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spk04: Ladies and gentlemen, thank you for standing by. Welcome to the Gameta Sales Conference call for the full year 2022 financial results. My name is Catherine, and I'll be your operator for today's call. Please be advised that this call is being recorded at Gameta Sales request. I would now like to introduce your host for today, Mike Koskowski of Gameta Sales Corporate Communications. Please go ahead.
spk06: Thank you, Catherine, 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 full year of 2022. Earlier this morning, we issued a press release summarizing our financial results and providing a business update, which is available on our website at www.cometacell.com. Here with me on our call today are Abby Jenkins, President and Chief Executive Officer, Ronit Simantov, Chief Medical Officer and Scientific Officer, Michelle Corfin, Chief Operating Officer and Chief Commercial Officer, and Shai Lankry, Chief Financial Officer. During this call, we may make forward-looking statements about our future expectations and plans, including with respect of the timing and initiation and progress of and data reported from the preclinical and clinical trials of our product candidates, regulatory filings, including the review of the BLA for Amaduvacil by the FDA, commercialization planning efforts, the potentially life-saving or curative therapeutic and commercial potential of Gametacel's product candidates, including GDA201 and Amadugacel, and our expectations regarding our projected cash, cash equivalents, and investments to be used for operating activities. Our actual results may differ materially from what we project today due to a number of important factors, the scope, progress, and expansion of our clinical trials and impacts to the cost thereof, scientific, clinical, regulatory, and technical developments, those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such product candidates, as well as those considerations described in the risk factor sections of our most recent quarterly report on Form 10Q and other filings that we make with the SEC from time to time. These forward-looking statements represent our views only as of today, And we caution you that we may not update them in the future, whether as a result of new information or future events, except as required by applicable law. Now I'll turn the call over to our president and CEO, Abby Jenkins.
spk02: Thank you, Mike, and everyone who is joining us this morning. I want to start this call by grounding us in GametaCell's mission. When I joined the company last September, I was drawn to the commitment to discovering, developing, and delivering advanced cell therapies that offer patients with cancer hope for cures. In our industry, particularly when we are focused on talking about our earnings, we talk extensively about our science, potential indications, manufacturing, go-to-market plans, and projected revenues. As we do that, it's good to remember the North Star of unmet patient needs. Gametacel was founded to pursue those needs, and it elected to do so in one of the most challenging areas of medicine and science, stem cell transplants. We believe we have the opportunity to potentially save lives with our science, and so we aim to keep our focus squarely on that goal as we make decisions about how to move forward as a company. Our belief has been and remains that Gametacel represents a compelling investment thesis. We have a robust short-term catalyst in the pending FDA approval of Amidubacil, our lead product candidate, and great long-term potential in our pipeline of natural killer cell therapies, including clinical stage GDA201 and our three engineered preclinical NK cell therapy candidates. In recent weeks, we've had positive data presented on both OmniduvaCell and GDA201 at the Transplantation and Cellular Therapy or TCT meeting, showing why we believe we are on the right path to bring meaningful innovation to patients with hematologic malignancies. Our intrinsic NK cell therapies, which are derived from healthy human donors, are differentiated from other NK approaches and have data showing that they may not only stimulate direct cytotoxic effects, but may trigger a response from the adaptive immune system, which is very promising. Unfortunately, we are in an extremely challenging economic environment. In our last earnings call, we guided a cash runway to the middle of 2023 and thus need to ensure that while we continue to pursue fundraising in support of bringing AmiDubicel to patients if approved, we also reduce