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Gamida Cell to Host Virtual Event Highlighting GDA-201 and NAM-Enabled, Genetically Modified NK Cell Therapy Pipeline
https://finance.yahoo.com/news/gamida-cell-host-virtual-event-110000991.html
BOSTON, September 28, 2021--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced that it will host a virtual event detailing the company’s proprietary NAM-enabled natural killer (NK) cell therapy pipeline on Tuesday, October 26, 2021 at 8:00 a.m. ET.
During the event, the company will highlight updates on the clinical development of GDA-201, its lead cryopreserved, off-the-shelf cell therapy candidate for the treatment of patients with follicular and diffuse large b-cell lymphomas, and Gamida Cell’s new development programs leveraging next-generation, NAM-enabled, genetically modified NK cells in development for solid tumors and hematological cancers. Specifically, Gamida Cell will provide an update on the following genetically modified NK cell therapies:
GDA-301, a CISH knockout and membrane-bound IL-15 NK cell construct that has demonstrated increased potency against leukemia and multiple myeloma cell lines
GDA-501, a CAR-HER2 NK cell construct that has shown increased cytotoxicity against an ovarian tumor cell line
GDA-601, a CD38 knockout + CD38 CAR NK cell construct that has yielded increased cytotoxicity against a multiple myeloma cell line
The event will feature management presentations and participation by the following speakers:
Jeff Miller, M.D., Professor of Medicine, Division of Hematology, Oncology and Transplantation at University of Minnesota
Veronika Bachanova, M.D., Ph.D., Hematologist/Oncologist at University of Minnesota Health
Patient treated with GDA-201
The live event will be available at the following link. A replay of 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 GDA-201
Gamida Cell applied the capabilities of its nicotinamide (NAM)-based cell expansion technology to develop GDA-201, an innate NK cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical trial results, as reported at the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition1. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, GDA-201 improves antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. For more information on the clinical study of GDA-201, please visit https://www.gamida-cell.com/our-rd/ and www.clinicaltrials.gov.
GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
Gamida Cell to Present Corporate Highlights at Multiple Investor Conferences in September
https://finance.yahoo.com/news/gamida-cell-present-corporate-highlights-110000107.html
BOSTON, September 02, 2021--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced that company management will present its corporate highlights at the following virtual investor conferences in September:
H.C. Wainwright 23rd Annual Global Investment Conference, September 13-15, 2021. Company presentation will be available to view on-demand beginning on September 13 at 7:00 a.m. ET.
Baird’s 2021 Global Healthcare Conference, September 14, 2021 with a presentation at 11:25 a.m. ET.
In the fourth quarter of 2021, Gamida Cell is targeting a BLA submission for omidubicel, the first potential approval of a cell therapy for blood cancer patients in need of an allogeneic bone marrow transplant. This submission is expected to occur by the end of the year, subject to a pre-BLA meeting with the U.S. Food and Drug Administration (FDA) planned for the fourth quarter. In the third quarter of 2021, the Company is planning an IND submission to support the initiation of a Phase 1/2 clinical study of cryopreserved, off-the-shelf GDA-201 in patients with follicular and diffuse large b-cell lymphomas.
A webcast of both conference presentations 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 Gamida Cell
Gamida Cell is an advanced cell therapy company committed to cures for patients with blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn or Twitter at @GamidaCellTx.
Hi Spideyboy,
In Ref to:
Trillium Therapeutics Inc. TRIL entered into a definitive agreement with pharma giant Pfizer PFE, whereby it will be acquired by the latter.
....For Pfizer, the acquisition is expected to strengthen its hematology portfolio with the addition of Trillium’s next-generation immuno-therapeutics targeting hematological malignancies.
https://finance.yahoo.com/news/trillium-tril-acquired-pfizer-2-160304451.html
With a quick glance i see that GMDA is by far more
advanced than TRIL. Wouldn't you think that GMDA
would have been a better option for PFE? (and us
naturally)
What Kind Of Investors Own Most Of Gamida Cell Ltd. (NASDAQ:GMDA)?
Simply Wall St
Fri, August 13, 2021, 10:00 AM
https://finance.yahoo.com/news/kind-investors-own-most-gamida-070017051.html
Every investor in Gamida Cell Ltd. (NASDAQ:GMDA) should be aware of the most powerful shareholder groups. Insiders often own a large chunk of younger, smaller, companies while huge companies tend to have institutions as shareholders. We also tend to see lower insider ownership in companies that were previously publicly owned.
Gamida Cell is not a large company by global standards. It has a market capitalization of US$332m, which means it wouldn't have the attention of many institutional investors. Taking a look at our data on the ownership groups (below), it seems that institutional investors have bought into the company. Let's take a closer look to see what the different types of shareholders can tell us about Gamida Cell.
Check out our latest analysis for Gamida Cell
ownership-breakdown
What Does The Institutional Ownership Tell Us About Gamida Cell?
Institutional investors commonly compare their own returns to the returns of a commonly followed index. So they generally do consider buying larger companies that are included in the relevant benchmark index.
As you can see, institutional investors have a fair amount of stake in Gamida Cell. This implies the analysts working for those institutions have looked at the stock and they like it. But just like anyone else, they could be wrong. It is not uncommon to see a big share price drop if two large institutional investors try to sell out of a stock at the same time. So it is worth checking the past earnings trajectory of Gamida Cell, (below). Of course, keep in mind that there are other factors to consider, too.
earnings-and-revenue-growth
It looks like hedge funds own 5.6% of Gamida Cell shares. That catches my attention because hedge funds sometimes try to influence management, or bring about changes that will create near term value for shareholders. The company's largest shareholder is FMR LLC, with ownership of 10.0%. In comparison, the second and third largest shareholders hold about 7.9% and 7.3% of the stock.
We did some more digging and found that 8 of the top shareholders account for roughly 51% of the register, implying that along with larger shareholders, there are a few smaller shareholders, thereby balancing out each others interests somewhat.
While it makes sense to study institutional ownership data for a company, it also makes sense to study analyst sentiments to know which way the wind is blowing. There are a reasonable number of analysts covering the stock, so it might be useful to find out their aggregate view on the future.
Insider Ownership Of Gamida Cell
While the precise definition of an insider can be subjective, almost everyone considers board members to be insiders. Company management run the business, but the CEO will answer to the board, even if he or she is a member of it.
I generally consider insider ownership to be a good thing. However, on some occasions it makes it more difficult for other shareholders to hold the board accountable for decisions.
Our data cannot confirm that board members are holding shares personally. Not all jurisdictions have the same rules around disclosing insider ownership, and it is possible we have missed something, here. So you can click here learn more about the CEO.
General Public Ownership
The general public, with a 22% stake in the company, will not easily be ignored. This size of ownership, while considerable, may not be enough to change company policy if the decision is not in sync with other large shareholders.
Private Company Ownership
We can see that Private Companies own 15%, of the shares on issue. It's hard to draw any conclusions from this fact alone, so its worth looking into who owns those private companies. Sometimes insiders or other related parties have an interest in shares in a public company through a separate private company.
Public Company Ownership
It appears to us that public companies own 10% of Gamida Cell. It's hard to say for sure but this suggests they have entwined business interests. This might be a strategic stake, so it's worth watching this space for changes in ownership.
Gamida Cell Ltd (GMDA) CEO Julian Adams on Q2 2021 Results - Earnings Call Transcript
Aug. 11, 2021 1:17 PM ETGamida Cell Ltd. (GMDA)
Gamida Cell Ltd (GMDA) Q2 2021 Earnings Conference Call August 11, 2021 8:00 AM ET
Company Participants
Joshua Hamermesh - Chief Business Officer
Julian Adams - CEO & Director
Ronit Simantov - Chief Medical Officer
Michele Korfin - Chief Operating & Chief Commercial Officer
Shai Lankry - CFO
Conference Call Participants
Jonathan Miller - Evercore ISI
Edward Tenthoff - Piper Sandler & Co.
Douglas Buchanan - JMP Securities
Yinglu Zhang - RBC Capital Markets
Vernon Bernardino - H.C. Wainwright & Co.
Mark Breidenbach - Oppenheimer
Chad Messer - Needham & Company
Operator
Ladies and gentlemen, thank you for standing by. Welcome to Gamida Cell's Conference Call for Second Quarter 2021 Financial Results. My name is Krystal and I'll be the operator for today's call. Please be advised that this call is being recorded at Gamida sales request.
Now I would now like to introduce your host for today's conference, Mr. Josh Hamermesh, Chief Business Officer. Please go ahead.
Joshua Hamermesh
Thank you, Krystal, 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 2021. Earlier this morning, we issued a press release summarizing our financial results and progress across the company, which is available on our website at www.gamidacell.com.
Here with me on our call today are Julian Adams, Chief Executive Officer; Ronit Simantov Chief Medical Officer; Michele Korfin, Chief Operating Officer and Chief Commercial Officer; and Shai Lankry, Chief Financial Officer. There will also be a Q&A session following our prepared remarks.
During this call, we may make forward-looking statements about our future expectations and plans, including in respect of the timing and initiation and progress of and data reported from the clinical trials of our product candidates, anticipated regulatory filings, including the submission of the BLA for omidubicel to the FDA, commercialization planning efforts, the potentially life-saving or curative therapeutic and commercial potential of omidubicel and our expectations regarding our projected cash to be used for operating activities and cash runway.
Our actual results may differ materially from what we project today due to a number of important factors, including the impact of the COVID-19 pandemic on our operations, the scope progress and expansion of our clinical trials and cost impact thereof, clinical, scientific, regulatory and technical developments and 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 annual report on Form 20-F 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, future events or otherwise.
And now I'd like to turn the call over to Julian.
Julian Adams
Thank you, Josh, and thanks to everyone for joining us this morning. This was a productive quarter for Gamida Cell. We continue to execute on our plan to launch the first allogeneic stem cell therapy, omidubicel for cancer patients in need of a stem cell transplant. In addition, based on promising preliminary studies, we have accelerated our plans to develop a unique NAM enabled natural killer or NK cell GDA-201 for patients with follicular lymphoma and diffuse large B-cell lymphoma. And we are very excited about the expansion of our cell therapy pipeline with 4 new NAM enabled genetically modified NK cell -- cells targeting cancers. Patients are at the forefront of our work, and we are committed to turning our NAM enabled NK product candidates into curative therapies.
I'll start with our most advanced program omidubicel, a potentially life-saving treatment for patients with blood cancers who are in need of a stem cell transplant. This quarter, we announced the results of a Phase III clinical study of omidubicel, which were published in blood, the official Journal of the American Society for Hematology. The published results demonstrate that transplantation with omidubicel needs to fasten neutrophil and platelet recovery compared with the standard of care.
Additionally, the data demonstrates that omidubicel results in fewer bacterial, fungal and viral infections and less time in the hospital. These results add to the compelling body of evidence for the potential of omidubicel as a life-saving therapy that can benefit patients in need of a bone marrow transplant and help reduce the burden on our health care system.
We continue to execute our plan of action to toward becoming a commercial company in 2022, as we prepare for our BLA submission for omidubicel by the end of this year, subject to a pre-BLA meeting with the agency in the fourth quarter. Omidubicel has the potential to be the first FDA approved cell therapy for stem cell transplants. Michele will provide an update on launch readiness later on in the call.
Moving to our NK pipeline. We believe that NK cells hold tremendous potential as a best-in-class next-generation immunotherapy. NK cells antibodies first-line of defense in providing innate immunity. They also have immune privileged properties, which obviate the requirement for HLA matching. Given that any healthy adult donor can provide an apheresis unit, from which we apply our proprietary NAM technology to expand and produce a cryopreserved off-the-shelf allogeneic natural killer cell treatment for cancer patients.
Our NAM enabled NK cells display several important cell surface markers, including high expression of CD16, the Fc-gamma RIII receptor for antibodies, which allows the combination with monoclonal antibodies to target tumors through enhanced antibody-dependent cellular cytotoxicity or ADCC.
Importantly, NAM also increases CD62L were L selected expression, which leads to in vivo homing and retention in lymphoid tissues. Furthermore, NAM increases secretion of inflammatory cytokines for activation of host adaptive immune cells. The combination of these activities results in increased cytotoxicity for more efficient tumor cell killing and durable responses. The combination of NK cells with therapeutic antibodies increased GDA-201's potency of killing an enhanced ADCC, both in vitro and in vivo, supporting clinical treatment with GDA-201 in parallel with selected antibodies for both specific malignancies.
We are advancing the power of NK cells to the next level with our second candidate in clinical development, GDA-201, which has demonstrated remarkable results in preliminary studies as a potential treatment for patients with follicular and diffuse large B-cell lymphomas.
We have completed the GMP batches with our cryopreserved formulation of GDA-201 and are on track to submit an IND in this quarter to support a multicentered Phase I/II study by the end of the year.
Today, we announced that we are expanding the reach of both the NAM technology and the power of NK cells through the growth of our NK pipeline to now include genetically modified variants and proprietary therapies using CRISPR/Cas9 and CAR technologies.
Ronit will give more detail on this exciting new development shortly. And we look forward to providing a more detailed update at an R&D Day later this year. I'm extremely proud of the progress our team has made with this expansion, and I believe that our technology, combined with our expertise in NK biology holds great promise for further -- to further our vision of bringing curative therapies to patients.
I want to conclude my introductory remarks by really thanking our employees for their continued dedication to our mission and hard work.
And with that, I will turn the call over to Ronit.
Ronit Simantov
Thank you, Julian. I'm very excited to provide more detail on our NK pipeline expansion, which we announced this morning. We're confident in the potential to leverage our NAM technology for these newly announced targets based on the encouraging clinical data we've demonstrated with GDA-201 for patients with lymphoma. These new programs will involve genetic modifications intended to direct NK cells against cancer cells, enhancing targeting and persistence and improving cytotoxicity against both hematologic malignancies and solid tumors. This pipeline expansion [indiscernible] research that we've been conducting here at Gamida Cell and in collaboration with key academic researchers and represents important progress in the development of NK therapies for patients.
Our new product candidates include GDA-301, a Knockout of CISH or cytokine inducible SH2 containing protein in NK cells using CRISPR/Cas9 with concomitant insertion of membrane-bound interleukin-15 or IL-15. CISH is a regulator of IL-15 signaling and CISH dilution increases NK sensitivity to IL-15 by lowering the NK activation threshold. NK cells equipped with membrane-bound IL-15 are designed for enhanced persistence and improved antitumor effects.
In preclinical studies, we've demonstrated elevation of pro-inflammatory cytokines and enhanced potency and cytotoxic activity in the cell. We believe that the CISH target coupled with membrane-bound IL-15 has potential across multiple tumor types.
Additionally, today, we announced the development of GDA-401, which is genetically engineered towards an undisclosed target designed to enhance NK cell survival in a solid tumor microenvironment. As with GDA-301, we believe that GDA-401 has potential application across a broad range of solid tumors.
The third development candidate in our NK pipeline is GDA-501, a chimeric antigen receptor or CAR engineered NK cell, designed to target HER2-positive solid tumors. This candidate has the potential to enhance homing to and activity against tumors over expressing HER2, such as breast cancer, ovarian, lung, bladder and gastric cancers. The NK CAR is based on a single chain variable fragment of the widely used humanized monoclonal antibody trastuzumab. GDA-501 CAR was selected out of several constructs that are primarily focused on optimizing the intracellular signaling domain. These were further validated in preclinical studies, showing increase in cytotoxicity and enhanced potency.
The fourth development candidate in our NK pipeline is GDA-601, which is designed to target multiple myeloma. There is strong biological rationale for the augmentation of allogeneic NK cells with a CAR to enhance myeloma targeting. And CD38 is an established immunotherapeutic target in multiple myeloma. However, CD38 expression on NK cells, which is increased during NK expansion represents a barrier to the development of CD38 CAR NK cell therapy. To overcome anticipated targeting our refractory side of NK cells by anti CD38, we applied CRISPR/Cas9 genome editing to disrupt CD38 protein expression in NK. We combine this with ACD 38 targeting CAR designed to enhance killing of CD38 positive myeloma cells, and we have demonstrated this in preclinical studies.
We believe that NK cells are a very promising new approach to the treatment of cancers, and we are proud to be at the forefront of the research to advance this powerful technology.
I'll now turn the call over to Michele Korfin, our Chief Operating Officer and Chief Commercial Officer, who will talk more about our launch readiness for omidubicel. Michel?
Michele Korfin
Thank you, Ronit, and good morning, everyone. Today, I will review our progress on our commercial manufacturing and launch readiness activities. As we continue to advance our breakthrough therapy, omidubicel for patients in need of an allogeneic stem cell transplant. As Julian mentioned, we are working towards BLA submission for omidubicel in the fourth quarter of this year, and our launch planning and manufacturing activities are underway to support a potential U.S. launch in 2022.
This quarter, we continued to make important progress preparing both our facilities for commercial manufacturing readiness. CMC qualification activities progressed at both the Gamida Cell owned manufacturing facility in Israel and at Lonza. We have made significant advancements in analytical method validation, analytical comparability and clinical manufacturing. We are on track to finalize the CMC qualification requirements for the BLA submission.
In addition, we are very excited about hiring Vladimir and Melnikov as our Senior Vice President, Global Manufacturing and Operations. Vladimir's broad and deep experience provide key expertise as we advance our commercial manufacturing readiness. We believe that there is a significant opportunity with omidubicel. In the U.S. alone, there are over 40,000 patients per year with hematologic malignancies who consider a bone marrow transplant. Unfortunately, only approximately 10,000 patients are able to make it to transplant for a variety of reasons. We have done extensive research and collaboration with the Center for International Blood and Marrow Transplant Research or CIBMTR and independent market research firms to fully assess the unmet need. This market research has enabled us to develop a well-informed launch strategy to reach these patients in transplanters.
Based on our commercial insights, the opportunity for omidubicel can be summarized in 2 key categories. First is increasing access for patients, especially those who are eligible for transplant and cannot find a match. And also improving outcomes-based on the unmet clinical needs with current donor sources that can be addressed by omidubicel. One specific area of advantage for omidubicel is that it has less stringent matching criteria for patients as compared to graft sources from match related or unrelated donors. This is particularly important for patients of non-Caucasian descent who tend to have a more challenging time finding a suitable match donor.
In fact, in the omidubicel Phase III trial, over 40% of the patients enrolled were non-Caucasian, illustrating the important need for a suitable graft source in this patient population. If approved, we believe omidubicel will provide a timely and attractive option for a suitable graft source to patients in need of a bone marrow transplant who would otherwise undergo a search for a matched donor that could take several months, causing high levels of anxiety and also uncertainty for patients who are at great risk or high-risk for relapse.
Upon FDA approval, we believe omidubicel will be an important therapy option for patients in the U.S. in need of an allogeneic stem cell transplant and we are focused on developing a strong launch strategy. Specifically, we have hired a very experienced commercial leadership team in the U.S. and continue to augment the capabilities of our team.
Additionally, we continue to have active dialogue with physicians and payers and feedback on the value proposition of omidubicel has been highly encouraging. Specifically, payers are encouraged by the potential for faster time to neutrophil engraftment, decreased infections, decrease in hospitalizations and less graft-versus-host disease as compared to published literature for other graft sources.
In preparation for the potential approval of omidubicel in the U.S., the development of Gamida Cell assist continues to progress, which will be an important source of support to patients, caregivers and transplant teams throughout each patient's journey with omidubicel. This is a program like no other for patients undergoing a transplant.
We have hired the Gamida Cell Assist leadership team that will be focused on supporting the patients journey with omidubicel. The Gamida cell Assist team will include an experienced case management team that will be focused on ensuring patient access and providing support to patients, their caregivers and the transplant team at the hospital throughout each step of the process.
Gamida Cell Assist will have a number of key roles. One of the most important roles is compliance with the FDA's chain of identity requirements. Gamida Cell Assist will start our chain of identity, which is a unique patient identifier that will follow the patient through the entire process. In addition, we will be able to provide the hospitals and patients with assistance to support access to omidubicel, such as benefit verifications or travel and logic needs. Gamida Cell is committed to supporting a positive journey for patients in their transplant centers so they could focus on what matters most, the patient experience and successful clinical outcomes.
In summary, we are excited by the potential of omidubicel to be the first FDA-approved cell therapy for bone marrow transplant, and we are encouraged by the clinical data and feedback from physicians, payers and patients. We are progressing our launch preparations and remain on track for product launch in 2022, with a focus on assuring a positive patient and transplant center experience.
I will now call -- turn the call over to Shai to review our financial results. Shai?
