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spk10: Thank you, Crystal, and good morning, everyone. Welcome to today's call, during which we will provide an update on the company and review our financial results for the second quarter of 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.gametacell.com. Here with me on our call today are Julian Adams, Chief Executive Officer, Ronit Simintov, Chief Medical Officer, Michelle Corfin, Chief Operating Officer and Chief Commercial Officer, and Shai Lankre, Chief Financial Officer. There will also be a 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 and 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 Omidubacil to the FDA, commercialization planning efforts, the potentially life-saving or curative therapeutic and commercial potential of Omidubacil, 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 pandemic 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 candidates, as well as those considerations described in the risk factor section of our most recent annual report, on Form 20F 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.
spk11: Thank you, Josh, and thanks to everyone for joining us this morning. This was a productive quarter for GametaCell. we continue to execute on our plan to launch the first allogeneic stem cell therapy, Omidubacil, for cancer patients in need of a stem cell transplant. In addition, based on promising preliminary studies, we have accelerated our plans to develop a unique NAM-enabled natural killer, or NK cell, GDA201, for patients with follicular lymphoma and diffuse large B-cell lymphoma. and we are very excited about the expansion of our cell therapy pipeline with four new NAM-enabled genetically modified NK cells targeting cancers. Patients are at the forefront of our work, and we are committed to turning our NAM-enabled NK product candidates into curative therapies. I'll start with our most advanced program, Hormoduga Cell. potentially life-saving treatment for patients with blood cancers who are in need of a stem cell transplant. This quarter, we announced the results of a Phase III clinical study of omadubacil, which were published in Blood, the official journal of the American Society for Hematology. The published results demonstrate that transplantation with omadubacil leads to faster neutrophil and platelet recovery compared with the standard of care. Additionally, The data demonstrate that omadugasel results in fewer bacterial, fungal, and viral infections and less time in the hospital. These results add to the compelling body of evidence for the potential of omadugasel as a life-saving therapy that can benefit patients in need of a bone marrow transplant and help reduce the burden on our healthcare system. We continue to execute our plan of action to toward becoming a commercial company in 2022 as we prepare for our BLA submission for Omidugacel by the end of this year, subject to a pre-BLA meeting with the agency in the fourth quarter. Omidugacel has the potential to be the first FDA-approved cell therapy for stem cell transplants. Michelle will provide an update on launch readiness later on in the call. Moving to our NK pipeline, we believe that NK cells hold tremendous potential as a best-in-class next-generation immunotherapy. NK cells are the body's first line of defense in providing innate immunity. They also have immune-privileged properties which obviate the requirement for HLA matching. Given that any healthy adult donor can provide an apheresis unit, from which we apply our proprietary NAM technology to expand and produce a cryopreserved, off-the-shelf, allogeneic natural killer cell treatment for cancer patients. Our NAM-enabled NK cells display several important cell surface markers, including high expression of CD16, the FC gamma R3 receptor for antibodies, which allows the combination with monochromal antibodies to target tumors through enhanced antibody-dependent cellular cytotoxicity, or ADCC. Importantly, NAM also increases CD62L, or L-selectin expression, which leads to in vivo homing and retention in lymphoid tissues. Furthermore, NAM increases secretion of inflammatory cytokines for activation of host adaptive immune cells. The culmination of these activities results in increased cytotoxicity for more efficient tumor cell killing and durable responses. The combination of NK cells with therapeutic antibodies increased GDA201's potency of killing and enhanced ADCC, both in vitro and in vivo, supporting clinical treatment with GDA201 in parallel with selected antibodies for specific malignancies. We are advancing the power of NK cells to the next level with our second candidate in clinical development, GDA201, which has demonstrated remarkable results in preliminary studies as a potential treatment for patients with follicular and diffuse large B cell lymphomas. We have completed the GMP batches with our cryopreserved formulation of GDA201 and are on track to submit an IMD in this quarter to support a multi-centered Phase I-II study by the end of the year. Today, we announced that we are expanding the reach of both the NAMM technology and the power of NK cells through the growth of our NK pipeline to now include genetically modified variants and proprietary therapies using CRISPR-Cas9 and CAR technologies. Ronit will give more detail on this exciting new development shortly. and we look forward to providing a more detailed update at an R&D day later this year. I'm extremely proud of the progress our team has made with this expansion, and I believe that our technology combined with our expertise in NK biology holds great promise to further our vision of bringing curative therapies to patients. I want to conclude my introductory remarks by really thanking our employees for their continued dedication to our mission and hard work. And with that, I will turn the call over to Roni.
