Gamida Cell Ltd.

Q1 2021 Earnings Conference Call

5/11/2021

spk00: Again, ladies and gentlemen, this is the operator speaking. Today's conference is scheduled to begin shortly. Please continue to stand by, and we thank you for your patience. Thank you. Thank you. Ladies and gentlemen, thank you for standing by. Welcome to the Media Cells conference call for the first quarter 2021 financial results. My name is Ludi, and I'll be your operator for today's call. Please be advised that today's call is being recorded at the Media Cells request. Now I would like to introduce your host for today's conference, Mr. Josh Hammermesh, Chief Business Officer. Please go ahead.
spk03: Thank you, Ludi, 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.gomitacel.com. Here with me on the call today are Julian Adams, Chief Executive Officer, Michelle Corfin, our Chief Operating Officer and Chief Commercial Officer, and Shai Lankri, Chief Commercial Officer. Ronit Simantav, our Chief Medical Officer, and Tracy Lodi, Chief Scientific Officer, are also on hand for the question and answer 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 factor section of our Form 20F and in other filings that give me the 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.
spk09: Thank you, Josh, and thanks to everyone for joining us this morning. Those of you who have been following our progress know that Gametacel 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 of what could be the first ever FDA-approved bone marrow transplant graft product for blood cancer patients in need of a stem cell transplant. At GametaCell, 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 improved patient outcomes. 2021 has gotten off to a strong start, marked by continued progress across our pipeline towards key milestones. We continue to be encouraged by the clinical profile of our product candidates, Omidubicel and GDA201. 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 towards submitting the BLA in the fourth quarter of 2021. Our second candidate in clinical development is GDA201. an advanced cell therapy that utilizes our NAM cell expansion technology to harness the power of the innate immune system and has demonstrated remarkable results in patients with non-Hodgkin lymphoma, specifically follicular lymphoma and diffuse large B-cell lymphoma histologies. This past quarter, we continued to make progress toward the production of a cryopreserved product to support a multicentered Phase I-II 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 NAM expanded NK cells. This morning, we will review both programs and summarize our progress around plans to bring Omadugazel to patients in the commercial setting pending FDA approval. Let me share More details with you starting with our lead program, Omadubacil, which as a reminder has FDA breakthrough therapy designation as well as orphan drug status. Our successful phase three trial demonstrated, meeting both primary and secondary endpoints, that Omadubacil 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 Omidubacil to the FDA in the fourth quarter of this year and meet the anticipated commercial supply needs. As we continue to advance Omidubacil 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 Gameta Cell Assist, a program designed to support a positive patient and transplant center experience. And Michelle will elaborate further on this effort. Moving to the rest of our pipeline, we are thrilled by the emerging profile of GD8201, our first lead candidate from our NAM expanded NK cell program. Natural killer cells are 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 GDA201 improves NK cells' direct tumor cell killing as well as antibody-dependent cellular cytotoxicity, known as ADCC. In a Phase I trial, GDA201 demonstrated impressive proof-of-concept and striking early signs of efficacy with multiple durable complete responses while being very well tolerated in heavily pretreated patients with relapsed or refractory lymphoma. The study was designed to assess the safety of GDA201 in combination with rituxan in non-Hodgkin lymphoma. As a result of these encouraging data, we developed a GMP cryopreserved formulation and have initiated manufacturing runs in preparation for a multicentered 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 I trial, we plan to submit an IND for GDA201 in the second half of this year to enable our Phase I-II study in lymphoma patients with follicular lymphoma, or diffuse large B-cell lymphoma. Additionally, we are maximizing the potential of our NAMM 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 are making bring potentially life-saving therapies to patients. I'll now turn the call over to Michelle Corfin, our Chief Operating Officer and Chief Commercial Officer, who will talk more about our launch readiness for Omidubacil. Michelle?