Shai Lankry
Thank you, Michele, and good morning, everyone. Today, I will summarize our financial results for the second quarter of 2021. As of June 30, 2021, our total cash position will $150.2 million compared to $127.2 million as of December 31st of last year. Research and development expenses for the quarter were $13.5 million compared to $9.3 million for the same period in 2020. The increase was mainly due to omidubicel commercial manufacturing readiness activities as well as the advancements of GDA-201 and our emerging NK pipeline, including broadening our scientific capabilities and talent.
Commercial expenses in the quarter were $5.2 million compared to $1 million for the same period last year. The increase was mainly attributed to progress with omidubicel commercial readiness activities, which includes, among other things the hiring of an experienced commercial leadership team.
Share and administrative expenses were $3.8 million for the second quarter of 2021 compared to $2.5 million for the same period in 2020. The increase was mainly due to higher in key management position to support the business growth.
Finance income net was $1.2 million for the quarter compared to finance expense net of $2.2 million in the same period last year. The increase was primarily due to noncash income resulting from revaluation of warrants, offset by interest expenses from the $75 million convertible note financing we did earlier this year.
Net loss for the quarter was $21.3 million compared to a net loss of $15.1 million for the same period last year. We continue to expect cash use for ongoing operating activities this year to range from $110 million to $120 million. We anticipate that our current total cash position will support our ongoing operating activities into the second half of 2022. This cash runway guidance based on our current operational plan and exclude any additional funding that may be received, or business development activities that may be undertaken.
With that, I will turn the call back over to Julian.
Julian Adams
Thanks, Shai. Our vision has always been define curious for patients, hematologic malignancies and blood disorders. And we are excited that the many opportunities ahead. Our accomplishments in 2021 will build extraordinary momentum and create a foundation for success in 2022. With omidubicel, we expect to submit the BLA in the fourth quarter of this year, and we are committed to being launched ready at the time of approval. The GDA-201 on its heels with compelling data, we are planning to initiate a Gamida Cell sponsored clinical study in lymphoma before the end of the year. We plan to share data on the mechanism of action of our NAM platform, translational data and more mature clinical data at major medical meetings and in peer-reviewed publications this year.
Lastly, we're excited about our NK pipeline expansion announced today and look forward to updating you as we have more progress to report later this year.
Now we will open the call for your questions. Krystal, operator.
Question-and-Answer Session
Operator
[Operator Instructions]. Your first question comes from the line of Ted Tenthoff from Piper Sandler.
Julian Adams
Krystal, let's maybe just go to the next caller. We'll give Ted another Chance.
Operator
Your next question comes from the line of Jonathan Miller from Evercore ISI.
Jonathan Miller
Congrats on all the new programs that you just announced. Couple of things across the pipeline. Can you talk to us about spending ramp for OMI commercial launch? How big a team you anticipate needing? And what the time line of that ramp is going to be as we anticipate both the BLA and the subsequent approval? Secondly, on OMI, you've mentioned this enormous potential market question in the states, but what volume do you anticipate current manufacturing being able to fill maybe come from the other side, the supply side of that curve. Then talking about the pipeline, maybe a little bit I'm curious about the timing of clinical initiation of these pipeline programs. Are any of these anticipated to have an IND before the contemplated current cash runway is up? And what is the time line for getting more clarity on the specifics of those programs, especially the target of the 401 asset?
Julian Adams
Michele, let me ask you to respond to the commercial expansion and the capacity question.
Michele Korfin
Absolutely. So in regards to your question about omidubicel field team and timing. So when you look at the benchmarks in the cell therapy space, specifically, if you look at the core T companies that are also focused on the transplant centers in the U.S., their range for personnel is approximately 25 to 30 commercial account managers and approximately 10 to 15 medical science liaisons that would fall under Ronit's team. We do know that in the U.S., 70 transplant centers make up approximately 80% or account for 80% of the transplant. So we actually do feel we could be on the lower end of those ranges and have a very thorough, but efficient footprint in the field. So we're looking on the lower end of those ranges that I've mentioned. So the commercial cap managers closer to the 25 and the medical science liaisons closer to the 10, the lower end of that range.
In terms of ramp-up, so on the commercial side, we have hired Linda Stamler, who was our Vice President for both marketing and account management. So we have the leader of both the marketing and account management team in place already, and Linda is now in the process of mapping up the timing -- hiring the account manager side. And Ronit and her team have made excellent progress in bringing in strong leaders on the medical affairs side also. So the leadership team and also some of the field hiring is already in place. So that's the question on the commercial footprint. In regards to manufacturing, the team at our commercial manufacturing facility in Israel, has really made outstanding progress, not only with getting ready for the qualification requirements for BLA, but also getting ready for commercialization. When the facility was designed in Israel, was designed as a modular facility.
So as we're seeing this encouraging data come in for our forecast going forward upon potential FDA approval, we have the ability to add additional modules at our facility in Israel in Kiryat Gat. So we feel very confident that we not only already have the facility in place for launch readiness for commercial needs, but also, we know what the long-term looks like for adding additional cores or additional modules.
So let me stop there, John, and see if you have any questions on what I just said, and then I could turn to Ronit for the NK question.
Jonathan Miller
No, that was a fabulous response. I guess while we're talking about -- what we're talking to you about the commercial launches and what the opportunities are. Do you have any updated color on the EU market? How the opportunity is different there? And any update on BD for ex U.S.?
Michele Korfin
Yes. So let me talk about the EU market, and I also mentioned other markets. So we have undertaken commercial assessments in both Europe and other parts of the world, including Asia. We're encouraged by the opportunities. There's certainly the great need for other potential graft sources, other cell therapies for allogeneic stem cell transplant patients in Europe and also in certain areas throughout the world, including Asia. So we're certainly very focused on launching omidubicel in the U.S., we feel very confident in our strategy and our execution plans to do it, and we're currently assessing what a potential path to launch could be in Europe and in Asia. The clinical study was designed as a head-to-head comparator. So we do recognize the applicability of that study in certain parts of the world, specifically in Europe.
Jonathan Miller
I'm just saying with regard to the further pipeline in our NK 301, 401. Ronit, do you want to comment on timing? And I'll just cover the general cash position as well.
Ronit Simantov
Yes, absolutely. So we are in the midst of preclinical studies for each of the programs that I've outlined, including in vitro and in vivo studies. And as we build the evidence and prepare the information, we will advance those through IND. We're not providing specific detail about the IND timing right now. But what I can say is that we will have an opportunity later this year in an R&D Day to give more color and detail about all of the aspects of that program. So we look forward to sharing more detail later.
Jonathan Miller
It's clear that we've been able to repurpose a lot of our knowledge, including cryopreservation and cell expansion. But couple that with the technologies for CRISPR/Cas9 and CAR technologies to be able to enhance our pipeline so quickly. Obviously, we will need to raise additional capital to prosecute all these programs. But currently, I see this as an embarrassment of ridges in our pipeline.
Julian Adams
So I certainly look forward to seeing what you have to share with us in the R&D Day.
Operator
Your next question comes from the line of Ted Tenthoff from Piper Sandler.
Edward Tenthoff
Congrats on all the progress. I'm just wondering, listening to your prepared remarks and also some of the question answer. I'm wondering if you're at all contemplating NK cells are my favor too, but are you contemplating evaluating other cell types that could be processed from umbilical court? And from donors?
Julian Adams
Yes. Ted, thank you for your question. In fact, the NAM technology has broad applicability, we've been able to expand dendritic cells, we've been able to expand gamma delta T-cells, this is really just a question of bandwidth in prioritization and we've had some very, very good luck with the NK cell program. And obviously, a lot of attention in the field is being paid to the NK field. That said, it doesn't preclude us from expanding other cell types with therapeutic potential.
Edward Tenthoff
Great. That's really exciting. Looking forward to the BLA and also 201 getting into the clinic?
Julian Adams
Thanks, Ted.
Operator
Your next question comes from the line of Jason Butler from JMP Securities.
Douglas Buchanan
Thanks for taking the questions and congrats on the progress. First one, just wondering if you could give us an update on the expanded access program for omidubicel. And will we see any data from the EAP before the pre-BLA meeting or the BLA submission this year? And then second question on the NK programs. You mentioned Julian leveraging your experience with the cryopreservation of 201. Can you just maybe speak to your plans for manufacturing for the new programs? Will they be cryopreserved products from the start in the clinical development? Or how will you integrate those into your manufacturing facilities?
Julian Adams
So let me turn the first question to Ronit to talk about the EAP, and then I'll answer your NK question.
Ronit Simantov
Absolutely. So our expanded access program is currently running, and we're using it in -- as a method for serving as our clinical bridging cohorts for both the Lonza, Netherlands and Kiryat Gat facilities for our commercial manufacturing programs, and we've been able to do that as the expanded access study has been open and enrolled patients in order to do that. We have some results from those from that study. And we will be happy to share those in collaboration with our academic collaborators. When we all feel that those data mature and ready for publication or presentation. So we are also very excited about other data that we will be sharing further data on our Phase III study and other potential data that have been submitted and hope to make those available by the end of the year in medical meetings as well.
Douglas Buchanan
Okay.
Julian Adams
And Jason, let me respond about the NK program. We intend to only use cryopreserved off-the-shelf products going forward. So our pipeline is so designed that we can both manufacture the cells from apheresis units and then genetically manipulate them and cryopreserve them, and that will be our playbook going forward.
Operator
Your next question comes from the line of Gregory Renza from RBC Capital Markets.
Yinglu Zhang
This is Yinglu on for Greg. First, maybe a follow-up on the EAP. I was wondering how should we think about the time line for manufacturing and data collection for clinical comparability for the site in Israel? And how does that align with your expectation for a pre-BLA meeting and submission in the fourth quarter? And then another one on the NK program now that you have multiple in the pipeline. How do you think about selection and execution across the 5 programs?
Julian Adams
So Ronit, would you comment again on the EAP?
Ronit Simantov
Absolutely. So we have 6 sites for the EAP open in the U.S. with investigators who have worked with us before and are incredibly enthusiastic about enrolling patients. And so as we advance our manufacturing, we have been able to slot in patients for the program and treat them. And we will continue to do that as we advance forward towards submitting the BLA using the facility in Kiryat Gat to treat patients in the coming months.
Julian Adams
And with regards to the NK, the selection process will be all data-driven. We have created a number of very, very interesting targets. We're looking at cell lines, but will eventually augment these to mouse models using PDX models as well as other sophisticated models to make the best selections of product -- for product development. And this will also be informed by our commercial colleagues, who will go careful market assessments and unmet need assessments for the various programs that we are developing.
Yinglu Zhang
Great. Thank you. And congrats on the progress.
Operator
Your next question comes from the line of Vernon Bernardino from H. C. Wainwright.
Vernon Bernardino
Very excited for your progress with the omidubicel and look forward to its filing later this year and further progress on the new programs. I was wondering if you could provide some insight regarding the market research you conducted. Specifically, I was wondering if the market research included a component regarding what effect the pandemic has had on transplantation procedures, particularly the ability to conduct these procedures during surges of COVID cases. But also whether the market researches has prompted any changes in your strategy and targeting that the groups that you identified as a various opportunities?
Julian Adams
Michele, let me invite you to answer on the market research activities.
Michele Korfin
So we conducted a number of different types of market research. And what we're very encouraged by is that the consistency of the research. So this latest round of market research that we conducted. It was over 100 transplanters in the U.S., and it was with the actual clinical data from the Phase III study. Prior research before the study had been completed or all the data set was in was with what we would refer to as a targeted product profile. Now we were getting physician transplant or feedback on the actual clinical data. They were very encouraged by a number of factors, the primary endpoint, the secondary endpoints and the exploratory endpoints.
Payers also that we spoke to, we're encouraged by the clinical data and also recognize the importance of reduction in health care resource utilization, specifically around reduction in time and hospital reduction for interventions due to less infections. So the takeaway from the research continues to be very encouraging. So it has not changed our strategy. What it has done is actually help to better inform our strategy and give us more encouragement and confidence in the opportunity.
Now, Vernon, you -- the question around COVID has been very, very challenging for patients. And we certainly hope that we see this pandemic begin to get to a more stable place for patients. What we can say that comes out in the research is it was very difficult to align donors with patients during the pandemic. Unrelated donors was very difficult because you had to align the donor with the patient. And we know even in traditional times, that could take 2 to 3 months and we were being told during COVID is sometimes it was just not possible to align that the donor with the patient. One of the benefits of omidubicel with our starting material being cord blood that is bank, that the cord blood banks. During our Phase III study, we were still able to access that the cord blood that was required for manufacturing have our proprietary NAM technology expand the cells appropriately and return them to the center. So that was something that came out during the market research as a benefit from omidubicel given that we don’t have to bring a donor into hospital setting as you see with other graft sources.
Vernon Bernardino
That's perfect.
Michele Korfin
So Vernon, let me stop there and see if you have any questions.
Vernon Bernardino
No, that's perfect. That's exactly the insight I was looking for.
Operator
Your next question comes from the line of Mark Breidenbach from Oppenheimer.
Mark Breidenbach
Just a few for me, all kind of the geared towards the NK programs. First, now that the Phase I/II protocol for GDA-201 has been finalized. Can you give us a little color on the study side and the specifics doses that will be tested in Phase I. How many sites you plan to activate that sort of thing. And then I was hoping Ronit could describe the interest signaling domains of the HER2 and CD38 CAR constructs that are being used in some of the new products? Are they both the same? And maybe you can point to any key differences between these and competing CAR NK constructs? And finally, with respect to the use of membrane-bound IL-15, I'm just wondering if you see any IT barriers to this type of -- to putting this type of construct in GDA-301, given that other NK developers are also pursuing similar approaches.
Julian Adams
So Ronit, would you comment on the GDA-201 Phase I/II?
Ronit Simantov
Sure. So in terms of the GDA-201 Phase I/II, we'll be conducting it as a Phase I first at a limited number of sites in the United States, appropriate to a Phase I. We are using doses based on our experience using the product that we tested with the University of Minnesota. So we have experience there in terms of the number of cells, and we'll be using similar dosing based on that experience. After we complete the Phase I, which will be used to evaluate safety as Phase Is are. We'll be transferring the study over to a larger number of sites. To conduct the Phase II. And we've not announced yet the number of patients that will be tested in the Phase II nor the number of sites, but I can share that the operational activities are underway. There's enthusiasm and excitement by potential investigators and all the executional activities in terms of getting the sites and the investigators lined up for the study are happening right now in preparation for initiating the study later this year.
Julian Adams
And once we file the IND and are cleared to open the study, we'll provide more details on the study design, number of patients and some of your other follow-up questions.
Ronit Simantov
Absolutely.
Julian Adams
With regard to the pipeline, we're staying silent on the details of the intracellular signaling today. But at an R&D Day later this year, we planned to go into a lot more detail and rest assured that we've filed all the appropriate intellectual property submissions. And I'm quite confident that we'll have present to operate with the -- the designated genetic manipulations that are underway, both for the CAR and for the Knockout pathways. Mark, are you there?
Mark Breidenbach
Yes. So here, and I assume that, that covers the member-bound IL-15 as well?
Julian Adams
Yes.
Mark Breidenbach
All right. Thank you.
Julian Adams
We've looked at a number of different constructs and really are doing head-to-head comparisons and really just picking the best of the best in the lab.
Operator
[Operator Instructions]. Your next question comes from the line of Chad Messer from Needham & Company.
Chad Messer
Between NDAs and INDs and pipeline expansions, it sounds like you guys certainly are busy over there. We've covered a lot of ground, but maybe just on the pipeline. I was wondering if I could get your thoughts on the HER2 target? You've got a lot of really cutting age technologies or thrown at NAM, which is exciting to see. This is an extremely well-balanced target may be one of the most in oncology with antibodies and small molecules and then in development, any number of other ways are going at it. Just wondering what particular advantages you think you bring in HER targeting specifically in solid tumor target too by the way very exciting to see that. And where you might think the unmet need is, where you think you would develop this? I mean, presumably in some noncellular failures to targeted therapies. But if there's a particular place you see the need?
Julian Adams
It's an excellent question. Obviously, we think that the HER2 CAR has the potential to be as effective, if not much more effective than combining it with Herceptin, the monoclonal antibody. And that's part of our engineering strategy is to make the CARs effective to be able to be used in solid tumors. As you know, solid tumors have a very immunosuppressive microenvironment. And so there are a lot of barriers. And so far, really no one has reported data in solid tumors with any great efficacy, but it's still early days. And what was mentioned in the prepared remarks is that there are a number of HER2-positive cancers. But in particular, I think a lot about gastric cancer and some of the lesser-known cancers that are not as well served by Herceptin or Perjeta. So we're thinking a lot about the various tumor models that we will develop and the clinical program could be a basket trial allowing that offer to patients that are refractory, obviously, to enter the trial.
Operator
There are no further question at this time. Mr. Julian, please continue.
Julian Adams
Well, it just remains for me to thank everyone for joining us on today's call. And we look forward to updating you in the future. Bye for now.
Operator
Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
Gamida Cell Ltd. 2021 Q2 - Results - Earnings Call Presentation
August 2021
Aug. 11, 2021 12:00 PM ETGamida Cell Ltd. (GMDA)
The following slide deck was published by Gamida Cell Ltd. in conjunction with their 2021 Q2 earnings call.
https://static.seekingalpha.com/uploads/sa_presentations/535/73535/original.pdf
Gamida Cell Reports Second Quarter 2021 Financial Results and Provides Company Update
https://finance.yahoo.com/news/gamida-cell-reports-second-quarter-110000781.html
BLA submission for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant, expected in fourth quarter of 2021
Commercial readiness activities underway to support potential launch in 2022
Phase 1/2 clinical trial of GDA-201 in patients with follicular and diffuse large B-cell lymphomas expected to start by the end of the year
Four new development programs announced leveraging next-generation, NAM-enabled, genetically-modified NK cells in solid tumor and hematological cancers
Company to host conference call at 8:00 a.m. ET today
BOSTON, August 11, 2021--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, today reported financial results for the quarter ended June 30, 2021. Net loss for the second quarter of 2021 was $21.3 million, compared to a net loss of $15.1 million for the same period in 2020. As of June 30, 2021, Gamida Cell had total cash and cash equivalents of $150.2 million.
During the quarter, the company continued to execute on plans to submit a Biologic License Application (BLA) for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant. This submission is expected to occur by the end of the year, subject to a pre-BLA meeting with the U.S. Food and Drug Administration (FDA) planned for the fourth quarter. In addition, Gamida prepared to begin a Phase 1/2 trial of GDA-201 in non-Hodgkin lymphoma (NHL), expected to occur by the end of 2021. Also, the company expanded its NAM-enabled natural killer (NK) cell pipeline targeting solid-tumor and hematological cancers, including genetically modified variants of proprietary NK therapies using both CRISPR/Cas9 and CAR methodologies.
"Our progress this quarter represents a major step forward for Gamida Cell and our mission to bring cancer patients potentially curative cell therapies," said Julian Adams, Ph.D., chief executive officer of Gamida Cell. "We are delivering against key process development, quality and manufacturing milestones in preparation for a BLA submission for omidubicel while also advancing our go-to-market strategy for our planned commercial launch. In parallel, we bolstered our NAM-enabled NK pipeline both by readying to advance GDA-201 into the clinic based on its encouraging clinical data in patients with hematological cancers and by expanding our NK cell pipeline to address solid and liquid tumors."
Q2 and Recent Developments
Omidubicel: Advanced Cell Therapy
Continued advancement toward planned BLA submission for omidubicel to the FDA in the fourth quarter of this year. The company’s activities included CMC qualification requirements at both the Gamida–owned facility in Israel and at Lonza, a contract manufacturing organization that will be supplying commercial material upon FDA approval. Advancements were made in analytical methods validation, analytical comparability and clinical manufacturing for Expanded Access Program patients, which are also planned to be used for clinical comparability.
Advanced launch planning activities by expanding Gamida’s commercial, operational and medical affairs teams. Conducted further market research and health economic and outcomes research (HEOR) to support planned market entry and market access activities. Readied Gamida Cell Assist, supply chain and logistics programs to facilitate positive patient and transplant center experiences at time of launch.
Announced that results of the international, multi-center, randomized Phase 3 clinical study of omidubicel were published in Blood, the official journal of the American Society of Hematology. This pivotal trial compared the safety and efficacy of omidubicel to standard umbilical cord blood transplant in patients with high-risk hematologic malignancies undergoing a bone marrow transplant. The results demonstrate that transplantation with omidubicel leads to faster neutrophil and platelet recovery, and results in fewer bacterial, viral and fungal infections and less time in the hospital, compared to a standard umbilical cord blood graft.
