Gamida Cell Ltd. (NASDAQ:GMDA) Q4 2023 Earnings Call Transcript

Gamida Cell Ltd. (NASDAQ:GMDA) Q4 2023 Earnings Call Transcript March 27, 2023

Operator: Ladies and gentlemen, thank you for standing by. Welcome to the Gamida Cell’s 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 Gamida Cell’s request. I would now like to introduce your host for today Mike Ciskowski of Gamida Cell, Corporate Communications. Please go ahead.

Unidentified Company Representative: 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.gamidacell.com. Here with me on our call today are Abi Jenkins, President and Chief Executive Officer; Ronit Simantov, Chief Medical Officer and Scientific Officer; Michele Korfin, 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 Omidubicel by the FDA, commercialization planning efforts, the potentially life-saving or curative therapeutic and commercial potential of Gamida Cell’s product candidates, including GDA-201 and Omidubicel, and our expectations regarding our projected cash, cash equivalent, and investment 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 Factors section of our most recent quarterly report on Form 10-Q 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, Abi Jenkins.

Abigail Jenkins: Thank you, Mike, and everyone who is joining us this morning. I want to start this call by grounding us in Gamida Cell’s mission. When I joined the company last September, I was drawn to its 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. Gamida Cell 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 Gamida Cell represents a compelling investment thesis. We have a robust short-term catalyst in the pending FDA approval of Omidubicel, our lead product candidate, and great long-term potential in our pipeline of natural killer cell therapies, including clinical stage GDA-201 and our three engineered preclinical NK cell therapy candidates. In recent weeks, we’ve had positive data presented on both Omidubicel and GDA-201 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 Omidubicel 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 Omidubicel.

We are doing this because Omidubicel has significant clinical evidence that it may increase access and improve outcomes for patients in need of an allogeneic stem cell transplant. If approved, Omidubicel will be the first advanced cell therapy for stem cell transplant and may mark the only hope for the approximately 1200 patients that go and transplanted each year, including those who are ethnically or racially diverse. The safety profile of Omidubicel in our Phase 3 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 Omidubicel 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 Omidubicel as a new alternate donor source. We believe Omidubicel can fulfil 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 Omidubicel to patients in the US, we’ve made the difficult decision to discontinue development of our early pipeline candidates GDA-301, GDA-501 and GDA-601. We will, however, continue enrollment in our Phase 1 clinical trial of GDA-201. 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 meetings. 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, 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 Omidubicel. These measures collectively will extend our cash runway through the third quarter.

We believe these changes will make Gamida Cell a more focused, prioritized and attractive investment opportunity and create a path for near-term value creation with the potential approval and launch of Omidubicel. While we will be focused on bringing Omidubicel to patients in the US, if approved in May, we will also explore strategic options, including potential US 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 Omidubicel in a more robust manner. We are encouraged by the initial clinical efficacy and safety profile of GDA-201 and our preclinical pipeline.

But we must take these steps to sustain the company and position ourselves to bring Omidubicel to the patients who need it. Finally, last week, we announced the appointment of Shawn Cline 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 Shawn’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 Omidubicel as we prepare for approval and commercialization. Ronit?

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Ronit Simantov: Thanks, Abi, and good morning, everyone. Thank you for joining us on our call this morning. In light of our approaching PDUFA date and the strategic restructuring outlined by Abi, I’ll focus on the latest regulatory and clinical updates on Omidubicel before Michele discusses our commercialization plans and manufacturing progress. First. As Abi 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 3 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 to neutrophil engraftment in the as treated per protocol population of ten days for patients transplanted with Omidubicel compared to 20 days for the comparator 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 transplant. Subsequent data have also shown reduced health care resource utilization and improved patient reported outcomes with Omidubicel.

