Q1 2021 Gamida Cell Ltd Earnings Call
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Joe to begin shortly for you.
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Again, ladies and gentlemen, this is the operator speaking at a conference is scheduled to begin shortly discontinue the standby and we thank you for your patience.
[music].
Ladies and gentlemen, thank you for standing by Walgreens, The Gametothallus conference call for the first quarter 2021 financial results.
My name is Judy and I'll be your operator for today's call.
Please be advised of the beach call is being recorded at the meet yourself request.
Now I would like to introduce your host for today's conference Mr. Josh Hammer Nash Chief Business Officer. Please go ahead.
Thank you Louis 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 first quarter of 2021 earlier. This morning, we issued a press release summarizing our financial results and progress across the company, which is available on our website at.
Of the U W thought commute of cell dotcom here.
Here with me on the call today are Julian Adams, Chief Executive Officer, Michele <unk>, our Chief operating Officer, and Chief Commercial Officer, and Shively inquiry Chief commercial officer.
The mentor, our Chief Medical Officer, and Tracy Loady Chief Scientific Officer are also on hand for the question and answer of portion of the call following our prepared remarks.
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.
For a number of important factors, including the considerations described in the risk factors section of our form 20-F and in other filings that could meet the 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 now I'd like to turn the call over to Julian.
Thank you Josh.
Thanks to everyone for joining us this morning.
Those of you who've been following our progress no. The gamete of cell is approaching a major inflection point in the company's history as we approach a BLA submission later this year and prepare for the potential product launch what could be the first ever FDA approved bone marrow transplant graft.
Product for blood cancer patients can need of the stem cell transplant.
At the gamete of cell, we are dedicated to advancing to cell therapy programs that leverage our proprietary nan cell expansion platform.
With the potential to redefine standard of care for patients with the blood cancers and serious hematologic disorders.
This platform continues to demonstrate compelling results in clinical trials based on critical features such as cell expansion functionality and safety all leading to improved patient outcomes.
2021 has gotten off to a strong start marked by continued progress across our pipeline towards key milestones.
We continue to be encouraged by the clinical profile of our product candidates on the.
<unk> cell and GDA 201.
Oh Madhu the cell has the potential to transform medical practice for patients with hematologic malignancies and be the first FDA approved cell therapy for bone marrow transplant.
Commercial preparations are ongoing as we work towards submitting the BLA in the fourth quarter of 2021.
Our second candidate in clinical development is GDA 201.
And advanced cell therapy that utilizes our nam cell expansion technology to harness the power of the innate immune system and has demonstrated remarkable results in patients with non Hodgkin lymphoma, specifically follicular lymphoma, and diffuse large b cell lymphoma histology.
This past quarter, we continued to make progress towards the production of a cryopreserved product to support a multicenter phase one two trial later this year.
Additionally, we are excited about the progress we are making in our R&D activities to pursue the development of genetically modified Nam expanded NK cells.
This morning, we will review both programs and summarize our progress around plans to bring home of Duke of South of the patients in the commercial setting pending pending FDA approval.
Let me share more details for huge starting with our lead program <unk>, which as a reminder has FDA breakthrough therapy designation as well as orphan drug status.
Our successful phase III trial demonstrated.
Meeting, both primary and secondary endpoints that AUM of DUBA salad dresses, a key unmet need for patients in need of of bone marrow transplant by expanding the CD 34 positive stem cells, and creating a suitable dose of highly functional cells.
We are on track to submit the BLA for them of Dubai cell to the FDA in the fourth quarter of this year and meet the anticipated commercial supply needs.
As we continue to advance <unk> cell for a potential launch and prepare to become a commercial organization. We have taken important steps to establish key commercial capabilities, including the creation of gamete of cell assist.
The program designed to support a positive patient and transplant center experience.
The Michelle will elaborate further on this effort.
Moving to the rest of our pipeline we are thrilled by the emerging profile of GDA two of one our first lead candidate from our Nam expanded NK cell program.
Natural killer cells are innate immune cells that hold tremendous promise as an approach for treating cancer.
By leveraging our Nam technology to expand the NK cells derived from healthy adult donors.