spk05: Thank you, Julian. I'm very excited to provide more detail on our NK pipeline expansion, which we announced this morning. We're confident in the potential to leverage our NAMM technology for these newly announced targets based on the encouraging clinical data we've demonstrated with GDA201, for patients with lymphoma. These new programs will involve genetic modifications intended to direct NK cells against cancer cells, enhancing targeting and persistence, and improving cytotoxicity against both hematologic malignancies and solid tumors. This pipeline expansion stems from research that we've been conducting here at GametaCell and in collaboration with key academic researchers. and represents important progress in the development of NK therapies for patients. Our new product candidates include GDA301, a knockout of SISH, or cytokine-inducible SH2-containing protein in NK cells using CRISPR-Cas9, with concomitant insertion of membrane-bound interleukin-15, or IL-15. SISH is a regulator of IL-15 signaling, And FISH deletion increases NK sensitivity to IL-15 by lowering the NK activation threshold. NK cells equipped with membrane-bound IL-15 are designed for enhanced persistence and improved antitumor effects. In preclinical studies, we've demonstrated elevation of pro-inflammatory cytokines and enhanced potency and cytotoxic activity in these cells. We believe that the CISH target coupled with membrane-bound IL-15 has potential across multiple tumor types. Additionally, today, we announced the development of GDA-401, which is genetically engineered towards an undisclosed target designed to enhance NK cell survival in a solid tumor microenvironment. As with GDA-301, we believe that GDA-401 has potential application across a broad range of solid tumors. The third development candidate in our NK pipeline is GDA501, a chimeric antigen receptor, or CAR, engineered NK cell designed to target HER2-positive solid tumors. This candidate has the potential to enhance HOM2 and activity against tumors overexpressing HER2, such as breast cancer, ovarian, lung, bladder, and gastric cancers. The NK-CAR is based on a single-chain variable fragment of the widely used immunized monoclonal antibody trastuzumab. GDA501-CAR was selected out of several constructs that are primarily focused on optimizing the intracellular signaling domain. These were further validated in preclinical studies, showing increase in cytotoxicity and enhanced potency. The fourth development candidate in our NK pipeline is GDA601, which is designed to target multiple myeloma. There is strong biological rationale for the augmentation of allogeneic NK cells with a CAR to enhance myeloma targeting. And CD38 is an established immunotherapy to target multiple myeloma. However, CD38 expression on NK cells, which is increased during NK expansion, represents a barrier to the development of a CD38 CAR NK cell therapy. To overcome anticipated targeting or fracture site of NK cells by anti-CD38, we applied CRISPR-Cas9 genome editing to disrupt CD38 protein expression in NK. We combined this with a CD38 targeting CAR designed to enhance killing of CD38 positive myeloma cells, and we have demonstrated this in preclinical studies. We believe that NK cells are a very promising new approach to the treatment of cancers. and we are proud to be at the forefront of the research to advance this powerful technology. 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 Omidubatel. Michelle?