We’ve had two recent data presentations on Omidubicel 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 TCT as Abby referenced in February. In our presentation at ASH, we compared the results of our Phase 3 trial with results from existing donor sources matched unrelated donors, mismatched unrelated donors and haploidentical donors using data reported to CIBMTR. After adjusting for baseline variables, the results showed that Omidubicel was associated with a more rapid rate of neutrophil engraftment, with a median of ten days for Omidubicel versus 15 to 20 days for the other graft sources. There were comparable rates of grades three to four acute graft versus host disease or GVHD and of chronic GVHD, as well as comparable overall survival.

These results suggest that Omidubicel may be an effective and important new graft source option making allogeneic stem cell transplant available to more patients. In the Omidubicel presentation in February at TCT, we presented new data characterizing peripheral blood lymphocytes measured in correlation with time to neutrophil and platelet engraftment in Omidubicel-transplanted and standard cord blood-transplanted patients. These data shows that at 7 Day post-transplant from Omidubicel- transplanted patients showed a statistically significant correlation between CD3+ and CD4+ T cell counts and time to neutrophil engraftment. Patients transplanted with standard cord blood showed no such correlation at Day 7 post-transplant and only began to show immune recovery starting at 14 Days.

These data support past finding that Omidubicel stimulates a factor immune response than standard cord blood, which may be a contributing mechanism resulting in the lower incidence of serious bacterial, fungal and viral infections in Omidubicel-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 Omidubicel across five clinical trials. The analysis showed a three-year overall survival of 62.5% and disease-free survival of 54%. With up to 10 years of follow-up, Omidubicel showed durable hematopoiesis. We’re very excited by these data showing the long-term safety and durability of Omidubicel. 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 Michele, who will provide an update on our plans to launch Omidubicel in the US market upon potential FDA approval. Michele?

Michele Korfin: Thank you, Ronit, and good morning, everyone. I want to provide an update on where we are in terms of our launch plans for Omidubicel in the US market. As Ronit shared, Omidubicel 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, Omidubicel’s clinical outcomes, including rapid time to neutrophil engraftment, 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 Omidubicel 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. Omidubicel’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 Omidubicel to address this unmet need. In addition, there are opportunities to improve outcomes by using Omidubicel when it addresses limitations or mitigates risk of other donor sources. These include, the first off, Omidubicel has demonstrated statistically significant faster time to neutrophil engraftment versus standard cord blood, which currently represents about 5% of the donor sources, and this was in our Phase 3 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.

Secondly, Omidubicel offers a faster time from donor source identification to transplant as compared to matched unrelated donors and mismatched unrelated donors. With the availability for Omidubicel 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, Omidubicel offers a faster time to neutrophil engraftment as presented in our oral presentation at ASH and Omidubicel did not require post-transplant cyclophosphamide or PTCy in our Phase 3 study.

PTCy helps to mitigate graft versus host disease, although cyclophosphamide is cardiotoxic, so could present risks and/or adverse events for patients. In regard to manufacturing, our state-of-the-art manufacturing facility in Kiryat Gat in Israel is already producing Omidubicel for clinical study patients and is ready for commercial production. We’re showing the ability to deliver Omidubicel back to a transplant center with an approximately 30 . And we have completed our Israel Ministry of Health and FDA pre-licensing inspections with no 483 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 3 study, and we have an established partnership with them following potential FDA approval to support transplant center access to Omidubicel. Upon approval, we are ready to deliver Omidubicel to transplant centers. One of the most important things we must do with onboard transplant centers to ensure they have the necessary procedures and logistics to deliver a cell therapy like Omidubicel 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 Abi described at the beginning of the call, aims to expand the team responsible for the launch of Omidubicel, although slowing the ramp of hiring and expense as compared to our plans earlier this year.

The vast majority of our resources will be focused on Omidubicel and supporting this launch. The keys to launch success will be the on-boarding of transplant centers and ensuring a positive experience for patients and care teams. In the US, 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 Omidubicel 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 Gamida Cell assist to facilitate access. In regards to the patient access, we’ve already met with US 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 onetime 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 Omidubicel. With the combination of increased access and improved outcomes, we believe Omidubicel 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 US. 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 on transplanted 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 in 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 cord and mismatched unrelated donor and once transplanters gain experience, they will consider Omidubicel 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 Omidubicel 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 Omidubicel 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.

