Q4 2022 Gamida Cell Ltd Earnings Call

Speaker 1: For you.

Speaker 2: 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 GOMEDA sales request. I would now like to introduce your host for today, Mike Koskowski of GOMEDA Cell Corporate Communications. Please go ahead.

Speaker 3: 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.

Speaker 3: 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.cometasel.com.

Speaker 3: Here with me on our call today are Abby Jenkins, President and Chief Executive Officer, Ronit Simontov, Chief Medical Officer and Scientific Officer, Michelle Corfin, Chief Operating Officer and Chief Commercial Officer, and Shai Langley, Chief Financial Officer.

Speaker 3: 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.

Speaker 3: commercialization planning efforts, the potentially life-saving or curative therapeutic and commercial potential of gametocell's product candidates, including GDA 201 and Amadubicel, and our expectations regarding our projected cash, cash equivalents, and investments to be used for operating activities.

Speaker 3: 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.

Speaker 3: and in the endeavor of building a business around such product candidates, as well as those considerations described in the risk factors 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...

Speaker 4: developing and delivering advanced cell therapies that offer patients with cancer hope for cures.

Speaker 4: 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 revenue.

Speaker 4: As we do that, it's good to remember the North Star of unmet patient needs.

Speaker 4: The MedaCell 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 transplant.

Speaker 4: 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.

Speaker 4: Our beliefs have been and remain that the MedaCell represents a compelling investment thesis.

Speaker 4: We have a robust short-term catalyst in the pending FDA approval of AmiDubicil, 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.

Speaker 4: In recent weeks, we've had positive data presented on both aminubicil and GDA201 at the transplantation and cellular therapy or GCT meeting showing why we believe we are on the right path to bring meaningful innovation to patients with hematologic malignancies.

Speaker 4: 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.

Speaker 4: 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 Ami do to sell to patients if approved.

Speaker 4: We also reduce expenses.

Speaker 4: also reduce expenses to preserve our cash runway.

Speaker 4: Therefore, today we are taking decisive action with a strategic restructuring to prioritize our organizational efforts and resources around the commercial launch of Ami D'Vesto.

Speaker 4: We are doing this because ONIU itself has significant clinical evidence that it may increase access and improve outcomes for patients in need of an allergenic stem cell transplant.

Speaker 4: If approved, Ami Bivisou will be the first advanced self-air fleet for stem cell transplant and may mark the only hope for the approximately 1200 patients that go untransplanted each year, including those who are ethnically or racially diverse.

Speaker 4: The safety profile of Amidu Bissou in our Phase III clinical study was consistent with the expected toxicities of an allergenic stem cell transplant following conditioning therapy and there was no increase in adverse events, serious adverse events, or infusion reactions in the Amidu Bissou arm compared to control.

Speaker 4: 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.

Speaker 4: We've had positive interactions with patients, trans planners, and advocacy leaders in the STEM cell transplant space encouraging us that they are looking forward to having the opportunity to have on the do-this-self as a new, alternate donor source.

Speaker 4: We believe Army Ducos can fulfill our mission of having a meaningful, potentially life-saving impact on patients.

Speaker 4: With today's announcement that we are strategically restructuring the organization to dedicate the vast majority of our resources to bring Omni-Dubacel to patients in the U.S., we've made the difficult decision to discontinue development of our early pipeline candidates GDA 301, 501, and 601. We will, however, continue enrollment in our Phase 1 clinical trial of GDA 201.

Speaker 4: 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.

Speaker 4: We will also close our operations in Jerusalem and consolidate Israeli operations into our state of the art manufacturing site in Kiriqat.

Speaker 4: Finally, we will flow our ramp of hiring and expenses related to the launch of Army Dupesel.

Speaker 4: These measures collectively will extend our cash runway through the third quarter.

Speaker 4: We believe these changes will make Camilla Fell a more focused, prioritized, and attractive investment opportunity and create a path for near-term value creation with the potential approval and launch of all you do this so.