expenses to preserve our cash runway. Therefore, today, we are taking decisive action with a strategic restructuring to prioritize our organizational efforts and resources around the commercial launch of AmiDubicel. We are doing this because AmiDubicel has significant clinical evidence that it may increase access and improve outcomes for patients in need of an allogeneic stem cell transplant. If approved, amibibicel will be the first advanced cell therapy for stem cell transplant and may mark the only hope for the approximately 1,200 patients that go untransplanted each year, including those who are ethnically or racially diverse. The safety profile of Omidubacill in our Phase III clinical study was consistent with the expected toxicities of an allogeneic stem cell transplant following conditioning therapy, and there was no increase in adverse events, serious adverse events, or infusion reactions in the Omidubacill arm compared to control. We've had productive interactions with the FDA, including a recently completed late-cycle meeting earlier this quarter and a pre-licensing inspection of our manufacturing facility in the fourth quarter of 2022 with no 483 observations to date, significantly de-risking our path to approval. We've had positive interactions with patients, transplanters, and advocacy leaders in the stem cell transplant space encouraging us that they are looking forward to having the opportunity to have Amidubacil as a new alternate donor source. We believe Amidubacil can fulfill our mission of having a meaningful, potentially life-saving impact on patients. With today's announcement that we are strategically restructuring the organization to dedicate the vast majority of our resources to bring Amidubacil to patients in the U.S., we've made the difficult decision to discontinue development of our early pipeline candidates, GDA301, 501, and 601. We will, however, continue enrollment in our phase one clinical trial of GDA201. Let me be clear. We believe in the scientific and therapeutic potential of these candidates. In fact, now more than ever, based on the data presented at the recent medical meeting. These changes are being made solely for economic reasons. Further to these changes, we will implement a headcount reduction of 17% beginning this week and extending into the second quarter, with the majority of impacted headcount tied to the discontinuation of our NK preclinical pipeline development. We will also close our operations in Jerusalem and consolidate Israeli operations into our state-of-the-art manufacturing site in Kiryat Gat. Finally, we will slow our ramp of hiring and expenses related to the launch of Amidu Basel. These measures collectively will extend our cash runway through the third quarter. We believe these changes will make ComidaCell a more focused, prioritized, and attractive investment opportunity and create a path for near-term value creation with the potential approval and launch of Omidubacill. While we will be focused on bringing Omidubacill to patients in the U.S. if approved in May, We will also explore strategic options, including potential U.S. and global partnerships that may enable us to do so with a more significant level of investment than our current resources allow. This has been an extremely difficult decision. Our team has worked hard on the discovery work to support these NK programs and prepare for the launch of AmiDubasel in a more robust manner. We are encouraged by the initial clinical efficacy and safety profile of GDA201 and our preclinical pipeline. But we must take these steps to sustain the company and position ourselves to bring Omidubacill to the patients who need it. Finally, last week we announced the appointment of Shawn Klein Tomasello as chairwoman of our board of directors. Shawn, who has been on our board since 2019, is a highly respected and seasoned biotech executive with tremendous experience in all dimensions of our industry, including corporate strategy and commercialization of innovative hematology, oncology, and cell therapy products. On behalf of the board and the entire company, we thank Robert Blum, our previous chairman, for his dedicated service over the past five years and look forward to Sean's leadership as we approach our May 1st PDUFA date. These changes, both the strategic restructuring of the company and the evolution of the board support our transformation from a clinical stage to commercial stage company. Now I'll turn the call over to Ronit to take us through key data supporting Omidubacill as we prepare for approval and commercialization. Ronit?
