Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
How about DOWN 7%. Pedro is right......the shorts have taken complete control of this stock with 7% short interest. With news like this, and even better news coming this one should be up a in the 7-8$ range by now, but yet everyday it is driven down and down.
We will see in a couple of months what happens when the BIG news is released, but I don't hold out too much hope for this to rise more than a few bucks, and then driven down again====such a shame really since this is the real deal.
GDA-201 is good news, however 'Omidubicel
BLA submission is on track to be completed
in the second quarter of 2022' is much more
important to move the needle north!
GDA is still early stage. I will not be too surprised
to see GMDA EOD at +5-8% at most.
(Hope to be proved wrong!)
It's getting to the point where we cannot trade anymore. The "Wolf-Pack" has already started to "short-attack" this company (during premarket trading).
Gamida Cell Announces FDA Clearance of IND and Removal of Clinical Hold for NK Cell Therapy Candidate GDA-201
https://finance.yahoo.com/news/gamida-cell-announces-fda-clearance-110000105.html
Company advancing plans to begin Phase 1/2 study in patients with follicular and diffuse large B-cell lymphomas
BOSTON, April 26, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, today announced that the U.S. Food and Drug Administration (FDA) cleared its investigational new drug (IND) application and removed the clinical hold for a cryopreserved formulation of GDA-201. GDA-201 is an off-the-shelf cell therapy candidate for the treatment of patients with follicular and diffuse large B cell lymphomas. Gamida Cell expects to initiate a company-sponsored Phase 1/2 clinical study in patients with follicular and diffuse large B-cell lymphomas in 2022.
"FDA clearance of our IND for the cryopreserved formulation of GDA-201 represents a significant milestone for the company and reflects our team’s expertise in the development of NAM-enabled cell therapies," said Julian Adams, Ph.D., chief executive officer of Gamida Cell. "Previously announced data from an investigator-sponsored (IS) study evaluating the fresh formulation of GDA-201 demonstrated durable complete responses in heavily pretreated patients with relapsed or refractory lymphoma. We are pleased to advance our plans to begin the company sponsored Phase 1/2 study and progress our novel cryopreserved formulation of GDA-201 with objective to address the unmet need that exists for patients with follicular and diffuse large B cell lymphomas."
GDA-201 leverages Gamida Cell’s proprietary NAM technology platform to expand the number and functionality of NK cells to direct tumor cell killing properties and antibody-dependent cellular cytotoxicity (ADCC). In an investigator-sponsored Phase 1/2 study in patients with relapsed or refractory lymphoma, treatment with the fresh formulation of GDA-201 with rituximab demonstrated significant clinical activity. Of the 19 patients with non-Hodgkin lymphoma (NHL) , 13 complete responses and one partial response were observed, with an overall response rate of 74% and a complete response rate of 68%. At the December 2021 Annual Meeting of American Society of Hematology, two-year follow-up data were reported on outcomes and cytokine biomarkers associated with survival. The data demonstrated a median duration of response of 16 months (range 5-36 months) and an overall survival at two years of 78% (95% CI, 51%–91%). In the IS study, GDA-201 was well-tolerated and no dose-limiting toxicities were observed in 19 patients with NHL and 16 patients with multiple myeloma. The most common Grade 3/4 adverse events were thrombocytopenia, hypertension, neutropenia, febrile neutropenia, and anemia. There was no incidents of cytokine release syndrome (CRS), neurotoxic events, GvHD or marrow aplasia.
Gamida Cell Presents Updated Omidubicel Data During Best Abstract Award Session at 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings
https://finance.yahoo.com/news/gamida-cell-presents-updated-omidubicel-000000045.html
Omidubicel is a first-in-class, advanced NAM-enabled stem cell therapy candidate with breakthrough and orphan drug designations being evaluated as the first potential allogeneic advanced cell therapy donor source for patients with blood cancers in need of a transplant
Oral presentation includes updated analysis demonstrating enhanced circulatory pDC, NK cell and CD4+ T cell recovery with omidubicel
Rapid immune cell recovery results in reduced rates of infection; no increase in GvHD rates compared with standard umbilical cord transplantation
Omidubicel BLA submission is on track to be completed in the second quarter of 2022
BOSTON, April 26, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with solid and hematological cancers and other serious diseases, today announced that updated infection data on omidubicel in comparison to umbilical cord blood transplantation (UCB), was shared in an oral presentation at the 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings (TCT), being held in Salt Lake City, UT, April 23-26, 2022.
The presentation, which received a TCT Best Abstract Award, titled "Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel is Associated with Enhanced Circulatory Plasmacytoid Dendritic Cells (pDC), NK Cells and CD4+ T Cells with Lower Rates of Severe Infections Compared to Standard Umbilical Cord Blood Transplantation," was presented by Paul Szabolcs, M.D., Division of Blood and Marrow Transplantation and Cellular Therapy, UPMC Children’s Hospital of Pittsburgh, Pittsburg, PA. The data from a sub-study of the Phase 3 randomized trial of omidubicel showed early and enhanced recovery of variety of immune cells, including circulatory dendritic cell subtypes, NK cells and CD4+ T cells within the first 28 days and sustained B-cell recovery from Day 28 onwards, and such immune recovery was associated with lower rates of severe infection. The data from an additional analyses of CD4+ subsets, T-cell receptor repertoire diversity and recent thymic emigrants support the long-term durability and functionality of the omidubicel graft.
"These data provide mechanistic support for the reduced infection rates seen with omidubicel-treated patients in the Phase 3 study, and clear demonstration of the benefits of omidubicel over standard cord blood transplantation, which can be associated with immune and hematopoietic recovery challenges that are devastating to patients," said Ronit Simantov, M.D., Chief Medical Officer of Gamida Cell. "As we advance omidubicel through the FDA review process, these data demonstrate that the therapy has the potential to change the outlook for patients suffering from blood cancer, who all too often struggle with post-transplant recovery complications."
Gamida Cell initiated a rolling Biologics License Application (BLA) submission for omidubicel in the first quarter of 2022 and is on-track to complete submission of all modules of the BLA in the second quarter of 2022.
In total, Gamida Cell is presenting two oral and six poster presentations at TCT 2022. All poster presentations are publicly available at www.ASTCT.org.
Gamida Cell Announces Results of New Health Economic and Outcome Study Reporting Improved Health Equity and Health Outcomes With Omidubicel at 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings
April 25 2022
Omidubicel is a first-in-class, advanced NAM-enabled stem cell therapy candidate with breakthrough and orphan drug designations being evaluated as the first potential allogeneic advanced cell therapy donor source for patients with blood cancers in need of a transplant
Study highlights increases in omidubicel use in eligible patients were associated with higher proportions of patients undergoing allo-HCT and overall improved outcomes, with improvements being greater among racial minorities
Only 20% of Black cancer patients can find a matched unrelated donor through donor registries, limiting access to disease-altering allogeneic hematopoietic stem cell transplants
Omidubicel BLA submission on track to be completed in second quarter of 2022
Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with solid and hematological cancers and other serious diseases, today announced the results of a new study demonstrating the potential impact of access to omidubicel on health disparities in allogeneic hematopoietic stem cell transplant in a poster presentation at the 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings (TCT), being held in Salt Lake City, UT, April 23-26, 2022.
The study, titled “Projected Impact of Omidubicel on Racial and Ethnic Disparities in Allogeneic Hematopoietic Cell Transplant Access and Outcomes for Patients with Hematologic Malignancies in the US,” leveraged a decision-tree model to project allo-HCT access and clinical outcomes in a hypothetical population of 10,000 allo-HCT–eligible patients in the U.S. with hematologic malignancies without an available match-related donor. The study concluded that broad use of omidubicel will extend access for allo-HCT-eligible patients, decrease time to transplant and improve clinical outcomes, notably among racial and ethnic groups with worse status quo outcomes. Projected increases in one-year overall survival ranged (with 20% omidubicel use among allo-HCT–eligible patients) from 2.5% for whites patients to 6.3% for Black patients. The study also concluded that higher levels of modeled omidubicel uptake were associated with greater improvements in clinical outcomes and greater reductions in racial disparities.
Previous studies indicate that non-white patients have a lower likelihood of finding an appropriate match in the U.S. public donor registries, with Black patients have a 16-20% chance of finding an appropriate match. Given that an allogeneic stem cell transplant is intended as a curative option, if patients cannot find an appropriate match they will not have access to allogeneic stem cell transplant, a potentially curative treatment. The Phase 3 study of omidubicel demonstrated the ability of the therapy to be used as a donor source for racially and ethnically diverse patients with 40% of patients enrolled in the study being non-white.
“Today, minority groups comprise only about 30% of all allogeneic hematopoietic stem cell transplant transplants, indicating that lack of access to a matched donor is a significant barrier to treatment in the current landscape,” said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell. “This study is encouraging in that it projects that broad access to omidubicel has the potential to open up allo-HSCT as an effective treatment for more patients and address the barriers that have contributed to this alarming health disparity. These data are particularly encouraging as we continue to advance our rolling BLA submission to the FDA and move closer to bringing the therapy to more patients in need.”
Gamida Cell initiated a rolling Biologics License Application (BLA) submission for omidubicel in the first quarter of 2022 and is on-track to complete submission of all modules of the BLA in the second quarter of 2022.
In addition to this poster, two oral presentations and four additional poster presentations on omidubicel and a poster presentation on GDA-201, the company’s leading NK cell therapy program, will be shared during the conference. All poster presentations will be publicly available at www.ASTCT.org. Details below:
Title (Oral Presentation): Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel is Associated with Enhanced Circulatory Plasmacytoid Dendritic Cells (pDC), NK Cells and CD4+ T Cells with Lower Rates of Severe Infections Compared to Standard Umbilical Cord Blood Transplantation (Part of Best Abstract Award Session)
Presenting Author: Paul Szabolcs, M.D., Division of Blood and Marrow Transplantation and Cellular Therapy, UPMC Children’s Hospital of Pittsburgh, Pittsburg, PA
Session Title: Tandem Meetings Best Abstracts Session in the Scientific Track
Session Date / Time: Monday, April 25, 2022, 6:00 PM - 6:15 PM MT, SPCC, Ballroom D
Title (Oral Presentation): Allogeneic HSCT with Omidubicel demonstrates sustained clinical improvement versus standard myeloablative UCBT: Final results of a Phase III randomized multicenter study
Presenting Author: Mitchell Horwitz, M.D., Professor of Medicine, Duke Cancer Institute
Session Title: Oral Abstract - Session L - Consider the Source: Stem Cell Grafts and Donors
Session Date / Time: Tuesday, April 26, 2022, 3:15 PM – 3:30 PM MT
Title: (Poster): Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) With Omidubicel: Long-Term Follow-Up From A Single Center (ASH Encore)
Lead Author: Chenyu Lin, M.D., Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University Medical Center, Durham, NC
Title (Poster): Total Costs of Care and Complication Rates Among Patients with Hematologic Malignancies Who Receive Allogeneic Hematopoietic Cell Transplants in the US
Lead Author: Richard Maziarz, M.D., Professor of Medicine, Medical Director Adult Blood and Marrow Stem Cell Transplant Program, Oregon Health and Science University, Portland, OR
Title (Poster): Hospitalization and Healthcare Resource Use of Omidubicel Vs Umbilical Cord Blood (UCB) for Hematological Malignancies in a Global Randomized Phase III Clinical Trial Setting
Lead Author: Navneet Majhail, M.D., Taussig Cancer Institute, Department of Hematology and Oncology, Cleveland Clinic, Cleveland, OH
Title (Poster): HRQOL following transplantation with omidubicel versus UCB in patients with hematologic malignancies: Results from a Phase III randomized , multicenter study
Lead Author: Mitchell Horwitz, M.D., Professor of Medicine, Duke Cancer Institute
Title (Poster): Transcriptional and Metabolic Profiling of Nicotinamide-Enhanced Natural Killer (NAM-NK) Cells (GDA-201)
Lead Author: Dima Yackoubov, Scientist, Gamida Cell
About Omidubicel
Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell transplant for patients with hematologic malignancies (blood cancers), for which it has been granted Breakthrough Status and orphan drug designation by the FDA. Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). For more information on clinical trials of omidubicel, please visit the Gamida Cell website.
Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
About NAM Technology
Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we are able to enhance, expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. This allows us to administer a therapeutic dose of cells that may help cancer patients live longer better lives.
Gamida Cell to Present Corporate Highlights and Participate in Panel Discussion at the Needham Healthcare Conference
https://finance.yahoo.com/news/gamida-cell-present-corporate-highlights-120000400.html
BOSTON, April 07, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with solid and hematological cancers and other serious diseases, announced that company management will present at the upcoming 21st Annual Needham Virtual Healthcare Conference on April 12, 2022 at 1:30 p.m. EDT. Management will discuss 2022 catalysts and potential milestones including executing its U.S. commercial strategy for the launch of the first allogenic stem cell therapy upon U.S. Food and Drug Administration approval, accelerating the development of its first-in-class NAM-enabled natural killer (NK) cell therapy, GDA-201, as a new approach for patients with follicular and diffuse large B-cell lymphomas, and expansion of its NAM-enabled cell therapy pipeline with multiple next-generation, genetically engineered NK cells.
Additionally, Julian Adams, Ph.D., chief executive officer of Gamida Cell, will participate in a live panel discussion titled "Company Perspectives: Companies Discussing Key Features and Differentiators in the NK Cellular Therapeutics Space," on April 14, 2022 at 11:00 a.m. EDT.
The 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 NAM Technology
Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM, we are able to expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. This allows us to administer a therapeutic dose of cells that may help cancer patients live longer better lives.
Gamida Cell Ltd. (NASDAQ:GMDA)
https://finance.yahoo.com/news/10-best-biotech-stocks-under-141250414.html
Number of Hedge Fund Holders: 12
Share Price as of March 28: $4.1265
Headquartered in Jerusalem, Israel, Gamida Cell Ltd. (NASDAQ:GMDA) develops cell therapies for blood cancers, lymphoma, multiple myeloma, and hematologic diseases. It is one of the best cheap biotech stocks to invest in, priced at $4.1265.
