 was an important executional year for Gamida Cell. And today, I will highlight the substantial progress we have made advancing our programs and building our team.Turning first at omidubicel cell. In December, we completed patient enrolment in our Phase 3 study in patients with high risk hematologic malignancies. As we are nearly two months into this year, we are narrowing our guidance to expect to report top line data from the Phase 3 study in the second quarter of 2020.Positive data would enable us to submit a BLA for omidubicel with the FDA in the fourth quarter of 2020, and position us for potential approval and launch in 2021. We will use a common technical document for our regulatory filing, which enables us to streamline the work required to file a marketing authorization application or MAA for omidubicel in the EU next year.Omidubicel has orphan drug designation in the U.S. and Europe, and is the first bone marrow transplant product to receive breakthrough therapy designation from the FDA. The ability to bring omidubicel to patients broadly would represent a significant advancement in the field of stem cell transplants.We are also advancing key activities required to bring omidubicel to patients following potential FDA approval. Work is on-going to build out the manufacturing infrastructure both at Lonza and at our own facility to help ensure that we will have sufficient and reliable commercial supply. We are also working to develop comprehensive hospital services and paced assistance programs designed to seamlessly bring omidubicel to patients.Turning to GDA-201. We continue to be very pleased with the data from the Phase 1 investigator sponsored study in patients with non-Hodgkin lymphoma and multiple myeloma. Last December, we reported data at the American Society for Haematology or ASH, annual meeting and will provide a further update on GDA-201 at a medical meeting in the first half of this year.Based on multiple complete responses observed in heavily pre-treated patients with non-Hodgkin's lymphoma, we are focused on the activities required to submit an investigational new drug application to the FDA in the fourth quarter of this year.The IND will enable us to initiate a multi-center, multi-does Phase 1/2 clinical study in patients with non-Hodgkins lymphoma next year using our cryopreserved formulation.Both omidubicel and GDA-201 were creating using our proprietary NAM technology platform which is designed to enhance the number and functionality of our genetic donor cells. This represents an important advance because preserving therapeutic functionality has been a key limitation of prior approaches.Last week, at the transplantation and cellular therapy or TCT meeting, we presented preclinical data that reinforce our understanding of the mechanism of action underlying our NAM platform. The data suggests that NAM mimics the hypoxic environment in the bone marrow niche to preserve the function and long term engraftment ability of stem cells.These data provide scientific rationale for favorable engraftment and patient outcomes observed in the previously reported Phase 1/2 clinical study of omidubicel. We are continuing to study the NAM mechanism of action for omidubicel to characterize the biochemical events during the expansion process, and we are initiating similar mechanism of action studies with GDA-201.Over the past year, we made key several appointments several key appointments with the management team to add depth and expertise as well as to establish new functions. During 2019, Tom Klima joined us as Chief Commercial Officer and Tracey Lodie joined us Chief Scientific Officer.Last month, we appointed Jas Uppal, as Chief Regulatory and Quality Officer. She previously worked at Ipsen, Karyopharm and Biogen and has been instrumental in developing and executing global regulatory strategy for multiple products in oncology and rare diseases. Her experience is already making a positive impact on our Plan BLA submission.I'll now turn the call over to Ronit Simantov, our Chief Medical Officer to provide a further update on omidubicel and GDA-201. Ronit?

[Ronit Simantov:]