spk01: 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, amadubacil, 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 gametacel-owned facility in Israel and a commercial facility for which we have a contractual relationship with Lonza. Given that neither of these commercial facilities were used for the Phase III amadubacil registration trial, we need to demonstrate comparability from these commercial facilities with the clinical manufacturing supply. We have 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 simulations for qualification. The methods validations are underway with a planned completion in the second quarter of 2021. and we anticipate finalizing our analytical comparability runs and process performance qualification runs 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 is a significant opportunity with Amadubacil, specifically in the U.S. market alone, as there are over 40,000 patients with hematologic malignancies who consider transplant each year. There are about 10,000 patients who are actually transplanted, and then, unfortunately, there are almost 9,000 patients who are eligible but not transplanted. The extensive market research we have conducted has enabled us to develop a strong launch strategy. Upon FDA approval, Amadubacil will be an important therapy option for patients in need of an allogeneic stem cell transplant. Based on our market insights, the opportunity for Amadubacil 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 Amadubacil clinical profile. Physician-impaired feedback has been encouraging in that the Amadubacil 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, decreased infections, decrease in hospitalizations, and less graft-versus-host disease as compared to published literature for other graft sources. We also hear from physicians that age of the donor 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 for amadubacil is umbilical cord blood, the donor age is not a concern. Additionally, due to the less stringent genetic matching criteria for amadubacil as compared to other donor sources, amadubacil may provide the opportunity to expand access to bone marrow transplant for patients who otherwise could not find a suitable donor. Amadubacil, if 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 in the transplant centers have a positive experience with Amadubacil following FDA approval, patients, 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 Omidubacill and we are working diligently with payers to ensure reimbursement upon FDA approval. Outreach has already begun with U.S. 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 Gameta Cell Assist to provide assistance to ensure that positive and personalized patient experience. This is a program like no other for patients undergoing a transplant. Gameta Cell Assist will consist of a dedicated, experienced team that will be focused on supporting the patient's journey with Amaduva Cell. Our Gameta 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. Gameta 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. Gameta Cell Assist will start our chain of identity, which is a unique patient identifier that will follow the patient throughout the entire process. Just as importantly, Gameta 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 Amaduba Cell such as benefits verification or travel and lodging needs. GametaCell 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 are excited by the potential of AmidubaCell to be the first FDA-approved cell therapy for bone marrow transplant, and we are encouraged by the clinical data and the feedback from physicians, payers, and patients. We have our Amadubasel 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.
spk07: Thank you, Michelle, and good morning, everyone. Today, I will summarize our financial results for the first quarter of 2021. As of March 31st, 2021, our total cash positions was $174.8 million, compared to $127.2 million as of December 31, 2020. The March 31st cash balance includes the $75 million in gross proceeds from our recent financing with iBridge Capital Management, which 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 omnidirectional commercial manufacturing readiness activities and the advancement of our GDA 201 program, including broadening our scientific capabilities and talent. Commercial expenses in the quarter were $4.4 million compared to $1.5 million for the same period last year. The increase was mainly attributed to our progress with omnidirectional commercial readiness activities which includes, among other things, the hiring of an experienced commercial leadership team. General and administrative expenses were $3.4 million for the first quarter of 2021, compared to $3 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 was $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 million financing and non-cash expenses resulting from revaluation of warrants and Israel 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 use for ongoing operating activities this year to range from $110 to $120 million. We anticipate that 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 business development activities that may be undertaken. With that, I will turn the call back over to Julian.
spk09: Thanks, Shai. We are dedicated to finding cures for patients with hematologic malignancies and blood disorders, as well as solid tumors, and we are excited about the opportunities ahead. We could have not gotten this far without an accomplished team, and I thank each of our employees for their unwavering dedication towards advancing potentially life-saving therapies for cancer patients. With omadubacil, we expect to submit the BLA in the fourth quarter of this year and are committed to being launch ready at the time of approval. With GDA201, we have very compelling data in lymphoma and are planning to initiate a gametacel-sponsored clinical study, which could potentially support registration if the data are consistent with the phase one results. 2021 is already off to a strong start and will prove to be a transformational year for Gametacel 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 Gametacel will make in the second half of this year, including Omidubacil BLA submission and initiating the company-sponsored Phase I-II 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?
spk00: Ladies and gentlemen, To ask a question at this time, simply press the star, then the number one on your telephone keypad. Again, that will be star one on your telephone keypad. And our first question comes from the line of Ted Tantop of Piper Sandler. Your line is open.
spk10: Great. Thank you very much, and congrats on all the progress. I'm curious what is sort of still being done for the BLA program And I'm assuming you guys would anticipate an adcom, but just wanted to get a sense of your expectations around that. Thanks so much.
spk09: So 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 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 Lanza, our second supplier. And in addition, Michelle outlined how she's building up the commercial team and going to be the sell assist and services. Michelle, I don't know if you want to add anything to that.
