Q3 2020 Gamida Cell Ltd Earnings Call
Shannon and I'll be operator for today's call.
Please be advised that this call is it could be the sales request.
Now I would like to introduce your host for today's conference Mr., Josh Hamish Chief Business Officer. Please go ahead.
Thank you Shannon and good morning, everyone welcome to todays call during which we will provide an update on the company and review our financial results for the third quarter of Twentytwenty earlier.
Earlier. This morning, we issued a press release summarizing our financial results and progress across the company, which is available on our website at Www Dot give me to sell dot com.
Here with me on our call today is Julian Adams, Chief Executive Officer, Roni, Cementos, Chief Medical Officer, and Shai Landry Chief Financial Officer.
Michelle Corfo, and our Chief operating officer, and Chief Commercial Officer, and Tracy loading our Chief Scientific Officer are also on hand for the Q and a portion of the call following our prepared remarks.
During this call.
We may make forward looking statements about our future expectations and plans.
Clearly clinical development and commercial objectives, the therapeutic potential of our product candidates and our operational plans and strategies and projected operating expenses and cash runway.
Actual results may differ materially from what we project today due to a number of important factors, including the considerations described in the risk factor section of our form 20-F and in other filings that you need to sell makes with the FCC from time to time.
These forward looking statements represent our views only as of today and we caution you that we may not update 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 Julien.
Thank you, Josh and thanks to everyone for joining us this morning.
I'd give me to sell we're committed to developing cell therapies with the potential to provide cures for patients with blood cancers and rare serious humans allergic diseases.
We've continued to make very strong progress over the past few months with both of our programs when we do sell which could be the first ft approved engineered graft source for bone marrow transplant.
And Judy to a one and natural killer or NK cell therapy, which has the potential in both haematological malignancies and solid tumors.
Today, we'll review both programs and summarize our progress around plans to potentially bring them into the cell to patients in the commercial setting.
Starting with home and do so.
In October we were thrilled to report.
Our global randomized phase three study of I'm going to be so.
That all three second secondary endpoints related to platelet engraftment infections and hospitalizations.
These results strengthen our confidence in the clinical potential of them to do so and build upon the positive primary endpoint data we reported earlier this year.
We expect to report additional details from the clinical study by the end of the year.
We also anticipate initiating the BLE submission.
For Omid do this out on a rolling basis in the fourth quarter.
Which position, which positions us for a potential launch in the second half 2021.
We're also making good progress.
Other key launch activities required to bring on but it does help the patients following potential FDA approval.
Our show expansion platform also led to the generation of G.D.A. tool one.
Our NK cell based.
Got a candidate.
NK cell therapies offer tremendous potential for transforming the care of hematology malignancies.
We are pleased to be pioneering and novel approach that harnesses the power of our cell expansion technology.
It's uniquely improves.
Antibody dependent cellular cytotoxicity.
ADCC.
And the Nvvault homing potential of Gd eight to a one to address the limitations of NK cells.
With Judy eight to a one our goal is to develop an off the shelf allogeneic cell therapy with response rates similar to the car Ts in lymphoma, well potentially offering a more favorable safety profile.
Data from our ongoing phase one study have demonstrate have demonstrated striking early signs of efficacy.
With multiple complete responses in patients with advanced lymphoma.
We will be presenting updated data next month at the American Society for hematology.
Josh.
And you will not meeting next month.
Rooney will review, our ash abstracts in greater detail.
We're continuing to plan for our next trial, which will be a phase one two multi centered study in patients with advanced lymphoma.
I have developed a cryopreserved formulation of GDP to a one.
Working on GMP scale up this formulation to enable our eye and be submission in 2021.
Our hope is if the data are compelling this study could serve as the basis for a registrational trial to an accelerated approval pathway.
As we advance our clinical programs and prepare for the potential launch next year, we're continuing to make key hires within the organization, who bring new capabilities and further enhance our strong team.
Today, we announced the appointment of Steve Jamison to the role of senior Vice President.
Information technologies.
Steve brings 25 years of I.T. experience, primarily in the life sciences industry, including roles at Verastem Infinity Ariad Endo aside.
Additionally, this week Roxio man Ghani joined give me to sell as a senior vice president market access.
She has nearly 20 years of experience in market access and patient support commercial.
Commercial organizations, including Celgene and Roche.