On January 19, H.C. Wainwright analyst Vernon Bernardino reiterated a Buy rating on Gamida Cell Ltd. (NASDAQ:GMDA) with a $22 price target. This came in light of the company announcing its successful Type B meeting with the FDA and plans to initiate in the first half of 2022 a rolling Biologics License Application submission for omidubicel, a cell therapy for blood cancer. He calls Gamida Cell Ltd. (NASDAQ:GMDA) a top pick for 2022.
Among the hedge funds tracked by Insider Monkey, 12 funds were bullish on Gamida Cell Ltd. (NASDAQ:GMDA), with combined stakes worth $13.1 million. Rock Springs Capital Management is the biggest shareholder of the company, with 2.15 million shares worth $5.4 million.
Spire Wealth Management Buys Shares of 55,125 Gamida Cell Ltd. (NASDAQ:GMDA)
Posted by Stephan Byrd on Mar 22nd, 2022
https://www.tickerreport.com/banking-finance/8564111/spire-wealth-management-buys-shares-of-55125-gamida-cell-ltd-nasdaqgmda.html
Gamida Cell logoSpire Wealth Management bought a new stake in Gamida Cell Ltd. (NASDAQ:GMDA – Get Rating) during the fourth quarter, according to its most recent filing with the Securities and Exchange Commission (SEC). The fund bought 55,125 shares of the company’s stock, valued at approximately $140,000.
Other institutional investors and hedge funds also recently added to or reduced their stakes in the company. Bank of New York Mellon Corp purchased a new position in Gamida Cell in the third quarter valued at about $39,000. Guild Investment Management Inc. purchased a new position in Gamida Cell in the third quarter valued at about $71,000. Phoenix Holdings Ltd. purchased a new position in Gamida Cell in the third quarter valued at about $114,000. Cubist Systematic Strategies LLC boosted its stake in Gamida Cell by 54.5% in the third quarter. Cubist Systematic Strategies LLC now owns 33,523 shares of the company’s stock valued at $131,000 after acquiring an additional 11,821 shares during the last quarter. Finally, Jane Street Group LLC purchased a new position in Gamida Cell in the third quarter valued at about $143,000. Hedge funds and other institutional investors own 53.43% of the company’s stock.
Gamida Cell Ltd. (NASDAQ:GMDA) Given Consensus Rating of "Buy" by Brokerages
https://www.marketbeat.com/instant-alerts/nasdaq-gmda-consensus-analyst-rating-2022-03-2-3/
MONDAY, MARCH 21, 2022 | MARKETBEAT
Gamida Cell logoGamida Cell Ltd. (NASDAQ:GMDA - Get Rating) has been given an average recommendation of "Buy" by the seven brokerages that are covering the stock, Marketbeat Ratings reports. Seven research analysts have rated the stock with a buy recommendation. The average 1 year price objective among brokerages that have updated their coverage on the stock in the last year is $13.39.
Several equities research analysts recently issued reports on the stock. Zacks Investment Research raised shares of Gamida Cell from a "hold" rating to a "buy" rating and set a $3.75 price objective for the company in a research note on Thursday, February 3rd. HC Wainwright reaffirmed a "buy" rating and set a $22.00 price objective on shares of Gamida Cell in a report on Wednesday, March 16th. Finally, JMP Securities reissued a "buy" rating and set a $17.00 target price on shares of Gamida Cell in a research report on Tuesday, February 1st.
Several hedge funds and other institutional investors have recently added to or reduced their stakes in GMDA. Stonepine Capital Management LLC increased its stake in Gamida Cell by 288.8% during the third quarter. Stonepine Capital Management LLC now owns 1,724,201 shares of the company's stock valued at $6,759,000 after acquiring an additional 1,280,694 shares during the period. Altshuler Shaham Ltd lifted its position in Gamida Cell by 93,785.0% in the third quarter. Altshuler Shaham Ltd now owns 499,468 shares of the company's stock worth $1,968,000 after purchasing an additional 498,936 shares during the period. Marshall Wace LLP acquired a new stake in Gamida Cell during the third quarter worth $1,463,000. Renaissance Technologies LLC increased its holdings in Gamida Cell by 153.3% in the 3rd quarter. Renaissance Technologies LLC now owns 531,184 shares of the company's stock valued at $2,082,000 after buying an additional 321,484 shares during the period. Finally, Yahav Achim Ve Achayot Provident Funds Management Co Ltd. bought a new stake in Gamida Cell in the 3rd quarter valued at $686,000. Institutional investors and hedge funds own 53.43% of the company's stock.
Gamida Cell Ltd. (GMDA) Q4 2021 Earnings Call Transcript
By Motley Fool Transcribing - Mar 15, 2022 at 12:01PM
Gamida Cell Ltd. ( GMDA -2.10% )
Q4 2021 Earnings Call
Mar 15, 2022, 8:00 a.m. ET
Contents:
Prepared Remarks
Questions and Answers
Call Participants
Prepared Remarks:
Operator
Ladies and gentlemen, thank you for standing by. Welcome to Gamida Cell's conference call for the fourth quarter and full year 2021 financial results. My name is Howard 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, Heather DiVecchia, Gamida Cell's chief of staff. Please go ahead.
Heather DiVecchia -- Chief of Staff
Thank you, Howard, 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 fourth quarter and full year 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 website at www.gamidacell.com. Here with me on our call today are Julian Adams, chief executive officer; Ronit Simantov, our chief medical officer and chief scientific officer; Michele Korfin, our chief operating officer and chief commercial officer; and Shai Lankry, chief financial officer.
Julian Adams -- Chief Executive Officer
Thank you, Heather, and thanks to everyone for joining us this morning. Before I begin, I want to take a moment to acknowledge the major events in the Ukraine, that are impacting the world globally over the past few weeks. While we don't have any operations in the Ukraine or Russia and expect minimal impact to our operations, as global citizens, our thoughts are with all those affected. At Gamida Cell, we are incredibly proud to be part of the significant advancements occurring in the field of cell therapy.
As it continues to grow and progress -- progress toward cures for patients in need. 2021 was an important year for us as we progressed our two clinical stage NAM-enabled cell therapy programs, Omidubicel and GDA-201. Both of which hold significant potential to benefit patients suffering from hematologic malignancies and serious blood disorders. Additionally, we further expanded our NAM-enabled platforms with the addition of genetically modified NAM-enabled NK cell constructs, allowing us to leverage our expertise in NK cells to potentially treat various hematologic malignancies and solid tumors.
I will start today's call by commenting on our lead program, Omidubicel, which has breakthrough therapy designation and the potential to be the first FDA-approved cell therapy for stem cell transplant. Throughout 2021, we announced several data presentations which contribute to the evidence for Omidubicel's potential efficacy, and also the positive health economic impact of Omidubicel, with data demonstrating a reduction in healthcare resource utilization. As Ronit will describe later on in this call, this reduction in healthcare resource utilization is very important for patients, hospitals, and payers. The robust data that we have generated in support of the potential for Omidubicel led us to our most recent and exciting milestone last month, namely the initiation of the rolling BLA for Omidubicel.
With the submission of our non-clinical module following the receipt -- the recent receipt of positive CMC focused Type B meeting correspondence from the FDA. In this correspondence, the FDA confirmed analytical comparability between our wholly owned commercial manufacturing facility in Israel to the Omidubicel batches that were produced at the clinical manufacturing sites for the Phase three study. This month, we also submitted our clinical module to the FDA. We are on track to submit the remaining modules and the complete -- and complete the full BLA submission by the end of the second quarter.
We are thrilled to have [Audio gap] reached this inflection point and look forward to working with the FDA to bring Omidubicel to patients as soon as possible. Beyond on Omidubicel, we are also developing our NAM-enabled NK pipeline, which is led by GDA-201. GDA-201 leverages our proprietary NAM technology platform to expand natural killer cells to enhance their functionality, direct tumor cell killing properties, an antibody-dependent cellular cytotoxicity or ADCC. We are highly encouraged by the potential of GDA-201, which has produced truly remarkable results in a phase one investigator sponsored study, where we have seen very high and complete durable responses in both follicular lymphoma and diffuse large B-cell lymphoma.
In September 2021, we submitted an IND application to the FDA for a phase one two trial with a cryopreserved formulation of GDA-201 in patients with diffuse large B-cell lymphoma and follicular lymphoma. Following this submission, we were placed on clinical hold in November of 21, prior to patients being dose since the FDA had questions about donor eligibility procedures and assay qualification. We are actively working with the FDA to address their comments to enable an IND acceptance and study initiation. This year, we plan to initiate dosing in this phase one/two study.
Moving to our newest product candidates, a genetically modified NAM NK enabled cell therapy programs. Last year, we were excited to establish a broad pipeline of NK product candidates that utilize CAR and CRISPR mediated strategies to increase targeting potency and persistence against hematologic malignancies and solid tumors. Robust preclinical evidence gives us the confidence that these new NAM-enabled NK product candidates hold promise as potentially curative therapies for both hematologic cancers and solid tumors. Furthermore, we announced a research collaboration with the Dana-Farber Cancer Institute for GDA-601, a CD38 CRISPR knockout combined with a CD38 CAR NK cell construct that has demonstrated promising preclinical results against multiple myeloma cell lines.
We are excited to leverage the expertise of researchers at Dana-Farber to study the in vitro NK cell killing activity of GDA-601 in multiple myeloma. Throughout 2022, we plan to execute preclinical proof of concept studies for these genetically modified NK therapeutic targets, and by the end of 2022, select a pipeline candidate for IND enabling studies. With the progress we achieved in 2021, we are encouraged about what the future holds for Gamida Cell in '22. And of course, this wouldn't be possible without our employees, whose dedication is focused on advancing therapies to help address unmet needs for patients.
I am grateful for and proud of their continued determination and focus on patients, which has brought us to where we are today. Before turning the call over to Ronit, I would like to take a moment to congratulate her on her recent promotion. Now, assuming the role of not only chief medical -- medical officer but also chief scientific officer, we at Gamida thank you all for your contributions thus far, and look forward to your continued work toward the vision with your expanded role. Ronit?
Ronit Simantov -- Chief Medical Officer
Thanks, Julian, and good morning, everyone. Thank you for joining us on our call. In 2021, we had the opportunity to present a broad range of scientific and clinical data on Omidubicel. Tying together, free clinical and translational analyzes with clinical data, patient experience, long-term outcomes, and value to the healthcare system.
In pre-clinical presentations in 2021, we demonstrated that our nicotinamide or NAM platform, generates a unique cellular phenotype through modulation of metabolic pathways leading to highly functional and potent stem cells. In translational data, we showed that patients treated with Omidubicel had robust functional reconstitution of T and B cell subsets, dendritic cells and natural killer cells in the days and weeks following transplant. The translational data provided mechanistic support for the clinical results of our global phase three randomized trial. The results of which were published in October 2021, demonstrating rapid somatic poetic recovery, significantly decreased infections and shorter duration of hospitalization for patients transplanted with Omidubicel.
Of note, the patients in our clinical trial were in critical need of allogeneic transplant for hematologic malignancies, with few or no alternatives available. Looking back at the totality of our experience with Omidubicel, we presented follow-up data from over 10 years of clinical studies demonstrating long-term sustainable [Inaudible] and immune competence in patients. We then went on to show that Omidubicel could decrease the cost to the healthcare system, as patients treated with Omidubicel had reduced healthcare resource utilization, including blood transfusions, outpatient procedures, and time in intensive care units. At next month's transplantation and cellular therapy meetings in Salt Lake City, we have eight abstracts accepted and planned to report new data focused on patient outcomes and health related quality of life.
Taken together, we have continued to add to the body of evidence supporting the mechanism of action, clinical activity, patient experience, and value of Omidubicel as a potential life-saving therapy. Moreover, we are confident in the scientific and clinical package we have assembled, and our efforts to make Omidubicel available to patients in need of a hematopoietic stem cell transplant. We also made considerable progress in our NAM-based natural killer cell platform. We presented preclinical data characterizing the properties in GDA-201.
We showed that NAM mediates set of cellular processes, expanding NK cells while down regulating differentiation, cellular stress, and exhaustion pathways that are typically activated in culture. GDA-201 cells are characterized by a rejuvenated NK phenotype similar to cytokine induced memory like NK cells, and were shown to be highly cytotoxic in in vitro and in vivo assays. These findings were supported by the clinical data reported in the phase one investigator sponsored study at the University of Minnesota. At ASH, we presented two-year follow-up data in patients with non-Hodgkin lymphoma, showing an overall response rate of 74%, including 13 out of 14 complete responses with a median duration of response of 16 months.
78% overall survival and toxicities in line with those reported previously for GDA-201. We've now developed a cryopreserved formulation and plan to initiate a multi-center company sponsored study this year in patients with follicular lymphoma and diffuse large B-cell lymphoma. In addition, we reported that we have expanded upon our NAM platform to develop genetically modified NK cells, GDA-301, GDA-501 and GDA-601, each of which is proceeding with preclinical proof of concept studies as we advance toward IND enabling studies. Overall, 2021 was a tremendously productive year in research and development and clinical research.
We look toward continuing to validate the therapeutic potential of our product candidates. I will now turn the call over to Michele, who will talk more about our launch readiness for Omidubicel. Michelle?
Michele Korfin -- Chief Operating Officer and Chief Commercial Officer
Thank you, Ronit, and good morning, everyone. This year has started off strong already, as last month we initiated our rolling BLA submission for Omidubicel. We continue to make excellent progress advancing our Gamida owned manufacturing facility in Israel. The FDA acknowledgment of the analytical comparability from our planned Gamida commercial facility as compared to the facility used for the phase three study was an important milestone as we work toward advancing Omidubicel.
The commercial opportunity for Omidubicel is extremely encouraging. Based on our continued assessment of market insights, and we continue to focus on our commercial preparation. In parallel with our rolling BLA submission, we are additionally assessing strategic alternatives for the potential commercialization of Omidubicel, including potentially partnerships to expand the reach of Omidubicel. Omidubicel has the potential to be the first FDA-approved advanced cell therapy product for allogeneic stem cell transplant in patients with hematology -- hematologic malignancies.