spk00: Thanks, Abby, and good morning, everyone. Thank you for joining us on our call this morning. In light of our approaching sedufidate and the strategic restructuring outlined by Abby, I'll focus on the latest regulatory and clinical updates on Omidubacill before Michelle discusses our commercialization plan and manufacturing progress. First, as Abby mentioned, we held our late cycle meeting with the FDA as planned in the first quarter. Our discussions with the agency continue to be productive as we head towards our PDUFA date of May 1st. We do not anticipate an advisory committee and there have been no significant safety or efficacy issues to date. As a reminder, the study that supports our regulatory submission was a successful phase three global randomized study that met its primary and all secondary endpoints. The study randomized 125 patients ages 12 to 65 with high-risk hematologic malignancies who needed an allogeneic stem cell transplant and had no readily available matched donor. The study demonstrated a median time for neutrophil engraftment in the as-treated per protocol population of 10 days for patients transplanted with Omiduba cells compared to 20 days for the comparative group transplanted with standard cord blood. These results were both statistically significant and clinically meaningful, given the importance of neutrophil engraftment as a key milestone in the recovery of patients who have undergone stem cell transplants. Subsequent data have also shown reduced healthcare resource utilization and improved patient-reported outcomes with homodupacil. We've had two recent data presentations on homodupacil at key medical meetings. a podium presentation at the American Society of Hematology meeting in December, as discussed on our last earnings call, and an oral presentation at PCT, as Abby referenced, in February. In our presentation at ASH, we compared the results of our Phase III trial with results from existing donor sources, matched unrelated donors, mismatched unrelated donors, and haploid dentable donors, using data reported to CIBMTR. After adjusting for baseline variables, the results showed that omadubacil was associated with a more rapid rate of neutrophil engraftment, with a median of 10 days for omadubacil versus 15 to 20 days for the other graft sources. There were comparable rates of grades 3 to 4 acute graft-versus-host disease, or GVHD, and of chronic GVHD, as well as comparable overall survival. These results suggest that Omidubacil may be an effective and important new graft source option, making allogeneic stem cell transplants available to more patients. In the Omidubacil presentation in February at TCT, we presented new data characterizing peripheral blood lymphocytes measured in correlation with time to neutrophil and platelet engraftment in Omidubacil transplanted and standard core blood transplanted patients. These data showed that at seven days post-transplant, homoduca cell transplanted patients showed a statistically significant correlation between CD3 and CD4 positive T-cell counts and time for neutrophil engraftment. Patients transplanted with standard cord blood showed no such correlations at day seven post-transplant and only began to show immune recovery starting at 14 days. These data support past findings that homoduca cell stimulates a factor immune response in standard cord blood, which may be a contributing mechanism resulting in the lower incidence serious bacterial, fungal, and viral infections in Omidubacill transplanted patients. We also have a publication in press in the journal Transplantation and Cellular Therapy, now available online, reporting on long-term follow-up of patients transplanted with Omidubacill across five clinical trials. The analysis showed a three-year overall survival of 52.5% and disease-free survival of 54%. With up to 10 years of follow-up, Omidubacil showed durable hematopoiesis. We're very excited by these data, showing the long-term safety and durability of Omidubacil. The data in these presentations and publications continue to support the clinical... We prepare to bring potentially curative therapy to patients following... With that, I will turn the call over to Michelle, who will provide an update on our plans to launch Omidubacil in the U.S. market on potential FDA approval. Michelle?
spk03: Thank you, Ronit, and good morning, everyone. I want to provide an update on where we are in terms of our launch plans for Amadubacil in the U.S. market. As Ronit shared, Amadubacil continues to amass a body of evidence that shows it may be an effective and important new donor source option. We continue to have positive interactions with transplanters, transplant center teams, and payers as we prepare for launch. For transplanters, Amadubacil's clinical outcomes, including rapid time to neutrophil advancement, durable response, and quality of life, are appealing in a new donor source option. As we approach our May 1st PDUFA date, we continue to work toward maximizing a positive patient and transplant center experience when using Amadubacil as the donor source of choice. From a commercial standpoint, our research shows an unmet need for a new donor source for allogeneic stem cell transplant that potentially increases patient access to transplant and improves outcomes over existing donor sources. From an access standpoint, about 1,200 patients each year are eligible for stem cell transplant but do not receive one because they cannot find a donor. Amadubacil's less stringent matching criteria offers hope for those patients that they will be able to find a donor source. We know this is at least in part a health disparities issue with patients who are white or Caucasian having a higher chance of finding a match. For example, patients who are white have a 79% chance of finding a match in the donor registry, while patients who are black or African American have just a 29% chance. and this is according to Be The Match. Our Phase 3 study had over 40% of patients enrolled who were racially and ethnically diverse. This demonstrates both the unmet need for non-Caucasian patients and also the ability for AmidubaCell to address this unmet need. In addition, there are opportunities to improve outcomes by using AmidubaCell when it addresses limitations or mitigates risks of other donor sources. These include First off, Omidipacil has demonstrated