Thank you, Julian. And good morning everyone. Our most important clinical milestone this year is reporting data from our Phase 3 study of omidubicel. As a reminder, this trial is designed to evaluate the safety and efficacy of omidubicel compared to standard umbilical cord blood for allogeneic bone marrow transplant in approximately 120 patients.Gamida Cell is the first company to conduct a global randomized Phase 3 study for a novel bone marrow transplant graft, and the completion of patient enrolment in the study was a significant accomplishment for us and for the bone marrow transplant community. We truly appreciate the participation and support from the patients and from the investigators who are helping to move the field forward.As Julian mentioned, we expect to report top line data via a press release in the second quarter of this year. The first read out will be focused on the primary endpoint comparing the time to neutrophil engraftment in the two arms. The study is well powered to detect a difference of seven days, which would be a clinically meaningful treatment effect.Additional study endpoints we’ll read out after the neutrophil engraftment analysis. Therefore we anticipate reporting the study results at a medical meeting in the second half of the year. Positive data from this study will reinforce our belief that omidubicel can provide a potentially curative treatment option to patients who currently have no available donor and potentially improve outcomes for any patient who needs a transplant.We're also evaluating omidubicel in an investigator sponsored Phase 1/2 study in patients with severe Aplastic Anemia, a rare and life threatening blood disorder. Last year, we completed the first cohort of the study, which showed that all three patients treated successfully underwent a bone marrow transplant consisting of omidubicel plus a haploidentical stem cell graft.Currently, patients are being enrolled into the second cohort, which is designed to evaluate omidubicel as a standalone graft. We expect to report additional data from this study in the second half of the year. We're also continuing to advance our second cell therapy program, GDA-201, a natural killer based therapy. Natural Killer and K-cells have potent anti tumor properties. The tumor killing activity of NK cells is greatly enhanced by antibodies that recognize tumor cells, which trigger Antibody-Dependent Cellular Cytotoxicity or ADCC.The binding of an antibody to a cell market for destruction, by activated NK cells. In the past, a key limitation to the therapeutic utility of NK cells has been the ability to generate sufficient numbers of highly functional cells and culture. We are using our NAM technology to potentially overcome this limitation.The on-going Phase 1 study was designed to assess the safety of three increasing doses of GDA-201 in combination with monoclonal antibody and to determine the recommended Phase 2 dose. The trials being conducted by Dr. Veronica Bachanova at the University of Minnesota. We've already achieved our Phase 1 objectives, and as additional patients are enrolled, we continue to be very encouraged by the safety and activity observed.We most recently reported data from this study in an oral presentation at the American Society of Haematology or ASH meeting, which included data from 22 patients, nine patients with non-Hodgkin's lymphoma and 13 patients with multiple myeloma.Since most of the responses observed to date are in patients with lymphoma, I will focus my comments on those patients. At ASH, we reported clinical activity at all doses evaluated, which is particularly encouraging to see in a population of heavily pre-treated patients with advanced disease.Among nine patients with non-Hodgkin's lymphoma, there were five complete responses among patients who were treated with a single dose of GDA-201. There was also a patient with partial response after 1 dose, who was re-treated with an additional infusion without lympho depletion. This patient subsequently achieved a complete response. So in all, there were six complete responses out of nine patients.Of interest, one of these patients with a history of CLL and Richter transformation had a tumor that continued to shrink over approximately 10 months post therapy before becoming a complete response. This is clinically and scientifically very interesting, because it suggests that GDA-201 elicit and adapted immune response.We also continue to be pleased with the safety profile of GDA-201. There were no dose limiting toxicities in our experience, no GvHD, no tumor lysis syndrome, and strikingly no neuro toxicity has been observed.In summary, we think this is highly compelling data for first in-human study. We're focused on the activities required to enable an IND submission in the fourth quarter, which includes GMP scale up of our cryo preserved formulation. Simultaneously, we are working on key strategic and operational activities to enable the initiation of a multicentered, multidose Phase 1/2 study in patients with lymphoma next year.With that, I will turn the call over to Shai to review our financial results.

[Shai Lankry:]

Thank you, Ronit and good morning everyone. This morning, I will review our 2019 full year financial results. As of December 31, 2019 we had total cash, cash equivalent and available for sale securities of $55.4 million compared to $60.7 million as of December 31, 2018.As a reminder, we completed the following offering last July with total gross proceeds of $40.3 million. Research and development expenses for the year were $31.5 million compared to $22 million for the same period in 2018.The increase was mainly due to clinical activities relating to the advancements of omidubicel and GDA-201 programs as well as additional headcount; we can [Indiscernible] the organization.The commercial organization was established in 2019, and the total commercial expenses for the year were $4.7 million. These expenses were mainly due to a $2.4 million of cash and non-cash expenses related to hiring and establishing the commercial organization, as well as $2.3 million related to professional services and other expenses.General and administrative expenses were $12.1 million for the year, compared to $11.6 million in 2018. The increase was mainly due to a $1.3 million increase in rent and other expenses, as well as $1 million increase in professional services expenses, associated with being a publicly traded company offset by $1.8 million decrease related to establishing the commercial expenses line item in our P&L.Net finance income was $13.8 million for the year, compared to net finance expense of $19.2 million in 2018. The increase was primarily due to non-cash income resulting from re-valuation of warrants, offset by non-cash expenses from the Israeli Innovation Authority royalty-bearing grant liability and the implementation of the new IFRS 16 accounting standards.Net loss for the year was $34.4 million compared to a net loss of $52.9 million in 2018. We expect to report top line data from the Phase 3 study of omidubicel in the second quarter. Positive data would trigger additional activities in the second half of the year, including additional clinical studies to board into potential of omidubicel and activities to support the commercial readiness. Therefore today, we are providing financial guidance for the operating expenses for the first six months of the year, which expect to range from $30 million to $35 million.In addition, we anticipate that our current total cash position will support our on-going operating activities into the fourth quarter of this year. This cash run rate guidance is based on our current operational plans, including the assumption that we'll continue to advance both our commercial readiness and/or our clinical programs and exclude any additional funding that may be received or business [ph] development activities that may be undertaken.With that, I will turn the call back over to Julian.