Speaker 4: While we will be focused on bringing on easy-to-fell to patients in the US if accrued and made, 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 that our current resources

Speaker 4: This has been an extremely difficult decision.

Speaker 4: Our team has worked hard on the discovery work to support these NK programs and prepare for the launch of Army Do This Cell in a more robust manner.

Speaker 4: We are encouraged by the initial clinical efficacy and safety profile, a GDA-101, and our preclinical pipeline.

Speaker 4: But we must take these steps to sustain the company and position ourselves to bring on and give us all to the patients who need it.

Speaker 4: Finally, last week we announced the appointment of Sean Klein Thomas-Thelibal as chairwoman of our Board of Directors.

Speaker 4: Sean, 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 self-aircraft products.

Speaker 4: 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 looks forward to Sean's leadership as we approach our day first to do today. 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.

Speaker 4: Now I'll turn the call over to Ronit to take us through key data supporting on E-Jubicel as we prepare for approval and commercialization.

Speaker 4: Ready? Thanks, Abby, and good morning, everyone. Thank you for joining us on Recall this morning.

Speaker 4: In light of our protein to do-to-date and the strategic restructuring outline by Abby, I'll focus on the latest regulatory and clinical updates on the digital self. Before we shell, discusses our commercialization plans and manufacturing progress.

Speaker 4: First, in Abby mentioned, we held our late cycle meeting with the FDA as planned in the first quarter.

Speaker 4: Our discussions with agency continue to be productive as we head towards our Purdue today to May 1st. We do not anticipate an advisory committee and there have been no significant safety or efficacy issues today.

Speaker 4: 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 end points.

Speaker 4: The study of randomized 125 patients aged 12 to 65 with high-risk cumulative limitancy who needed an allergenic stem cell transplant and had no readily available match donor.

Speaker 4: The study demonstrated a median pine-canutus lung graph in the as-treated per-procal population of 10 days for patients transplanted with only do-the-self. Contact your 20 days for the comparative group transplanted with standard cord blood.

Speaker 4: These results were both statistically significant and clinically meaningful, given the importance of mutual engravenants for the key milestone in the recovery of patients who have undergone stem cell transplant.

Speaker 4: Subsequent data has also shown reduced healthcare resource utilization and improved patient-reported outcomes with homoducous cells.

Speaker 4: We've had two weekly data presentation for our region of the cell at key medical meeting.

Speaker 4: A coding presentation at the American Society of Humanitargy meeting in December , a discussed on our last earnings call, and an oral presentation at PCT is Abbey Reference in February .

Speaker 4: In a presentation at Ash, we compare the results of our phase 3 trial with results from existing donor sources, matched unrelated donors, mismatched unrelated donors, and half-life identical donors, using data reported to CIBMPR.

Speaker 4: After adjusting for baseline variables, the results show that only do the cell was associated with a more rapid rate of mutual enraffment, with a median of 10 days for only do the cell versus 15 to 20 days for the other graft forces.

Speaker 4: There were comparable rates of grades 3 to 4, acute grafts, the birth of post disease, or GBHD, and a chronic GBHD, as well as comparable overall survival.

Speaker 4: These results suggest that on Medusael maybe in effective and important new graph course options, making Algenex stem cell transplants available to mortgations.

Speaker 4: In the Omnibus cell presentation in February at TCT, we presented new data characterizing peripheral blood lymphocytes measured in correlation with time musical and cyclic ingrathmet in Omnibus cell transplanted and standard cord blood transplanted patient. These data shows that its seven days post-transplant, homodibus cell transplanted patient showed a specifically significant correlation.

Speaker 5: between CT3 and CT4 positive p-cell counts and time-consuming just on graphing.

Speaker 5: Patient transplanted with standard core blood should know such correlations that they seven-code transplant and only began to show immune recovery starting at 14 days.

Speaker 5: These data support path findings that omaduvitil stimulates a factor immune response in standard cord blood, which may be a contributing mechanism resulting in the lower incidence of serious fungal and viral infections in home to the co-transmented patients.