spk00: Thank you, Rony, and good morning, everyone. Today, I will review our progress on our commercial manufacturing and launch readiness activities. As we continue to advance our breakthrough therapy, Amadubacil, for patients in need of an allogeneic stem cell transplant. As Julia mentioned, we are working towards BLA submission for Amadubacil in the fourth quarter of this year, and our launch planning and manufacturing activities are underway to support a potential US launch in 2022. This quarter, we continue to make important progress preparing both our facilities for commercial manufacturing readiness. CMC qualification activities progressed at both the GametaCell-owned manufacturing facility in Israel and at Lonza. We have made significant advancements in analytical methods validation, analytical comparability, and clinical manufacturing. We are on track to finalize the CMC qualification requirements for the BLA submission. In addition, we are very excited about hiring Vladimir Melnikov as our Senior Vice President, Global Manufacturing and Operations. Vladimir's broad and deep experience provide key expertise as we advance our commercial manufacturing readiness. We believe that there is a significant opportunity with Amadou Bissell 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, and independent market research firms to fully assess the unmet need. This market research has enabled us to develop a well-informed launch strategy to reach these patients and transplanters. Based on our commercial insights, the opportunity for Amadubacil can be summarized in two key categories. First is increasing access for patients, especially those who are eligible for a transplant and cannot find a match, and also improving outcomes based on the unmet clinical needs with current donor sources that can be addressed by Amadubacil. One specific area of advantage for Amadubacil is that it has less stringent matching criteria for patients as compared to graft 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 match donor. In fact, in the Amadubacil phase 3 trial, over 40% of the patients enrolled were non-Caucasian, illustrating the important need for a suitable graft source in this patient population. If approved, we believe Amadubacil 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 also uncertainty for patients who are at great risk or high risk for relapse. Upon FDA approval, we believe Amaduvacil will be an important therapy option for patients in the U.S. in need of an allogeneic stem cell transplant, and we are focused on developing a strong launch strategy. Specifically, we have hired a very experienced commercial leadership team in the U.S. and continue to augment the capabilities of our team. Additionally, we continue to have active dialogue with physicians and payers, and feedback on the value proposition of amadubacil has been highly encouraging. Specifically, 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. In preparation for the potential approval of Amadubacil in the U.S., the development of Gameta Cell Assist continues to progress, which will be an important source of support to patients, caregivers, and transplant teams throughout each patient's journey with Amadubacil. This is a program like no other for patients undergoing a transplant. We have hired the Gameta Cell Assist leadership team that will be focused on supporting the patient's journey with Amadubacil. The Gameta Cell Assist team will include an experienced case management team that will be focused on ensuring patient access and providing 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 through the entire process. In addition, we will be able to provide the hospitals and patients with assistance to support access to Amaduba Cell, such as benefit verifications or travel and lodging needs. Kameda Cell is committed to supporting a positive journey for patients in their transplant centers so they could focus on what matters most, the patient experience and successful clinical outcomes. In summary, we are excited by the potential of Amaduba 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, payers and patients. We are progressing our launch preparations and remain on track for product launch in 2022 with a 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.
spk07: Thank you, Michelle, and good morning, everyone. Today, I will summarize our financial results for the second quarter of 2021. As of June 30th, 2021, our total cash position was $150.2 million compared to $127.2 million as of December 31st of last year. Research and development expenses for the quarter were $13.5 million compared to $9.3 million for the same period in 2020. The increase was mainly due to Omidubicil commercial manufacturing readiness activities as well as the advancements of GDA 201 and our emerging NK pipeline, including broadening our scientific capabilities and talent. Commercial expenses in the quarter were $5.2 million, compared to $1 million for the same period last year. The increase was mainly attributed to progress with Omidubisol commercial readiness activities, which includes, among other things, the hiring of an experienced commercial leadership team. General and administrative expenses were $3.8 million for the second quarter of 2021, compared to $2.5 million for the same period in 2020. The increase was mainly due to hiring key management positions to support the business growth. Finance income net was $1.2 million for the quarter, compared to finance expense net of $2.2 million in the same period last year. The increase was primarily due to non-cash income resulting from revaluation of warrants offset by interest expenses from the $75 million convertible note financing we did earlier this year. Net loss for the quarter was $21.3 million, compared to a net loss of $15.1 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 2022. This cash runway guidance is based on our current operational plan and excludes any additional funding that may be received or business development activities that may be undertaken. With that, I will turn the call back over to Julian.