spk01: Yeah, 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 ADCOM. So in regards to the BLA, we are finalizing the CMC requirements for the BLA. at both Kierkegaard 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 in time we're focused on manufacturing commercial batches for the EAP and then in the second and third quarter of this year we will finalize the BLA requirements for Lonza. In regards to Kirigat, the team has progressed very nicely in first quarter. We completed engineering runs. We completed 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 in Kirigat, targeting by roughly the end of third quarter, the analytical comparability and the PPQ runs. So to summarize... We have made very nice progress year-to-date at both Lonza and at Kierkegaard in terms of the CNC requirements for the BLA. So with that, let me turn it back to Julian or Rony to answer your question in regards to the adcom.
spk09: Yeah, Rony, please, could you comment on any additional data we might – any additional follow-up from the Phase 3 data and our plans –
spk06: Yeah, sure. Thanks, Ted. So we will, you know, 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 III study to include up to one year post-transplant for every patient. or at least one year follow-up after transplant for every patient, with some patients having an additional follow-up after that. And so all of those data will be included in the BLS submission. Now, in terms of an outcome, we don't know yet whether we will have one, but we certainly will be prepared for one should we need to engage in an advisory committee meeting.
spk10: Makes sense. Thank you so much.
spk09: And I would just add, we're in extensive conversations not only with patients key transplant centers and KOLs in the field, as well as regular conversations with FDA. As we enjoy breakthrough therapy designation, we have kind of an open line to FDA to continue to prepare for the BLA submission.
spk00: And our next question comes from the line of Jonathan Miller of Evercore ISI. Your line is open.
spk11: Hi, guys. Thanks so much for taking the question. One clarification on manufacturing comparability and the CMC. I was under the impression that you would have to generate actual commercial product and dose patients with it in order to get that CMC comparability. Is that true? And if so, what would we hear about those patients and when? That's one question. Second, I'd love to hear your updated thoughts on potential partnerships for OMI-XUS. I think you had been talking about doing that. Do you have a preferred timing for when we could expect a deal like that, and what are you looking for in a potential partner XUS?
spk09: So let me invite Ronit to talk about the ongoing EAP study and the clinical comparability from our manufacturing sites.
spk06: Sure. Sure. So we have an open expanded access protocol, which is really a single-arm protocol where all patients receive omadubacillin. And we're using that to execute our clinical comparability for both of our manufacturing sites and basically enrolling patients with product manufactured 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 sites. 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 extent of data required, and we're confident that we'll be able to provide the level of data that they are asking for in terms of the patients treated with omodubacill at each site.
spk09: And Josh, can you comment about Omidubusel and other territories?
spk03: Yeah. So, John, we continue to explore our strategic options for the optimal way to commercialize Omidubusel 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 Amidusol for patients around the world.
spk11: Great. Thanks so much, guys.
spk00: And our next question comes from the line of Jason Butler of JMP Security. Your line is open.
spk02: Hi. Thanks for taking the question. First one, Michelle, you talked about the opportunity to increase the number of patients that might be eligible for a transplant. Could you maybe expand, put some numbers around how that opportunity compares to or differs from the population that it today we know is eligible but not matched. I guess that first bucket versus the third bucket of the opportunities you talked about before.
spk01: Yeah, 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 profile of Amadubacil. So when you go back to the data that Ronit, Dr. Horowitz, and Professor Sanz has presented, you 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, you know, 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 amadubacil, both in regards to some of the safety data around decreased infections, decreased in graft-versus-host disease, but also the rapid time to neutrophil and graft. They say there is a percentage of patients that I may consider now eligible if amadubacil was available. So we have a guide on specific numbers from that portion, but what we have said is overall, once we reach peak market share, we're probably at about 2,500 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 based on current donor modalities, 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 for a Medeva cell.
spk02: Great. And then, thank you. Just a follow-up on the data you'll have at BLA. I think you mentioned you'll have one-year follow-up data for most, if not all, patients. I guess to what extent do you expect FDA to weigh one-year survival rate, and is this data you think could be included in the label? Thanks.
spk09: Ronit, would you handle that, please?
spk06: Of course. So we will have one-year data on all patients will have been at least one year after transplant. So 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 you know, 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 Omidupacil to whatever extent we're able to.
spk02: Okay, great. And then just one quick one from me. Sorry, you mentioned before you're making progress on the cryopreserved NK products. What are the next steps in terms of manufacturing, and when could we hear an update on the progress towards a cryopreserved, you know, product that could be used in a multicenter study?
spk09: Thank you for that. Tracy, could you elaborate?