GDA-201: NAM-Enabled NK Immunotherapy
Prepared for filing of an Investigational New Drug (IND) application with the FDA.
Finalized clinical study protocol and statistical plan for a planned Phase 1/2 clinical trial of allogeneic, cryopreserved GDA-201 in patients with follicular and diffuse large B-cell lymphoma.
Conducted study start-up activities, including contract research organization (CRO) and clinical site selections.
NAM-Enabled NK Cell Pipeline Expansion
Advanced four new development programs that involve modifications intended to direct NK cells against specific tumor markers to improve their cancer killing capabilities against both hematological and solid tumors. Newly designated product candidates include:
GDA-301: Knockout of CISH (cytokine inducible SH2 containing protein) in NK cells using CRISPR/Cas9 in combination with a membrane-bound IL-15/IL-15Ra. Designed to improve tumor killing by promoting activation and inhibiting negative feedback signals. Potential applications exist across a range of solid tumors and lymphoma.
GDA-401: Undisclosed target genetically engineered to enhance NK cell survival in the solid tumor microenvironment for potential application across a broad range of solid tumors.
GDA-501: CAR-engineered NK cells to target HER2+ solid tumors with the potential to enhance homing and activation against cancers with HER2 overexpression, including breast, ovarian, lung, bladder, gastric and others.
GDA-601: Knockout of CD38 on NK cells to avoid fratricide by CD38 targeted antibodies in combination treatment of multiple myeloma, combined with a CD38 CAR designed to enhance killing of cancerous cells.
Advanced additional NAM-enabled research programs targeting immunosuppressive pathways using both CRISPR/Cas9 and CAR, with potential to treat solid tumor and blood cancers.
Corporate
Hired Vladimir Melnikov as Senior Vice President, Global Operations and Manufacturing. Vladimir has over 25 years of experience in the biopharmaceutical industry. He previously served as general manager at Omrix Biopharmaceuticals and biologic technical operations lead at Ethicon Biosurgery, both part of a Johnson & Johnson Company. In those roles he supervised three Israeli biotech manufacturing sites and technology transfer to external partners. Vladimir will have responsibility for the company’s Israeli manufacturing site and manufacturing partnership with Lonza.
Hired Josh Patterson as General Counsel, effective August 30, 2021. Josh has over 20 years of experience as in-house legal counsel for biopharmaceutical companies. Josh will be joining Gamida Cell from Akcea Therapeutics, a wholly owned subsidiary of Ionis Pharmaceuticals, where he is currently General Counsel. Josh will be responsible for building, leading and managing the legal function for Gamida Cell.
Second Quarter 2021 Financial Results
Research and development expenses in the second quarter of 2021 were $13.5 million, compared to $9.3 million for the same period in 2020. The increase was mainly due to omidubicel commercial manufacturing readiness activities, and the advancement of the GDA-201 program, including broadening scientific capabilities and talent.
Commercial expenses in the second quarter of 2021 were $5.2 million, compared to $1.0 million for the second quarter of 2020. The increase was mainly attributed to progress with omidubicel commercial readiness activities.
General and administrative expenses were $3.8 million for the second quarter of 2021, compared to $2.5 million for the same period in 2020. The increase was mainly due to the hiring of key management positions to support business growth.
Finance income, net, was $1.2 million for the second quarter of 2021, compared to $2.2 million for the second quarter of 2020. The increase was primarily due to non-cash income, resulting from revaluation of warrants offset by interest expenses that resulted from the $75 million convertible note financing in February 2021.
Net loss for the second quarter of 2021 was $21.3 million, compared to a net loss of $15.1 million for the same period in 2020.
2021 Financial Guidance
Gamida Cell reiterates its prior financial guidance and expects cash used for ongoing operating activities in 2021 to range from $110 million to $120 million. The company believes that its current cash and cash equivalents will support the ongoing operating activities into the second half of 2022. 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.
Expected 2021 Developments and Milestones
Gamida Cell plans to achieve the following key milestones during the second half of 2021:
Omidubicel
Pre-BLA meeting with FDA in the fourth quarter of 2021
BLA submission to the FDA in the fourth quarter of 2021
Commercial readiness activities ongoing for potential launch following approval
GDA-201
IND submission to FDA in third quarter 2021
Initiation of a company-sponsored Phase 1/2 clinical study in NHL before year-end 2021
NK cell pipeline expansion
Advance pipeline of NAM-enabled, genetically-modified NK cells in solid tumor and blood cancers
Conference Call Information
Gamida Cell will host a conference call today, August 11, 2021, at 8:00 a.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 5258448. A recording of the webcast will be available approximately two hours after the event, for approximately 30 days.
Gamida Cell Announces the Date of Its Second Quarter 2021 Financial Results and Webcast
Wed, August 4, 2021, 3:00 PM
https://finance.yahoo.com/news/gamida-cell-announces-date-second-120000733.html
BOSTON, August 04, 2021--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced that the company will host a conference call and live audio webcast on Wednesday, August 11, 2021, at 8:00 a.m. ET to review its second quarter 2021 financial results and provide an update on the company.
Management will discuss the company’s progress during the quarter, including advances in the development of omidubicel, which has the potential to be the first approved cell therapy for blood cancer patients in need of an allogeneic bone marrow transplant, following the planned BLA submission in the fourth quarter of 2021. Gamida Cell will also provide an update on its pipeline of NAM-enabled natural killer (NK) cell therapies, including GDA-201 and genetically-modified NK cell constructs. The Company is planning an IND submission to support the initiation of a Phase 1/2 clinical study of cryopreserved, off-the-shelf GDA-201 in patients with follicular and diffuse large b-cell lymphomas.
The webcast will be available on the "Investors & Media" section of the Gamida Cell website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 9949715. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.
Form 6-K Gamida Cell Ltd.
Gamida Cell Ltd.
On August 2, 2021, Nurit Benjamini submitted her resignation from the Board of Directors of Gamida Cell Ltd. (the “Company”), which resignation will be effective August 18, 2021. Ms. Benjamini’s resignation was not the result of any disagreement with the Company. Effective upon Ms. Benjamini’s resignation on August 18, 2021, Stephen Wills, CFO of Palatin Technologies, Inc, will chair the Audit Committee and Ofer Gonen, CEO of Clal Biotechnology Industries, will join the Audit Committee.
Gamida Cell to Present at the BTIG Virtual Biotechnology Conference
https://finance.yahoo.com/news/gamida-cell-present-btig-virtual-120000826.html
Tue, August 3, 2021, 3:00 PM
BOSTON, August 03, 2021--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced that the company will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on Tuesday, August 10, 2021 at 3:00 p.m. ET.
The live webcast will be available on BTIG’s conference website at the time of the event, after which it will be available through BTIG’s research access.
In the fourth quarter of 2021, Gamida Cell is targeting a BLA submission for omidubicel, the first potential approval of a cell therapy for blood cancer patients in need of an allogeneic bone marrow transplant. In the second half of 2021, the Company is planning an IND submission to support the initiation of a Phase 1/2 clinical study of cryopreserved, off-the-shelf GDA-201 in patients with follicular and diffuse large b-cell lymphomas.
Hi Itstime,
I know of at least 3 companies whom
the FDA was supposed to come visit
their premises for inspection as
PDUFA.
The 3 companies are: SLGL, PLX and
MDWD.
Due to Covid restrictions no inspection
took place in all 3, no further date given.
In my opinion GMDA will face a similar
situation and suffer the same decrease
in sp as all 3, although GMDA has not yet
submitted BLA.
Hi Midas,
What are your thoughts on why sp is slipping?
Gamida Cell Ltd.
On June 25, 2021, Gamida Cell Ltd. (the “Company”) announced that Dr. Tracey Lodie, the Company’s Chief Scientific Officer, has tendered her resignation, effective on July 9, 2021, to pursue another opportunity at a private cell therapy company outside the area of oncology. Dr. Lodie will remain engaged with Gamida Cell by serving as a scientific advisor and consultant to the Company to see both omidubicel and GDA-201 through key regulatory and development milestones.
Gamida Cell Announces Publication in Blood, the Journal of the American Society of Hematology, of the First Pivotal Trial to ...
June 23 2021 - 07:00AM
Omidubicel is a first-in-class, NAM-enabled, advanced cell therapy being evaluated as a potential life-saving treatment for patients with blood cancers in need of an allogeneic hematopoietic stem cell (bone marrow) transplant
The Phase 3 clinical trial achieved both primary and secondary endpoints
Gamida Cell remains on track to submit a Biologics License Application for omidubicel in the fourth quarter of this year
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced that the results of a Phase 3 clinical study of omidubicel have been published in Blood, the official journal of the American Society of Hematology. Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell transplant solution for patients with hematologic malignancies.
The results demonstrate that transplantation with omidubicel leads to faster neutrophil and platelet recovery compared to a standard umbilical cord blood graft, and results in fewer early bacterial and viral infections and less time in the hospital.
“We are pleased that the data from this well-conducted international Phase 3 trial have been published in Blood, the highly respected, peer-reviewed journal of the American Society of Hematology,” said Ronit Simantov, M.D., chief medical officer of Gamida Cell. “The robust results of this clinical trial have demonstrated that omidubicel could provide an important new option for patients with hematologic malignancies in need of a bone marrow transplant.”
Data from this study were previously presented at the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy and Center for International Blood & Marrow Transplant Research, and most recently during the Presidential Symposium at the 47th Annual Meeting of the European Society for Blood and Marrow Transplantation. The pivotal study was an international, multi-center, randomized Phase 3 trial designed to compare the safety and efficacy of omidubicel to standard umbilical cord blood transplant in patients with high-risk hematologic malignancies undergoing a bone marrow transplant.
“Previous studies have shown that engraftment with omidubicel is durable, with some patients in the Phase 1/2 study now a decade past their transplant. The Phase 3 data reinforce omidubicel’s potential to be a new standard of care for patients who are in need of stem cell transplantation but do not have access to an appropriate matched donor,” said Mitchell Horwitz, M.D., lead author of the paper and a professor of medicine at the Duke Cancer Institute.
The full Blood manuscript is available here: https://ashpublications.org/blood/article/doi/10.1182/blood.2021011719/476235/Omidubicel-Versus-Standard-Myeloablative-Umbilical.
Details of Phase 3 Efficacy and Safety Results Shared in Blood
The intent-to-treat analysis included 125 patients aged 13–65 years with a median age of 41. Forty-four percent of the patients treated on study were non-Caucasian, a population known to be underrepresented in adult bone marrow donor registries. Patient demographics and baseline characteristics were well-balanced across the two study groups. Patients with acute lymphoblastic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, myelodysplastic syndrome or lymphoma were enrolled at more than 30 clinical centers in the United States, Europe, Asia, and Latin America.
Gamida Cell previously reported in May 2020 that the study achieved its primary endpoint, showing that omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment, a measure of how quickly the stem cells a patient receives in a transplant are established and begin to make healthy new cells and a key milestone in a patient’s recovery from a bone marrow transplant. The median time to neutrophil engraftment was 12 days for patients randomized to omidubicel compared to 22 days for the comparator group (p<0.001).
All three secondary endpoints, details of which were first reported in December 2020, demonstrated a statistically significant improvement among patients who were randomized to omidubicel compared to patients randomized to standard cord blood graft. Platelet engraftment was significantly accelerated with omidubicel, with 55 percent of patients randomized to omidubicel achieving platelet engraftment at day 42, compared to 35 percent for the comparator (p = 0.028). Hospitalization in the first 100 days after transplant was also reduced in patients randomized to omidubicel, with a median number of days alive and out of hospital for patients randomized to omidubicel of 61 days, compared to 48 days for the comparator (p=0.005). The rate of infection was significantly reduced for patients randomized to omidubicel, with the cumulative incidence of first grade 2 or grade 3 bacterial or invasive fungal infection for patients randomized to omidubicel of 37 percent, compared to 57 percent for the comparator (p=0.027). Additional data reported in the manuscript included a comparison of infection density, or the number of infections during the first year following transplantation, which showed that the risk for grade 2 and grade 3 infections was significantly lower among recipients of omidubicel compared to control (risk ratio 0.5, p<0.001).
Data from the study relating to exploratory endpoints also support the clinical benefit demonstrated by the study’s primary and secondary endpoints. There was no statistically significant difference between the two patient groups in incidence of grade 3/4 acute GvHD (14 percent for omidubicel, 21 percent for the comparator) or all grades chronic GvHD at one year (35 percent for omidubicel, 29 percent for the comparator). Non-relapse mortality was shown to be 11 percent for patients randomized to omidubicel and 24 percent for patients randomized to the comparator (p=0.09).
These clinical data results form the basis of a Biologics License Application (BLA) that Gamida Cell plans to submit to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2021.
Man, this thing looked so promising, but has become a complete dog. Must be a lot of shorting going on? Should have dumped when it was at 12 bucks..lol
Anyone know what's going on here?
Gamida Cell to Present Corporate Highlights at Multiple Investor Conferences in June
https://finance.yahoo.com/news/gamida-cell-present-corporate-highlights-120000902.html
Wed, June 9, 2021, 3:00 PM
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced that company management will present its corporate highlights at the following investor conferences in June:
JMP Securities Life Sciences Conference, June 16-17, 2021. In a fireside chat at 12:30 p.m. ET on June 16, 2021, management will discuss a corporate overview for 2021 with a special focus on multiple growth opportunities driven by advances in the development of omidubicel, a potentially life-saving NAM-enabled cell therapy with positive Phase 3 clinical data, and based on encouraging preliminary clinical results, NAM-enabled natural killer (NK) cell immunotherapies including GDA-201.
A.G.P. Summer Healthcare Symposium, June 17, 2021. The company will present its 2021 corporate highlights to investors in one-on-one meetings on June 17, 2021.
In the fourth quarter of 2021, Gamida Cell is targeting a BLA submission for omidubicel, the first potential approval of a cell therapy for blood cancer patients in need of an allogeneic bone marrow transplant. In the second half of 2021, the Company is planning an IND submission to support the initiation of a Phase 1/2 clinical study of cryopreserved, off-the-shelf GDA-201 in patients with follicular and diffuse large b-cell lymphomas.
A live webcast of the JMP Securities fireside chat 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.
Gamida Cell Announces Appointment of Senior Vice President, Global Operations and Manufacturing and Provides Commercial Manufacturing Update
https://finance.yahoo.com/news/gamida-cell-announces-appointment-senior-110000946.html
Mon, June 7, 2021, 2:00 PM
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced the appointment of Vladimir Melnikov as senior vice president, global operations and manufacturing. Mr. Melnikov brings over 25 years of experience in the biopharmaceutical industry, particularly in biologics manufacturing, operations, engineering and technology transfer. He will be based in the company’s wholly owned commercial manufacturing facility in Israel.
Prior to joining Gamida Cell, Mr. Melnikov served as general manager at Omrix Biopharmaceuticals and biologic technical operations lead at Ethicon Biosurgery, both part of a Johnson & Johnson Company. In those roles he supervised three Israeli biotech manufacturing sites and technology transfer to external partners. In positions of increasing responsibility at Omrix, he played a pivotal role in new product development and launch, process scale-up, development of new facilities and equipment and obtaining regulatory approvals. Mr. Melnikov has proven success in production, supply chain, engineering and leading multifunctional teams. Mr. Melnikov will have responsibility for the Gamida Cell global operations and manufacturing, which will include the company’s Israeli manufacturing site and oversight of the company’s contract manufacturing partnership with Lonza. The scope will focus on both omidubicel and readiness for Gamida Cell’s natural killer cell platform, including GDA-201. Mr. Melnikov holds a M.Sc. in life sciences from Hebrew University of Jerusalem, an MBA in biopharma from the College of Management, and he completed the Course of Directors and Senior Executives at Tel Aviv University.
"With Vladimir on board, we feel even more confident that we are making positive steps toward bringing omidubicel, our proprietary advanced cell therapy, to patients in need of an allogeneic hematopoietic stem cell transplant," said Julian Adams, Ph.D., chief executive officer of Gamida Cell. "In December 2020, the U.S. Food and Drug Administration provided clear feedback on what will be required for our commercial manufacturing facilities to be ready to submit a Biologics License Application for omidubicel, and we remain on track to submit our BLA in the fourth quarter of this year."
In addition to the appointment of Mr. Melnikov, Gamida Cell has made important progress in its strategy to have two commercial manufacturing facilities ready and available at the time of omidubicel’s potential approval. One of these manufacturing plants is wholly owned by Gamida Cell and located in Israel. The other site is a commercial manufacturing facility for which the company has a contractual relationship with Lonza. Construction of Gamida Cell’s Israel facility has been completed, and the initial production team has been hired, trained and qualified. In Q1 2021, the company successfully completed the required engineering runs and aseptic simulations for process qualification. Methods validations are underway, with planned completion in Q2 2021. Gamida Cell anticipates finalizing analytical comparability runs and process performance qualification by Q3 2021.
The company’s additional commercial facility, in partnership with Lonza, is currently manufacturing clinical batches for Gamida Cell’s expanded access program and is also progressing on the requirements.
"We are encouraged by the progress we are making to fulfill the FDA CMC requirements for our omidubicel BLA submission and are also diligently working on launch readiness," said Michele Korfin, chief operating officer and chief commercial officer of Gamida Cell. "The key focus of our omidubicel launch is to assure a positive patient and transplant center experience, including the best possible product. Manufacturing is a critical part of this, and we are also progressing well on our timeline to assure readiness for commercial manufacturing."
About Omidubicel
Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). In both Phase 1/2 and Phase 3 clinical studies (NCT01816230, NCT02730299), omidubicel demonstrated rapid and durable time to engraftment and was generally well tolerated.1,2 Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn®, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.
Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
OPPENHEIMER RELEASES A BUY RATING ON GAMIDA CELL (GMDA)
https://www.markets.co/oppenheimer-releases-a-buy-rating-on-gamida-cell-gmda/316897/
May 11, 2021 Christine Brown Healthcare
In a report released yesterday, Mark Breidenbach from Oppenheimer assigned a Buy rating to Gamida Cell (GMDA – Research Report), with a price target of $17.00. The company’s shares closed last Tuesday at $6.84.
Gamida Cell to Present at the RBC Capital Markets Global Healthcare Conference
https://finance.yahoo.com/news/gamida-cell-present-rbc-capital-120000987.html
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced that Julian Adams, Ph. D., chief executive officer of Gamida Cell, will participate in a fireside chat at the RBC Capital Markets Global Healthcare Conference on Wednesday, May 19, 2021 at 3:40 p.m. ET.
A live webcast of the presentation 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 Gamida Cell
Gamida Cell is an advanced cell therapy company committed to cures for patients with blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn or Twitter at @GamidaCellTx.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210512005198/en/
Contacts
For investors:
Stephanie Ascher
Stern Investor Relations, Inc.
stephanie.ascher@sternir.com
1-212-362-1200
For media:
Rhiannon Jeselonis
Ten Bridge Communications
rhiannon@tenbridgecommunications.com
1-978-417-1946
Gamida Cell Ltd. (GMDA) CEO Julian Adams on Q1 2021 Results - Earnings Call Transcript
May 11, 2021 1:46 PM ETGamida Cell Ltd. (GMDA)
Gamida Cell Ltd. (NASDAQ:GMDA) Q1 2021 Results Conference Call May 11, 2021 8:00 AM ET
Company Participants
Josh Hamermesh - Chief Business Officer
Julian Adams - CEO
Michele Korfin - COO and Chief Commercial Officer
Shai Lankry - Chief Commercial Officer
Ronit Simantov - Chief Medical Officer
Tracey Lodie - Chief Scientific Officer
Conference Call Participants
Ted Tenthoff - Piper Sandler
Jonathan Miller - Evercore ISI
Jason Butler - JMP Securities
Vernon Bernadino - H.C. Wainwright
Gregory Renza - RBC Capital Markets
Josh Hamermesh
Thank you, Lodie, 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 first quarter of 2021.
Earlier this morning, we issued a press release summarizing our financial results and progress across the Company, which is available on our website at www.gamida-cell.com. Here with me on our call today are Julian Adams, Chief Executive Officer; Michele Korfin, our Chief Operating Officer and Chief Commercial Officer; and Shai Lankry, Chief Commercial Officer. Ronit Simantov, Chief Medical Officer; Tracey Lodie, our Chief Scientific Officer, are also on hand for the Q&A portion of the call following our prepared remarks.
