Q2 2021 Gamida Cell Ltd Earnings Call

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Ladies and gentlemen, this is the operator the this conference that I go to begin momentarily until the time of your lines will again be plays in the whole. Thank you for your patience again, ladies and gentlemen. This is the operator today's conference scheduled to begin momentarily until the time your lines will again be placed on hold thank you for your patience.

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Ladies and gentlemen, thank you for standing by welcome to them. He does sales conference call for second quarter, two I need to any one thing that holds the folks lightning is the cross sell and all of the DUC Quakers fourth of the Skol beats. The advice that this call is being recorded at the me the cell to request.

Now I would now like to introduce your host for today's conference Mr. Josh Hamermesh Chief Business Officer. Please go ahead.

Thank you Crystal and good morning, everyone welcome to today's call during which we will provide an update on the company and review our financial results for the second quarter of 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 www dot commute of cell dotcom.

Here with me on our call today are Julian Adams, Chief Executive Officer, Rohit, Simmental, Chief Medical Officer, Michelle Courson, Chief operating Officer, and Chief Commercial Officer, and <unk> Chief Financial Officer. There will also be a Q&A session. Following our prepared remarks.

During this call we may make forward looking statements about our future expectations and plans, including in respect of the timing and initiation and progress of.

And data reported from the clinical trials of our product candidates anticipated regulatory filings, including the submission of the BLA for on the do the cell to the FDA commercialization planning efforts, the potentially life saving or curative therapeutic and commercial potential of omidria to cell and our expectations regarding our projected cash.

Cash to be used for operating activities and cash runway of our actual results may differ materially from what we project today due to a number of important factors, including the impact of the COVID-19 pandemic on our operations the scope of progress and expansion of our clinical trials and cost impacts thereof clinical scientific ready.

Tori and technical developments and those inherent in the process of developing and commercializing product candidates that are safe and effective for use of human therapeutics and in the endeavor of building the business around such product candidates as well as those considerations described in the risk factors section of our most recent annual report.

On form 20-F, and other filings that we make with the SEC from time to time.

These forward looking statements represent our views only as of today and we caution you that we may not update them in the future whether as a result of new information future events or otherwise and now I'd like to turn the call over to Julian.

Thank you, Josh and thanks to everyone for joining us this morning.

This was a productive quarter forgive me the cell.

We continue to execute on our plan to launch.

First allogeneic stem cell therapy, Oh, Madhu, the self for cancer patients in need of the stem cell transplant.

In addition, based on promising preliminary studies, we have accelerated our plans to develop a unique NAV enabled the natural killer or NK cell GDA 201 for patients with Follicular lymphoma, and diffuse large b cell lymphoma.

And we are very excited about the expansion of our cell therapy pipeline with four new NAV enabled genetically modified NK cell cell.

Targeting cancers.

Patients are at the forefront of our work and we are committed to returning our NAV enabled NK product candidates and secured the therapy.

I'll start with our most advanced program from into the cell.

Potentially life saving treatment for patients with blood cancers, who are in need of the stem cell transplant.

This quarter, we announced the results of the phase III clinical study of all of them into the cell, which were published in blood. The official journal of the mountain.

<unk> put in the college.

The published results demonstrate the transplantation with them into the cell needs to pass the neutrophil and platelet recovery.

With the standard of care.

Additionally, the day to demonstrate that.

On the do good cell results in fewer bacterial fungal and viral infections and less time in the hospital.

These results add to the compelling body of evidence for the potential of omitted. The cell is a lifesaving therapy that can benefit patients in need of the bone marrow transplant and help reduce the burden on our health care system.

The continued to execute our plan of action to towards becoming a commercial company in 2022, as we prepare for our BLA submission.

On the do the cell by the end of this year.

Object to a pre BLA meeting with the agency in the fourth quarter.

On the do Michelle.

Has the potential to be the first FDA approved cell therapy for <unk>.

Stem cell transplant.

Michelle will provide an update on launch readiness later on in the call.

Moving to our pipeline, we believe the NK cells hold true.

And then the potential as the best in class next generation immunotherapy.

And T cells of the body cruise line of defense and providing innate immunity.

They also have immune privileged properties, which albeit the requirement for HLA matching.

Given that any healthy adult zone can provide the nature of leases unit.

From which we apply our proprietary NAV technology to expand the produce a cryopreserve off the shelf allogeneic natural killer cell treatments for cancer patients.

Our NAV enabled NK cell.

Like several important cell surface markers, including high expression of <unk> 16, the FC Gamma receptors of antibody, which allows the combination with monoclonal antibodies the target tumors through enhanced antibody dependent cellular cytotoxicity or <unk>.

Importantly, NAV also increases.

Two L L selectin expression, which leads the in vivo Hogan and the tension and lymphoid tissues.

Furthermore, NAV increases the Queen.

<unk> of inflammatory cytokines.

The activation of.

The hosted that the immune cells.

The combination of these activities result in increased cytotoxicity.

For more efficient tumor cell, killing and durable responses.

The combination of NK cells therapeutic antibodies increased GDA 201 potency.

Kelly and enhanced the ADC.

Both in vitro and in vivo supporting clinical treatment with GDA 201.

Paolo selected antibodies for the specific malignancies.

We are advancing the power of NK cell to the next level with our second candidate <unk>.

Clinical development of GDA two of one.

Which has demonstrated remarkable results and preliminary studies as the potential treatment for patients with Follicular and diffuse large b cell lymphoma.

We have completed the GMP batches without Cryopreserved formulation of GDA 201 are on track to submit an IMD in this quarter.

Could support a multicenter phase one two study by the end of the year.

Today, we announced that we're expanding the reach of both the NAND technology and the power of NK cells to the growth of our NK pipeline to now include genetically modified varian and proprietary therapies using CRISPR past nine and car technologies.

Rooney will give more detail on this exciting new developments shortly and.

And we look forward to providing a more detailed update at in R&D.

The day later this year.

I'm extremely proud of the progress our team has made with this expansion and I believe that our technology combined with our expertise in NK biology.

Holds great promise for further.

To further our vision of bringing therapies to patients.

I want to conclude my introductory remarks by really thanking our employees for their continued dedication to our mission and hard work.

And with that I will turn the call over to Randy.

Thank you Julien.

I'm very excited to provide more detail on our NK pipeline expansion, which we announced this morning.

We're confident in the potential to library of NAV technology for the newly announced target based on the encouraging clinical data we've demonstrated with GDA 201 for patients with from pharma.

The new program will involve genetic modifications and tenants of direct NK cells against cancer cell enhancing targeting and persistence and improving cytotoxicity against both hematologic malignancies.

In solid tumors.

The pipeline expansion stems from research that we've been conducting here at the meat of cell and in collaboration with key academic researchers and represents important progress in the development of NK therapy for patients.

A new product candidate <unk> 301 of them.

Knockout of the fish or cytokine ingestible ethics to containing protein in NK cells, using CRISPR Cas night with concomitant assertion of membrane bound interleukin 15 of IL 15.

That's just the regulator of IL 15, signaling and fish dilution increases encase sensitivity of the IL 15 by lowering the NK activation threshold.

NK cell equipped with the membrane bound IL 15 are designed for enhanced persistence and improved anti tumor effect.

In preclinical studies, we've demonstrated elevation of pro inflammatory cytokines and enhanced potency and cytotoxic activity in the cell.

We believe that the fish target coupled with membrane bound IL 15 of potential across multiple tumor types.

Additionally, today, we announced the development of GTA for one which is genetically engineered towards an undisclosed target the Saar.

To enhance NK cell survival and of solid tumor microenvironment.

The C. D. E 301, we believe the GTA for one have potential application across a broad range of solid tumor.

The third development candidate in our pipeline of GTA five of one of.

The merit antigen receptor of car engineered NK cell designed to target her two positive solid tumors.

