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Interesting perspective and thank you. I hope you are correct on all accounts.
Following up on your sentiment apropos a potential buyout, where things stand today, have you reconsidered your initial position? TIA
“In my opinion FDA approval will be obtained, followed by a raise (at a price of $3-4 at very best)”
Incredibly dismal where things stand this morning. I too believe Gamida will gain FDA approval. Unfortunately the cash situation has them in a VERY vulnerable situation and I now envision a raise at the $1.50-$2.00 range given all the disclosures announced yesterday. This executive team really botched things up with respect to managing their finances IMHO.
I will be holding all my shares until the FDA renders their decision. GLTA
Gamida Cell tanks after dismal cash runway guidance for 2023
Mar. 27, 2023 12:30 PM ETGamida Cell Ltd. (GMDA)
By: Preeti Singh, SA News Editor
Gamida Cell (NASDAQ:GMDA) is trading around -25% on Monday after it said at
the end of its 2022 results it expects current cash and cash equivalents to support operations through Q3 2023.
Net loss for 2022 was $79.4M and EPS missed analysts' estimates as well. Gamida (GMDA) reported higher expenses from the closing on a senior secured convertible term loan of $25M. It also posted higher costs linked to its corporate headquarters and headcount-related expenses, and professional services.
Commercial launch readiness expenses declined and so did R&D costs after the conclusion of its Phase 3 study of omidubicel.
Gamida (GMDA) has outlined plans for a strategic restructuring, prioritizing the launch of omidubicel and reducing operating expenses to extend the cash runway.
The company has had productive interactions with the FDA on the authorization process for omidubicel and plans to allocate most of its resources to launch the drug, if approved.
However, investment into the launch and ramp-up in commercialization will still be slower than previously planned amid a dearth in financial resources.
Gamida Cell Ltd. (GMDA) Q4 2023 Earnings Call Transcript
Mar. 27, 2023 12:25 PM ETGamida Cell Ltd. (GMDA)
Gamida Cell Ltd. (NASDAQ:GMDA) Q4 2023 Earnings Conference Call March 27, 2023 8:00 AM ET
Company Participants
Abigail Jenkins - President and Chief Executive Officer
Ronit Simantov - Chief Medical and Chief Scientific Officer
Michele Korfin - Chief Operating and Chief Commercial Officer
Shai Lankry - Chief Financial Officer
Conference Call Participants
Edward Tenthoff - Piper Sandler
Jonathan Miller - Evercore ISI
Mark Breidenbach - Oppenheimer
Jason Butler - JMP Securities
Vernon Bernardino - H.C. Wainwright
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?
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 [Technical Difficulty] we prepare to bring potentially curative therapy to patients following [Technical Difficulty].
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 [Technical Difficulty].
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.
Question-and-Answer Session
Operator
Thank you. [Operator Instructions] 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
[Operator Instructions] 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. [Operator Instructions] 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.
Oy - Vey, a bloody slaughterhouse
if i ever saw one.
Well that’s not a very rosy earnings report:
They need cash, and/or a partner to commercialize their drug closest to approval which is hopefully only a month away.
They are basically throwing everything into this approval.
If they don’t get it, they’re in deep trouble.
At best they get a partnership and cash infusion, and at worst a large cash raise.
At this point, I would think a partnership is unlikely before their PDUFA.
A cash could happen but more likely right after the PDUFA and into any price pop IMO.
I’m already we’ll under water on this. Might eat my losses and see how this plays out from the side lines to see if they can pull this out of a nosedive.
