Gamida Cell Ltd. (GMDA) Q1 2021 Earnings Call Transcript

Gamida Cell Ltd. (GMDA 4.22%)
Q1 2021 Earnings Call
May 11, 2021, 8:00 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Ladies and gentlemen, thank you for standing by. Welcome to Gamida's health conference call for the first-quarter 2021 financial results. My name is Ludy, and I'll be your operator for today's call. [Operator instructions] Now I would like to introduce your host for today's conference, Mr.

Josh Hamermesh, chief business officer. Please go ahead.

Josh Hamermesh -- Chief Business Officer

Thank you, Ludy, 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 first 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.gamida-cell.com. Here with me on our call today are Julian Adams, chief executive officer; Michele Korfin, our chief operating officer and chief commercial officer; and Shai Lankry, chief commercial officer.

Ronit Simantov, chief medical officer; Tracey Ludy, our chief scientific officer, are also on hand for the Q&A portion of the call following our prepared remarks. During this call, we may make forward-looking statements about our future expectations and plans, including clinical development and commercial objectives, the therapeutic potential of our product candidates, our operational plans and strategies, and projected operating expenses and cash runway. Our actual results may differ materially from what we project today due to a number of important factors, including the considerations described in the Risk Factors section of our Form 20-F and in other filings that Gamida Cell makes 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.

Now I'd like to turn the call over to Julian.

Julian Adams -- Chief Executive Officer

Thank you, Josh. And thanks to everyone for joining us this morning. Those of you who've been following our progress know that Gamida Cell is approaching a major inflection point in the company's history, as we approach a BLA submission later this year, and prepare for the potential product launch, what could be the first-ever FDA approved bone marrow transplant graph product for blood cancer patients in need of a stem cell transplant. At Gamida Cell, we are dedicated to advancing two cell therapy programs that leverage our proprietary NAM cell expansion platform with the potential to redefine standards of care for patients with blood cancers and serious immunologic disorders.

This platform continues to demonstrate compelling results in clinical trials based on critical features, such as cell expansion, functionality, and safety, all leading to improve patient outcomes. 2021 has gotten off to a strong start marked by continued progress across our pipeline toward key milestones. We continue to be encouraged by the clinical profile of our product candidates, omidubicel and GDA-201. Omidubicel has the potential to transform medical practice for patients with hematologic malignancies and be the first FDA-approved cell therapy for bone marrow transplant.

Commercial preparations are ongoing as we work toward submitting the BLA in the fourth quarter of 2021. Our second candidate in clinical development is GDA-201, an advanced cell therapies that utilize our NAM cell expansion technology to harness the power of the innate immune system and has demonstrated remarkable results in patients with non-Hodgkin's lymphoma specifically follicular lymphoma, and diffuse large B cell lymphoma histologies. This past quarter, we continue to make progress toward the production of a cryopreserved product to support a multicenter Phase 1/2 trial later this year. Additionally, we are excited about the progress we are making in our R&D activities to pursue the development of genetically modified these NAM-expanded NK cells.

This morning, we will review both programs and summarize our progress around plans to bring omidubicel for patients in the commercial setting pending FDA approval. Let me share more details with you starting with our lead program omidubicel, which as a reminder has FDA breakthrough therapy designation as well as orphan drug status. Our successful Phase 3 trial demonstrated meetingboth primary and secondary endpoints that omidubicel addresses a key unmet need for patients in need of a bone marrow transplant by expanding the CD34 positive stem cells and creating a suitable dose of highly functional cells. We are on track to submit the BLA for omidubicel to the FDA in the fourth quarter of this year and meet the anticipated commercial supply needs.

As we continue to advance on the omidubicel for a potential launch and prepare to become a commercial organization, we have taken important steps to establish key commercial capabilities, including the creation of Gamida Cell Assist, a program designed to support a positive patient and transplant center experience. Michelle will elaborate further on this after. Moving to the rest of our pipeline, we are thrilled by the emerging profile of GDA-201, our first lead candidate from our NAM expanded NK cell program. Natural killer cells, our innate immune cells that hold tremendous promise as an approach for treating cancer, by leveraging our NAM technology to expand NK cells derived from healthy adult donors while enhancing their functionality.