Of particular relevance Seo served in a leadership role at kite pharma.
Was instrumental in securing patient access for yes Carter.
We're excited to welcome Steven receivable to that got me to sell team and look forward to their contributions as we look toward a potential on Medusa launch next year.
I want to conclude my introductory remarks by acknowledging the challenges.
Of this year as we navigate through a global pandemic we're.
We are committed to the health and safety of our employees and continue to advance our business well implementing work from home policies shift work in our laboratories and manufacturing facilities travel bans and regular cobot testing for employees working on site.
We continue to watch our timelines very carefully today.
Our anticipated milestones for both home to do so and G.D.A. tool one are unchanged.
We continue to expect to initiate the BLS submission for almond due to sell on a rolling basis in the second half of 2021.
Sorry.
By the end of the year, which sets us up for a potential approval and launch in the second half of 2021.
We're planning to submit the I.M.D. for Judy a twofold, one to enable our multicenter phase one two study in lymphoma next year.
I am very proud of the work we are doing.
In an effort to bring curious to patients and I am impressed by the hard work and dedication of our employees.
I'll now turn the call over to need Cementos, our chief Medical officer to provide a further update on home into Brazil, and GDH were one we need.
Thank you Joanne and good morning, everyone.
This morning, I'll review, our clinical programs and highlight a recently published ash abstract describing data from the studies on the do the sell in patients with severe a plastic anemia and for TV to a one in patients with non Hodgkin lymphoma.
As Joe noted this year, we reported that our global Phase three study of 'em, we do the sales and 125 patients with hematologic malignancies met the primary endpoint and all three secondary endpoints.
We are proud of this record.
Well executed trial and we truly appreciate the support of our collaborators in the transplant community, who are working with us to help move the fields forward, especially while working to COVID-19.
I'll briefly highlight what we have reported so far.
In May we announced that the study met its primary endpoint tied to neutrophil engraftment a key milestone in recovery from bone marrow transplant simplifying how quickly stem cell patients received became established and began to make helping yourself.
The study showed that on the EBITDA was generally well tolerated in the intent to treat analysis. The median planting is just going back that was 12 days and patients randomized on budget, so compared to 22 days for patients and the comparative group randomized to stand the cord blood transplant. The P value was less than 0.001.
Last month, we announced that all three pre specified secondary endpoint of the study demonstrated a statistically significant improvement among patients randomized to on the dermacell versus the comparative but.
Specifically the secondary endpoints were platelet engraftment by day 42 incidents agree to a grade three bacterial or invasive fungal infection.
And the number of days alive in the hospital and the first hundred days following transplant.
Rapid Matt what recovery, reducing infections and shortening hospitalizations are all clinically meaningful outcome valued by physicians patients and their family.
Our data analyses are still ongoing and we hope to present the data in a peer viewed forum at the end of the year.
Overall I see three data coupled with our recently presented observational study, which showed improved survival in patients with adult donors less than 30 years old reinforce our belief that on the dip is supposed to be an important graft option for any patient who does not have a suitable matched donor.
We believe him do the cell has potential beyond hematologic malignancies, and evaluating only gives us on patients with severe in classic anemia, a rare life threatening blood disorder.
Investigator sponsored phase one two study is being led by Dr., Richard child's at the National Institutes of health.
We previously reported data from an initial cohort of three patients successfully underwent a reduced intensity conditioning regimen and we see the stem cell transplant, consisting of only do sell plus haploidentical stem cell graft.
Dr. Type then initiated a second cohort of patients to evaluate on when do we sell as a standalone graft.
Initial data from this cohort will be presented at Ash next month.
The abstract published last week included data from the three patients in cohort, one and five patients in cohort two.
The data showed that on the Dermacell was generally well tolerated and led to rapid sustained engraftment with a median follow up of 10 months seven of eight patients had early sustained engraft, Nick when you to fill and play the recovery occurring at a meeting of handmade and 31 days respectively.
There was no evidence of acute or chronic gvhd and the patients remain transfusion independence.
The study, which is still ongoing highlights the potential for how much of the sales to be used in non malignant bone marrow diseases.
And lends further support to value on budget, so more broadly using reduced intensity conditioning, which could make on the dermacell most feasible treatment option for elderly frail patients or others unable to withstand a myeloablative regimen.