Murocman
Gamida Cell Reports Full Year 2022 Financial Results and Provides Company Update
https://finance.yahoo.com/news/gamida-cell-reports-full-2022-110000509.html
Company reports on productive interactions with FDA and preparations for launch of omidubicel, if approved, in advance of May 1 PDUFA date
Company outlines strategic restructuring, plans to prioritize omidubicel launch and reduce operating expenses to extend cash runway
Company to explore strategic options to support a broader launch of omidubicel, including potential US and global partnerships with pharmaceutical companies
Company intends to continue GDA-201 Phase 1 study, discontinue development of natural killer (NK) cell preclinical candidates and consolidate its operations in Israel in Kiryat Gat
Company to host conference call at 8:00 am ET today
BOSTON, March 27, 2023--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today provided a business update and reported financial results for the year ended December 31, 2022. Net loss for 2022 was $79.4 million, compared to a net loss of $89.8 million in 2021. As of December 31, 2022, Gamida Cell had total cash and cash equivalents of $64.7 million.
The company highlighted positive data, productive regulatory interactions and progress on commercial readiness activities supporting its lead product candidate, omidubicel, an advanced cell therapy candidate for allogeneic stem cell transplant, as it advances toward its May 1, 2023 target Prescription Drug User Fee Act (PDUFA) action date. The company also announced a strategic restructuring of its operations to prioritize launch of omidubicel to ensure that, if approved, patients who may potentially benefit will have access to therapy. To reduce expenses, the company will discontinue development of its preclinical NK cell therapy candidates while continuing to enroll patients in the GDA-201 Phase 1 clinical trial.
"Our mission is to bring potentially curative therapies to patients," said Abbey Jenkins, President and Chief Executive Officer of Gamida Cell. "We believe we have a clear path to approval and are preparing for the commercial launch of omidubicel, if approved. Given the challenging economic environment, to date, we have not been able to raise adequate funding to support our full pipeline and enable a more robust launch of omidubicel, if approved. As a result, we are taking decisive actions to do three things 1) prioritize resources toward the launch 2) reduce expenses across the board 3) seek potential commercial or strategic partnerships to maximize patient access to omidubicel, a potentially life-saving therapy. Today’s actions are difficult. Especially since our engineered NK cell therapy candidates, which are derived from healthy donors, have demonstrated encouraging pre-clinical data that differentiate them from other NK cell therapy approaches. The science is promising, but these changes are economically necessary to ensure omidubicel reaches as many patients as possible."
Today Gamida Cell announced it would:
Implement a strategic restructuring to focus on omidubicel launch, if approved: The company intends to allocate the vast majority of its resources to executing a launch of omidubicel, if approved, although with a more limited investment and slower ramp than previously planned in order to manage its financial resources. The company reported productive interactions with the FDA, including a recently completed Late Cycle Meeting and a previously reported Pre-Licensing Inspection of the company’s Kiryat Gat, Israel, manufacturing facility, with no 483 observations received to date. Recently presented data continue to support the clinical benefits and safety of omidubicel, which, if approved, may be a valuable new donor source for patients in need of allogeneic stem cell transplant. Commercial readiness activities have made progress as the company prepares to onboard approximately 10-15 of the top 70 transplant centers in the United States in 2023. Omidubicel has received positive feedback from leading transplant centers, including ones that did not participate in the company’s clinical trials. The company has met with U.S. payers, including payers that cover more than 90% of commercially covered lives, and reported that payers indicate they anticipate covering a one-time therapy with curative intent.
Continue its GDA-201 Phase 1 study: The company will continue to enroll patients in its GDA-201 Phase 1 dose escalation study.
Reduce operating expenses in order to extend its cash runway: The company will discontinue the development of its engineered NK cell therapy preclinical pipeline, including GDA-301, GDA-501 and GDA-601, while maintaining the IP to these candidates. It will implement a headcount reduction of 17%, with the majority of impacted headcount tied to the discontinuation of the pre-clinical NK cell therapy candidates. The company will also close its operations in Jerusalem and consolidate Israel operations at its state-of-the-art manufacturing facility in Kiryat Gat. These changes are expected to extend the company’s cash runway through Q3 2023.
Explore strategic options: The company intends to seek potential commercial or strategic partnerships to maximize patient access to omidubicel, if approved.