Shai Lankry: Thank you, Michele, and good morning, everyone. Today, I will summarize our financial results for 2022. As Abi mentioned earlier, today’s strategic restructuring addresses a number of needs and reflect the more focused use of our resources prioritizing the launch of Omidubicel if approved and extending our cash runway through Q3. As of December 31st, 2022, our total cash position, including the recent $25 million convertible loan we closed with Highbridge in December was approximately $64.7 million compared to $95.9 million as of December 31st, 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&E 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 year. The decrease was primarily due to an $8.2 million decrease in launch readiness activities offset by an increase of $1.1 million in headcount 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 calculated expenses as well as a $1 million increase in professional services expenses. Finance expenses net were $4.4 million in 2022 compared to $2.6 million in 2021. The increase was primarily due to expenses relating to the Highbridge 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 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 plan 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 Abi.

Abigail Jenkins: 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 Gamida Cell was founded to do, it’s our mission. As we are on the precipice of bringing Omidubicel 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 PDUFA 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.

Omidubicel, 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.

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Q&A Session

Operator: Thank you. Our first question comes from Edward Tenthoff with Piper Sandler. Your line is open.

Edward Tenthoff: Great. Thank you very much. I’m sorry for the difficult decisions with respect to the headcount, but I know the focus on Omidubicel payoff. 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? 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 sort of how they anticipate onboarding and utilizing Omidubicel? Thanks so much.

Michele Korfin: Hi, Ted. Good morning. It’s Michele. So I just want to make sure I heard you well. The question was converting centers over upon FDA approval?

Edward Tenthoff: 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 how they anticipate incorporating Omidubicel into their practice?

Michele Korfin: Yes, 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 all. So 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 study. 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 Omidubicel in lieu of current donor sources based on our clinical outcomes, our 30-day turnaround time that we have demonstrated both in our Phase 3 study, but also in our EAP.

In partnership with the discussions with the centers, we’ve also talked extensively to US 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 their payer mix and make sure we’re proactively engaging with those payers, too.

Edward Tenthoff: Great. That’s helpful. Well, fingers crossed and looking forward to the launch and talking soon about that.

Michele Korfin: Perfect. Thank you, Ted.

Operator: We have a question from Jon Miller with Evercore ISI. Your line is open.

Jonathan Miller: Hey, guys. Thanks so much for taking my question. And again I’m also sorry for the tough decisions that you’ve had to make, but looking forward to potential approval. I’d love to ask more about the commercial partnership. So 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 center set up, what exactly are you looking for a potential partner besides cash obviously? And what do you expect the role of the partner to be in a potential move?

Abigail Jenkins: Sure. Jon, I’ll start and then, Michele, you can chime in. So I would say we — I wouldn’t call the PDUFA data a gating item. I think the fact that Omidubicel 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. Michele, over to you for the second part of the question.

Michele Korfin: Yes. Thank you, and good morning, Jon. 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 areas is infrastructure. There’s — although we have a clear launch strategy and we’ve begun our launch executing — 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, Jon, 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.

Ronit Simantov: And one thing I would add, Jon, 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.

Jonathan Miller: 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?

Shai Lankry: Hey, Jon. This is Shai. I will address your first question. So we do not comment on specific I would say plan for GDA or Omidubicel. I can tell you the vast majority, as we mentioned in our prepared remarks, goes to Omidubicel. And as for the NK or the specific to GDA-201, our cash guidance, including taking this program all the way through the end of Phase 1 or through the first quarter. This will happen probably this year or early next year.

Ronit Simantov: And I’ll chime in, Jon, this is Ronit. So this is the Phase 1 dose escalation study and the study is designed to enroll patients that are separated by the DLT observation period of 28 days. So it’s a pretty slow pace of enrollment. And 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 GDA-201 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.

Jonathan Miller: Thanks so much.

Operator: Thank you. Our question comes from Mark Breidenbach with Oppenheimer. Your line is open.