[Julian Adams:]

Thanks, Shai. I will conclude, thanks Shai. I will conclude by reviewing our anticipated milestones for 2020, which are as follows. One, report top line omidubicel data from the second quarter. Two, present the Phase 3 omidubicel data at a medical meeting in the second half of the year. Three, assuming positive data submit BLA for omidubicel in the fourth quarter, four, report additional omidubicel data from the Phase 1/2 study in patients with severe aplastic anemia in the second half of the year. Five, present additional GDA-201 data in the first half of the year. And finally, six, file the IND for GDA-201 in the fourth quarter.2020 has the potential to be a transformational year for the company. And we are very focused on the activities required to deliver on our milestones, which we hope will drive value for shareholders. We have a strong team in place committed to delivering the next generation of cell therapies to patients, and we look forward to providing updates on our progress.Now we will open the call for questions. Operator?

[Operator:]

[Operator Instructions].And your first question comes from the line of Jason Butler from JMP Securities.

[Jason Butler:]

Hi. Thanks for taking the questions and congrats on the progress. Just a couple on omidubicel Phase 3 readout. I just want to clarify; you mentioned earlier that the top line release will focus on the primary end point. What -- will we get any secondary endpoints in the top line release and safety data or will it just be the primary endpoint? And then from the BLA submission perspective, beyond the clinical section of the BLA, are there any other kind gating item to other components for example CMC that we should be aware of? And then I have a follow up on the commercial readiness.

[Julian Adams:]

Okay. Let me direct the first part of your question to Ronit to talk about the endpoints.

[Ronit Simantov:]

Sure. Thanks for the question. So the top line data, the primary endpoint results is the time to neutrophil engraftment, which is an objective and rapidly reading out endpoint. And we built that analysis in, so that we could report data from the study quickly and get a real read on what's important.So that announcement will have that top line data as well as some basic demographics and sort of steady numbers, but won't contain any of the other endpoints which will take longer to mature and read out. And at the time that we presented the full data set we'll have those other endpoints and the rest of it.

[Julian Adams:]

And Jason with regards to the BLA, its important maybe to note that there are three important sections to the BLA. One is the clinical section, which is of course ongoing, and we need to finalize clinical study report to submit to the BLA, that will happen in the fourth quarter. The non-clinical section is virtually complete. And finally the CMC section of the BLA is ongoing and the expectation is that we will be preapproval inspection ready contemporaneously with filing the BLA. So the FDA will need to inspect the site, and the manufacturing site for the BLA to be accepted.

[Jason Butler:]

Great. Very helpful, thanks Julian. And then just on the commercial side, can you talk about where you believe awareness today in key transplant centers in the U.S. is with omidubicel and the company, and the work you're doing to continue to build awareness throughout 2020 and in anticipation of a launch?

[Julian Adams:]

Yes. I'll ask Tom to answer that question.

[Thomas Klima:]

Yes, hi good morning, Jason. Tom Klima. The -- I think we've discussed this before, but the opportunity for omidubicel patients is relatively concentrated to about 70 transplant centers in the United States. So just to remind you about 80% of the opportunity is concentrated in 70 transplant centers. We were in a good portion of those in the clinical trials, so we already have existing relationships and awareness. We are also working on disease state and unmet need educational campaigns as well as expanding our awareness throughout 2020 in addition to completing some of the foundational market research so that we continue to fine tune our understanding and finding our internal projections.

[Jason Butler:]

Great. Thanks for taking the question.

[Operator:]

Your next question comes from the line of Gregory Renza from RBC Capital Markets.

[Gregory Renza:]

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

[Julian Adams:]

Our pleasure.