Enhancing the functionality, we believe GDA 201 improves NK cells direct tumor cell, killing as well as antibody dependent cellular cytotoxicity known as a BCC.
And the phase one trial GDA 201 demonstrated impressive proof of concept and striking early signs of efficacy with multiple durable complete responses, while being very well tolerated in heavily pretreated patients with relapsed or refractory lymphoma.
The study was designed to assess the safety of GDA 201 in combination with Rituxan in non Hodgkin lymphoma.
As a result of these encouraging data we developed a GMP cryopreserved formulation and have initiated manufacturing runs in preparation for a multicenter study with an off the shelf allogeneic cell therapy in patients with lymphoma.
Based on the significant clinical activity, we've seen so far in the phase one trial, we put we plan to submit an IND for GDA 201 in the second half of this year to enable our phase one two study in lymphoma patients with Follicular lymphoma diffuse large b cell lymphoma.
Additionally, we are maximizing the potential of our NAV technology platform to develop a pipeline of gene edited NK cell therapies with enhanced function for both hematological malignancies and solid tumors.
I want to conclude my introductory remarks by thanking our employees for their hard work and dedication and I continue to be impressed by the progress we are making.
Bring potentially life saving therapies to patients.
I'll now turn the call over to Michele <unk>, our Chief operating Officer, and Chief Commercial Officer, who will talk more about our launch readiness for AUM of do Michelle Michelle.
Thank you Julian and good morning, everyone. Today, I will review our progress on our manufacturing and launch readiness activities as we continue to advance our of breakthrough therapy arm of deep itself for patients in need of an allogeneic stem cell transplant.
During the our type B meeting with the FDA in December 2020, we received clear feedback on what will be required for our commercial manufacturing facilities to be ready for BLA submission. This includes our the meat of cell owned facility in Israel and the commercial facility for which we have a contractual relationship with lots of them.
Given that neither of these commercial facilities were used for the phase III I'm going to the self registration trial, we need to demonstrate comparability from these commercial facilities with the clinical manufacturing supply.
We've made important progress preparing both of these facilities for commercial manufacturing readiness.
Start with our state of the art Israeli facility.
The facility construction has been completed and our team has achieved each of our internal timeline milestones. Since construction was completed we have hired trained and qualified our initial production team.
During the first quarter of this year. Our team has successfully completed the required engineering runs in the septic process simulations for qualification. The methods validation are underway with the planned completion in the second quarter of 2021, and we anticipate finalizing our analytical comparability runs and process performance qualification.
Ron's or P P queues and third quarter of 'twenty one.
For the launch of a commercial facility. We are currently manufacturing clinical batches for our expanded access program and are progressing on the BLA requirements. We are currently on track for the CMC requirements for our BLA, which we plan to submit in the fourth quarter of 2021.
We believe that there is a significant opportunity with all of the deepest cell specifically in the U S. Market alone is there are over 40000 patients with hematologic malignancies, who consider transplant each year.
There are about 10000 patients who are actually transplanted and then unfortunately, there are almost 9000 patients who are eligible but not transplanted.
The extensive market research we've conducted has enabled us to develop a strong launch strategy.
Part of FDA approval of a deep of cell will be an important therapy option for patients in need of an allogeneic stem cell transplant.
Based on our market insights the opportunity from a deeper cell can be summarized in three categories first increasing access for patients who are eligible and not matched.
The second improving outcomes based on clinical needs with current donor sources and in addition, increasing eligibility based on the encouraging on the <unk> cell clinical profile.
Physician and payer feedback has been encouraging and not the other type of cell product profile based on clinical data is viewed positively and they understand the potential clinical advantages.
For specifically for payers payers are encouraged by the potential for faster time to neutrophil and graph net decreased infections decrease in hospitalizations and less graft versus host disease as compared to published literature for other grafts sources.
We also hear from physicians that each of the donor is a factor in the air consideration.
In partnership with CIB MTR, we have utilized real world data to demonstrate that of transplant donors were less than or equal to 30 years of age the patient had a statistically greater survival probability.