spk11: Thanks, Shai. Our vision has always been to find cures for patients with hematologic malignancies and blood disorders, and we are excited at the many opportunities ahead. Our accomplishments in 2021 will build extraordinary momentum and create a foundation for success in 2022. With Omidubasel, we expect to submit the BLA in the fourth quarter of this year, and we are committed to being launch ready at the time of approval. The GDA201 on its heels with compelling data, we are planning to initiate a to meet a cell-sponsored clinical study in lymphoma before the end of the year. We plan to share data on the mechanism of action of our NAM platform, translational data, and more mature clinical data at major medical meetings and in peer-reviewed publications this year. Lastly, we're excited about our NK pipeline expansion announced today and look forward to updating you as we have more progress to report later this year. Now we will Open the call for your questions. Crystal, operator.
spk01: Thank you, sir. Ladies and gentlemen, as a reminder to ask questions, you will need to press star 1 on your telephone. To read your question, press the pound key. Please stand by. We'll compile the Q&A roster. Your first question comes from the line of Ted Tenhoff from Piper Settlers. Sir, your line is open. Excuse me, sir. Your line is open. Please check your phone if you're in mute.
spk11: Crystal, let's maybe just go to the next caller. We'll give Ted another chance.
spk01: Your next question comes from the line of Jonathan Miller from Evercore ISI. Sir, your line is open.
spk02: Hi, guys. Thanks so much for taking the question, and congrats on all the new programs that you just announced. A couple of things across the pipeline. Can you talk to us about spending ramp for OMI commercial launch, how big a team you anticipate needing, and what the timeline of that ramp is going to be as we anticipate both the BLA and the subsequent approval? Secondly, Anomi, you've mentioned this enormous potential market, of course, in the States, but what volume do you anticipate current manufacturing being able to fill? Maybe coming from the other side, the supply side of that curve. Then talking about the pipeline maybe a little bit, I'm curious about the timing of clinical initiation of these pipeline programs. Are any of these anticipated to have an IND before the contemplated current cash runway is up? And what is the timeline for getting more clarity on the specifics of those programs, especially the target of the 401 asset?
spk11: Thank you, John. Michelle, let me ask you to respond to the commercial expansion and the capacity questions.
spk00: Absolutely, and good morning, John. So in regards to your question about Amadou Bissell field team and timing, so when you look at the benchmarks in the cell therapy space, you know, specifically if you look at the core T companies that are also focused on the transplant centers in the U.S., their range for personnel is approximately 25 to 30 commercial account managers and approximately 10 to 15 medical science liaisons that would fall under Ronit's team. We do know that in the U.S., 70 transplant sensors make up approximately 80% or account for 80% of the transplant. So we actually do feel we could be on the lower end of those ranges and have a very thorough but efficient footprint in the field. So we're looking on the lower end of those ranges that I've mentioned. So, you know, the commercial cat manager is closer to the 25 and the medical science liaison is closer to the 10, the lower end of that range. In terms of ramp up, so on the commercial side we have hired Linda Stamler who was our vice president for both marketing and account management. So we have the leader of both the marketing and account management team in place already. And Linda is now in the process of mapping out the timing for hiring the account manager side. And, you know, Ronit and her team have made excellent progress in bringing in strong leaders on the medical affairs side also. So the leadership team and also some of the field hiring is already in place. So that's the question on the commercial footprint. In regards to manufacturing, the team at our commercial manufacturing facility in Israel has really made outstanding progress not only with getting ready for the qualification requirements for BLA, but also getting ready for commercialization. When the facility was designed in Israel, it was designed as a modular facility. So as we're seeing this encouraging data come in for our forecast going forward upon potential FDA approval, we have the ability to add additional modules at our facility in Israel in Kirigat. So we feel very confident that we not only already have the facility in place for launch readiness for commercial needs, but also we know what the long-term looks like for adding additional cores or additional modules. So let me stop there, John, and see if you have any questions on what I just said, and then I could turn to Ronit for the NK questions.
spk02: That was a fabulous response. Thanks. I guess while we're talking to you about the commercial launches and what the opportunities are, do you have any updated color on the EU market, how the opportunity is different there, and any update on BD for XUS?