Mark Breidenbach: Hey, good morning, guys. Thanks for taking the questions. Just a couple of really quick ones for me. First of all, I’m wondering how large of a commercial team and field force you think you need to cover the 10 to 15 sites that you will be targeting in 2023? And are all of those personnel already on-boarded 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.

Michele Korfin: 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 account, 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 10 to 15 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, be mindful of the cash runway, and we’ll look to add more personnel as resources increase. The ultimate goal, as we’ve guided in the past, is to get to approximately 24 commercial account managers and 12 MSLs. I’ll just touch briefly, not field focused, but our operations team at our facility in Israel is in place as is our quality team. So that’s staffed appropriately for launch.

Ronit Simantov: I can take the late cycle meeting question, Mark. This is Ronit. So as you’ve heard before, our interactions with FDA 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 will not — 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 PDUFA date.

Mark Breidenbach: Okay. Thanks so much.

Operator: Our next question comes from Gil Blum with Needham & Company. Your lines is open.

Unidentified Analyst: Hi. This is Ronen 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.

Ronit Simantov: This is Ronit. Was it not Gil? I didn’t hear?

Abigail Jenkins: Ronen.

Ronit Simantov: It’s Ronen. 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.

Unidentified Analyst: Thank you.

Operator: Our next question comes from Jason Butler with JMP Securities. Your line is open.

Jason Butler: 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? And then 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.

Michele Korfin: 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 transplant, 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 studies, some were not, and we’re very encouraged by the feedback from those centers. The centers — we’re 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 to 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 a very engaging dialogue with a majority of the top centers throughout the US, 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.

Jason Butler: Thank you.

Operator: Our next question comes from Vernon Bernardino from H.C. Wainwright. Your line is open.

Vernon Bernardino: Hi, everyone. Thanks for taking my questions. 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 head count reduction of 17%, does that include some of the hires you had made so far or is that basically across the board and core decision regarding a straight headcount reduction in the firm?

Abigail Jenkins: Sure. Thanks, Vernon. 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.

Vernon Bernardino: Okay. And can you describe if how much of the close down of the operations in Jerusalem will have an effect?

Shai Lankry: Hi, Vernon. This is Shai.

Vernon Bernardino: Hi, Shai.

Shai Lankry: So as we mentioned in our prepared remarks, till this strategic change, we did add cash till the middle of the year, and with those changes, we extend our cash runway by another — which the way we see this is a one element of the restructuring. The other one, we do believe that the make — the changes we are making today will make Gamida Cell 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 site. Again, we do not comment on very specific, I would say, element of the business plan, but the vast majority of our spending will go to Omidubicel versus the Jerusalem site is more dedicated to the R&D team.

Vernon Bernardino: And can you remind us again on how much of a grant from the Israeli government do you get for operations in Israel?

Shai Lankry: So we are keeping the operation in Israel. We do have two sites in Israel. One site is Kiryat Gat, which is the lead manufacturing site, and this is the main, I would say, purpose of all our funds that we received from the Israel Innovation Authority. So there is no issue in terms of grants from the Isreal Innovating Authority. We continue with the R&D specifically to Omidubicel and the manufacturing and all the IP related. Overall, today, it’s approximately $50 million we received in the last 20 years.

Vernon Bernardino: Thank you very much. That information is very helpful and looking forward to launch and best of luck.

Shai Lankry: Thank you.

Operator: Thank you. And I am showing no further questions in the queue. I’d like to turn it back to Abi Jenkins for closing remarks.

Abigail Jenkins: Thank you, Catherine. I want to reiterate that the changes we’ve announced today will make Gamida Cell a more focused, prioritized and attractive investment opportunity and create a path for near-term value creation with the potential approval and launch of Omidubicel. And to be clear, we do plan to launch immediately following approval is granted on May 1st. Our leadership team will be available after the call if there are any opportunities for follow-up discussions. We’ll keep you current on all of our developments, and we thank you again for your interest and support of Gamida Cell. Thank you, everyone, for joining us on today’s call.

Operator: This concludes today’s conference call. Thank you for participating. You may now disconnect.