Q2 2022 Gamida Cell Ltd Earnings Call
The conference will begin shortly to raise your hand during Q&A you can dial star one one.
[music].
Ladies and gentlemen.
And I'll be your operator.
Todays call. Please be advised that this call is being.
Now I would like to introduce your host for today's conference Heather.
Gamete of sales director of Investor Relations and corporate Communications. Please go ahead. Thank.
Thank you Olivia 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 2022.
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 the meter dash so dot com.
Here with me on the call today are Julian Adams, Chief Executive Officer, <unk>, <unk>, our Chief Medical Officer, and scientific Officer, Michele <unk>, Our Chief operating Officer, and Chief Commercial Officer, <unk>, <unk>, our Chief Financial Officer.
During this call we may make forward looking statements about our future expectations and plans, including in respect of the timing of initiation and progress, though and data reported from the preclinical and clinical trials of our product candidates regulatory filings, including the review of the BLA for <unk> by the FDA commercialization.
Planning effort, the potential life, saving or curative therapeutic and commercial potential of the meter sells product candidates, including GDA 201, and now into the cell and our expectations regarding our projected cash cash equivalents and investments to be used for operating activities are.
Our actual results may differ materially from what we project today due to a number of important factors, including the impact of COVID-19 pandemic on our operations the scope progress and expansion of our clinical trials and impacts to the cost thereof, clinical scientific regulatory and technical developments there.
Inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics and in the endeavor of building a business around such product candidates as well as those considerations described in the risk factors section of our most recent quarterly report on Form 10-Q 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 or future events.
As required by applicable law.
Now I'd like to turn the call over to Julian.
Thank you Heather and thanks to ebb.
One for joining us this morning.
This was an extraordinary quarter progamete itself as we continue our momentum into the second half of 2022 focused on delivering a multiple milestones and accomplishments for all our stakeholders.
Although we have accomplished this quarter continues to lay the groundwork for even larger inflection points.
Advancing toward the potential commercialization of our first NAV enabled cell therapy candidate <unk>.
Continuing the development of our lead.
NAND enabled cell therapy candidates GDA 201 for patients with lymphoma, we need new treatment options.
Developing our expanding pipeline of genetically modified NAV enabled to NK cell therapy candidates supported by robust preclinical data.
Exploring future opportunities that leverage our proprietary NAV technology across a broad range of innate and adaptive immune cells.
Recently, we announced our <unk> biologics license application or BLA was accepted by the FDA.
Granted priority review with the Paducah date of January 30th.
2023.
We are pleased to have received priority review, which validates the importance of them in Brazil.
Patients with blood cancers in need of an allogeneic.
Medical had extend cell transplant.
As a reminder, <unk> has breakthrough therapy designation as well as orphan drug status.
With the U S with you underway.
We are continuing with our preparations to support a potential commercial launch if.
If approved <unk> has the potential to achieve 20% to 25%.
Of the addressable market at peak market share by improving outcomes for patients based.
On our encouraging clinical data and increasing access, especially for patients who are eligible for transplant, but cannot find that match. This.
This 20% to 25% equates to 2000 2500 patients treated in the U S. Each year.
Michelle will provide additional detail on our launch strategy and plans later in this call.
Beyond <unk>, we also announced the dosing of our first patient in our company sponsored phase <unk> clinical study evaluating a cryopreserved readily available formulation of GDA 201, our lead program, our expanding laminate world NK pipeline for the treatment.
A follicular and diffuse large b cell lymphoma.
We continue to be encouraged by the results.
<unk> and our phase one investigator sponsored study of the fresh formulation.
<unk> will provide additional detail on the phase one two study.
Supporting GDA 201.
Our continued focus on patients and our vision for advancing potentially curative cell therapies has never been more important.
Prior to turning the call over to <unk> I'd like to thank my colleagues at could meet itself for their dedication to our mission <unk>.
Additionally, give me to sell would like to sincerely. Thank the <unk>.
Clinical trials sites.
And the patients and their families that had been in such important partners as we advance our pipeline of Nam enabled cell therapies.