[Gregory Renza:]

Thank you. I just want to turn Julian, just back to the end point and expectations on the omidubicel top line readout, and perhaps run if you could just perhaps provide just additional context and color on the clinical meaning from the translation of time to neutrophil engraftment and how that how that can be a benefit and perhaps any specific benchmarks in the marketplace that you're looking at or that we should keep in mind, and I think if I heard correctly, that your mention of detecting a difference of seven days that with that read out? Thank you.

[Julian Adams:]

Ronit.

[Ronit Simantov:]

I'll go ahead and do. Yes, thanks. I'll go ahead and do that. So neutrophil engraftment represents the time it takes for the neutrophils or the infection fighting cells to grow again or to be back into circulation after they've been obliterated by the very harsh conditioning chemotherapy that patients get to cure their leukemia or lymphoma. And every day that a patient has very very low neutrophils, is the day that they can get serious life threatening infections and other complications.And so every day that they have where they're not neutropenic or where their cells have grown back, is another day that they can have a healthier immune system and potentially leave the hospital. So for -- our impression of the clinical significance of this is that, saving patients days of neutropenia will save them days of infection, save them days in the hospital, save them other complications that are associated with neutropenia. And this is something that's supported by the bone marrow transplant community that for years has been fighting for improvements in neutropenia time points for patients.Most neutrophil engraftment with therapies such as sibling or unrelated donors takes place within a couple of weeks after transplant. We've seen numbers like 16 to 18 days, sometimes sooner in children. But the vocal cord transplant classically and historically has had much longer times neutrophil engraftment and taking three weeks or more. And that's been a real source of complications in patients who have cord blood graft.And even improving upon the 16 to 18 days for patients with any transplant would be an opportunity to improve the time that the patient has with less complications such as infection, less time, meeting very expensive medications and less time in the hospital at all.In terms of what we're looking for, for a difference, we're with 120 patients or so, we are very well powered to detect the clinically meaningful difference. We think of clinically meaningful difference of about a week of would make a difference in the value proposition and in sort of the way that the patients clinically feel and do and the impact of the system. So that's why I mentioned the seven day difference. That's something that I think would be useful. But, really every single day of less neutropenia is important to patients and has potential real, incredibly meaningful implications.

[Gregory Renza:]

Great. Thank you. That's very helpful. And just one more from me. Just with respect to the Phase 3 and how that's progressed, you certainly met all your timelines, enrollment has been at a satisfactory pace. I'm just curious, do you have any comment during what you've learned, so obviously short of the data read out that's pending, but what you've learned about the potential commercial utility the commercial and practice and patient reception of a product profile such as omidubicel from the experiences with the approval that's been underway for some time now. Thank you very much.

[Julian Adams:]

Ronit, maybe you can start the beginning of that answer and then Tom, I’d ask you to also comment.

[Ronit Simantov:]

Absolutely. So conducting clinical trial globally at over 50 sites, has really given us the opportunity to engage with some fantastic transplant centers, investigators and all of their staff on a -- on a very intense and personal basis. So we've really been inside all of these centers, teaching them, working with them, going through things with them, and then engaging with them over the past year or two. So it's been a great opportunity to learn about the centers, and to learn about the practices, as well as to have them learn about Gamida Cell and about omidubicel. And that's really taught us a lot, Tom.

[Thomas Klima:]

Oh sorry, I'm sorry – Ronit, I thought you were done. Greg, just add to that, we've been doing market researches as we've shared in the past in the transplant centers both in the United States and outside the United States. And we're pleasantly continued to be pleasantly surprised that the response to the omidubicel target product profile has been very well received.And if you remember the transplant community and the transplants being done today, there's a significant amount of unmet need both in terms of patients who never make it to transplant for whatever reason, but also in some of the current existing modalities in some of the shortcomings. So when we show a target product profile to physicians, they're telling us that they're excited about it. They're telling us that they'll use it. And they're telling us that not only will they get more patients to transplant that they would use it in place of some of the other modalities.

[Julian Adams:]

In addition I'd like to add that, on the patient advocacy side, we've formed a strategic relationship with “Be The Match” which is the governing body that helps patients get matched for transplant. And so we are working very closely with them to coordinate the ability to source umbilical cord blood from which we expand the stem cells for patients.So at every level, both from the physicians, the patient advocates and other work ongoing, we are creating an enhanced awareness. And obviously, this will all be more poignant, when we have the primary endpoint.

[Gregory Renza:]

Great. Thank you very much for taking the question.

[Operator:]

Your next question comes from the line of Matthew Luchini from BMO Capital.