So for example in the case of related donors, if an AML patient is diagnosed at 16, which is the median age of diagnosis their family members, who could potentially be matched related or handful of identical donors would probably be above that 30 years of age.
Given the starting material from the <unk> cell is of belittle cord blood the donor he just not of concern.
Additionally, due to the less stringent genetic matching criteria from a day, but cell as compared to other donor sources on the deepest cell may provide the opportunity to expand access the bone marrow transplant for patients who otherwise could not find a suitable donor.
I'm Gonna do the cell if approved will be an important therapy option for patients in need of an allogeneic stem cell transplant. Our launch strategy goal is to ensure that patients and the transplant centers have a positive experience with them of deep itself following FDA approval.
Since the transplant center and caregivers.
Education of the transplant centers is an important aspect of our strategy. We know that 70 centers make up about 80% of the transplants in the United States. We have direct experience with 20 of those centers through our clinical trial and know many others from past professional experiences. We are confident that we will be able to.
Effectively partner with the centers to educate them on line Madhu the cell and we are working diligently with payers to ensure reimbursement upon FDA approval.
Outreach has already begun with U S payers and the discussions have been positive, including the recognition of the clinical data and the importance of the secondary endpoints such as reduced hospital time and reduced infections.
Additionally, we plan to build an outstanding team to support patients transplant centers and caregivers through the process.
As Julian mentioned, we are excited to continue our progress developing the meat of cell assist to provide assistance to ensure that positive and personalized patient experience. This is a program of like no other for patients undergoing a transplant.
The meat of cell assist will consist of a dedicated experienced team that will be focused on supporting the patient journey with them of do the cell.
Our gamete of cell assist team will consist of experienced case management team, who will be focused on ensuring patient access and provide support to patients their caregivers and the transplant team at the hospitals throughout each step of the process.
Can you just tell us this will have a number of key roles one of the most important roles as compliance with the Fda's chain of identity requirements. The meat of cell assist will start our chain of identity, which is a unique patient identifier that will follow the patient throughout the entire process. Just as importantly, gamete of cell assist is going to be that single point of cash.
Contact for the hospitals and patients.
As such we will be able to provide the hospitals and patients with the assistance to support access to I'm, a deep of cell such as benefits verification or travel and lodging beats for.
Amidah cell is committed to supporting a positive journey for patients in their transplant centers. So they can focus on what matters most of the patient experience and successful clinical outcomes.
We are excited by the potential of Ahmedou the cell to be the first FDA approved cell therapy for bone marrow transplant and we are encouraged by the clinical data and the feedback from physicians payers and patients. We have our of deepest felt launch strategy and plan in place with a key focus on assuring a P.
Positive patient and transplant center experience.
I will now turn the call over to Shai to review our financial results.
Thank you Michelle and good morning, everyone today, I will summarize our financial results for the first quarter of 2021.
As of March 31, 'twenty, 'twenty, one or the total cash position was $174 $8 million compared to $127 $2 million as of December 31st 2020.
The March 31st cash balance includes the $75 million from gross proceeds from our recent financing with Highbridge capital management the close this quarter.
Research and development expenses for the quarter was $11 $4 million compared to seven $9 million for the same period in 2020 the.
The increase was mainly due to only do be so commercial manufacturing readiness activities.
And the advancement of our of GDA, two of one program, including broadening our scientific capabilities and talent.
Commercial expenses in the quarter for $4 million compared to 1.5 came into loans for the same period last year the E.
It was mainly attributed to our progress.
So commercial readiness activity, which includes among other things the hiring of an experienced commercial leadership team.
General and administrative expenses for three $4 million for the first quarter of 2021 compared to $3 million for the same period in 2020. The increase was mainly due to the hiring of key management position to support the growth of our business.
Finance income net zero point $7 million for the quarter compared to finance income net of $1 $7 million in the same period last year the.
The decrease was primarily due to interest expenses following the recent $75 million financing and non cash expenses, resulting from revaluation of warrants from Israel innovation authority royalty bearing bluntly the league.
Net loss for the quarter was $18 million compared to a net loss of $10 $6 million for the same give me all of last year.
