Gamida Cell Ltd. (NASDAQ:GMDA) Q2 2023 Earnings Call Transcript

Gamida Cell Ltd. (NASDAQ:GMDA) Q2 2023 Earnings Call Transcript August 14, 2023

Gamida Cell Ltd. misses on earnings expectations. Reported EPS is $-0.31 EPS, expectations were $0.18.

Operator: Ladies and gentlemen, thank you for standing by. Welcome to the Gamida Cell’s Conference Call for Second Quarter 2023 Financial Results. My name is Michele, and I’ll be your operator for today’s call. Please be advised that this call is being recorded at Gamida Cell’s request. And now I would like to introduce your host for today’s call, Mike Kuczkowski of Gamida Cell Corporate Communications. Mike, please go ahead.

Mike Kuczkowski: Thank you, and good morning, everyone. Welcome to today’s call, during which we will provide an update on the company and review our financial results for the second quarter of 2023. 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.gamida-cell.com. Here with me on our call today are Abbey Jenkins, President and Chief Executive Officer; Michele Korfin, Chief Operating Officer and Chief Commercial Officer; Ronit Simantov, Chief Medical Officer and Chief Scientific Officer; and Terry Coelho, our Chief Financial Officer. Before we begin, I want to remind everyone that during this call, we may make forward-looking statements about our future expectations and plans, including with respect to the product and product candidates, the potentially life-saving or curative therapeutic and commercial potential of Gamida Cell’s product Omisirge; expectations regarding the commercial launch of Omisirge and its potential to capture market share.

The company’s plans for commercial or strategic partnerships to support the launch of Omisirge and the company’s anticipated financial runway. Our actual results may differ materially from what we project today due to a number of important factors, including those related to clinical, scientific, regulatory and technical developments and those inherent in the process of developing and commercializing products and product candidates that are safe and effective for use as human therapeutics and in the endeavor of building a business around our product and product candidate, 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 may 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 will turn the call over to our President and CEO, Abbey Jenkins. Abbey?

Abbey Jenkins: Thank you, Mike, and everyone joining us today. I’ll begin by providing a brief corporate update. I know many of you are wondering how our launch is progressing, while we’ve made remarkable progress since the FDA approval of Omisirge in April. We are seeing a very high level of interest and engagement from transplant centers and are exceeding expectations with transplant center onboarding, as Michele will discuss in more detail shortly. As of this morning, we have onboarded 12 transplant centers and have eight additional transplant centers currently in the onboarding process against a goal of 10 to 15 for the year. That is tremendous progress for our first four months of launch. We’ve confirmed coverage with U.S. payers that cover more than 85% of commercial life.

This includes confirmed national coverage with nine out of the top 10 payers. In June, we confirmed coverage and reimbursement for Omisirge with Medicare. This means the vast majority of patients now have coverage in place for Omisirge. We are thrilled with the progress we are making on the launch of Omisirge. This demonstrates that there is significant interest from transplanters to have Omisirge available as a donor source opportunity for patients. And it signals that the real-world potential of Omisirge is consistent with the market research we conducted prior to and just after approval. In fact, based on this progress, we plan to hire four account managers and two additional medical science liaisons, or MSLs, to join the existing team of four account directors and four medical science liaisons to further support the demand for Omisirge As many of you know, we hosted an Investor Day on June 29 to discuss the unmet need in stem cell transplant patients and the role Omisirge may play in addressing those needs.

We were joined by two thought leaders in stem cell transplantation. Dr. Steven Devine, Chief Medical Officer at the National Marrow Donor Program, Be The Match and Senior Scientific Director at the CIBMTR, the Center for International Blood and Marrow Transplant Research; and Dr. Usama Gergis, Professor of Oncology and Director of Transplant and Cellular Therapy at the Sidney Kimmel Cancer Center at Thomas Jefferson University in Philadelphia. Dr. Devine address the unmet need regarding access to stem cell transplant. He explained that while approximately 20,000 people are eligible each year for transplant, only about half of these patients actually receive one. He outlined a variety of barriers including highlighting the inequities and access for patients who are racially or ethnically diverse and Omisirge’s potential to help expand access and address those health disparity.