With that I'll turn the call over to Randy.
Thanks, Julian and good morning, everyone. Thank you for joining us on our call. This morning.
As Julian mentioned, we are excited to share their a BLA for <unk> was accepted by the FDA with priority review.
Recall that our submission was based on a successful global phase III randomized study comprised of 125 patients aged 12 to 65 with high risk hematologic malignancy that were in need of allogeneic stem cell transplant, but had no readily available match donor.
The study demonstrated a median time to neutrophil and grassman of 12 date for patients randomized to <unk> compared to 22 days for the comparator group.
These results were not only statistically significant but also highly clinically significant of neutrophil and <unk> is a key milestone in recovery in patients undergoing bone marrow transplant.
Turning to GDA 201.
Lead product candidate in our NK cell therapy pipeline, leveraging our proprietary NAV technology and the expansion of NK cells to <unk>.
Enhance their functionality direct tumor cell, killing property and antibody dependent cellular cytotoxicity or <unk>.
Despite recent advances in the development of therapies for patients with lymphoma, we continue to hear from lymphoma experts that there was a high unmet need among patients with lymphoma, who have active disease after previous treatment.
Data from the investigator led study at the University of Minnesota on the fresh formulation of GDA 201 were reported at Ash in December of last year and demonstrated an overall response rate of 74% with durable responses of 78% and two year survival of 78% and heavily.
Pretreated patients with lymphoma.
Recently translational data from this study were presented at the American Association of Cancer Research International meeting on advances in malignant lymphoma.
Tumor biopsies were analyzed with high resolution multiplex imaging techniques to identify the cells found in the lymphoma tissue.
At 16 days after treatment with GDA 201 image. It showed that CD 20 positive lymphoma cells, we're no longer detectable, but the tumor with infiltrated with CD eight and CD four positive T cells, which are immune cells that can target tumors.
These findings help us to generate in our composite about the potential mechanism of action of GDA 201.
The data suggests that initial tumor cell, killing by GDA 201 triggered an adaptive immune response recruiting T cells that can provide further anti tumor effects.
This hypothesis will be explored further with additional research.
As Jonathan highlighted we recently announced the dosing of the first patient in a company sponsored.
Phase one two clinical study evaluating GDA 201 for the treatment of Follicular and diffuse large b cell lymphoma.
The study is designed to include patients who have relapsed refractory lymphoma accurately two prior treatments, which may include car T cell therapy or stem cell transplant.
The phase one dose escalation portion of the study is designed to evaluate the safety of increasing doses of GDA 201 with dosing similar to those in the previous investigator led study.
Up to four dose levels will be tested to determine the maximum tolerated dose and recommended phase two dose based on the dose limiting toxicity.
Phase one also includes patients with Follicular diffuse large b cell marginal zone and mental cell lymphoma histology.
The phase II expansion portion of the study is designed to evaluate the safety and efficacy of GDA 201, and two separate cohorts of approximately 30 patients each with Follicular lymphoma, and diffuse large b cell lymphoma.
The study is currently open at three sites in a number of sites will be limited during the dose escalation phase.
Investigators are enthusiastic about enrolling patients in the study and treating patients with GDA 201.
We're looking forward to patients participating in this trial and to progressing this important therapy candidates through the clinic.
In our expand yourself therapy pipeline. We are also developing our genetically modified Nam enabled NK cell therapy, and hematologic malignancies and solid tumors.
These novel product candidates leverage car and CRISPR mediated strategy to increase targeting potency and persistence and are supported by robust preclinical data.
We are evaluating multiple product candidates, including <unk> hundred one <unk> 401, GTA fiber, one and <unk> 601.
<unk> 601 is also being advanced with a research collaboration with the Dana Farber Cancer Institute, which allows us to leverage the expertise of researchers researchers at Dana Farber to study the in vitro NK cell, killing activity of <unk> in multiple myeloma.
We believe our broad based NAV enabled NK platform is well positioned to explore potential partnership opportunity and we look forward to the continued development of these cell therapeutics.
