Gamida Cell Ltd. (NASDAQ:GMDA) Q2 2022 Earnings Conference Call August 15, 2022 8:00 AM ET
Company Participants
Heather DiVecchia – Director of IR & Corporate Communications
Julian Adams – CEO
Ronit Simantov – CMO & Chief Scientific Officer
Michele Korfin – COO & Chief Commercial Officer
Shai Lankry – CFO
Conference Call Participants
Edward Tenthoff – Piper Sandler
Jonathan Miller – Evercore
Gilbert Blum – Needham
Mark Breidenbach – Oppenheimer
Operator
Ladies and gentlemen and I will be your Operator for today’s call. Please be advised that this call is being recorded at Gamida Cell’s request.
Now, I would like to introduce your host for today’s conference, Heather DiVecchia, Gamida Cell’s Director of Investor Relations and Corporate Communications. Please go ahead.
Heather DiVecchia
Thank you, [Lydia] 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.gamidacell.com.
Here with me on the call today are, Julian Adams, Chief Executive Officer; Ronit Simantov, our Chief Medical Officer and Chief Scientific Officer; Michele Korfin, our Chief Operating Officer and Chief Commercial Officer and Shai Lankry, our Chief Financial Officer.
During this call, we may make Forward-Looking Statements about our future expectations and plans including in respect to the timing of initiation and progress of, and data reported from the pre-clinical and clinical trials of our product candidates, regulatory filings, including the review of the BLA for Omidubicel by the FDA, commercialization planning efforts, the potentially life-saving or curative therapeutic and commercial potential of Gamida Cell’s product candidate, including GDA-201 and Omidubicel, and our expectations regarding our projected cash, cash equivalent, and investment to be used for operating activities.
Our actual results may differ materially from what we project today due to a number of important factors, including the impacts of COVID-19 pandemic on our operations, the scope, progress and expansion of our clinical trials and impact to the cost thereof, clinical, scientific, regulatory and technical developments, those 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 except as required by applicable law.
Now I would like to turn the call over to Julian.
Julian Adams
Thank you, Heather, and thank you to everyone for joining us this morning. This was an extraordinary quarter for Gamida Cell as we continue our momentum into the second half of 2022, focused on delivering on 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 towards the potential commercialization of our first NAM enabled cell therapy candidate or maneuver cell.
Continuing the development of our lead, NAM enabled cell therapy candidate GDA-201 for patients with lymphoma who need new treatment options. Developing our expanding pipeline of genetically modified NAM enabled NK cell therapy candidates, supported by robust preclinical data, and exploring future opportunities that leverage our proprietary NAM technology across a broad range of innate and adaptive immune cells. Recently, we announced our Omidubicel biologics license application for BLA was accepted by the FDA and granted priority review with a PDUFA date of January 30, 2023. We are pleased to have received priority review which validates the importance of Omidubicel for patients with blood cancers in need of an allogeneic hematopoietic stem cell transplant.
As a reminder, Omidubicel has breakthrough therapy designation as well as orphan drug status. With the U.S. review underway, we are continuing with our preparations to support a potential commercial launch. If approved, Omidubicel cell 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 a match. This 20% to 25% equates to 2,000 to 2,500 patients treated in the U.S. each year. Michele will provide additional detail on our launch strategy and plans later in this call.
Beyond Omidubicel, we also announced the dosing of our first patient in our company sponsored Phase I/II clinical study evaluating a cryopreserved readily available formulation of GDA-2-1 our lead program and our expanding NAM enabled NK pipeline for the treatment of follicular and diffuse large B-cell lymphomas. We continue to be encouraged by the results observed in a Phase 1 investigator sponsored study of the fresh formulation. Ronit will provide additional detail on the Phase I/II 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 Ronit, I’d like to thank my colleagues at Gamida Cell for their dedication to our mission. Initially, Gamida Cell would like to sincerely thank the clinical trials sites, and the patients and their families that have been in such important partners as we advanced our pipeline of NAM enabled cell therapies.