Fourth Quarter and Recent Developments
Omidubicel: Advanced Cell Therapy
New data presented at ASH and TCT: The company 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 at the 2023 Tandem Meetings, Transplantation & Cellular Therapy (TCT) Meetings of the American Society for Transplantation & Cellular Therapy and the Center for International Blood and Marrow Transplant Research in February. Seven days post-transplant, omidubicel-transplanted patients showed a statistically significant correlation between CD3+/CD4+ T cell counts and time to neutrophil engraftment. Similar correlations were noted between CD3+/CD8+/CD19+ cell counts and time to platelet engraftment. Patients transplanted with standard cord blood showed no such correlations at Day 7 post-transplant, and only began to show correlations starting at 14 days post-transplant. Data support past findings that omidubicel stimulates a faster immune response than standard cord blood, which may be a contributing mechanism resulting in the lower incidence of serious bacterial, fungal and viral infections for omidubicel-transplanted patients.
New publication in press: The company reported a publication in press in 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.
Manufacturing readiness: The company’s state-of-the-art manufacturing facility in Kiryat Gat, Israel, is ready for commercial launch if omidubicel is approved and is currently producing omidubicel for the company’s Extended Access Program (EAP) and its ongoing omidubicel aplastic anemia study. The facility, which has completed its Israeli Ministry of Health and FDA pre-licensure inspections with no 483 observations to date, has the ability to deliver omidubicel back to the transplant center within approximately 30 days from the start of manufacturing.
Commercial readiness: The company continues to advance efforts throughout the organization to prepare for the launch of omidubicel, if approved.
GDA-201: Intrinsic NK Cell Therapy
New data presented at Tandem Meetings: The company presented a poster at the 2023 Tandem Meetings, Transplantation & Cellular Therapy (TCT) Meetings of the American Society for Transplantation & Cellular Therapy and the Center for International Blood and Marrow Transplant Research reporting new preclinical data on the cryopreserved formulation of GDA-201, which showed increased potency and enhanced cytotoxicity. GDA-201 cells were tested for viability, phenotyping, function and potency. Previous characterization of GDA-201 showed high levels of CD56, CD16, CD49a and CD62L expression, low levels of CD57, and low levels of immune checkpoints such as LAG3 and CD200R. The new analyses showed that cryopreserved GDA-201 exhibited high viability (>90%) and high purity up to 12 months post-manufacturing and preserved the ability to proliferate post-thaw. GDA-201 maintained high levels of expression of CD16, which mediates antibody-dependent cellular toxicity, and CD62L, which is a homing and retention marker. GDA-201 also demonstrated high potency, based on the intracellular secretion of TNF-alpha & IFN-gamma and extracellular degranulation marker CD107a.
In addition, external investigator Veronika Bachanova, M.D., Ph.D., Professor at the University of Minnesota Medical School, gave an oral presentation highlighting novel observations of "on treatment" tumor biopsies from eight patients treated with GDA-201 in a Phase 1 study. The microscopic spatial analysis demonstrated that while GDA-201 cells were virtually undetectable in tumors after 14 days, T cells were observed in 50-95% of tumor site cellularity. Most biopsies obtained as early as three to seven days post-infusion showed strong indications of widespread tumor death. These observations suggest that GDA-201 infusions trigger profound immune microenvironment changes, supporting the influx of host T cells early post-GDA-201 infusion. These findings further suggest the engagement of the adaptive immune system and effective tumor elimination.
Corporate Developments
On March 20, the company announced that Shawn Cline Tomasello was elected Chairwoman of the Board of Directors, succeeding Chairman Robert I. Blum, who resigned. Ms. Tomasello joined the Gamida Cell Board of Directors in June 2019. She has extensive experience in leading successful commercial activities at several pharmaceutical companies and providing key strategic guidance on company boards. Dr. Anat Cohen-Dayag and Dr. Naama Halevi Davidov also resigned from the company’s Board of Directors.
In December, the company and its wholly owned subsidiary, as borrower, closed on a senior secured convertible term loan of $25 million with certain funds managed by Highbridge Capital Management, LLC. The loan has a maturity date of December 12, 2024.