Our Phase 3 study had over 40% of patients who were racially and ethnically diverse, which demonstrates both the unmet need and also Omisirge’s ability to be a viable donor source for these patients. Dr. Devine concluded that today, no patient should go without a potentially curative transplant because they can’t find a match. Dr. Gergis’ presentation was especially for young. He shared the story of his patient who was eligible for a stem cell transplant 1.5 years ago, but struggled to find a donor, illustrating the need for Omisirge as a new donor source. This person was a young black patient who could not find a match from a family member. Unfortunately, the only options available to this patient were mismatched unrelated donors. Throughout this talk, Dr. Gergis explained that timing is key with transplant as the patient could potentially relapse and become ineligible for transplant or become too weak to withstand the transplantation process.

He said that if he was treating this patient today, he likely would have chosen Omisirge as the donor source and highlighted the 30-day turnaround for Omisirge as a positive benefit. Dr. Gergis also discussed a decision tree research model developed in partnership with Gamida Cell, evaluating outcomes in patients undergoing transplant. The research showed that availability of Omisirge at a 20% peak market share may increase transplant access, particularly for patients who are racially and ethnically diverse, demonstrating a 25% overall increase in allogeneic stem cell transplant rates with the degree of benefit largest for black patients and those of Asian, Hispanic and multiracial background. This makes us very optimistic about the potential role Omisirge may have in addressing what we estimate to be about 1,700 patients who are eligible for stem cell transplant annually, but for whom — but for who are unable to find a donor.

That’s in addition to the transplanters potentially choosing Omisirge instead of other donor sources. As we heard from both Dr. Gergis and Dr. Devine, there is a clear need for Omisirge, which we believe is reflected in the launch progress we’re seeing. We remain committed to our two-pronged corporate strategy announced at the end of March, which involves, first, launching Omisirge in the U.S. with the goal of onboarding 10 to 15 transplant centers by the end of 2023, a goal we now expect to meet or exceed. And secondly, pursuing a strategic partnership or transaction with a biopharmaceutical company to expand transplant center onboarding and accelerate patient access to Omisirge. On the second part of that strategy, we are continuing conversations with potential strategic partners.

We believe our early launch success is a promising sign of Omisirge’s long-term potential. Onboard to help with these efforts is our recently appointed Chief Financial Officer, Terry Coelho, who joined the team in May. Terry is a seasoned finance executive with over 35 years of experience across all areas of finance and business development at both emerging growth and established global companies. She was most recently Executive Vice President, CFO and Chief Business Development Officer at CinCor Pharma Inc., where she led the company’s successful initial public offering and follow-on financing in 2022. She’s also held senior financial and executive roles at several other companies, including Novartis Pharmaceuticals, where for close to eight years, she held roles of increasing responsibility, including as finance lead for the Oncology-Hematology franchise and later led the Global Oncology development finance function.

We are thrilled to have Terry on board to support Gamida Cell’s ongoing transition into a commercial stage company and help drive our strategic partnership efforts. In addition, the Gamida Cell Board of Directors appointed Jeremy Blank, Founding Partner and Chief Investment Officer of Community Fund to the Board. Community Fund is a significant shareholder in Gamida Cell, Jeremy has a deep experience as an investment adviser for both companies and investors and we believe he is well positioned to help the Board support our execution of Gamida Cell’s corporate strategy to identify the right partner to fully resource the launch of Omisirge. Jeremy believes strongly in our two pronged corporate strategy. In terms of our current financial position, we are pleased to share that we have strengthened our balance sheet significantly in the past quarter enabling us to effectively drive our launch efforts while also extending our cash runway into Q2 of 2024.

You’ll hear more details on our financials from Terry in just a moment. So to summarize. We have made significant progress on the commercial launch of Omisirge, exceeding expectations in terms of both securing payer coverage and onboarding transplant centers. We heard inspiring testimony from external thought leaders about Omisirge’s potential to increase access and address barriers to care for patients in need of a stem cell transplant at our recent Investor Day. And it’s delightful to say that we have heard similarly positive feedback from transplant centers during our onboarding process. We continue to progress our discussions to secure a business development transaction and we are thrilled to have Terry on board as our new CFO. We are confident in our team’s ability to deliver Omisirge to patients and its potential to save lives.

I’ll now turn the call over to Michele for a more in-depth update on our commercial launch. Michele, over to you.