We believe GDA-201 improves NK cells direct tumor cell killing as well as antibody-dependent cellular cytotoxicity known as ADCC. In a Phase 1 trial, GDA-201 demonstrated impressive proof of concept and striking early signs of efficacy with multiple durable complete responses while being very well tolerated in heavily pre-treated patients with relapsed or refractory lymphoma. The study was designed to assess the safety of GDA-201 in combination with Rituxan in non-Hodgkin lymphoma. As a result of these encouraging data, we develop a GMP cryopreserved formulation and have initiated manufacturing runs in preparation for a multicenter study with an off-the-shelf allogeneic cell therapy in patients with lymphoma.

Based on the significant clinical activity we've seen so far in the Phase 1 trial, we put the plan to submit an IND for GDA-201 in the second half of this year to enable our Phase 1/2 study in lymphoma patients with follicular lymphoma, or diffuse large B cell lymphoma. Additionally, we are maximizing the potential of our NAM technology platform to develop a pipeline of gene-edited NK cell therapies with enhanced function for both hematological malignancies and solid tumors. I want to conclude my introductory remarks by thanking our employees for their hard work and dedication, and I continue to be impressed by the progress we're making to bring potentially life-saving therapies to patients. I'll now turn the call over to Michele Korfin.

Our chief operating officer and chief commercial officer will talk more about our launch readiness for omidubicel. Michele?

Michele Korfin -- Chief Operating Officer and Chief Commercial Officer

Thank you, Julian, and good morning, everyone. Today, I will review our progress on our manufacturing and launch readiness activities. As we continue to advance our breakthrough therapy, omidubicel for patients in need of an allogeneic stem cell transplant. During our Type B meeting with the FDA in December 2020, we received clear feedback on what will be required for our commercial manufacturing facilities to be ready for BLA submission.

This includes our Gamida Cell-owned facility in Israel and a commercial facility for which we have a contractual relationship with Lonza. Given that neither of these commercial facilities was used for the Phase 3 omidubicel registration trial, we need to demonstrate comparability from these commercial facilities with the clinical manufacturing supply. We've made important progress preparing both of these facilities for commercial manufacturing readiness. Let me start with our state-of-the-art Israeli facility.

The facility construction has been completed and our team has achieved each of our internal timeline milestones since construction was completed. We have hired, trained, and qualified our initial production team, and during the first quarter of this year, our team has successfully completed the required engineering runs and aseptic process simulation for qualification. The methods validations are under way with a planned completion in the second quarter of 2021 and we anticipate finalizing our analytical compatibility runs and process performance qualification or PPQs in third quarter of '21. For the Lonza commercial facility, we are currently manufacturing clinical batches for our expanded access program and are progressing on the BLA requirements.

We are currently on track for the CMC requirements for our BLA, which we plan to submit in the fourth quarter of 2021. We believe that there was a significant opportunity with omidubicel, specifically in the U.S. market alone as there are over 40,000 patients with hematological malignancies, who consider transplant each year. There were about 10,000 patients were actually transplanted, and then unfortunately, there are almost 9,000 patients were eligible, but not transplanted.

The extensive market research we have conducted has enabled us to develop a strong launch strategy. Upon FDA approval, omidubicel will be an important therapy option for patients in need of an allogeneic stem cell transplant. Based on our marketing sites, the opportunity for omidubicel can be summarized in three categories; first, increasing access for patients who are eligible and not matched; second, improving outcomes based on clinical needs with current donor sources and in addition increasing eligibility based on the encouraging omidubicel clinical profile. Physician and payer feedback has been encouraging and not the omidubicel product profile based on clinical data is viewed positively and they understand the potential clinical advantages.

More specifically, for payers, payers are encouraged by the potential for faster time to neutrophil engraftment, decrease infections, decrease in hospitalizations, and less graft versus host disease as compared to published literature for other grass sources. We also hear from physicians that each of the donors is a factor in their consideration. In partnership with CIBMTR, we have utilized real-world data to demonstrate that if transplant donors were less than or equal to 30 years of age, the patient had a statistically greater survival probability. So for example, in the case of related donors, if an AML patient is diagnosed at 60, which is the median age of diagnosis, their family members who could potentially be matched related or haploidentical donors would probably be above that 30 years of age, given the starting material from omidubicel is umbilical cord blood, this donor age is not a concern.