For patients with hematologic malignancies that are deemed eligible for an allergenic stem cell transplant, the procedure is their best chance for a potential cure. In the U.S., there are approximately 8,000 patients above the age of 12, with hematologic malignancies who undergo an allergenic stem cell transplant each year. Unfortunately, though, there are approximately 1,200 patients each year who are also aged 12 and up with hematologic malignancies who are deemed eligible for an allergenic stem cell transplant but cannot find an appropriate donor. Unfortunately, we observe racial disparity in the U.S.
in regards to access to allogeneic stem cell transplants. Few are non-caucasian and do not have access to a family member donor, we have a very low likelihood of finding a match in the public database. For example, patients who are African-American may only have about a 20% chance of finding a match. For patients in need of a stem cell transplant, this is often their only chance for a cure.
We are diligently working to advance Omidubicel and to expand access to patients. Based on encouraging clinical data and the less stringent matching criteria, transplanters feedback indicates that Omidubicel has the potential to improve outcomes for allogeneic stem cell transplant patients compared to other donor sources, and expand access for patients who cannot find a suitable donor. In the U.S., there are approximately 200 transplant centers that perform allogeneic stem cell transplants. 70 of those centers conduct about 80% of the transplants, and our medical team continues to engage with those top 70 centers through one on one meetings and at medical conferences.
We also continue to assess market insights from transplanters in the U.S. Based on extensive market research. We see the potential for Omidubicel to treat approximately 2,000 to 2,500 patients per year upon reaching peak market share. This equates to approximately 20% to 25% market share of the addressable population.
Our market access team is also actively engaging in meetings with national and regional commercial payers, and the feedback continues to be very encouraging. Payers recognize the overall value proposition, including the strength of the Omidubicel clinical data and the health economic data we have published to date. In summary, we are excited by the potential of Omidubicel to be the first FDA-approved cell therapy for allogeneic stem cell transplant. And we are also encouraged by the clinical data and feedback from physicians and payers.
I will now turn the call over to Shai, to review our financial results.
Shai Lankry -- Chief Commercial officer
Thank you, Michele, and good morning, everyone. Today, I will summarize our financial results for the full year of 2021. As of December 31, 2021, our total cash position was approximately $96 million, compared to $127.2 million at December 31st of last year. Research and development expenses for the year were $50.2 million, compared to $38.9 million for the same period in 2020.
The increase was primarily due to a $5.4 million increase in Omidubicel commercial manufacturing readiness activities and the advancements of our NK programs, as well as an increase of $5.9 million in broadening our scientific capabilities and talent. Commercial expenses in 2021 were $20 million, compared to $8.9 million in 2020. The increase was mainly due to a $6.5 million increase in commercial readiness expenses and $4.6 million increase in headcount within our commercial organization. Going forward, we anticipate reducing our near-term commercial readiness expenses as we are assessing alternative for the commercialization of Omidubicel including potential U.S.
or global partnership. General administrative expenses rose $17 million in 2021, compared to $13.2 million in 2020. The increase was mainly due to a $2.6 million increase in professional services expenses, and a $1.2 million increase in headcount and related expenses. Finance expenses net were $2.6 million in 2021, compared to $0.6 million in 2020.
The increase was primarily due to a $4.4 million interest expenses in our convertible notes offset by a $2.1 million capitalization and other non-cash income and $0.2 million increase in interest income from cash management. Net loss in 2021 was $89.8 million compared to a net loss of $61.6 million in 2020. We continue to expect cash use for ongoing operating activity this year to range from $60 million to $70 million. We anticipate the recurring total cash position will support our ongoing operating activities into mid-2023.
This cash one way guidance is based on our current operational plan and excludes any additional funding that may be received or business development activities that may be undertaken. I will now turn the call back over to Julian.
Julian Adams -- Chief Executive Officer
Thank you, Shai. As we look ahead into what we have set out to accomplish in this year, 2022. I believe we are well-positioned to deliver on our mission of developing potentially curative cell therapies for patients with blood cancers, solid tumors, and other serious blood disorders. We look toward our full BLA submission for Omidubicel, expected in the second quarter of this year.
And the planned initiation of our phase one/two multi-center Gamida's cell sponsored study for GDA-201 and non-Hodgkin lymphoma. We are excited for the opportunity to continue leveraging our unique NAM-enabled platform across a broad range of cell therapies. And I look forward to providing updates throughout the year. Now we will open the call for questions.
Operator?
Questions & Answers:
Operator
[Operator instructions] Our first question or comment comes from the line of Jonathan Miller from Evercore ISI. Your line is open.
Jonathan Miller -- Evercore ISI -- Analyst
Hey, guys. Thanks for taking my questions. First, maybe on GDA-201. It feels like the language here seems a little bit similar to last update.
And I just wondered if you had any additional color on your recent interactions with the agency, and what your current thoughts are and ability to get that IND [Inaudible]?. And then maybe secondly, I'm happy to see the runway guidance reinstated, but just wanted to get some clarity. How much commercial prep is included in the current runway guidance -- and maybe how much clinical work for GDA-201 is included in that guidance?
Julian Adams -- Chief Executive Officer
So let me begin by addressing the first part of your question. We haven't had any direct communication with the FDA. The FDA provided absolute clarity on what issues we needed to resolve. Most of those issues are resolved and we are getting ready to resubmit the amendment to the IND, and we'll be announcing when the IND is accepted.
Regarding runway guidance, let me turn it over to Michelle and Shai to talk about launch readiness and use of cash forge support of GDA-201. Michelle?
Michele Korfin -- Chief Operating Officer and Chief Commercial Officer
Thank you, Julian, and good morning, Jonathan. So Jonathan, I'll start and then I'll turn to Shai for the additional financials. So in regards to runway guidance, so for 2021, we were able to complete a lot of the key milestones for commercial preparation that led to the increase that Shai discussed for opex. So some of those included, the market insights such as quantitative assessments from transplanters and feedback from payers.
In addition of very, very important milestone for us in 2021, was the readiness of Gamida Cell Assist, although Gamida Cell sits within the commercial organization. It plays a critical role in starting the chain of identity and monitoring the chain of identity and chain of custody. Although Omidubicel has less stringent requirement, it is still an individualized therapy and hence we need to demonstrate chain of identity chain of custody. That key work for Gamida Cell Assist, including building the team, developing the processes, and establishing the IT infrastructure was all completed in 2021.
So what that allowed us to do in 2022 as we are assessing our strategic alternatives or potential strategic alternatives for launch. It allowed us to decrease the spend in regards to some of the commercial preparation because of the fact that so much had been done in '21. So let me turn to Shai to give us the actual financial details. And then Jonathan, we'll see if you have any follow-up questions.
Shai Lankry -- Chief Commercial officer
Thank you, Michelle. So, Jonathan, for your question, I would divide the answer into two. As Michele [Inaudible] for the commercial. We did an internal robust process of prioritization our expense in 2022 in order to meet the cash one way guidance.
And I can tell you that all the critical activity will continue to be advanced. And in addition, as we mentioned in -- in the previous comments, we did reduce some of the spending, which are less critical for the next few months. As for the R&D GDA-201 in particular, I can assure you that we continue to advance the GDA-201, and we did -- as part of that -- as part of the prioritization, we didn't reduce any of the GDA-201. We continue to advance this program, including the potential initiation of trials later this year and first patient in.
Jonathan Miller -- Evercore ISI -- Analyst
Thanks so much, guys.
Julian Adams -- Chief Executive Officer
Thank you, Jon.
Operator
Thank you. Our next question or comment comes from the line of Ted Tenthoff from Piper Sandler. Your line is open.
Ted Tenthoff -- Piper Sandler -- Analyst
Great. Thank you very much, and good morning, everybody. So I want to dig in a little bit more to the considerations with respect to what we do best on marketing. To me, it seems like the greatest value would be retained if this is a therapy that you take to market yourself.
But can you give it a little bit more just in terms of how you're assessing this? Could this be overseas deal where you keep the U.S.? Could this be a global deal? Give us maybe a sense for how and what kinds of options you're considering. Thanks.
Julian Adams -- Chief Executive Officer
So, Ted, thank you for your question and good morning. As was mentioned in the script, we're assessing our strategic alternatives for Omidubicel, and that's driven by our desire to see as many patients as possible, gain access to Omidubicel. So we are discussing regional deals, potential regional deals, as well as potentially U.S. deals with partners that may have a unique interest in the hematology-oncology franchise and that pairs up with their portfolio, and already has significant infrastructure to be able to deliver on Omidubicel to as many patients as possible.
Our involvement will always be very intimate, because we are the manufacturer and as you know in cell therapies, the manufacturing facilities is critical to supporting any kind of commercial product. So we haven't made any choices yet. And we're starting and certainly once the BLA is fully filed and accepted, that will open up avenues for conversations with interested parties.
Ted Tenthoff -- Piper Sandler -- Analyst
Yup. Very helpful, truly. And I appreciate that additional color.
Julian Adams -- Chief Executive Officer
My pleasure.
Operator
Thank you. Our next question or comment comes from the line of Jason Butler from JMP Securities. Your line is open.
Jason Butler -- JMP Securities -- Analyst
Hi, thanks for taking the question. Just another on Omidubicel. Can you just talk about plans for additional data presentations this year, including from the open label extension to extended -- expanded access program? Thank you.
Julian Adams -- Chief Executive Officer
So thank you, Jason, for your question. Ronit mentioned during the prepared remarks, that we have eight abstract TCT, but maybe Ronit, you could perhaps highlight other venues where we might present the maturing dataset for Omidubicel.
Ronit Simantov -- Chief Medical Officer
Absolutely, and thank you, Jason, for your question. So a TCT, as I mentioned, we'll be focusing on long-term follow up information, as well as patient reported outcomes, health related quality of life, additional immune reconstitution data and some preclinical data as well, and some information on the value and cost of care. In terms of the expanded access program, we are continuing to recruit patients for the expanded access program have not made a definitive decision about what the appropriate time would be to present that growing cohort of patients. But when there is a, I think, critical amount of information that's worth presenting, we certainly will do that either by the end of the year at a hematological meeting or maybe next year at the transplant meeting.
Jason Butler -- JMP Securities -- Analyst
Great. Thank you.
Operator
Thank you. Our next question or comment comes from the line of Gil Blum from Needham & Company. Your line is open.
Gil Blum -- Needham and Company -- Analyst
Good morning, everyone, and thanks for taking our questions. So this one's for Michelle. From your discussions with physicians, what feedback are you been getting regarding their interest in an FDA-approved transplant versus what they've been doing to date? The focus here being whether they have an opinion on something that is FDA-approved and the feedback that you've heard so far.
Michele Korfin -- Chief Operating Officer and Chief Commercial Officer
Thank you, Gil, and good morning. We -- we've done a lot of work speaking to physicians and what -- what is encouraging for them about Omidubicel, which falls into the category of an FDA-approved therapy is the following. So, the first off, Omidubicel will take on the responsibility around chain of identity and chain of custody from the time of the patient selection from Omidubicel all the way through the return of the therapy to the center. So that's an important responsibility, and that's something that comes with being an FDA-approved therapy.
The other aspect is around the Omidubicel itself. So the NAM technology allows us to not only expand but enhance the cells. And some of the challenges associated with using other donor sources is to have an adequate number of cells. Does the donor potentially have some co-morbidities that could potentially be affecting the donor ability? So the fact with Omidubicel that we will be an FDA regulated therapy with sort of a defined threshold around release criteria, that that is viewed as a positive.
I will say consistently the feedback we hear from U.S. transplant ERS is that when they see the Omidubicel clinical data, they see Omidubicel opportunity for their patients falling into two key categories. The first from the physician's perpection -- perspective, is the ability to improve outcomes as compared to donor sources that they're currently using. And then the second that very critical one of those patients who were deemed eligible for transplant but can't find a match, they see a very important opportunity for Omidubicel, given the fact we have a less stringent matching criteria, we demonstrated in our clinical study we had approximately 40% of patients that were non-caucasian in our clinical study.
So those two key opportunities really do resonate consistently when we speak to physicians.
Julian Adams -- Chief Executive Officer
And if I may add, Michelle. There's no question that having a quality assured product with specifications and an FDA label clearly gives us the opportunity to engage with physicians and educate, and over time, this is an exercise in behavioral economics, if you will. If physicians find patients that are suitable for Omidubicel and have a good experience that will go a long way to encouraging them to continue to prescribe Omidubicel. So we think that an FDA label for the first ever sponsored randomized phase three study is a significant game changer for the field of -- hematopoietic stem cell transplant.
Gil Blum -- Needham and Company -- Analyst
All right. Thank you, Michele, and thank you, Julian, for taking our question.
Michele Korfin -- Chief Operating Officer and Chief Commercial Officer
Thank you, Gil.
Julian Adams -- Chief Executive Officer
Thank you, Gil.
Operator
[Operator instructions] Our next question or comment comes from the line of Matthew Cross from Alliance Global. Your line is open.
Matthew Cross -- Alliance Global Partners -- Analyst
Hi, good morning, and thanks for taking a couple of questions for me. Both on the NK cell side. One, I wanted to ask regarding the cryopreservation status for GDA-201. I know you'd previously tested Omidubicel as both a cryopreserved and non-cryopreserved product.
Since you're finalizing these -- these IND requirements with the FDA for 201, I was just hoping to get a recap on the clinical supply chain for that asset in terms of cold chain and what's required for that product in particular, given continuing supply issues at a broad level.
Julian Adams -- Chief Executive Officer
So let -- let me take that on. The team has worked very diligently through 2021 to perfect and optimize the cryopreservation. We now have product and stability with many months of stability, maintain that liquid nitrogen. So the goal of this is to have an off the shelf product to enable a multi-center phase one/two study, and be able to recruit patients with a -- single treatment with GDA-201.
So all of those activities have been attended to, and we're just finalizing the amendment to the IND to resubmit to the FDA and begin the clinical study in 2022.
Matthew Cross -- Alliance Global Partners -- Analyst
Got it. OK. Thanks, Julian, appreciate the confirmation there. And then you had stated that you're looking to select a candidate for IND enabling studies this year out of genetically modified NK cell program.
But just wanted to confirm whether I'm taking that statement overly, literally. Are you looking at advancing one of these four programs to [Inaudible] IND this year and kind of tabling the rest for a bit? Or all of these making progress, and maybe just one will become a frontrunner during the year? Thanks.