We continue to expect cash used for ongoing operating activities. This year the range from $110 million to $120 million and anticipate the recurring total cash flow machine will support our ongoing operating activities into the second half of next year and to achieve multiple important manufacturing commercial and regulatory milestones.
This cash runway guidance based on our current operational plan and excludes any additional funding the CB received or basically both of the activities that may be undertaken we did I will turn the call back over to Julien.
Thanks Shai.
We are dedicated to finding cures for patients with hematologic malignancies, and blood disorders, as well as solid tumors.
And we are excited about the opportunities ahead.
We could have not gotten this far without an accomplished team and I. Thank each of our employees for their unwavering dedication towards advancing potentially lifesaving therapies for cancer patients.
With all of Madhu, Michelle we expect to submit the BLA in the fourth quarter of this year and are committed to being launch ready at the time of approval.
With the GDA two of one we have very compelling data in lymphoma and are planning to initiate the gamete of cell sponsored clinical study, which could potentially support registration if the data are consistent with the phase one results.
2021 is already off to a strong start.
And who proved to be a transformational year for gamete of cell and all of its stakeholders. Most importantly patients in need of better treatment options.
In conclusion, we are very excited about the important achievements that can meet the cell will make in the second half of this year, including on the Dubai cell BLA submission and initiating the company sponsored phase <unk> study in non Hodgkin lymphoma.
We understand the importance of our work for cancer patients the healthcare system and society in general as.
As you've heard today the company is on a path to transform the way cellular therapies can treat patients with cancer.
We look forward to updating you on our progress throughout the year.
And now we will open the call for questions.
Operator.
Ladies and gentlemen.
To ask a question at this time simply press Star then the number one on the telephone keypad.
I guess that would be sort of line on your telephone keypad.
And our first question comes from the line of Ted can talk of Piper Sandler Your line is open.
Great. Thank you very much for my congrats from all of the progress.
What is sort of still being done for the BLA.
I'm, assuming you guys would anticipate the outcome.
Hum.
Just wanted to get a sense of your expectations around that thanks, so much.
So let.
Let me begin and thank you Ted for your for your question, obviously right now were.
Involved in two very distinct activities, one is making sure that our manufacturing.
Of cell therapies is.
The meeting all of the FDA requirements.
And we're going through all of the validation and qualification runs.
Both our site in Israel and.
Alonza.
Our second supplier.
And in addition, Michele outlined how she's building out the commercial team and can be the cell assist and services Mrs.
Michel I don't know if you want to add anything to that.
Yeah. Thank you Ted So I'll I'll take the the BLA question, and then I'll turn it back to either Julian aren't Rohit for for the response of the AD com. So in regards to the the BLA. We are finalizing the CMC requirements for the BLA at both the tier gotten alonza, we are making very nice progress to date in both air.
He is so at Atlanta, we have completed a number of the initiatives required at this point in time, where we're focused on manufacturing commercial batches for the a pea and then in the second third second and third quarter of this year, we will finalize the BLA requirements for Lancer and record secure got the team has.
The very nicely in first quarter, we completed engineering runs we completed a set of the process simulation. We're in the process of completing the method validation runs, which we had discussed after our type B meeting with FDA in December and then we will finalize and care of God I'm targeting by the roughly the end of third quarter of the analytical comparability.
<unk> and the P. P. Q run so to summarize we have made very nice progress year to day Apple of slander and of care got in terms of the CMC requirements for the BLA.
So with that let me turn it back to Julian or ruin need to answer your question regards to the outcome.
Roni. Please could you comment on any additional data, we might oh and the additional follow up from the phase III day.
Data and.
Our plans for sort of thing.
Thanks, Thanks, Kevin.
We will let you know a very important part of the BLA of course is the clinical aspects of the submission and we are preparing all of the clinical sections for submission. We expect additional follow up data on the patients in the phase three study.
To include up to one year post transplant for every patient.
Or at least one year follow up after the transplant for every patient with some patients having additional follow up after that and so all of those data will be included in the BLA submission now in terms of of how come we don't know yet whether we will have one but we certainly will be prepared for line should we need to engage in it and the advisory Committee meeting.