Additionally, due to the less stringent genetic matching criteria from omidubicel as compared to other donor sources, omidubicel may provide the opportunity to expand access to bone marrow transplants for patients who otherwise could not find a suitable donor. Omidubicel approved will be an important therapy option for patients in need of an allogeneic stem cell transplant. Our launch strategy goal is to ensure that patients and the transplant centers have a positive experience with omidubicel following FDA approval since the transplant center and caregivers. Education of the transplant centers is an important aspect of our strategy.

We know that 70 centers make up about 80% of the transplants in the United States. We have direct experience with 20 of those centers through our clinical trial and know many others from past professional experiences. We are confident that we will be able to effectively partner with the centers to educate them on omidubicel and we are working diligently with payers to ensure reimbursement upon FDA approval. Outreach has already begun with US payers and the discussions have been positive, including the recognition of the clinical data and the importance of the secondary endpoints such as reduced hospital time and reduced infections.

Additionally, we plan to build an outstanding team to support patients, transplant centers, and caregivers through the process. As Julian mentioned, we are excited to continue our progress developing from Gamida Cell Assist to provide assistance to ensure a positive and personalized patient experience. This is a program like no other for patients undergoing a transplant community. Gamida Cell Assist will consist of a dedicated experienced team that will be focused on supporting the patient's journey with omidubicel.

Our Gamida Cell Assist team will consist of an experienced case management team who will be focused on ensuring patient access and provide support to patients, their caregivers, and the transplant team at the hospital throughout each step of the process. The Gamida Cell Assist will have a number of key roles. One of the most important roles is compliance with the FDA's chain of identity requirements. The Gamida Cell Assist, we'll start our chain of identity, which is a unique patient identifier that will follow the patient throughout the entire process.

Just as importantly, Gamida Cell Assist is going to be that single point of contact for the hospitals and patients. As such, we will be able to provide the hospitals and patients with assistance to support access to omidubicel such as benefits verification or travel and lodging needs. Gamida Cell is committed to supporting a positive journey for patients and their transplant centers. So, they can focus on what matters most the patient experience and successful clinical outcomes.

We were excited by the potential of omidubicel to be the first FDA-approved cell therapy for bone marrow transplants, and we are encouraged by the clinical data and the feedback from physicians, payers, and patients. We have our omidubicel launch strategy and plan in place with a key focus on assuring a positive patient and transplant center experience. I will now turn the call over to Shai to review our financial results.

Shai Lankry -- Chief Commercial officer

Thank you, Michelle. Good morning everyone. Today, I will summarize our financial results for the first quarter of 2021. As of March 31, 2021, our total cash position was $174.8 million, compared to $127.3 billion as of December 31, 2020.

The March 31st cash balance includes the $75 billion in gross proceeds to our recent financing with Highbridge Capital Management closed this quarter. Research and development expenses for the quarter were $11.4 million, compared to $7.9 million for the same period in 2020. The increase was mainly due to omidubicel commercial manufacturing activity and the advancements for our GDA-201 program including broadening our scientific capabilities and talent. Commercial expenses in the quarter were $4.4 million, compared to $1.5 billion for the same period last year.

The increase was mainly attributed to our progress with omidubicel commercial readiness activities, which includes among other things the addition of an experienced commercial leadership team. General and administrative expenses were $3.4 million for the first quarter of 2021, compared to $2 million for the same period in 2020. The increase was mainly due to the hiring of key management positions to support the growth of our business. Finance income net $0.7 million for the quarter, compared to finance income net of $1.7 million in the same period last year.

The decrease was primarily due to interest expenses following the recent $75,000 financing and non-cash expenses resulting from the revaluation of warrants and Israeli Innovation Authority, royalty-bearing grant liability. Net loss for the quarter was $18 million, compared to a net loss of $10.6 million for the same period last year. We continue to expect cash used for ongoing operating activities this year to range from $110 million to $120 million. We anticipate our current total cash position will support our ongoing operating activities into the second half of next year and to achieve multiple important manufacturing, commercial and regulatory milestones.

This cash runway guidance is based on our current operational plans and excludes any additional funding that may be received or due to development activities that may be undertaken. With that, I will turn the call back over to Julian.