[Matthew Luchini:]

Hi, good morning guys. Thanks for taking the questions and congrats on the continued progress. A couple from me. So first, I guess thinking about the target population we've heard some color around awareness and target centers. But I guess, as we think about the actual population, we know the study has been run in the core by population but there's also a potential for the broader transplant population. So I'm just wondering how from a -- how we should be thinking about the label, and what might come out of that such that you could address that bigger population?And then secondly on reimbursement, I think probably the expectation is that this could be that omidubicel will be reimbursed similar to CAR-T. So just was curious how we should be thinking about reimbursement dynamics here?And then lastly, on 201, we've talked about in the past about prior preservation being a key step to enabling the multi-dose, multi-center study and I just was hoping to get a little bit more color on where things stand in terms of ability to cropreserve product? Thank you.

[Julian Adams:]

Okay, Ronit, can you comment on the real world data study we're doing as well looking at other modalities of transplant?

[Ronit Simantov:]

Yes, absolutely. So one of the ways that we can address the broader transplant population is through our collaboration with the Center for International Blood and Marrow Transplant Research, CIBMTR where we're doing a concurrent real world data study concurrent to the population that's in our Phase 3 study. And collecting data on other transplant modalities so that we can place our results in the context of patients and other transplant today, so that will help us kind of build the message around where omidubicel fits in -- in terms of the broader transplant population.

[Julian Adams:]

And earlier, Ronit commented on this, and this was also presented at the recent TCT meeting by cord blood connect, that all other modalities whether it's matched unrelated donors or Haploidentical donors engraphed between 16 days and 19 days, cord blood itself is on average around 20 days to 25 days. So we believe that omidubicel may be best-in-class in terms of a transplant graft. Again, we are awaiting the data to demonstrate that.

[Thomas Klima:]

And then, this is Tom, just to add to and answer your question around reimbursement. There are some, I think similarities to how we believe that omidubicel will be reimbursed similar to CAR-T and that it will likely be reimbursed through a carve out mechanism. So payers would likely pay for not only the transplant, but then also pay for the product through a carve out mechanism. The main difference to know between omidubicel and CAR-T is that with I would just speak about omidubicel.Based on our patient demographic center in our study, we believe that the pair mix will be about 70% commercial payers roughly, and 30% all other. One of the challenges that the CAR-T have faced is that they had a much larger Medicare and Medicaid population, and as you know the entire process takes a little bit longer than some of the commercial processes do. But we're confident that it will be reimbursed and believe that it'll be reimbursed the [Indiscernible] mechanism.

[Julian Adams:]

And lastly, let me comment on GDA-201 manufacturing. We did it. We have announced that we've successfully learned how to cryo preserve and saw the cells with very good recovery. About 80% recovery, but we still need to optimize and get this into a GMP format, and do both engineering runs, and qualification runs prior to filing an IND. So that's going to take us much of the remainder of this year to enable an IND filing that will be an off the shelf cryo preserved product to be able to have a multicentre, multidose approach.

[Matthew Luchini:]

Great, thanks. And just quickly yes, no clarification question. When the Phase 3 data are press released in top line format. Are we going to be getting safety information as well or is it only going to be the primary efficacy standpoint? Thanks.

[Julian Adams:]

Ronit, can you reiterate what we’re going to announce?

[Ronit Simantov:]

Sure, there'll be no detailed safety information. There may be a broad statement about safety based on sort of the overall look, but no detailed safety information at that point.

[Julian Adams:]

And I would just remind you and the audience that we have had external data safety monitoring board throughout the study and they get data every month, and they meet on a bi annual basis, and we have had no safety signals that are concerning to date.

[Matthew Luchini:]

Okay. Thank you for taking all the questions.

[Operator:]

Your next question comes from the line of Chad Messer from Needham & Company.

[Chad Messer:]

Great. Good morning and thanks for taking my questions. Maybe we can just start with 201 in terms of the upcoming additional data that we're going to get, wondering if you can share what we should expect in terms of the amount of data. Obviously, more follow up which is important but are they going to potentially be more NHL patients treated? And is the protocol written in a way that it's possible we would see additional patients with re treatment?

[Julian Adams:]

Ronit, would you like to handle that as well.

[Ronit Simantov:]

Yes, happy to take that. Thanks, Chad. So, the additional -- there will be additional patients and additional follow up in the next data update. And there is, yes the protocol is has been amended to allow for re treatment under certain conditions. And so there will be more data on patients, who have been re treated as well.