statistically significant faster time to neutrophil engraftment versus standard core blood, which currently represents about 5% of the donor sources. And this was in our phase three study. And statistically significant faster time to neutrophil engraftment versus other donor types, which was presented in the ASH real-world evidence analysis that Ronit previously mentioned. Amadubacil offers a faster time from donor source identification to transplant as compared to matched unrelated donors and mismatched unrelated donors, with availability for Amadubacil being approximately 30 days from start of manufacturing as compared to approximately two to three months required to align an unrelated donor to a patient. Matched unrelated donors constitute about 43% of stem cell transplants, and mismatched unrelated donors are about 7%. And finally, compared to haploidentical donors, which comprise about 24% of transplants, amadubacil offers a faster time to neutrophil engraftment, as presented in our oral presentation at ASH, and amadubacil did not require post-transplant cyclophosphamide, or PTCI, in our Phase III study. PTCI helps to mitigate graft-versus-host disease, although cyclophagy is cardiotoxic, so could present risks and or adverse events for patients. In regard to manufacturing, our state-of-the-art manufacturing facility in Kirigat in Israel is already producing amadubacil for clinical study patients and is ready for commercial production. We're showing the ability to deliver Omidubacill back to a transplant center within approximately 30. And we have completed our Israeli Ministry of Health and FDA pre-licensing inspections with no 43 observations to date. This facility is also modular, so we can add additional cores for additional capacity as demand grows. We have a key partnership with Be The Match. They are very committed to partnering with us to introduce this new advanced cell therapy. Transplant centers are experienced at using the Be The Match resources to identify donor sources. We partnered with Be The Match for our phase three study, and we have an established partnership with them following potential FDA approval to support transplant center access to AmaduvaCell. Upon approval, we are ready to deliver AmaduvaCell to transplant centers. One of the most important things we must do is onboard transplant centers to ensure they have the necessary procedures and logistics to deliver a cell therapy like Amadubacel to patients in need. We are finding strong interest from transplant centers, including centers that were not participants in our clinical trials. The strategic restructuring Abby described at the beginning of the call aims to expand the team responsible for the launch of Amadubacel although slowing the ramp of hiring and expense as compared to our plans earlier this year. The vast majority of our resource will be focused on Amiduba Cell and supporting this launch. The keys to launch success will be the onboarding of transplant centers and ensuring a positive experience for patients and care teams. In the U.S., 70 transplant centers perform 80% of all transplants. We had initially anticipated our early launch sites would be focused on clinical trial sites. We are now encouraged by positive feedback coming from top transplant centers that were not part of our clinical trials. So based on the level of resourcing we have available, we are preparing approximately 10 to 15 of those top 70 centers for the initial launch, and we are optimistic this could scale up once additional resources are available. We have the key objective of assuring a positive patient experience, including essential programs, such as education and training sessions, and process and logistic reviews in place. Although LAMA-DUPA-SL has a less stringent matching criteria than other sources, there is still a matching requirement. So we must work with centers to assure appropriate chain of identity and chain of custody. In addition, at the time of potential FDA approval, we will have our patient support systems in place through Gameta Cell Assist to facilitate access. In regards to patient access, we've already met with U.S. payers, including payers that cover more than 90% of commercially covered lives. We also have an established ICD-10 PCS code, which has already been granted by CMS. Payers have indicated they anticipate covering a one-time therapy with curative intent upon FDA approval, and we also have discussed paths to reimbursement with both commercial payers and CMS. Over the last few years, we have conducted extensive market insight gathering, including four independent studies with consistent findings on the potential for amadupacil. With the combination of increased access and improved outcomes, We believe Omidubacill has the potential to capture 20 to 25% of the addressable patient population at peak share, which would equate to 2,000 to 2,500 patients per year in the U.S. We expect our uptake to come through the combination of market expansion and share shift. The market expansion will come from those approximately 1,200 patients a year we estimate go untransplanted because they cannot find a match. And the share shift potential has been very consistent in our market insight studies, focused mainly on the strength of our clinical data and our 30-day turnaround time. Although we anticipate share capture from all donor sources, we anticipate the early stages of the launch will begin from standard cored and mismatched unrelated donor, and once transplanters gain experience, they'll consider Amaduba Cell in lieu of HAPLO and other sources. Again, back to our mission. This company was built to deliver potentially curative therapies to patients. We have a compelling therapy in Amadubasol that, if approved, may increase access and improved outcomes, addressing critical unmet needs. We are now putting virtually everything we have behind this launch with the expectation that this could have a meaningful and positive impact on patients' lives. From a manufacturing, account management, and market access perspective, we are in a position to launch. We are very excited at the prospect of launching Amadubacil in the US, and through increased investment and or strategic partnership, we have the potential to reach more transplant centers and patients at a faster pace. I will now turn the call over to Shai to review our financial results.