During this call, we may make forward-looking statements about our future expectations and plans, including clinical development and commercial objectives, the therapeutic potential of our product candidates, our operational plans and strategies, and projected operating expenses and cash runway. Our actual results may differ materially from what we project today due to a number of important factors, including the considerations described in the Risk Factors section of our Form 20-F and in other filings that Gamida Cell makes 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, future events or otherwise.
Now, I’d like to turn the call over to Julian.
Julian Adams
Thank you, Josh. And thanks to everyone for joining us this morning. Those of you who've been following our progress know that Gamida Cell is approaching a major inflection point in the Company's history, as we approach a BLA submission later this year, and prepare for the potential product launch, what could be the first ever FDA approved bone marrow transplant graph product for blood cancer patients in need of a stem cell transplant.
At Gamida Cell, we are dedicated to advancing two cell therapy programs that leverage our proprietary NAM cell expansion platform with the potential to redefine standards of care for patients with blood cancers and serious immunologic disorders. This platform continues to demonstrate compelling results in clinical trials based on critical features, such as cell expansion, functionality and safety, all leading to improve patient outcomes.
2021 has gotten off to a strong start marked by continued progress across our pipeline towards key milestones. We continue to be encouraged by the clinical profile of our product candidates, omidubicel and GDA-201. Omidubicel has the potential to transform medical practice for patients with hematologic malignancies and be the first FDA approved cell therapy for bone marrow transplant. Commercial preparations are ongoing as we work towards submitting the BLA in the fourth quarter of 2021.
Our second candidate in clinical development is GDA-201, an advanced cell therapies that utilizes our NAM cell expansion technology to harness the power of the innate immune system and has demonstrated remarkable results in patients with non-Hodgkin's lymphoma specifically follicular lymphoma and diffuse large B cell lymphoma histologies.
This past quarter, we continue to make progress toward the production of a cryopreserved product to support a multicenter Phase 1/2 trial later this year. Additionally, we are excited about the progress we are making in our R&D activities to pursue the development of genetically modified this NAM expanded NK cells. This morning, we will review both programs and summarize our progress around plans to bring omidubicel for patients in the commercial setting pending FDA approval.
Let me share more details with you starting with our lead program omidubicel, which as a reminder has FDA breakthrough therapy designation as well as orphan drug status. Our successful Phase 3 trial demonstrated meetingboth primary and secondary endpoints that omidubicel addresses a key unmet need for patients in need of a bone marrow transplant by expanding the CD34 positive stem cells and creating a suitable dose of highly functional cells.
We are on track to submit the BLA for omidubicel to the FDA in the fourth quarter of this year and meet the anticipated commercial supply needs. As we continue to advance on the omidubicel for a potential launch and prepare to become a commercial organization, we have taken important steps to establish key commercial capabilities, including the creation of Gamida Cell Assist, a program designed to support a positive patient and transplant center experience. Michelle will elaborate further on this after.
Moving to the rest of our pipeline, we are thrilled by the emerging profile of GDA-201, our first lead candidate from our NAM expanded NK cell program. Natural killer cells, our innate immune cells that hold tremendous promise as an approach for treating cancer, by leveraging our NAM technology to expand NK cells derived from healthy adult donors while enhancing their functionality. We believe GDA-201 improves NK cells direct tumor cell killing as well as antibody-dependent cellular cytotoxicity known as ADCC.
In a Phase 1 trial, GDA-201 demonstrated impressive proof-of-concept and striking early signs of efficacy with multiple durable complete responses while being very well tolerated in heavily pre-treated patients with relapsed or refractory lymphoma. The study was designed to assess the safety of GDA-201 in combination with Rituxan in non-Hodgkin lymphoma.
As a result of these encouraging data, we develop a GMP cryopreserved formulation and have initiated manufacturing runs in preparation for a multicenter study with an off-the-shelf allogeneic cell therapy in patients with lymphoma. Based on the significant clinical activity we've seen so far in the Phase 1 trial, we put the plan to submit an IND for GDA-201 in the second half of this year to enable our Phase 1/2 study in lymphoma patients with follicular lymphoma, or diffuse large B cell lymphoma.
Additionally, we are maximizing the potential of our NAM technology platform to develop a pipeline of gene edited NK cell therapies with enhanced function for both hematological malignancies and solid tumors. I want to conclude my introductory remarks by thanking our employees for their hard work and dedication, and I continue to be impressed by the progress we're making to bring potentially lifesaving therapies to patients.
I'll now turn the call over to Michele Korfin. Our Chief Operating Officer and Chief Commercial Officer will talk more about our launch readiness for omidubicel. Michele?
Michele Korfin
Thank you, Julian, and good morning, everyone. Today, I will review our progress on our manufacturing and launch readiness activities. As we continue to advance our breakthrough therapy, omidubicel for patients in need of an allogeneic stem cell transplant.
During our Type B meeting with the FDA in December, 2020, we received clear feedback on what will be required for our commercial manufacturing facilities to be ready for BLA submission. This includes our Gamida Cell owned facility in Israel and a commercial facility for which we have a contractual relationship with Lonza.
Given that neither of these commercial facilities were used for the Phase 3 omidubicel registration trial, we need to demonstrate comparability from these commercial facilities with the clinical manufacturing supply. We've made important progress preparing both of these facilities for commercial manufacturing readiness.
Let me start with our state-of-the-art Israeli facility. The facility construction has been completed and our team has achieved each of our internal timeline milestones since construction was completed. We have hired, trained and qualified our initial production team, and during the first quarter of this year, our team has successfully completed the required engineering runs and aseptic process simulation for qualification.
The methods validations are underway with a planned completion in the second quarter of 2021 and we anticipate finalizing our analytical compatibility runs and process performance qualification or PPQs in third quarter of '21. For the Lonza commercial facility, we are currently manufacturing clinical batches for our expanded access program and are progressing on the BLA requirements. We are currently on-track for the CMC requirements for our BLA, which we plan to submit in the fourth quarter of 2021.
We believe that, there was a significant opportunity with omidubicel, specifically in the U.S. market alone as there are over 40,000 patients with hematological malignancies, who consider transplant each year. There were about 10,000 patients were actually transplanted, and then unfortunately, there are almost 9,000 patients were eligible, but not transplanted. The extensive market research we have conducted has enabled us to develop a strong launch strategy.
Upon FDA approval, omidubicel will be an important therapy option for patients in need of an allogeneic stem cell transplant. Based on our marketing sites, the opportunity for omidubicel can be summarized in three categories; first, increasing access for patients who are eligible and not matched; second, improving outcomes based on clinical needs with current donor sources and in addition increasing eligibility based on the encouraging omidubicel clinical profile.
Physician and payer feedback has been encouraging and not the omidubicel product profile based on clinical data is viewed positively and they understand the potential clinical advantages. More specifically, for payers, payers are encouraged by the potential for faster time to neutrophil engraftment, decrease infections, decrease in hospitalizations and less graft versus host disease as compared to published literature for other grass sources. We also hear from physicians that each of the donors is a factor in their consideration.
In partnership with CIBMTR, we have utilized real-world data to demonstrate that if transplant donors were less than or equal to 30 years of age, the patient had a statistically greater survival probability. So for example, in the case of related donors, if an AML patient is diagnosed at 60, which is the median age of diagnosis, their family members who could potentially be matched related or haploidentical donors would probably be above that 30 years of age, given the starting material from omidubicel is umbilical cord blood, this donor age is not a concern.
Additionally, due to the less stringent genetic matching criteria from omidubicel as compared to other donor sources, omidubicel may provide the opportunity to expand access to bone marrow transplants for patients who otherwise could not find a suitable donor. Omidubicel approved will be an important therapy option for patients in need of an allogeneic stem cell transplant. Our launch strategy goal is to ensure that patients and the transplant centers have a positive experience with omidubicel following FDA approval since the transplant center and caregivers.
Education of the transplant centers is an important aspect of our strategy. We know that 70 centers make up about 80% of the transplants in the United States. We have direct experience with 20 of those centers through our clinical trial and know many others from past professional experiences. We are confident that we will be able to effectively partner with the centers to educate them on omidubicel and we are working diligently with payers to ensure reimbursement upon FDA approval.
Outreach has already begun with US payers and the discussions have been positive, including the recognition of the clinical data and the importance of the secondary endpoints such as reduced hospital time and reduced infections. Additionally, we plan to build an outstanding team to support patients, transplant centers and caregivers through the process.
As Julian mentioned, we are excited to continue our progress developing from Gamida Cell Assist to provide assistance to ensure that positive and personalized patient experience. This is a program like no other for patients undergoing a transplant community. Gamida Cell Assist will consist of a dedicated experienced team that will be focused on supporting the patient's journey with omidubicel.
Our Gamida Cell Assist team will consist of an experienced case management team who will be focused on ensuring patient access and provide support to patients, their caregivers, and the transplant team at the hospital throughout each step of the process. The Gamida Cell Assist will have a number of key roles. One of the most important roles is compliance with the FDA's chain of identity requirements. The Gamida Cell Assist, we'll start our chain of identity, which is a unique patient identifier that will follow the patient throughout the entire process.
Just as importantly, Gamida Cell Assist is going to be that single point of contact for the hospitals and patients. As such, we will be able to provide the hospitals and patients with assistance to support access to omidubicel such as benefits verification or travel and lodging needs. Gamida Cell is committed to supporting a positive journey for patients and their transplant centers. So, they can focus on what matters most the patient experience and successful clinical outcomes.
We were excited by the potential of omidubicel to be the first FDA approved cell therapy for bone marrow transplants, and we are encouraged by the clinical data and the feedback from physicians, payers and patients. We have our omidubicel launch strategy and plan in place with a key focus on assuring a positive patient and transplant center experience.
I will now turn the call over to Shai to review our financial results.
Shai Lankry
Thank you, Michelle. Good morning everyone. Today, I will summarize our financial results for the first quarter of 2021. As of March 31, 2021, our total cash position was $174.8 million, compared to $127.3 billion as of December 31, 2020. The March 31st cash balance includes the $75 billion in gross proceeds to our recent financing with Highbridge Capital Management closed this quarter.
Research and development expenses for the quarter were $11.4 million, compared to $7.9 million for the same period in 2020. The increase was mainly due to omidubicel commercial manufacturing activity and the advancements for our GDA-201 program including broadening our scientific capabilities and talent. Commercial expenses in the quarter were $4.4 million, compared to $1.5 billion for the same period last year. The increase was mainly attributed to our progress with omidubicel commercial readiness activities, which includes among other things the addition an experienced commercial leadership team.
General and administrative expenses were $3.4 million for the first quarter of 2021, compared to $2 million for the same period in 2020. The increase was mainly due to the hiring of key management position to support the growth of our business. Finance income net $0.7 million for the quarter, compared to finance income net of $1.7 million in the same period last year. The decrease was primarily due to interest expenses following the recent $75,000 financing and non-cash expenses resulting from revaluation of warrants and Israeli Innovation Authority, royalty-bearing grant liability.
Net loss for the quarter was $18 million, compared to a net loss of $10.6 million for the same period last year. We continue to expect cash used for ongoing operating activities this year to range from $110 million to $120 million. We anticipate our current total cash position will support our ongoing operating activities into the second half of next year and to achieve multiple important manufacturing, commercial and regulatory milestones. This cash runway guidance is based on our current operational plans and excludes any additional funding that may be received or due to development activities that may be undertaken.
With that, I will turn the call back over to Julian.
Julian Adams
Thanks, Shai. We are dedicated to finding cures for patients with hematologic malignancies and blood disorders as well as solid tumors, and we're excited about the opportunities ahead. We could have not gotten this far without an accomplished team, and I think each of our employees for their unwavering dedication towards advancing potentially lifesaving therapies for cancer patients.
With omidubicel, we expect to submit the BLA in the fourth quarter of this year and are committed to be launch ready at the time of approval. With GDA-201, we have very compelling data in lymphoma and are planning to initiate a Gamida Cell sponsored clinical study, which could potentially support registration, if the data are consistent with the Phase 1 results. 2021 is already off to a strong start and will prove to be a transformational year for Gamida Cell, and all of its stakeholders, most importantly, patients in need of better treatment options.
In conclusion, we are very excited about the important achievements that Gamida Cell will make in the second half of this year including omidubicel BLA submission and initiating the Company-sponsored Phase 1/2 GDA-201 study in non-Hodgkin lymphoma. We understand the importance of our work for cancer patients, the healthcare system and society in general. As you've heard today, the Company is on a path to transform the way cellular therapies can treat patients with cancer.
We look forward to updating you on our progress throughout the year, and now we will open the call for questions. Operator?
Question-and-Answer Session
Operator
[Operator instructions] And our first question comes from the line of Ted Tenthoff of Piper Sandler. Your line is open.
Ted Tenthoff
Great, thank you very much, and congrats on all the progress. I'm curious what is sort of still being done for the BLA, as I'm assuming you guys with anticipated outcome, but just wanted to get a sense of your expectations around that? Thanks so much.
Julian Adams
So, but let me begin and thank you, Ted, for your question. Obviously, right now, we're involved in two very distinct activities. One is making sure that our manufacturing of cell therapies is meeting all of the FDA requirements. And we're going through all of the validation and qualification runs of both our site in Israel and at Lonza. Our second supplier, and in addition, Michelle outlined, how she's building up the commercial team and Gamida Cell Assist, and services. Michelle, I don't know if you want to add anything to that.
Michele Korfin
Thank you, Ted. So I'll take the BLA question and then I'll turn it back to either Julian or Ronit for the response to the outcome. So, in regards to the BLA, we are finalizing the CMC requirements for the BLA at both Kiryat Gat and Lonza. We are making very nice progress to date in both areas. So, at Lonza, we have completed a number of the initiatives required. At this point time we're focused on manufacturing commercial batches VAP, and then in the second, third, second or third quarter of this year, we will finalize the BLA requirements for Lonza.
In regard to Kiryat Gat, the team has progressed very nicely in first quarter we completed engineering runs. We completed aseptic process simulation. We're in the process of completing the method validation runs, which we had discussed after our Type B meeting with FDA in December. And then we'll finalize and Kiryat Gat targeting by the roughly the end of third quarter the analytical variability and the PPQ runs. So to summarize, we have made very nice progress year-to-date at both Lonza and Kiryat Gat in terms of the CMC requirements for the BLA. So with that, let me turn it back to Julian or Ronit to answer your question in regards to the AdCom.
Julian Adams
Yes, Ronit, please. Could you comment on any additional data we might -- any additional follow-up from the Phase 3 data and our plans for?
Ronit Simantov
Yes, sure. Thanks. Thanks Ted. So, we will -- a very important part of the BLA, of course, is the clinical aspect of the submission and we are preparing all of the clinical sections for submission, we expect additional follow-up data on the patients in the Phase 3 study to include up to one year post transplant for every patient, or at least one year out follow back to handset for every patient with some patients having additional follow-up after that, and so all of those data will be included in the BLA submission. Now in terms of outcome, we don't know yet whether we will have one but we certainly will be prepared for one. We need to engage in advisory committee meetings.
Ted Tenthoff
Make sense? Thank you so much. And I would just add, we're in extensive conversations, not only with key transplant centers, and KOLs in the field as well as regular conversations with FDA, as we enjoy break-through therapy designation. We have a kind of an open line to an FDA to continue to prepare for the BLA submission.
Operator
And our next question comes from the line of Jonathan Miller of Evercore ISI. Your line is now open.
Jonathan Miller
Hi guys. Thanks for taking the question. One in clarification, on manufacturing compensability in the CMC, I was under the impression that you would have to generate actual commercial product and dose patients with it in order to get that CMC compatibility. Is that true? And if so, what would we hear about those patients and when? That's one. Second, I'd love to hear your updated thoughts on potential partnerships for only ex-U.S. I think you had been talking about doing that. Do you have preferred timing for when we could expect a deal like that and what are you looking for in a potential partner ex-U.S.?
Julian Adams
So, let me invite Ronit to talk about, the ongoing EAP study and the clinical compatibility from our manufacturing sites.
Ronit Simantov
Sure. So, we have an open expanded access protocol, which is really a single arm protocol, where all patients receive omidubicel and we're using that to execute our clinical comparability for both of our manufacturing sites, and basically enrolling patients with product manufacturer, at the site that we need to and that it's available from. So, we don't intend to provide updates on an ongoing basis around those patients or their outcomes. We're going to treat patients from both sides. We will have data to submit to FDA for the BLA and we're on-track to do that. So, I wouldn't expect to hear anything about that. We have had conversations with FDA about the extensive data required and we're confident we'll be able to provide the level of data that they are asking for in terms of the patients treated with omidubicel.
Jonathan Miller
And Josh, can you comment about omidubicel in other territories?
Josh Hamermesh
Yes. So ,John, we continue to explore our strategic options for the optimal way to commercialize omidubicel outside of the United States. We've recently conducted some market research assessments to best understand the territories and the opportunities in those territories. We're not commenting or providing further guidance on timing or capabilities of potential partners. It's sort of the obvious stuff, we're looking for the best way to provide access and maximize the value of omidubicel for patients around the world.
Operator
And your next question comes from the line of Jason Butler of JMP Securities. Your line is open.
Jason Butler
Hi. Thanks for taking the question. First one, Michele, you talked about, the opportunity to increase the number of patients that might be eligible for a transplant. Could you maybe expand some numbers around how that opportunity compares to or differs from the population that today we know is eligible, but not matched? I guess that first bucket versus the third bucket of the opportunities you talked about before.
Michele Korfin
Yes, thank you, Jason, good to hear from you. So, in regards to the three opportunities increase in eligibility was based on the physician feedback on the clinical profiles omidubicel. So, when you go back to the data that Ronit, Dr. Hurwitz and Professor Saunders has presented, we see the decrease in infection rate. That's generally the one that and also the graft versus host disease data.
So, when physicians see those aspects of the clinical profile, the transplanters will say, there are some patients that I may not feel have the appropriate performance status to undergo transplant with current donor modalities, but based on the clinical profile of omidubicel, both in regards to the safety date around decreased infections decrease in graft versus host disease, but also the rapid time to nutrient graphs that they say there is a percentage of patients that I may consider now eligible omidubicel was available.
So, we haven't guide on a guided on specific numbers from that portion. But what we have said is overall, once we reach a peak market share, we're probably at about 2500 patients, once we reach that peak market share, and we're excited by all three of those opportunities, both increasing eligibility, the increase or improving outcomes for patients from based on current donor modality, but also very importantly, that portion of the patients that are currently eligible but just can't find a match. That's also an incredibly important opportunity from omidubicel.
Jason Butler
Right. And then thank you. And just as a follow-up on the data, you'll have a BLA. I think you mentioned you'll have one year follow-up data for most of the old patients. I guess to what extent you expect FDA to weigh one year survival rate? And is this data you think could be included in the label?
Julian Adams
Thanks. Ronit, would you handle that, please.
Ronit Simantov
Of course. So, we will have one year data on -- all patients will have been at least one year after transplant so that the data will include one year data on all patients. One year survival data are actually important in the transplant field. They're used as a marker for evaluation of transplant centers and transplanters are familiar with looking at one year transplant data.
So, we expect those data to be important. As the study wasn't powered to detect a statistical difference in the two arms with respect to overall survival data, but we will show those data and certainly share them and include them in the BLA. And we expect to use those data to show the utility of omidubicel to whatever extent we're able to.
Jason Butler
Okay, great. And then just one quick one for me. So, you mentioned before you're making progress on the client preserving cryo products, what are the next steps in terms of manufacturing and when can we hear an update on the progress towards a cryo preserved product we could use in a multicenter study?
Julian Adams
Thank you for that. Tracy, could you elaborate?
Tracey Lodie
Sure, I'd be happy to thank you, Jason and hope you're well. So, we continue to make fantastic progress and I can update since we spoke last that we have now finalized the cryopreservation formulation in the research setting. And we have successfully manufactured two engineering runs which are practice runs at our GMP facility, which is right out of [indiscernible] University near there in Israel. So, the team has made significant progress now and not only finalizing the cryopreservation, but now made this to scale to clinical scale. So, the next step actually are just to continue manufacturing now for the clinical runs, so that we can store up enough inventory, and we're on-track to do that prior to the IND submission of the Phase 1/2, which we plan is on-track for the latter half of this year.
Operator
Your next question comes from the line of Vernon Bernadino of H.C. Wainwright. Your line is open.