Speaker 5: We also have a publication in press in the journal Transplantation and Solar Therapy, now available online.

Speaker 5: Reporting on long-term follow-up of patients, transplanted with all the do-it-self across five clinical trials.

Speaker 5: He now has shown a three year overall survival of 52.5% and the V3 survival of 54%.

Speaker 5: With up to 10 years of follow-up, our MusicSelv shows durable, kinatocoleosis. We are very excited by these data, showing the long-term safety and durability of our MusicSelv.

Speaker 5: The data in these presentations and publications continues to support the clinical needs prepared to bring potentially-curative therapy to patients. With that, I will turn the call over to Michelle, who will provide an update on our plans to launch a Lizardous Cell in the US market upon potential FDA approval.

Speaker 5: and publications continues to support the clinical needs prepared to bring potentially curative therapy to patients. With that, I will turn the call over to Michelle, who will provide an update on our plans to launch a reserve of the Cell in the US market upon potential FDA approval. Michelle?

Speaker 2: Thank you, Ronit, and good morning, everyone. I want to provide an update on where we are in terms of our launch plans from Adubacel in the U.S. market. Thank you.

Speaker 2: As we're in each shared, Medusael continues to amouse a body of evidence that shows it may be an effective and important new donor source option.

Speaker 4: We continue to have positive interactions with transplants, transplants center teams, and payers as we prepare for launch.

Speaker 4: For translanters, Amadouba cells clinical outcomes, including rapid time to neutral harassment, 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.

cruise outcomes over existing donor sources.

From an access standpoint, 1,200 patients each year are eligible for stem cell transplant, but do not receive one because they cannot find a donor.

Amadubicil'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 three study had over 40% of patients enrolled who were racially and ethnically diverse.

This demonstrates both the unmet needs for non-calcation patients and also the ability from addubacel to address this unmet needs. In addition, there are opportunities to improve outcomes by using amadubacel when it addresses limitations or mitigates risks of other donor sources.

These include the first off on the tip itself has demonstrated statistically significant faster time to neutral and graphment 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 nuchefone graphment versus other donor type, which was presented in the ash real world evidence analysis that Roni previously mentioned.

Secondly, Amadubicil offers a faster time from donor source identification to transplant as compared to matched unrelated donors and mismatched unrelated donors. With availability for Amadubicil 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 happenodontical donors, which comprise about 24% of transplants, Amidubicel offers a faster time to nudgeful graftment, as presented in our oral presentation at ash, and Amidubicel did not require post-transplant cyclophosphamide or PTCI in our face through study.

CTSI helps to mitigate graft versus host disease, although cyclophonic 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 Amadouba cells for clinical study patients and is ready for commercial production. We're showing the ability to deliver Amadouba cells 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 force for additional capacity as the man 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 Amadupacil.

Upon approval, we are ready to deliver on a due to cell to transplant centers.

One of the most important things we must do is on-board transplant centers to ensure they have the necessary procedures and logistics to deliver a cell therapy like Amidu to cell 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.

In order to expand the team responsible for the launch of on the do the self, although slowing the ramp of hiring an expense as compared to our plans earlier this year.

The vast majority of our resource will be focused on Amadou Bisset-L and supporting this launch.

The key to launch success will be the onboarding 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 all transplants in the US.

logistic reviews in place. Although I'm a due to the survival, I strange it match in 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 gametes cell assist to facilitate access. In regards to 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 one-time therapy with curative intent upon FDA approval, and we also have discussed paths to reimbursement with both commercial payers and CMS. Thank you.

Over the last few years, we have conducted extensive market insight gathering, including four independent studies with consistent findings on the potential for Amadubasil.

With the combination of increased access and improved outcomes, we believe on the Dibbisale has the potential to capture 20 to 25% of the addressable patient population at peak share, which would equate to 2000 to 2500 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 1200 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.

focus mainly on the strength of our clinical data and our 30-day turnaround time.