Julian Adams -- Chief Executive Officer
So, Matt, thank you for your very important question. So right now, we have three candidates that are progressing. It's all data driven, and my comments about GDA-601 further allowed us to expand our collaboration with Dana-Farber to look at multiple myeloma cell lines, as well as fresh patient isolates, who are patients who have been heavily pretreated. So the idea is progress all three, but select one candidate for IND enabling studies, and then subsequently continue to make progress on the other candidates.
Again, it'll all be data driven, and we'll select the candidate with the most compelling data going forward.
Matthew Cross -- Alliance Global Partners -- Analyst
Great. OK. Thanks for the clarification there as well. I appreciate all the answers.
Operator
Thank you. I'm showing no additional in the queue -- additional questions in the queue at this time. I'd like to turn the conference back over to Julian Adams for any closing remarks.
Julian Adams -- Chief Executive Officer
Thank you, operator, and thank you everyone for joining us on today's call. We look forward to engaging with you, and have a good day, everyone, and see you next quarter.
Operator
[Operator signoff]
Duration: 39 minutes
Call participants:
Heather DiVecchia -- Chief of Staff
Julian Adams -- Chief Executive Officer
Ronit Simantov -- Chief Medical Officer
Michele Korfin -- Chief Operating Officer and Chief Commercial Officer
Shai Lankry -- Chief Commercial officer
Jonathan Miller -- Evercore ISI -- Analyst
Ted Tenthoff -- Piper Sandler -- Analyst
Jason Butler -- JMP Securities -- Analyst
Gil Blum -- Needham and Company -- Analyst
Matthew Cross -- Alliance Global Partners -- Analyst
More GMDA analysis
All earnings call transcripts
This article represents the opinion of the writer, who may disagree with the “official” recommendation position of a Motley Fool premium advisory service. We’re motley! Questioning an investing thesis – even one of our own – helps us all think critically about investing and make decisions that help us become smarter, happier, and richer.
This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability.
The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.
Gamida Cell Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Company Update
https://finance.yahoo.com/news/gamida-cell-reports-fourth-quarter-110000407.html
- Initiated rolling BLA submission for omidubicel in the first quarter of 2022 with full BLA submission on track for first half of 2022 -
- Finished fourth quarter of 2021 with approximately $96 million in cash; sufficient cash to fund the company’s operations into mid-2023 -
- Company to host conference call at 8:00 a.m. ET today -
BOSTON, March 15, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, today provided a business update and reported financial results for the year and quarter ended December 31, 2021. Net loss for 2021 was $89.8 million, compared to a net loss of $61.6 million in 2020. As of December 31, 2021, Gamida Cell had total cash and cash equivalents of $95.9 million.
During the past quarter and into 2022, Gamida Cell:
Continued to advance omidubicel, a potentially life-saving cell therapy treatment for patients with blood cancers in need of stem cell transplant. In the first quarter of 2022, Gamida Cell initiated a rolling Biologics License Application (BLA) submission for omidubicel following the receipt of positive Type B meeting correspondence from the U.S. Food and Drug Administration (FDA).
Progressed activities to address the FDA’s clinical hold on the Investigational New Drug (IND) application for GDA-201, which was imposed based on FDA questions about donor eligibility procedures and assay qualification prior to the initiation of the study in patients with follicular and diffuse large B-cell lymphomas.
Advanced the company’s NAM-enabled natural killer (NK) cell pipeline, including targets GDA-301, GDA-501 and GDA-601, which focus on solid-tumor and hematological cancers. These targets utilize CAR, membrane bound- and CRISPR-mediated technologies to increase targeting, potency and persistence against hematologic malignancies and solid tumors.
"Throughout 2021, Gamida Cell made meaningful progress advancing our broad immunotherapy pipeline of potentially curative cell therapies for patients with solid tumor and blood cancers and other serious blood diseases, resulting in the recent initiation of our rolling BLA submission for omidubicel, which we expect to complete in the second quarter of this year. Additionally, we are continuing to work diligently to respond to the FDA regarding our IND for GDA-201, and expect to initiate our Phase 1/2 study in patients with follicular and diffuse large B-cell lymphomas once the clinical hold has been removed," said Julian Adams, Ph.D., chief executive officer of Gamida Cell. "Looking ahead in 2022, we are continuing to progress our genetically modified NK cell immunotherapy programs leveraging CAR- and CRISPR-mediated technologies focused on addressing unmet needs for patients with hematologic malignancies and solid tumors and we will select a product candidate for IND-enabling studies by the end of the year."
Fourth Quarter and Recent Developments
Omidubicel: Advanced Cell Therapy
BLA submission: Following the receipt of positive Type B meeting correspondence from the FDA confirming that analytical comparability has been established between Gamida Cell’s wholly-owned commercial manufacturing facility and the product that was manufactured for the Phase 3 study, Gamida Cell initiated a rolling BLA submission for omidubicel in the first quarter of 2022. As part of the rolling BLA, Gamida Cell submitted the nonclinical and clinical modules of the omidubicel BLA and is on-track to complete submission of all remaining modules of the BLA by the first half of 2022. In parallel with the BLA submission, the company is assessing alternatives for the commercialization of omidubicel, including potential U.S. or global partnerships.
New data presented at ASH: At the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition in December 2021, Gamida Cell presented clinical updates and a health economic analysis on hospital resource utilization.
Data collected from a subset of patients in the omidubicel Phase 3 trial showed that, in addition to more rapid short-term hematopoietic recovery, omidubicel-treated patients had more rapid recovery of a wide variety of immune cells including CD4+ T cells, B cells, monocytes, NK cells, and dendritic cells than the control arm. The robust recovery of a broad range of the immune system correlated with and supported clinical data showing fewer severe bacterial, fungal, and viral infections in patients treated with omidubicel.
Resource utilization data during the first 100 days after transplant showed that omidubicel-treated patients had significantly shorter durations of hospitalization, intensive care unit time, consultant visits, procedures, and transfusions than the control arm. These data provide further evidence of the clinical benefit associated with the more rapid hematopoietic recovery in patients treated with omidubicel and the corresponding reduction in healthcare resource utilization.
An analysis of outcomes of patients with hematologic malignancies treated with omidubicel over a 10-year period showed long-term sustained bone marrow function and immune recovery, with a 10-year overall survival of 48%. These data provide further support for the long-term clinical benefit of omidubicel with long-lasting hematopoietic recovery.
GDA-201: NAM-Enabled NK Cell Therapy
IND for Phase 1/2 Study: Gamida Cell is working diligently to address the clinical hold on the IND for a Phase 1/2 study of GDA-201. Gamida Cell expects to initiate a company-sponsored Phase 1/2 clinical study in patients with follicular and diffuse large B-cell lymphomas in 2022.
New data presented at ASH: Gamida Cell presented 2-year survival and correlation data with cytokine IL7 at the ASH Annual Meeting and Exposition in December 2021. This analysis provided longer follow-up in the investigator-led study of GDA-201 in patients with non-Hodgkin lymphoma and demonstrated an overall survival rate of 78% at two years with a median duration of response of 16 months.
NAM-Enabled NK Cell Pipeline Expansion
Advanced NAM-enabled genetically modified NK pipeline: Gamida Cell continues to progress its NAM-enabled genetically modified NK pipeline, which utilizes CAR, membrane bound- and CRISPR-mediated technologies to increase targeting, potency and persistence against hematologic malignancies and solid tumors. The company plans to execute preclinical proof of concept studies for these genetically modified NK therapeutic targets and to select a product candidate for IND enabling studies by the end of 2022. These therapeutic targets 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;
GDA-501: anti HER2 CAR-engineered NK cells to target solid tumors expressing HER2, based on a single-chain variable fragment of the widely used humanized monoclonal antibody trastuzumab; and
GDA-601: CRISPR Knockout of CD38 on NK cells combined with anti CD38 CAR. CD38 is an established immunotherapeutic target in multiple myeloma, but its expression on NK cells and its further induction during ex vivo NK cell expansion represents a barrier to the development of an anti CD38 CAR-NK cell therapy. Gamida Cell is advancing this program with a collaboration with the Dana-Farber Cancer Institute to study the in vitro cytotoxicity of GDA-601 in fresh samples from multiple myeloma patients.
GDA-401: A development candidate with the target still undisclosed.
Full Year 2021 Financial Results
Research and development expenses were $50.2 million in 2021, compared to $38.9 million in 2020. The increase was primarily due to a $5.4 million increase in omidubicel commercial manufacturing readiness activities and advancing the NK programs, as well as an increase of $5.9 million in broadening the company scientific capabilities and talent.
Commercial expenses in 2021 were $20.0 million, compared to $8.9 million in 2020. The increase was attributable mainly to a $6.5 million increase in commercial readiness expenses and a $4.6 million increase in headcount within the commercial organization. Going forward, the company anticipates reducing its near-term commercial readiness expenses, as it is assessing alternatives for the commercialization of omidubicel, including potential U.S. or global partnerships.
General and administrative expenses were $17.0 million in 2021, compared to $13.2 million in 2020. The increase was mainly due to a $2.6 million increase in professional services expenses and a $1.2 million increase in headcount and related expenses.
Finance expenses, net, were $2.6 million for 2021, compared to $0.6 million for 2020. The increase was primarily due to a $4.4 million interest expenses from convertible notes, offset by a $2.1 million capitalization and other non-cash expenses, and a $0.3 million increase in interest income from cash management.
Net loss for 2021 was $89.8 million, compared to a net loss of $61.6 million in 2020.
2022 Financial Guidance
Gamida Cell expects cash used for ongoing operating activities in 2022 to range from $60 million to $70 million.
Gamida Cell expects that its current cash and cash equivalents will support the company’s ongoing operating activities into mid 2023. This cash runaway 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 Milestones in 2022
Omidubicel
Completion of full BLA submission to the FDA in the first half of 2022
GDA-201
Initiation of a company-sponsored Phase 1/2 clinical study in follicular and diffuse large B-cell lymphomas
NK cell pipeline expansion
Establish preclinical proof of concept studies of the NAM-enabled, genetically modified NK therapeutic targets
Select pipeline candidate for IND-enabling studies
Conference Call Information
Gamida Cell will host a conference call today, March 15, 2022, 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 1696742. A recording of the webcast will be available approximately two hours after the event, for approximately 30 days.
Gamida Cell to Present Corporate Highlights at the Oppenheimer 32nd Annual Healthcare Conference
https://finance.yahoo.com/news/gamida-cell-present-corporate-highlights-210000499.html
BOSTON, March 10, 2022--(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 upcoming Oppenheimer 32nd Annual Healthcare Conference on March 16, 2022 at 2:00 p.m. ET.
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.
Gamida Cell Announces the Date of Its Fourth Quarter and Full Year 2021 Financial Results and Webcast
https://finance.yahoo.com/news/gamida-cell-announces-date-fourth-130000729.html
Tue, March 8, 2022, 3:00 PM
BOSTON, March 08, 2022--(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 Tuesday, March 15, 2022, at 8:00 a.m. ET to review its fourth quarter and full year 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 1696742. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.
3.6900+0.3300 (+9.8214%)
As of 12:36PM EST. Market open.
Nice! Robust volume too!
Gamida Cell surges 22% following rolling BLA submission for omidubicel
Feb. 09, 2022 3:05 PM ETGamida Cell Ltd. (GMDA)
By: Jonathan Block, SA News Editor
Shares of Gamida Cell (GMDA +22.3%) have surged higher after the company today said it started a rolling submission of a Biologics License Application ("BLA") for omidubicel, a treatment for patients with blood cancers in need of stem cell transplant.
The company is aiming to complete the submission by Q2.
Although he rates Gamida Cell as a hold, Seeking Alpha contributor Bret Jensen says the company has a favorable risk/reward profile.
3.7200+0.6300 (+20.3884%)
As of 02:14PM EST. Market open.
Gamida Cell Shares Surge On Rolling Omidubicel Marketing Application In US
https://www.benzinga.com/general/biotech/22/02/25511786/gamida-cell-shares-surge-on-rolling-omidubicel-marketing-application-in-us?utm_campaign=partner_feed&utm_source=TechInvestorNews&utm_medium=partner_feed&utm_content=site
by Vandana Singh
February 9, 2022 12:54 PM | 1 min read
GMDA has initiated the Biologics License Application (BLA) rolling submission process with the FDA for omidubicel, in patients with blood cancers needing stem cell transplant.
The company remains on track to complete the BLA submission in Q2 of 2022.
Omidubicel has the potential to be the first FDA-approved advanced cell therapy product for allogeneic stem cell transplant.
Gamida Cell begins rolling submission with FDA for omidubicel for stem cell transplant
Feb. 09, 2022 8:36 AM ETGamida Cell Ltd. (GMDA)
By: Ravikash, SA News Editor
Gamida Cell (NASDAQ:GMDA) began a rolling submission of its biologics license application (BLA) with the U.S. Food and Drug Administration for omidubicel, a treatment for patients with blood cancers in need of stem cell transplant.The company said it remains on track to complete the BLA submission in Q2 2022.
"In the phase 3 study, omidubicel achieved a statistically significant reduction in time to neutrophil engraftment, reduced hospitalization time, decreased risk of infection and shorter time to platelet engraftment.
Based on this positive data, we believe omidubicel has the potential to address the existing unmet needs in allogeneic transplant, offering a new standard of care and the opportunity to treat even more patients," said Gamida CEO Julian Adams.
The company noted that omidubicel has the potential to be the first FDA approved advanced cell therapy product for allogeneic stem cell transplant.
Do Institutions Own Gamida Cell Ltd. (NASDAQ:GMDA) Shares?
https://finance.yahoo.com/news/institutions-own-gamida-cell-ltd-105205150.html
The big shareholder groups in Gamida Cell Ltd. (NASDAQ:GMDA) have power over the company. Institutions will often hold stock in bigger companies, and we expect to see insiders owning a noticeable percentage of the smaller ones. 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$183m, which means it wouldn't have the attention of many institutional investors. Our analysis of the ownership of the company, below, shows that institutions are noticeable on the share registry. We can zoom in on the different ownership groups, to learn more about Gamida Cell.
Check out our latest analysis for Gamida Cell
ownership-breakdown
What Does The Institutional Ownership Tell Us About Gamida Cell?
Many institutions measure their performance against an index that approximates the local market. So they usually pay more attention to companies that are included in major indices.