This candidate has the potential to enhance home to an activity against tumors expressing her two such of breast cancer ovarian lung bladder and gastric cancers.

The NK car is based on a single chain variable fragment of the widely use humanized monoclonal antibody trastuzumab.

G day five of one car with selected out of several contracts that are primarily focused on optimizing the interest cellular signaling domain is worth.

Further validated in preclinical studies, showing increase in cytotoxicity and enhanced potency.

The first development candidate in our pipeline is G. D. Six out of one which is designed to target multiple myeloma.

The strong biological rationale for the augmentation of allogeneic NK cells with the car to enhance myeloma targeting and see the 38 isn't established immunotherapy the targeted multiple myeloma.

However city of 38 expression on NK cell, which is increased during NK expansion represent the barrier to the development of the CD 38 car NK cell therapy.

To overcome the anticipated targeting of our practice side of NK cell by anti CD 38, we applied CRISPR Cas nine genome editing to disrupt the T 38 protein expression and in Kay.

We combine this with the city of 38 targeting car designed to enhanced killing of <unk> 38 positive myeloma cell and we've demonstrated this in preclinical studies.

We believe that NK cells are of very promising new approach of the treatment of cancers, and we are proud to be at the forefront of the research to advance the powerful technology.

I'll now turn the call over to Michele <unk>, our Chief operating officer, and Chief Commercial Officer, who will talk more of that our launch readiness for all of them into the cell.

Michelle.

Thank you Ronnie and good morning, everyone.

I will review our progress on our commercial manufacturing and the launch readiness activities as we continue to advance our breakthrough therapy arm into the cell for patients in need of an allogeneic stem cell transplant ex.

Julia mentioned, we are working towards BLA submission from the day, but fell in the fourth quarter of this year and our launch planning and manufacturing activities are underway to support a potential U S launch in 2022.

This quarter, we continued to make important progress preparing both our facilities for commercial manufacturing readiness.

CMC qualification activities progress at both the gamete of cell owned manufacturing facility in Israel and Atlanta.

We have made significant advancements in analytical method validation analytical comparability and clinical manufacturing.

We are on track to finalize the CMC qualification requirements for the BLA submission.

In addition, we are very excited about hiring Vladimir Melnikov as our senior Vice President Global manufacturing and operations Vladimir was broad and deep experience provide key expertise as we advance our commercial manufacturing readiness.

We believe that there is a significant opportunity with all of the day the sell.

In the U S alone there are over 40000 patients per year with hematologic malignancies, who consider a bone marrow transplant.

Unfortunately, only approximately 10000 patients are able to make it the transplant for a variety of reasons. We have done extensive research in collaboration with the center for international Blood and marrow transplant research, our CIB MTR and independent market research firms to fully assess the unmet need there.

This market research has enabled us to develop a well informed launch strategy to reach these patients and transplant centers.

Based on our commercial insights the opportunity from the <unk> can be summarized in two key categories.

First is increasing access for patients, especially those who are eligible for transplant and cannot find a match and.

And also improving outcomes based on the unmet clinical needs with current owner of sources that can be addressed by on the day the film.

What specific area of advantage from the data is that it has less stringent matching criteria for patients as compared the grass sources from match related or unrelated donors.

This is particularly important for patients of non Caucasian the scent, who tend to have a more challenging time, finding a suitable match donor.

In fact in the Ahmedou the cell phase III trial over 40% of the patients enrolled were non Caucasian.

Illustrating the important need for a suitable graft source in this patient population.

If approved we believe all of them and doing the study will provide a timely and attractive option for a suitable graft source to patients in need of of bone marrow transplant, who would other otherwise undergo a search for a matched owner of that could take several months, causing high levels of anxiety and also uncertainty for patients who are of great rest of our high risk for relapse.

Yeah.

Upon FDA approval, we believe Ahmed do the cell will be an important therapy option for patients in the U S. In need of an allogeneic stem cell transplants, and we are focused on developing a strong launch strategy spin.

Specifically, we have hired a very experienced commercial leadership team in the U S and continue to augment the capabilities of our team.

Additionally, we continue to have active dialogue with physicians and payers and feedback on the value proposition of <unk> itself has been highly encouraging.

Specifically payers are encouraged by the potential for faster time to each phone craftsman decreased infections decrease in hospitalizations and less graft versus host disease as compared to published literature for other graph sources.

In preparation for the potential approval of all of the data from the U S. The development of the meat of cell assessed continues to progress, which will be an important source of support to patients caregivers and transplant teams throughout each patient's journey with all of my data cell. This.

This is a program like no other for patients undergoing a transplant.

We have hired the gamete of cell assist leadership team that will be focused on supporting the patient's journey with them of David So.

But the meat of cell assist team will include an experienced case management team that will be focused on ensuring patient access and providing support the patients their caregivers and transplant team at the hospital 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 of 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 fall of the patient through the entire process.

In addition, we will be able to provide the hospitals and patients with the assistance to support access to on the date the cell such as benefit verifications or traveling logic needs.

<unk> is committed to supporting a positive journey for patients in their transplant centers. So they could focus on what matters most of the patient experience and successful clinical outcomes.

In summary, we are excited by the potential of on the day, but felt to be the first FDA approved cell therapy for bone marrow transplant and we are encouraged by the clinical data and feedback from physicians payers and patients.

We are progressing our launch preparations and remain on track for product launch in 2022 with a focus on ensuring a positive patient and transplant center experience.

I will now call turn the call over to Shai to review our financial results shy.

Yeah.

Thank you Michelle and good morning, everyone today, I will summarize our financial results for the second quarter of 2021.

As of June 30 of 2021, our total cash flow vision $152 million compared to $127.2 million as of December 31 of last year.

Recently kind of development expenses for the quarter were $13.5 million compared to $9.3 million for the same period in 2020 the increase was.

Due to omit the visa commercial manufacturing readiness activities as well of the advancements of GDA two of one and on the emerging pipeline, including broadening of our scientific capabilities and talent.

Commercial expenses in the quarter of $5.2 million compared to $1 million for the same period last year. The increase was mainly attributed pregnancy. Let me give you sort of commercial readiness activities, which includes among other things the hiring of an experienced commercial leadership team.

General and administrative expenses were $3.8 million for the second quarter of 2021 compared to $2.5 million from the same period in 2020. The increase was mainly due to hiring key management division to support the business of growth.

Finance income net was $1.2 million per the quarter corporate compared to finance expense net of $2.2 million in the same period last year. The increase was primarily due to non cash income resulted from revaluation of warrants offset by interest expenses from the 75 million built on the convertible note financing we did it.

Alere of D C.

Net loss for the quarter.

The $1.3 million compared to the net loss of $15.1 million for the same period last year.

We continue to expect cash used for ongoing activities. This year to range from $110 million to $120 million, we anticipate that our current total cash position will support our ongoing operating activities into the second half of 2022.

This cash runway guidance based on our current operational plan and excludes 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 Julien.

Thanks Shai.

Our vision has always been to find cures for patients with hematologic malignancies, and blood disorders, and we are excited about the many opportunities ahead.

Our accomplishments in 2021 will build extraordinary and the momentum and create a foundation for success in 2022.

On the <unk>, we expect to submit the BLA in the fourth quarter of this year and we are committed to being launch ready at the time of approval.

The GDA 201 on its heels.

With compelling data, we are planning to initiate.

The meat of cell sponsored clinical study in lymphoma before the end of the year.

The plan to share data on the mechanism of action of our non platform translational data and more mature of clinical data at major medical meetings and in peer reviewed publications this year.

Lastly, we're excited about our NK pipeline expansion announced today and look forward to updating you as we have more progress to report later this year.

Now we will open the call for your questions.

Crystal operator.

Thank you, Sir ladies and gentlemen.

As a reminder to ask the question you read the press Star one on your telephone.

Got a question press the pound key the Sun visor compile the gain last day.