Throughout the rest of the year, we plan to continue to conduct preclinical proof of concept studies for these genetically modified NK therapeutic target.
By the end of 'twenty to 'twenty, two we plan to select a pipeline candidate for IND, enabling studies.
With that I will turn the call over to Michelle who will talk more about Oh, Madhu selling commercial plants Michelle.
Thank you Ronnie and good morning, everyone based on the exciting milestone of FDA acceptance of our <unk> BLA with priority review, we have an incredibly high priority escondida itself to ensure patient access to <unk> upon its potential approval.
We have diligently worked to define the unmet need that all my people felt could address and have a clear launch strategy and a well defined plan with our outstanding launch leadership team in place. We are now ready to move to launch execution.
Upon potential FDA approval <unk> has the potential to address a great unmet need for patients.
Therefore, we are motivated to ensure that we are prepared to bring this important therapy to patients as quickly as possible following approval.
Starting with manufacturing we are preparing for launch readiness at our gamete of cell manufacturing facility.
This facility was integral for the completion of our BLA and is also now focused on commercial readiness.
We are ready to manufacture ahmedou to sell upon FDA approval.
Our facility in Israel is modular so we will have the ability to add additional cores as demand increases from give yourself. We're confident we could support the launch demand requirements from our facility from both a production and a supply chain standpoint.
Team has finalized our end to end processes to validate our approach to assure chain of identity and chain of custody for our commercial process to ensure a positive transplant center and patient experience.
We've also been successfully manufacturing clinical batches and Alexander manufacturing facility and have been able to deliver on the EBITDA back to the transplant centers within 30 days.
Beyond manufacturing, we are also working hard to ensure that upon FDA approval that patients could have broad access to all the data itself.
For the approximately 8000 patients above the age of 12 with hematologic malignancies, who undergo an allogeneic stem cell transplant. Each year. This procedure may be their best chance for a potential cure.
There are two key opportunities that we focus on that obviously to sell may address for these patients upon FDA approval first potentially improving outcomes as compared to other donor sources based on transplant or feedback and also potentially increasing access to therapy.
For potentially improving outcomes, we have extensive market research that points to Peter and consistent insights transplants are see important opportunities from a deep itself to potentially improve outcomes based on their experiences with other donor sources. This opportunity is due to the strength of our clinical data the ability to.
Provide patients with a pre defined number of cells.
And the ability to provide on the GT felt within approximately one month as compared to unrelated donors that may take on average two to three months to align the donor and the patient.
Unfortunately, there were approximately 1200 additional patients each year, who are ages 12, and up with hematologic malignancies, who are deemed eligible for an allogeneic stem cell transplant or cannot find an appropriate jonah.
In terms of potentially increasing access for these patients. Unfortunately, there is racial disparity in the U S. In regards to access to allogeneic stem cell transplant.
Our non Caucasian and do not have access to a family member donor very low likelihood of finding a match of the public database.
For example, published data indicate that a black patients in the U S has less than a 20% chance of finding a match in the public database of a patient cannot find an appropriate donor they will unfortunately succumbed to their cancer.
On the <unk> itself has a less stringent matching criteria for patients and Moreover, we demonstrated our ability to match racially and ethnically diverse patients in our phase III study is 40% of the patients in our study were non Caucasian.
As Julian mentioned, we anticipate that if approved these two opportunities combined may result in armidale to sell capturing approximately 20% to 25% of the addressable market once we reach peak market share.
So if approved this will equate to approximately 2000 to 2500 patients treated each year in the U S with <unk>.
We understand the importance of educating both the transplant centers and payers with regards to reaching transplant centers in the U S.
We haven't optimized and targeted approach.
With transplant centers that perform allogeneic stem cell transplants are extremely concentrated.
For reference in the U S are approximately 200 transplant centers that perform allogeneic stem cell transplants.
<unk> of those centers conduct approximately 80% of the transplants.
Our medical affairs colleagues have been actively engaged with transplant centers and the feedback on our clinical data supports the positive feedback we have heard in our blinded market in stripes.
