Gamida Cell Ltd (GMDA) CEO Julian Adams on Q3 2021 Results - Earnings Call Transcript
Nov. 15, 2021 12:04 PM ETGamida Cell Ltd. (GMDA)
Gamida Cell Ltd (NASDAQ:GMDA) Q3 2021 Earnings Conference Call November 15, 2021 8:00 AM ET
Company Participants
Joshua Hamermesh - Chief Business Officer
Julian Adams - CEO & Director
Ronit Simantov - Chief Medical Officer
Michele Korfin - Chief Operating & Chief Commercial Officer
Shai Lankry - CFO
Jas Uppal - Chief Regulatory and Quality Officer
Conference Call Participants
Ted Tenthoff - Piper Sandler
Jonathan Miller - Evercore ISI
Gregory Renza - RBC Capital Markets
Nishant Gandhi - Needham & Company
Mark Breidenbach - Oppenheimer
Operator
Ladies and gentlemen, thank you for standing by. Welcome to Gamida Cell's Conference Call for Third Quarter 2021 Financial Results. My name is Henry and I'll be the operator for today's call. Please be advised that this call is being recorded at Gamida Cell's request.
Now I would now like to introduce your host for today's conference, Mr. Josh Hamermesh, Chief Business Officer. Sir, please go ahead.
Joshua Hamermesh
Thank you, Henry, 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 third 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.gamidacell.com.
Here with me on our call today are Julian Adams, Chief Executive Officer; Ronit Simantov Chief Medical Officer; Michele Korfin, Chief Operating Officer and Chief Commercial Officer; Shai Lankry, Chief Financial Officer and additionally, Jas Uppal, our Chief Regulatory and Quality Officer will join for the 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 of 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 omidubicel to the FDA, commercialization planning efforts, the potentially life-saving or curative therapeutic and commercial potential of omidubicel and our expectations regarding our projected cash to be used for operating activities and cash runway.
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 on our operations, the scope, progress and expansion of our clinical trials and cost impact thereof, clinical, scientific, regulatory and technical developments and 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 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.
Julian Adams
Thank you, Josh, and thanks to everyone for joining us this morning. This was an important quarter for Gamida Cell as we continue to advance our mission of bringing potentially curative cell therapies to cancer patients. We are at a crucial inflection point in the field of cell therapy, where we are starting to see multiple development programs that offer the potential for clinical benefit for patients with hematologic malignancies and serious blood disorders.
I am proud that Gamida Cell is at the forefront of this research with our two advanced clinical stage NAM enabled cell therapy programs; omidubicel and GDA-201. We also recently expanded our pipeline of generically modified NAM-enabled NK cell constructs and we are excited about sharing new data and developments on our cell therapy pipeline at major -- multiple major international medical meetings this quarter.
Let me start today's call with an update on our lead program omidubicel, which has breakthrough therapy designation and the potential to be the first FDA approved cell therapy for hematopoietic stem cell transplant. Omidubicel is supported by a robust body of evidence, including positive phase three results, demonstrating strong efficacy, an important benefit to patients in need of a bone marrow transplant.
We recently had a pre-BLA meeting during which the FDA requested that Gamida Cell provide revised analysis of the analytical data generated at Gamida Cell's wholly owned commercial manufacturing facility in Israel to demonstrate comparability to the omidubicel batches that were produced at the clinical manufacturing sites for the phase three study. We are confident that we can execute the analytical comparability that the FDA has requested in a timely manner to enable a BLA submission in the first half of '22.
It is also important to note that the FDA did not request additional clinical data to initiate the BLA submission once analytical comparability is demonstrated. In collaboration with the FDA, we will work towards our BLA submission to bring omidubicel to patients as soon as possible.
Moving to our NK cell pipeline, it is extremely exciting to be at the front -- at the forefront of the cutting edge research that is being conducted in the emerging field of NK cell therapy. NK cells have tremendous promise for treating cancer. NK cells are the body's first line of defense providing innate immunity and have immune privileged properties that obviate the requirement for donor matching, which can lead to a cryopreserved off the shelf product for patients.