Your first question comes from the line of Ted can hop from Piper Sandler Sir Your line is open.

Yeah.

Excuse me Sir your line is open.

Okay.

Yeah.

Please check your phone if you're in mute.

Crystal, Let's maybe just go to the next caller.

We'll give another chance.

Your next question comes from the line of Jonathan Miller from Evercore ISI. Your line is open.

Hi, guys. Thanks, so much for taking the question and congrats on all of the new programs that you just announced a couple of things the across the pipeline.

Can you talk to us about spending ramp for Omi commercial launch of how big of team you anticipate needing and what the.

Timeline of that ramp is going to be as we anticipate the both the BLA and the subsequent approval.

Secondly on <unk> you you've mentioned this enormous potential market of question the states, but what volume do you anticipate current manufacturing being able to fill.

So maybe kind of from the other side of the supply side of it of that curve.

Then talking about the pipeline, maybe a little bit.

Uh huh.

I'm curious.

About the timing of clinical initiation of these pipeline programs or any of these are anticipated to have an IND before the contemplated current cash runway is up.

And.

What is the timeline for getting more clarity on the specifics of those programs, especially of the target of the 401.

F N.

Thank you John Michel.

Let me ask you to respond to the commercial expansion.

And the capacity question.

Absolutely and good morning, John So in regards to your question about on the G of the cell field team and timing. So when you look at the benchmarks and the the cell therapy space.

Specifically, if you look at the car T companies that are also focused on the transplant centers in the U S.

There the range for personnel of it.

Ultimately 25 to 30 commercial account managers and approximately 10 to 15 medical science liaisons that would fall under Ronnie's team.

We do know that in the U S 70 transplant centers to make up approximately 80% or accounts for 80% of the transplant. So we actually do see or we could be on the lower end of those ranges and have a very thorough about efficient footprint in the field. So we're looking on the lower ends of those range of that I've mentioned.

So from the.

The commercial account managers closer to the 25 of the medical science liaison to closer to the turn of the lower end of that range.

In terms of of ramp up so on the commercial side, we have hired Linda Stamler, who is our vice president for both marketing and account management. So we have the leader of both the marketing and account management team in place already and Linda is now in the process of mapping out the timing of hiring the account manager side.

And Ronnie and her team has made excellent progress on bringing in strong leaders on the medical Affairs side also so the leadership team and also some of the sales hiring is already in place.

So that's the question on the the the commercial footprint in the cards to manufacturing the.

Jim at our commercial manufacturing facility in Israel has really made outstanding progress not only with getting ready for the qualification requirements for a BLA, but also getting ready for commercialization. When the facility was designed in Israel was defined as a module of our facility. So as we're seeing that's encouraging data come in.

And for our forecast going forward upon potential FDA approval, we have the ability to add additional modules modules at the at our facility in Israel and cure of God. So we feel very confident that we not only already have the facility in place for launch readiness for commercial needs, but also we know what the long term.

Like for adding additional cores of additional modules.

So let me stop there John and see if you have any questions on what I, just said and then I can turn to Rohit for the NK question.

There was a fabulous response, thanks, I guess, while we're talking about when we're talking to you about the commercial launches and what the opportunities are do you of any updated color on the EU market, how the opportunity is different there and any update on BD for ex U S.

Yeah. So let me talk about the the EU market and I also mentioned other markets. So we have undertaken commercial assessments in both Europe and other parts of the world, including Asia.

We're encouraged by the the opportunities you know, there's certainly the the great need for.

Other potential graph sources other cell therapies for allogeneic stem cell transplant patients in Europe and also in certain areas throughout the world, including Asia. So we are there.

Certainly very focused on launching on the tumor cell in the U S. We feel very confident in our strategy and our execution plans to do it and we're currently assessing what a potential path to launch could be in Europe and in Asia. The clinical study was designed as a head to head the comparator. So we do recognize the applicability.

The of that study in certain parts of the world specifically in Europe.

Thank you.

Excellent and really what's the true.

Please go ahead.

I'm, just saying with regard to the <unk>.

Further pipeline.

And our N K three of one 401.

Ronnie do you want to comment on timing.

And I'll just cover the general cash cash position as well.

Yeah, absolutely so where are the preclinical studies.

For each of the programs that I've outlined.

Including in vitro and in vivo study and as we build the evidence and prepare the information we will advance those through the IMD, we're not providing specific detail about the IMD timing right now, but what I can say is that we will have a an opportunity later.

Yeah, and on R&D day to give more color and detail about all of the assets of that program. So we look forward to sharing more detail later.

Thanks Renee.

It's clear that we've.

Been able to.

Repurpose, a lot of our knowledge, including cryopreservation and cell expansion.

But couple that with the technologies for CRISPR Cas nine in car technologies.

The to be able to and hence our pipelines. So quickly obviously, we will need to raise additional capital to prosecute all of these programs, but the currently.

Currently I see this as an embarrassment of riches.

And our pipeline.

So I certainly look forward to seeing what you have to share with us in the R&D day.

Thanks.

Okay.

Your next question comes from the line of Bad Ben Hoff from Piper Sandler Your line is open.

Great. Thank you very much and the congrats on all the progress.

I'm just wondering of listening to your prepared remarks, and I'll sort of some of the question the answer.

I'm wondering if you're at all contemplating NK cells of my favorite too, but are you contemplating evaluating other cell types that could be.

The processed from umbilical cord.

Thanks, very much and from from donors. Thank you.

Yeah, Ted Thank you for your question in fact the.

And then the technology has broad applicability, we have been able to expand dendritic cells, we've been able to.

Expand gamma Delta T cells.

It's just it's really just the question of bandwidth and prioritization and we've had some very very good luck with the NK cell program and obviously a lot of attention in the field is being.

Being paid to the NK field.

That said.

It doesn't preclude us from expanding other cell types the therapeutic potential.

Great that's really excited and looking forward to the BLA and also a 201 get them into the clinic.

Thanks Ted.

Your next question comes from the line of Jason Jason Butler from JMP Securities. Your line is open hi.

Hi, Thanks for taking the questions and congrats on the progress.

The first one I'm just wondering if you could give us an update on the the expanded access program from the <unk> cell and will we see any data from the EAP.

Before the pre BLA meeting or of the BLA submission. This year and then second question on the antenna programs.

You mentioned, you're leveraging your experience with the cryopreservation of.

Two of one can you just maybe speak to your plans for manufacturing for the new programs will they be cryo preserve products from from the start of.

And of the clinical development or how will you integrate those into your manufacturing facilities.

So let me turn the first question to <unk> to talk about the EAP and then I'll answer your question.

Absolutely. So our expanded access program and are currently running and we're using it and as of the method for serving as our clinical bridging cohorts from both along of the Netherlands and carry out got facilities.

For our commercial manufacturing programs and we've been able to do that as the expanded access study has been open and enrolled patients in order to do that we have some.

From those from that study and we will be happy to share those in collaboration with our academic collaborators are when they when we all feel that those data are mature and ready for publication of.

The presentation so.

So we are I'm also very excited about other data that we will be sharing I'm sorry, other data on our phase III study and other potential data that had been submitted and hope to make those available by the end of the ear of medical meetings as well.

Yes.

Right.

And Jason let me respond about the NK.

The program.

We intend to only use cryo preserved off the shelf.

Products going forward so.

Our pipeline is so design that we can of.

Both manufacture of the sales from April of <unk> units.

And then Jay.

Genetically manipulate them and cryopreserve them and that would be our playbook.

Playbook going forward.

Great. Thanks for taking the questions.

Okay.

Thank you. Your next question comes from the line of Gregory <unk> from RBC capital markets. Your line is open.

Hi, This is the ingo on for Greg and thank you for taking our questions.

Maybe a follow up on the EAP.

I was wondering how should we think about the timeline for manufacturing of data collection for clinical comparability for the siding, Israel and how does that align with your expectation for a pre BLA meeting and submission of the fourth quarter and then another line on the NK program now that you have multiple in the pipe.