spk12: Thank you, Michelle, and good morning, everyone. Today, I will summarize our financial results for 2022. As Abby mentioned earlier, today's strategic restructuring addresses a number of needs and reflects the more focused use of our resources, prioritizing the launch of honeydew basilica proof and extending our cash runway through Q3. As of December 31, 2022, our total cash position, including the recent $25 million converted alone with COVID-19 in December, was approximately $64.7 million, compared to $95.9 million as of December 31, 2021. Research and development expenses for 2022 were $42.7 million compared to $50.2 million in 2021. The decrease was mainly due to a $9.6 million decrease in clinical and operational activities related to the conclusion of our Phase 3, offset by an increase of $1.1 million in T&A and other expenses, as well as $1 million decrease in Israel Innovation Authority grants. Commercial expenses for the year were $12.9 million, compared to $20 million in prior years. The decrease was primarily due to the $8.2 million decrease in launch readiness activities, offset by an increase of $1.1 million in ad count related expenses. General and administrative expenses for 2022 were $19.4 million, compared to $70 million for 2021. The increase was mainly driven by an increase of $1.4 million attributed to our corporate headquarters and income-related expenses, as well as the $1 million increase in professional services expenses. Finance expenses next were $4.4 million in 2022 compared to $2.6 million in 2021. The increase was primarily due to expenses relating to the average convertible loan we signed back in December. Net loss for the year was $79.4 million, compared to a net loss of $89.8 million in 2021. As I've mentioned before, the actions we are announcing today will extend our cash runway through Q3. This cash runway guidance is based on our current operational plans and excludes any additional funding that may be received for business development activities that may be undertaken. With that, I will turn the call back over to Abby.
spk02: Thank you, Shai. Before I turn the call back over to Catherine for questions, I want to bring us back around to the beginning and summarize some key points from our discussion today. We believe in bringing potentially curative advanced cell therapies to patients. That's what the MediCell was founded to do. It's our mission. As we were on the precipice of bringing our MediCell to market, we are ready. We are ready from a manufacturing and regulatory perspective. We've had productive interactions with regulators and have completed both our pre-license inspection and late cycle meeting as we head toward our PDUCA date of May 1st, which is significantly de-risking our path to approval. We are ready from a commercial and medical perspective. We have strong market insights and a clear strategy that is focused on onboarding transplant centers and ensuring a positive experience for patients and transplant center teams. We are ready as an organization We are making the difficult decisions through the strategic restructuring of the company that will enable us to launch this therapy successfully. Our launch will ramp more slowly than we were planning at the end, at the beginning of 2022, at the end of 2022, but we are committed to ensuring this meaningful therapy gets to patients and that transplant centers have a positive onboarding experience. While we are doing everything we can do to ensure a successful US launch, we will be exploring strategic options, including potential US and global partnerships, to enable a more robust commercial effort. Amigubicel, if approved, has the potential to increase access and improve outcomes. It can make a meaningful difference in the lives of people who need this potentially curative therapy. This will be our primary focus as we go forward, and we are ready. Now, let's open the call for questions. Catherine, over to you.
spk04: Thank you. To ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, press star 1-1 again. Please stand by while we compile the Q&A roster.
spk01: Our first question comes from Edward with Piper .
spk04: Your line is open.