spk00: Yeah, so let me talk about the EU market and also mention other markets. So we have undertaken commercial assessments in both Europe and other parts of the world, including Asia. We're encouraged by the opportunities. You know, there's certainly the great need for other potential graft sources, other cell therapies for allogeneic stem cell transplant patients in Europe and also in certain areas throughout the world, including Asia. So we are certainly very focused on launching Amiduta Cell in the U.S. We feel very confident in our strategy and our execution plans to do it, and we're currently assessing what a potential path to launch could be in Europe and in Asia. You know, the clinical study was designed as a head-to-head comparator, so we do recognize the applicability of that study in certain parts of the world, specifically in Europe.
spk11: Thank you. Excellent. Ronit, let me turn, oh, please, go ahead. I'm just saying, with regard to the further pipeline in our NK301, 401, Ronit, do you want to comment on timing And I'll just cover the general cash position as well.
spk05: Yeah, absolutely. So we are in the midst of preclinical studies for each of the programs that I've outlined, including in vitro and in vivo studies. And as we build the evidence and prepare the information, we will advance those through IND. We're not providing specific detail about the IND timings, right now, but what I can say is that we will have an opportunity later this year in an R&D day to give more color and detail about all of the aspects of that program. So we look forward to sharing more detail later.
spk11: Thanks, Ronit. It's clear that we've been able to repurpose a lot of our knowledge, including cryopreservation and cell expansion, but couple that with the technologies for CRISPR-Cas9 and car technologies to be able to enhance our pipeline so quickly. Obviously, we will need to raise additional capital to prosecute all these programs, but currently I see this as an embarrassment of riches in our pipeline.
spk02: Well, I certainly look forward to seeing what you have to share with us on the R&D day. Thanks.
spk01: Your next question comes from the line of Ted Penhoff from Piper Sadler. Your line is open.
spk08: Great. Thank you very much, and congrats on all the progress. I'm just wondering, listening to your prepared remarks and also some of the question answer, I'm wondering if you're at all contemplating, NK cells are my favorite too, but are you contemplating evaluating other cell types that could be processed from umbilical cord? Thanks very much. And from donors, thank you.
spk11: Yeah, Ted, thank you for your question. In fact, the NAM technology has broad applicability. We've been able to expand dendritic cells. We've been able to expand expand gamma delta T cells. You know, it's really just a question of bandwidth and prioritization, and we've had some very, very good luck with the NK cell program, and obviously a lot of attention in the field is being paid to the NK field. That said, it doesn't preclude us from expanding other cell types with therapeutic potential.
spk08: Great. That's really exciting. Looking forward to the BLA, and also 201 getting into the clinic.
spk11: Thanks, Ted.
spk01: Your next question comes from the line of Jason Butler from JMP Securities. Your line is open.
spk12: Hi. Thanks for taking the questions, and congrats on the progress. First one, just wondering if you could give us an update on the expanded access program from Aduba Cell, and will we see any data from the EAP? before the pre-BLA meeting or the BLA submission this year. And then second question on the NK programs. You mentioned leveraging your experience with the cryopreservation of 201. Can you maybe speak to your plans for manufacturing for the new programs? Will they be cryopreserved products from the start of the clinical development or How will you integrate those into your manufacturing facilities?
spk11: Thanks. So let me turn the first question to Ronit to talk about the EAP, and then I'll answer your NK question.
spk05: Absolutely. So our expanded access program is currently running, and we're using it as a method for – serving as our clinical bridging cohort for both Alonzo Netherlands and Kiryat Ghat facilities for our commercial manufacturing programs, and we've been able to do that as the expanded access study has been opened and enrolled patients in order to do that. We have some results from that study, and we will be happy to share those in collaboration with our academic collaborators when we all feel that those data are mature and ready for publication or presentation. So we are also very excited about other data that we will be sharing, further data on our phase three study and other potential data that have been submitted and hope to make those available by the end of the year in medical meetings as well.
spk11: Jason, let me respond about the NK program. We intend to only use cryopreserved off-the-shelf products going forward. Our pipeline is so designed that we can both manufacture the cells from apheresis units and then genetically manipulate them and cryopreserve them. And that will be our playbook going forward.
spk12: Great. Thanks for taking questions.