Make sense. Thank you so much.
And I would just add we're in extensive conversations not only with the key transplant centers.
And kols in the field as well as regular conversations with FDA.
As we enjoyed breakthrough therapy designation we have.
Of an open line to the FTA too.
The continued to prepare.
For the BLA submission.
And our next question comes from the line of Jonathan Miller of Evercore ISI. Your line is open.
Hi, guys. Thanks, so much for taking the question.
One clarification on manufacturing comparability in the the CMC I was under the impression that you would have to generate actual commercial product in the dose patients with it in order to get that the CMC comparability is that true and if so what would we hear about those patients.
And when that's one second.
The second I'd love to hear your updated thoughts on potential partnerships for <unk> ex U S. I think you had been talking about doing that do you have a.
Preferred timing for when we could expect the deal like that and what are you looking for in a potential partner ex U S.
So let me invite for.
Need to talk about.
Ongoing EAP study in the clinical comparability from our manufacturing sites.
Sure.
So we are we haven't open expanded access protocol, which is really a single arm protocol, where all patients receive Oh, Madhu, Michelle and we're using that.
To execute our clinical comparability for both of our manufacturing sites and basically enrolling patients with product manufactured at the at the site that we need two of them and then it's available for them. So we.
We don't intend to provide updates on an ongoing basis around those patients for their outcomes.
We're going to treat patients from both sites, we will have data to submit to FDA for the BLA and we're on track to do that so yeah.
Wouldn't expect to hear anything about that we have had conversations with you about the extensive data required and we're confident they'll be able to provide the level of data that they are asking for in terms of the patients treated with how much of the Saudi site.
And Josh can you.
Can you comment about.
Oh, Madhu cell and other territories.
So John we continue to explore our strategic options for the optimal way to commercialize on the do the cell outside of the United States. We've recently conducted some market research assessments to the best understand the the.
The the territories and the opportunities in those territories.
Commenting of providing further guidance on the on timing.
Or or capabilities of potential partners, it's sort of the the obvious stuff we're looking for the.
The the best way to provide access and maximize the value of all of the do the sulfur patients around the world.
Great. Thanks, so much guys.
And our next question comes from the line of Jason Butler of JMP Securities. Your line is open.
Hi, Thanks for taking the question.
First one Michel you talked about the the opportunity to increase the number of patients that might be eligible for transplant could you may be expand I put some numbers around how that opportunity.
Impairs Chu of differs from the the population that today, we know as eligible but not matched I guess that first bucket versus the third bucket of the opportunities you talked about before.
Yeah. Thank you Jason.
Good to hear from you. So in regards to the the three opportunities increase and eligibility was based on the the physician feedback on the clinical profile of arm of <unk> cell. So when you go back to the data that Rooney, Dr. Horowitz and Professor Sanchez presented you see the decrease in infection rates. That's generally the one that and also the the.
First of all hostess. These data so when physicians see those aspects of the clinical profile the transplant or so will say you know there are some patients that I may not feel had the appropriate performance status to undergo transplant with current donor modalities, but based on the clinical profile of arm of <unk> cell. Both in regards to the some of the safety data around decreased infections decreased in the graft versus host disease.
But also the the rapid time to neutrophil graphs that they say there is a percentage of patients that I may consider now eligible if I'm a day, but sort of what's available. So you know we havent guide on guided on specific numbers from that portion, but what we have said is overall once we reach peak market share, where we're probably at about 2500 patients.
Once we reach that peak market share and we're excited by all three of those opportunities both the increasing eligibility the the increase or improving outcomes for patients from based on current donor modalities, but also very importantly that portion of the patients that are currently eligible but just can't find it match. That's also an incredibly important opportunity from a type of cell.
Yeah.
Great and then.
Thank you just a follow up on the the data you'll have a BLA.
I think you mentioned you you'll have one year follow up data for most if not all patients.
I guess to what extent do you expect the SBA to away one year survival rate and is this day to do you think could be included in the label. Thanks.
Roni.
How would you handle that please of course.
So we will have one of your data on on.
All patients will have been at least one year after transplant. So there is the the.