Julian Adams -- Chief Executive Officer

Thanks, Shai. We are dedicated to finding cures for patients with hematologic malignancies and blood disorders as well as solid tumors, and we're excited about the opportunities ahead. We could have not gotten this far without an accomplished team, and I think each of our employees for their unwavering dedication toward advancing potentially lifesaving therapies for cancer patients. With omidubicel, we expect to submit the BLA in the fourth quarter of this year and are committed to be launch-ready at the time of approval.

With GDA-201, we have very compelling data in lymphoma and are planning to initiate a Gamida Cell sponsored clinical study, which could potentially support registration, if the data are consistent with the Phase 1 results. 2021 is already off to a strong start and will prove to be a transformational year for Gamida Cell, and all of its stakeholders, most importantly, patients in need of better treatment options. In conclusion, we are very excited about the important achievements that Gamida Cell will make in the second half of this year including omidubicel BLA submission and initiating the Company-sponsored Phase 1/2 GDA-201 study in non-Hodgkin lymphoma. We understand the importance of our work for cancer patients, the healthcare system, and society in general.

As you've heard today, the Company is on a path to transform the way cellular therapies can treat patients with cancer. We look forward to updating you on our progress throughout the year, and now we will open the call for questions. Operator?

Questions & Answers:

Operator

[Operator instructions] And our first question comes from the line of Ted Tenthoff of Piper Sandler. Your line is open.

Ted Tenthoff -- Piper Sandler -- Analyst

Great. Thank you very much, and congrats on all the progress. I'm curious what is sort of still being done for the BLA, as I'm assuming you guys with the anticipated outcome, but just wanted to get a sense of your expectations around that? Thanks so much.

Julian Adams -- Chief Executive Officer

So -- but let me begin and thank you, Ted, for your question. Obviously, right now, we're involved in two very distinct activities. One is making sure that our manufacturing of cell therapies is meeting all of the FDA requirements. And we're going through all of the validation and qualification runs of both our site in Israel and at Lonza.

Our second supplier, and in addition, Michelle outlined, how she's building up the commercial team and Gamida Cell Assist, and services. Michelle, I don't know if you want to add anything to that.

Michele Korfin -- Chief Operating Officer and Chief Commercial Officer

Thank you, Ted. So I'll take the BLA question and then I'll turn it back to either Julian or Ronit for the response to the outcome. So, in regards to the BLA, we are finalizing the CMC requirements for the BLA at both Kiryat Gat and Lonza. We are making very nice progress to date in both areas.

So, at Lonza, we have completed a number of the initiatives required. At this point time we're focused on manufacturing commercial batches VAP, and then in the second, third, second or third quarter of this year, we will finalize the BLA requirements for Lonza. In regard to Kiryat Gat, the team has progressed very nicely in the first quarter we completed engineering runs. We completed an aseptic process simulation.

We're in the process of completing the method validation runs, which we had discussed after our Type B meeting with FDA in December. And then we'll finalize and Kiryat Gat targeting by roughly the end of third quarter the analytical variability and the PPQ runs. So to summarize, we have made very nice progress year to date at both Lonza and Kiryat Gat in terms of the CMC requirements for the BLA. So with that, let me turn it back to Julian or Ronit to answer your question in regards to the AdCom.

Julian Adams -- Chief Executive Officer

Yes, Ronit, please. Could you comment on any additional data we might -- any additional follow-up from the Phase 3 data and our plans for?

Ronit Simantov -- Chief Medical Officer

Yes. Sure. Thanks. Thanks, Ted.

So we will -- a very important part of the BLA, of course, is the clinical aspect of the submission and we are preparing all of the clinical sections for submission, we expect additional follow-up data on the patients in the Phase 3 study to include up to one-year post-transplant for every patient, or at least one year out follow back to handset for every patient with some patients having additional follow-up after that, and so all of those data will be included in the BLA submission. Now in terms of outcome, we don't know yet whether we will have one but we certainly will be prepared for one. We need to engage in advisory committee meetings.

Ted Tenthoff -- Piper Sandler -- Analyst

Make sense? Thank you so much. And I would just add, we're in extensive conversations, not only with key transplant centers, and KOLs in the field as well as regular conversations with FDA, as we enjoy break-through therapy designation. We have a kind of an open line to an FDA to continue to prepare for the BLA submission.