The most advanced candidate in our NAM-enabled NK pipeline GDA-201 leverages our proprietary NAM technology platform in the expansion of NK cells to enhance their functionality, direct tumor cell killing properties and antibody dependent cellular cytotoxicity or ADCC. GDA-201 has produced truly remarkable results in a phase one investigator sponsored study, where we have seen very high and durable responses in both follicular lymphoma and diffused large B-cell lymphoma.
As we have previously reported, the phase one study had an overall response rate of 74% and 68% complete response rates and an impressive duration with several patients maintaining their complete responses for over two years after treatment.
During the third quarter, we submitted an IMD application to the FDA for a phase one, two trial with cryopreserved formulation in patients with diffuse large B-cell lymphoma and follicular lymphoma. Before initiating our clinical study, we must address the clinical hold by responding to the FDA's questions about donor eligibility procedures and sterility assay qualification. We believe these questions are addressable and we plan to respond expeditiously to enable IND acceptance and patient enrolment.
Due to the clinical whole, the initiation of the phase one, two trial will occur in 2022. We will provide an update and additional guidance on timing when we have further clarity from the FDA.
This quarter, we made progress advancing our genetically modified NAM enabled NK cell therapy programs, which utilize CAR and CRISPR mediated strategies to increase targeting potency and the persistence against hematologic malignancies and solid tumors. We were excited to highlight these new programs at an R&D day in October. Importantly, we are pleased to announce a research collaboration with the Dana-Farber Cancer Institute for our GDA-601 cell therapy, which is a CD38 CRISPR knockout combined with a CD38 CAR are NK cell construct that has demonstrated promising preclinical results against multiple myeloma cell lines. Together with Dana-Farber, we will be studying the great potential of GDA-601 in multiple myeloma.
Our NAM-enabled NK product candidates hold tremendous promise for both hematologic cancers and solid tumors and we look forward to advancing our work in this very important field.
I want to conclude my introductory remarks by expressing my gratitude to our employees for their dedication and hard work or it's driving forward our important mission. Their continued determination and focus on patients have brought us to where we are today.
And with that, I will turn the call over to Ronit Simantov our Chief Medical Office.
Ronit Simantov
Thank you, Julian and good morning, everyone. Thank you for joining us on our call. I'm excited to join you this morning and describe the recent data we presented at the Society for Immunotherapy of Cancer or SITC 36 Annual Meeting. Additionally, I'll a provide a preview on what we'll be presenting at the upcoming 63rd Annual Meeting of the American Society of Hematology or ASH.
The data presented at SITC provided extensive characterization of the activity of GDA-201 by examining the phenotype killing capacity and anti-tumor activity of the cell. The data showed that GDA-201 features a unique phenotype characteristic of a rejuvenated NK cell or non-exhaustive phenotype according to classical lineage stages, retaining potent anti-tumor effects in-vitro and in-vivo assays.
We also presented data where we used artificial to analyze differential express genes and metabolites in GDA201 or NAM enabled NK cells. The data illustrated the network of interactions associated with the enhanced biological function of NAM enabled NK with increased cytotoxicity, ABCC, homing and SU in-vivo anti-tumor abilities as compared to NK cells that were expanded without NAM. These data give us key insights into the mechanism of action of NAM enabled NK cell expansion, which is important as we move GDA-201 into the next phase of clinical development and relevant to the cell therapies and are expanding NK cell pipe line.
We're also very much looking forward to the presentations that we have coming up at the ASH Meeting, which will be held from December 11th to the 14th. For omidubicel, we will have an oral presentation on immune reconstitution as well as two poster presentations, one with long-term follow data in patient treated with omidubicel and one on hospital and healthcare resource utilization.
Additionally for GDA-201, we will have a poster presentation with two-year follow-up data from the phase one study. Data we plan to present demonstrate that patients treated with omidubicel had more rapid recovery of a wide variety of immune cells associated with a lower risk of infection. Additionally, omidubicel treated patients had significantly shorter durations of hospitalization, intensive care unit time, consultant visits, procedures and transfusions. In an analysis of outcomes of patients with hematologic malignancies treated with omidubicel over a 10 year period patients showed long term sustained bone marrow function and immune recovery.