The data will include one year data on all patients one of your survival data are actually important in the transplant field of use as.
A marker for valuation of transplant centers and transplant yours are familiar with looking at one year of transplant data. So so we expect those data to be important.
As you know the study wasn't powered to detect statistical difference in the two arms with respect to overall survival data, but we will show those data and certainly share them and include them in the BLA and.
We expect to them to use those data to show the utility of Oh, Madhu the cell to whatever extent, we're able to.
Okay, Great and then just one quick one from me for you you mentioned before you're making progress on the Cryopreserved NK products. What are the next steps are in terms of manufacturing and when could we hear an update on on the progress towards the prior preserved.
That could be used in the multicenter study.
Thank you for that Tracy could you.
Elaborate.
Sure I'd be happy to thank you, Jason and hope you're well.
We continue to make fantastic progress and I can update since we spoke last that we have now finalized the cryopreservation formulation of the research setting.
And we have successfully manufactured two engineering runs which of practice runs at our GMP facility, which is right out of Hadassah University near there in Israel.
The team has made significant progress now and not only finalizing the cryopreservation, but now made the two scale to clinical scale. So the next step actually are just to continue manufacturing now for the clinical run so that we can store.
Announced inventory and we're on track to do that prior to the IMD submission of the phase one two.
Which we plan and is on track sales the latter half of this year.
Great. Thanks for taking the questions.
Thank you.
And our next question comes from the line of Jordan.
Do you know of H C. Wainwright your line is open.
Thanks for taking my question and congrats on the progress.
Just for.
Perhaps just a question for Michelle what reimbursement levels of currently available for.
Bone marrow transplant of use of vocal cord blood.
And can these be initially applied for use of what of the solar most favorite Brooklyn, the established at the time of AUM of good peso approval.
Hi, there of earned a nice to hear from you. So irregardless of reimbursement let me, let me talk about the commercial payers in the U S and government.
So just taking a step back we anticipate the majority of patients who would be receiving all of the Davis of would fall under private or for commercial payers. Although Medicare certainly this is an area of key focus for us too. So let me start with the commercial payors. So commercial payers in the transplant centers in the U S have confidential contracts that they negotiate in regards to their.
Reimbursement, so I would not be able to speak specifically on the details of that but here's what I can tell you. We've had a number of conversations through either market research with the U S payers or direct one to one communications what what payers are saying is they would most likely reimburse on the DUBA cell at time of FDA approval via their carve out mechanism, which is part of the contract so what.
Does that mean in practice the reimbursed the transplant center for the agreed to rates for hospitalization provider care and then the carve out the reimbursement from a deep of cell that's consistent with what they did with car Ts in many cases upon FDA approval and that's what they're saying they would do for Ahmedou the cell, where we're encouraged by that and also the.
Transplant centers are comfortable with that approach.
On the Medicare side, there are established diagnosis related groups or DRG ease for allogeneic stem cell transplants and Theres also some always continual evolution of of how to enhance the our Gs there was some updates in the proposed inpatient prospective payment rule that just came out but the the key.
The takeaway on the Medicare side is there are of DRG is that a therapy like on the tube itself could be mapped to and then in addition, we are preparing to apply for the new technology add on payment of ore and tap, which would that also support the additional reimbursement of <unk>. If approved so those are the two key avenues in terms of the commercial and then on the Medicare.
Our side.
I have a somewhat asked you this before but do you anticipate the establishment of the reimbursement to follow the pathway that was followed by the car T cell therapies.
So keep the pace of the commercial the the what we're hearing from the payers is similar to what they did for in many cases for car T. They would carve out the reimbursement with AUM of 2%. So that's something that transfer.
Transplant centers, and you know or are used to it and encouraged by so in that case, yes in the case of Medicare the difference between all of the data some car Ts, where when car Ts where proved there was no appropriate or common DRG for them to be mapped to vs. In the case of armour DUBA cell. There are allogeneic stem cell transplant DRG that are already established.
So that is that is one difference with the with the car T.
Terrific very encouraging thanks for taking my question and congrats again on the progress.
You.