Full Year 2022 Financial Results
Research and development expenses, net were $42.7 million in 2022, compared to $50.2 million in 2021. The decrease was primarily due to a $9.6 million decrease in clinical and operational activities relating to the conclusion of our Phase 3 study of omidubicel, offset by an increase of $1.1 million in T&E and other expenses as well as a $1.0 million decrease in Israeli Innovation Authority grants.
Commercial expenses in 2022 were $12.9 million, compared to $20.0 million in 2021. The decrease was primarily due to a $8.2 million decrease in commercial launch readiness expenses, offset by an increase of $1.1 million in headcount related expenses.
General and administrative expenses were $19.4 million in 2022, compared to $17.0 million in 2021. The increase was mainly driven by an increase of $1.4 million attributed to our corporate headquarters and headcount-related expenses as well as a $1.0 million increase in professional services expenses.
Financial expenses, net, were $4.4 million for 2022, compared to $2.6 million for 2021. The increase was primarily due to expenses relating to the closing on a senior secured convertible term loan of $25 million with certain funds managed by Highbridge Capital Management, LLC.
Net loss for 2022 was $79.4 million, compared to $89.8 million in 2021.
2023 Financial Guidance
Gamida Cell expects its current cash and cash equivalents will support the company’s ongoing operating activities through the third quarter of 2023. This cash runway guidance is based on the company’s current operational plans and excludes any additional funding and any business development activities that may be undertaken.
Conference Call Information
Gamida Cell will host a conference call today, March 27, 2023, at 8:00 a.m. ET to discuss these financial results and company updates. To access the conference call, please register here and be advised to do so at least 10 minutes prior to joining the call. A live conference call webcast can be accessed in the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com. A webcast replay will be available approximately two hours after the event for approximately 30 days.
About Omidubicel
Omidubicel is an advanced cell therapy candidate for allogeneic hematopoietic stem cell (bone marrow) transplant that, if approved, has the potential to expand access and improve outcomes for patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment compared to standard umbilical cord blood in an international, multicenter, randomized Phase 3 study (NCT02730299) in patients with hematologic malignancies undergoing allogeneic bone marrow transplant. The Phase 3 study also showed reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. One-year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by a significant reduction in infectious complications as well as reduced non-relapse mortality and no significant increase in relapse rates nor increases in graft-versus-host-disease (GvHD) rates. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the U.S. and E.U. Omidubicel has a PDUFA target action date of May 1, 2023.
Omidubicel is an investigational stem cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. For more information about omidubicel, please visit https://www.gamida-cell.com.
About GDA-201
GDA-201 is an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. Preclinical studies have shown that GDA-201 may address key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, these data suggest GDA-201 may improve antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. A multicenter Phase 1/2 study of GDA-201 for the treatment of non-Hodgkin lymphoma is ongoing.
GDA-201 is an investigational cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority.
Gamida Cell FY 2022 Earnings Preview
Mar. 24, 2023 10:46 AM ETGamida Cell Ltd. (GMDA)
By: Pranav Ghumatkar, SA News EditorGamida Cell (NASDAQ:GMDA) is scheduled to announce
FY earnings results on Monday, March 27th, before market open.
The consensus EPS Estimate is -$1.19 (+21.7% Y/Y)
Over the last 1 year, GMDA has beaten EPS estimates 25% of
the time and has beaten revenue estimates 25% of the time.
Quite a courages move.
Serious:
Will be adding today below $1.30. I consider this a buying opportunity.
I am just letting steam off!
I agree it would certainly be nice, but if there’s nothing material that happened then the company isn’t obligated.
Their silence and directors departing doesn’t help, and the roller coaster will likely continue as you say.
Murocman
What Is a Press Release?
A press release is a piece of news or information that companies send out to inform the public about something noteworthy or of material significance.
Question is:
Has the meeting taken place?
If it went well, imo, it would be nice for
GMDA to issue a PR accordingly.
Naturally if FDA raised some additional
issues, shareholders should be informed.
In the meantime, as i mentioned a few posts ago,
the crazy roller coaster will continue.