Taking together, these data provide further evidence of the strong clinical benefit associated with more rapid and lasting hematopoietic recovery with omidubicel. For GDA-201, we will share a two year follow analysis from the investigator led study in patients with non-Hodgkin lymphoma, demonstrating a median duration of response of 16 months and 78% overall survival of two years with reported toxicities in line with those seen previously. These data further strengthen our confidence in the safety and activity of GDA-201.
There are further details that each of the presentations and the press release we issued this morning and we plan to provide further updates during ASH. Regarding the clinical program in GDA-201, colleagues on my team are preparing for the initiation of our multi sensor study in patients with non-Hodgkin lymphoma, with operational activities and meetings with investigators and thought leaders ongoing. We continue to hear from experts that there is a high unmet need among patients with lymphoma who have active disease after previous treatment. Investigators are enthusiastic about beginning to enroll patients in this study and treating patients with GDA-201.
I'll now turn the call over to Michele Korfin, our Chief Operating Officer and Chief Commercial Officer, who will talk more about our commercial opportunity for omidubicel. Michelle?
Michele Korfin
Thank you, Ronit and good morning, everyone. We remain excited about the opportunity from omidubicel to provide an important option to patients who need a bone marrow transplant and do not have a suitable matched donor. In the US alone there are over 40,000 patients per year with hematologic malignancies who consider a bone marrow transplant. Unfortunately only approximately 10,000 patients are able to make it to transplant for a variety of reasons.
We have done extensive research in collaboration with the Center for International Blood and Marrow Transplant Research, or CIBMTR conducted independent market research and spoken to hundreds of transplanters to fully assess the unmet need. Based on these commercial insights, the opportunity for omidubicel can be summarized into two key categories. The first one is increasing access for patients, especially those who are eligible for transplant and cannot find a match and second improving outcomes based on the unmet clinical needs with current donor sources that can be addressed by omidubicel.
One specific area of advantage from omidubicel is that it has a less stringent matching criteria for patient as compared to 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. Data from be [indiscernible] highlight that a patient's ethnic background greatly impacts his or her ability to find a match with some patient groups facing only approximately a 20% likelihood of finding a match in the public matching database.
In the omidubicel phase three trial over 40% of the patients enrolled were not Caucasian, illustrating the important need for a suitable graft source in this patient population. Upon FDA approval or potential FDA approval, we believe omidubicel will provide a timely and attractive option for a suitable graft source to patients in need of a bone marrow transplant who would otherwise undergo a search for a matched donor that could take several months causing high levels of anxiety and uncertainty for patients with cancer who are at high risk for relapse. In our clinical trials, we consistently delivered omidubicel to sites within 30 days of cord blood unit selection.
Based on our extensive assessment of the market opportunity, we anticipate there will be approximately 2,400 patients receiving omidubicel each year once we reach peak market share, which would be about three years after launch. We anticipate this peak market share to be between 20% to 25% of the addressable patients. We continue to have active dialogue with physicians and payers and feedback on the value proposition of omidubicel has been highly encouraging, specifically from payers they are encouraged by the potential for faster time to neutrophil and graft decreased infections, decrease in hospitalization and less graph versus host disease as compared to published literature for other graph sources.
Now, in my role as Chief Operating Officer, let me transition to discuss the ongoing activities to address the FDA's feedback about our analytical comparability data to enable the omidubicel BLA submission. Under the leadership of Vladimir Melnikov, our Senior Vice President, Global Manufacturing and Operations, we have completed the production runs for BLA readiness, and the team is now conducting the revised analysis that FDA has requested to demonstrate that the omidubicel produced and Gamida Cell wholly owned commercial manufacturing facility in Israel is analytically comparable to the omidubicel that was produced at the clinical manufacturing site for the phase three study. We feel that the analysis that the FDA has requested is addressable and we look forward to working with the FDA to complete the requirements to enable the BLA submission.
Transitioning to GDA-201, there is a great unmet need for relapse refractory patients with lymphoma. In the US and U5, there are approximately 40,000 patients who reach at least their third line of treatment. During our discussions with both US and EU physicians, they were consistent with the challenges they see with their current treatment options and relapse refractory lymphoma. These included the need for therapies that balance efficacy, especially complete responses with a tolerable safety profile.