With that, I’ll turn the call over to Ronit.
Ronit Simantov
Thanks, Julian, and good morning, everyone. Thank you for joining us on our call this morning. As Julian mentioned, we’re excited to share that BLA for Omidubicel 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 malignancies that were in need of allergen stem cell transplant, but has no readily available matched donor. The study demonstrated a median time to neutrophil engraftment of 12 days for patients randomized to Omidubicel compared to 22 days for the comparator group. These results were not only statistically significant, but also highly clinically significant as neutrophil engraftment is a key milestone in recovery in patients undergoing bone marrow transplant.
Turning to GDA-201 our lead product candidate in our NK cell therapy pipeline, leveraging our proprietary NAM technology and the expansion of NK cells to enhance their functionality, direct tumor cell killing properties, and antibody dependent cellular cytotoxicity or ADCC.
Despite recent advances in the development of therapies for patients with lymphoma, we continue to hear from lymphoma experts that there is 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 and two year survival of 78% in heavily pretreated patients with lymphoma.
Recently, translational data from the 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 images showed that CD-20 Positive lymphoma cells were no longer detectable. But the tumor was infiltrated with CDA and CD-4 positive T-cells, which are immune cells that can target tumors. These findings help us to generate and [adopt this] about the potential mechanism of action of GDA-201. The data suggests that initial tumor cell killing by GDA-201 triggers an adaptive immune response, recruiting T-cells that can provide further anti-tumor effects. This hypothesis will be explored further with additional research.
As Julian highlighted, we’ve recently announced the dosing of the first patient in our company sponsored Phase I/II clinical study evaluating GDA-201 for the treatment of follicular and diffuse large B-cell lymphomas. The study is designed to include patients who have relapsed or refractory lymphoma after at least two prior treatments, which may include car T-cell therapy or stem cell transplant.
The phase 1 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 II dose based on the dose limiting toxicity.
Phase 1 also includes patients with follicular, diffuse large B-cell, marginal zone and mantle cell lymphoma histology. The Phase II expansion portion of the study is designed to evaluate the safety and efficacy of GDA-201 in 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, and a number of sites will be limited during the dose escalation phase. Investigators are enthusiastic about enrolling patients in this study and treating patients with GDA-201. We’re looking forward to patients participating in this trial and progressing this important therapy candidate through the clinic.
In our expanding cell therapy pipeline, we are also developing our genetically modified NAM enabled NK cell therapy in hematologic malignancies and solid tumors. These novel products candidates, leverage CAR and CRISPR mediated strategies to increase targeting potency and persistence and are supported by robust preclinical data. We are evaluating multiple product candidates, including GDA-301, GDA-401, GDA-501, and GDA-601. GDA-601 is also being advanced with a research collaboration with the Dana Farber Cancer Institute, which allows us to leverage the expertise of researcher at Dana Farber to study the in vitro NK cell killing activity of GDA-601 in multiple myeloma.
We believe our broad based NAM 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 targets. By the end of 2022, we plan to select a pipeline candidates for IND enabling studies.
With that, I will turn the call over to Michele who will talk more about Omidubicel and commercial plants. Michele?
Michele Korfin
Thank you, Ronit. And good morning, everyone. Based on the exciting milestone of FDA acceptance of our Omidubicel BLA with priority review, we have an incredibly high priority at Gamida Cell to ensure patient access to Omidubicel upon its potential approval. We have diligently worked to define the unmet need that Omidubicel 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, Omidubicel 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 Gamida Cell manufacturing facility. This facility was integral for the completion of our BLA and it’s also now focused on commercial readiness. We are ready to manufacture Omidubicel upon FDA approval.