GLTU,
Good question. From all I have learned, they are not required to disclose the results/topics discussed with the FDA. From what I understand, the meeting is an opportunity for Gamida to answer any remaining FDA questions about the application. From here on out to May 1, I would not expect any official disclosures from the company. Just my take on the overall situation.
Are they required to put out a press release after the late cycle meeting if nothing new is requested or required?
TIA,
Murocman
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Director Departures
On March 15, 2023, Dr. Anat Cohen-Dayag submitted her resignation from the board of directors (the “Board”) of Gamida Cell Ltd. (the “Company”), which resignation was effective immediately. Dr. Cohen-Dayag was a member of the Board’s Nominating and Governance Committee and chairperson of the Board’s Science and Technology Committee.
On March 16, 2023, Dr. Naama Halevi Davidov submitted her resignation from the Board, which resignation was effective immediately. Dr. Halevi Davidov was a member of the Board’s Audit Committee.
On March 17, 2023, Mr. Robert Blum submitted his resignation from the Board, which resignation was effective immediately. Mr. Blum was chairperson of the Board, chairperson of the Board’s Nominating and Governance Committee, and a member of the Board’s Compliance Committee.
(seems to me an explanation for sp depreciation the days
prior and including yesterdays official PR).
Appointment of Chairwoman of the Board
On March 20, 2023, the Board appointed Ms. Shawn Tomasello as chairwoman of the Board, effective immediately. The Board also appointed Ms. Tomasello to the Board’s Audit Committee, effective immediately.
Appointments to Board Committees
On March 20, 2023, the Board appointed Mr. Ken Moch and Dr. Ivan Borrello to the Board’s Nominating & Governance Committee, with Mr. Moch to serve as the chair of such committee. In addition, on March 20, 2023, the Board appointed Dr. Julian Adams to the Board’s Compliance Committee.
Item 7.01 Regulation FD Disclosure.
On March 20, 2023, the Company issued a press release entitled “Gamida Cell Announces Changes to Board of Directors.” The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Very possible. Management changes this close to the FDA decision date don’t give investors, including myself a “good feeling”. Perhaps the meeting with FDA highlighted deficiencies in the application. Only a guess on my part. Going to be an interesting five weeks.
I wonder if this news was the
reason for yesterdays turmoil?
Gamida Cell Announces Changes to Board of Directors
https://finance.yahoo.com/news/gamida-cell-announces-changes-board-203000989.html
Shawn Cline Tomasello to become Chairwoman, succeeding Chairman Robert I. Blum, who is resigning; Company focuses on upcoming regulatory milestone and commercialization
Directors Dr. Naama Halevi-Davidov and Dr. Anat Cohen-Dayag also stepping down
BOSTON, March 20, 2023--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced the resignation of Chairman Robert I. Blum. The Board of Directors has elected Shawn Cline Tomasello Chairwoman, effective immediately.
"On behalf of my fellow board members and Gamida Cell’s employees, I want to thank Robert for his dedicated service to this company," said Abbey Jenkins, Gamida Cell President and Chief Executive Officer. "Robert has been a tireless advocate for Gamida Cell for the past five years and has provided strong oversight through many critical decisions. Shawn 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 therapies. We look forward to her leadership as we approach our May 1 FDA target action date for omidubicel and, if approved, shift our focus to commercialization."
Shawn Cline Tomasello joined Gamida Cell’s Board of Directors in June 2019, bringing extensive experience in leading successful commercial activities at several pharmaceutical companies and providing key strategic guidance on company boards. Most recently, she served as Chief Commercial Officer of Kite Pharma, now part of Gilead Sciences, where she oversaw the global commercialization of Yescarta®, the first approved CAR-T therapy for non-Hodgkin lymphoma, and was a key executive in the Kite/Gilead acquisition for $11.9 billion in August 2017. Prior to joining Kite, Ms. Tomasello was Chief Commercial Officer and had responsibility for medical affairs at Pharmacyclics. While at Pharmacyclics, the company’s market cap increased from $8 billion to $19 billion, and it was ultimately acquired by AbbVie for $21 billion. Ms. Tomasello has extensive strategic experience in building world-class organizations working across all relevant encompassing functions. She holds a bachelor’s degree in marketing from the University of Cincinnati and an MBA from Murray State University and currently also serves on the public boards of AlloVir, TCR2 Therapeutics, Inc. and 4D Molecular Therapeutics.