Michele Korfin: Thank you, Abbey, and good morning, everyone. Gamida Cell continues to advance efforts and prioritize resources across the organization to execute Omisirge’s launch and ensure patients in need could have access to Omisirge. We are pleased to share that the launch is off to a great start. Our real-world launch experience is consistent with both our pre- and post-approval market insights both in terms of unmet needs with existing donor sources and interest in Omisirge from transplanters and the multidisciplinary teams at their centers. As you may recall, Gamida Cell conducted a total of five independent blinded market insight studies with healthcare providers and payers, both pre and post approval. That showed Omisirge has the potential to capture approximately 20% market share at peak, which we estimate could occur by 2028.

The insights were consistent that the market share capture for Omisirge could come from transplanters using Omisirge instead of other donor sources as well as transplanters using Omisirge for those approximately 1,700 patients who are eligible for transplant each year and could not find an appropriate donor. Although we previously estimated this number to be about 1,200, we now have independent data that show it is more likely about 1,700 patients each year who cannot find an appropriate donor. As a reminder, a patient with a hematologic malignancy goes to transplant since that may be their only potential remaining treatment option. For those approximately 1,700 patients who could not find a donor, they will most likely succumb to their disease.

We are passionate at Gamida about making sure transplant centers have access to Omisirge as a potential option for their patients. Today and in the past few months since approval, we have seen very strong interest in Omisirge from transplant centers, including centers that were not part of the Phase 3 trial. As of this morning, 12 transplant centers have been onboarded, including centers such as Duke University Medical Center, Jefferson Health in Philadelphia, the Ohio State and UCLA Health. And eight additional transplant centers are actively in the onboarding process. We are engaged with virtually all of the top 70 centers, which conduct about 80% of the transplant in the U.S. I am very excited to say that Gamida Cell remains on track to possibly exceed our goal of onboarding 10 to 15 transplant centers by the end of 2023 and that we have exceeded our expectations with regard to the number of centers on boarded to date.

Our transplant center onboarding team works closely with transplant center personnel on the clinical training and administrative policies and procedures required to begin using Omisirge as a donor source. How quickly a transplant center is onboarded is determined by the needs of each individual transplant center. This can include factors like staff availability to participate in the onboarding and the status of patients currently under evaluation who may be good candidates from research. Our team is nimble and customizes onboarding time lines to meet individual transplant center and patient needs. The clinical approach and policies and procedures needed for Omisirge are consistent with other donor sources and are, therefore, very familiar to transplant center personnel.

So ultimately, the onboarding process can be completed very quickly, typically more quickly than for other cell therapies. We have also been focused on ensuring payer coverage for Omisirge. We have confirmed coverage for the vast majority of patients in the U.S. In fact, more than 85% of commercial lives have confirmed coverage. This includes national coverage with nine out of the top 10 payers. And we are in ongoing discussions with additional commercial payers to further expand coverage. Last year, we secured our Omisirge-specific ICD-10 codes and in June, we announced that we now also have confirmed CMS coverage and reimbursement for patients covered by Medicare. We also have all the required documentation in place for patients who are covered under Medicaid, the Department of Defense and the Department of Veteran Affairs.

We know from our clinical trials and working in transplant that it takes time to evaluate patients and get them ready for transplant. This is true for all donor sources and the specific time line and approach for preparing a patient for transplant can vary by transplant center based on each center’s policies and procedures. I am excited to share that patients are enrolled in the Gamida Cell’s program, which was created to ensure healthcare providers and patients can access therapy and have a personalized positive experience. When a transplant physician enrolls a patient in Gamida Cell Assist, it signals that they intend to use Omisirge as the patient’s donor source. The transplant centers enroll patients to Gamida Cell Assist, select Omisirge and schedule their manufacturing date and can also work with Gamida Cell Assist for patient assistance, including benefit verification, patient support programs and co-pay or coinsurance assistance.

This is a significant step for the patient in terms of their journey to transplantation. Once the Omisirge donor source is selected by the patient’s transplanter and the cord blood unit is received by Gamida Cell, we are ready to begin manufacturing. As a reminder, we have been successfully manufacturing clinical batches in our facilities for over a year. We have an experienced team in place, and we are ready to reliably deliver Omisirge within 30 days from the start of manufacturing. To continue the rapid expansion of our commercial launch and support the demand for Omisirge, we have plans to hire four account managers and two additional medical science liaisons to support the current team of four regional account directors and four MSLs. We feel this is an appropriate investment to capitalize on the momentum and interest we are seeing from transplant centers.