spk05: 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 in not only finalizing the cryopreservation, but now made this to scale, to clinical scale. So the next steps actually are just to continue manufacturing now for the clinical run so that we can store up enough inventory, and we're on track to do that prior to the IND submission of the Phase I-II, which we plan and is on track for the latter half of this year.
spk02: Great. Thanks for taking the questions.
spk05: Thank you.
spk00: And our next question comes from the line of Bernardino of HC Wainwright. Your line is open.
spk08: Thanks for taking my question, and congrats on the progress. Just perhaps as a question for Michelle, what reimbursement levels are currently available for bone marrow transplant or use of vocal cord blood? And can these be initially applied for use of omoducil or must the reimbursement be established at the time of omoducil approval?
spk01: Hi there, Vernon. Nice to hear from you. So in regards to 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 Amadubacil 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 with 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 are saying is they would most likely reimburse on the DubaCell 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 for amadubacil. 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 amadubacil. 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. There's also some always continual evolution of how to enhance DRGs. There was some updates in the proposed inpatient perspective payment rule that just came out. But the key takeaway on the Medicare side is there are DRGs that a therapy like Amidubacil 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.
spk08: I've somewhat asked you this before, but do you anticipate the establishment of reimbursement to follow the pathway that was followed by the CAR-T cell therapies?
spk01: So in the case 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 Amaduba. So that's something that transplant centers are used to and encouraged by. So in that case, yes. In the case of Medicare, the difference between amadubacil and CAR-Ts were when CAR-Ts were approved, there was no appropriate or common DRG for them to be mapped to versus in the case of amadubacil. There are allogeneic stem cell transplant DRGs that are already established. So that is one difference with the CAR-Ts.
spk08: Terrific, very encouraging. Thanks for taking my question and congrats again on the progress.
spk01: Thank you.
spk00: And once again, if you would like to ask a question, simply press the start and the number one on your telephone keypad. Our next question comes from the line of Gregory Renza of RBC Capital Markets. Your line is open.
spk04: Good morning, Julian and team. Thanks for the update and thanks for taking my question. Perhaps just one on each program, Jillian. As the Amidibacill data circulated in the physician community and after a series of meetings across this year so far, what are you learning that is either reinforcing or incremental on the Amidibacill profile that you think is worth highlighting? And then secondly, on GDA201, 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.
spk09: So let me direct that question to Ronit on the clinical side. She has a lot more contact with physicians.
spk06: Thank you. And, Greg, we have been in touch and reaching out to physicians 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 the study and about omodubacillin 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 use it for were it available, patients who wouldn't have fit the mold for other opportunities in transplant, 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 hematologic malignancies. That's what we've learned, that folks who were not previously familiar with omadubasel and are now learning about it are enthusiastic about it.
spk09: And for GDA201, again, let me refer you to Tracy to answer.
spk05: Sure. And thank you for the question, Greg. Good to hear from you. As you know, the NK field is expanding 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 GDA201, which distinguishes us, and then where we're going in terms of the engineering. So I think the key benefits of GDA201 really is our quick manufacturing process that we're able to isolate this from the peripheral 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 this, which has maintained the phenotype and the function in the lab of these cells. And so as it 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-NKs and other iPSC-derived CAR-NKs, which require heavily on significant genetic engineering. Our cells do not persist past seven to 10 days you know, in the patients what we've seen by fax analysis, at least in the IST phase one, but therefore we think it's a different mechanism that's going on with GD8201 and that their ability, in part because of our expanded with our NAM technology, to maintain their function post-in vivo transplants and as well as secreting of cytokines and really activating the adaptive immune response of the patients that we're working on, still to prove this in 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, you know, our NAMM technology because we believe this would not be possible without the NAMM actually, you know, 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 is the R&D team is making tremendous progress that we're really excited about and actually doing some gene editing in which we think will improve the cells as we look to other tumor types, and especially in solid tumor types and how we can improve then 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 even improve that as we expand out to different indications. So thank you for the question.
spk04: Thank you.
spk00: And I'm showing no further questions at this time. I would like to turn it back to Mr. Julian Adams for the closing remarks.
spk09: Just 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 at GametaCell enough, particularly in this pandemic year where they've just worked tirelessly and with such commitment. to realize the potential of our programs for patients. Thank you all.
spk00: Ladies and gentlemen, this concludes today's presentation. Thank you for participating. You may now disconnect and have a lovely day.
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