Turning to payers our conversations with these groups are progressing our payer team has been actively engaged with payers at the national and regional level, we will be proactively reaching out to payers, who cover at least 90% of our lives in the U S. We continue to hear consistent feedback on the overall value proposition of <unk>, including the strength.
The clinical data and the health economic data, we have published to date.
Hospitalization represents the majority of charges associated with transplant, so how a reduction in healthcare resource utilization in terms of reduced days in the hospital and reduce days in the ICU are very important components of the <unk> value proposition.
In addition, we saw a reduction in the number of transfusion and consultant visits.
These reduction in health care resources are very meaningful to the Payor transplant center and most importantly, the patient.
We are excited to continue to hear positive feedback across all stakeholders and are extremely encouraged and driven by the potential of <unk>.
We are equally encouraged with the advancement of our <unk> one program in lymphoma lymphoma is the largest patient population of all the blood cancers with a global incidents of over 600000 patients.
There are approximately 40000 patients with relapse refractory lymphoma in the U S and EU, which is the patient population that will be studied in the GDA 201 phase <unk> clinical trial.
There is an unmet need for effective and safe new therapies with a curative approach for these patients.
We look forward to the continued advancement of the GDA 201 trial.
I will now turn the call over to Shai to review our financial results.
Thank you Michelle and good morning, everyone.
Today, I will summarize our financial results for the second quarter of 2022.
As of June 32022, our total cash position was approximately $55 million compared to $96 million of December 31, 2021.
Research and development expenses for the quarter were $10 $6 million compared to $13 forming on doors in the same quarter last year. The decrease was mainly due to a $2 $4 million decrease in clinical activities related to the conclusion of a formal do we feel phase III clinical trial.
From your point permanent or <unk> clinical program.
Richard expenses for the quarter were $3 2 million compared to $5 million in the second quarter of 2021.
This was primarily due to reducing our near term commercial readiness expenses.
We are assessing strategic approaches for the commercialization of <unk>.
General and administrative expenses were $4 $3 million from the second quarter of 2022 compared to $3 $9 million for the same period in 2001.
The increase was mainly due to <unk> $9 million increase in professional services expenses.
A decrease of zero point, frankly, mandara and headcount and related expenses.
Finance expenses net Brazil $45 million for the second quarter of 2022 compared to $1 $3 million for the same period last year. The decrease was due to <unk> 6 million decrease in non cash expenses and an increase of zero point doing indoors.
Income from cash management.
Net loss for the second quarter of 2022 was $18 $6 million compared to a net loss of $23 6 million in the second quarter of 'twenty one.
We continue to expect cash used for ongoing operating activities. This year to range from $65 million to $70 million. We anticipate the recurring just total cash position will support our ongoing operating activities into 2023, excluding the cost of commercializing on Adobe So.
Following the corporate restructuring announced in January of this year. We are now realizing the decrease to our cash burn and will continue to diligently manage our cash position to fund our operation.
Finally, we are continuing to evaluate our cash needs and assessing all financing options to support our corporate strategy to bring on when do we start to patients.
Cash run rate guidance is based on our current operating 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.
Thank you Shai.
For the rest of 2022, there is no higher priority than to enable the successful commercialization of our first <unk> enabled stem cell therapy from a <unk> to benefit the thousands of cancer patients here in the U S.
Need a curative approach.
Our allogeneic stem cell therapy may offer.
We are also excited about the potential of GDA 201 as.
And the NK cell therapy that may benefit tens of thousands of patients worldwide.
We look forward to the results of this promising new approach for lymphoma patients and our company sponsored phase two open label Multicenter study.
We continue to demonstrate our leadership role in the development of NAV enabled cell therapies to the expansion of our pipeline with multiple genetically modified Nam enabled NK cell therapy candidates.
We believe that our curative approach.
Hey.
Make a difference in the lives of.
Patients worldwide and help redefine how patients are treated in the future.
Now, let's open the call for questions operator.