In addition, physicians discuss the importance of new therapies with improved duration of response, GDA tool, one clinical data received positive feedback from physicians and payers in a global assessment, including the balance of encouraging overall and complete responses and the safety data that included no cytokine release syndrome and no neurotoxicity, which are often seen with other cell therapies.
Although there have been advances for patients with lymphoma, there are still significant unmet needs and relapse refractory patients that GDA-201 could address. In summary, we are excited by the potential of AMBA cell to be the first FDA approved cell therapy for bone marrow transplant. And we are encouraged by the clinical data and feedback from physicians and payers.
Finally, we are confident that we could address the FDA's feedback from our pre meeting to enable the BLA in a timely manner. We are also very encouraged by the initial GDA 2 0 1 data that Roone discussed and recognize the opportunity to further develop a new therapy for patients with relapse refractory lymphoma.
Thank you. And I will now turn the call over to Shai to review our financial results.
Shai Lankry
Thank you, Michelle and good morning, everyone. Today, I will summarize our financial result for the third quarter of 2021. As of September 30, 2021, our total cash position was $120.8 million compared to $127.2 million as of December 31 of last year. As far as our total expected cash used for this year and the cash run rate going forward, I can share that we are actively reassessing our financial expenditures and previous financial guidance due to the updated timing of the omidubicel BLA submission and we will be updating our previous financial guidance.
Research and development expenses for the quarter were $12.4 million compared to $10.5 million for the same period in 2020. The increase was mainly due to omidubicel commercial manufacturing readiness activities, and the advancements of the GDA-201 program, including bordering scientific capabilities and talent. Commercial expenses in the quarter were $6 million compared to $1.9 million for the same period last year. The increase was mainly attributed to progress with omidubicel commercial readiness activities. Going forward following the FDA recent feedback, we are reassessing our commercial readiness expenditures.
General and administrative expenses were $4.8 million for the third quarter of 2021, compared to $2.7 million for the same period in 2020. The increase was mainly due to professional expenses and the hiring of key management position to support the business. Finance income net was $3.5 million for the quarter compared to $0.3 million in the same period last year. The increase was primarily due to non-cash income resulting from revaluation of rents offset by convertible note interest expenses. Net loss for the quarter was $19.6 million compared to a net loss of $14.8 million for the same period last year. We look forward to providing an update on our financial guidance as soon as we are able to do so.
With that, I will turn the call back over to Julian.
Julian Adams
Thanks, Shai. I'm proud to be part of a team that is working towards a very important mission to develop cures for patients with hematologic malignancies and blood disorders. We're excited for the opportunity to continue to leverage our unique NA enabled platform across a broad range of cell therapies so that we can fulfill our promise to deliver potentially curative approaches to cancer patients in need. With omidubicel, we are working towards our BLA submission in the first half of '22, and continue to prepare to be launched ready at the time of approval. We are about the potential for GDA-201 and are working with the FDA to resolve their issues and initiate a GAM cell sponsored clinical study. Lastly, we are excited by our genetically modified NK cell products and look forward to providing further updates.
Now, we will open up the call for questions, operator?
Question-and-Answer Session
Operator
[Operator instructions] Your first question comes from Ted Tenthoff of Piper Sandler. Your line's now open. Okay,
Ted Tenthoff
Great. Thank you so much for taking my question. I just wanted to ask with respect to the analysis, how big of an issue is this appreciating that there's no additional clinical requirements or anything along those lines, but again, with the understanding that your anticipation is to file in the first half, is this pretty routine stuff, maybe you can give us a little bit more color. Thanks so much guys.
Julian Adams
Ted, thank you for your question. It's a pretty technical answer to get into details and we won't get into the FDA direct feedback, but at a higher level, we do not have to do additional experiments. We just have to reanalyze our data and I think from where I understand the FDA it's that it's a pretty routine situation for them.
Ted Tenthoff
Great. Thank you. And then just to get a sense with respect to the Israeli manufacturing facility and bringing everything in house, what kind much supply would you be able ultimately to deliver from Israel and would that be both omidubicel and ultimately GDA-201. Thanks so much.