We look forward to the presentation of the data in a virtual poster session at Ash on Saturday December sales.
In addition to only do the sell beat our advancing our NK program GDH worldwide.
Natural killer cells in self help tremendous promise for treating cancer.
The field sales several developmental challenges, including the ability to expand into sales and culture, while preserving the functionality our technology addresses this challenge and a phase one data provide impressive proof of concept.
The clinical study is designed to assess the safety of three increasing doses of Gd tool one in combination with a monoclonal antibody in relapsed or refractory patients with non hodgkin lymphoma or multiple myeloma.
Well it to determine the recommended phase two dose.
The study being conducted by Dr., Veronica Bakken, Nova at the University of Minnesota.
The abstract submitted to ash, which was accepted for all presentation includes data from 30 patients as of the cut off in July 2020.
15 patients with non Hodgkin lymphoma, and 15 patients with multiple myeloma.
First it's important to note that due to a one was generally well tolerated with no dose limiting toxicities, no gvhd and importantly, no never toxicity observed.
I'll focus on the 15 patients with non Hodgkin lymphoma, who were treated with GDP to a one and we're talking to now.
Histologies included eight patients with diffuse large b cell lymphoma, six patients with Follicular lymphoma, and one patients with mantle cell lymphoma pace.
Patients had a median of three prior lines of therapy with a range of one to eat line and 87% had advanced stage disease.
Given this patient population, we were thrilled to see clinical activity at all doses evaluated.
The abstract supported that among the 15 patients there were 10 complete responses and one partial response for an overall response rate of 73%.
Median duration of response was 8.7 months in this population and we were encouraged to see responses out 25 months.
Also of note for patient underwent meet treatment due to a one without wonderful depleting chemotherapy, which likely contributed to deepening of responses and to be patient.
This finding supports our plan to evaluate multiple doses and potentially exclude the requirement for local depletion in our company sponsored study, which is expected to begin next year.
Next month all presentation at Ash mix. That's include longer term follow up for the patients already reported as well as data from additional patients who were enrolled in a valuable since the time of abstract submission.
I'm very proud of our team and their commitment to advancing our clinical studies during the global pandemic.
And I look forward to sharing additional data from both programs at Ash in just a few weeks.
With that I will turn the call over to shy to review our results.
Thank you Randy and good morning, everyone today.
All right our financial results for the third quarter 2020.
As of September Thirtyth 2020, we had total cash and cash equivalents of $73.3 million compared to $55.4 million. It will be sent to carry through 2019.
Research and development expenses for the quarter were $10.5 million compared to $7.5 million for the same period in 2019 Nasally was mainly due to believe readiness preparation increasing clinical activities related to the advantage that you get to a one and the initiation of you're going to be sales expanded access studies.
Commercial expenses in the quarter were $1.9 million compared to $1.7 million for the same period last year. The increase was mainly attributed to obviously be sales commercial readiness activities.
General and administrative expenses were $2.7 million from the third quarter of 2020 compared to $2.8 million for the same period in 2018. The decrease was mainly driven by reduced travel expenses.
Finally income that was the $1.3 billion for the quarter compared to $1.7 million in the same period in 2019. The decrease was primarily due to non cash income, resulting from revaluation of warrants owned by the company shareholders.
Net loss for the quarter was $40.8 million compared to a net loss of $10.1 million the same period last year.
We expect that our cash you are going to bring a cubic is this your range from $60 million to $65 million, we anticipate the recurrent total cash position will support our ongoing activities into the second half of next year.
This cash runway guidance based on our current operational plan and exclude any additional funding maybe receive or business development activities.
We've taken we date I will turn the call back over to Julian.
Thanks Shai.
We are committed to finding cures for patients with human logic malignancies, and blood disorders, and we're excited about the opportunities ahead.
With Ahmadullah. So we expect to present, our phase three data and initiate a rolling BLA submission by the end of the year.
GDH were one we have very compelling data in lymphoma and are working hard to initiate our own clinical study, which could transition to a registrational trial. If the data are consistent with our ongoing phase one study.
We hope to finish the year strong and to carry our momentum into 2021.
Which we expect to be a transformational year for me to sell as we prepare for a potential approval and launch of them into the cell in the U.S.
Now we will open the call for questions.
Operator.