Gamida Cell already has institutions on the share registry. Indeed, they own a respectable stake in the company. This can indicate that the company has a certain degree of credibility in the investment community. However, it is best to be wary of relying on the supposed validation that comes with institutional investors. They too, get it wrong sometimes. 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
Gamida Cell is not owned by hedge funds. FMR LLC is currently the largest shareholder, with 9.1% of shares outstanding. Federated Hermes, Inc. is the second largest shareholder owning 7.9% of common stock, and Novartis AG holds about 7.3% of the company stock.
We also observed that the top 9 shareholders account for more than half of the share register, with a few smaller shareholders to balance the interests of the larger ones to a certain extent.
While studying institutional ownership for a company can add value to your research, it is also a good practice to research analyst recommendations to get a deeper understand of a stock's expected performance. There are plenty of analysts covering the stock, so it might be worth seeing what they are forecasting, too.
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.
Most consider insider ownership a positive because it can indicate the board is well aligned with other shareholders. However, on some occasions too much power is concentrated within this group.
Our data suggests that insiders own under 1% of Gamida Cell Ltd. in their own names. However, it's possible that insiders might have an indirect interest through a more complex structure. It has a market capitalization of just US$183m, and the board has only US$1.2m worth of shares in their own names. Many tend to prefer to see a board with bigger shareholdings. A good next step might be to take a look at this free summary of insider buying and selling.
General Public Ownership
With a 29% ownership, the general public, mostly comprising of individual investors, have some degree of sway over Gamida Cell. 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
It seems that Private Companies own 15%, of the Gamida Cell stock. Private companies may be related parties. Sometimes insiders have an interest in a public company through a holding in a private company, rather than in their own capacity as an individual. While it's hard to draw any broad stroke conclusions, it is worth noting as an area for further research.
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 Initiates Rolling Submission of Biologics License Application for Omidubicel
https://finance.yahoo.com/news/gamida-cell-initiates-rolling-submission-120000650.html
On track to complete the BLA submission in the first half of 2022
BOSTON, February 09, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, today announced that it has initiated the Biologics License Application (BLA) rolling submission process with the U.S. Food and Drug Administration for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant. The company remains on track to complete the BLA submission in the second quarter of 2022.
"We are pleased to reach this important milestone for omidubicel and bring this potential therapy one step closer to reaching patients in need," said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell. "In the Phase 3 study, omidubicel achieved a statistically significant reduction in time to neutrophil engraftment, reduced hospitalization time, decreased risk of infection and shorter time to platelet engraftment. Based on this positive data, we believe omidubicel has the potential to address the existing unmet needs in allogeneic transplant, offering a new standard of care and the opportunity to treat even more patients."
Omidubicel has the potential to be the first FDA approved advanced cell therapy product for allogeneic stem cell transplant. For patients with hematologic malignancies that are deemed eligible for an allogeneic stem cell transplant, the procedure is their best chance for a potential cure. In the U.S., there are approximately 8,000 patients above the age of 12 with hematologic malignancies who undergo an allogeneic stem cell transplant each year and we believe that number of patients may grow over time1. Unfortunately, there are approximately 1,000 patients each year, who are above the age of 12 and are deemed eligible for an allogeneic stem cell transplant but cannot find an appropriate donor2. Based on its encouraging clinical data and less stringent matching criteria, omidubicel has the potential to improve outcomes for allogeneic stem cell transplant patients compared to other donor sources and expand access for patients who cannot find a suitable donor.
Gamida Cell Announces Appointment of Anat Cohen-Dayag and Naama Halevi-Davidov to its Board of Directors
https://finance.yahoo.com/news/gamida-cell-announces-appointment-anat-211500197.html
BOSTON, January 31, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, today announced the addition of Anat Cohen-Dayag, Ph.D., and Naama Halevi-Davidov, Ph.D., to its Board of Directors as Class II Directors.
"We are very excited to be adding these accomplished leaders to our Board as we continue to advance our robust pipeline of advanced cell therapies," said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell. "Anat and Naama’s expertise further strengthens the scientific and financial capabilities on our board, which is crucial to our mission to create cures for people living with serious diseases."
Dr. Anat Cohen-Dayag has over 25 years of experience in the biotech industry, both in R&D and executive leadership roles. Dr. Cohen-Dayag is President and Chief Executive Officer and a member of the Board of Directors of Compugen Ltd. Under her leadership, Compugen transformed from a service provider in the field of computational biology to a therapeutic discovery and development company advancing an innovative immuno-oncology pipeline originating from the company’s computational discovery platforms. Prior to Compugen, Dr. Cohen-Dayag served as Head of R&D and was a member of the executive management team of Mindsense Biosystems Ltd. Dr. Cohen-Dayag holds a B.Sc. in Biology from Ben-Gurion University, and an M.Sc. in Chemical Immunology and a Ph.D. in Cellular Biology, both from the Weizmann Institute of Science.
Dr. Naama Halevi-Davidov has over 25 years of financial experience in the technology sector, holding various executive leadership roles. Dr. Halevi-Davidov served as Chief Financial Officer of Kaltura, Inc., a global software company from 2012 through 2017. Dr. Halevi-Davidov’s leadership saw the company through its global expansion, raising over $100M in funding, overseeing acquisitions, and managing revenue growth from zero to tens of millions of dollars. In recent years, Dr. Halevi-Davidov has served as a strategic financial advisor to a number of growing Hi-tech companies, including Healthy IO Ltd., a digital healthcare company and Joytunes Ltd., a wellbeing education app. Dr. Halevi-Davidov now serves on the Board of Kaltura, Inc. (Nasdaq: KLTR), is Chair of the Compensation Committee and a member of the Company's Audit Committee. Dr. Halevi-Davidov is a Certified Public Accountant in Israel. She received a Ph.D. in Strategy, a Master’s in Business Administration and a Bachelor of Arts in Accounting and Economics all from Tel Aviv University.
Gamida Cell provides key program updates and 2022 outlook
Jan. 31, 2022 8:51 AM ETGamida Cell Ltd. (GMDA)
By: Mamta Mayani, SA News Editor1 Comment
Gamida Cell (NASDAQ:GMDA) announces key program and business updates.
Following the recent receipt of positive Type B meeting correspondence from the FDA, the company will initiate a rolling BLA submission for omidubicel for patients with blood cancers in need of a stem cell transplant, in Q1 2022 and plans to complete the full BLA submission in H1 2022.
In parallel with the planned BLA submission, GMDA will evaluate alternatives for the commercialization of omidubicel, including potential U.S. or global partnerships.
With the objective of extending cash runway into mid-2023, Gamida Cell is reducing operating expenses primarily by implementing a workforce reduction of ~10% and delaying other hiring and planned spending in 2022.
The company expects to initiate Phase 1/2 clinical study of GDA-201 in patients with follicular and diffuse large B-cell lymphomas in 2022.
Gamida Cell plans to report its Q4 and FY 2021 financial results on March 16, 2022.
Gamida Cell Provides Key Program Updates and 2022 Financial Guidance
https://finance.yahoo.com/news/gamida-cell-provides-key-program-133000349.html
Initiating rolling BLA submission for omidubicel in the first quarter of 2022 with full BLA submission on track for first half of 2022
Evaluating strategic alternatives for commercialization of omidubicel, including potential licensing or partnering
Reducing operating expense to extend cash runway to fund activities into mid-2023 in consideration of the timeline for potential FDA approval of omidubicel
BOSTON, January 31, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, today provided key program and business updates.
Initiating rolling BLA submission for omidubicel. Following the recent receipt of positive Type B meeting correspondence from the U.S. Food and Drug Administration (FDA), Gamida Cell will initiate a rolling Biologics License Application (BLA) submission for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of a stem cell transplant, in the first quarter of 2022 and plans to complete the full BLA submission in the first half of 2022.
Evaluating strategic alternatives for omidubicel. In parallel with the planned BLA submission, the company will be assessing alternatives for the commercialization of omidubicel, including potential U.S. or global partnerships.
Reducing operating expenses. With the objective of extending its cash runway into mid-2023, consistent with the timeline for potential U.S. approval of omidubicel, the company is reducing operating expenses primarily by implementing a workforce reduction of approximately 10% and delaying other hiring and planned spending in 2022.
Readying to advance GDA-201. The company is addressing comments received from FDA in connection with the clinical hold placed on the IND submission for GDA-201, its lead NAM-enabled innate NK cell immunotherapy. Gamida Cell expects to initiate a company-sponsored Phase 1/2 clinical study in patients with follicular and diffuse large B-cell lymphomas in 2022.
Advancing genetically modified NK cell immunotherapy programs. The company continues to advance itsNAM-enabled genetically modified NK pipeline, which utilizes CAR, membrane bound- and CRISPR-mediated strategies to increase targeting, potency and persistence against hematologic malignancies and solid tumors. The company plans to execute preclinical proof of concept studies for these genetically modified NK therapeutic targets and to select pipeline candidates for IND enabling studies by the end of 2022.
"We are pleased that productive interactions with the FDA enable us to initiate a rolling submission of the BLA for omidubicel this quarter and to complete the full BLA submission during the first half of this year," said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell. "As we advance omidubicel towards potential approval, we will be assessing strategic alternatives for the best way to bring this important therapy to patients, including potential U.S. or global commercialization partnerships. With the strategic steps we are taking, we believe Gamida Cell will be in a stronger position to support omidubicel through the regulatory approval process while we also continue to advance our NK cell pipeline programs, all as intended to serve our goal of providing access to life-saving cell therapies to patients in need."
2022 Financial Guidance
Gamida Cell ended 2021 with approximately $96.1 million in cash and cash equivalents (unaudited). The company expects cash used for ongoing operating activities in 2022 to range from $60 million to $70 million in cash and cash equivalents based on its current operating plans. The company anticipates that its current cash will support the company’s ongoing operating activities into mid-2023, excluding any additional financing or business development activities that may be undertaken. Gamida Cell plans to report its fourth quarter and full-year 2021 financial results on March 16, 2022, at which time the company will provide an update on its 2022 milestones and more detailed financial guidance.
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 blood cancers. Omidubicel is the first bone marrow transplant graft to receive Breakthrough Therapy Designation from the U.S. FDA and has also received Orphan Drug Designation in the U.S. and EU. Gamida Cell has completed an international, multi-center, randomized Phase 3 study (NCT0273029) evaluating the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing allogeneic bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant. That study achieved its primary endpoint, demonstrating a highly statistically significant reduction in time to neutrophil engraftment, a key milestone in a patient’s recovery from a bone marrow transplant. The Phase 3 study also achieved its secondary endpoints of reduced time to platelet engraftment, reduced infections and shorter days of hospitalization. For more information about omidubicel, please visit https://www.gamida-cell.com.
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 nicotinamide (NAM)-enabled 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. 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 about GDA-201, please visit https://www.gamida-cell.com.
GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
About Gamida Cell
Gamida Cell is pioneering a diverse immunotherapy pipeline of potentially curative cell therapies for patients with solid tumor and blood cancers and other serious blood diseases. We apply a proprietary expansion platform leveraging the properties of NAM to allogeneic cell sources including umbilical cord blood-derived cells and NK cells to create therapies with potential to redefine standards of care. These include omidubicel, an investigational product with potential as a life-saving alternative for patients in need of bone marrow transplant, and a line of modified and unmodified NAM-enabled NK cells targeted at solid tumor and hematological malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, Twitter, Facebook or Instagram at @GamidaCellTx.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to timing of initiation and progress of, and data reported from, the clinical trials of Gamida Cell’s product candidates (including GDA-201), anticipated regulatory filings (including the timing of submission of the BLA for omidubicel to the FDA), commercialization planning efforts, and the potentially life-saving or curative therapeutic and commercial potential of omidubicel, and Gamida Cell’s expectations for the expected clinical development milestones set forth herein. Any statement describing Gamida Cell’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to a number of risks, uncertainties and assumptions, including those related to the impact that the COVID-19 pandemic could have on our business, and including the scope, progress and expansion of Gamida Cell’s clinical trials and ramifications for the cost 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. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cell’s Annual Report on Form 20-F, filed with the Securities and Exchange Commission (SEC) on March 9, 2021, as amended, and other filings that Gamida Cell makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cell’s actual results could differ materially and adversely from those anticipated or implied thereby. Although Gamida Cell’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell. As a result, you are cautioned not to rely on these forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220131005177/en/
Contacts
For investors:
Courtney Turiano
Stern Investor Relations, Inc.
courtney.turiano@sternir.com
1-212-362-1200
For media:
Rhiannon Jeselonis
Ten Bridge Communications
rhiannon@tenbridgecommunications.com
1-978-417-1946
Business Wire
Gamida Cell Ltd. (NASDAQ:GMDA)
Number of Hedge Fund Holders: 12
Decline in Share Price in 2021: 75.8%
Like most other stocks in the ARK portfolio, Gamida Cell Ltd. (NASDAQ:GMDA), a clinical-stage biotech firm developing therapies for cancer and blood diseases, has not had positive hedge fund coverage in the second half of 2021. At the end of the third quarter of 2021, 12 hedge funds in the database of Insider Monkey held stakes worth $26 million in Gamida Cell Ltd. (NASDAQ:GMDA), compared to 14 the preceding quarter worth $53 million.