Although we anticipate shared capture from all donor sources, we anticipate the early stages of the launch will begin from standard cord and mismatched unrelated donor. Once translators gain experience, they'll consider Amadubicil 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 Amadubasil 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 patient's lives.

From a manufacturing, account management, and market access perspective, we are in a position to launch.

We are very excited as the prospect of launching on the Dubitzo 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 Shine to review our financial results.

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 power resources, prioritizing the launch of on the Dubicilik approach and extending our cash runway through Q3. As of December 31, 2022, our total cash position is $1.5 million.

including the recent $25 million converted alone with low-grid hydrogen 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 space tree. The increase was mainly due to a $2.2 million increase in clinical and operational activities related to the conclusion of our space tree.

of $1.1 million in T&N Outer expenses, as well as $1 million decreased in Israeli Innovation Authority grant. Commercial expenses for the year were $12.1 million, compared to $20 million in prior years. The decrease was primarily due to...

the $8.2 million decrease in launch readiness activities opted by an increase of $1.1 million in edcon related expenses. General and administrative expenses for 2022 were $19.4 million, compared to $17 million for 2021. The increase was mainly driven by an increase of $1.4 million.

attributed to our corporate headquarters and completed expenses, as well as the one million dollar increase in professional services expenses.

Final expensive snacks were $4.4 million in 2022 compared to $2.6 million in 2021. The interest was primarily due to expenses relating to the IWG convertible loan in the time back in December .

Net loss for the year was $79.4 million compared to net loss of $89.8 million in 2021.

As I mentioned before, the actions we are announcing today will extend our cash runway to Q3. The 1.3 million dollar contract would be approved for the appropriate wages increase by December

These cash runway guidance is based on our current operational plan and it shows any additional funding between the REST for business development activities that may be undertaken. With that, I also have to call back over to Labby. Thank you, Shy.

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 for more discussion today.

We believe in bringing potentially curative advanced cell therapies to patients. That's what the ImitaCell was founded to do. It's our mission.

As we were on the precipice of bringing on you to the Selka market, we are ready. We are ready for a manufacturing and regulatory perspective. We've had productive interactions with regulators and have completed both a pre-lite-sense inspection and late cycle meetings.

As we head toward our producer 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 patient 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. I'm in view the spell. It's 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. Katherine, over to you. Thank you. Tathca question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, press star 11 again. Please stand by while we compile the Q&A roster. Thank you.

Our first question comes from Edward Tintha with Piper Sandley. Your line is open.

Great, thank you very much. I'm sorry for the difficult decisions with respect to the headcount, but I know the focus on Omen Dubasol payoff. I was pleased to hear about the inspection

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 quickly do you anticipate starting to convert over these 10 to 15 initial centers? Have you given any insight into sort of... How quickly do you anticipate starting to convert over these 10 to 15 initial centers?

how we anticipate onboarding and utilizing community results. Thanks so much. I'd say good morning. It's Michelle. So I just wanted to make sure I heard you well. The question was converting centers over upon FDA approval.

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 omidubacil into their practice.

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, we were excited by that also. Certainly a lot, a lot of focus has gone into building that facility and getting that facility ready for BLA.

acceptance and also getting ready for the inspections. So thank you for recognizing that. In regards to the centers, so based on our initial dialogue with centers, as I indicated, we anticipated approximately 10 to 15 centers on boarded 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

in our phase three 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 onboarded this year, we also understand their payer mix and make sure we're proactive.

John Miller with Evercore ISI, your line is open.

Hey guys, thanks so much for taking my question and again, I'm also sorry for the type of decision that you've had to make, but looking forward to the potential approval. I'd love to ask more about the commercial partnership. So do you expect that the PadooFA or the approval is a gating factor on getting commercial partners?

What do you expect the role of the partner to be in a potential launch?

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 dating item. I think the fact that Amidupicil 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 topic.