Thank you, ladies and gentlemen to ask a question at this time, you will need to press star one one.
Please standby, while we compile the Q&A roster.
Okay.
And our first question coming from the line of Edward <unk> from Piper Sandler Your line is open.
Great. Thank you very much.
So thinking towards.
Again, congrats on the all the progress the BLA acceptance et cetera.
Just wondering from the communications with the FDA.
Obviously manufacturing.
The clinical data workhorse is the FDA keenly focused on at look at evaluating or within Brazil.
What can we what should we be considering as plans for other overseas filing and potential regulatory activity. Thanks guys.
So thank you Ted for your question and.
I would say that the what you've identified is.
Actually the two pivotal aspects of our FDA review one is of course the clinical data.
Which the Ftes.
Extremely focused on as well as our manufacturing facility and anticipating a pre approval inspection.
Michelle would you comment on additional.
Activities.
Activities outside the U S as well.
For sure and take good morning. Thank you for joining the call as I mentioned in my prepared comments that are can be to fill one facility in Israel has been.
Was integral for the BLA filing and we can you to now focus on commercial readiness.
A very important point that I also alluded to is we have been manufacturing clinical batches at that facility. We have validated processes end to end to assure tradeoff identity and chain of custody that facility has advanced.
Very impressive and encouraging way. So we were excited to include that facility in our BLA.
In regard to overseas opportunities. So we have very encouraging opportunities to help advance on the data itself for patients and in many regions throughout the world. We've conducted assessments in Western Europe , and Japan and also in other regions such as Canada.
Most of what we see in terms of the opportunity from a data center in the US Is also the case overseas and in terms of its ability to improve outcomes and also to increase access for patients who are not currently able to find the donor. So we have a head to head study a very well conducted study led by running our teams so.
Once we are through the U S regulatory approval process. We will then look to advance regulatory activities in other regions. Knowing that there is an important patient need from deep itself throughout the world.
Great. That's very helpful. Thank you so much.
Yes.
Thanks Pat.
Right.
Thank you and our next question coming from the line of John Miller from Evercore. Your line is open.
Hi, guys. Thanks, so much for taking the question.
Is it because of your cash runway guidance explicitly not including commercialization from <unk>.
What is your I guess your focus on launching that internally versus your willingness to consider a partnership or a.
Gross drivers have has there been BD interest in the <unk> platform in the U S.
Okay.
We believe that we are best.
Payables to.
To launch on <unk> in the U S.
We have built a very strong commercial team under under Michelle and since the test.
Highly targeted and focused market.
I think we feel that.
The footprint is matches our capabilities.
Michelle would you like to further comment.
Sure. Thank you Julien good morning, John Thank you for joining us.
We did assess potential strategic alternatives and as Julian indicated we do believe that launching <unk> ourselves in the U S is the best option for patients and for <unk>.
We conducted a thorough assessment of the unmet needs that on the data itself could address we have a well thought out launch strategy at launch plan.
And also we have the experienced leadership team in place to launch a breakthrough cell therapy, such as Ahmed <unk> with.
This team is the commercial team, it's our medical affairs colleagues that I referenced during my prepared comments and most importantly, we have the leadership team at our computer manufacturing facility to a short readiness from a manufacturing standpoint.
So let me turn it back to you John to see if there's any follow up questions. Yes.
Yes that makes that makes perfect sense. Thanks, so much guys I guess, maybe switching gears I'd be really curious about.
The timeline for the Nexgen NK program once it's chosen how fast do you think you can get for mind, enabling studies into the clinic and Relatedly do you have updated guidance on GDA 201 that you've started patient dosing there.
Okay.
Thanks for your question, let me turn it over to remain to describe.
Our plans.
Thank you and thanks John .
In terms of the pipeline candidate after we select a candidate by the end of this year, we will move those forward to R&D, enabling studies and it does take about a year or two do those IND, enabling studies.
Put the IMD together file it than waiting for R&D exception acceptance, but during that time, we will also be designing.