Our facility in Israel is modular. So we will have the ability to add additional course as demand increases for Omidubicel. We’re confident we could support the launch demand requirements from our facility from both a production and a supply chain standpoint. The 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 have also been successfully manufacturing clinical batches in Alameda manufacturing facility and have been able to deliver Omidubicel back to the transplant centers within 30 days. Behind manufacturing we are also working hard to ensure that upon FDA approval that patients could have broad access to Omidubicel. For the approximately 8,000 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 Omidubicel 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 clear and consistent insights, transplant or see important opportunities from Omidubicel 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 predefined number of cells, and the ability to provide Omidubicel 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 are 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 but cannot find an appropriate donor. In terms of potentially increasing access for these patients unfortunately their age ratio disparity in the U.S. in regards to access to allogeneic stem cell transplant.
If you are non-Caucasian and do not have access to a family member donor, you have a very low likelihood of finding a match in the public database. For example, published data indicate that a black patient in the U.S. has less than a 20% chance of finding a match in the public database. As patient cannot find an appropriate donor, they will unfortunately succumb to their cancer. Omidubicel 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 as 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 Omidubicel 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 Omidubicel.
We understand the importance of educating both the transplant centers and payers with regards to reaching transplant centers in the U.S. We have an optimized and targeted approach as the transplant centers that perform allogeneic stem cell transplants are extremely concentrated. For reference in the U.S. there are approximately 200 transplant centers that perform allogeneic stem cell transplants. 70 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 insights.
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 allies in the US. We continue to hear consistent feedback on the overall value proposition of Omidubicel including the strength of the clinical data, and the health economic data we have published to-date.
Hospitalization represents the majority of charges associated with transplant. So our reduction in healthcare resource utilization, in terms of reduced days in the hospital and reduced days in the ICU are very important components of the Omidubicel value proposition. In addition, we saw a reduction in the number of transfusion and consultants visits. These reductions in healthcare resources are very meaningful for the payer, 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 Omidubicel.
We are equally encouraged with the advancement of our GDA-201 program in lymphoma. Lymphoma is the largest patient population of all the blood cancers with a global incidence of over 600,000 patients. There are approximately 40,000 patients with relapsed refractory lymphoma in the U.S. and EU, which is the patient population that will be studied in the GDA-201 Phase I/II 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.
Shai Lankry
Thank you, Michele, and good morning everyone. Today I will summarize our financial results for the second quarter of 2022. As of June 30, 2022, our total cash position was approximately $55 million compared to $96 million as of December 31, 2021. Research and development expenses for the quarter were $10.6 million compared to $13.4 million in the same quarter last year. The decrease was mainly due to a $2.4 million decrease in clinical activities relating to the conclusion of Omidubicel Phase III clinical trial and a decrease of $0.4 million in the GDA clinical program.
Commercial expenses for the quarter were $3.2 million, compared to $5 million in the second quarter of 2021. The decrease was primarily due to reducing our near term commercial readiness expenses as we were assessing strategic approaches for the commercialization of Omidubicel.
General and administrative expenses were $4.3 million in the second quarter of 2022, compared to $3.9 million for the same period in ’21. The increase was mainly due to $0.9 million increase in professional services expenses, offset by decrease of $0.5 million in headcount and related expenses.
Finance expenses net were $0.5 million for the second quarter of 2022, compared to $1.3 million for the same period last year. The decrease was due to a $0.6 million decrease in non-cash expenses, and an increase of $0.2 million in interest 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 ’21.
We continue to expect cash use for ongoing operating activities this year to range from $65 million to $70 million. We anticipate that our current total cash position will support our ongoing operating activities into mid 2023, excluding the cost of commercializing Omidubicel. Following the corporate restructuring announced in January of this year, we are now realizing the decrease to our cash burn and we’ve continued to diligently manage our cash flow decision to fund our operation.
Additionally, we’re continuing to evaluate our cash needs and assessing all financing options that supports our corporate strategy to bring Omidubicel to patient. This cash runway guidance is based on our current operational plan, and excludes any additional funding that may be received or business development activities that may be undertaken.