Line, how do you think about selection and execution across the five programs. Thank.

Thank you.

So would the.

Would you comment again on the EAP am I absolutely. So we we have six sites for the EAP open in the in the U S with investigators who.

We have worked with us before and are incredibly enthusiastic about enrolling patients and so as we advance our.

Our manufacturing, we have been able to slot in patients.

For four of the program.

Treat them and.

We will continue to do that as we advance forward towards submitting the BLA I'm using the facility and K I got to treat patients in the coming months.

And with regards to the N K the the selection process will be all data driven.

We have created.

A number of very very interesting targets.

Looking at cell lines, but will eventually.

Many of these two mouse models using pdx models as well as other.

Sophisticated models to make the best selections of our product per product development and this will also be informed by our.

Commercial colleagues, who will do a careful market assessments and unmet need of assessments.

For the various <unk>.

Progress that we are developing.

Great. Thank you and congrats on the part of that thank.

Thank you.

Your next question comes from the line of Vernon Bernardino from H C. Wainwright your line is of them.

Yeah.

Good morning, everyone.

Julian everyone. Thanks for taking my question.

Very excited for your progress of the Oh, My goodness all of Bill and look forward to its filing later this year and further progress on the new programs I was wondering if you could provide some insight regarding the market research we've conducted.

The first wondering if the market research, including the component regarding what effect of the pandemic has had on the transplant patient procedures, particularly the ability to conduct these procedures during the searches of corporate cases, but also whether the market research is pumped of any changes in your strategy in the targeting.

The group's debt.

The identified.

Of various opportunities.

Michelle let me invite you to.

The answer on the Mark.

The research activities.

Yes, Thank you and good morning, Vernon So are we going to adjust the number of different types of of market research on but we're very encouraged by is that the consistency of of the research. So this latest round of market research that we conducted it was over 100 transplants in the U S and it was with the actual clinical data from the phase II.

Study prior research before the study had been completed or all of the data set was in was with what we would refer to as the targeted product profile now we were getting physician transplant or feedback on the actual clinical data. They were very encouraged by a number of factors the.

Primary end point, the secondary endpoints and the exploratory endpoints payers also that we spoke to were encouraged by the clinical data and also recognize the importance of reduction in health care resource utilization, specifically around the reduction in time in the hospital reduction for interventions due to less infection. So the the takeaway from the research.

Continues to be very encouraging so it has not changed our strategy. What it has done is actually help to better inform our strategy and give us more encouragement and confidence in the opportunity.

Vernon you you. The question around Covid has been very very challenging for a patient and you know.

We certainly hope that we see this pandemic begin to get to a more stable place for patients. What we can say that comes out in the research is it was very difficult to a line donors with patients during the pandemic unrelated.

Unrelated donors was very difficult.

Because you have to align the donor with the patient and we know even in traditional times that could take two to three months of what we were what we were being told during Covid is sometimes of it was just not possible to align the donor with the patient one of the benefits of all of them or do the cell with our starting material being cord blood that is banked that the cord blood banks during our phase.

III study, we were still able to access the the cord blood that was required for manufacturing half of our proprietary NAV technology expand the sales appropriately and return them to the center. So that was something that came out through the market research as a benefit from the <unk> yourself given that we don't have to bring a donor.

The into a hospital setting.

As you can see what the other graph sources.

So finally, let me touch the preference if you have any questions. Thank you.

No that's perfect that's exactly the answer I was looking for thanks for providing it I appreciate it.

Vernon.

Yeah.

Yeah.

Your next question comes from the line of Mike. We then back from Oppenheimer. Your line is open.

Hey, good morning, guys. Thanks for taking the questions.

Just a few from me all kind of geared towards the NK programs.

No.

Phase one two protocol for GDA 201, it's been finalized can you give us a little color on the study size and the specific doses that will be tested in phase one.

How many sites you plan to activate that sort of thing.

And then I was hoping you could describe the.

The interest cellular signaling domains of the her two and CD 38 car construct for the day that are being used in some of the new products are are they both of the same.

And maybe you can point to any key differences between these and competing current state contracts and finally with respect to the use of the membrane bound IL 15, and I'm. Just wondering if you see the key barriers to the type of putting the type of contract and <unk> 301, given the other end.

Developers are also pursuing similar approaches thanks for taking the questions.

So.

Would you comment on the GDA 201 phase one two.

Sure.

Terms of the GDA two of one of phase one to be conducting it as a phase one first at a live of the limited number of sites in the United States appropriate two of phase one.

We are using doses based on our experience using the product that we tested with the University of Minnesota, We have experienced there in terms of the number of cell.

And we'll be using a similar dosing based on that experience.

After we complete the phase, one which will be.

We used to.

The evaluate safety.

Phase one or will.

We will be transferring the study over to a larger number of sites.

To conduct the phase two.

And we have not announced yet the number of patients.

That will be tested in the phase two nor the number of sites, but I can share that the operational activities are underway.

There's enthusiasm and excitement by potential investigators and the all of the execution of all activities in terms of getting the sites and the investigators lined up for.

For the study.

Our happening.

Right now in preparation for initiating the study later this year.

And once we file the IND cleared to open the study we'll provide more details.

On the study design number of patients.

Some of your other follow up questions asked of them.

With regards to the pipeline.

Where.

Thanks silent on of the details of the intracellular signaling today, but at an R&D day later this year.

We plan to go into a lot more detail and <unk>.

Rest assured that we've filed all of the appropriate intellectual property.

Submissions.

And are quite confident that we will have freedom to operate with with the.

The <unk>.

Does it made.

Kinetic manipulations.

That are underway, both for the car and for the the.

The market from that.

Pathways.

Yeah.

Mark are you there.

It's still here.

The team at that.

It covers the membrane bound IL 15 as well.

Yes.

Alright. Thank you we've looked at a number of different.

The construction and really Theyre doing head to head comparisons and it really just picking the best the.

The best of the best in the lab.

Yeah.

Alright, great. Thank you.

Again, ladies and gentlemen, if you want to ask a question. Please press star one.

Your next question comes from the line of Chad Messer from the midterm and company Sir Your line is open.

Yes.

Ah.

Great Good morning, and thanks for thanks for taking my question.

Between the NDA as an R&D pipeline expansions it sounds like the.

Certainly.

And the are busy over there.

We've covered a lot of ground, but maybe.

Maybe just on the.

The pipeline I was wondering if I could get your thoughts on on the her two target you've got a lot of really cutting edge technologies, you're thrown at amp at NAV.

<unk>, which is exciting to see this is a extremely well valid of target maybe maybe one of the most in oncology with <unk>.

Antibodies of small molecules.

And then in development of any number of other ways of going at it.

Just wondering what particular advantages you think you, bringing her targeting specifically in solid tumor target too by the way very very exciting to see that.

And where you might think of the unmet need is where do you think you would develop this I mean, presumably in from non cellular failures to targeted therapies, but if there is of particular place you see the need.

Yeah.

Hum.

It's an excellent question.

Obviously, we think that the her two car has the potential to be.

As effective if not much more effective.

And then combining it with herceptin the.

Monoclonal antibody.

And Thats.

Part of our engineering strategy is to is to make.

The cash.

Cars.

Effective to be able to be used in solid tumors as you know solid tumors have a.

Immunosuppressive microenvironment and so there are a lot of barriers and so far really no. One has reported the data in solid tumors.

With the with any great efficacy, but it's still early days.

And.

What was mentioned in the in the prepared remarks is that there are a number of her two positive cancers, but.

In particular I I.

A lot about gastric cancer and some of the lesser.

Lesser known.

Cancers that are not as well served by the herceptin.

Per Janet so.

We're thinking a lot about the.

The various tumor models that we will develop.

And the clinical program.

Could be a basket trial.