[Chad Messer:]

All right. Very exciting. Looking forward to that. And then maybe a couple on the omidubicel sort of commercial preparedness. I know, you've made several comments on that already, but do you have specific goals in terms of what throughput you'd like to have at the at the time of launch for manufacturing. You've got in-house on Lonza and what's your view of the state of the availability? I know you've got a partnership with Be-The Match but the availability of getting cord blood that match for most of your patients?

[Julian Adams:]

So in the launch year, we have more than enough supply and this will be an on-going education process, since cord blood supply is critical to our success. I will remind you that there are about four million babies born every year in the United States. So I think cord blood supply will not be limiting. And we are still doing market research to better quantify the uptake in the launch here, but have projections out to multiple thousands of transplants between these years three to five. So we were scaling up accordingly.

[Chad Messer:]

All right. Great. Thank you.

[Operator:]

[Operator Instructions] Your next question comes from the line of Mark Breidenbach from Oppenheimer.

[Mark Breidenbach:]

Hey, good morning. And thanks for taking the questions. So over the weekend at TCT, we saw a fairly large trial results from a randomized study of double cord blood versus haploid transplant, and that certainly seem to favor the haploid transplant arm, especially in terms of overall survival.So I'm wondering, if you can just give us an overview of why you think is the goal of the omidubicel simply to reduce -- enough to you’ve raised any potential survival advantage for when transplanting with omidubicel and I'm also wondering if you have any plans to do a post approval randomized trial versus haploid once omidubicel is approved?

[Julian Adams:]

So let me just begin. The trial you referring to the CTN-1101 trial, which was a cooperative group study used reduced intensity conditioning, so I think it's impossible to compare it -- those patients to the patients in our current study. Ronit, do you have any further comments analyzing these having seen this presentation?

[Ronit Simantov:]

Yes, I think that's the key point. Reduced intensity conditioning is not any longer considered appropriate conditioning for most robust healthy adults who are getting a transplant. It may be appropriate for the older or frail population, but not for the group of adults that was included in this study. So for that reason it is a bit hard to interpret these without -- these results also included double core transplant, the very different type of transplant than we're doing. We're using a single unit of omidubicel rather than a double cord transplant for the patient.So I think, I think the results were instructive in terms of sort of giving us some benchmarks about what the issues are. And what's interesting in terms of treatment related mortality, and I think that yes, our results of our Phase 2 study did show that achievement related mortality will decrease in patients who got omidubicel compared to historical controls who got standard core. So we anticipate that if the Phase 3 results recapitulate the Phase 2, then we'll observe that as well. And that certainly will have an important clinical impact on patients.And we're looking forward to seeing the rest of the results and putting them into context with the results that we see in their field.

[Mark Breidenbach:]

Okay, so you’re not seeing a need to maybe run a randomized trial versus half of them.

[Julian Adams:]

So let me comment on that. There are -- first of all I think Haploidentical transplant is a perfectly legitimate approach. If you have a haploid donor. However about 25% of patients getting haploid transplants are over the age of 50 and they are suboptimal donors. We think that at least that portion of the population should probably not get a haploid. They have worse outcomes. And with regards to doing additional randomized studies, I think the real world data will teach us a lot about where omidubicel fits in the treatment paradigm. So we currently, we do not have a plan to do a post approval randomized trial with haplo.

[Mark Breidenbach:]

Okay. Got it. Just a quick one on GDA-201 and your upcoming company sponsored trial. Can we safely assume that you'll be focusing on the same NHL subtypes that were enrolling in Dr. Bachanova study or we're going to be seeing more follicular lymphoma in tDLBCL patients or will it be open to other flavors of NHL? And I'm curious if you'll be allowing patients who respond to then go on to receive a transplant post response?

[Julian Adams:]

Well 90% of patients with lymphoma are either of the follicular or tDLBCL the largest population. There are rare types of lymphoma, MALT and mediastinal and Mantle cell. We haven't designed the study yet, and we will be meeting with KOLs and will -- as the year progresses, we will make those decisions at a future time.

[Mark Breidenbach:]

All right. Thank you for taking your questions.

[Operator:]

And at this time, I show no further questions. I will now turn the call back to Julian.

[Julian Adams:]

So thank you everyone for joining us on today's call. We are really excited about the opportunities that lie ahead, and look forward to sharing updates on our progress throughout the year. Operator?

[Operator:]

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