Julian Adams
Yeah. Thank you for your question. We have built a state of the art facility in Israel with room to expand, and let me tell -- let me ask Michelle to further elaborate on the state of this facility.
Michele Korfin
Yeah. Thank you, Julian. And good morning, Ted. So, yes, as Julian indicated, the Israeli facility is state of the art and we built it in a modular approach. So we have the ability to add additional cores as needed. So from the standpoint of addressing the demand, we feel confident that we'll have the capacity because we do have that ability to be modular and add course. And we built the facility with the vision for both omidubicel and the NK platform.
So omidubicel as we've discussed, we're in the process of finalizing our BLA readiness requirements for omidubicel and then getting ready for commercial manufacturing. The production team is also working very closely with the R&D team to initiate the technology transfer from our research facility to our facility in Israel, the commercial manufacturing facility for the NK platform initially first GDA-201. So that was the vision for the facility was both on omidubicel and the NK platform.
Operator
Your next question comes from Jonathan Miller of Evercore. Your line is now open,
Jonathan Miller
Right? Thanks so much guys. And congrats on the progress. It still seems odd to me that the FDA would clear the IND and then hold dosing, issue a hold prior to patient dosing. So maybe could you give some color on what interactions you've had since the hold came on? Maybe get some clarity on like what the official status of that IND is at the moment. And I think to recall a few weeks ago in the R&D day, you thought, you said you thought that this would be relatively quick process to give them the analysis that they wanted. So I just want to check on what your progress was there.
And then secondly on omidubicel, I noticed the [indiscernible] abstract at ASH, which I would love to see, but of course this is being pulled. It looks from allele. So it's just versus cord blood. Can you give us some color on what here you've done for Omi versus other graph sources that maybe in the US and the EU are responsible for a greater proportion of overall HSCT? Thanks.
Julian Adams
Okay, John, I will try to address all three of your questions, but in such a way as, let me invite Jazz to comment on what we can share with the FDA interactions vis-à-vis the GDA-201 clinical hold.
Jas Uppal
Thank you, Julian. So we just call letter we are confident that we will be able to progress soon, given the progress that's already been made to its resolving the FDA concerns. The assays have now been qualified for the drug product per FDA's request and also new lab has been identified that will help address FDA's comment regarding donor eligibility. So there's been very good progress -- been had. Ronit, perhaps you can also share a clinical update
Ronit Simantov
In terms of the clinical update yes, so we are continuing to work with the site to move forward with the clinical protocol and the operational activities needed to initiate the site officially. So that once the IMD hold is lifted, we can just move forward to site initiation and then patient enrollment. So from a clinical protocol point of view, we have no other changes that we're making at this point, and we're just proceeding with the operational pieces.
Julian Adams
And Ronit, since we have you on the line, can you also comment on the HEOR question and the abstract and what can we extrapolate that to other modalities?
Ronit Simantov
Yeah, absolutely. So, we are doing HEOR analyses. The first one that is -- that will be presented at Ash is a utilization analysis that looks at resource utilization in patients who were on the study. And the patients on the study as you correctly mentioned are omidubicel versus standard cord. And so those direct data from our study could be analyzed and quantified and that's what all be presented at Ash.
Now at the same time, we are doing additional HEOR analyses using CIBMTR databases and other sources of information to look at the broader context of the HEOR benefit potentially from omidubicel. Those will be presented at a later date in additional meetings that will update you about when we're able to.
Julian Adams
Your final question maybe turn it to Michelle
Michele Korfin
In regards to HEOR Julian?
Julian Adams
I'm sorry, Jonathan, you had a third part of your question. Have we answered?
Jonathan Miller
I think you got to most of it guys thanks so much. I guess, in the detail on HEOR, what I was hoping for was some color around what you already knew versus other graph sources, but I'll look forward to seeing this presentations when they're available.
Operator
Your next question comes from Jason Butler of JMP Securities. Your line still open.