Going back to our mission, Gamida Cell was built to deliver potentially curative therapies for patients with blood cancers. Omisirge is a core element in delivering on that mission based on its potential to increase access and address critical unmet needs and stem cell transplantation. We are prioritizing every resource possible to support this launch, knowing the meaningful impact Omisirge can potentially have on patients’ lives. The interest and enthusiasm from transplant centers are both gratifying and supportive of the prelaunch market insights. Our team at Gamida Cell has been working hard to meet transplant center demand and ensure that every patient in need of a stem cell transplant has access to Omisirge. With that, I’d like to turn the call over to Ronit Simantov, our Chief Medical and Chief Scientific Officer.

Ronit?

Ronit Simantov: Thank you, Michele, and good morning, everyone. Thank you for joining us today. My team and I have been speaking with physicians across the country, and the feedback we hear on Omisirge echoes what Michele has shared. We see a clear need for transplant options for their patients and are eager to make Omisirge available at their institution. Today, I will provide a few updates on recent data for Omisirge and for our NK cell therapy candidate, GDA-201. First, results of the prospective substudy of the Phase 3 Omisirge trial were recently published in the Journal Transplantation and Cellular therapy. Our Phase 3 study, which over 40% of patients were members of ethnic and racial minority groups demonstrated rapid neutrophil engraftment, a key early marker of transplant success and lower rates of serious infection, in patients transplanted with Omisirge compared to cord blood using real-world data from CIBMTR, we also showed that transplantation with Omisirge led to faster hematopoietic recovery than other donor sources.

A potential mechanism for these observations was elucidated in a substudy of 37 patients from the Phase 3 trial, which showed prompt and robust recovery of immune cells after transplant with Omisirge, with up to a 70-fold advantage in median cell counts across most cell populations, including NK, T and B cells. The authors concluded that the faster recruitment and development of immune cells may account for the reduced rate of bacterial, fungal and viral infections observed after transplantation with Omisirge versus cord blood. We continue to present and publish data that add to the scientific and clinical understanding of Omisirge and provide insights to the transplant community. I’ll now turn to GDA-201, our allogeneic NK cell therapy candidate, derived from adult donors and manufactured using our proprietary nicotinamide or NAM technology.

We presented data at the International Society for Cell and Gene Therapy, or ISCT 2023 Annual Meeting in June, demonstrating the robustness of cryopreserved GDA-201. We showed that NAM expansion of NK cells led to the expression of lymphoid homing marker CD62 ligand and decreased levels of lineage exhaustion markers CD57 and CD161, providing further phenotypic characterization of GDA-201. In addition, data from the investigator-led study at the University of Minnesota using the fresh formulation of GDA-201 were published in the July 19th edition of Science Translational Medicine. The publication included preclinical, clinical and translational data. The preclinical data demonstrated that our NAM technology increased metabolic fitness, energy charge and glucose flux in NK cells.

The implications of these findings are significant given recent research showing the importance of metabolic fitness in cellular therapy. The clinical data shows 74% overall response rate and 57% complete response rate in heavily pretreated patients with non-Hodgkin lymphoma, treated with GDA-201 and translational data in biopsy specimens showed that tumor regression was associated with dense host T cell infiltration into lymph node tissue after GDA-201 treatment suggesting that GDA-201 generated an adaptive immune response in patients. These data provide further evidence that GDA-201 NK cells which originate from human donors and are expanded using our NAM technology can overcome the historic limitations of NK cells as a viable therapeutic.

We are excited about these new insights on metabolic fitness, cytotoxicity and engagement of the adaptive immune system as we proceed with our Phase 1 dose escalation study of GDA-201. We are enrolling patients with non-Hodgkin lymphoma at six U.S. sites and expect to report data in the first quarter of 2024. I will now turn the call over to Terry Coelho, our Chief Financial Officer. Terry?

Terry Coelho: Thank you, Ronit, and good morning, everyone. As Abbey mentioned earlier, I’m pleased to share that the company has strengthened its balance sheet in the second quarter. We ended the second quarter with $54.1 million in cash as a result of combined net proceeds of $34.7 million from both the April equity offering and funds raised using the at-the-market or ATM facility in the quarter. In addition, the outstanding principal balance of our 2022, $25 million convertible term loan was $10 million as of June 30, 2023, a reduction of $9 million as compared to the balance of $19 million at the end of the first quarter. The $9 million reduction reflects primarily voluntary share exchanges by the lender in addition to the payment of a monthly installment in shares.