ARK first bought a stake in Gamida Cell Ltd. (NASDAQ:GMDA) in the third quarter of 2020, buying over 186,000 shares at an average price of $4.26 per share. The fund then added to that position substantially in the next three quarters, by 72%, 108%, and 2% respectively, before slashing it by over 9% between June and September 2021. It now owns 623,674 shares in Gamida Cell Ltd. (NASDAQ:GMDA) worth $2.4 million.
https://finance.yahoo.com/news/15-worst-stock-picks-cathie-163728887.html
Gamida Cell Ltd. (NASDAQ: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, recently announced that following receipt of positive Type B meeting correspondence from the U.S. Food and Drug Administration (FDA) yesterday, the company plans to initiate a rolling Biologics License Application (BLA) submission for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant. As previously disclosed, in late 2021 the FDA requested a revised analysis of the manufacturing data generated at Gamida Cell's wholly owned commercial manufacturing facility to demonstrate the analytical comparability to the Lonza clinical manufacturing site that produced omidubicel for the Phase 3 study. Gamida Cell and the FDA have now reached alignment that analytical comparability has been established between the commercial manufacturing facility and the product that was manufactured for the Phase 3 study. Based on this demonstration of comparability, along with the positive clinical results of the Phase 3 study, the FDA has agreed that the initiation of a rolling BLA submission is appropriate. Additional clinical data will not be required to initiate the BLA submission.
https://www.prnewswire.com/news-releases/gastrointestinal-cancer-treatment-trials-driven-by-rising-incidences-of-colorectal-cancer-301464414.html
NEW ARTICLE : H.C. Wainwright Sticks to Its Buy Rating for Gamida Cell (GMDA) stck.pro/news/GMDA/21588586
Analysts Offer Insights on Healthcare Companies: Gamida Cell (GMDA)
January 19 2022 - 08:36AM
There's a lot to be optimistic about in the Healthcare sector as 2 analysts just weighed in on Gamida Cell (GMDA – Research Report) and Acutus Medical (AFIB – Research Report) with bullish sentiments. Gamida Cell (GMDA) Needham analyst Gil Blum maintained a Buy rating on Gamida Cell today and set a price target of $12.00. The company's shares closed last Tuesday at $2.22, close to its 52-week low of $2.10. According to TipRanks.
https://www.tipranks.com/news/blurbs/analysts-offer-insights-on-healthcare-companies-gamida-cell-gmda-and-acutus-medical-afib?utm_source=advfn.com&utm_medium=referral
Gamida Cell plans rolling BLA submission for omidubicel for blood cancers; shares up 18%
Jan. 19, 2022 11:07 AM ETGamida Cell Ltd. (GMDA)
By: Jonathan Block, SA News Editor
Following a positive Type B meeting with the FDA, Gamida Cell (GMDA +18.9%) plans rolling BLA submission for omidubicel for blood cancers in need of stem cell transplant.
Omidubicel has Breakthrough Therapy Designation and has the potential to be the first FDA-approved advanced cell therapy for allogeneic bone marrow transplant, according the Gamida Cell.
Gamida Cell says that the FDA and the company have come to agreement that analytical comparability has been established between the commercial manufacturing facility and the omidubicel that was manufactured for the Phase 3 study by another company.
Check out why Seeking Alpha contributor Bret Jensen has a neutral rating on Gamida Cell.
Gamida Cell Provides Update on Omidubicel BLA Submission
https://finance.yahoo.com/news/gamida-cell-provides-omidubicel-bla-120000727.html
Planning to initiate rolling BLA submission for omidubicel following positive Type B meeting with FDA
Full BLA submission on track for first half of 2022
BOSTON, January 19, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, announced that following receipt of positive Type B meeting correspondence from the U.S. Food and Drug Administration (FDA) yesterday, the company plans to initiate a rolling Biologics License Application (BLA) submission for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant. As previously disclosed, in late 2021 the FDA requested a revised analysis of the manufacturing data generated at Gamida Cell’s wholly owned commercial manufacturing facility to demonstrate the analytical comparability to the Lonza clinical manufacturing site that produced omidubicel for the Phase 3 study. Gamida Cell and the FDA have now reached alignment that analytical comparability has been established between the commercial manufacturing facility and the product that was manufactured for the Phase 3 study. Based on this demonstration of comparability, along with the positive clinical results of the Phase 3 study, the FDA has agreed that the initiation of a rolling BLA submission is appropriate. Additional clinical data will not be required to initiate the BLA submission.
"We are very pleased that our productive interactions with the FDA have resulted in alignment on the omidubicel manufacturing comparability analysis and agreement to initiate a rolling submission of our BLA application," said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell. "Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the FDA and has the potential to be the first FDA-approved advanced cell therapy for allogeneic bone marrow transplant. Initiating the BLA submission will move us one step closer toward bringing potentially curative therapies to patients. We plan to complete the full BLA submission in the first half of this year, which will be an important achievement for Gamida Cell and the bone marrow transplant community."
Gamida Cell Announces Data to be Presented at 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings
January 07 2022 - 01:41PM
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, today announced eight presentations at the 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings (TCT) being held in Salt Lake City, UT, from February 2-6, 2022.
New data and analyses on omidubicel will be presented including an oral presentation by Dr. Mitchell Horwitz of Duke Cancer Institute detailing one-year post-transplant follow up from the phase 3 study; a poster by Dr. Horwitz presenting health-related quality of life data; a new analysis of the projected impact of omidubicel on racial and ethnic disparities in allogeneic hematopoietic cell transplant to be presented by Dr. Usama Gergis of Jefferson University; and an abstract which has received TCT’s Best Abstract Award to be presented by Dr. Paul Szabolcs from the Children’s Hospital of Pittsburgh providing updated analyses of immune reconstitution data in patients transplanted with omidubicel during the phase 3 study.
Details about the TCT presentations are as follows:
Title: Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplant with Omidubicel Demonstrates Sustained Clinical Improvement Versus Standard Myeloablative Umbilical Cord Blood Transplantation (UCBT): Final Results of a Phase III Randomized, Multicenter Study (oral presentation)
Abstract Number: 86
Lead Author: Mitchell Horwitz, M.D., Professor of Medicine, Duke Cancer Institute
Time: Sunday, February 6, 2022, 12:50-1:10 p.m.
Abstract highlights: One-year post-transplant follow up from the omidubicel Phase 3 trial showed that the advantages of early engraftment and lower infections with omidubicel translated into long term benefits in the first year post-transplant, as demonstrated by reduction in non-relapse mortality and no increase in relapse rates compared to UCBT. There was a continued trend toward improved OS in favor of the omidubicel arm over time (73% vs 60%). The overall and sustained clinical benefit of omidubicel makes it an important addition to the options for allogeneic HSCT.
Title: Health-Related Quality of Life (HRQL) Following Transplantation with Omidubicel Versus UCB In Patients with Hematologic Malignancies: Results from a Phase III Randomized, Multicenter Study (poster)
Abstract Number: 509
Lead Author: Mitchell Horwitz M.D., Professor of Medicine, Duke Cancer Institute
Time: February 2-5, 2022
Abstract highlights: This study compared changes in HRQL measures (FACT-G and EQ-5D) that were assessed in the Phase III study of omidubicel. Along with statistically significantly faster time to engraftment, shorter hospitalizations and lower infection risk, omidubicel was associated with meaningfully greater preservation or improvement of important HRQL domains compared to UCB.
Title: Projected Impact of Omidubicel on Racial and Ethnic Disparities in Allogeneic Hematopoietic Cell Transplant (allo-HCT) Access and Outcomes for Patients with Hematologic Malignancies in the US (poster)
Abstract Number: 325
Lead Author: Usama Gergis, M.D., MBA, Director, Stem Cell Transplant and Cellular Therapy Program, Jefferson University
Time: February 2-5, 2022
Abstract highlights: The under-representation of racial and ethnic minorities in donor registries is well-established and a source of inequity in access to care. Over 40% of patients enrolled in the omidubicel Phase III study were racial and ethnic minorities. The study assessed the projected impact of omidubicel access on racial and ethnic health disparities in a projection model. Broad access to omidubicel was projected to decrease time to allo-HCT and improve allo-HCT outcomes overall, with the greatest improvements among racial and ethnic groups least served by current graft sources, thus helping to reduce racial disparities and improving health equity in allo-HCT care.
Title: Total Costs of Care and Complication Rates Among Patients with Hematologic Malignancies Who Receive Allogeneic Hematopoietic Cell Transplants (allo-HCT) in the US (poster)
Abstract Number: 334
Lead Author: Richard Maziarz, M.D., Professor of Medicine, Medical Director Adult Blood and Marrow Stem Cell Transplant Program, Oregon Health and Science University, Portland, OR
Time: February 2-5, 2022
Abstract highlights: A commercial claims and encounters database was utilized to quantify the total cost of care associated with allo-HCT and real-world complication rates after allo-HCT among US commercially insured patients. The study concluded that patients with hematologic malignancies undergoing allo-HCT experienced significant health resource use and costs post-HCT. Hospitalizations accounted for 80% of the total costs. Complications, especially acute GVHD and infections, were commonly observed in post-transplant medical billings, which may still underestimate the full clinical incidence. Reducing need for in-patient care can significantly reduce total cost of care in this population.
Title: Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel is Associated with Enhanced Circulatory Plasmacytoid Dendritic Cells (pDC), NK Cells and CD4+ T Cells with Lower Rates of Severe Infections Compared to Standard Umbilical Cord Blood Transplantation (winner of TCT’s Best Abstract Award; oral presentation; initial data presented at the American Society of Hematology Annual Meeting 2021 to be updated for TCT)
Abstract Number: 5
Lead Author: Paul Szabolcs, M.D., Division of Blood and Marrow Transplantation and Cellular Therapy, UPMC Children’s Hospital of Pittsburgh, Pittsburg, PA
Time: Friday, February 4, 2022, 6:20-6:35 p.m.
Title: Transcriptional and Metabolic Profiling of Nicotinamide-Enhanced Natural Killer (NAM-NK) Cells (GDA-201) (poster; initial data presented at Society for Immunotherapy of Cancer Annual Meeting 2021 to be updated for TCT)
Abstract Number: 266
Lead Author: Dima Yackoubov, Scientist, Gamida Cell
Time: February 2-5, 2022
Title: Hospitalization and Healthcare Resource Use of Omidubicel vs Umbilical Cord Blood (UCB) for Hematological Malignancies in a Global Randomized Phase III Clinical Trial Setting (poster, encore presentation from American Society of Hematology Annual Meeting 2021)
Abstract Number: 419
Lead Author: Navneet Majhail, M.D., Taussig Cancer Institute, Department of Hematology and Oncology, Cleveland Clinic, Cleveland, OH
Time: February 2-5, 2022
Title: Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) with Omidubicel: Long-Term Follow-Up from a Single Center (poster; encore presentation from American Society of Hematology Annual Meeting 2021)
Abstract Number: 322
Lead Author: Chenyu Lin, M.D., Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University Medical Center, Durham, NC
Time: February 2-5, 2022
About Omidubicel
Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with hematologic malignancies (blood cancers), for which it has been granted Breakthrough Status by the FDA. 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 nicotinamide (NAM)-enabled 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 about GDA-201, please visit https://www.gamida-cell.com.
GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
Alliance Global Partners Thinks Gamida Cell’s Stock is Going to Recover
December 13 2021 - 01:35PM
In a report released today, Matthew Cross from Alliance Global Partners maintained a Buy rating on Gamida Cell (GMDA – Research Report), with a price target of $11.00. The company's shares closed last Monday at $2.33, close to its 52-week low of $2.25. According to TipRanks.com, Cross is ranked #2333 out of 7742 analysts. Gamida Cell has an analyst consensus of Strong Buy, with a price target consensus of $14.50. See the top stocks recommended by analysts >> The company has a one-year high of $15.00 and a one-year low of $2.25. Currently, Gamida Cell has an average volume of 380.9K.
https://www.tipranks.com/news/blurbs/alliance-global-partners-thinks-gamida-cells-stock-is-going-to-recover?utm_source=advfn.com&utm_medium=referral
Gamida Cell Presents Two-Year Survival Data for GDA-201 and Resource Utilization Analysis for Omidubicel at 63rd ASH Annual Meeting
https://finance.yahoo.com/news/gamida-cell-presents-two-survival-140000263.html
Data from patients with NHL treated in Phase 1 investigator-led study of GDA-201 demonstrates median duration of response of 16 months; safety outcomes consistent after two years
Poster presentation highlights reductions in hospitalization and healthcare resource utilization for omidubicel
BOSTON, December 13, 2021--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, today announced that two-year follow-up data for GDA-201, the company’s lead candidate in its NAM-enabled NK cell therapy pipeline, will be presented at the 63rd American Society of Hematology (ASH) Annual Meeting, being held in Atlanta, Georgia. Additionally, for patients who participated in the phase 3 trial of omidubicel, the company will be presenting a poster of an analysis of resource utilization data from the first 100 days after bone marrow transplant.
The poster titled "GDA-201, A Novel Metabolically Enhanced Allogeneic Natural Killer (NK) Cell Product Yields High Remission Rates in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma (NHL): 2-year survival and correlation with cytokine IL7" includes longer term follow-up from the phase 1, investigator-led study of GDA-201 in combination with rituximab (NCT03019666) in patients with relapsed or refractory non-Hodgkin lymphoma (NHL) and reports on 2-year outcomes and cytokine biomarkers associated with survival. The data demonstrated a median duration of response of 16 months (range 5- 36 months), an overall survival at 2 years of 78% (95% CI, 51%–91%) and a safety profile similar to that reported previously.
"We are excited to share this compelling two-year data from our investigator-led study of GDA-201 which demonstrate an extended duration of response in patients with NHL," said Julian Adams, Ph.D., Chief Executive Officer, of Gamida Cell. "The durable response in this patient group provides strong support as we work to progress GDA-201 through the development process for patients in need."
Gamida Cell will also present a poster related to its omidubicel program titled "Hospitalization and Healthcare Resource Use of Omidubicel Vs Cord Blood Transplantation for Hematological Malignancies in a Global Randomized Phase III Clinical Trial," which includes an analysis of resource utilization data from the first 100 days after transplant for 108 patients in the phase 3 trial showing that the omidubicel-treated patients had significantly shorter durations of hospitalization, intensive care unit stays, consultant visits, procedures, and transfusions than the control arm. These data provide further evidence of the clinical benefit associated with the more rapid hematopoietic recovery in patients treated with omidubicel and the corresponding reduction in healthcare resource utilization.
"This analysis clearly demonstrates the potential of omidubicel to significantly shorten a patient’s hospital length of stay, reduce time in ICU settings and decrease usage of healthcare resources, likely resulting in lower overall costs to the healthcare system," said Ronit Simantov, M.D., Chief Medical Officer of Gamida Cell. "These findings are particularly important as they demonstrate the impact of omidubicel on the experience for patients during the critical post-transplant period."
Both posters will be available today, Monday, December 13, 2021, 6:00-8:00 p.m. ET, during the ASH Annual Meeting and Exposition.
About GDA-201
Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled 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. 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 about GDA-201, please visit https://www.gamida-cell.com.