Per acre to patients through brands.

The refractory obviously two to enter the trial.

Alright, great. Thanks.

There are no further question at this time Mr. Julien Please continue.

Well it just remains for me the thank everyone for joining us on today's call and we look forward to updating you in the future.

Bye for now.

Ladies and gentlemen, this concludes on today's conference call. Thank you for participating you may now disconnect.

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Thank you Crystal and good morning, everyone welcome to today's call during which we will provide an update on the company and review our financial results for the second quarter of 2021 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 commute of cell Dot com.

Here with me on our call today are Julian Adams, Chief Executive Officer, Rodney Southern Power, Chief Medical Officer, Michelle Courson, Chief operating Officer, and Chief Commercial Officer, and <unk> Chief Financial Officer. There will also be a Q&A session. Following our prepared remarks.

During this call we may make forward looking statements about our future expectations and plans, including in respect of the timing and initiation and progress of.

And data reported from the clinical trials of our product candidates anticipated regulatory filings, including the submission of the BLA for on the do the cell to the FDA commercialization planning efforts, the potentially life saving or curative therapeutic and commercial potential of vomited itself and our expectations regarding our projected cash.

Cash to the used for operating activities and cash runway of our actual results may differ materially from what we project today due to a number of important factors, including the impact of the COVID-19 pandemic on our operations the scope of progress and expansion of our clinical trials and cost impacts thereof clinical scientific Greg.

<unk> and technical developments and those inherent in the process of developing and commercializing product candidates that are safe and effective for use of human therapeutics and in the endeavor of building the business around such product candidates as well as those considerations described in the risk factors section of our most recent annual report.

On form 20-F, and other filings that we make with the SEC from time to time. These.

These forward looking statements represent our views only as of today and we caution you that we may not update them in the future whether as a result of new information future events or otherwise and now I'd like to turn the call over to Julian.

Thank you, Josh and thanks to everyone for joining us this morning.

This was a productive quarter forgive me the cell we.

We continue to execute on our plan to launch the.

The first allogeneic stem cell therapy on the.

The Dubai cell for cancer patients in need of the stem cell transplant.

In addition, based on promising preliminary studies, we have accelerated our plans to develop a unique NAV enabled the natural killer or NK cell GDA 201, four patients with Follicular lymphoma, and diffuse large b cell lymphoma.

And we are very excited about the expansion of our cell therapy type line with four new NAV enabled genetically modified NK cell.

Targeting cancers.

Patients are at the forefront of of our work and we have many per Kearney, our NAV enabled NK product candidates and take care of the therapy.

I'll start with our most advanced program from Adobe cell.

Potentially lifesaving treatment for patients with blood cancers, who are in need of the stem cell transplant the.

This quarter, we announced the results of the phase III clinical study of all of them into the cell, which were published in the official journal of the mountain.

Sadly putting the colleges.

The published results demonstrate the transplantation without going through the sale lease.

The faster neutrophil and platelet recovery.

And one of the standard of care.

Additionally, the day to demonstrate that Oh Madhu good sales results in fewer bacterial fungal and viral infections and less time in the hospital.

These results add to the compelling body of evidence of the potential of Oh, My goodness cell as a life saving therapy that can benefit patients in need of the bone marrow transplant and help reduce the burden on our health care system.

The continued to execute our plan of action to towards becoming a commercial company in 2022, as we prepare for our BLA submission.

On the do the cell by the end of this year.

Subject to a pre BLA meeting with the agency in the fourth quarter.

On the tumor cell.

Has the potential to be the first FDA approved cell therapy.

Stem cell transplants.

Michelle will provide an update on the launch readiness later on in the call.

Moving to our pipeline, we believe the NK cell hold tremendous potential as the best in class next generation of immunotherapy.

And pay cells of the bodies of cruise line of defense and providing innate immunity.

They also have immune privileged properties, which albeit the requirement for HLA matching.

Given that any healthy adult zone of can provide the nice releases unit.

From which we apply our proprietary NAV technology to expand the produce a cryopreserve off the shelf allogeneic natural killer cell treatments for cancer patients.

Our NAV enabled NK cell.

Like several important cell surface markers, including high expression of <unk> 16, the FC Gamma receptor antibodies, which allows the combination with monoclonal antibodies the target tumors through enhanced antibody dependent cellular cytotoxicity or <unk>.

Importantly, NAV also increases.

Two L where L selectin expression, which leads the in vivo of homeland and the tension and lymphoid tissues.

Furthermore, NAV increases the Queen.

<unk> of inflammatory cytokines.

The activation.

Of hosted that immune cell.

Combination of these activities result in increased cytotoxicity five for more efficient tumor cell, killing and durable responses.

The combination of NK cells with therapeutic antibodies increased GDA 201.

And the enhanced the agency.

Both in vitro and in vivo.

For the clinical treatment with GDA 201.

In parallel with selected antibodies for sales.

Allegiances.

We are advancing the power of NK cell to the next level with our second candidate in clinical development TVA to of one.

Which has demonstrated remarkable results and preliminary studies as the potential treatment for patients with Follicular and diffuse large b cell lymphoma.

We have completed the GMP batches without Cryopreserved formulation of GDA 201 are on track to submit an IMD in this quarter.

To support a multi center phase one two study by the end of the year.

Today, we announced that we're expanding the beach.

Both of the NAV technology, and the power of NK cells to the growth.

Of our Interstate pipeline to now include genetically modified variance and proprietary therapies using CRISPR past nine and car technologies.

Rohit will give more detail on this exciting new developments shortly and we look forward to providing a more detailed update at an R&D day.

Day later this year.

I'm extremely proud of the progress our team has made this expansion and I believe that our technology combined with our expertise of NK biology.

Holds great promise for further.

To further our vision of bringing curative therapies to patients.

A lot of conclude my introductory remarks by really thanking our employees for their continued dedication to our mission and hard work.

And with that I will turn the call of Germany.

Thank you Julian.

I'm very excited to provide more detail on our NK pipeline expansion, which we announced this morning.

We're confident in the potential to leverage our NAV technology for the newly announced target based on the encouraging clinical data we've demonstrated with GDA 201 for patients with lymphoma.

The new program will involve genetic modifications and tenants of direct and T cell against cancer cell and hence the targeting and persistence and improving cytotoxicity against both hematologic malignancies.

And solid tumors.

The pipeline expansion stems from research that we've been conducting here at the need of cell and in collaboration with key academic researchers and represents important progress in the development of NK therapy for patients.

Our new product candidate <unk> 301 of them.

Knockout of the fish or cytokine and visible at the chip attaining protein in NK cells, using CRISPR Cas night with concomitant expression of membrane bound interleukin 15 of IL 15.

This is the regulator of IL 15, signaling and fish dilution increases and pay sensitivity of the IL 15 by lowering the NK activation threshold.

NK cell equipped with the membrane bound IL 15 are designed for enhanced persistence and improved anti tumor effects.

In preclinical studies, we demonstrated the elevation of pro inflammatory cytokines and enhanced potency and cytotoxic activity in the cell.

We believe that the fish target coupled with membrane bound IL 15 of potential across multiple tumor types.

Additionally, today, we announced the development of GTA for one which is genetically engineered towards the undisclosed target the <unk>.

To enhance NK cell survival and of solid tumor microenvironment.

The C. D 301, we believe the GDA floor of one have potential application of across a broad range of solid tumor.

The third development candidate in our pipeline is GTA five of one.

The Merrick antigen receptor of car engineered NK cell designed to target her two positive solid tumors.

This candidate has the potential to enhance home to an activity against tumors expressing her too such as breast cancer ovarian lung bladder and gastric cancers.

The NK car is based on a single chain variable fragment of the widely use humanized monoclonal antibody trastuzumab.

To date five of one car with selected out of several construct that is primarily focused on optimizing the interest cellular signaling domain.

Further validated in preclinical studies, showing an increase of cytotoxicity and enhanced potency.