spk01: Thank you. Your next question comes from the line of Gregory Rensa from RBC Capital Markets. Your line is open.
spk06: Hi. This is for Greg. Thank you for taking our questions. First, maybe a follow-up on the EAP. I was wondering how should we think about the timeline for manufacturing and data collection for clinical comparability for the site in Israel, and how does that align with your expectation for a pre-BLA meeting and submission in the fourth quarter? And then another one on the NK programs, now that you have multiple in the pipeline, how do you think about selection and execution across the five programs? Thank you.
spk11: So, Ronit, would you comment again on the EAP?
spk05: Absolutely. So we have six sites for the EAP open in the U.S. with investigators who have worked with us before and are incredibly enthusiastic about enrolling patients. And so as we advance our manufacturing, we have been able to slot in patients for the program and treat them. And we will continue to do that as we advance forward towards submitting the BLA using the facility in Kiryat Ghat to treat patients in the coming months.
spk11: And with regards to the NK, the selection process will be all data driven. We have created a number of very, very interesting targets. We're looking at cell lines, but we'll eventually augment these to mouse models using PDX models as well as other sophisticated models to make the best selections for product development. And this will also be informed by our commercial colleagues who will do careful market assessments and unmet need assessments for the various programs that we are developing.
spk06: Great, thank you, and congrats on the program.
spk03: Thank you.
spk01: Your next question comes from the line of Vernon Bernardino from H3WineRite. Your line is open.
spk09: Good morning, everyone. I'm Julian, everyone. Thanks for taking my question. I'm very excited for your progress with the OMADU-BSL-BLA and look forward to its filing later this year and further progress on the new programs. I was wondering if you could provide some insight regarding the market research you conducted. Specifically, I was wondering if the market research included a component regarding what effect the pandemic has had on transplantation procedures, particularly the ability to conduct these procedures during surges of COVID cases, but also whether the market research has prompted any changes in your strategy in targeting the groups that you identified as various opportunities.
spk11: Michelle, let me invite you to answer on the market research activities.
spk00: Yes, thank you, and good morning, Vernon. So we conduct a number of different types of market research, and what we're very encouraged by is the consistency of the research. So this latest round of market research that we conducted, it was over 100 transplanters in the U.S., and it was with the actual clinical data from the Phase III study. Prior research before the study had been completed or all the data set was in was with what we would refer to as a targeted product profile. Now we were getting physician transplant or feedback on the actual clinical data. They were very encouraged by a number of factors, the primary endpoint, the secondary endpoint, and the exploratory endpoint. Payers also that we spoke to were encouraged by the clinical data and also recognize the importance of reduction in healthcare resource utilization, you know, specifically around reduction in time in hospital, reduction for interventions due to less infection. So the takeaway from the research continues to be very encouraging. So it has not changed our strategy. What it has done is actually helped to better inform our strategy and give us more encouragement and confidence in the opportunity Now, Vernon, the question around COVID has been very, very challenging for patients. And we certainly hope that we see this pandemic begin to get to a more stable place for patients. What we can say that comes out in the research is it was very difficult to align donors with patients during the pandemic. Unrelated donors was very difficult. because you had to align the donor with the patient. And we know even in traditional times, that could take two to three months. And what we were being told during COVID is sometimes it was just not possible to align the donor with the patient. One of the benefits of Amaduvacil with our starting material being cord blood that is banked at the cord blood banks, during our phase three study, we were still able to access the cord blood that was required for our manufacturing have our proprietary NAM technology expand the cells appropriately and return them to the center. So that was something that came out through the market research as a benefit from a DubaCell, given that we don't have to bring a donor into a hospital setting, as you see with other graph sources. So, Vernon, let me stop there and see if you have any questions. Thank you.
spk09: No, that's perfect. That's exactly the insight I was looking for. Thanks for providing it. I appreciate it.
spk11: Thank you, Vernon.
spk01: Your next question comes from the line of Mark Breedenbeck from Oppenheimer. Your line is open.