"I’m excited to take on the role of Chairwoman," said Ms. Tomasello. "Gamida Cell is at an inflection point, with the potential FDA approval of omidubicel in the near term. This company has a therapy that can make a meaningful difference in the lives of patients, and an executive team that I’m confident can execute an effective launch."
In addition, the company announced the resignations of Dr. Anat Cohen-Dayag and Dr. Naama Halevi-Davidov. Both joined the Board in January 2022. Dr. Cohen-Dayag chaired the Science and Technology Committee and served on the Nominating and Governance Committee. Dr. Halevi-Davidov was a member of the Audit Committee.
About Gamida Cell
Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company has a diverse pipeline of potentially curative cell therapy candidates for patients with blood cancers and solid tumors. We apply a proprietary expansion platform leveraging the properties of NAM to cell sources including umbilical cord blood-derived cells and natural killer (NK) cells to create allogeneic cell therapy candidates with the potential to redefine standards of care. These include omidubicel, an advanced cell therapy candidate for allogeneic hematopoietic stem cell transplant that, if approved, has the potential to expand access and improve outcomes for patients with blood cancers, and a line of enhanced and engineered NK cells targeted at solid tumors and hematological malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, Twitter, Facebook or Instagram at @GamidaCellTx.
My SWAG, nothing to do with pending FDA decision. Someone holding a significant position is de-risking their portfolio and liquidating. The next 5 weeks could be incredibly volatile. JMHO
No idea for todays price downfall.
Gamida Cell Announces the Date of Its Fourth Quarter and Full Year 2022 Financial Results and Webcast
https://finance.yahoo.com/news/gamida-cell-announces-date-fourth-120000455.html
BOSTON, March 20, 2023--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that the company will host a conference call and live audio webcast on Monday, March 27, 2023, at 8:00 a.m. ET to review its fourth quarter and full year 2022 financial results and provide an update on the company.
To access the conference call, please register here and be advised to do so at least 10 minutes prior to joining the call. A live webcast of the conference call can be accessed in the "Investors & Media" section of the Gamida Cell website at www.gamida-cell.com. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.
153,000 Shares in Gamida Cell Ltd. (NASDAQ:GMDA) Purchased by FNY Investment Advisers LLC
https://www.marketbeat.com/instant-alerts/nasdaq-gmda-sec-filing-2023-03-17/
FNY Investment Advisers LLC acquired a new position in shares of Gamida Cell Ltd. (NASDAQ:GMDA - Get Rating) in the fourth quarter, according to its most recent Form 13F filing with the SEC. The firm acquired 153,000 shares of the company's stock, valued at approximately $197,000. FNY Investment Advisers LLC owned about 0.26% of Gamida Cell at the end of the most recent quarter.
Other hedge funds and other institutional investors have also recently modified their holdings of the company. BlackRock Inc. lifted its holdings in shares of Gamida Cell by 2.2% in the 3rd quarter. BlackRock Inc. now owns 459,683 shares of the company's stock worth $731,000 after acquiring an additional 10,092 shares during the last quarter. Virtu Financial LLC grew its stake in shares of Gamida Cell by 57.6% in the third quarter. Virtu Financial LLC now owns 31,922 shares of the company's stock valued at $51,000 after buying an additional 11,667 shares in the last quarter. Bank of America Corp DE grew its stake in shares of Gamida Cell by 539.0% in the first quarter. Bank of America Corp DE now owns 15,214 shares of the company's stock valued at $63,000 after buying an additional 12,833 shares in the last quarter. Victory Capital Management Inc. grew its stake in shares of Gamida Cell by 14.3% in the third quarter. Victory Capital Management Inc. now owns 114,569 shares of the company's stock valued at $182,000 after buying an additional 14,305 shares in the last quarter. Finally, Cubist Systematic Strategies LLC acquired a new stake in shares of Gamida Cell in the second quarter valued at $42,000. 56.19% of the stock is owned by institutional investors and hedge funds.