Operator

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

Jonathan Miller -- Evercore ISI -- Analyst

Hi, guys. Thanks for taking the question. One in clarification, on manufacturing compensability in the CMC, I was under the impression that you would have to generate actual commercial products and dose patients with it in order to get that CMC compatibility. Is that true? And if so, what would we hear about those patients and when? That's one.

Second, I'd love to hear your updated thoughts on potential partnerships for only ex-U.S. I think you had been talking about doing that. Do you have preferred timing for when we could expect a deal like that and what are you looking for in a potential partner ex-U.S.?

Julian Adams -- Chief Executive Officer

So let me invite Ronit to talk about, the ongoing EAP study and the clinical compatibility from our manufacturing sites.

Ronit Simantov -- Chief Medical Officer

Sure. So we have an open expanded access protocol, which is really a single-arm protocol, where all patients receive omidubicel and we're using that to execute our clinical comparability for both of our manufacturing sites, and basically enrolling patients with the product manufacturer, at the site that we need to and that it's available from. So we don't intend to provide updates on an ongoing basis around those patients or their outcomes. We're going to treat patients from both sides.

We will have data to submit to FDA for the BLA and we're on track to do that. So I wouldn't expect to hear anything about that. We have had conversations with FDA about the extensive data required and we're confident we'll be able to provide the level of data that they are asking for in terms of the patients treated with omidubicel.

Jonathan Miller -- Evercore ISI -- Analyst

And, Josh, can you comment about omidubicel in other territories?

Josh Hamermesh -- Chief Business Officer

Yes. So, John, we continue to explore our strategic options for the optimal way to commercialize omidubicel outside of the United States. We've recently conducted some market research assessments to best understand the territories and the opportunities in those territories. We're not commenting or providing further guidance on timing or capabilities of potential partners.

It's sort of the obvious stuff, we're looking for the best way to provide access and maximize the value of omidubicel for patients around the world.

Operator

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

Jason Butler -- JMP Securities -- Analyst

Hi. Thanks for taking the question. First one, Michele, you talked about, the opportunity to increase the number of patients that might be eligible for a transplant. Could you maybe expand some numbers around how that opportunity compares to or differs from the population that today we know is eligible, but not matched? I guess that first bucket versus the third bucket of the opportunities you talked about before.

Michele Korfin -- Chief Operating Officer and Chief Commercial Officer

Yes. Thank you, Jason. Good to hear from you. So in regards to the three opportunities increase in eligibility was based on the physician feedback on the clinical profiles omidubicel.

So when you go back to the data that Ronit, Dr. Hurwitz and Professor Saunders has presented, we see the decrease in infection rate. That's generally the one that and also the graft versus host disease data. So when physicians see those aspects of the clinical profile, the transplanters will say, there are some patients that I may not feel have the appropriate performance status to undergo transplant with current donor modalities, but based on the clinical profile of omidubicel, both in regards to the safety date around decreased infections decrease in graft versus host disease, but also the rapid time to nutrient graphs that they say there is a percentage of patients that I may consider now eligible omidubicel was available.

So we haven't guide on a guided on specific numbers from that portion. But what we have said is overall, once we reach a peak market share, we're probably at about 2500 patients, once we reach that peak market share, and we're excited by all three of those opportunities, both increasing eligibility, the increase or improving outcomes for patients from based on current donor modality, but also very importantly, that portion of the patients that are currently eligible but just can't find a match. That's also an incredibly important opportunity from omidubicel.

Jason Butler -- JMP Securities -- Analyst

Right. And then -- thank you. And just as a follow-up on the data, you'll have a BLA. I think you mentioned you'll have one year follow-up data for most of the old patients.

I guess to what extent you expect FDA to weigh one year survival rate? And is this data you think could be included in the label?

Julian Adams -- Chief Executive Officer

Thanks. Ronit, would you handle that, please.

Ronit Simantov -- Chief Medical Officer

Of course. So we will have one-year data on -- all patients will have been at least one year after transplant so that the data will include one-year data on all patients. One-year survival data are actually important in the transplant field. They're used as a marker for evaluation of transplant centers and transplanters are familiar with looking at one-year transplant data.