The combined principal balance of the 2022 note and the $75 million senior convertible note is $85 million as of June 30, down from $94 million at the end of the first quarter. Research and development expenses were $8.7 million in the second quarter of 2023 compared to $10.6 million in the same quarter in 2022. The decrease of $1.9 million was primarily due to a $1.6 million reduction associated with the discontinuation of development of our engineered NK cell therapy pipeline and $700,000 in lower Omisirge Phase 3 spend including a decrease in payments for manufacturing services, partially offset by a decrease of $400,000 in Israeli Innovation Authority income. Commercial expenses were $3.9 million in the second quarter of 2023 compared to $3.2 million in the second quarter of 2022.

The increase of $700,000 was attributable to an increase in launch readiness activities. General and administrative expenses were $6.3 million in the second quarter of 2023 compared to $4.3 million in the same period in 2022. The increase of $2 million was associated with higher professional services expenses of $1 million, in part due to the April follow-on offering and business development activities. Financial expenses were $12.9 million net in the second quarter of 2023 compared to $500,000 in the same period of 2022. The increase of $12.4 million was primarily due to noncash expenses totaling approximately $10.4 million, including the fair value impact on our warrants liability of $4.9 million, the fair value impact on the 2022 convertible note of $4.3 million and a decrease in capitalization of finance cost to fixed assets of $600,000.

In addition, the increase was due to higher cash expenses of $2 million, including $1.7 million in issuance costs from our April 2023 underwritten public offering and an increase of $1 million in interest expenses associated with the 2022 convertible note, partially offset by increased interest income of $500,000. Our net loss was $31.7 million in the second quarter of 2023 compared to a net loss of $18.6 million in the second quarter of 2022, driven primarily by the increase in financial expenses of $12.4 million. As I mentioned before, as of June 30, 2023, Gamida Cell had total cash and cash equivalents of $54.1 million compared to $64.7 million as of December 31, 2022. The decrease of $10.4 million is due primarily to net cash used in operating activities of $44.3 million, partially offset by $34.7 million in net cash proceeds from the issuance of shares and warrants in our underwritten public offering, along with the issuance of shares via the ATM facility.

Subsequent to the quarter close and through August 9, the company raised an additional $14 million in net proceeds via the ATM facility. The company expects its current cash and cash equivalents, including the funds raised via the ATM subsequent to the close of the second quarter to support its ongoing operating activities into the second quarter of 2024, based on Gamida Cell’s current operational plans and excluding commercialization activities beyond the initial launch of Omisirge as well as any additional financing activities that may be undertaken. We believe that this cash runway will enable us to effectively support the launch of Omisirge while pursuing strategic alternatives. With that, I’ll turn the call back over to Abbey for some concluding remarks.

Abbey?

Abbey Jenkins: Thank you, Terry. Before I turn the call over to the operator for questions, I want to bring us back around to the beginning of the call and summarize the key points from our discussion today. We’ve made great progress on the commercial launch of Omisirge. We are on track to possibly exceed our goal of onboarding 10 to 15 transplant centers this year, which is the first prong of our two-pronged strategy. And we have confirmed coverage from payers that cover more than 85% of commercial lives, along with securing Medicare coverage and reimbursement. We are also continuing to execute on the second prong of our strategy, to pursue a strategic partnership or transaction in order to expand transplant center onboarding and accelerate patient access to Omisirge.

Conversations with potential strategic partners are ongoing. The Phase 1 clinical trial for GDA-201 is proceeding as expected, and we look forward to the data readout in early 2024. We have strengthened our balance sheet significantly, enabling us to effectively drive these efforts and extending our cash runway into Q2 of 2024. Most importantly, we are thrilled that patients now have access to a new stem cell donor source. We believe our early launch success is a promising sign of Omisirge’s long-term potential to increase access and address critical unmet needs in stem cell transplantation. Now let’s open the call for questions. Operator?

Q&A Session

Operator: [Operator Instructions] Our first question comes from Jason Butler with JMP Securities. Your line is open.

Jason Butler: Hi. Thanks for taking the questions and congrats on all the progress. Just wondering if more color on the patients that are already in the Gamida Cell Assist program, where along the process towards treatment are they? And what would need to happen between now and then actually getting treated or for – between now and you actually starting the manufacturing process for these patients. Thanks.