Unidentified Analyst
Hi, it's [indiscernible] for Jason. Thanks for taking our questions. I guess the first one, just to the stay on the omidubicel BLA, I guess we thought the FDA was looking for clinical comparability as part of the, the request. Did they, did they change their mind and did they explain why they changed their mind if they did? And did you show the agency any clinical data from the commercial product?
Julian Adams
Okay. I begin. Yes, they did change, change their guidance to us. And I'll ask Jazz to elaborate. I don't think they justified why they changed their mind, but I think it's commonly understood and expected that if you have analytical comparability that should lead to clinical comparability and we do have an expanded access program, so we will continue to collect data and obviously all those data will be shared with FDA in real time. Jas. Do you have anything further to add
Jas Uppal
Thank you, Julian. So yes, absolutely. comparability a really important topic. And it's key for moving forward in a new manufacturing facility as such. We had planned proactively for this topic with the FDA and had justified to them that clinical data should not be required from the facility FDA has come back and agreed with our proper, that clinical data are not required for submission of the B, but they have asked us to represent the analytical comparability data via new analysis.
Unidentified Analyst
Okay, great. Thank you. And then the SITC poster for GDA-201 with the machine learning component is pretty interesting. It sounds like you can apply some of that to informed development of the future NK candidates. Can you give us any specifics on how you might apply those results and then as far as the Ash to your follow for GDA-201, any changes in how you see that product potentially fitting in the treatment paradigm, particularly with the duration. Thanks.
Julian Adams
Okay. Let me take the first part with AI learning. So what we really have done is detailed transcription profiling and metabolic profiling, and then there's a program called ingenuity, which is an AI learning tool, which classifies pathways and does pathway analysis and in, so doing, we can inform the transcript data into this machine learning approach which surveys or literature or references, et cetera, and builds on the development of the different biochemical pathways and in the cell as well as the metabolite pathway ways. So yes, it can be applied and should be applied to every cellular product because there are a lot of things going on during the cell culture period, and particularly with our NA enabled activity, we are drastically affecting gene in a positive way to make the cells more potent and more useful. Let me turn it to, to Ron, to talk about Ash.
Ronit Simantov
Yes. And, and if I could add something to your comments about the artificial intelligence media analysis sit the, the entire platform of NK cells that we've been we've been discussing is based on the NA enabled NK product. And so understanding the mechanisms of, of the differential expression induced by NAM helps us in the development of all the genetically modified NAM, construct NK constructs. So specific information will be used in the development of those constructs with respect to the Ash presentation on GDA-201, we continue to update the on these patients.
So we had patients who have been treated now up to a little over three years. And so what we will show in the presentation will be information patient by patient of where those patients are after treatment. And this gives us further confidence in the duration and potential efficacy of G D H O one with our company sponsored study in the cry preserved formulation. So it, it just gives further confidence in the, in the product.
Operator
Your next question comes from Gregory Renza of RBC Capital Markets. Your line is now open.
Gregory Renza
Good morning, Julian team. Thank you for the update. And thanks for taking my question. Julian, certainly in light of the omidubicel delay and a lot going on for GAM cell. Just curious if you could comment on how these developments do affect your overall approach to the larger portfolio, certainly with omidubicel and GDA-201 through 601.
What are you looking at? What inputs are, are you either waiting for just as far as how you're planning to allocate resources and you certainly mentioned the reassessment of, of spend planning, but as far as your think, your thinking around the portfolio and totality, any comments would be appreciated. Thank you. Yeah.
Julian Adams
Obviously first and foremost, we have to readdress the FDA comments and get back on track with our submissions and the conduct of future trials. As we consider all of this you know, the, we, we still have a strong cash position. And the first and foremost, you know, it's going to be dedicated towards in the enablement of OOU cell and GDA 2 0 1 for programs that are further back in, in, in, and not yet pre preclinical development stage the expenses can be very easily managed. It it's a lo it's not a burdensome process for us to be able to prosecute those. But of course, as we said, we're still reassessing and still need to determine our timelines and our allocation of capital in a responsible way
Gregory Renza
That's helpful. Thank you. Maybe just one last one, as you think about capturing value for omidubicel. Just curious if you could provide us an update on where your thinking is as far as partnerships or, or, or regulatory advancements in those regions. Thanks again,
Julian Adams
I'm glad, for this question, because we have actually studied the ex-US territories and let me turn it over to Michelle to provide some insights.