So we expect those data to be important. As the study wasn't powered to detect a statistical difference in the two arms with respect to overall survival data, but we will show those data and certainly share them and include them in the BLA. And we expect to use those data to show the utility of omidubicel to whatever extent we're able to.

Jason Butler -- JMP Securities -- Analyst

OK. Great. And then just one quick one for me. So you mentioned before you're making progress on the client preserving cryo products, what are the next steps in terms of manufacturing and when can we hear an update on the progress toward a cryopreserved product we could use in a multicenter study?

Julian Adams -- Chief Executive Officer

Thank you for that. Tracy, could you elaborate?

Tracey Ludy -- Chief Scientific Officer

Sure. I'd be happy to thank you, Jason, and hope you're well. So we continue to make fantastic progress and I can update since we spoke last that we have now finalized the cryopreservation formulation in the research setting. And we have successfully manufactured two engineering runs which are practice runs at our GMP facility, which is right out of Hadassah University near there in Israel.

So the team has made significant progress now and not only finalizing the cryopreservation but now made this to scale to clinical scale. So the next step actually are just to continue manufacturing now for the clinical runs, so that we can store up enough inventory, and we're on track to do that prior to the IND submission of the Phase 1/2, which we plan is on track for the latter half of this year.

Operator

Your next question comes from the line of Vernon Bernadino of H.C. Wainwright. Your line is open.

Vernon Bernadino -- H.C. Wainwright -- Analyst

Thanks for taking my question and congrats on the progress. Just perhaps this is a question for Michele. What reimbursement levels are currently available for bone marrow transplant or use of umbilical cord blood? And can it initially applies for use of omidubicel and must be perfectly established at the time of omidubicel approval?

Ronit Simantov -- Chief Medical Officer

Hi, Vernon. Nice to hear from you. So here we go to some reimbursement. Let me talk about the commercial payers in the U.S.

and government. So, just taking a step back, we anticipate the majority of patients who would be receiving omidubicel would fall under private or commercial payers although Medicare certainly is an area of key focus for us too. So let me start with the commercial payers. So commercial payers in the transplant centers in the U.S.

have confidential contracts that they negotiate in regards to their reimbursement. So I would not be able to speak specifically on the details of that. But here's what I can tell you. We've had a number of conversations through either market research with U.S.

payers or direct one-to-one communications. What payers were saying is? They would most likely reimburse omidubicel at time of FDA approval via their carve-out mechanism, which is part of the contract. So what does that mean in practice? They reimburse the transplant center for the agreed to rates for hospitalization provider care and then they carve out the reimbursement from omidubicel, that's consistent with what they did with CAR-Ts in many cases upon FDA approval, and that's what they're saying they would do for omidubicel. We're encouraged by that, and also the transplant centers are comfortable with that approach.

On the Medicare side, there are established diagnosis related groups or DRGs for allogeneic stem cell transplants. And there is also some always continual evolution of how to enhance DRGs. There was some update in the proposed in-patient perspective payment rule that just came out, but the key takeaway on the Medicare side is there are DRGs that a therapy like omidubicel could be mapped to. And then in addition, we are preparing to apply for the new technology add-on payment or NTAP, which would then also support the additional reimbursement if approved.

So those are the two key avenues in terms of the commercial, and then on the Medicare side.

Vernon Bernadino -- H.C. Wainwright -- Analyst

I know someone asked you this before, but do you anticipate the established reimbursement to follow the pathway that was followed by CAR-T cell therapies?

Ronit Simantov -- Chief Medical Officer

So in terms of the commercial, what we're hearing from the payers is similar to what they did in many cases, for CAR-T they would carve out the reimbursement with omidubicel. So that's something that, transplant centers and are used to getting encouraged by. So in that case, yes. In the case of Medicare, the difference between omidubicel and CAR-T were when CAR-T were approved, there was no appropriate or common DRG for them to be mapped to versus in the case of omidubicel, there are allogeneic STEM cell transplant DRGs that are already established.

So that is more difference with the CAR-T.

Operator

[Operator instructions] Our next question comes from the line of Gregory Renza of RBC Capital Markets. Your line is open.

Gregory Renza -- RBC Capital Markets -- Analyst

Thanks for the update and thanks for taking my question. Well, perhaps just one on each program, Julian just with as the omidubicel data circulated in the physician community and after a series of meetings across this year so far. What do you learn that is either reinforcing or incremental on the omidubicel profile that they think is worth highlighting? And then secondly, on GDA-201, just curious, what is your view on the various engineering and expansion strategies across the NK space and where perhaps, would 201 fit in there? Thank you very much.