I was expressing my frustration
in regards share price.
What do u mean?
Gamida Cell to Present Corporate Highlights at the Oppenheimer 33rd Annual Healthcare Conference
https://finance.yahoo.com/news/gamida-cell-present-corporate-highlights-130000048.html
BOSTON, March 07, 2023--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that Abbey Jenkins, President and Chief Executive Officer, will present its corporate highlights at the upcoming Oppenheimer 33rd Annual Healthcare Conference on March 14th, 2023 at 9:20 a.m. ET.
Ms. Jenkins will discuss company updates, including preparations for the potential approval of the lead product candidate, omidubicel, which has a target PDUFA action date with the U.S. Food and Drug Administration (FDA) of May 1, 2023.
The webcast will be available on the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com, and will be available for at least 14 days following the event.
About Omidubicel
Omidubicel is an advanced cell therapy candidate for allogeneic hematopoietic stem cell (bone marrow) transplant that, if approved, has the potential to expand access and improve outcomes for patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment in comparison to standard umbilical cord blood in an international, multi-center, randomized Phase 3 study (NCT02730299) in patients with hematologic malignancies undergoing allogeneic bone marrow transplant. The Phase 3 study also showed reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. One year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by significant reduction in infectious complications as well as reduced non-relapse mortality and no significant increase in relapse rates nor increases in graft-versus-host-disease (GvHD) rates. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the US and EU. Omidubicel has a PDUFA target action date of May 1, 2023.
Omidubicel is an investigational stem cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. For more information about omidubicel, please visit https://www.gamida-cell.com.
GMDA............................https://stockcharts.com/h-sc/ui?s=GMDA&p=W&b=5&g=0&id=p86431144783
Novartis Pharma Now Owns 5.80% of Gamida Cell (GMDA)
https://www.nasdaq.com/articles/novartis-pharma-now-owns-5.80-of-gamida-cell-gmda
March 03, 2023 — 05:29 pm EST
Written by George Maybach for Fintel ->
Fintel reports that Novartis Pharma has filed a 13D/A form with the SEC disclosing ownership of 4.34MM shares of Gamida Cell Ltd (GMDA). This represents 5.8% of the company.
In their previous filing dated March 11, 2021 they reported 5.19MM shares and 8.80% of the company, a decrease in shares of 16.51% and a decrease in total ownership of 3.00% (calculated as current - previous percent ownership).
Analyst Price Forecast Suggests 641.82% Upside
As of March 3, 2023, the average one-year price target for Gamida Cell is $12.65. The forecasts range from a low of $7.07 to a high of $23.10. The average price target represents an increase of 641.82% from its latest reported closing price of $1.70.
The projected annual revenue for Gamida Cell is $18MM. The projected annual non-GAAP EPS is -$1.09.
What is the Fund Sentiment?
There are 74 funds or institutions reporting positions in Gamida Cell. This is a decrease of 9 owner(s) or 10.84% in the last quarter. Average portfolio weight of all funds dedicated to GMDA is 0.03%, an increase of 35.97%. Total shares owned by institutions decreased in the last three months by 4.25% to 25,165K shares. The put/call ratio of GMDA is 0.04, indicating a bullish outlook.
What are large shareholders doing?
GMDA / Gamida Cell Ltd Ownership
Rock Springs Capital Management holds 4,120K shares representing 5.53% ownership of the company. No change in the last quarter.
Meitav Dash Investments holds 3,655K shares representing 4.91% ownership of the company. No change in the last quarter.
QVG2Q - Growth Portfolio Investor Class holds 2,327K shares representing 3.12% ownership of the company. In it's prior filing, the firm reported owning 2,579K shares, representing a decrease of 10.80%. The firm decreased its portfolio allocation in GMDA by 28.34% over the last quarter.