Thank you, ladies and gentlemen to ask a question you need to press star one on your telephone to withdraw your question press the pound key please stand by we compiled the kewaunee roster.
Our first question comes from Jonathan Miller with Evercore. Your line is open.
Thank you so much for taking the questions guys and congrats on all the progress.
I'd love to start with.
Only due to sell it clearly looks superior to send a cord blood and very intriguing they said the transmitter.
The trial was against equivalent obviously, you're not those other sources. So I guess in your conversations with docs and payers how have they characterize as somebody with those potential versus not just cord blood, but other.
Transplant sources, but I know that you're targeting do you expect initial commercial uptake to mostly be replacing chord, where do you hope to start replacing other modalities in a meaningful way immediately as well.
Then just on GE a cure one you know obviously the data in the ash abstract looks very interesting, especially in lets you Larry and then probably NHL.
How are you planning on structuring. The next set of trials is there any signs of activity in myeloma.
Do you expect that to be.
Potentially better with a difference Matt Campbell agent and how are you approaching.
The broader heme malignancies base there outside of energy.
So let me ask will need to.
Cover the first part of your question.
Out of positions Ah.
View, our data do Brasil compared with other transplant modalities and then Michelle you could.
Comment on the potential.
Launch activities and introduction of them it to.
To the marketplace.
Thanks, Julie and I will start with how physicians are reacting tell me give us so.
Wrapping neutrophil engraftment.
As attractive no matter, what the graft source it.
It's an opportunity for patients.
To have a superior outcomes after transplant to get out of isolation room to have a lower incidence of infection than other complication.
Generally to have improved outcomes and so that's the difference that we speak to our very impressed with the level of Engraftment that we're seeing supported by.
The other clinically relevant endpoint from the secondary endpoint. So we believe that Ahmadullah Sal is potentially attractive graft source for patients who don't have a suitably matched donor or from another source.
Okay excellent. Thank you. Thank you Randy. Thank you for the question. So you know I Oh reiterate what Reid said based on our discussions with physician if the patient does not have access to a match related donor there is the potential for them to be an ahmadullah cell candidate your physician.
And payers have been very encouraged by the clinical profile to date from a deeper sell across efficacy safety and the ability to provide the patient with PAMA do but sell in the clinical trial. Our experience was four weeks from the time of identification of the corporate money.
Factoring until we turn to vomit do but sell so those three aspects efficacy safety and the logistics have received very encouraging feedback from physicians and so there was an opportunity for us to do but sell across all current treatment modalities from a graph source standpoint.
Every course too to launch you know, we're very excited as doing indicated to begin to add exceptional personnel to our commercial team, including rossetto among Connie joining us. This week. So we're we're building up the team in expectation of a potential launch in the second half of 2021, our launch Obama do but so is absolutely going to be focused on a show.
During a positive experience for the transplant center and that the patient. So hence we have four key tenants that we're working on to prepare for the launch preparing to educate the transplant centers. So they understand the alma do but so clinical profile and the appropriate patients educating the payers yeah. We've been encouraged by the initial payer feedback, but we recognize that will be.
Very important to make sure we continue on.
Third is having that appropriate support group to help initiate the chain of identity to shore that that is established at the time of treatment decision, but also to provide any additional patient reimbursement support another fourth key areas around manufacturing readiness. So we are excited by our profit.
First in all four of those areas. So thank you for the question.
And related to GDP to a one let me ask it.
We need again to comment on the clinical experience so far and then I'll ask a.
Tracy to talk about the potential for combination with other monoclonal antibodies.
Thanks, So in terms of TV to a one we're very impressed with the data that we've observed in lymphoma. So far in both insulin histologies and aggressive histologies and so what we foresee is that our next study will include the opportunity to evaluate.
GDH were one in different Histologies, obviously with the appropriate methodology for validating them.
Separately.
And so that's what I can say about the design of our next study we think that will include both.
In terms of myeloma, we just didn't see the level of responses that we observed in lymphoma.
It it potentially could be attributed to the antibody.
And there may be opportunities to explore myeloma.
Using either a different anybody or or different methodology I'll try to facing.
Thank you Roni and yes, and so I will reiterate that were very excited about what we see in non Hodgkin's lymphoma in particular to your question around multiple myeloma, we do believe.