The first development candidate in our pipeline is GTA six out of one which is designed to target multiple myeloma.

The strong biological rationale for the augmentation of allogeneic NK cells with the car to enhance myeloma targeting and see the 38 is an established immunotherapy the targeted multiple myeloma.

However, CD 38 expression on NK cell, which is increased during N. K expansion represent the barrier to the development of the CD 38 car NK cell therapy.

To overcome the anticipated targeting of our practice side of the NK cells by anti CD 38, we applied CRISPR Cas nine genome editing the disrupt CD 38 protein expression and in Kay we.

Combine this with the city of 38 targeting car designed to enhanced killing of any 38 positive myeloma cell and we've demonstrated this in preclinical studies.

We believe that NK cells are of very promising new approach of the treatment of cancers, and we are proud to be at the forefront of the research to advance the powerful technology.

I'll now turn the call over to Michele <unk>, our Chief operating officer, and Chief Commercial Officer, who will talk more of that our launch readiness on the day of itself.

Michelle.

Thank you Ronnie and good morning, everyone. Today, I will review our progress on our commercial manufacturing out of the launch readiness activities as we continue to advance our breakthrough therapy arm into the cell for patients in need of an allogeneic stem cell transplant.

The Leo mentioned, we are working towards BLA submission from the day, but fell in the fourth quarter of this year and other launch planning and manufacturing activities are underway to support a potential U S launch in 2022.

This quarter, we continued to make important progress preparing both our facilities for commercial manufacturing readiness.

The empty qualification activities progressed and both the gamete of cell owned manufacturing facility in Israel and Atlanta.

We have made significant advancements in analytical method validation analytical comparability and clinical manufacturing.

We are on track to finalize the CMC qualification requirements for the BLA submission.

In addition, we are very excited about hiring Vladimir known the cough as our senior Vice President Global manufacturing and operations Vladimir was broad and deep experience provide key expertise as we advance our commercial manufacturing readiness.

We believe that there is a significant opportunity with on the type of cell.

In the U S alone there are over 40000 patients per year with hematologic malignancies, who consider a bone marrow transplant.

Unfortunately, only approximately 10000 patients are able to make it the transplant for a variety of reasons. We have done extensive research in collaboration with the center for international Blood and marrow transplant research, our CIB MTR and independent market research firms to fully assess the unmet need this.

Market research has enabled us to develop a well informed launch strategy to reach these patients and transplant centers.

Based on our commercial insights the opportunity for them and do the cell can be summarized in two key categories.

First is increasing access for patients, especially those who are eligible for transplant and cannot find a match and.

And also improving outcomes based on the unmet clinical needs with current owner of sources that can be addressed by on the day the film.

What's the.

It's a big area of advantage from the data is that it has less stringent matching criteria for patients as compared to the graph sources from match related or unrelated donors.

This is particularly important for patients of non Caucasian descent, who tend to have a more challenging time, finding a suitable matched donor.

In fact in the on the <unk> phase III trial over 40% of the patients enrolled were non Caucasian.

Illustrating the important need for a suitable graft source in this patient population.

If approved we believe all of them a day to start we'll provide a timely and attractive option for a suitable graph sourced to patients in need of of bone marrow transplant, who would other otherwise undergo a search for a matched owner of that could take several months, causing high levels of anxiety and also uncertainty for patients who are of great rest of high risk from relapse.

Upon FDA approval, we believe on the do the cell will be an important therapy option for patients in the U S. In need of an allogeneic stem cell transplants, and we are focused on developing a strong launch strategy spin.

Specifically, we have hired a very experienced commercial leadership team in the U S and continue to augment the capabilities of our team.

Additionally, we continue to have asked of dialogue with physicians and payers and feedback on the value proposition of all of the deep itself has been highly encouraging.

Specifically payers are encouraged by the potential for faster time to huge phone craftsman decreased infections decrease in hospitalizations and less graft versus host disease as compared to published literature for other craft sources.

In preparation for the potential approval of all the data from the U S. The development of gamete of cell assist continues to progress, which will be an important source of support to patients caregivers and transplant teams throughout each patient's journey with almost the itself.

This is a program like no other for patients undergoing a transplant.

We have hired the meat of cell assist leadership team that will be focused on supporting the patient's journey with them of David cell.

But the meat of cell assist team will include an experienced case management team that will be focused on ensuring patient access and providing support the patients their caregivers and transplant team at the hospital 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 gamete of cell assist will start our chain of identity, which is a unique patient identifier that will fall of the patient through the entire process and.

In addition, we will be able to provide the hospitals and patients with the assistance to support access to on the date the cell such as benefit verifications or traveling logic needs.

The meat of cell is committed to supporting a positive journey for patients in their transplant centers. So they could focus on what matters most of the patient experience and successful clinical outcomes.

In summary, we are excited by the potential of on the day, but felt to be the first FDA approved cell therapy for bone marrow transplant and we are encouraged by the clinical data and feedback from physicians payers and patients.

We are progressing our launch preparations and remain on track for product launch in 2022 with a focus on ensuring a positive patient and transplant center experience.

I will now call turn the call over to Shai to review our financial results choice.

Yeah.

Thank you Michelle and good morning, everyone. Good day.

Summarizing our financial results for the second quarter of 2021.

As of June 30 of 2021, our total cash position when the $152 million compared to $127.2 million.

730 <unk> of loss.

Last year.

Research and development expenses for the quarter were $13.5 million compared to $9.3 million for the same period in 2020 net increase was mainly due to omit the visa commercial manufacturing readiness activities.

All of the advancements of GDA two of one and all of our emerging pipeline, including broadening our scientific capabilities and talent.

Commercial expenses in the quarter were $5.2 million compared to $1 million for the same period last year. The increase was mainly attributed the pregnancy. I mean give me sort of commercial readiness activities, which include among other things the hiring of an experienced commercial leadership team.

General and administrative expenses were $3.8 million per the second quarter of 2021 compared to $2.5 million from the same period in 2020. The increase was mainly due to hiring key management position to support the business of growth.

Finance income net was $1.2 million per the quarter corporate compared to finance expense net of $2.2 million in the same period last year. The increase was primarily due to non cash income resulted from revaluation of warrants offset by interest expenses from the 75 million billions of convertible note financing we did.

Or do you see of.

Net loss for the quarter.

The $1.3 million compared to the net loss of $15. One of them you can go for the same period last year.

We continue to expect cash used for ongoing operating activities. This year to range from $110 million to $120 million. We anticipate the current total cash position will support our ongoing operating activities into the second half of 2022.

This cash runway guidance based on our current operational plan and excludes 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 Julien.

Thanks Shai.

Our vision has always been to find cures for patients with hematologic malignancies, and blood disorders, and we are excited about the many opportunities ahead.

Our accomplishments in 2021 will build extraordinary momentum and create a foundation for success in 2022.

Oh Madhu the cell, we expect to submit the BLA in the fourth quarter of this year and we are committed to being launch ready at the time of approval.

The GDA 201 on its heels.

With compelling data, we are planning to initiate.

The meat of cell sponsored clinical study in lymphoma before the end of the year.

The plan to share data on the mechanism of action of our NAV.

<unk> platform translational data and more mature of clinical data at major medical meetings and the peer reviewed publications this year.

Lastly, we're excited about our NK pipeline expansion announced today and look forward to updating you as we have more progress to report later this year.

Now we will open the call for your questions.

Crystal operator.

Thank you, Sir ladies and gentlemen.

As a reminder to ask question you read the press star one on the telephone. So we got a question does the bounty. Please standby were compiled the gain last day.

Your first question comes from the line of Ted can hop from Piper Sandler Sir Your line is open.

Yeah.

Excuse me Sir your line is open.

Yeah.

Just check your phone if you're in mute.

Crystal, Let's maybe just go to the next caller.

Yeah.