Kranot Hishtalmut Le Morim Ve Gananot Havera Menahelet holds 2,212K shares representing 2.97% ownership of the company. No change in the last quarter.
FDCAX - Fidelity Capital Appreciation Fund holds 1,812K shares representing 2.43% ownership of the company. In it's prior filing, the firm reported owning 1,122K shares, representing an increase of 38.06%. The firm increased its portfolio allocation in GMDA by 103.61% over the last quarter.
Gamida Cell Background Information
(This description is provided by the company.)
Gamida Cell is an advanced cell therapy company committed to cures for patients with blood cancers and serious blood diseases. The company harnesses its cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need.
This story originally appeared on Fintel.
1.7040+0.0440 (+2.6506%)
As of 12:53PM EST. Market open.
Volume 971,195
Avg. Volume 528,084
Positive momentum continues.
Nice!
Certainly some interesting volume today. Perhaps the meeting with the FDA went well (IF it took place). Otherwise perhaps people finally woke up to the opportunity GMDA presents. Time will tell.
1.6399+0.1699 (+11.56%)
As of 11:35AM EST. Market open.
Volume 693,198
Avg. Volume 480,327
Nice action so far today.
IMHO, we will start to see the share price of GMDA slowly move back up albeit very modestly for the near term. I agree with your assessment, May 2023 is a huge month. Good luck!!
GMDA
As part of its ongoing BLA review, FDA issued an information request and viewed the data in the response as a major amendment, resulting in an extension of the omidubicel Prescription Drug User Fee Act (PDUFA) date from January 30, 2023 to May 1, 2023. The agency also rescheduled Gamida Cell’s late-cycle meeting to the first quarter of 2023.
PLX
Pegunigalsidase alfa acts as an enzyme replacement therapy. A final decision is expected in May 2023. The submission included data on a dosing schedule of both every two weeks and every four weeks. It is not clear which dosing schedule will be in the label.
In the U.S.A. Chiesi resubmitted the BLA to the FDA on November 9, 2022. This included data for dosing every four weeks. On December 5, 2022 the FDA accepted the pegunigalsidase alfa BLA, with a PDUFA (action) date set to May 9, 2023. There has been no announcement as to whether the FDA will call for an Advisory Committee hearing.
May 2023, a make or break for me!
$GMDA This week we’ll be attending #Tandem23, the premier event in the field of stem cell transplant and cellular therapy hosted by
@ASTCT and @CIBMTR
The event takes place both virtually and in person in Orlando, FL from February 15-19. More info: registration.tandemmeetings...
https://stocktwits.com/dup007/message/512004411
we closed the nasdaq... BIG MOVES
Welcoming cell therapy pioneer @GamidaCellTx to the @NasdaqExchange Closing Bell. 🧬🛎$GMDA strives to enable patients with cancer and other serious diseases to achieve cures through next-generation cell therapies. #NasdaqListed pic.twitter.com/BImse0qX2x
— Nasdaq Exchange (@NasdaqExchange) February 6, 2023
BIG MOVES
Welcoming cell therapy pioneer @GamidaCellTx to the @NasdaqExchange Closing Bell. 🧬🛎$GMDA strives to enable patients with cancer and other serious diseases to achieve cures through next-generation cell therapies. #NasdaqListed pic.twitter.com/BImse0qX2x
— Nasdaq Exchange (@NasdaqExchange) February 6, 2023
Thank you. I appreciate the guidance. Will be fascinating to see how this all plays out. I may add here to my original position ($2.68).
I am quite sure that once PDUFA action
date fetches positve outcomes, the
offering will immediately take place.
Thank you sir for sharing. Do you and others here believe raising more capital will take place before or after the pending PDUFA target action date coming in May?
TIA
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5 Nahum Heftsadie Street
Givaat Shaul
Jerusalem 91340
Israel
97222 659 666
http://www.gamida-cell.com
https://investors.gamida-cell.com/static-files/19b66eb5-8912-4828-a311-64227b63ec0f
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