Vernon Bernadino
Thanks for taking my question and congrats on the progress. Just perhaps this is a question for Michele. What reimbursement levels are currently available for bone marrow transplant or use of umbilical cord blood? And can it be initially apply for use of omidubicel [indiscernible] established at the time of omidubicel approval?
Ronit Simantov
Hi, Vernon, nice to hear from you. So, here we go to some reimbursement. Let me talk about the commercial payers in the U.S. and government. So, just taking a step back, we anticipate the majority of patients who would be receiving omidubicel would fall under private or commercial payers although Medicare certainly is an area of key focus for us too. So, let me start with the commercial payers.
So, commercial payers in the transplant centers in the U.S. have confidential contracts that they negotiate in regards to their reimbursement. So, I would not be able to speak specifically on the details of that. But here's what I can tell you. We've had a number of conversations through either market research with U.S. payers or direct one-to-one communications. What payers were saying is? They would most likely reimburse omidubicel at time of FDA approval via their carve-out mechanism, which is part of the contract.
So, what does that mean in practice? They reimburse the transplant center for the agreed to rates for hospitalization provider care and then they carve out the reimbursement from omidubicel, that's consistent with what they did with CAR-Ts in many cases upon FDA approval, and that's what they're saying they would do for omidubicel. We're encouraged by that, and also the transplant centers are comfortable with that approach.
On the Medicare side, there are established diagnosis related groups or DRGs for allogeneic stem cell transplants. And there is also some always continual evolution of how to enhance DRGs. There was some update in the proposed in-patient perspective payment rule that just came out, but the key takeaway on the Medicare side is there are DRGs that a therapy like omidubicel could be mapped to.
And then in addition, we are preparing to apply for the new technology add on payment or NTAP, which would then also support the additional reimbursement if approved. So, those are the two key avenues in terms of the commercial, and then on the Medicare side.
Vernon Bernadino
I know someone asked you this before, but do you anticipate the established reimbursement to follow the pathway that was followed by CAR-T cell therapies?
Ronit Simantov
So in terms of the commercial, what we're hearing from the payers is similar to what they did for in many cases, for CAR-T they would carve out the reimbursement with omidubicel. So that's something that, transplant centers and are used to getting encouraged by. So in that case, yes. In the case of Medicare, the difference between omidubicel and CAR-T were when CAR-T were approved, there was no appropriate or common DRG for them to be mapped to versus in the case of omidubicel, there are allogeneic STEM cell transplant DRGs that are already established. So, that is more difference with the CAR-T.
Operator
[Operator instructions] Our next question comes from the line of Gregory Renza of RBC Capital Markets. Your line is open.
Gregory Renza
Thanks for the update and thanks for taking my question. Well perhaps just one on each program, Julian just with as the omidubicel data circulated in the physician community and after a series of meetings across this year so far. What do you learn that is either reinforcing or incremental on the on the omidubicel profile that they think is worth highlighting? And then secondly, on GDA-201, just curious, what is your view on the various engineering and expansion strategies across the NK space and where perhaps, would 201 fit in there? Thank you very much.
Julian Adams
So, let me direct that question to Ronit on the clinical side, a lot more contact with physicians.
Ronit Simantov
Thank you and Greg, we have been in touch and reaching out to a number of transplanters across the U.S. especially many who were not investigators in our clinical study to talk to them about the results of a study and about omidubicel and to get their feedback on the results of the study. And we've been hearing an enormous amount of enthusiasm about the potential.
They each have been able to think of patients that they would have been able to, or would have wanted to do the foreword available. Patients who wouldn't have fit the mold for other opportunities and transplants couldn't find a match or just weren't appropriate for some of the other modalities.
And I think people are looking forward to having another option when they're looking for a grasp for their patients with illogic malignancies. So, that's what we've learned that folks who were not previously familiar with omidubicel, and are now learning about it are enthusiastic.
Julian Adams
And for GDA-201, again, let me refer you to Tracy, to answer.
Tracey Lodie
Sure, and thank you for the question, Greg. Good to hear from you. So as the NK field, is expanding and with many different approaches, and really information flowing very nicely. And we're really pleased to be, in this and at the forefront of this with our clinical data set. And so I'll say a few things about, GDA-201 which distinguishes us, and then where we're going in terms of the engineering.
So, I think the key benefits of GDA-201 really is our quick manufacturing process, that we're able to isolate this perfect blood from normal donors have a product within 14-days. And now as I said, we're very excited to have a cryopreserved formulation of that, which has maintained the phenotype and the function in the lab of these cells. And so as a bore out in the clinical trial, we're really excited about the combined ability of our technology with other therapies and especially with other antibodies.
So, I think this distinguishes us from heavily engineered CAR in case in other IPSC-derived CAR in case which required heavily on significant genetic engineering. Our cells do not persist past 7 to 10 days in the patients, what we've seen by fax analysis, at least in the IST Phase 1. But therefore, we think it's a different mechanism that's going on with GDA-201 and that their ability in part, because of our expanded with our NAM technology to maintain their function posting vivo-transplant as well as to creating our cytokine activating adaptive immune response, that we are working on still to provision some translational studies.
And we think this is what's really leading to some of the durability that we've seen in the ongoing study. So, we're excited about that and to continue to explore the potential. And this is what distinguishes, our NAM technology because we believe this would not be possible without the NAM actually improving the fitness of the cells around the metabolism and really around the ability for them to be very active, when we're expanding them and not be exhausted.
Where we're going in the future? The R&D team is making tremendous progress that we're really excited about and actually doing some gene editing in which we think we will improve the cells as we look to other tumor types, and especially in solid tumor types and how we can improve them, the persistence, which we think may be needed for this and also to tackle those difficult solid tumor types.
So, we're making great progress and we think we have a product that is distinguished and we're looking forward to improve that as we expand out to different indications. So, thank you for the question.
Operator
And I am showing no further questions. At this time, I would like to turn it back to Mr. Julian Adams for the closing remarks.
Julian Adams
Thank you, everyone for joining us on today's call and we look forward to updating you in the future, and we really appreciate your continued support.
And once again, I can't thank of the employees of Gamida Cell enough, particularly in this pandemic year where they just worked tirelessly and with such commitment to realize the potential of our programs for patients.
Thank you all.
Gamida Cell Reports First Quarter 2021 Financial Results and Provides Company Update
https://finance.yahoo.com/news/gamida-cell-reports-first-quarter-110000291.html
BLA submission for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant, expected in fourth quarter of 2021
Pre-commercial and manufacturing activities underway to support potential launch of omidubicel in 2022
Phase 1/2 clinical trial of allogeneic, off-the-shelf GDA-201 in NHL planned with IND submission anticipated in the second half of 2021
Strengthened financial position with sale of $75M exchangeable senior notes in February 2021; sufficient liquidity to fund the company’s operations into the second half of 2022
Company to host conference call at 8:00 a.m. ET today
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today reported financial results for the quarter ended March 31, 2021. The company also highlighted progress with omidubicel, an advanced cell therapy with positive Phase 3 clinical data, as a potentially life-saving treatment option for patients in need of an allogeneic hematopoietic stem cell (bone marrow) transplant, and GDA-201, a natural killer (NK) cell immunotherapy in Phase 1/2 development for patients with non-Hodgkin lymphoma (NHL).
"In the first quarter of this year, we made significant progress on key initiatives across all functions of our business, starting with omidubicel, a potentially transformative treatment option for patients with hematological malignancies," said Julian Adams, Ph.D., chief executive officer of Gamida Cell. "We are working diligently to bring this novel therapy to patients, with submission of a BLA to the FDA anticipated in the fourth quarter of this year. We are progressing well with our manufacturing readiness activities in response to the clear feedback from the FDA regarding registration of our commercial manufacturing facilities and are actively building our launch readiness capabilities, including market access and support services, to ensure a positive patient experience at transplant at the time of potential FDA approval."
"We also continue to expand our clinical pipeline with plans to submit an IND for our GDA-201 natural killer cell therapy, initiate a multi-center Phase 1/2 clinical study in NHL and continue to advance our R&D activities to pursue the development of genetically modified NAM-enabled NK cells in solid tumors. Importantly, we are well positioned to deliver our 2021 corporate goals and objectives toward improving the lives of the patients we serve," Dr. Adams continued.
Omidubicel, a proprietary, investigational advanced cell therapy for allogeneic bone marrow transplant
Omidubicel is the foundational product based on Gamida Cell's proprietary cell expansion technology. During the quarter, Gamida Cell continued to advance omidubicel, the first cell therapy for bone marrow transplant to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). The company anticipates submitting a Biologics License Application (BLA) to the FDA in the fourth quarter of this year, based on the results of an international, randomized Phase 3 study of omidubicel that was designed to evaluate the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing a bone marrow transplant compared to patients who received a standard umbilical cord blood transplant. The study achieved its primary endpoint, a statistically significant reduction in time to neutrophil engraftment, as well as all key secondary endpoints. A key milestone in a patient’s recovery, neutrophil engraftment is a measure of how quickly the stem cells a patient receives in a bone marrow transplant are established and begin to make healthy new cells. In the recently completed Phase 3 study, the median time to neutrophil engraftment was 12 days for patients randomized to omidubicel compared to 22 days for the comparator group (p < 0.001). Additionally, the study met key secondary endpoints related to the speed of platelet engraftment, decrease in infections and reduction in hospitalizations, all significant clinical measures in bone marrow transplant.
In February 2021, the company presented details of the results of the omidubicel Phase 3 study at the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy and Center for International Blood & Marrow Transplant Research. The study’s intent-to-treat analysis included 125 patients aged 13–65 years with a median age of 41. Patients were enrolled at more than 30 clinical centers in the United States, Europe, Asia, and Latin America. Racial and ethnic diversity and baseline characteristics which were well-balanced across the two study groups. Diseases included acute lymphoblastic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, myelodysplastic syndrome or lymphoma.
In addition to the efficacy results described above, safety results were also presented, showing decreased incidence related to grade III/IV acute GvHD (14 percent for omidubicel, 21 percent for the comparator) and comparable results for all grades chronic GvHD at one year (35 percent for omidubicel, 29 percent for the comparator). Transplants with umbilical cord blood, the comparator, have been historically shown to result in low incidence of GvHD in relation to other graft sources and, in this study, omidubicel demonstrated a similar GvHD profile.
The data from the study relating to exploratory endpoints also supported the clinical benefit demonstrated by the study’s primary and secondary endpoints. The rate of infection was significantly reduced for patients randomized to omidubicel, with the cumulative incidence of first grade II or grade III bacterial or invasive fungal infection for patients randomized to omidubicel of 37 percent, compared to 57 percent for the comparator (p = 0.027). Additionally, the study demonstrated a reduction in the incidence of viral infections. Non-relapse mortality was 11 percent for patients randomized to omidubicel and 24 percent for patients randomized to the comparator (p=0.09). Overall survival at 15 months following randomization was 73 percent for patients randomized to omidubicel and 62 percent for patients randomized to control (p=0.16), median overall survival was not yet reached. Non-relapse mortality and overall survival were exploratory endpoints that were not powered for statistical significance. When considering the patient experience following transplant, faster hematopoietic recovery, fewer bacterial and viral infections and fewer days in hospital are all meaningful results and represent potentially important advancements in care. Learn more.
Gamida Cell also reported data from the Phase 3 study in March 2021, in an oral session at the Presidential Symposium of the 47th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT 2021). Additionally, the session was featured in a panel discussion, "EBMT Talks: Live with the Best Abstracts."
Additional omidubicel highlights:
Progress with commercial manufacturing readiness: Gamida Cell is making important progress to address the clear feedback received during a Type B meeting with the FDA in December 2020 for commercial manufacturing facilities to be ready for BLA submission. These facilities include the Gamida Cell facility in Israel and a commercial facility for which the company has a contractual relationship with Lonza. Both of these facilities are currently on track to meet the FDA requirements that will be required for BLA submission.
Continued launch readiness: The company continues to progress commercial launch readiness activities for the potential launch of omidubicel in 2022, pending FDA approval. Based on market research insights, there is a clear opportunity to improve outcomes based on clinical needs with current donor sources, increase access for patients who are eligible and not matched for transplant, and increase patient eligibility based on the encouraging clinical profile of omidubicel.
Gamida Cell announced the Gamida Cell Assist program. The transplant process can be challenging and complex for patients, caregivers and the entire transplant care team. Gamida Cell Assist is designed to focus on patient access and support at each step of the process. Once the program is launched, the Gamida Cell Assist case management team will provide a consistent, single point of contact for patients and health care professionals, work with the transplant center to track production of omidubicel for each individual patient, and provide real-time updates on the status of the therapy. The services provided will include coverage and reimbursement support, which may include financial, travel and lodging assistance. Gamida Cell is committed to supporting a positive journey for patients and their transplant teams so they can focus on what matters most, the patient experience and successful clinical outcomes. Learn more.
Phase 1/2 study of omidubicel in patients with severe aplastic anemia: Gamida Cell is actively evaluating omidubicel in an investigator-sponsored Phase 1/2 study in patients with severe aplastic anemia (SAA). Results to date have shown that omidubicel can result in rapid engraftment and can achieve sustained hematopoiesis in patients who are at high risk for graft failure with conventional umbilical cord blood transplant.
GDA-201, a proprietary innate NK cell immunotherapy
Continued advancement of Phase 1/2 study of GDA-201: Gamida Cell is preparing for the submission of an investigational new drug (IND) application for cryopreserved, off-the-shelf GDA-201 to enable a multi-center, Phase 1/2 clinical study in patients with NHL in the second half of this year. Gamida Cell is pioneering a potentially curative, novel approach that harnesses the power of its cell expansion technology, which improves antibody-dependent cellular cytotoxicity and tumor targeting of NK cells. Learn more.
Advancing NK cell R&D activities: The company continues to advance R&D activities to support pipeline growth, including the development of genetically modified NK cells.
Corporate Highlights
Strengthened financial position: In February 2021, the company completed a $75 million financing with Highbridge Capital Management, LLC, before deducting offering expenses. This financing will be used to support manufacturing, regulatory and potential commercial development activities for omidubicel and to further the preclinical and clinical development of GDA-201.
First Quarter 2021 Financial Results
Research and development expenses in the first quarter of 2021 were $11.4 million, compared to $7.9 million for the same period in 2020. The increase was mainly due to omidubicel commercial manufacturing readiness activities and advancing the GDA-201 program, including broadening the company’s scientific capabilities and talent.
Commercial expenses in the first quarter of 2021 were $4.4 million compared to $1.5 million for the first quarter of 2020. The increase was mainly attributed to progress with commercial readiness activities, including the hiring of an experienced commercial leadership team.
General and administrative expenses were $3.4 million for the first quarter of 2021 compared to $3.0 million for the same period in 2020. The increase was mainly due to the hiring of key management positions to support the growth of the business.
Finance income, net, was $0.7 million for the first quarter of 2021, compared to finance income, net, of $1.7 million for the first quarter of 2020. The decrease was primarily due to interest expenses following the recent $75M financing with Highbridge Capital Management, and non-cash expense resulting from revaluation of warrants, and Israeli Innovation Authority royalty-bearing grant liability.
Net loss for the first quarter of 2021 was $18.0 million, compared to a net loss of $10.6 million for the same period in 2020.
As of March 31, 2021, Gamida Cell had total cash and cash equivalents of $174.8 million, compared to $127.2 million as of December 31, 2020.
2021 Financial Guidance
Gamida Cell expects cash used for ongoing operating activities in 2021 to range from $110 million to $120 million.
Gamida Cell expects that its current cash and cash equivalents will support the company’s ongoing operating activities into the second half of 2022. 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.
Expected 2021-2022 Milestones and Key Events
Gamida Cell expects the following milestones and key events through 2022:
Omidubicel
BLA submission to the FDA in the fourth quarter of 2021
Manufacturing and launch readiness activities ongoing for potential FDA approval in 2022
GDA-201
Submit company-sponsored IND application to the FDA and initiate a Phase 1/2 clinical study in NHL patients in the second half of 2021
Conference Call Information
Gamida Cell will host a conference call today, May 11, 2021, at 8:00 a.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 5258448. A recording of the webcast will be available approximately two hours after the event, for approximately 30 days.
Gamida Cell Announces the Date of Its First Quarter 2021 Financial Results and Webcast
https://finance.yahoo.com/news/gamida-cell-announces-date-first-120000220.html
May 04 2021 - 08:00AM
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced that the company will host a conference call and live audio webcast on Tuesday, May 11, 2021, at 8:00 a.m. ET to review its first quarter 2021 financial results and provide an update on the company.
The webcast will be available on the “Investors & Media” section of the Gamida Cell website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 5258448. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.
About Gamida Cell
Gamida Cell is an advanced cell therapy company committed to cures for patients with blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn or Twitter at @GamidaCellTx.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210504005487/en/
For investors:
Stephanie Ascher
Stern Investor Relations, Inc.
stephanie.ascher@sternir.com
1-212-362-1200
For media:
Matthew Corcoran
Ten Bridge Communications
mcorcoran@tenbridgecommunications.com
1-617-866-7350
Company presentation April:
Gamida Cell (GMDA) Presents At 20th Annual Needham Virtual Healthcare Conference - Slideshow
Apr. 15, 2021 2:49 PM ETGamida Cell Ltd. (GMDA)
The following slide deck was published by Gamida Cell Ltd. in conjunction with this event.
https://static.seekingalpha.com/uploads/sa_presentations/68/68068/original.pdf
Gamida Cell (GMDA)
H.C. Wainwright analyst Vernon Bernardino reiterated a Buy rating on Gamida Cell today and set a price target of $27.00. The company’s shares closed last Wednesday at $8.09.
https://www.analystratings.com/articles/analysts-top-healthcare-picks-arena-pharma-arna-cardiff-oncology-crdf/
Gamida Cell to Present at the 20th Annual Needham Virtual Healthcare Conference
April 07 2021 - 08:00AM
Business Wire
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced that Julian Adams, Ph. D., chief executive officer of Gamida Cell, will present at the 20th Annual Needham Virtual Healthcare Conference on Wednesday, April 14, 2021 at 2:15 p.m. ET.
A live webcast of the presentation 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.
In GMDA?
Yes, I have been in since about the 4s.
After April 6th will look to rebalance my portfolio and aim to pick up some more.
The revenue potential stated here from USA is double my long-time ago conservative estimate. Combine the EU market and a market cap of 10 billion should be easy going.
Excellent.
Given the consistency of the different clinical study results the BLA should be able to be filed successfully, and I feel this company is just a waiting game to approval, which is an easy thing to do. I wouldn't expect any more dilution for quite some time.
GLTA
Gamida Cell (GMDA)
https://finance.yahoo.com/news/rbc-sees-40-plus-upside-163631526.html
We’ll stick with the healthcare sector, and take a look at Gamida, a biotech company focused on using cell therapy to create cures for blood cancers and other serious blood disorders. The company has a proprietary platform that can expand on multiple types of cells. The goal is to create a cell therapy that provides a therapeutic-level dose to the patient.
Gamida’s pipeline includes two agents, under investigation for the treatment of four conditions. At the early stages of the clinical phase process, GDA-201 is being studied as treatment for non-Hodgkin Lymphoma as well as Multiple Myeloma, two dangerous blood cancers. Omidubicel, the second agent, is also in early stages of trials for its efficacy against severe aplastic anemia, but is much farther along in testing as a treatment for high-risk hematologic malignancies.
Earlier this month, Gamida released results of Phase 3 clinical study of omidubicel against those malignancies at the European Society for Blood and Marrow Transplantation (EBMT 2021). The release, recapping data previously made public in December, was based on clinical data from 125 patients aged 13 to 65. Gamida stated that the study’s secondary endpoints “demonstrated a statistically significant improvement” among patients treated with omidubicel. In addition, patients given the drug were significantly less likely to require hospitalization in the first 100 days after treatment. Gamida states that it will use this clinical data to support its submission of a Biologics License Application (BLA) to the US FDA in 4Q21.