Julian Adams -- Chief Executive Officer

So let me direct that question to Ronit on the clinical side, a lot more contact with physicians.

Ronit Simantov -- Chief Medical Officer

Thank you. And, Greg, we have been in touch and reaching out to a number of transplanters across the U.S. especially many who were not investigators in our clinical study to talk to them about the results of a study and about omidubicel and to get their feedback on the results of the study. And we've been hearing an enormous amount of enthusiasm about the potential.

They each have been able to think of patients that they would have been able to, or would have wanted to do the foreword available. Patients who wouldn't have fit the mold for other opportunities and transplants couldn't find a match or just weren't appropriate for some of the other modalities. And I think people are looking forward to having another option when they're looking for a grasp for their patients with illogic malignancies. So that's what we've learned that folks who were not previously familiar with omidubicel, and are now learning about it are enthusiastic.

Julian Adams -- Chief Executive Officer

And for GDA-201, again, let me refer you to Tracy, to answer.

Tracey Ludy -- Chief Scientific Officer

Sure. And thank you for the question, Greg. Good to hear from you. So as the NK field is expanding and with many different approaches, and really information flowing very nicely.

And we're really pleased to be, in this and at the forefront of this with our clinical data set. And so I'll say a few things about, GDA-201 which distinguishes us, and then where we're going in terms of the engineering. So I think the key benefits of GDA-201 really is our quick manufacturing process, that we're able to isolate this perfect blood from normal donors have a product within 14 days. And now as I said, we're very excited to have a cryopreserved formulation of that, which has maintained the phenotype and the function in the lab of these cells.

And so as a bore out in the clinical trial, we're really excited about the combined ability of our technology with other therapies and especially with other antibodies. So I think this distinguishes us from heavily engineered CAR in case in other IPSC-derived CAR in case which required heavily on significant genetic engineering. Our cells do not persist past seven to 10 days in the patients, what we've seen by fax analysis, at least in the IST Phase 1. But therefore, we think it's a different mechanism that's going on with GDA-201 and that their ability in part, because of our expanded with our NAM technology to maintain their function posting vivo-transplant as well as to creating our cytokine activating adaptive immune response, that we are working on still to provision some translational studies.

And we think this is what's really leading to some of the durability that we've seen in the ongoing study. So we're excited about that and to continue to explore the potential. And this is what distinguishes, our NAM technology because we believe this would not be possible without the NAM actually improving the fitness of the cells around the metabolism and really around the ability for them to be very active when we're expanding them and not be exhausted. Where we're going in the future? The R&D team is making tremendous progress that we're really excited about and actually doing some gene editing in which we think we will improve the cells as we look to other tumor types, and especially in solid tumor types and how we can improve them, the persistence, which we think may be needed for this and also to tackle those difficult solid tumor types.

So we're making great progress and we think we have a product that is distinguished and we're looking forward to improve that as we expand out to different indications. So thank you for the question.

Operator

And I am showing no further questions. At this time, I would like to turn it back to Mr. Julian Adams for the closing remarks.

Julian Adams -- Chief Executive Officer

Thank you, everyone, for joining us on today's call and we look forward to updating you in the future, and we really appreciate your continued support. And once again, I can't thank the employees of Gamida Cell enough, particularly in this pandemic year where they just worked tirelessly and with such commitment to realize the potential of our programs for patients. Thank you, all.

Duration: 44 minutes

Call participants:

Josh Hamermesh -- Chief Business Officer

Julian Adams -- Chief Executive Officer

Michele Korfin -- Chief Operating Officer and Chief Commercial Officer

Shai Lankry -- Chief Commercial officer

Ted Tenthoff -- Piper Sandler -- Analyst

Ronit Simantov -- Chief Medical Officer

Jonathan Miller -- Evercore ISI -- Analyst

Jason Butler -- JMP Securities -- Analyst

Tracey Ludy -- Chief Scientific Officer

Vernon Bernadino -- H.C. Wainwright -- Analyst

Gregory Renza -- RBC Capital Markets -- Analyst

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