Given research data that we think the combo with that particular antibody either through the math is not optimal until we are working on a research engineered programs to genetically modify the NK cells, which will actually allow us to combine with different antibodies.
That we think will be more potent in multiple myeloma, but this will be not part of.
Our trial next year. In addition to that we continue to be excited about the activity of NK cells and the safety of NK cells with our now expanded platform. So we do have ongoing research programs looking at combination with antibodies with solid tumors as well.
And that will be in the future and hopefully we will present that work at it.
Conference sometime next year.
So thank you for the question, yes. Thank you so much guys.
Thank you. Our next question comes from Ted Tenthoff with Piper Sandler Your line is okay.
Great. Thank you very much for them.
Credit cards.
Time for the company for a lot going on.
[laughter] I think you guys her breakthrough designation and work from that you would seek accelerated approval we have been.
[laughter].
Okay that make.
And do you anticipate this would require a.
Tom thing.
So I'll take that Ted. Thank you for your question. So just we do to reiterate we do have breakthrough therapy designation.
But this is a pivotal phase three study and we're seeking full approval not accelerated approval, but we broadly speaking the profit priority review.
Which as you know is a six month review.
Yes.
And we don't anticipate the need for an advisory committee because weve met all of our endpoints, both primary and secondary endpoints with statistical significance.
Great and I appreciated the color on that.
Commercial prep that I'm looking forward to the presentations at ash. Thanks, so much.
Thanks Ted.
Our next question comes from Jason Butler with JMP Securities. Your line is open.
Hi, Thanks for taking the questions and congrats on all the progress.
First I want to do this so I'm just.
The a plastic anemia market.
Dynamics can you just walk us through what the patient auction.
Auctions are today and how much itself can change that and obviously, it's a rare.
A rare indication can you give us a sense of the size of the patient population in the U.S. and then for two out one just.
Any update on the manufacturing process here and you know.
To what extent, you're you're through the work that needs to be done to us is that the idea.
Really could you discuss a plastic anemia.
Absolutely so patients with a plastic anemia tend to be young.
It's got a bi modal distribution most of the patients are young.
And are treated with transfusion to support they're red blood cells, and platelets and immuno suppressive therapy, because most of the time, it's an immunologically mediated disease, where the immune system to attack the bone marrow.
Patients with severe aplastic anemia have very low counts that are very dangerous they can be susceptible to infection, leading and other complication.
And the only cure for severe aplastic anemia is bone marrow transplant.
For patients who don't have a match.
There really is no cure and you know they subsist on support a therapy, but.
There's really no opportunity for UC here other than a bone marrow transplant.
What on the Dsos offering is a potential for secure in patients who don't have a match.
And particularly important are the result of the results of the study that we are.
Well that were published Navtech are particularly important because.
Patients with a plastic anemia tend to have a higher rate of graft rejection. They translate don't take easily in patients with severe aplastic anemia, because of the way the bone marrow Scott this immune system and.
There, there's just a difficulty in supporting and graphic and so the fact that a single unit of 'em Dermacell.
But its sustained and wrap it in past, it's actually a very very positive sign so what we don't do that so can offer for these patients is the potential for cure that that may just not exist for them currently.
Maybe a question enemy is a rare disease and the numbers of patients in the west there are measured in the hundreds.
Thank you Tracy can you talk about the G eight to a one progress in our manufacturing.
Sure and thank you Jason for the question. So I'll just remind you that the.
The clinical results that Rami, just summarize were with a fresh product.
With our collaborator at Minnesota still active meters. So we've made tremendous progress.
No.
Making a cryopreserved formulation. So our intent next year is to have an off the shelf cryopreserved product. We have that final formulation now and it's just a matter of manufacturing this under GMP conditions and we.
I actually have the flexibility to manufacture this.
Active vdsl and we're all in we're also looking at some external.
Capabilities from manufacturing for the clinical trial for next year, but we remain on track to having that al off the shelf product for the child for next year.
Okay, great very helpful. Thanks.
Our next question comes from Gregory rental with RBC capital markets. Your line is now open.
Hey, good morning, Julien and team.
Rather than the progress and thanks for taking my question I just could go bonds at some earlier questioning just around the progress of the deal is filing what do you see as the gating factors are critical path.
Few this and perhaps for each margin or are there any components that you're still waiting for in terms of data or or information and just trying to understand the expectation of timing. Once you start that how long that will take for perhaps each module or in total and in light of your goals for a second to have 2021 wants potential. Thank you.