The other areas is infrastructure. You know, there's, 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.

full launch. And one thing I would add John said 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.

for data release from that is? Hey, John . This is Shail. I'll address your first question. So we do not comment on a specific, I would say, plan for GDA or OMI. I can tell you the vast majority, as we mentioned in our third remark, goes to OMI-Dugicel. And as for the NK, or the specific GDA-201, as suspect, I have not Pfitzschlatt and shakes her less than six minutes to find out why. Family Long-density

Our cash guidance including taking this program all the way through the end of phase one I will see the first quote. Did it will happen probably this year or early next year?

And I'll chime in, John . This is Ramee. 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 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. Thanks so much.

Thank you. One moment for our next question. Our question comes from Mark Breidenbach with Oppenheimer. Your line is open. 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 in Field Force you think you 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 bad interaction. Thanks again for taking the questions.

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 and

of the 10 to 15 transplant centers. In addition, Roe need has higher her medical affairs in MSL lead and they've hired some MSLs too. So our intention is stated earlier is to ramp up over time, be mindful of the cash runway. And we'll look to add more personnel as resources.

appropriately for launch.

I can take the late cycle meeting question, Mark. This is Ramit. So as you've heard before, our interactions with FDA have been continuous since the acceptance of the DLA 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.

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 caduceus date. Okay, thanks so much.

Our next question comes from Gil Blum with Needham & Company. Your line is open.

Hi, this is Rohit Onfer. 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? Technology will happen over the next few weeks, or at least Democracy will happen over the next few weeks.

This is Ronnie. Would it not feel I didn't hear Roman Roman. Thank you. So, in terms of the in case of therapy pipeline, we very much believe in the potential of our pipeline in its differentiation from other in case. And we've 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.

economic conditions to continue to advance that pipeline. We will maintain the IP to those assets and will certainly consider financial solutions to allow the development of those assets at some point.

Thank you. Our next question comes from Jason Butler with JNP Securities and Line is Open.

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. 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.

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 let us to target those 10 to 15 centers. You know, what I would say in regards to why it's 10 to 15, we wanna 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. Thank you.

Our next question comes from

Vernon Bernadino from HC Wainwright, your line is open.

Hi, everyone. Thanks for taking my question. I'm sorry to hear about the difficult decisions, but congrats on the progress you've made. It's been great so far. 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. Sure, thanks, Vernon. The 17% reduction in headcount is mainly related to employees who are working on the early NK pipeline. So with that discontinuation, we're ramping down.

employee who are working on this program primarily. Okay, and can you describe if how much of the closed down of operations in Jerusalem will have an effect? I don't know, this is Sean. I show.

So as we mentioned in our prepared remarks, until this strategic change, we did add the cash to the vehicle of the year.

And we go, changes to extend our cash runway by another, which the way we see this is the one element of the restructuring. The other one we do believe that the changes we are making today will make a 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, close on calls, 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 Amr Dubisel versus the Jerusalem site is more dedicated to the R&D. kn!?

Can you remind us again on how much of a grant from the Israeli government do you get for operations in Israel?

So we are keeping the operation in Israel. We do have two sites in Israel. One site is the curious gut which is the lead manufacturing site and this is the main I would say in purpose of all our fund that we received in the Israeli Innovation Authority. So there is no issue in terms of of grants from the Israeli Innovation Authority. We continue with the R&D specifically to want

and the manufacturing and all the IP related. Overall today, it's approximately $50 million we received in the last 20 years. Thank you very much. That information is very helpful and looking forward to launch and best of luck.

Overall today, it's approximately $50 million we received in the last 20 years. Thank you very much. That information is very helpful and I'm looking forward to the launch and best of luck. Thank you.

Thank you, and I'm showing no further questions in the queue. I'd like to turn it back to Abby Tinkant for closing remarks. Thank you, Katherine. I want to reiterate that the changes we've announced today will make to me to sell 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-easy-to-be-sell. Thank you.

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 discussions. We'll keep you current on all of our developments and we thank you again for your interest and support of Gimme to Sell. Lets get started structure best art

Thank you everyone for joining us on today's call. This concludes today's conference call. Thank you for participating. You may now disconnect.

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