spk05: Great. Thank you very much. I'm sorry for the difficult decisions with respect to the headcount, but I know the focus on Omidubasil will pay off. I was pleased to hear about the inspections. Can you give us a sense of sort of what happens if you get the green light on May 1st? You know, how quickly do you anticipate starting to convert over these 10 to 15 initial centers. Are they ready to go? Have they given any insight into how to anticipate onboarding and utilizing HOMI-DUBA-SEL. Thanks so much.
spk03: Hi, Ted. Good morning. It's Michelle. So, I just want to make sure I heard you well. The question was converting centers over upon FDA approval.
spk05: No, so I know you said that you have the initial 10 to 15 that you'll be focused on, the first 10 to 15 centers. I'm wondering what this launch in the early days could look like in terms of have they stated, you know, how they anticipate incorporating Omidubacill into their practice?
spk03: Yeah, no, thank you. I appreciate that. So let me, I'll answer your question. I do want to thank you for recognizing the pre-licensing inspection. We were excited by that also. Certainly a lot of focus has gone into building that facility and getting that facility ready for BLA acceptance and also getting ready for the inspection. So thank you for recognizing that. In regards to the centers, so based on our initial dialogue with centers, as I indicated, we anticipate approximately 10 to 15 centers onboarded by the end of 2023. The feedback from the centers has been consistent with the market insight studies. You know, when our medical team asked the centers for unmet needs, it's focused on those two key categories. It's those patients who are currently eligible for transplant who cannot find an appropriate donor, and then also the opportunity to use Omidubacill in lieu of current donor sources based on our clinical outcomes, our 30-day turnaround time that we have demonstrated both in our phase three study, but also in our EAP. In partnership with the discussions with the centers, we've also talked to ostensibly to U.S. payers, both on the government side and on the commercial side. We're very encouraged by that feedback. And we've made sure that as we're meeting with those 10 to 15 centers that we anticipate being on board this year, we also understand, you know, their payer mix and make sure we're proactively engaging with those payers too.
spk05: Great. That's helpful. Well, fingers crossed and looking forward to the launch and talking soon about that.
spk01: Perfect. Thank you, Ted. One moment.
spk04: We have a question from John Miller with Evercore ISI. Your line is open.
spk11: Hey, guys. Thanks so much for taking my question. And, again, I'm also sorry for the tough decision that you've had to make, but looking forward to potential approval. I'd love to ask more about the commercial partnership. Do you expect that the PDUFA or the approval is a gating factor on getting a commercial partnership ready to go, kind of ready to go? And then within that, if you're ready for launch and you've got the manufacturing all set up and you've got your initial centers set up, what exactly are you looking for in a potential partner besides cash, obviously? And what do you expect the role of the partner to be in a potential launch?
spk02: Sure, John, I'll start and then Michelle, you can chime in. So I would say we, I wouldn't call the PDUFA date a gating item. I think the fact that Omnidupacil is quite a meaningful therapy and as we're nearing our PDUFA date, we've been noticed and we have certainly generated some interest. So we are in the early stages of having some conversations, but I don't, I think obviously it will be an important milestone in the process, but not the gating matter. Michelle, over to you for the second part.
spk03: Yeah, thank you. And good morning, John. Thank you for the question. So in regards to what we're looking for in a partner, as you alluded to, the additional support from the capital side is certainly critical. The other area is infrastructure. Although we have a clear launch strategy and we've begun our launch execution, there's still aspects of our infrastructure we haven't built out yet due to resource constraints. So That's something that we would look to from a potential partner. What I could say, John, is the team we have hired so far for the launch execution, both in regards to the commercial individuals, the medical individuals, and manufacturing are outstanding individuals, incredibly experienced. It's just a matter of adding additional infrastructure to support them and then adding additional resources to be able to maximize the full launch.
spk02: And one thing I would add, John, to that is that the BD efforts are in parallel to our ongoing fundraising activities. While this expense reduction is extending us through the third quarter, we know that it will be important to explore all sources, BD being one of them, as fundraising opportunities because our number one priority is to make sure we can get this product to as many transplant centers and as many patients as needed as quickly as possible.