spk04: Hey, good morning, guys. Thanks for taking the questions. Just a few for me, all kind of geared toward the NK programs. First, now that the Phase 1-2 protocol for GDA-201 has been finalized, Can you give us a little color on the study size and the specific doses that will be tested in Phase 1? How many sites do you plan to activate, that sort of thing? And then I was hoping Ronit could describe the intracellular signaling domains of the HER2 and CD38 CAR constructs that are being used in some of the new products. Are they both the same? and maybe you can point to any key differences between these and competing CAR-NK constructs. And finally, with respect to the use of membrane-bound IL-15, I'm just wondering if you see any IT barriers to putting this type of construct in GD8301, given that other NK developers are also pursuing similar approaches. Thanks for taking the questions.
spk11: So, Ronit, would you comment on the GDA201 Phase 1-2?
spk05: Sure. So, in terms of the GDA201 Phase 1-2, we'll be conducting it as a Phase 1 first at a limited number of sites in the United States appropriate to a Phase 1. We are using doses based on our experience using the product that We tested with the University of Minnesota. We have experience there in terms of the number of cells, and we'll be using similar dosing based on that experience. After we complete the phase one, which will be used to evaluate safety, as phase ones are, we'll be transferring the study over to a larger number of sites to conduct the phase two. And we've not announced yet the number of patients that will be tested in the phase two, nor the number of sites, but I can share that the operational activities are underway. There's enthusiasm and excitement by potential investigators and all of the executional activities in terms of getting the sites and the investigators lined up for the study. are happening right now in preparation for initiating the study later this year.
spk11: And once we file the IND and are cleared to open the study, we'll provide more details on the study design, number of patients, and some of your other follow-up questions.
spk05: Absolutely.
spk11: With regard to the pipeline, we're staying silent on the details of the intracellular signaling today, but at an R&D day later this year, we plan to go into a lot more detail and rest assured that we've filed all the appropriate intellectual property submissions and are quite confident that we will have freedom to operate with the designated genetic manipulations. that are underway, both for the car and for the knockout pathways.
spk10: Mark, are you there?
spk04: Yep, I'm still here. And I assume that it covers the memory-bound IL-15 as well?
spk11: Yes. All right, thank you. We've looked at a number of different... constructs and really they're doing head-to-head comparisons and really just picking the best of the best in the lab.
spk04: All right, great. Thank you.
spk01: Again, ladies and gentlemen, if you want to ask questions, please press star 1. Your next question comes from the line of chat, from Nidham and Company, so your line is open.
spk03: Great. Good morning, and thanks for taking my question. Between NDAs and INDs and pipeline expansions, it sounds like you guys certainly are busy over there. We've covered a lot of ground, but maybe just on the pipelines, wondering if I could get your thoughts on the HER2 target. You've got a lot of really cutting-edge technologies you're throwing at NAMM, which is exciting to see. This is an extremely well-ballanted target, maybe one of the most in oncology with antibodies and small molecules and then in development any number of other ways of going at it. Just wondering what particular advantages you think you bring in her targeting specifically and solid tumor target too, by the way, very exciting to see that. and where you might think the unmet need is, where you think you would develop this. I mean, presumably in some non-cellular failures to targeted therapies, but if there's a particular place you see the need.
spk11: Thanks. It's an excellent question. Obviously, we think that the HER2 CAR has the potential to be as effective, if not much more effective, then combining it with Herceptin, the monoclonal antibody. And that's part of our engineering strategy is to make the CARs effective to be able to be used in solid tumors. As you know, solid tumors have a very immunosuppressive microenvironment, and so there are a lot of barriers in so far Really no one has reported data in solid tumors with any great efficacy, but it's still early days. And what was mentioned in the prepared remarks is that there are a number of HER2-positive cancers, but in particular I think a lot about gastric cancer and some of the lesser-known cancers that are not as well served by Herceptin. or Progena. So we're thinking a lot about the various tumor models that we will develop, and the clinical program could be a basket trial allowing all HER2 patients that are refractory, obviously, to enter the trial.
spk03: All right, great. Thanks.
spk01: During the further question at this time, Mr. Julian, please continue.
spk11: Well, it just remains for me to thank everyone for joining us on today's call, and we look forward to updating you in the future.
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