And initiating operational activities for the clinical trial, so that as soon as the R&D is accepted and just like we did with GDA 201, we can move forward and initiated a new study. So it will take at least a year to get those thing after we select a candidate.
In terms of GDA 201, so now that we've dosed our first patients were safely in.
In the phase one portion of phase one portion timeline can vary depending on what you observed in the phase one portion.
There is the ability to expand cohort.
The dose limiting toxicity or.
Observed anything that.
You'd like to.
Testing more patients on but basically it will take approximately a year to go through the phase one portion and then move over to the phase two portion expansion.
Where we will have more sites enrolled and we'll be able to.
Move more quickly on the phase two.
Thanks, so much.
Thank you John .
Thank you our next question coming from the line of Gil Blum from Needham Your line is open.
Hi, good morning, everyone and thanks for taking our questions just a few questions on GDA 201 here.
So we're going to have a bunch of updates across allogeneic cellular therapeutics in the upcoming ash meeting.
Thanks updates can help increase the profile for two day tier one just general awareness of NK cells.
Yes, thanks for that question Gil.
Absolutely.
Significantly.
NK cells have been.
Reported to be quiet.
Quite well tolerated as compared to car T cells. So I think interest in.
GDA 201 will absolutely increase.
As we continue to progress our R. R.
Trial going forward.
Maybe a bit of a mechanistic question for Roni <unk>. It was very interesting figure the biopsy information that you've provided.
At the meeting.
So as far as T cell infiltration is there any thinking around maybe using reduced intensity conditioning less conditioning equaling more T cells into patients.
Thanks Gil.
I agree I think these are really interesting data, we obviously need to do more to elucidate further exactly the type of T cells in the core analogy of the T cells found in the biopsies and understand more in a greater number of patients what's going on.
The use of the cause the flu side conditioning regimen in patients who are undergoing cellular therapy is something that is also quite interesting to us as you recall in the fresh formulation.
Study, we gave second doses without.
Without the length of the preneed chemotherapy, although we now became the first step with without one for the planned chemotherapy and there is a.
Okay.
A general consensus that the LIFO depletion in net.
Necessary in some way the exact doses.
We are still not quite well elucidate and we're interested in Unix and interested in exploring sort of a cytokine effect of that chemotherapy, which has been attributed.
To which the effect efficacy has been attributed in terms of the cytokine environment. So definitely something that we're interested in looking at and as we move forward with our dosing. We are open to exploring sort of conditioning regimens that may be useful in potentially hitting responsive cushioning at two one.
Okay. Thank you and maybe a last one you mentioned potential partnerships and the discussion on GDA 201.
We are already thinking of partnering GDA 201, despite it being in the very early stage or this is more like.
Strategic collaboration with another agent or what does the same thing around here.
Yes, so we do.
We have an interest in exploring.
What is the most efficient way to bring GDA 201.
Two patients.
Potentially in the commercial setting.
We are exploring.
All of our options.
And can't comment right now on any partnering discussions, but we'll do so in the future.
Okay excellent. Thank you for taking all of our questions. This morning.
Thank you and our next question coming from the line of Mark Breidenbach from Oppenheimer. Your line is open.
Hey, good morning, and congrats on the recent progress.
Julien I was wondering if you can give us a sense for how much of the additional prelaunch investment.
Think would be needed to support Ahmedou as host U S launch assuming you continue with plans to go it alone on the launch.
And is there a contingency plan in place in case. The BLA is approved ahead of its produced to date.
Thank you for your excellent question and optimism.
Shai, maybe you could comment on the launch.
Planning budget.
Absolutely so good morning.
So.
As Michelle alluded to in our prepared remarks.
This is not an expensive they would say budgets it needed to launch army there'll be Phil.
Talking about roughly between $30 million to $40 million to prepare the company to launch on May <unk>.
And we are evaluating if any you can imagine anybody at the company we are evaluating all options.
This operation.
Okay, that's super helpful.
No go ahead.
Jane do you want to add your remarks, as well no and I think we're quite confident that we can.
Execute.