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 Presents New Omidubicel Data at 63rd ASH Annual Meeting
https://finance.yahoo.com/news/gamida-cell-presents-omidubicel-data-210000441.html
Oral presentation demonstrated rapid and sustained T cell and B cell recovery following transplantation with omidubicel in a subset of patients in Phase 3 study, providing mechanistic support for reducing viral infections
Additional poster presentation highlighting long-term data from single-center study with 10-year follow-up after omidubicel transplantation showing omidubicel continues to be safe and effective with no unexpected long-term complications
BOSTON, December 11, 2021--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, presented clinical updates on omidubicel in two presentations on the first day of the 63rd American Society of Hematology (ASH) Annual Meeting being held in Atlanta, Georgia and virtually December 11-14, 2021.
In an oral presentation titled "Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel is Associated with Robust Immune Reconstitution and Lower Rates of Severe Infection Compared to Standard Umbilical Cord Blood Transplantation," Gamida Cell shared data from an analysis of a subset of 37 patients from the Phase 3 randomized trial of omidubicel. The analysis was aimed at investigating the reduced infection rates observed in the study and showed that the omidubicel-treated patients had more rapid recovery of a wide variety of immune cells including CD4+ T cells, B cells, NK cells and dendritic cell subtypes. The robust recovery of the immune system provides rationale for fewer severe bacterial, fungal and viral infections in patients treated with omidubicel. Further analyses are ongoing to further characterize the immune recovery following omidubicel transplantation.
"These results demonstrating rapid and functional reconstitution of the immune cells - particularly the T cell recovery which is known to lag in cord blood transplants - provides mechanistic support for the lower rates of severe infection observed in the omidubicel-treated patients," said Paul Szabolcs, M.D., Division of Blood and Marrow Transplantation and Cellular Therapy, UPMC Children's Hospital of Pittsburgh. "These data provide encouraging support for patients suffering from blood cancers who are particularly vulnerable to devastating infections following transplant."
An additional poster presentation unveiled today, "Allogeneic Stem Cell Transplantation with Omidubicel: Long-Term Follow-up from a Single Center," includes outcomes of 22 patients in the Phase 1 and 2 studies of omidubicel at Duke University over a 10-year period and shows long-term sustained bone marrow function and immune recovery. With a median follow-up of 2.3 years the estimated 10-year overall survival (OS) is 48.5% and disease-free survival (DFS) is 43.6%, with no major and or unexpected long-term complications. Durable hematopoiesis was observed at up to 10 years with one case of secondary graft failure and no secondary malignancies.
"Following our positive Phase 3 study results that showed enhanced hematopoietic recovery with omidubicel, it is extremely encouraging to see these additional data that demonstrate the durability of the graft, providing long-term recovery of the hematopoietic system," said Ronit Simantov, M.D., Chief Medical Officer of Gamida Cell. "The analyses presented at ASH build on our understanding of the clinical benefits of omidubicel and provide compelling evidence of its potential to change the outlook for a patient population in dire need of enhanced treatment options."
Gamida Cell will present additional clinical updates at ASH including two-year survival data for GDA-201, the company’s lead NAM-enabled NK cell therapy, and an analysis of hospital and healthcare resource use for patients treated with omidubicel compared to cord blood transplantation. Both poster presentations will be publicly available on Monday, Dec. 13.
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 blood cancers. Omidubicel is the first bone marrow transplant graft to receive Breakthrough Therapy Designation from the U.S. FDA and has also received Orphan Drug Designation in the U.S. and EU. For more information about omidubicel, please visit https://www.gamida-cell.com.
Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
What do you guys think about Gamida-cell $GMDA
https://www.reddit.com/r/RobinHoodPennyStocks/comments/r6i5nt/what_do_you_guys_think_about_gamidacell_gmda/
Gamida Cell Ltd, 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 upcoming virtual investor conferences:
Evercore ISI 4th Annual HealthCONx Conference, November 30, 2021 with a presentation at 1:25 p.m. ET.
Piper Sandler 33rd Annual Virtual Healthcare Conference, December 2, 2021. Company pre-recorded fireside chat will become available to registered conference attendees on Monday, November 22, 2021 at 10:00 a.m. ET.
JMP Securities Hematology and Oncology Summit, December 6, 2021 with a fireside chat at 10:00 a.m. ET.
Upcoming Catalysts
NiCord (omidubicel) Hematologic Malignancies - Phase 3 Phase 3 data to be presented at ASH December 13, 2021. BLA filing due 1H 2022.
RBC Capital Thinks Gamida Cell’s Stock is Going to Recover
November 23 2021 - 04:11AM
RBC Capital analyst Gregory Renza maintained a Buy rating on Gamida Cell (GMDA – Research Report) on November 15 and set a price target of $10.00. The company's shares closed last Monday at $2.78, close to its 52-week low of $2.75. According to TipRanks.com, Renza is a 1-star analyst with an average return of -1.1% and a 30.3% success rate. Renza covers the Healthcare sector, focusing on stocks such as Global Blood Therapeutics, Verrica Pharmaceuticals, and Inovio Pharmaceuticals. Currently, the analyst consensus on Gamida Cell is a Strong Buy with an average price target of $14.50, which is a 389.9% upside from current levels.
https://www.tipranks.com/news/blurbs/rbc-capital-thinks-gamida-cells-stock-is-going-to-recover?utm_source=advfn.com&utm_medium=referral
Gamida Cell to Present Corporate Highlights at Multiple Upcoming Investor Conferences
https://finance.yahoo.com/news/gamida-cell-present-corporate-highlights-130000364.html
BOSTON, November 16, 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 upcoming virtual investor conferences:
Evercore ISI 4th Annual HealthCONx Conference, November 30, 2021 with a presentation at 1:25 p.m. ET.
Piper Sandler 33rd Annual Virtual Healthcare Conference, December 2, 2021. Company pre-recorded fireside chat will become available to registered conference attendees on Monday, November 22, 2021 at 10:00 a.m. ET.
JMP Securities Hematology and Oncology Summit, December 6, 2021 with a fireside chat at 10:00 a.m. ET.
A webcast of each event 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 Ltd (GMDA) CEO Julian Adams on Q3 2021 Results - Earnings Call Transcript
Nov. 15, 2021 12:04 PM ETGamida Cell Ltd. (GMDA)
Gamida Cell Ltd (NASDAQ:GMDA) Q3 2021 Earnings Conference Call November 15, 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
Jas Uppal - Chief Regulatory and Quality Officer
Conference Call Participants
Ted Tenthoff - Piper Sandler
Jonathan Miller - Evercore ISI
Gregory Renza - RBC Capital Markets
Nishant Gandhi - Needham & Company
Mark Breidenbach - Oppenheimer
Operator
Ladies and gentlemen, thank you for standing by. Welcome to Gamida Cell's Conference Call for Third Quarter 2021 Financial Results. My name is Henry and I'll be the operator for today's call. Please be advised that this call is being recorded at Gamida Cell's request.
Now I would now like to introduce your host for today's conference, Mr. Josh Hamermesh, Chief Business Officer. Sir, please go ahead.
Joshua Hamermesh
Thank you, Henry, 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 third 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; Shai Lankry, Chief Financial Officer and additionally, Jas Uppal, our Chief Regulatory and Quality Officer will join for the 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 of 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 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 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 an important quarter for Gamida Cell as we continue to advance our mission of bringing potentially curative cell therapies to cancer patients. We are at a crucial inflection point in the field of cell therapy, where we are starting to see multiple development programs that offer the potential for clinical benefit for patients with hematologic malignancies and serious blood disorders.
I am proud that Gamida Cell is at the forefront of this research with our two advanced clinical stage NAM enabled cell therapy programs; omidubicel and GDA-201. We also recently expanded our pipeline of generically modified NAM-enabled NK cell constructs and we are excited about sharing new data and developments on our cell therapy pipeline at major -- multiple major international medical meetings this quarter.
Let me start today's call with an update on our lead program omidubicel, which has breakthrough therapy designation and the potential to be the first FDA approved cell therapy for hematopoietic stem cell transplant. Omidubicel is supported by a robust body of evidence, including positive phase three results, demonstrating strong efficacy, an important benefit to patients in need of a bone marrow transplant.
We recently had a pre-BLA meeting during which the FDA requested that Gamida Cell provide revised analysis of the analytical data generated at Gamida Cell's wholly owned commercial manufacturing facility in Israel to demonstrate comparability to the omidubicel batches that were produced at the clinical manufacturing sites for the phase three study. We are confident that we can execute the analytical comparability that the FDA has requested in a timely manner to enable a BLA submission in the first half of '22.
It is also important to note that the FDA did not request additional clinical data to initiate the BLA submission once analytical comparability is demonstrated. In collaboration with the FDA, we will work towards our BLA submission to bring omidubicel to patients as soon as possible.
Moving to our NK cell pipeline, it is extremely exciting to be at the front -- at the forefront of the cutting edge research that is being conducted in the emerging field of NK cell therapy. NK cells have tremendous promise for treating cancer. NK cells are the body's first line of defense providing innate immunity and have immune privileged properties that obviate the requirement for donor matching, which can lead to a cryopreserved off the shelf product for patients.
The most advanced candidate in our NAM-enabled NK pipeline GDA-201 leverages our proprietary NAM technology platform in the expansion of NK cells to enhance their functionality, direct tumor cell killing properties and antibody dependent cellular cytotoxicity or ADCC. GDA-201 has produced truly remarkable results in a phase one investigator sponsored study, where we have seen very high and durable responses in both follicular lymphoma and diffused large B-cell lymphoma.
As we have previously reported, the phase one study had an overall response rate of 74% and 68% complete response rates and an impressive duration with several patients maintaining their complete responses for over two years after treatment.
During the third quarter, we submitted an IMD application to the FDA for a phase one, two trial with cryopreserved formulation in patients with diffuse large B-cell lymphoma and follicular lymphoma. Before initiating our clinical study, we must address the clinical hold by responding to the FDA's questions about donor eligibility procedures and sterility assay qualification. We believe these questions are addressable and we plan to respond expeditiously to enable IND acceptance and patient enrolment.
Due to the clinical whole, the initiation of the phase one, two trial will occur in 2022. We will provide an update and additional guidance on timing when we have further clarity from the FDA.
This quarter, we made progress advancing our genetically modified NAM enabled NK cell therapy programs, which utilize CAR and CRISPR mediated strategies to increase targeting potency and the persistence against hematologic malignancies and solid tumors. We were excited to highlight these new programs at an R&D day in October. Importantly, we are pleased to announce a research collaboration with the Dana-Farber Cancer Institute for our GDA-601 cell therapy, which is a CD38 CRISPR knockout combined with a CD38 CAR are NK cell construct that has demonstrated promising preclinical results against multiple myeloma cell lines. Together with Dana-Farber, we will be studying the great potential of GDA-601 in multiple myeloma.
Our NAM-enabled NK product candidates hold tremendous promise for both hematologic cancers and solid tumors and we look forward to advancing our work in this very important field.
I want to conclude my introductory remarks by expressing my gratitude to our employees for their dedication and hard work or it's driving forward our important mission. Their continued determination and focus on patients have brought us to where we are today.
And with that, I will turn the call over to Ronit Simantov our Chief Medical Office.
Ronit Simantov
Thank you, Julian and good morning, everyone. Thank you for joining us on our call. I'm excited to join you this morning and describe the recent data we presented at the Society for Immunotherapy of Cancer or SITC 36 Annual Meeting. Additionally, I'll a provide a preview on what we'll be presenting at the upcoming 63rd Annual Meeting of the American Society of Hematology or ASH.
The data presented at SITC provided extensive characterization of the activity of GDA-201 by examining the phenotype killing capacity and anti-tumor activity of the cell. The data showed that GDA-201 features a unique phenotype characteristic of a rejuvenated NK cell or non-exhaustive phenotype according to classical lineage stages, retaining potent anti-tumor effects in-vitro and in-vivo assays.
We also presented data where we used artificial to analyze differential express genes and metabolites in GDA201 or NAM enabled NK cells. The data illustrated the network of interactions associated with the enhanced biological function of NAM enabled NK with increased cytotoxicity, ABCC, homing and SU in-vivo anti-tumor abilities as compared to NK cells that were expanded without NAM. These data give us key insights into the mechanism of action of NAM enabled NK cell expansion, which is important as we move GDA-201 into the next phase of clinical development and relevant to the cell therapies and are expanding NK cell pipe line.
We're also very much looking forward to the presentations that we have coming up at the ASH Meeting, which will be held from December 11th to the 14th. For omidubicel, we will have an oral presentation on immune reconstitution as well as two poster presentations, one with long-term follow data in patient treated with omidubicel and one on hospital and healthcare resource utilization.
Additionally for GDA-201, we will have a poster presentation with two-year follow-up data from the phase one study. Data we plan to present demonstrate that patients treated with omidubicel had more rapid recovery of a wide variety of immune cells associated with a lower risk of infection. Additionally, omidubicel treated patients had significantly shorter durations of hospitalization, intensive care unit time, consultant visits, procedures and transfusions. In an analysis of outcomes of patients with hematologic malignancies treated with omidubicel over a 10 year period patients showed long term sustained bone marrow function and immune recovery.
Taking together, these data provide further evidence of the strong clinical benefit associated with more rapid and lasting hematopoietic recovery with omidubicel. For GDA-201, we will share a two year follow analysis from the investigator led study in patients with non-Hodgkin lymphoma, demonstrating a median duration of response of 16 months and 78% overall survival of two years with reported toxicities in line with those seen previously. These data further strengthen our confidence in the safety and activity of GDA-201.
There are further details that each of the presentations and the press release we issued this morning and we plan to provide further updates during ASH. Regarding the clinical program in GDA-201, colleagues on my team are preparing for the initiation of our multi sensor study in patients with non-Hodgkin lymphoma, with operational activities and meetings with investigators and thought leaders ongoing. We continue to hear from experts that there is a high unmet need among patients with lymphoma who have active disease after previous treatment. Investigators are enthusiastic about beginning to enroll patients in this study and treating patients with GDA-201.
I'll now turn the call over to Michele Korfin, our Chief Operating Officer and Chief Commercial Officer, who will talk more about our commercial opportunity for omidubicel. Michelle?