And once again, if you would like to ask the question simply press Star then the number line.
One key debt.
Our next question comes from the line of graduating the venture of RBC capital markets. Your line is open.
Good morning, Julien and team thanks for the update and thanks for taking my question perhaps.
Parents, just just one on each program Julian just with the.
And as the idea of the cell data circulated in the physician community and after a series of meetings across this year. So far what are you learning that is either reinforcing or incremental on the on the did the cell profile of that you think is worth highlighting and then secondly on GDA 201, just curious what is your view on the various.
The engineering, an extension strategies across the NK space, where perhaps would two of won't fit in there. Thank you very much.
Let me direct that question to <unk> on the on the clinical side.
Lot more.
Contact with the physicians.
Yeah.
Thank you and Greg we have been in.
In touch and reaching out to a number of transplant or across the U S.
Especially many who will not invest.
Investigators in our clinical study to talk to them about the results of the study and the bad on the do the sell in to get their feedback on them is also of the studying and we've been hearing and enormous amount of enthusiasm.
That's the potential.
They each have been able to think of patients that they would have been able to oh would've wanted to use it for word available patients who wouldn't have fit the mold for other opportunities.
Opportunities in transplant couldn't find of match or just lack of appropriate for for some of the other modality.
And I think people are looking forward to having another option when theyre looking for of glass for their patients with hematologic malignancies. So that that's what we've learned that folks who were not previously familiar with them into the cell and are now learning about it are enthusiastic about it.
And for GDA two of one again, let me.
Refer you to Tracey to answer.
Sure.
Thank you for the question Greg good good to hear from you.
And as you know the NK field.
It is expanding and with many different approaches and really information.
<unk> flowing very nicely and we're really pleased to be in the sand at the forefront of this with our clinical data stack.
And so all of I'll say, a few things about <unk> two of one which distinguishes us and then where we're going in terms of the engineering. So I think the key benefits of GDA 201 really quick.
Quick manufacturing process that we are able to isolate this from the peripheral blood from normal donor.
Have a product within 14 days and now as I said, we're very excited to have a cryopreserved formulation of the switch has maintained the phenotype and the function in the lab of the of the.
The cells and Joe as it bore out in the clinical trial, we're really excited about the combined ability of our technology with other therapies and especially with other antibodies. So I think this distinguishes us from heavily engineered car NK and other IP of C derived.
Current cage, which require heavily on significant genetic engineering.
Our salaries do not persist past seven to 10 days.
In the patients what we've seen by facts analysis at least in the ISG phase one, but therefore, we think it's a different mechanism that's going on with GDA two of one and that their ability and in part because of lot of expanded with our NAND technology can maintain their function post in vivo.
<unk> plant as well as secreting of cytokines of activating the adaptive immune response at the patients that we're working on.
Still the provision some translational studies.
And we think this is what's really leading to some of the durability that we've seen in the ongoing study. So we're excited about that and to continue to explore the potential.
And this is what distinguishes our NAND technology, because we believe this would not be possible without the nam actually improving the fitness of the cell around the metabolism and really around the ability for them to be very active when we're expanding them and not be exhausted.
Where we're going in the future is the R&D.
R&D team is making tremendous progress that we're really excited about and actually doing some gene editing and which we think will improve the salads as we look to other tumor types and especially in solid tumor types and how we can improve then the persistence of so we think may be needed for this and also.
To tackle the difficult down the solid tumor type so we're making great progress and we think we have of products that you know is distinguished and we're looking forward to even improve that as we expand out the different indication.
Thank you for the question.
Thank you.
And I'm showing no further questions at this time I would like to turn it back to Mr. Julian Adams for any closing remarks.
Just thank you everyone for joining on us for joining us on today's call and we look forward to updating you in the future.
And we really appreciate it.
The continued support.
And once again.
I can't thank the employees of can be the cell enough, particularly in this pandemic year, where they've just worked tirelessly.
And with such commitment.
To realize the potential of our programs for.
For print for patients. Thank you all.
Ladies and gentlemen. This concludes today's presentation. Thank you for participating you may now disconnect and have the lovely day.
Yes.
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