Again under Michelle's leadership in medical Affairs team.
Think we can cover this.
Really focused.
Transplant center engagement.
And we feel very confident in our abilities.
Okay fair enough and just a quick one maybe for Roni.
In the company sponsored trial.
One can you just tell us what the starting dose was was it was the 20 million cells per kilogram sort of like we saw in the University of Minnesota trial, and can you tell us what tumor consolidate the first patient presented with thank you very much.
Thanks Mark.
We are starting at a dose very close to the 20 million doses I think 259 tenths of the <unk> cells per kilogram and that was really just on the basis of.
Sort of our manufacturing capability in calculations of the Escalations to make some nice round about the same but it was guided by the first dose level in the in the fresh we're not going to comment yet about detailed about the patient but at the right time, we'll certainly share those.
Okay. Thanks, so much for taking my questions and congrats again on the progress.
Thank you.
Okay.
Thank you and as a reminder, ladies and gentlemen to ask a question. Please press star one one.
And our next question coming from the line of Jason Butler from JMP Securities. Your line is open.
Hi, it's Roy in for Jason Thanks for taking the question just a really quick one on the.
The contracts that you've mentioned between the payers and the transplant centers for <unk> cel can you just provide some additional details on that process is once it's approved as <unk> added to a list of options or would you need to go through committees and if so it sounds like much of that is going to happen before approval is that the case.
Michelle This is for you.
Thank you Julien good morning, Roy Thank you for joining us.
So.
Let's talk about the commercial payers first and then I'll talk about Medicare.
So in regards to the patient mixture, we do anticipate the majority of patients will fall under commercial payers, but thats roughly between $50 to 60% and then probably about.
Roughly 25% or so Medicare.
Roughly 5% Medicaid So we're focused on both commercial and Medicare, Let's talk about commercial first so commercial Payors have said publicly and also in our discussions with them that upon FDA approval of <unk>.
Therapies that are onetime therapies with curative intent they will cover these therapies and we saw that with the car T. Is also so what that means to your question is they're not going to have to convene.
Our formulary review committee or our pharmacy and Therapeutics Committee meeting.
<unk> payers such that they will cover these onetime therapies with curative intent upon FDA approval. So coverage is.
Well defined in terms of reimbursement so those contracts as you alluded to between the payers and the transplant centers are individual contracts. They are highly confidential that's not anything that the manufacturer gets involved with it because it's between that transplant centers in the payers, but we have had ongoing dialogue with both the transplant centers and the payer.
Our sites to understand what the process will look like for reimbursement upon FDA approval and we're very encouraged that transplants understand payers are both saying, yes. There are mechanisms in place within our current contracts that allow for reimbursement upon FDA approval and as I've mentioned, we've been actively engaged in <unk>.
I'll back analyses, we've published much of that data already and we will continue to generate data that is needed as part of their ongoing discussions for reimbursement.
And then just on the Medicare side, we've already begun to apply for the required codes that would be needed for Medicare we understand with Medicare that <unk> would be mapped at this point in time to the allogeneic stem cell transplant DRG and then Medicare also have mechanisms in place to pay for or to reimburse the centers.
For the actual donor source so on both the commercial side on the Medicare side, we are very encouraged by the coverage and then also the reimbursement.
So let me stop there and turn it back to you to see if theres any other questions.
Perfect No that is it thank you very much.
Thank you.
And I am showing no further questions at this time I would now like to turn the call back over to Mr. Julian Adams for any closing remarks.
Thank you.
Our leadership team will be available after the call for questions. At this time I would now like to turn the call back over to Mr. Julian Adams for any closing remarks.
Thank you.
Our leadership team will be available after the call is there any opportunities for follow up discussions.
We'll keep you current on all of our drug development and we thank you again for your interest and support and can meet itself.
You everyone for joining us support and can meet itself.
Thank you everyone for joining us on today's call.
You may now disconnect teleconference for today. Thank you for your participation you may now disconnect good day.
The conference will begin shortly.
As Johan during Q&A, you can dial star one one.
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