With it I will turn the call back over to Julian.
Julian Adams
Thank you Shai. For the rest of 2022, there is no higher priority than to enable the successful commercialization of our first NAM enabled stem cell therapy, Omidubicel to benefit the 1000s of cancer patients here in the U.S. who need a curative approach that allogeneic stem cell therapy may offer. We are also excited about the potential of GDA-201 as an NK cell therapy that may benefit 10s of 1000s of patients worldwide.
We look forward to the results of this promising new approach for lymphoma patients in our company sponsored Phase I/II open label multicenter study. We continue to demonstrate our leadership role in the development of NAM enabled cell therapies through the expansion of our pipeline with multiple genetically modified NAM enabled NK cell therapy candidates. We believe that our curative approach may make a difference in the lives of cancer patients worldwide and help redefine how patients are treated in the future.
Now let’s open the call for questions. Operator?
Question-And-Answer Session
Operator
Thank you. [Operator Instructions] And our first question coming from the line of Edward Tenthoff, Piper Sandler. Your line is open.
Edward Tenthoff
Great, thank you very much. Just thinking towards and again, congrats on the all the progress the BLA stem cell [etc]. Just wondering from the communications with the FDA, obviously manufacturing the clinical data, what else is the FDA keenly focused on at look at evaluating Omidubicel and what should we be considering as plans for other overseas filings and potential regulatory activity? Thanks guys.
Julian Adams
So thank you Ed for your question. And I would say that what you’ve identified is actually the two pivotal aspects of our FDA review. One is, of course, the clinical data, which the FDA is extremely focused on, as well as our manufacturing facility and anticipating a pre-approval inspection. Michele, would you comment on additional activities and activities outside the U.S. as well?
Michele Korfin
For sure, and Ed good morning. Thank you for joining the call. As I mentioned in my prepared comments, our Gamida Cell owned facility in Israel has been, it has was integral for the BLA filing, and we continue to now focus on commercial readiness. But 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 a short chain of identity and chain of custody. That facility has advanced in a very impressive and encouraging way. So we were excited to include that facility in our BLA.
In regard to overseas opportunities. So we have a very encouraging opportunities to help advance Omidubicel for patients in many regions throughout the world. We’ve conducted assessments in Western Europe, in Japan and also in other regions such as Canada. And most of what we see in terms of the opportunity from Omidubicel in the US is also the case overseas in terms of those ability to improve outcomes and also to increase access for patients who are not currently able to find a donor.
So we have a head-to-head study, a very well conducted study led by Ronit and her team. So once we are through the U.S. regulatory approval process, we will then look to advanced regulatory activities in other regions knowing that there’s an important patient need from Omidubicel throughout the world.
Edward Tenthoff
Great, that’s very helpful. Thank you so much.
Julian Adams
Thanks Ed.
Operator
Thank you. And our next question coming from the line of Jonathan Miller from Evercore. Your line is open.
Jonathan Miller
Hi, guys, thanks so much for taking the question. I was interested because of your cash runway guidance explicitly not including commercialization from Omidubicel. What is your, I guess, your focus on launching that internally versus your willingness to consider a partnership or for partners has there been BD interest in the only platform in the U.S.?
Julian Adams
So we believe that we are best able to launch Omidubicel in the U.S. We have built a very strong commercial team under Michele and since it’s a highly targeted and focused market, I think we feel that the footprint matches our capabilities. Michele, would you like to further comment?
Michele Korfin
Sure. Thank you, Julian. Good morning, Jon, thank you for joining us. We did assess potential strategic alternatives and as Julian indicated, we do believe that launching Omidubicel ourselves in the U.S. is the best option for patients and for Gamida. We conducted a thorough assessment of the unmet needs that Omidubicel could address. We have a well thought out launch strategy and launch plan. And also, we have the experience leadership team in place to launch a breakthrough cell therapy such as Omidubicel. I mean 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 Gamida manufacturing facility to assure readiness from the manufacturing standpoint. So let me turn it back to you, Jon, to see if there’s any follow up questions.