Yes, So let me cover the sort of the cadence of filing.
Our Nonclinical module is ready and that's.
We anticipate.
Beginning the filing with that particular module.
And that will be followed or early next year by the clinical module.
And lastly, the manufacturing module module freed the CMC section will complete within a six month timeframe.
The full filing of the BLE.
Gotcha very very helpful. And then we've spoken about this before but I can certainly get questions on RMBS.
The intellectual property of comedy there. So I'm just wanted to see if you could just take an opportunity to provide some color on on your view of the protection you have there with respect to the product and the process. Thank you very much.
But I'd be happy to.
Our.
Patent expiry, we have quite a number of patents for the longest patent expiries up to 2038.
But importantly, because we have orphan drug status, we have 12 years exclusivity in the us for a BLE and 10 years in Europe.
And finally, we have many trade secrets or that are not in the public domain.
And because on the do the seller is a personal.
Personalized manufacturing where on the do sales consumed by the recipient patient there.
There is no inventory, so it's really not possible to make a biosimilar ER and suites.
Feel that.
The exclusivity period is very very strong for us.
That's great. Thanks, you and look forward to the data into the year.
Thanks, Greg.
Our next question comes from Vernon Bernardino with H.C. Wainwright. Your line is open.
Hi, everyone. Thanks for taking my question and congrats on the.
The progress and the.
Strong affect your results.
Okay, and I spent to me seems VP.
Expansion of the collaboration with the B U can match therapies.
Topper, let's bars.
Supply of cord blood units to buy this again as far as.
Supply and the and the effects of the pandemic on that supply has just wondering also if you could comment on.
I guess the.
The effects of.
The pandemic.
The nation of cord blood units.
If there is any effect and what you have done as far as what would need to be done to.
Provide a smooth process, but the supply of the unit.
So overdo the so commercial.
Session has begun thank you.
So let me get to begin by discussing the pandemic and then I'll turn it over to Michele to talk about commercial supply.
As it would happen it actually made it easier to.
Shit cord blood units because there are no volunteers involved so for a matched unrelated donor when heska locate the donor and they still have to be willing to donate and come to a.
Uh huh.
And then.
An infusion center to donate their their bone marrow.
And that was dampened by the pandemic, because obviously healthy.
Adult owners.
We're reticence to go to.
Hospital settings.
And.
That's certainly not the case with cord blood units is there all cryopreserved and shipping was routine and we never experienced a delay based on the pandemic.
And Michelle maybe you could comment on the sort of commercial supply.
Agreement with be the match.
Absolutely and thank you for the question. So we're very excited to continue our partnership with be the match. So we had an important partnership with them for the phase three study and we're excited to extend that partnership for commercialization upon potential FDA approval, you know coming back to what I had said earlier you know very very.
Weren't part of our launches assuring a positive experience for the transplant center and the patients.
The transplant centers have an established relationship with be the match so by us being able to continue our partnership. It provides for you know the continuation of the partnership that the transplant Center already has you know they partner with be the match when they are looking for a graph source beyond a matched unrelated donor or.
Related to owners. So we're excited to be able to continue that partnership we do think that it will be very beneficial for the transplant centers in terms of streamlining beat the logistics associated with using ahmadullah sell upon potential FDA approval.
Yes, It does sound that's a very important relationship. Thanks for taking my question.
Thanks, Julian Thanks, Michele Good luck looking further forward to dash data.
Thank you Vernon.
Our next question comes from Gill with Needham <unk> Company. Your line is open.
Hello, everyone. This is bill on for Chad and thank you for screening squeezing us then.
My question is gone.
Regarding the.
Pinnacle study of Gd eight to a one that's planned for next year.
Could you kind of discuss a little bit what your expectations are at least initially.
The key feature of next year's trial will be.
Obviously with an off the shelf cryopreserved product.
And it will be a multi centered study.
It will be designed as a phase one two study.
And let me ask Randy to talk about how we're going to Uh huh.
Enrolled different histologies different cohorts of patients.
Hey, Thanks, Julian and thanks, So I think yeah I didn't give you pretty much captured. It's the main features are that it will be a multicenter study because the cryopreservation will allow us to ship the product to different sites much as we did with on the Dermacell.