spk11: Thanks. That makes sense. One final one then from me. Obviously, you say you're continuing on with the GDA 201 Phase 1. Can you characterize the ongoing spend is for that program specifically and when the next potential for data release from that is?
spk12: Hey, John. So, Vicky Shah, I'll address your first question. So, we do not come with a specific, I would say, plan for GDA or AMI. I can tell you the vast majority, as we mentioned in our first remark, goes to AMI-dubby cells. And as for the NK, or the specific GDA201, our cash guidance including taking this program all the way through the end of phase one, I believe the first quarter, it will happen probably this year or early next year.
spk00: And I'll chime in, John. This is Rani. So this is the phase one dose escalation study, and the study is designed to enroll patients that are separated by the VLT observation period of 28 days. So it's a pretty slow pace of enrollment and the costs are estimated to be minimal compared to the other things that we need to do. And so the priority for us was continuing to treat those patients and understanding more about the safety and efficacy of GDA201 in that patient cohort. So, we will, based on the design of the study, have some information probably at the end of the year or very beginning of next year that we can share.
spk01: Thanks so much. Thank you. One moment for our next question.
spk04: Our question comes from Mark Breedenbach with Oppenheimer. Your line is open.
spk10: Hey, good morning, guys. Thanks for taking the questions. Just a couple really quick ones for me. First of all, I'm wondering how large of a commercial team and field force do you think we need to cover the 10 to 15 sites that you'll be targeting in 2023? And are all of those personnel already onboarded at this point? And then the second question is just on the late cycle meeting that you recently had with the FDA. I was hoping maybe you could just comment on key learnings or takeaways from that interaction. Thanks again for taking the questions.
spk03: Excellent. Thank you, Mark. I'll start with the personnel, and then I'll turn to Ronit for late cycle meeting. So in regard to personnel, I'll talk about a few key categories. First off, we do have our full market accounts. I'm sorry our full market access team needed for launch in place these were very critical hires that have been working closely with the payers in addition to the operations teams in the transplant centers we've also we have our head of marketing and account management on board and she's done an outstanding job in addition to our initial regional account directors so that will be the team on the commercial side working to onboard the the 10 to 15 and transplant centers in addition Ronit has hired her medical affairs and MSL lead and they've hired some MSLs too so our intention as stated earlier is to ramp up over time being mindful of the cash runway and we'll look to add more personnel as resources increase the ultimate goal as we've got in the past is to get to approximately 24 commercial account managers and 12 MSLs I'll just touch briefly, not field focus, but our operations team at our facility in Israel is in place as is our quality team. So that's staffed appropriately for launch.
spk00: I can take the late cycle meeting question, Mark. This is Ramit. So as you've heard before, our interactions with SBA have been continuous since the acceptance of the BLA. And we've had dialogue with them that's been quite productive all throughout. The late cycle meeting itself, which took place during the first quarter, was extremely productive, and there were no surprises there. We continue to understand that there are no safety or efficacy issues that are raised at this point that we're aware of, and we're feeling quite positive moving forward towards our to-do for date.
spk01: Okay. Thanks so much. Our next question comes from Gil Blum with Needham & Company.
spk04: Your line is open.
spk09: Hi, this is Rohit on for Gil. Thanks for taking our questions. In terms of the pipeline, do you still plan to continue the development of 301, 501, and 601 down the line once financing is secured? Thanks.
spk00: This is Ronit. Was it not Gil? I didn't hear. It was Roman. Oh, it was Roman. Thank you. So in terms of the NK cell therapy pipeline, we very much believe in the potential of our NK pipeline and its differentiation from other NKs. And we have shown already, have shown some quite interesting in vitro and in vivo data that shows the potential of these cells to have rapid and intense cytotoxic activity. So overall, it's very promising. However, at this time, we're not in an economic position to continue to advance that pipeline. We will maintain the IP to those assets, and we'll certainly consider financial solutions to allow the development of those assets at some point.
spk01: Thank you.
spk04: Our next question comes from Jason Butler with JMP Securities. Your line is open.
