Gamida Cell Ltd (GMDA) 2019 Q4 法說會逐字稿

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 be your operator for today's call. (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.

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.gamidacell.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'll 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 20-F 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.

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 to omidubicel, 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 topline 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 US 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 transplant.

We are also advancing key activities required to bring omidubicel to patients following potential FDA approval. Work is ongoing 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 Hematology, 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 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-dose Phase 1/2 clinical study in patients with non-Hodgkin lymphoma next year using our cryopreserved formulation. Both omidubicel and GDA-201 were created using our proprietary NAM technology platform which is designed to enhance the number and functionality of allogeneic donor cells. This represents an important advance because preserving therapeutic functionality has been a key limitation of prior approaches.

Last week, at the Transplantation & 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 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 as 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 planned 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?

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 topline data via a press release in the second quarter of this year. The first readout will be focused on the primary endpoint, comparing the time to neutrophil engraftment in the two arms. The study is well powered to detect a difference of seven days, which would be a clinically meaningful treatment effect. Additional study endpoints will read out after the neutrophil engraftment analysis. Therefore, we anticipate reporting the study results at a medical meeting in the second half 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 NK cells have potent anti-tumor properties. The tumor killing activity of NK cells is greatly enhanced by antibodies that recognize tumor cells, which trigger antibody-dependent cellular cytotoxicity, or ADCC.

The binding of an antibody to a cell marks it for destruction by activated NK cells. In the past, a key limitation to the therapeutic utility of NK cells has been the ability to generate sufficient numbers of highly functional cells and culture. We are using our NAM technology to potentially overcome this limitation.

The ongoing 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. Veronika 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 Hematology -- 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 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 lymphodepletion. 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 elicits an adaptive 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 neurotoxicity has been observed.

In summary, we think this is highly compelling data for a 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 cryopreserved formulation. Simultaneously, we are working on key strategic and operational activities to enable the initiation of a multi-center, multi-dose 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.

Thank you, Ronit and good morning, everyone. This morning, I will review our 2019 full year financial results. As of December 31st, 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 a follow-on 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 within the R&D organization. The commercial organization was established in 2019, and the total commercial expenses for the year were $4.7 million. These expenses were mainly due to a $2.4 million 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 revaluation 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.

As you know, we expect to report topline 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 broaden the 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 ongoing 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 all our clinical programs and exclude any additional funding that may be received or business development activities that may be undertaken.

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

Thanks, Shai. I will conclude by reviewing our anticipated milestones for 2020, which are as follows. One, report topline omidubicel data in this 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 the 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?

Thank you, ladies and gentlemen. (Operator Instructions). Jason Butler, JMP Securities.

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 topline release will focus on the primary endpoint. Will we get any secondary endpoints in the topline 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 time-gating items to other components -- for example, CMC -- that we should be aware of? And then I have a follow-up on the commercial readiness.

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

Sure. Thanks for the question. So, the topline 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 topline data as well as some basic demographics and sort of study 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 present the full data set, we'll have those other endpoints and the rest of it.

And Jason, with regards to the BLA, it's 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 a final 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 -- the manufacturing site for the BLA to be accepted.

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 US is with omidubicel and the company, and the work you're doing to continue to build awareness throughout 2020 in anticipation of a launch?

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

Hey, good morning, Jason. Tom Klima. 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 fine tune our internal projections.

Great. Thanks for taking the question.

Gregory Renza, RBC Capital Markets.

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

Our pleasure.

Thank you. I just want to turn, Julian, just back to the endpoint and expectations on the omidubicel topline readout. And perhaps, Ronit, 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 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 with that read out. Thank you.

Ronit?

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 a 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, 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 umbilical cord transplant, classically and historically, has had much longer times to neutrophil engraftment, 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 needing very expensive medications, and less time in the hospital at all.

In terms of what we're looking for a difference, we're -- with 120 patients or so, we are very well powered to detect the clinically meaningful difference. We think a clinically meaningful difference of about a week would make a difference in the value proposition and in sort of the way that the patients clinically feel [and do and] the impact to 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.

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 commentary on what you've learned -- so, obviously, short of the data readout 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's from the experiences with the [pivotal] that's been underway for some time now. Thank you very much.

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

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 very intense and personal basis. We've really been inside all of these centers, teaching them, working with them, going through things with them, and 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?

Greg, just add to that, we've been doing market research, 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 -- continuing 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, but they would use it in place of some of the other modalities.

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.

Great. Thank you very much for taking the question.

Matthew Luchini, BMO Capital.

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 is being run in the cord blood population but there's also a potential for the broader transplant population. So, I'm just wondering 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 in the past about cryopreservation 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 cryopreserve product. Thank you.

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

Yes, absolutely. So, one of the ways that we can address the broader transplant population is through our collaboration with the Center for International Bone 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 modalities. But that will help us kind of build the message around where omidubicel fits in, in terms of the broader transplant population.

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.

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 Ts in 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 note between omidubicel and CAR Ts is that with -- I'll just speak about omidubicel. Based on our patient demographic center in our study, we believe that the payer mix will be about 70% commercial payers, roughly, and 30% all other. One of the challenges that the CAR Ts have faced is that they had a much larger Medicare and Medicaid population. And, as you know, the NTAP 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 through a carve-out mechanism.

And lastly, let me comment on GDA-201 manufacturing. We did -- we have announced that we've successfully learned how to cryopreserve 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, cryopreserved product to be able to have a multi-center, multi-dose approach.

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

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

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

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 biannual basis. And we have had no safety signals that are concerning, to date.

Okay. Thank you for taking all the questions.

Chad Messer, Needham & Company.

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 there 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 retreatment?

Ronit, would you like to handle that, as well?

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 has been amended to allow for retreatment under certain conditions. And so there will be more data on patients who have been retreated as well.

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 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 bloods that match for most of your patients?

So, in the launch year, we have more than enough supply, and this will be an ongoing education process, since cord blood supply is critical to our success. I will remind you that there are about 4 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 year, but have projections out to multiple thousands of transplants between years three to five. So, we're scaling up accordingly.

All right. Great. Thank you.

(Operator Instructions) Mark Breidenbach, Oppenheimer.

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 haplo transplant. And that study seemed to favor the haplo 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 with omidubicel simply to reduce TRM enough to erase 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 haplo, once omidubicel is approved?

So, let me just begin. The trial you are referring to -- the CTN-1101 trial, which was a cooperative group study -- used reduced intensity conditioning, so I think it's impossible to compare those patients to the patients in our current study.

Ronit, do you have any further comments analyzing these -- having seen this presentation?

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 results. These results also included double core transplants. It's a 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 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 treatment-related mortality will decrease in patients who got omidubicel compared to historical controls who got standard cord.

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 the field.

Okay, so you're not seeing a need to maybe run a randomized trial versus haplo, then.

So let me comment on that. There are -- first of all, I think haploidentical transplant is a perfectly legitimate approach, if you have a haplo donor. However, about 25% of patients getting haplo 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 haplo. They have worse outcomes.

And with regards doing additional randomized studies, I think the real-world data will teach us a lot about where omidubicel fits in the treatment paradigm. So, currently, we do not have a plan to do a post-approval randomized trial with haplo.

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's study? Or are we going to be seeing more follicular lymphoma in DLBCL 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.

Well, 90% of patients with lymphoma are either of the follicular or DLBCL, 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.

All right. Thank you for taking the questions.

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

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?

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