Among the bulls is RBC’s Gregory Renza who wrote: "We believe that, if successful, omidubicel (NiCord) has a role in the HSCT treatment paradigm across several patient segments including those with no existing donor options. Should the data continue to demonstrate a favorable profile and the program ultimately convert, we see potential for more than $1.4B in peak sales, with GMDA capturing ~$800M revenues from assumed standalone U.S. efforts…”
To this end, Renza rates GMDA shares an Outperform (i.e. Buy) along with a $14 price target. Investors stand to pocket a 95% gain should the analyst's thesis play out. (To watch Renza’s track record, click here)
Wall Street was clearly impressed by Gamida’s results, as the stock has a unanimous Strong Buy consensus rating, based on 6 recent Buy-side reviews. The stock is selling for $8.95, and its $19 average price target suggests a one-year upside of 112%. (See GMDA stock analysis on TipRanks)
Gamida Cell Presents Efficacy and Safety Results of Phase 3 Study of Omidubicel in Patients with Hematologic Malignancies at the 47th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT)
https://finance.yahoo.com/news/gamida-cell-presents-efficacy-safety-142400116.html
-Abstract will be shared at Presidential Symposium and featured in this year’s "Live with Best Abstracts" session-
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced the results of a Phase 3 clinical study of omidubicel presented in an oral session at the Presidential Symposium of the 47th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT 2021). In addition to the Presidential Symposium, the session will be featured in a live panel discussion, "EBMT Talks: Live with the Best Abstracts."
"There is an acute need in stem cell transplantation to treat patients who do not have access to a matched donor, and the results of this global Phase 3 study demonstrate that omidubicel has the potential to address this critical gap," said Professor Guillermo F. Sanz, M.D., Ph.D., Head, Hematology Department, Hospital Universitario y Politécnico La Fe in Valencia, Spain. "In the study, treatment with omidubicel showed faster hematopoietic recovery, fewer bacterial and viral infections and fewer days in hospital. These pivotal data create a compelling case that omidubicel could transform outcomes for patients."
This clinical data set, which was also recently presented at the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy (ASTCT) and Center for International Blood & Marrow Transplant Research (CIBMTR), or the TCT Meetings, was from the international, multi-center, randomized Phase 3 study of omidubicel designed to evaluate the safety and efficacy of omidubicel in patients with high-risk hematologic malignancies undergoing a bone marrow transplant compared to patients who received a standard umbilical cord blood transplant.
"The inclusion of the omidubicel Phase 3 results in these prominent sessions at EBMT 2021 and other recent prestigious peer-reviewed settings reinforce the strength of these data and the potential of omidubicel to make a meaningful impact in the hematopoietic bone marrow transplant treatment landscape," said Julian Adams, Ph.D., chief executive officer of Gamida Cell. "As always, we thank the patients and investigators in this global clinical trial for their contributions as we work to bring this potentially curative cell therapy to those whose future depends on stem cell transplantation but who do not have a matched donor."
The full presentation shared at the Presidential Symposium is available on the Gamida Cell website.
Details of Phase 3 Efficacy and Safety Results Shared at EBMT
Patient demographics including racial and ethnic diversity and baseline characteristics were well-balanced across the two study groups. The study’s intent-to-treat analysis included 125 patients aged 13–65 years with a median age of 41. Diseases included acute lymphoblastic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, myelodysplastic syndrome or lymphoma. Patients were enrolled at more than 30 clinical centers in the United States, Europe, Asia, and Latin America.
Gamida Cell previously reported in May 2020 that the study achieved its primary endpoint, showing that omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment, a measure of how quickly the stem cells a patient receives in a transplant are established and begin to make healthy new cells, and a key milestone in a patient’s recovery from a bone marrow transplant. The median time to neutrophil engraftment was 12 days for patients randomized to omidubicel compared to 22 days for the comparator group (p < 0.001).
All three secondary endpoints demonstrated a statistically significant improvement among patients who were randomized to omidubicel in relation to patients randomized to the comparator group (intent-to-treat). Platelet engraftment was significantly accelerated with omidubicel, with 55 percent of patients randomized to omidubicel achieving platelet engraftment at day 42, compared to 35 percent for the comparator (p = 0.028). The rate of infection was significantly reduced for patients randomized to omidubicel, with the cumulative incidence of first grade 2 or grade 3 bacterial or invasive fungal infection for patients randomized to omidubicel of 37 percent, compared to 57 percent for the comparator (p = 0.027). Hospitalization in the first 100 days after transplant was also reduced in patients randomized to omidubicel, with a median number of days alive and out of hospital for patients randomized to omidubicel of 60.5 days, compared to 48.0 days for the comparator (p = 0.005). The details of these data were first reported in December 2020.
Data from the study relating to exploratory endpoints also support the clinical benefit demonstrated by the study’s primary and secondary endpoints. There was no statistically significant difference between the two patient groups related to grade III/IV acute GvHD (14 percent for omidubicel, 21 percent for the comparator) or all grades chronic GvHD at one year (35 percent for omidubicel, 29 percent for the comparator). Transplants with umbilical cord blood, the comparator, have been historically shown to result in low incidence of GvHD in relation to other graft sources, and in this study, omidubicel demonstrated a similar GvHD profile. Non-relapse mortality was shown to be 11 percent for patients randomized to omidubicel and 24 percent for patients randomized to the comparator (p = 0.09).
These clinical data results will form the basis of a Biologics License Application (BLA) that Gamida Cell expects to submit to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2021.
Gamida Cell price target lowered to $23 from $25 at Piper Sandler Piper Sandler analyst Edward Tenthoff lowered the firm's price target on Gamida Cell to $23 from $25 and keeps an Overweight rating on the shares. With the Highbridge convertible note, Tenthoff estimates Gamida Cell holds pro forma cash of $202M, which will fund operations into the second half of 2022, the analyst tells investors in a research note. Gamida Cell expects to file an IND for GDA-201 and initiate a Phase I/II study in DLBCL and follicular lymphoma in 2H21, the analyst adds.
https://thefly.com/landingPageNews.php?id=3263168&headline=GMDA-Gamida-Cell-price-target-lowered-to--from--at-Piper-Sandler1615310331
GAMIDA CELL (GMDA) RECEIVED ITS THIRD BUY IN A ROW
https://www.markets.co/gamida-cell-gmda-received-its-third-buy-in-a-row-5/302857/
March 9, 2021 Bryan Anderson
After Piper Sandler and Oppenheimer gave Gamida Cell (NASDAQ: GMDA) a Buy rating last month, the company received another Buy, this time from Needham. Analyst Chad Messer maintained a Buy rating on Gamida Cell today and set a price target of $14.00. The company’s shares closed last Tuesday at $8.41.
According to TipRanks.com, Messer is a 4-star analyst with an average return of 6.6% and a 46.8% success rate. Messer covers the Healthcare sector, focusing on stocks such as Ionis Pharmaceuticals, Autolus Therapeutics, and Sarepta Therapeutics.
The word on The Street in general, suggests a Strong Buy analyst consensus rating for Gamida Cell with a $19.00 average price target.
Gamida Cell Ltd. (GMDA) CEO Julian Adams on Q4 2020 Results - Earnings Call Transcript
https://seekingalpha.com/article/4412515-gamida-cell-ltd-gmda-ceo-julian-adams-on-q4-2020-results-earnings-call-transcript
Mar. 09, 2021 12:07 PM ETGamida Cell Ltd. (GMDA)
Gamida Cell Ltd. (NASDAQ:GMDA) Q4 2020 Results Conference Call March 9, 2021 8:30 AM ET
Company Participants
Josh Hamermesh - Chief Business Officer
Julian Adams - CEO
Ronit Simantov - Chief Medical Officer
Shai Lankry - CFO
Michele Korfin - COO and Chief Commercial Officer
Tracey Lodie - Chief Scientific Officer
Conference Call Participants
Ted Tenthoff - Piper Sandler
Jonathan Miller - Evercore ISI
Roy Buchanan - JMP Securities
Gregory Renza - RBC Capital Markets
Mark Breidenbach - Oppenheimer
Gil Blum - Needham & Company
Operator
Ladies and gentlemen, thank you for standing by. Welcome to Gamida Cell’s Conference Call for the Full Year Financial 2020 Results. My name is Brandi, and I’ll be your operator for today’s call. Please be advised that this call is being recorded at Gamida Cell’s request.
Now, I would like to introduce your host for today’s conference, Mr. Josh Hamermesh, Chief Business Officer. Please go ahead.
Josh Hamermesh
Thank you, Brandi, 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 2020.
Earlier this morning, we issued a press release summarizing our financial results and progress across the Company, which is available on our website at www.gamida-cell.com. Here with me on our call today are Julian Adams, Chief Executive Officer; Ronit Simantov, Chief Medical Officer; and Shai Lankry, Chief Financial Officer. Michele Korfin, our Chief Operating Officer and Chief Commercial Officer; and Tracey Lodie, our Chief Scientific Officer, are also on hand for the Q&A portion of the call following our prepared remarks.
During this call, we may make forward-looking statements about our future expectations and plans, including clinical development and commercial objectives, the therapeutic potential of our product candidates, our operational plans and strategies, and projected operating expenses and cash runway. Our actual results may differ materially from what we project today due to a number of important factors, including the considerations described in the Risk Factors section of our Form 20-F and in other filings that Gamida Cell makes 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, future events or otherwise.
Now, I’d like to turn the call over to Julian.
Julian Adams
Thank you, Josh. And thanks to everyone for joining us this morning.
At Gamida Cell, we are at the forefront of developing and commercializing potentially curative medicines for patients by harnessing our proprietary NAM cell expansion technology. This platform provides us with an opportunity to create therapies that could redefine standards of care for patients with life-threatening diseases.
2020 was an important year for Gamida Cell as we made significant progress across our entire pipeline, including omidubicel, which is poised to become the first FDA approved cell therapy for bone marrow transplantation. And GDA-201, an innate natural killer cell or NK cell therapy. Today, we’ll review both programs and summarize our progress around plans to bring omidubicel to patients in the commercial setting, pending FDA review.
Starting with our lead program, omidubicel has completed a pivotal randomized Phase 3 study. This global trial evaluated omidubicel versus standard cord blood in patients with hematologic malignancies, who needed a bone marrow transplant, but did not have a suitable match donor. The primary endpoint of the study was time to neutrophil engraftment, or the time it took for the white blood cells to recover following transplantation.
In 2020, we reported the omidubicel Phase 3 data including primary and secondary endpoints, demonstrating its clinical benefit and made important advances to be launched ready upon FDA approval. Following our December Type B meeting with FDA, we now have a very clear understanding of the omidubicel commercial manufacturing requirements. We are on track to fulfill these requirements to submit the full BLA by the end of 2021 and meet the commercial supply needs.
As we continue to advance omidubicel for a potential launch and prepare to become a commercial organization, we are establishing key commercial capabilities, including the creation of Gamida Cell Assist a program designed to support a positive patient and transplant center experience. With over 13,000 patients with hematologic malignancies eligible for transplant annually and approximately 200 transplant centers in the U.S., we plan to focus on patient access and support of every individual and their caregivers at each step of the process.
In addition, we have conducted extensive market research, and I’ve been encouraged by the feedback from physicians and payers indicating the opportunity for omidubicel to improve safety and efficacy outcomes. Following FDA approval, the market research supports that omidubicel will be an important therapy for all patients in need of an allogeneic stem cell transplant, who do not have access to an appropriate match related donor. Omidubicel cell also has the opportunity to increase access for patients who are not currently able to find a match.
Moving to the rest of our pipeline, we’re also pleased to report significant progress for GDA-201, our first NK cell-based product candidate. Natural killer cells are innate immune cells that hold tremendous promise for treating cancer. A challenge in the field includes the ability to expand NK cells in culture while preserving their functionality. Our NAM based technology addresses this challenge and potentially improves their direct tumor killing potential and antibody-dependent cellular cytotoxicity known as ADCC.
GDA-201 has demonstrated impressive proof-of-concept in our Phase 1 study, which was designed to assess the safety of GDA-201 in combination with a monoclonal antibody in non-Hodgkin lymphoma, or multiple myeloma. The data from our ongoing Phase 1 study has demonstrated striking early signs of efficacy with multiple durable complete responses, while being very well tolerated in patients with advanced lymphoma.
We have now developed a cryopreserved formulation in support of our vision to support a multicenter off-the-shelf allogeneic cell therapy with durable deep responses and a favorable safety profile. Furthermore, we are leveraging the NAM expansion platform to develop a pipeline of gene edited NK cell product candidates with enhanced function for both hematologic malignancies and solid tumors.
Based on the impressive clinical data generated by both omidubicel and GDA-201, we have significantly strengthened our financial position by raising approximately $220 million in the past year. These proceeds will support the development of both programs and provide sufficient capital through the potential omidubicel product approval and launch by mid-2020.
I want to conclude my introductory remarks by acknowledging the challenges of the past year as we navigated through the COVID-19 pandemic and the resilience and dedication of the Gamida Cell team as we work to bring cures to patients.
I’ll now turn the call over to Ronit Simantov, our Chief Medical Officer, to provide further details on omidubicel and GDA-201. Ronit?
Ronit Simantov
Thank you, Julian, and good morning, everyone.
This morning, I’ll review our clinical programs and highlight the data we presented throughout 2020 on both omidubicel and GDA-201. I’ll start with the Phase 3 study of omidubicel.
In May 2020, we were pleased to report that the study met its primary endpoint time to neutrophil engraftment. In October, we reported the Phase 3 study also met all three pre-specified secondary endpoints, platelet engraftment, infections and hospitalizations. These positive study outcomes, as well as additional exploratory endpoints were presented in a peer reviewed setting for the first time at the TCT meeting a few weeks ago. And there will be an encore presentation at the presidential session of the European Bone Marrow Transplant annual meeting next week.
The trial was well conducted and rigorously designed study, analyzed on an intent-to-treat basis. 125 patients were randomized, 52 with omidubicel arm, and 53 for standard cord blood. Demographics and baseline disease characteristics were well balanced and reflected a diverse population of patients with hematologic malignancies in need of allogeneic bone marrow transplant.
Clinical outcomes supported the superior neutrophil engraftment demonstrated in the primary endpoint analysis. Specifically, patients randomized to omidubicel had fewer serious bacterial, fungal and viral infections than the comparative group. Patients also spent significantly less time in the hospital in first 100 days after transplant.
Importantly, omidubicel was generally well tolerated. And in particular, the incidence of both acute and chronic graft versus host disease, which has been shown to be lower in patients transplanted with cord blood than in other modalities, was statistically similar in the two arms.
While the study was not designed to detect a difference in relapse or mortality endpoints, we reported the results of these analyses, including non-relapse or transplant-related mortality, which was 11% for patients randomized to omidubicel and 24% for patients randomized to comparator, and overall survival, which was 73% in the omidubicel arm and 52% for control.
The data we presented in 2020 continued to strengthen our confidence in the clinical potential of omidubicel. I want to thank the investigators, patients and caregivers that participated in our study. We are grateful for their support as we move the field forward. With these data in hand, we anticipate submitting the BLA for omidubicel in the fourth quarter of this year. We believe that omidubicel also has potential to treat patients with diseases beyond hematologic malignancies and are currently investigating omidubicel in patients with severe aplastic anemia, a rare life-threatening blood disorder, in an investigator sponsored Phase 1/2 study being led by Dr. Richard Childs at the National Institutes of Health.
At the recent American Society of Hematology Conference, we presented data from a total of eight patients, three who underwent stem cell transplant with omidubicel plus haploidentical stem cells, and five patients who received omidubicel as a standalone graft. The data showed that transplantation with omidubicel following reduced intensity conditioning was generally well-tolerated and led to rapid engraftment. With a median follow-up of 10 months, seven of the eight patients had early and sustained engraftment and were no longer dependent on transfusion. Neutrophil and platelet recovery occurred at the median of 10 days and 31 days, respectively.
We are encouraged by these data in patients who are at high risk for graft failure with conventional cord blood transplant. This study is still ongoing.
As Julian mentioned, in addition to omidubicel, we are advancing our first NK cell therapy, GDA-201. We have demonstrated impressive proof-of-concept in our Phase 1 study, which is designed to assess the safety of GDA-201 in combination with a monoclonal antibody in patients with non-Hodgkin lymphoma or multiple myeloma. The study is being conducted by Dr. Veronika Bachanova at the University of Minnesota.
At ASH, we presented safety data from 35 patients with relapse or refractory disease, 19 patients with non-Hodgkin lymphoma and 16 with myeloma. GDA-201 was generally well-tolerated with no dose limiting toxicity, no GvHD and importantly, no neurotoxicity observed.
We were also very impressed with the promising clinical activity at all doses evaluated in patients with lymphoma. These patients were heavily pre-treated with the median of three prior lines of chemotherapy. Of the 19 patients with lymphoma, 13 had complete responses and 1 had a partial response for an overall response rate of 74% and a complete response rate of 68%. Responses were observed in patients with follicular and diffuse large B-cell histologies. We’re developing a cryopreserved formulation and will be submitting our IND in the second half of this year. This will allow us to conduct a multicenter, multi-dose study to explore the potential of GDA-201 as off-the-shelf cell therapy in patients with lymphoma. I’m very proud of our team and their dedication to advancing our clinical study during the global pandemic.
I’ll now turn the call over to Shai to review our financial results.
Shai Lankry
Thank you, Ronit, and good morning, everyone. Today, I will summarize our financial results for the full year of 2020.
As of December 31, 2020, we had total cash and cash equivalents of $127.2 million, compared to $55.4 million as of December 31, 2019. As Julian mentioned, during 2020, we were able to significantly enhance our capital position with raising total of $144 million in gross proceeds from our May and December public offerings. In addition, in February 2021, we announced a $75 million financing with Highbridge Capital Management. Those financing transactions extend our cash run way beyond the potential BLA approval of omidubicel expected by mid-2022.
Research and development expenses for the year were $41.5 million, compared to $31.5 million in 2019. The increase was mainly due to advancing the GDA-201 clinical program, and clinical activities related to concluding our Phase 3 trials, as well as additional headcount within the R&D organization.
Commercial expenses in 2020 were $8.7 million, compared to $4.7 million last year. The increase was mainly attributed to omidubicel launch readiness activities, which includes addition to our commercial leadership team.
General and administrative expenses were $12.2 million for 2020, compared to $12.1 million for 2019. The increase was mainly attributed to $1.3 million increase in professional services expenses, including legal insurance, offset by a decrease of $1.2 million in travel, and non-cash compensation expenses.
Finance expenses, net, were $10.4 million for the year, compared to finance income, net, of $13.8 million in 2019. The increased expenses were primarily due to non-cash expenses, resulting from revaluation of warrants owned by our shareholders, and the revaluation of the Israeli Innovation Authority royalty-bearing grant liability.
Net loss for the year was $72.7 million, compared to a net loss of $34.4 million last year. We expect that our cash used for ongoing operating activities this year will range from $100 million to $120 million. We anticipate our current total cash position will support our ongoing operating activities into the second half of next year. This cash runway guidance is based on our current operational plans and excludes any additional funding that may be received or business development activities that may be undertaken.
With that I will turn the call back over to Julian.
Julian Adams
Thanks, Shai. We are dedicated to finding cures for patients with hematologic malignancies and blood disorders. And we’re excited about the opportunities ahead. With omidubicel, we expect to submit the BLA in the fourth quarter of this year and are committed to being launch-ready at the time of approval. With GDA-201, we have very compelling data in lymphoma and are planning to initiate the Gamida Cell sponsored clinical study, which could transition into a registrational trial, if the data are consistent with our Phase 1 results.
So, as you can see, we expect 2021 to be a transformational year for Gamida Cell. And we look forward to updating you on our progress throughout the year.
Now, we will open the call for questions. Brandi?
Question-and-Answer Session
Operator
[Operator Instructions] Your first question comes from the line of Ted Tenthoff with Piper Sandler.
Ted Tenthoff
Great. Thank you very much, and congrats on all the progress. Julian, maybe you can just walk us through sort of what’s being done both in terms of preparing for the BLA submission, but also concurrently with respect to commercial build-up as you prepare for omidubicel? Thank you.
Julian Adams
Okay. Let me begin with the modules that are being prepared for the BLA submission. The non-clinical module is complete and ready. And the clinical module will be completed in the near-term. And lastly, the CMC module will be completed by the fourth quarter, all of which will be necessary for BLA submission.
Let me turn it over to Michele to talk about our commercial preparations.
Michele Korfin
Excellent. Thank you, Julian. And good morning, Ted. In regards to commercial, there’s really been three key aspects we’re focused on. The first is leaders, and Shai alluded to this in his prepared remarks. We brought in some outstanding leaders on the commercial team, Rocio Manghani, leading Market Access with great experience in hematology and cell therapy; Linda Stamler, was recently brought on to lead Marketing and Account Management, and they joined a couple of our other already established leaders. So, we have a great leadership team in place. The next key area was to finalize the commercial strategy upon FDA approval, who have great market insights that support the fact that upon FDA approval on the omidubicel will be a very important therapy option for patients who need an allogeneic stem cell transplant who do not have access to an appropriate matched related donor. It’s a very exciting market opportunity for omidubicel, and we are very clear in terms of what now needs to be done to execute on that strategy. And that’s really the third part.