Michele Korfin
Yeah, no, thank you very much. So omidubicel acts as a very encouraging commercial opportunity in parts of Western Europe and in Asia specifically Japan. You know, although we do see an opportunity for am omidubicel to improve outcomes across all graft sources for Japan in particular, you see about a third of the patients utilizing cord blood as their transplant. So when Japanese physicians saw the head-to-head data versus cord for omidubicel, they were very, very encouraged.
So in both Western Europe and Japan, we see an encouraging opportunity and we continue to partner very closely with Josh Hammerman as our Chief Business Officer and others on our team around what's the appropriate way for patients to get access to omidubicel outside of the us. But I think the, probably the key takeaway is just the opportunity is there. And now how do we move forward in terms of allowing patients to have access jazz and her team have had good dialogue with EMA already. So we understand that the regulatory path forward, we look forward to continuing to advance those plans around allowing patients to eventually access on omidubicel outside of the us following regulatory approvals.
Julian Adams
And, I would add to that Michelle, that since we conducted the phase three as an international study with sites in Europe I think we have a the ability to file in Europe without additional studies for the adult population. Japan is always a little bit trickier because there are unique laws in Japan that would have us required to do a bridging study. But all of those are just technical issues and can be addressed.
Operator
Your next question comes from Nishant Gandhi of Needham & Company. Your line is now open.
Nishant Gandhi
Hi, good morning. Thank you for taking our questions. I have a question related to the GDA 2 0 1 data presented at SETI. The results showed that there's a decrease in CD 16 expression with NA cultivation compared to the standard NK cells. Was this be a potential issue for GDA 2 0 1?
Julian Adams
Yeah, let me begin and then turn it over to Ronit as well. First of all, the decrease in CD 16 is very modest at we still see high levels of CD 16, but to address this and to mitigate this variability in CD 16 expression, we are proposing quite high doses in terms of cells per kilo to overcome the donor to donor variability. Ronit, do you have anything to add?
Ronit Simantov
Yeah, I would say I would reiterate that it was a minimal decrease in addition in the context of an overall active non exhausted phenotype. The cells were quite active and so that, that mitigates any of the somewhat slight decrease in the C16 in terms of killing potential cetera. And again, we extrapolate that that was born out in the Minnesota data, and obviously we will look for the same activities as we see comparable comparably, potent and active NK cells in the cryopreserve formulation.
Operator
[Operator instructions] Next question comes from Mark Breidenbach of Oppenheimer. Your line's now open.
Mark Breidenbach
Hey, good morning guys. And thanks for the update. Just a quick one from me with regard to the Dola filing. Can we reasonably assume that another type B meeting we'll have to be scheduled with the FDA before, before a submission? Or is it kind of a situation where you, you can do the analysis and provide the data you need and then just submit the VLA without, without a separate meeting. Thanks.
Julian Adams
Yeah, I think we have a very good perspective on that. And let me ask, sorry, Jas to talk about our filing approach.
Jas Uppal
Thank you, Julian. So yes, we have requested a type B meeting to discuss the analytical comparability data and thereafter. We are not anticipating an additional type B meeting equivalent to a pre VLA FDA have guided us that we just need to submit an amendment to the IND rather than a type B meeting for that particular outcome.
Operator
No further question. I would like to turn the call back to I'm sorry, Julian Adams.
Julian Adams
I want to thank everyone who joined us on the call today. It is really a pivotal time for Gamida Cell. We have had FDA issues, no doubt. They're very technical in nature and very addressable and we are working hard to attend to that. Over and beyond that, I think the team is extremely dedicated and hardworking anThey're very technical in nature and very addressable and we are working hard to attend to that. Over and beyond that, I think the team is extremely dedicated and hardworking and I can't express enough gratitude to the whole Gamida Cell family for their dedication.
Additionally, and I also want to thank patients and their families who have participated in our clinical studies and have really donated to the benefit of our medical knowledge that I hope will prove extremely beneficial to the medical community going forward. And thank you all for your attention this morning.