Jonathan Miller
Yes, that makes perfect sense. Thanks so much, guys. I guess then maybe switching gears, I would be really curious about the timeline for the next-gen NK program, once it’s chosen how fast you think you can get from IND enabling studies into the clinic? And relatedly do you have updated guidance on GDA-201 now that you’ve started patient dosing there?
Julian Adams
Thanks. Thanks for your question. Let me turn it over to Ronit to describe our plans.
Ronit Simantov
Thanks. Thank you. And thanks, Jon. So in terms of the pipeline candidates, after we select a candidate by the end of this year, we will move those forward to IND enabling studies. And it does take about a year to do those IND enabling studies, put the IND together, file it, then waiting for R&D acceptance but during that time we will also be designing and initiating operational activities for the clinical trial so that as soon as the IND is accepted and just like we did with GDA-201 we can move forward and initiate a new study. So it will take at least a year to do those things after we select a candidate.
In terms of GDA-201. So now that we dose our first patients we’re safely in the Phase I portion. In phase I portion, timeline can vary depending on what you observe in the Phase I portion. There are the ability to expand cohort if you see dose limiting toxicities or observe anything that you’d like to test more patients on. But basically, it will take approximately a year to go through the Phase I portion and then move over to the Phase II portion expansion where we will have more sites enrolled and we’ll be able to move more quickly on the Phase II.
Jonathan Miller
Thanks so much.
Julian Adams
Thank you, John.
Operator
Thank you. Our next question coming from the line of Gilbert Blum from Needham. Your line is open.
Gilbert Blum
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 cell therapeutics in the upcoming NASH meeting. Do you think these updates can help increase the profile for GDA-201 and just general awareness NK cells?
Julian Adams
Yes, thanks for that question, Gil. Absolutely and significantly, NK cells have been reported to be 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 trial going forward.
Gilbert Blum
Maybe a bit of a mechanistic question for Ronit. It was very interesting to hear the biopsy information that you provided at the meeting. So if there’s T-cell infiltration, is there any thinking around maybe using reduced intensity conditioning, less conditioning equaling more T-cells in the patients?
Ronit Simantov
Thanks, Gil. So I agree, I think these are really interesting data. We obviously need to do more to elucidate further exactly the type of T-cells and the commonality of the T-cells found in the biopsies and understand more and a greater number of patients what’s going on. The use of 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 lymphodepleting chemotherapy, although we never gave the first doses without lymphodepleting chemotherapy and there is a general consensus that the lympho depletion is necessary in some way. The exact doses is are still not quite well elucidated. We’re interested in exploring sort of the cytokine effect of that chemotherapy, which has been attributed, to which the effect efficacy has been attributed in terms of the cytokinins environment. So definitely something that we’re interested in looking at. And as we move forward with our dosing, we are open to exploring the sorts of conditioning regimens that may be useful in potentiating responses to GDA-201.
Gilbert Blum
Okay, thank you. And maybe a last one, you mentioned, potential partnerships and the discussion on GDA-201. We already thinking of partnering GDA-201 despite it being in their early stage or this is more like strategic collaboration with another agent or what is the thinking around there?
Julian Adams
Yes. So we do have an interest in exploring what is the most efficient way to bring GDA-201 to patients, potentially, in the commercial setting. So we are exploring all of our options and can’t come in right now on any partnering discussions, but we’ll do so in the future.
Gilbert Blum
Okay, excellent. Thank you for taking all of our questions this morning.
Operator
Thank you. Our next question coming from the line of Mark Breidenbach from Oppenheimer. Your line is open.
Mark Breidenbach
Hey, good morning and congrats on the recent progress. Julian, I was wondering if you can give us a sense for how much of additional pre-launch investment you think would be needed to support Omidubicel’s 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 PDUFA date?