So, we’ve got our launch readiness plans underway. Really that all encompassing thought around making sure everything we’re doing is leading to a positive experience for the patients and for the transplant centers, we’re focused on four key aspects, making sure we educate the transplant centers, making sure that we educate the payers, the third is making sure we have that strong support system through Gamida Cell Assist, and finally, our commercial manufacturing readiness. Julian alluded to this in his prepared remarks. We’re moving along very nicely with our new facility in Israel and Kiryat Gat. We’re also partnering with Lonza for their readiness for the BLA. So, we’re very much looking forward to the opportunity to introduce omidubicel to patients upon FDA approval.
Operator
Your next question comes from the line of Jonathan Miller with Evercore ISI.
Jonathan Miller
Hi, guys. Thanks for taking my question. I’ll just follow up a little bit on that commercial ramp question. Obviously, the BLA in 4Q, you’ve got some time to prep. And I understand you’ve got a strategy in place now. How do you think about spend ramping throughout the year as you hire folks and how big a sales team will you need to achieve your commercial plan? Then secondly, I’d love to ask about GDA-201. One of the interesting factors about this product is naturalistic expansion of the NK cells with NAM. But now, you’re introducing additional -- later in the pipeline, you’re introducing additional engineering in gene editing to these products. How do you think about balancing, adding that functionality, while maintain a healthy cell profile and maintain a biological profiling if that product is there?
Julian Adams
So Michele, please address the first question. And thank you, Jonathan. And I will address the NK questions.
Michele Korfin
Yes, absolutely. Thank you, Jonathan. Good morning. So, in regards to the ramp-up and personnel, obviously, the personnel in the field will be key to our success. The good news for us is this is a very efficient launch from the standpoint of personnel and also through lead spending. So, when you look at the target, so let’s start with the transplant centers. There’s roughly 200 FACT accredited transplant centers in the U.S. We know many of these centers quite well. Ronit and her team had direct experience with at least 20 during the clinical trials. And then, we certainly know more centers, so. And we also know that 70 centers make up about 80% of the transplants in the U.S. So, we anticipate a very targeted and efficient launch in terms of field force.
In terms of actual numbers, so our field personnel will fall into three main categories with obviously supporting groups. The first will be on the commercial side, the account management team. If you look at benchmarks of other cell therapy launches in the U.S., you’re probably looking at 20 to 25 personnel that would be needed to effectively launch the therapy and have that positive patient experience. We’ll also have individuals focused on the payer space led by Rocio Manghani that’s also a relatively small footprint because the U.S. private payers are relatively consolidated. So, probably about 10 personnel there. And then, we’ll have an outstanding group led by Ronit’s medical affairs colleagues that are medical science liaisons who are supporting the educational initiatives with both the transplant centers and the payers.
So, we have a clear path going forward. And again, based on our experience and cell therapy, it will be a very efficient launch from a headcount spending standpoint.
Julian, I’ll turn it back to you.
Julian Adams
Turning to the NK cells. So, our first product candidate GDA-201 is a non-engineered expanded cell therapy in combination with rituximab for lymphoma. And let me invite Tracey to talk about our plans for engineering the NK cells, particularly as we consider addressing solid tumors.
Tracey Lodie
Sure. Thank you, Julian. And thanks for the question, Jonathan. And with regard to your first part, we’re still, as Julian said, expanding up our NK cells with nicotinamide. And because of this, we have unique potential in our NK cells to maintain receptors that are on the cell surface, such as CD62L, which we believe uniquely causes ourselves to home into T-malignancies and lymphoid organs, and as well as very important CD16 receptor for ADCC. So, additional editing efforts will maintain those properties and function of the cells that we see with NAM, but will further enhance what we think will allow ourselves to survive and suppresses tumor microenvironment by editing off some negative receptors and negative co-stimulatory receptors, just to make the cells potentially more active and persistent in the tumor microenvironment as we expand upon this research effort in the lab this year to make these engineered products.
So, I’ll turn it back to Julian.
Julian Adams
Have we adequately answered your question, Jonathan?
Jonathan Miller
Well, I look forward to seeing how that program develops and exactly how those behave. And indeed, for now, I think that...
Julian Adams
Yes. We haven’t named specific targets yet. We will do so at an appropriate time in the future. But, right now the research is ongoing under the Tracey’s supervision. And we’re very encouraged about what we’re seeing.
Operator
And your next question comes from the line of Jason Butler JMP Securities.
Roy Buchanan
Hi. It’s Roy on for Jason. Thanks for taking our questions. Sorry if I missed these in the prepared remarks. But, anything at the EBMT meeting next week that we can expect that’s different from the TCT meeting? And then, for omidubicel, just wondering if you can guys can disclose how many patients have been treated in the expanded access? Then, I had a follow-up on 201? Thanks.
Julian Adams
Ronit, this is for you.
Ronit Simantov
Thanks. So, with respect to the EBMT meeting, we’re excited at the opportunity that the data will be presented in the European forum. And it’s being highlighted in high-profile session, the Presidential session. There will also be a panel session in which the investigators, the European TI [indiscernible] who will be participating in a Q&A session live later on that same day. In terms of the data themselves, it’s basically the same data set that were presented at the TCT meeting, but of course, with some added nuance from Dr. Sanz, in his remarks and his panel discussion.
In terms of expanded access, we haven’t been updating on the number of patients or the progress at this point. The study is open at six sites across the U.S. It’s opening in a variety of sites, and there’s enthusiasm from investigators to enroll patients. In the future, we do hope to provide some detail about the patients and their outcomes. But, we haven’t been giving those updates on an ongoing basis.
Roy Buchanan
And then for 201, what remains gating for the IND filing? And here I’m on this that cryopreserved formulation has been finalized, then the FDA going to sign off on the formulation prior to the formal, full IND filing, or how does that work? Thanks.
Julian Adams
Tracey, would you address that, please?
Tracey Lodie
Sure. Thank you, Julian. In terms of what’s left before we file the IND, it really is CMC section for GDA-201 and finalizing their cryo formulation. The cryo formulation has been finalized in a lab. It’s now just a matter of -- and it’s scale for clinical scale. It’s now just a matter of manufacturing, enough of that for our clinical batches for stability at our GMP facility, which will be in Israel, before we’re able to file the IND. And yes, presumably, we’re in active discussions with the FDA. So, both the protocol and the final formulation of off the shelf our product that’s cryopreserved will be discussed and agreed upon with them.
Operator
Your next question comes from the line of Gregory Renza with RBC Capital Markets.
Gregory Renza
Hey Julian and team. Congratulations on all the progress, and thanks for taking my question. Julian, just in regards to the module that -- just wanted to confirm, I believe you mentioned that the clinical module will be completed, submitted shortly, as well as the manufacturing by end of the year. Just curious if you can maybe characterize or quantify just the level of analytical and critical comparability that is necessary from omidubicel with extensions, not disclosing the patients now but just curious if there is a data set of patient number that the FDA would like to see for their comfort there? And then, just in terms of the preparations, great to hear all the color from Michele. I’m just curious, what has -- the extended timeline for rolling 4Q 2020 start BLA end of this year, and what does that afford you as far as that preparation and getting that launch right? And maybe just the final question there for Michele. Where are the gaps or the skeptical areas that are most likely to get in the way of realizing the omidubicel vision ultimately? Thank you very much.
Julian Adams
Yes. So, let me just start at a high level and turn it to Ronit to talk about the clinical module and the CMC requirements. We had a very detailed conversation with FDA in December. And we have very clear understanding of what they’re looking for in terms of CMC both analytical compatibility, as well as clinical compatibility from our commercial manufacturing sites. Ronit, do you have anything more to add?
Ronit Simantov
Yes. I think, we’ve shared data with FDA about our clinical results and we told them or shared with them our plans in terms of the new commercial facilities. We believe that submitting a high-level data on three to five patients will be sufficient for establishing that -- the clinical results are adequate to support production at those sites. So, that’s where we landed in terms of the new production.
Julian Adams
And Michele, the second part of the question to you.
Michele Korfin
Yes, absolutely, and thank you. And interestingly, there was a two-part question. They are actually both addressed in the same way. So, what the extra time allowed us for commercial readiness and any concerns around potential gaps, what we were able to do with the additional few months was identified where were there potential challenges and how would we be able to overcome them? So, now we have that ability to address them proactively.
It really came down to three key areas, one was hiring. So, as I mentioned, we have been able to take the opportunity to hire some great individuals with commercial experience, both on the commercial side and then on the operation side too. The two specific areas that we’ve also been able to proactively focus on just addressing challenges would be around manufacturing for commercial readiness and our actual commercial launch. So, manufacturing for commercial readiness, we’re making very, very nice progress at our facility in Kiryat Gat, just not only in terms of the FDA requirements for the BLA, but also for overall commercial supply, readiness upon FDA approval. So, that is moving along nicely to plan.
And then, the second area around commercial readiness, this gave us some additional time to understand the needs of the transplant centers upon potential approval of omidubicel. And that’s in partnership with Ronit’s medical affairs team. We also have the opportunity to also partner with Ronit’s team to focus on the education of the commercial payers, and really making sure that they understand the great unmet need from omidubicel and understand the value proposition of omidubicel, both in terms of the clinical data and the health economic side. So, we’re excited about the progress on both the manufacturing and commercial side for launch readiness.
So, Julian, I’ll turn it back to you.
Julian Adams
Yes. And, we hopefully adequately answered your question. Any further follow-up on your end?
Gregory Renza
That’s great. Thank you very much. I appreciate the color.
Julian Adams
Thank you.
Operator
Your next question comes from the line of Mark Breidenbach with Oppenheimer.
Mark Breidenbach
Hey guys. Thanks for taking the questions. This is related to some of the others that have already come up. But Julian, I was wondering if you could give us a little more color on why the CMC module is the rate limiting step in the BLA application for BLA filing? And have you reached an agreement with the FDA regarding sort of the criteria yet?
Julian Adams
Yes. I mean, it’s not uncommon that CMC is usually the rate limiting step for any product, but in particular in cell therapy, where there’s a lot more attention and just different criteria to be adequate for supplying the commercial marketplace. So, this is not unusual. Michele, you can probably reflect on your experience at Kite, when you were launching as YESCARTA.
Michele Korfin
Thank you, Julian. So, we received very clear feedback from FDA at the December Type B meeting. In terms of the requirements we needed to focus on for the CMC module, just one point to recall is we manufactured our Phase 3 omidubicel at a different Lonza facility. And we knew -- this wasn’t a surprise for us. We knew we were going to be transitioning commercial supply to Lonza, Netherlands facility, and also to Kiryat Gat. So, what the FDA had discussed with us in December and what we’re focused on now is the compatibility requirements that are needed for the commercial facilities as compared to the Phase 3.
So, these are analytical compatibilities, the clinical data that we discussed, some of the methods validation work. All of that is mapped out and on track at our Kiryat Gat facility at this point time. Lonza, Netherlands had already begun some of the work on that. So, the big takeaway is FDA was very clear in December, and we’re now moving along nicely in partnership with our research colleagues and also our clinical colleagues to assure not only readiness for the BLA, but this also gives us the opportunity to assure readiness for the commercial supply from a manufacturing standpoint too.
Mark Breidenbach
Okay. That’s super helpful. And just a quick follow-up on GDA-201. Given that there are some key differences in the types of donors that you plan to use for your trial, and the fact that you’re using cryopreservation versus fresh product that we’ve seen in the academic sponsored study. I’m wondering if you have plans to present any preclinical, either in vitro cell filling essays or mouse data demonstrating equivalence between these two versions of GDA-201 later this year. Thanks.
Julian Adams
Thanks for your question. Tracey, I’ll turn that over to you as well.
Tracey Lodie
Yes, sure. Thank you. Yes. As you point out, for our IND filing, GDA-201 will now be a completely off-the-shelf and cryopreserved product. It’s still from the same source from normal donor apheresis material. But just as a reminder, the clinical study that was done with collaboration with Minnesota was from a related donor. So, the majority of those were haplo donors whereas this will be completely allo.
We do have plans to present some mechanistic work that we continue to do, understanding the further phenotype of our NAM expanded NK cells over this new manufacturing protocol, which is cryopreserved, and with our sites at presenting some of this work towards the end of this year at a conference, maybe likely ASH, but maybe another research conference. And at that time, we can present work on both pre-clinically and the compatibility between the fresh and the frozen that work is ongoing and in the lab in Israel. And we have done quite extensive studies to show that we maintain both the function and the phenotype with the expanded NAM NK cells, both at harvest and both after saw of the cryopreserved formulation, so that we will obviously present this data in the IND filing as well.
Operator
Your next question comes from the line of Gil Blum with Needham & Company.
Gil Blum
Hello, everyone, and thank you for taking our questions. So, just a quick one. We saw something of a trend with the overall survival in the pivotal study. Any thoughts on conducting an outcome study, maybe post approval or do you have any plans in that direction?
Julian Adams
So indeed, we saw strong trend for overall survival. I would remind you that we were not powered for overall survival. And let me invite Ronit to further comment on follow-up of our patients.
Ronit Simantov
Absolutely, Gil. So, thank you. So, in terms of following additional information on patients, we will have additional follow-up for the patients in our Phase 3 study over time, and as well as patients who enroll in our expanded access study, which is basically a single arm study of omidubicel. Post approval, we don’t have any clear plans yet at this point on the type of follow-up that will do for patients in the real world. But, all patients who are transplanted in the U.S. are followed in the registry by CIBMTR. So, there may be an opportunity to leverage that in the post marketing setting.
Gil Blum
Excellent. And maybe kind of another question. So, we see a lot of different benefits for the NAM platform. Any thoughts about using this for gene therapy purposes? It allows the expansion of hematopoietic stem cells. And now, you’re looking at engineered hematopoietic stem cells. So, I believe this is really large there.
Julian Adams
It’s a very good point. And that is not lost on us. And we are exploring quite a number of avenues in the laboratory setting. And we have nothing to report at this time. But stay tuned because we think this platform will be the gift that keeps on giving, as we entertain other expansion of different cell types. And again, we think this is a universal expansion platform and are doing a lot of preclinical work to understand with greater specificity the mechanism of action and how this can be applied across the board.
Operator
There are no further questions at this time. And I’d now like to turn the call back over to Julian for any closing remarks.
Julian Adams
Thank you everyone for joining us on today’s call, and we look forward to an exciting 2021 and future engagements with you all. Thank you.
New company presentation - March 2021
https://investors.gamida-cell.com/static-files/7100dbae-f233-4eed-a90b-dacf3e64c895
Gamida clibs 5.6% despite a Q4 miss, provides 2021 guidance
Mar. 09, 2021 11:22 AM ETGamida Cell Ltd. (GMDA)By: Manshi Mamtora, CFA
Gamida (GMDA +4.7%) Q4 net loss for 2020 was $72.7M, compared to a net loss of $34.4M in 2019.
GAAP EPS of -$1.66 misses consensus by $0.35.
R&D expenses in 2020 were $41.4M, compared to $31.5M in 2019.
As of December 31, 2020, had total cash and cash equivalents of $127.2 million, compared to $55.4 million as of December 31, 2019.
In addition, on February 16, 2020, company announced the sale of $75M exchangeable senior notes due in 2026 to Highbridge Capital Management.
Guidance 2020: Company expects cash used for ongoing operating activities in 2021 to range from $100M-120M; expects that its current cash and cash equivalents will support the company’s ongoing operating activities into 2H of 2022.
Expected 2021 milestones: Omidubicel: BLA submission to the FDA in Q4 2021 and commercial readiness activities underway for potential launch at approval.
GDA-201: submit company-sponsored IND application to the FDA and initiate a Phase 1/2 clinical study in NHL in the second half of 2021.
Gamida Cell Reports Full Year 2020 Financial Results and Provides Company Update
https://finance.yahoo.com/news/gamida-cell-reports-full-2020-120000220.html
– Primary and secondary endpoints were met, key exploratory endpoints supported clinical benefit in Phase 3 study of omidubicel in patients with hematologic malignancies; BLA submission anticipated in fourth quarter of 2021-
— Omidubicel commercial preparation underway, including the creation of Gamida Cell Assist, to support potential launch —
– GDA-201 demonstrated significant clinical activity in Phase 1 study of patients with non-Hodgkin lymphoma, with multiple complete responses observed; Phase 1/2 clinical trial planned with IND submission anticipated in the second half of 2021—
– Strengthened financial position with sale of $75M ordinary shares in December 2020 and $75M exchangeable senior notes in February 2021; sufficient liquidity to fund the company’s operations into the second half of 2022 —
– Company to host conference call at 8:30 a.m. ET today –
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases, today reported financial results for the year and quarter ended December 31, 2020. The company also highlighted progress with omidubicel, an advanced cell therapy in Phase 3 clinical development as a potentially life-saving treatment option for patients in need of bone marrow transplant, and GDA-201, a natural killer (NK) cell immunotherapy in Phase 1 development in patients with non-Hodgkin lymphoma (NHL).
"It has been a significant year for Gamida Cell, marked by a number of important achievements that have brought us closer to developing cures for blood cancers and serious hematologic diseases. Omidubicel, an advanced cell therapy that has met all primary, secondary and exploratory endpoints in our Phase 3 study in patients with hematological malignancies, represents a potentially transformative treatment option. The data we presented in 2020, demonstrating the clinical benefit of omidubicel, position us to submit our first BLA for omidubicel in the fourth quarter of 2021," said Julian Adams, Ph.D., chief executive officer of Gamida Cell. "We remain focused on both the BLA submission and preparing for potential commercial readiness, with the announcement of Gamida Cell Assist, a program designed to focus on patient access and a positive omidubicel experience for the patient and the transplant team. We are diligently working to bring omidubicel to patients as soon as possible."
"We believe our NAM-based cell expansion technology has potential for NK cell expansion and we are developing GDA-201, an NK-cell immunotherapy for the treatment of hematologic and solid tumors in combination with antibody therapies. This year, we made meaningful progress with GDA-201, which has demonstrated impressive early results in patients with heavily pre-treated NHL in a Phase 1 investigator-sponsored study. Following these results, we plan to submit an IND to the FDA in the second half of 2021 and initiate a Phase 1/2 study," Dr. Adams continued.
Omidubicel, an investigational advanced cell therapy for allogeneic bone marrow transplant
During the year, Gamida Cell made significant progress to advance its Phase 3 product candidate omidubicel, which is the first cell therapy for bone marrow transplant to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) and which has the potential to be the first FDA-approved engineered cell therapy which can be used as a bone marrow transplant graft. The company presented primary, secondary and exploratory endpoints from the company’s international, multi-center, randomized Phase 3 study of omidubicel demonstrating its clinical benefit as a treatment option for patients in need of a bone marrow transplant.
In May, Gamida Cell reported that the phase 3 study of omidubicel achieved its primary endpoint, demonstrating a statistically significant reduction in time to neutrophil engraftment, a key milestone in recovery from a bone marrow transplant. It was shown that the median time to neutrophil engraftment was 12 days for patients randomized to omidubicel compared to 22 days for the comparator group (p<0.001). The Phase 3 study was designed to evaluate the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing a bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant.
The Phase 3 study additionally met key secondary endpoints related to platelet engraftment, infections and hospitalization, all significant clinical measures in bone marrow transplant, as reported in October 2020. The prespecified secondary endpoints, analyzed in all randomized patients (intent-to-treat), were the proportion of patients who achieved platelet engraftment by day 42, the proportion of patients with Grade 2 or Grade 3 bacterial or invasive fungal infections in the first 100 days following transplant, and the number of days alive and out of the hospital in the first 100 days following transplant. All three secondary endpoints demonstrated a statistically significant improvement among patients who were randomized to omidubicel compared to the comparator group.
Recently, the results of the company’s Phase 3 study of omidubicel were presented at the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy and Center for International Blood & Marrow Transplant Research. The data from the study relating to exploratory endpoints also supported the clinical benefit demonstrated by the study’s primary and secondary endpoints. Safety results were also presented, showing no significant difference between the two patient groups related to grade III/IV acute GvHD (14 percent for omidubicel, 21 percent for the comparator) or all grades chronic GvHD at one year (35 percent for omidubicel, 29 percent for the comparator). Transplants with umbilical cord blood, the comparator, have been historically shown to result in low incidence of GvHD in relation to other graft sources, and in this study, omidubicel demonstrated a similar GvHD profile. The rate of infection was significantly reduced for patients randomized to omidubicel, with the cumulative incidence of first grade 2 or grade 3 bacterial or invasive fungal infection for patients randomized to omidubicel of 37 percent, compared to 57 percent for the comparator (p = 0.027). Additionally, the study demonstrated a reduction in the incidence of viral infections. Non-relapse mortality was 11 percent for patients randomized to omidubicel and 24 percent for patients randomized to the comparator (p=0.09). Overall survival at one year following transplant was 73 percent for patients randomized to omidubicel and 62 percent for patients randomized to control (p=0.16).When considering the patient experience following transplant, faster hematopoietic recovery, fewer bacterial and viral infections and fewer days in hospital are all meaningful results and represent potentially important advancements in care.