And that we will enroll patients.
Brent.
Histology of lymphoma, and analyze them in separate cohorts in order to best understand what the efficacy is in those different histologies I think that's the those are the broad strokes in terms of the expectations for that study.
All right, but.
Furthermore, under you dig too cool one could you put.
Put it into context, the ability to use multiple doses of the seller therapy, especially considering standard of care.
Right.
Sure [laughter].
So.
In this study in the phase one two study that we have been conducting at Minnesota.
There was interest.
In using.
Using a second dose.
Sales of GDP to a one in patients for one or two either.
First we wanted to explore the possibility of administering the sales.
Without ninefold depleting chemotherapy prior to administration.
And second we wanted to see if administering additional doses would deepen or consolidate responses in patients.
And there were four patients who had that second dose with lymphoma. It was tolerated fine.
We were able to administer it without getting chemotherapy.
But more importantly, perhaps we were able to.
See objective evidence of deepening of response in patients after that additional dose.
And so that.
So we think that's an interesting opportunity to administer but multiple doses and we will explore that further study.
One of the tenets of our approach is that we think that our end.
Okay cells in combination with Rituximab in lymphoma.
Our eliciting.
And adaptive immune response, that's certainly clinical evidence for that.
And we think that that's what.
Sort of ideal that's the biology of NK cells that were.
We think that is pertinent to the development of GDP to a one.
That makes sense.
One last one on AMR do but so.
Did I have that.
Oh.
Press release about the the match.
Going forward and I was thinking about the market as an expense do you think your relationship with the the match will be sufficient or are you guys going to have to look at other sources Oh cord blood. Thank you.
Michelle.
Yeah no. Thank you Gil for the question. So you know.
As I mentioned prior we're very excited about the partnership would be the match you know they are you know very very much a partner not only now for us, but also for the transplant centers up.
You don't we we don't proceed that there would be a challenge in terms of supply with utilizing be the managed to have a very extensive network amongst the cord blood bank. So at this point in time, we don't see a concern in terms of the supply from B the match.
I might add to that.
Exuberantly.
There are 4 million babies born every year in the United States. So we think that ultimately this is an inexhaustible supply as long as Obama do Michelle continues to serve patients.
Excellent that's very helpful. Thank you for taking our questions and we look forward for other presentations at ash as well thanks.
Yeah.
Thank you once again, ladies gentlemen, if you wish to ask a question at this time. Please press Star then one are you touched on telephone.
Our next question from Mark Breidenbach with Oppenheimer. Your line is open.
Hey, Thanks, and so glad you could squeeze me in.
Two questions on the on the due to sell.
With respect to the deal late filing I'm just curious if you've reached alignment with the FDA regarding the contents of the CMC analytical package, especially given that this is a first of its kind product.
The FDA would have to review.
So we're in regular discussions with the FDA, we've had multiple meetings this year, including one recently.
We're not commenting on the.
Details of those discussions, but I would say that the very collaborative we do enjoy the the breakthrough therapy designation.
Therefore, the FDA.
And we speak.
Speak often and and very cooperatively.
Okay and in your upcoming presentation of data from the phase three trial.
Will you be reporting treatment related mortality rate and I'm just wondering if there's a defined CRM threshold or you think it's important to stay below relative to other graft varieties.
So reni.
Would you care to comment.
Happy to comment on that.
Oh, yes in our in our phase one two study.
Wrapping neutrophil engraftment was associated with lower treatment related mortality in the 36 patients in the single arm phase one too.
Certainly the issue of treatment related mortality is very important to transplanters into patients.
And.
We will share those data when we present the rest of the SEC.
Secondary endpoints and the rest of the data.
Efficacy and safety data for the study.
Okay, but no no specific thresholds, but do you think it's important to stay below.
I think if we if we observe data that are relatively consistent with what we've observed in our previous study then that give us confidence that.
That wraps engraftment in associated with clinical benefit much of some of the other clinical endpoints that we see.
Got it thanks for taking the questions.
Sure.
Thank you and I'm currently showing no further questions at this time I'd like to turn the call back over to Julian Adams for closing remarks.
Thank you Shannon and thank you everyone for joining us on todays call. We are looking forward to the virtual ash meeting and to sharing additional program updates in the coming weeks.
Shannon.
That concludes today's call you may now disconnect.
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