Julian Adams
Thank you for your excellent question and optimism. Shai, maybe you could comment on the launch planning budget.
Shai Lankry
Yes, absolutely. Hi Mark, good morning. So as Michele alluded in her prepared remarks, this is not an extensive, I would say budget needed to launch Omidubicel. We are talking about roughly between $30 million to $40 million to prepare the company to launch Omidubicel. And we are evaluating as any, as you can imagine any biotech company, we are evaluating all options to bring Omidubicel to patient.
Mark Breidenbach
Okay, super helpful. Go ahead.
Shai Lankry
Julian, do you want to add your remarks as well?
Julian Adams
No. And I think we’re quite confident that we can execute again, under Michele’s leadership and Ronit’s medical affairs team, I think we can cover this highly focused transplant center engagement. And we feel very confident in our abilities.
Mark Breidenbach
Okay, fair enough. And just a quick one, maybe for Ronit. In the company sponsored trial of 201 can you just tell us what the starting dose was? Was it [20 million per kilogram], sort of like we saw in the University of Minnesota trial? And can you tell us what tumor histology is the patient presented with? Thank you very much.
Ronit Simantov
Thanks Mark. So we are starting at a dose very close to the 20 million doses that is 2.5 times 10 to the 7 cells per kilogram and that was really just on the basis of sort of our manufacturing feasibility and calculations of the escalation to make them nice and round. So it’s about the same, but it was guided by the first dose level in the fresh. We’re not going to comment yet about details about the patient but at the right time, we’ll certainly share those.
Mark Breidenbach
Okay, thanks so much for taking the questions. And congrats again on the progress.
Julian Adams
Thank you.
Operator
Thank you. [Operator Instructions] And our next question coming from the line of Jason Butler from JMP Securities. Your line is open.
Unidentified Analyst
Hi, it’s Ryan for Jason. Thanks for taking the questions. And just a really quick one on the contracts that you’ve mentioned between the payers and the transplant centers for Omidubicel. Can you just provide some additional details on that process is once it’s approved Omidubicel it’s added to a list of options, or do you need to go through committees? And if so it sounds like much of that’s going to happen before approval? Is that the case? Thanks.
Julian Adams
Michele, this is for you.
Michele Korfin
Thank you, Julian. Good morning, Ryan. Thank you for joining us. So there is, let’s talk about 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 that roughly between 50% to 60% and then probably about roughly 25% or so Medicare and roughly 5% Medicaid. So we’re focused on both commercial and Medicare.
Let’s talk about commercial first. So commercial payers have said publicly and also in our discussions with them that upon FDA approval of therapies that are one time therapies with curative intent, they will cover these therapies and we saw that with the CAR-T also. So what that means more to your question is, they’re not going to have to convene a formulary review committee or pharmacy and therapeutics committee meeting, they commercial payers have said 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, because it’s between the transplant centers and the payers. But we have had ongoing dialogue with both the transplant centers and the payer side to understand what the process will look like for reimbursement upon FDA approval. And we’re very encouraged that transplant centers and 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 health economic analyses. We’ve published much of that data already and we will continue to generate data in case 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 Omidubicel would be mapped at this point in time to the allogeneic stem cell transplant DRG. And then Medicare also has mechanisms in place to pay for or to reimburse the centers for the actual donor source. So on both the commercial side and the Medicare side, we are very encouraged by the coverage and then also the reimbursement. So let me stop there Ryan and turn it back to you to see if there’s any other questions.
Unidentified Analyst
Perfect. No, that is it. Thank you very much.
Michele Korfin
Thank you.
Operator
Now I’m 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.
Julian Adams
Thank you. Our leadership team will be available after the call, if there any opportunities for follow up discussions we’ll keep you current on all of our developments. And we thank you again for your interest and support in the Gamida Cell. Thank you everyone for joining us to support in Gamida Cell.
Operator
Thank you for your participation. You may now disconnect. Good day.
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