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.