spk08: Hi. Thanks for taking the questions. Can you give us any more color on how you selected the target 10 to 15 institutions in terms of willingness to be an early adopter and potential reimbursement access versus the number of potential patients at those centers? Second to that, can you just talk to us about how you think about expanding beyond that initial 10 to 15 and when that could happen? Thanks.
spk03: Yeah. No, thank you, Jason. Thank you for the question. So in regards to the selection of the 10 to 15, so as I mentioned in my prepared remarks, these are centers that are within the top 70 centers, and those top 70 make up 80% of the transplants. These are centers that have expressed interest in being onboarded and have demonstrated the ability to be onboarded fairly soon after potential FDA approval. These are centers, some of them were part of our clinical study, some were not. And we were very encouraged by the feedback from those centers. You know, the centers were comfortable with the payer mix of those centers. We've already met with the payers that would be working closely with those centers. So those were some of the aspects that led us target those 10 to 15 centers. What I would say in regards to why it's 10 to 15, we want to be mindful of the resources that we currently have. And as additional resources come in, either capital or potential support from a partner, we would look then to increase the number of centers beyond that 10 to 15. We've had very engaging dialogue with the majority of the top centers throughout the U.S., and we're encouraged by the feedback. So, as I mentioned, we'll start with the 10 to 15 as our target for this year and then look to increase that as additional resources come in.
spk08: Thank you.
spk01: Our next question comes from Vernon Bernard.
spk04: Bernardino from HC Wainwright. Your line is open.
spk07: Hi, everyone. Thanks for taking my question. And I'm sorry to hear about the difficult decisions, but congrats on the progress you've made. It's been great so far. So definitely looking forward to the launch. Most of my questions have already been answered, but one question I was wondering, is with the headcount reduction of 17%, does that include some of the hires you have made so far, or is that basically across the board and, you know, core decision regarding a straight headcount reduction in the firm?
spk02: Sure. Thanks, Bernice. The 17% reduction in headcount is mainly related to employees who are working on the NK pipeline, the early NK pipeline. So with that discontinuation, we're ramping down the employees who are working on those programs primarily.
spk07: Okay. And can you describe how much of the closed down of operations in Jerusalem will have an effect?
spk12: Hi Vernon, this is Shai. Hi Shai. So as we mentioned in our preferred remarks, till this strategic intake change, we did add the cash till the middle of the year, and with those changes, we extend our cash runway by another quarter, which the way we see it, this is one element of the restructuring. The other one, we do believe that the changes we are making today It will make AmidaCell more focused, prioritized, and attractive investment opportunity with a very clear near-term value creation point. In terms of your specific one on the Jerusalem side, close on calls, again, we do not comment on very specific, I would say, elements of the business plan, but the vast majority of our spending will go to AmidaCell versus the Jerusalem side is more dedicated to the R&D team.
spk07: And can you remind us again on how much of a grant from the Israeli government do you get for operations in Israel?
spk12: So we are keeping the operation in Israel. We do have two sites in Israel. One site is the Kiryat Gat. which is the lead manufacturing site. And this is the main, I would say, purpose of all our fund that we received from the Israeli Innovation Authority. So there is no issue in terms of grants from the Israeli Innovation Authority. We continue with the R&D specifically to Amidou Gissel and the manufacturing and all the IP related. Overall today, it's approximately $50 million we received in the last 20 years.
spk07: Thank you very much. That information is very helpful and I'm looking forward to launch and best of luck. Thank you.
spk04: Thank you. And I'm showing no further questions in the queue. I'd like to turn it back to Abby Jenkins for closing remarks.
spk02: Thank you, Catherine. I want to reiterate that the changes we've announced today will make ComitaSell a more focused, prioritized, and attractive investment opportunity and create a path for near-term value creation with the potential approval and launch of On Me, Do This Bell. And to be clear, we do plan to launch immediately following approval if granted on May 1st. Our leadership team will be available after the call if there are any opportunities for follow-up discussion. We'll keep you current on all of our developments, and we thank you again for your interest and support of Give Me This Bell. Thank you, everyone, for joining us on today's call.
spk04: This concludes today's conference call. Thank you for participating. You may now disconnect.
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