Additional omidubicel highlights:
Presented new Phase 1 data from study of omidubicel in patients with severe aplastic anemia (SAA) at ASH: In a poster presentation at ASH, Gamida Cell presented data demonstrating that patients with severe aplastic anemia treated with omidubicel achieved sustained early engraftment and robust immune reconstitution following reduced intensity conditioning. The data suggest that omidubicel can result in rapid engraftment and can achieve sustained hematopoiesis in patients who are at high risk for graft failure with conventional umbilical cord blood transplant. The study remains open for accrual of patients with SAA.
Advanced commercial launch readiness: Gamida Cell recently announced plans for the Gamida Cell Assist program. The transplant process can be challenging and complex for the patient, caregivers and the entire transplant care team. Gamida Cell Assist has been designed to focus on patient access and support of every individual and their caregivers at each step of the process. Once the program is launched, the Gamida Cell Assist case management team will provide a consistent, single point of contact for patients and health care professionals, and work with the transplant center to track production of omidubicel for each individual patient and provide real-time updates on the status of the therapy. The services provided will include coverage and reimbursement support, which may include financial, travel, and lodging assistance. Gamida Cell is committed to supporting a positive journey for patients and their transplant teams so they can focus on what matters most – the patient experience and successful clinical outcomes.
Expanded collaboration with Be The Match BioTherapies®: In October, Gamida Cell and Be The Match Therapies® expanded their existing strategic collaboration for omidubicel. In building upon the existing collaboration, Gamida Cell will work through Be The Match BioTherapies® for the supply of cord blood units, which serve as the starting material for omidubicel. The expanded agreement is designed to provide a smooth process throughout the omidubicel therapy supply chain.
GDA-201, an innate NK cell immunotherapy
Presented updated Phase 1 data at the 62nd ASH Annual Meeting: In December, Gamida Cell announced updated data from the ongoing Phase 1 study of GDA-201 in combination with monoclonal antibodies in patients with NHL and multiple myeloma at the ASH Annual Meeting. GDA-201 in combination with rituximab demonstrated significant clinical activity in relapsed and refractory NHL patients, with 13 complete responses and one partial response observed in the first 19 NHL patients, for an overall response rate of 74 percent. Overall survival and progression-free survival at one year in the NHL cohort suggest durable disease control, with a median follow-up of ten months (range 1–28 months), in heavily pretreated patients. Additionally, there were no dose-limiting toxicities, neurotoxic events, confirmed cytokine release syndrome, GvHD or marrow aplasia.
Continued advancing Phase 1 study of GDA-201: Gamida Cell continues to advance activities to enable the submission of an investigational new drug (IND) application for cryopreserved, off-the-shelf GDA-201 to enable a multi-center, Phase 1/2 clinical study in patients with NHL in the second half of 2021. Gamida Cell is pioneering a novel approach that harnesses the power of its cell expansion technology, which uniquely improves antibody-dependent cellular cytotoxicity and tumor targeting of NK cells.
Corporate Highlights
Strengthened financial position: In December 2020, the company executed an underwritten public offering raising approximately $75 million before deducting underwriting discounts, commissions and offering expenses. Also, in February 2021, the company announced a $75 million financing with Highbridge Capital Management, LLC before deducting offering expenses. These capital infusions will be used to support manufacturing, regulatory and potential commercial development activities for omidubicel and to further the preclinical and clinical development of GDA-201.
Full Year 2020 Financial Results
Research and development (R&D) expenses in 2020 were $41.4 million, compared to $31.5 million in 2019. The increase was mainly due to advancing the GDA-201 clinical program and clinical activities relating to concluding our Phase 3 clinical trial, as well as additional headcount within the R&D organization.
Commercial expenses in 2020 were $8.7 million, compared to $4.7 million in 2019. The increase was attributed to an increase in omidubicel commercial readiness activities as well as additional headcount within the Commercial organization.
General and administrative expenses were $12.2 million in 2020, compared to $12.1 million in 2019. The increase was mainly due to a $1.3 million increase in professional services expenses, including Legal and Insurance, offset by decrease of $1.2 million in Travel and non-cash compensation expenses.
Finance expenses, net, was $10.4 million for 2020, compared to finance income, net, of $13.8 million for 2019. The decrease was primarily due to non-cash expenses resulting from revaluation of warrants owned by certain of the company’s shareholders and the revaluation of the Israeli Innovation Authority royalty-bearing grant liability.
Net loss for 2020 was $72.7 million, compared to a net loss of $34.4 million in 2019.
As of December 31, 2020, Gamida Cell had total cash and cash equivalents of $127.2 million, compared to $55.4 million as of December 31, 2019. In addition, on February 16, 2020, Gamida Cell announced the sale of $75 million exchangeable senior notes due in 2026 to Highbridge Capital Management, LLC.
2020 Financial Guidance
Gamida Cell expects cash used for ongoing operating activities in 2021 to range from $100 million to $120 million.
Gamida Cell expects that its current cash and cash equivalents will support the company’s ongoing operating activities into the second half of 2022. 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.
Expected 2021 Milestones
Gamida Cell plans to achieve the following milestones during 2021:
Omidubicel
BLA submission to the FDA in the fourth quarter of 2021
Commercial readiness activities underway for potential launch at approval
GDA-201
Submit company-sponsored IND application to the FDA and initiate a Phase 1/2 clinical study in NHL in the second half of 2021
Conference Call Information
Gamida Cell will host a conference call today, March 9, 2021, at 8:30 a.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 1996281. A recording of the webcast will be available approximately two hours after the event, for approximately 30 days.
About Omidubicel
Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). In both Phase 1/2 and Phase 3 clinical studies (NCT01816230, NCT02730299), omidubicel demonstrated rapid and durable time to engraftment and was generally well tolerated.1,2 Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn®, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.
Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
About GDA-201
Gamida Cell applied the capabilities of its NAM-based cell expansion technology to develop GDA-201, an innate NK cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. GDA-201 is in Phase 1 development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.3 For more information on the clinical study of GDA-201, please visit www.clinicaltrials.gov.
GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
Gamida Cell Ltd. to Host Earnings Call
https://finance.yahoo.com/news/gamida-cell-ltd-host-earnings-103000568.html
NEW YORK, NY / ACCESSWIRE / March 9, 2021 / Gamida Cell Ltd. (NASDAQ:GMDA) will be discussing their earnings results in their 2020 Fourth Quarter Earnings call to be held on March 9, 2021 at 8:30 AM Eastern Time.
To listen to the event live or access a replay of the call - visit
https://www.investornetwork.com/event/presentation/75309
To receive updates for this company you can register by emailing info@investornetwork.com or by clicking get investment info from the company's profile.
About Investor Network
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SOURCE: Investor Network
You are welcome.This article too:
(in case you missed it)
#msg-162386452
Thank you for sharing this article sir!
Gamida: Catalysts Ahead, Looks Interesting
Mar. 07, 2021 9:07 AM ETGamida Cell Ltd. (GMDA)
https://seekingalpha.com/article/4412025-is-gamida-cell-stock-gmda-a-dip-buy-on-upcoming-catalysts
Summary
GMDA addressed its cash issues, but its approval got a little delayed.
That was because the FDA raised manufacturing concerns.
The company seems confident in its ability to address those.
Looking for more investing ideas like this one? Get them exclusively at The Total Pharma Tracker. Learn More »
Gamida Cell (GMDA) is an Israeli company developing an enhanced version of commonly used cord blood HSCT. I covered it in March 2019, when I said that while the low cash position and somewhat obscure nature of the therapy fails to convince us, this is interesting enough to bear watching.
Since I wrote that, Gamida has fallen, and kept on falling; until now. I wrote that on March 12, 2019, when the stock was trading near $12. Right after that, for the entire two years since now, the stock stayed below $12 - indeed, it went down to near penny stock level a few times. However, recently, the stock has seen some movement. It went up to over $11 recently, then fell back to current levels of $8. So we need to see - what changed?
The core value proposition of GMDA is that hematopoietic stem cell transfer or HSCT is curative for a number of cancers, but it has certain limitations. These are basically four - lack of rapid availability due to type mismatch, inefficient engraftment, delayed onset of immune activation leading to infections, and host rejection leading to graft versus host disease or GvHD. GMDA’s nicotinamide-based technology resolves all of these limitations some of the time. Its pipeline looks like this:
Source
The company recently published data from the phase 3 AML trial of lead candidate Omidubicel. The trial compared the time to neutrophil engraftment as the primary endpoint between nicotinamide enhanced ex vivo expanded umbilical cord blood grafts, i.e. Omidubicel, versus standard cord blood, in AML patients. The trial met its primary endpoint successfully and with statistically significant p-value.
Source
In terms of safety, there were fewer viral infections in the drug arm, showing the benefit of Omidubicel. Although Omidubicel did not differentiate itself statistically significantly from standard UBC for GvHD, either grade 2-4 or grade 3-4 at 100 days, there was a noticeable trend in favour of Omidubicel in terms of reduced incidence of GvHD.
The study showed, in summary:
Myeloablative transplantation with omidubicel results in
Faster hematopoietic recovery
Fewer early infections
Fewer days in the hospital
No excessive toxicity associated with omidubicel compared to standard umbilical cord blood transplantation
Durable engraftment >10yrs (earlier studies)
Omidubicel should be considered a new standard of care for patients eligible for umbilical cord blood transplantation
The trial successfully met the primary endpoint, and all three of its secondary endpoints. The prespecified secondary endpoints of the study were the proportion of patients who achieved platelet engraftment by day 42, the proportion of patients with Grade 2 or Grade 3 bacterial or invasive fungal infections in the first 100 days following transplant, and the number of days alive and out of the hospital following transplant.
The company had originally planned to bring the treatment to market this year. However, the FDA recommended that the company generate additional manufacturing- related data prior to requesting a pre-BLA meeting. The company now plans to file the NDA by the second half of 2021, and launch the drug by mid-2022 under a Breakthrough Therapy Designation.
Financials
GMDA has a market cap of $491mn and a cash reserve of $73mn. The company raised $65mn through an offering in December, and another $75mn from Highbridge Capital last month. So they are adequately funded, although they could certainly use more funds.
Bottom Line
HCST is a major market and the only curative approach in a number of cancers. GMDA’s treatment could, in theory and as demonstrated in trials, remove a number of its limitations. Of the four limitations I listed at the beginning, Omidubicel was able to address the first three adequately, and saw trends of betterment of GvHD problems in patients. They are trading a little lower than their recent highs because of diluting their shares, but the dilution was necessary. They are also trading low because of the slight delay in filing and approval. However, manufacturing concerns are quite common for these sorts of therapies, and the company seems confident in its ability to address them. As such, while this is NOT an official buy recommendation, this may be a buying opportunity for those investors with a greater tolerance for risk.
Gamida Cell: Buying The Dip
https://seekingalpha.com/article/4412009-gamida-cell-buying-dip
Mar. 07, 2021 1:51 AM ETGamida Cell Ltd. (GMDA)
Summary
We are circling back on Gamida Cell. The stock has had a roller coaster ride since we last highlighted it in October.
The company has recently addressed its funding needs.
We update our investment thesis on this small cell therapy concern to account for recent news below.
It is time to revisit Gamida Cell (GMDA). The stock shot straight up after we first profiled it in late October. However, the shares have come back down to earth due to recent weakness in the sector and after its did a couple of capital raises. We update our investment thesis on Gamida below to account for all the major news of the past few months.
Company Overview
Gamida Cell Ltd. (GMDA) is based in Israel and is a clinical stage or 'Tier 4' cell therapy concern. The company is focused on developing treatments for blood cancers and serious blood disorders. The stock currently sells for just north of $8.00 a share and sports an approximate market capitalization of $500 million.
Source: September Company Presentation
The company develops candidates for its pipeline using its proprietary platform that allows it to expand multiple cell types — including stem cells and natural killer or NK cells — while maintaining their original phenotype and potency. The company has two assets in the clinic undergoing evaluation for three indications.
Source: September Company Presentation
The most advanced candidate the company is developing is omidubicel which is a combination of NAM-expanded hematopoietic stem cells and differentiated immune cells that is being evaluated in patients in need of hematopoietic stem cell transplantation or HCST. The company disclosed encouraging Phase 3 trial results in May of last year and then disclosed more encouraging results from that trial in October as well as in February. Omidubicel has both Orphan Drug and Breakthrough Therapy designations for this indiciation.
Source: September Company Presentation
Gamida is currently in the application process (see next section) for this indication. As noted in our last article on Gamida, Piper Jaffray has estimated omidubicel will see peak sales north of $450 million, 6-7 years after launch. Omidubicel is also in much earlier stage development to treat Severe Aplastic Anemia.
Source: September Company Presentation
The other current drug candidate in Gamida's pipeline is GDA-201. This NAM-based immunotherapy is currently being evaluated in Phase 1 study for the treatment of relapsed or refractory non-Hodgkin’s lymphoma (NHL) and multiple myeloma [MM]
Recent Developments
A few notable developments have happened around Gamida since we posted our first profile of it four months ago. In mid-December the company announced that its rolling application for omidubicel won't happened by yearend 2020 as the company had hoped, based on FDA feedback. That application will now be filed in the second half of this year, this pushes back potential commercialization into 2022. A few days later, the company executed a secondary offering at $8.00 per share to raise approximately $65 million. This was followed by another capital raise two months later, this time involving exchangeable senior notes that raised an additional $75 million.
Analyst Commentary & Balance Sheet
The company has seen quite a bit of analyst action since our article of October 27th. On December 16th, RBC Capital reiterated its $12 price target and Buy rating on Gamida. Then following the trial news of February 9th, five analyst firms including Needham and Oppenheimer reissued Buy ratings. Price targets proffered within those ratings ranged between $17.00 to $27.00 a share. Three of those analyst ratings contained significant upward price target revisions.
Here is the commentary from Piper Sandler's analyst who boosted his price target from $13 to $25 on GMDA.
The analyst is citing the company's Phase 3 omidubicel data presented at the TCT Annual Meeting that showed "significantly lowered rate of serious infection" and reduced hospital stay. The analyst adds that along with less stringent HLA matching requirements, omidubicel can dramatically expand access and improve outcomes for HSCT patients, further stating that he is increasing his modeled value on omidubicel to $793 million from $550 million."
Gamida ended the third quarter with just over $70 million in cash and marketable securities on its balance sheet after posting a net loss of just under $15 million. With its two capital raises since then and assuming a similar quarterly burn rate, Gamida should have proforma cash on its balance at the end of FY2020 of between $185 million to $190 million, which means it is well funded to its gets to the commercialization phase and launch of omidubicel
Verdict
While up substantially since our last piece on the company, the shares of Gamida are off more than a third from recent highs. While having the BLA submission for omdubicel being moved back approximately six months was a disappointment, the company has addressed its funding concerns.
The shares also enjoyed strong analyst support and look undervalued just for the long term potential of omidubicel in HCST. I used this week's weakness in the biotech sector and the recent sell-off in the stock, to add some exposure to my holdings in GMDA. I did via a simple covered call strategy utilizing the September $7.50 call strikes. Options are both liquid and lucrative at that call strike. In addition, there are no major catalysts (outside a partnership deal or buyout) on the horizon until the BLA for omidubicel happens sometime in the second half of this year.
Gamida Cell to Present at Upcoming Investor Conferences
https://finance.yahoo.com/news/gamida-cell-present-upcoming-investor-120000445.html
Wed, March 3, 2021, 2:00 PM
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, announced today that company management will participate in two upcoming investor conferences in March:
H.C. Wainwright Global Life Sciences Conference, March 10, 2021. Company presentation will be available for on-demand viewing at 7:00 a.m. ET on Tuesday, March 9, 2021.
Oppenheimer 31st Annual Healthcare Conference, March 16-18, 2021. The company will present at 8:40 a.m. ET on Thursday, March 18, 2021.
A webcast of each presentation 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 Gamida Cell
Gamida Cell is an advanced cell therapy company committed to cures for patients with blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn or Twitter at @GamidaCellTx.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210303005223/en/
Contacts
For investors:
Stephanie Ascher
Stern Investor Relations, Inc.
stephanie.ascher@sternir.com
1-212-362-1200
For media:
Rhiannon Jeselonis
Ten Bridge Communications
rhiannon@tenbridgecommunications.com
1-978-417-1946
Gamida Cell Announces the Date of Its Full Year 2020 Financial Results and Webcast
https://finance.yahoo.com/news/gamida-cell-announces-date-full-120000781.html
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced that the company will host a conference call and live audio webcast on Tuesday, March 9, 2021, at 8:30 a.m. ET to review its full year 2020 financial results and provide an update on the company.
The webcast will be available on the "Investors & Media" section of the Gamida Cell website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 1996281. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.
Gamida Cell Announces Results from Phase 3 Study of Omidubicel to be Presented at the 47th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT)
https://finance.yahoo.com/news/gamida-cell-announces-results-phase-120000408.html
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced that results from the Phase 3 clinical trial of omidubicel will be presented in an oral session at the Presidential Symposium of the 47th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT 2021), which is being held virtually March 14–17, 2021.
Details about the presentation are as follows:
Time: Monday, March 15, 2021, at 3:24 p.m. CET (10:24 a.m. EST)
Abstract Number: GS2-7
Title: Results of a Phase III Randomized, Multicenter Study Comparing Omidubicel with Standard Umbilical Cord Blood Transplantation (UCBT) in Patients with High-Risk Hematologic Malignancies Following Myeloablation
Lead Author: Professor Guillermo F. Sanz, M.D., Ph.D.
The abstract will also be featured in a live panel discussion, "EBMT Talks: Live with Best Abstracts," on March 15 at 6:10 p.m. CET (1:10 p.m. EST).
Revealing The Truly Crowded Trades: Gamida Cell Ltd. (GMDA)
https://bovnews.com/2021/02/20/revealing-the-truly-crowded-trades-gamida-cell-ltd-gmda-benitec-biopharma-inc-bntc/
FEDERATED GLOBAL INVESTMENT MANA bought a fresh place in Gamida Cell Ltd. (NASDAQ:GMDA). The institutional investor bought 3.3 million shares of the stock in a transaction took place on 12/31/2020. In another most recent transaction, which held on 12/31/2020, WELLINGTON MANAGEMENT CO. LLP bought approximately 2.9 million shares of Gamida Cell Ltd. In a separate transaction which took place on 12/31/2020, the institutional investor, FIDELITY MANAGEMENT & RESEARCH C bought 728.6 thousand shares of the company’s stock. The total Institutional investors and hedge funds own 37.40% of the company’s stock.
According to WSJ, Gamida Cell Ltd. (GMDA) obtained an estimated Buy proposal from the 6 brokerage firms currently keeping a deep eye on the stock performance as compares to its rivals. 0 equity research analysts rated the shares with a selling strategy, 0 gave a hold approach, 6 gave a purchase tip, 0 gave the firm a overweight advice and 0 put the stock under the underweight category. The average price goal of one year between several banks and credit unions that last year discussed the stock is $19.50.
Thanks Midas, Well I think we need consider also the PE multiple in biotech..GL
Hi top123. i womder if you read this:
Omidubicel, also known as NiCord, has been developed using the company's proprietary nicotinamide (NAM) cell-expansion platform technology, which is used to increase both the number and efficacy of any type of donor cells. In addition to being a superior treatment option over the currently available umbilical cord blood transplant, omidubicel can also offer an off-the-shelf treatment option to around 5,200 blood cancer patients who are eligible for a bone marrow transplant, yet unable to undergo it due to low availability of matching donors. Within three years from its launch, the company expects omidubicel to treat around 2,000 U.S. patients annually and capture 20% share of the bone marrow transplantation market, which is estimated to be worth $13.9 billion by 2026. #msg-161885562
Hi Midas- Thanks for the link, If that article numbers are correct, what SP numbers are we looking at considering we have patent for 17 yrs to 2037, with PE ratio.. TIA
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