We'll give another chance.

Your next question comes from the line of Jonathan Miller from Evercore ISI, Sir Your line is open.

Hi, guys. Thanks, so much for taking the question and congrats on all of the new programs that you just announced a couple of things the across the pipeline.

Can you talk to us about spending ramp for Omi commercial launch of how big of team do you anticipate needing and what the.

Timeline of that ramp is going to be as we anticipate the both the BLA and the subsequent approval.

Secondly on only you you've mentioned this enormous potential market of the question the states, but what volume do you anticipate current manufacturing being able to fill.

So maybe coming from the other side of the supply side of the curve.

Then talking about the pipeline, maybe a little bit.

Uh huh.

I'm curious.

About the timing of clinical initiation of these pipeline programs are are any of these are anticipated to have an IND before the contemplated current cash runway is up.

And.

What is the timeline for getting more clarity on the specifics of those programs, especially of the target of the 401.

That's it.

Thank you John Michel.

Let me ask you to respond to the commercial expansion.

And the capacity question.

Absolutely and good morning, John So in regards to your question about how much of the cell field team and timing. So when you look at the benchmarks and the the cell therapy space.

Typically if you look at the car T companies that are also focused on the transplant centers in the U S.

The range for personnel.

Ultimately 25 to 30 commercial account managers and approximately 10 to 15 medical science liaisons that would fall under <unk>.

We do know that in the U S 70 transplant centers to make up approximately 80% or accounts for 80% of the transplant. So we actually do see or we could be on the lower end of those ranges and have a very thorough about efficient footprint in the field. So we're looking on the lower range of those ranges that I've mentioned.

So you know.

The commercial account managers closer to the 25 of the medical science liaison to closer to the turn of the lower end of that range.

In terms of of ramp up so on the commercial side, we have hired Linda Stamler, who is our vice president for both marketing and account management. So we have the leader of both the marketing and account management team in place already.

Linda is now in the process of mapping out the timing of hiring the account manager side and you know Rohit and her team has made excellent progress on bringing in strong leaders on the medical Affairs side also so the leadership team and also some of the fields hiring is already in place.

So that's the question on the the the commercial footprint in regards to manufacturing the two.

At our commercial manufacturing facility in Israel has really made outstanding progress not only with cash.

Ready for the qualification requirements for a BLA, but also getting ready for commercialization when the peso.

Somebody of his designs in Israel. It was defined as the modular facility. So as we're seeing that's encouraging data come in for our forecast going forward upon potential FDA approval, we have the ability to add additional modules modules at the at our facility in Israel and cure of God. So we feel very confident that we not only already.

Have the facility in place for launch readiness for commercial needs, but also we know what the long term looks like for adding additional cores or additional modules.

So let me stop there John and see if you have any questions on what I, just said and then I can turn to Ronit for the NK question.

I know that there was a fabulous response, thanks, I guess well we're talking about when we're talking to you about the commercial launches and what the opportunities are do you of any updated color on the EU market. The have the opportunity is different there and any update on BD for ex U S.

Yeah. So let me talk about the the EU market and I also mentioned other markets. So we have undertaken commercial assessments in both Europe and other parts of the world, including Asia.

We're encouraged by the the opportunities you know, there's certainly the the great need for.

Other potential craft sources other cell therapies for allogeneic stem cell transplant patients in Europe and also in certain areas throughout the world, including Asia. So we are there.

Certainly very focused on launching on the dutra cell in the U S. We feel very confident in our strategy and our execution plans to do it and we're currently assessing what a potential path to launch could be in Europe and in Asia. The the clinical study was designed as a head to head the comparator. So we do recognize the applicability.

The of that study in certain parts of the world specifically in Europe.

Thank you.

Excellent and many of them.

Oh. Please go ahead.

I'm, just saying with regard to the.

Further pipeline.

Our N K three of one 401.

Ronnie do you want to comment on timing and I'll just cover the general cash cash position as well.

Yeah, absolutely. So we are in the midst of preclinical studies.

For each of the programs that I've outlined.

Including in vitro and in vivo study and as we build the evidence.

And prepare the information we will advance those through <unk>, we're not providing specific detail about the IMD timing right now, but what I can say is that we will have.

And opportunity later this year in an R&D day to give more color and detail about all of the assets of that program. So we look forward to sharing more details later.

Thanks, Thanks Ronny.

It's clear that we have.

Been able to.

Repurpose of lot of our knowledge, including cryopreservation and cell expansion.

The couple that with the technologies for CRISPR cash nine and car technologies.

The to be able to hedge.

Hence our pipeline. So quickly obviously, we will need to raise additional capital to prosecute all of these programs, but the.

Currently I see this as an embarrassment of riches.

And our pipeline.

So I certainly look forward to seeing what you have to share with us in the R&D day.

Thanks.

Right.

Your next question comes from the line of Bad Ben Hoff from Piper Sandler Your line is open.

Great. Thank you very much and the congrats on all the progress of this.

Wondering of listening to your prepared remarks, and all sorts of all of the.

The question.

Or.

I'm wondering if you're at all contemplating NK cells from my favorite too, but are you contemplating evaluating other cell types that could be.

Processed from umbilical cord.

Thanks, very much and from from donors. Thank you.

Yeah, Ted Thank you for your question in fact.

The NAV technology.

Broad applicability, we have been able to expand dendritic cells, we've been able to expand.

Expand gamma Delta T cells.

It's just it's really just the question of bandwidth and prioritization and we've had some very very good luck.

With the NK cell program, and obviously a lot of attention in the field is.

Being paid to the NK field.

That said we do.

Doesn't preclude us from expanding other cell types the therapeutic potential.

Great that's really excited and looking forward to the BLA and also a 201 get them into the clinic.

Thanks Ted.

Your next question comes from the line of Jason Jason Butler from JMP Securities. Your line is open.

Hi, Thanks for taking the questions and congrats on the progress.

First of all I'm, just wondering if you could give us an update on the expanded access program from the <unk> the cell and will we see any data from the EAP.

Before the pre BLA meeting more of the BLA submission. This year and then second question on the NK programs.

You mentioned, you're leveraging your experience with the current preservation of.

Two of one can you just maybe speak to your plans for manufacturing for the new programs will they be cryo preserve products from from the start of.

And of the clinical development or how will you integrate those into your manufacturing facilities.

So let me turn the first question to <unk> to talk about the EAP and then I'll answer your question.

Absolutely. So our expanded access program is currently running and we are using it.

As of the method for serving as our clinical bridging cohorts from both the long of the Netherlands and carry out got facilities for our commercial manufacturing programs and we've been able to do that as the expanded access study has been open and enroll patients in order to.

The to do that we have some.

Results from those.

From that study and.

He will be happy to share those in collaboration with the our academic collaborators a win.

When we all feel that those data are mature and.

Ready for publication of our presentation.

We are also.

Very excited about other data that we will be sharing.

Our other data on our phase III study.

And the other potential data that had been submitted and hope to make those available by the end of the year and medical meetings as well.

Okay great.

And Jason let me respond about the NK.

Graham.

We intend to only use cryo preserved off the shelf.

The products going forward so.

Our pipeline is so design that we can.

Both manufacture of the sales from paper research units.

And then.

Genetically manipulate them and cryopreserve them and that would be our playbook.

Playbook going forward.

Great. Thanks for taking the questions.

The.

Your next question comes from the line of Gregory <unk> from RBC capital markets. Your line is open.

Hi, This is the English one for Greg. Thank you for taking our questions.

Maybe a follow up on the EAP.

I was wondering how should we think about the timeline for manufacturing of data collection for the clinical comparability for the siding, Israel and how does that align with your expectation for a pre BLA meeting and submission of the fourth quarter and then another one of the NK program now that you have multiple in the pipeline.

Line, how do you think about selection and execution across the five programs. Thank.

Thank you.

So would the.

Would you comment again on the EAP am I, absolutely. So we.