Michele Korfin: Hi, good morning. Jason, it’s Michele, and thank you for the question. So we do have patients enrolled in Gamida Cell Assist. So hence, the commercial manufacturing process is now underway. From the standpoint of just a reminder, we have successfully manufactured Omisirge for about a year at this facility for both our EAP and clinical trials. So the team is excited to now have the commercial manufacturing process started too. Jason, let me pause there and see if I fully address your question.

Jason Butler: Yes. I guess just to clarify, does that mean that you already have reimbursement approval for these patients? And then, can you — if you can, can you give us a sense of the patients in Gamida Assist now? Are they more heavily weighted towards commercial plans or Medicare. Thanks.

Michele Korfin: Yes. Excellent questions. So let’s start with both the coverage. Okay. Jason, could you hear me okay?

Jason Butler: Yes, yes, Michele.

Michele Korfin: Okay, perfect, great. So let’s start with coverage and reimbursement, and then we’ll talk about the patient mix. So from the stand point of coverage and reimbursement, we’re very encouraged with where we stand on both the commercial side and the CMS side. So let me start with commercial. So coverage, we have confirmed coverage for commercial payers who cover over 85% of the commercial lives. So that’s the coverage. From a reimbursement standpoint, what we’re hearing so far from the centers is they’re generally working with their respective payers utilizing single-case agreements those that have gone through already have gone through very smoothly and consistent with expectations from both the payer side and the center side.

So that’s the reimbursement side on the commercial side. Coverage and reimbursement for CMS or Medicare specifically, we did receive our ICD 10 codes last year and coverage was mapped to DRG 14, which is where we would expect it to be for an allogeneic stem cell transplant. And in June, we received confirmation from CMS that reimbursement will be covered under the legislation that led to Section 108. So — and that covers donor sources as the pass-through. So from the standpoint of Medicare, we have both the confirmed coverage and reimbursement. You asked about the patients that are on Gamida Cell Assist. We’ve seen a mixture of commercial and CMS patients. And yes, as I mentioned, we’re very encouraged — I’m very encouraged by both the confirmed coverage and also the reimbursement process to date on both the commercial and the Medicare side.

Jason Butler: Great. And then just last one for me. If you hit the target of onboarding centers this year, do you have the resources to continue to onboard centers above that initial target? Thanks.

Michele Korfin: Yes, so — as we mentioned in our prepared remarks, we are adding additional account managers, so four commercial account managers and Ronit and her team are adding additional MSLs. And your question is very astute. We do need to make sure that as that level of interest from centers continues to grow, which we’re very encouraged by that, we have the appropriate resources. So hence, the additional resources that we’ll be adding on both the account manager and the MSL side.

Jason Butler: Okay. Great. Thanks for taking the questions.

Michele Korfin: Thank you.

Unidentified Analyst: This is Ethan on for Gil. Thank you for taking our question. I was just wondering if you could tell us, based on the 12 centers onboarded so far how many of those are previously involved in clinical studies versus those not because I know that was a previous point at the Analyst Day. And then the second question is during the analyst event, I believe you guided that first commercial manufacturing might initiate in the third quarter, wondering if you were still on track for that or if that’s changed? Thank you.

Michele Korfin: Yes. So this is Michele, and thank you for the question. So let me – I’ll take the first one in regard to clinical – the 12 centers onboarded and clinical study participation, the vast majority of the centers onboarded were not in the clinical study. So we’re very encouraged by the fact that we have the strong level of interest from centers who were not part of the clinical studies. And our medical team has worked very closely with them as have our commercial team for onboarding. So that’s the first question. The second question, we do have patients enrolled in Gamida Cell Assist. So hence, once they are enrolled in Gamida Cell Assist, the commercial manufacturing process does initiate.

Unidentified Analyst: All right. Thanks for taking my question.

Michele Korfin: Excellent. Thank you.

Operator: [Operator Instructions]

Abbey Jenkins: Okay. I think well, that concludes our Q&A.

Operator: There are no further questions, I’d like to turn the call back over to Abbey Jenkins, President and CEO, for closing remarks.

Abbey Jenkins: Thank you all again for joining us. To recap just a few months after FDA approval of Omisirge, Gamida Cell is well positioned to bring Omisirge to patients with hematologic malignancies in need of a stem cell transplant in transplant centers across the country. Our team at Gamida Cell is working hard to meet the significant interest we are seeing from transplant centers, and we are so excited at the prospect of bringing Omisirge to patients. Thank you, everyone, for joining us on today’s call. And we look forward to providing further updates on future calls. Thank you.