We have six sites for the EAP open in the in the U S with investigators who have worked with us before.

And of incredibly enthusiastic about enrolling patients and so as we advance our manufacturing we have been able to slot in patients.

The four for the programs.

And treat them and.

We will continue to do that as we advance forward towards submitting the BLA using the facility and K I got to treat patients in the coming months.

And with regards to the N K the the selection process will be all data driven.

We have created.

A number of very very interesting targets.

We're looking at cell lines, but will eventually.

Many of these two mouse models using pdx models as well as other.

Sophisticated models to make the best selection of.

Product for product development and this will also be informed by our.

Commercial colleagues, who will do a careful market assessments and unmet need of assessments.

For the various <unk>.

Programs that we are developing.

Great. Thank you and congrats on the progress thank.

Thank you.

Your next question comes from the line of Brandenburg Nyina from H C. Wainwright. Your line is open.

Yeah.

Good morning, everyone.

Julian everyone. Thanks for taking my question.

Very excited for your progress of Oh, My goodness all of the OEM.

I look forward to its filing later this year and further progress on the new programs.

Wondering if you could provide some insight regarding the market research we've conducted.

Specifically I was wondering if the market research include a component regarding what effect of the pandemic has had on the transplant patient procedures, particularly the ability to conduct these procedures during the surges of Covid cases, but all of them.

Other than the market research is pumped with any changes in your strategy and the targeting of the.

The group's debt.

You identified as the.

Of various opportunities.

Michelle let me invite you to.

The answer on the Mark.

The research activities.

Yes, Thank you and good morning current and so we want to adjust the number of different types of of market research and what we're very encouraged by is that the consistency of of the research. So this latest round of market research that we conducted it was over 100 transplant. There's in the U S and it was with the actual clinical data from the phase III.

Study.

Liar research before the study had been completed or all of the data set was in was with what we would refer to as a targeted product profile now we were getting physician transplant or feedback on the actual clinical data. They were very encouraged by a number of factors the.

Primary end point, the secondary endpoints and the exploratory endpoint payers also that we spoke to were encouraged by the clinical data and all of sudden recognized the importance of reduction of healthcare resource utilization specifically around reduction of time in the hospital reduction for interventions due to the less infection. So the the takeaway from the research.

Continues to be very encouraging so it has not changed our strategy. What it has done is actually help to better inform our strategy and give us more encouragement and confidence in the opportunity.

Vernon you you. The question around Covid has been very very challenging for patients and.

We certainly hope that we see this pandemic begin to get to a more stable place for patients. What we can say that comes out in the research is it was very difficult to a line donors with patients during the pandemic.

Unrelated donors was very difficult.

Cause you had to align the donor with the patient and we know even in traditional times that could take two to three months of what we were what we were being told from Covid. It sometimes it was just not possible to align the donor with the patient one of the benefits of all of them and do the cell with our starting material being cord blood that is banked that the cord blood banks.

During our phase III study, we were still able to access the the cord blood that was required for manufacturing half of our proprietary NAV technology expand the sales appropriately and return them to the center. So that was something that came out through the market research as a benefit from the <unk> yourself given that we don't have to bring.

A donor or into a hospital setting.

As you see what the other graph sources.

So Brian let me go to the performance if you have any questions. Thank you.

No that's perfect that's exactly the answer that I was looking for thanks for providing it appreciate it.

Thank you Brendan.

Yeah.

Your next question comes from the line of Mike. We then back from Oppenheimer. Your line is open.

Hey, good morning, guys. Thanks for taking the questions.

Just a few from me all kind of geared towards the NK programs.

First now that the phase one two protocol for GDA 201 of its been finalized.

Give us a little color on the study size and the specific doses that will be tested in phase one.

Many sites you plan to activate that sort of thing.

And then I was hoping you could describe.

The intracellular signaling domains of the her two and CD 38 car construct for the deals that are being used in some of the new products or are they both of the same.

And maybe you can point to any key differences between these and competing current contracts and finally with respect to the use of the membrane bound IL 15, and I'm. Just wondering if you see the IP barriers to the type of the puts.

This type of contract and <unk> 301, given that other NK developers are also pursuing similar approaches thanks for taking the questions.

So.

Would you comment on the GDA 201 phase one two.

Sure.

So in terms of the GDA two of one.

Phase two will be conducting it as a phase one first at a live of the limited number of sites in the United States appropriate two of phase one.

We are using doses based on our experience using the product that we tested with the University of Minnesota, We have experienced there in terms of the number of cell.

And we'll be using a similar dosing based on that experience.

After we complete the phase one which will.

The used to.

Evaluate safety.

As phase one or.

We will be transferring the study over to a larger number of sites.

To conduct the phase two.

And we've not announced yet the number of patients.

That will be tested in the phase two of.

Nor the number of sites, but I can share that the operational activities are underway.

There is enthusiasm and excitement by potential investigators and the all of the execution of all activities in terms of getting the sites and the investigators lined up.

For the study.

Are happening.

Right now in preparation for initiating the study later this year.

And once we file the IND cleared to open the study we'll provide more details.

The study design number of patients.

Some of your other follow up questions.

With regards to the pipeline.

We're.

Thanks silent on the details of the intracellular signaling today, but at an R&D day later this year.

Plan to go into a lot more detail and rest.

Rest assured that we've filed all of the appropriate of intellectual property.

Hum submissions.

And are quite confident that we will have freedom to operate with with the.

The designated.

The genetic manipulations.

Are underway, both for the car and for the.

The market.

The pathways.

Yeah.

Mark are you there yet.

It's still here.

Thank you Matt that that covers the membrane bound IL 15 as well.

Yes.

Yeah.

Alright, thank you.

Looked at a number of different.

The construction and related of doing head to head comparisons and it really just picking the best.

The best of the best in the lab.

Alright, great. Thank you.

Yeah.

Again, ladies and gentlemen, if you wanted to ask a question. Please press star one.

Your next question comes from the line of Chad Messer from the midterm and company Sir Your line is open.

Yeah.

Great Good morning, and thanks for thanks for taking my question.

Between the NDA and indeed, the pipeline expansions it sounds like you guys certainly certainly are busy over there.

We've covered a lot of ground, but maybe.

Maybe just on the pipeline I was wondering if I could get your thoughts on on the her two target you've got a lot of really cutting edge technologies, you're thrown at amp at NAV.

<unk>, which is exciting to see this is a extremely well validated target maybe maybe one of the most in oncology with <unk>.

Antibodies of small molecules.

And then the development any number of other ways of going at it.

Just wondering what particular advantages you think you, bringing her targeting specifically in solid tumor target too by the way very very exciting to see that.

And where you might think of the unmet need is where where do you think you would develop this I mean, presumably in some non cellular failures to targeted therapies, but if there is of particular place you see the need.

Yes.

It's an excellent question.

Obviously, we think that the her two car has the potential to be.

As effective if not much more effective.

The combining it with herceptin the mine.

Cornwell of antibody.

And Thats.

Part of our engineering strategies is to make.

Okay.

The the cars.

Effective to be able to be used in solid tumors as you know solid tumors have a.

Very.

<unk> of microenvironment, and so there are a lot of barriers and so far really no. One has reported the data in solid tumors.

With any great efficacy, but it's still early days.

And.

What was mentioned in the prepared remarks is that there are a number of her two positive cancers, but.

In particular.

Think of a lot about gastric cancer and some of the lesser.

Lesser known.

Cancers that are not as well served by herceptin.

So.

We're thinking a lot about the.

The various tumor models that we will develop.

And the clinical program.

Could be a basket trial.

Hum.

All of her two patients too.

That are refractory obviously two to enter the trial.

Alright, great. Thanks.

There are no further question at this time Mr. Julianne. Please continue.

Well it just remains for me the thank everyone for joining us on today's call and we look forward to updating you in the future.

Bye for now.