Michele Korfin
Thank you, Ronit and good morning, everyone. We remain excited about the opportunity from omidubicel to provide an important option to patients who need a bone marrow transplant and do not have a suitable matched donor. In the US 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 in collaboration with the Center for International Blood and Marrow Transplant Research, or CIBMTR conducted independent market research and spoken to hundreds of transplanters to fully assess the unmet need. Based on these commercial insights, the opportunity for omidubicel can be summarized into two key categories. The first one is increasing access for patients, especially those who are eligible for transplant and cannot find a match and second improving outcomes based on the unmet clinical needs with current donor sources that can be addressed by omidubicel.
One specific area of advantage from omidubicel is that it has a less stringent matching criteria for patient as compared to graph 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 matched donor. Data from be [indiscernible] highlight that a patient's ethnic background greatly impacts his or her ability to find a match with some patient groups facing only approximately a 20% likelihood of finding a match in the public matching database.
In the omidubicel phase three trial over 40% of the patients enrolled were not Caucasian, illustrating the important need for a suitable graft source in this patient population. Upon FDA approval or potential FDA approval, 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 uncertainty for patients with cancer who are at high risk for relapse. In our clinical trials, we consistently delivered omidubicel to sites within 30 days of cord blood unit selection.
Based on our extensive assessment of the market opportunity, we anticipate there will be approximately 2,400 patients receiving omidubicel each year once we reach peak market share, which would be about three years after launch. We anticipate this peak market share to be between 20% to 25% of the addressable patients. We continue to have active dialogue with physicians and payers and feedback on the value proposition of omidubicel has been highly encouraging, specifically from payers they are encouraged by the potential for faster time to neutrophil and graft decreased infections, decrease in hospitalization and less graph versus host disease as compared to published literature for other graph sources.
Now, in my role as Chief Operating Officer, let me transition to discuss the ongoing activities to address the FDA's feedback about our analytical comparability data to enable the omidubicel BLA submission. Under the leadership of Vladimir Melnikov, our Senior Vice President, Global Manufacturing and Operations, we have completed the production runs for BLA readiness, and the team is now conducting the revised analysis that FDA has requested to demonstrate that the omidubicel produced and Gamida Cell wholly owned commercial manufacturing facility in Israel is analytically comparable to the omidubicel that was produced at the clinical manufacturing site for the phase three study. We feel that the analysis that the FDA has requested is addressable and we look forward to working with the FDA to complete the requirements to enable the BLA submission.
Transitioning to GDA-201, there is a great unmet need for relapse refractory patients with lymphoma. In the US and U5, there are approximately 40,000 patients who reach at least their third line of treatment. During our discussions with both US and EU physicians, they were consistent with the challenges they see with their current treatment options and relapse refractory lymphoma. These included the need for therapies that balance efficacy, especially complete responses with a tolerable safety profile.
In addition, physicians discuss the importance of new therapies with improved duration of response, GDA tool, one clinical data received positive feedback from physicians and payers in a global assessment, including the balance of encouraging overall and complete responses and the safety data that included no cytokine release syndrome and no neurotoxicity, which are often seen with other cell therapies.
Although there have been advances for patients with lymphoma, there are still significant unmet needs and relapse refractory patients that GDA-201 could address. In summary, we are excited by the potential of AMBA cell to be the first FDA approved cell therapy for bone marrow transplant. And we are encouraged by the clinical data and feedback from physicians and payers.
Finally, we are confident that we could address the FDA's feedback from our pre meeting to enable the BLA in a timely manner. We are also very encouraged by the initial GDA 2 0 1 data that Roone discussed and recognize the opportunity to further develop a new therapy for patients with relapse refractory lymphoma.
Thank you. And I will now turn the call over to Shai to review our financial results.
Shai Lankry
Thank you, Michelle and good morning, everyone. Today, I will summarize our financial result for the third quarter of 2021. As of September 30, 2021, our total cash position was $120.8 million compared to $127.2 million as of December 31 of last year. As far as our total expected cash used for this year and the cash run rate going forward, I can share that we are actively reassessing our financial expenditures and previous financial guidance due to the updated timing of the omidubicel BLA submission and we will be updating our previous financial guidance.
Research and development expenses for the quarter were $12.4 million compared to $10.5 million for the same period in 2020. The increase was mainly due to omidubicel commercial manufacturing readiness activities, and the advancements of the GDA-201 program, including bordering scientific capabilities and talent. Commercial expenses in the quarter were $6 million compared to $1.9 million for the same period last year. The increase was mainly attributed to progress with omidubicel commercial readiness activities. Going forward following the FDA recent feedback, we are reassessing our commercial readiness expenditures.
General and administrative expenses were $4.8 million for the third quarter of 2021, compared to $2.7 million for the same period in 2020. The increase was mainly due to professional expenses and the hiring of key management position to support the business. Finance income net was $3.5 million for the quarter compared to $0.3 million in the same period last year. The increase was primarily due to non-cash income resulting from revaluation of rents offset by convertible note interest expenses. Net loss for the quarter was $19.6 million compared to a net loss of $14.8 million for the same period last year. We look forward to providing an update on our financial guidance as soon as we are able to do so.
With that, I will turn the call back over to Julian.
Julian Adams
Thanks, Shai. I'm proud to be part of a team that is working towards a very important mission to develop cures for patients with hematologic malignancies and blood disorders. We're excited for the opportunity to continue to leverage our unique NA enabled platform across a broad range of cell therapies so that we can fulfill our promise to deliver potentially curative approaches to cancer patients in need. With omidubicel, we are working towards our BLA submission in the first half of '22, and continue to prepare to be launched ready at the time of approval. We are about the potential for GDA-201 and are working with the FDA to resolve their issues and initiate a GAM cell sponsored clinical study. Lastly, we are excited by our genetically modified NK cell products and look forward to providing further updates.
Now, we will open up the call for questions, operator?
Question-and-Answer Session
Operator
[Operator instructions] Your first question comes from Ted Tenthoff of Piper Sandler. Your line's now open. Okay,
Ted Tenthoff
Great. Thank you so much for taking my question. I just wanted to ask with respect to the analysis, how big of an issue is this appreciating that there's no additional clinical requirements or anything along those lines, but again, with the understanding that your anticipation is to file in the first half, is this pretty routine stuff, maybe you can give us a little bit more color. Thanks so much guys.
Julian Adams
Ted, thank you for your question. It's a pretty technical answer to get into details and we won't get into the FDA direct feedback, but at a higher level, we do not have to do additional experiments. We just have to reanalyze our data and I think from where I understand the FDA it's that it's a pretty routine situation for them.
Ted Tenthoff
Great. Thank you. And then just to get a sense with respect to the Israeli manufacturing facility and bringing everything in house, what kind much supply would you be able ultimately to deliver from Israel and would that be both omidubicel and ultimately GDA-201. Thanks so much.
Julian Adams
Yeah. Thank you for your question. We have built a state of the art facility in Israel with room to expand, and let me tell -- let me ask Michelle to further elaborate on the state of this facility.
Michele Korfin
Yeah. Thank you, Julian. And good morning, Ted. So, yes, as Julian indicated, the Israeli facility is state of the art and we built it in a modular approach. So we have the ability to add additional cores as needed. So from the standpoint of addressing the demand, we feel confident that we'll have the capacity because we do have that ability to be modular and add course. And we built the facility with the vision for both omidubicel and the NK platform.
So omidubicel as we've discussed, we're in the process of finalizing our BLA readiness requirements for omidubicel and then getting ready for commercial manufacturing. The production team is also working very closely with the R&D team to initiate the technology transfer from our research facility to our facility in Israel, the commercial manufacturing facility for the NK platform initially first GDA-201. So that was the vision for the facility was both on omidubicel and the NK platform.
Operator
Your next question comes from Jonathan Miller of Evercore. Your line is now open,
Jonathan Miller
Right? Thanks so much guys. And congrats on the progress. It still seems odd to me that the FDA would clear the IND and then hold dosing, issue a hold prior to patient dosing. So maybe could you give some color on what interactions you've had since the hold came on? Maybe get some clarity on like what the official status of that IND is at the moment. And I think to recall a few weeks ago in the R&D day, you thought, you said you thought that this would be relatively quick process to give them the analysis that they wanted. So I just want to check on what your progress was there.
And then secondly on omidubicel, I noticed the [indiscernible] abstract at ASH, which I would love to see, but of course this is being pulled. It looks from allele. So it's just versus cord blood. Can you give us some color on what here you've done for Omi versus other graph sources that maybe in the US and the EU are responsible for a greater proportion of overall HSCT? Thanks.
Julian Adams
Okay, John, I will try to address all three of your questions, but in such a way as, let me invite Jazz to comment on what we can share with the FDA interactions vis-à-vis the GDA-201 clinical hold.
Jas Uppal
Thank you, Julian. So we just call letter we are confident that we will be able to progress soon, given the progress that's already been made to its resolving the FDA concerns. The assays have now been qualified for the drug product per FDA's request and also new lab has been identified that will help address FDA's comment regarding donor eligibility. So there's been very good progress -- been had. Ronit, perhaps you can also share a clinical update
Ronit Simantov
In terms of the clinical update yes, so we are continuing to work with the site to move forward with the clinical protocol and the operational activities needed to initiate the site officially. So that once the IMD hold is lifted, we can just move forward to site initiation and then patient enrollment. So from a clinical protocol point of view, we have no other changes that we're making at this point, and we're just proceeding with the operational pieces.
Julian Adams
And Ronit, since we have you on the line, can you also comment on the HEOR question and the abstract and what can we extrapolate that to other modalities?
Ronit Simantov
Yeah, absolutely. So, we are doing HEOR analyses. The first one that is -- that will be presented at Ash is a utilization analysis that looks at resource utilization in patients who were on the study. And the patients on the study as you correctly mentioned are omidubicel versus standard cord. And so those direct data from our study could be analyzed and quantified and that's what all be presented at Ash.
Now at the same time, we are doing additional HEOR analyses using CIBMTR databases and other sources of information to look at the broader context of the HEOR benefit potentially from omidubicel. Those will be presented at a later date in additional meetings that will update you about when we're able to.
Julian Adams
Your final question maybe turn it to Michelle
Michele Korfin
In regards to HEOR Julian?
Julian Adams
I'm sorry, Jonathan, you had a third part of your question. Have we answered?
Jonathan Miller
I think you got to most of it guys thanks so much. I guess, in the detail on HEOR, what I was hoping for was some color around what you already knew versus other graph sources, but I'll look forward to seeing this presentations when they're available.
Operator
Your next question comes from Jason Butler of JMP Securities. Your line still open.
Unidentified Analyst
Hi, it's [indiscernible] for Jason. Thanks for taking our questions. I guess the first one, just to the stay on the omidubicel BLA, I guess we thought the FDA was looking for clinical comparability as part of the, the request. Did they, did they change their mind and did they explain why they changed their mind if they did? And did you show the agency any clinical data from the commercial product?
Julian Adams
Okay. I begin. Yes, they did change, change their guidance to us. And I'll ask Jazz to elaborate. I don't think they justified why they changed their mind, but I think it's commonly understood and expected that if you have analytical comparability that should lead to clinical comparability and we do have an expanded access program, so we will continue to collect data and obviously all those data will be shared with FDA in real time. Jas. Do you have anything further to add
Jas Uppal
Thank you, Julian. So yes, absolutely. comparability a really important topic. And it's key for moving forward in a new manufacturing facility as such. We had planned proactively for this topic with the FDA and had justified to them that clinical data should not be required from the facility FDA has come back and agreed with our proper, that clinical data are not required for submission of the B, but they have asked us to represent the analytical comparability data via new analysis.
Unidentified Analyst
Okay, great. Thank you. And then the SITC poster for GDA-201 with the machine learning component is pretty interesting. It sounds like you can apply some of that to informed development of the future NK candidates. Can you give us any specifics on how you might apply those results and then as far as the Ash to your follow for GDA-201, any changes in how you see that product potentially fitting in the treatment paradigm, particularly with the duration. Thanks.
Julian Adams
Okay. Let me take the first part with AI learning. So what we really have done is detailed transcription profiling and metabolic profiling, and then there's a program called ingenuity, which is an AI learning tool, which classifies pathways and does pathway analysis and in, so doing, we can inform the transcript data into this machine learning approach which surveys or literature or references, et cetera, and builds on the development of the different biochemical pathways and in the cell as well as the metabolite pathway ways. So yes, it can be applied and should be applied to every cellular product because there are a lot of things going on during the cell culture period, and particularly with our NA enabled activity, we are drastically affecting gene in a positive way to make the cells more potent and more useful. Let me turn it to, to Ron, to talk about Ash.
Ronit Simantov
Yes. And, and if I could add something to your comments about the artificial intelligence media analysis sit the, the entire platform of NK cells that we've been we've been discussing is based on the NA enabled NK product. And so understanding the mechanisms of, of the differential expression induced by NAM helps us in the development of all the genetically modified NAM, construct NK constructs. So specific information will be used in the development of those constructs with respect to the Ash presentation on GDA-201, we continue to update the on these patients.
So we had patients who have been treated now up to a little over three years. And so what we will show in the presentation will be information patient by patient of where those patients are after treatment. And this gives us further confidence in the duration and potential efficacy of G D H O one with our company sponsored study in the cry preserved formulation. So it, it just gives further confidence in the, in the product.
Operator
Your next question comes from Gregory Renza of RBC Capital Markets. Your line is now open.
Gregory Renza
Good morning, Julian team. Thank you for the update. And thanks for taking my question. Julian, certainly in light of the omidubicel delay and a lot going on for GAM cell. Just curious if you could comment on how these developments do affect your overall approach to the larger portfolio, certainly with omidubicel and GDA-201 through 601.
What are you looking at? What inputs are, are you either waiting for just as far as how you're planning to allocate resources and you certainly mentioned the reassessment of, of spend planning, but as far as your think, your thinking around the portfolio and totality, any comments would be appreciated. Thank you. Yeah.
Julian Adams
Obviously first and foremost, we have to readdress the FDA comments and get back on track with our submissions and the conduct of future trials. As we consider all of this you know, the, we, we still have a strong cash position. And the first and foremost, you know, it's going to be dedicated towards in the enablement of OOU cell and GDA 2 0 1 for programs that are further back in, in, in, and not yet pre preclinical development stage the expenses can be very easily managed. It it's a lo it's not a burdensome process for us to be able to prosecute those. But of course, as we said, we're still reassessing and still need to determine our timelines and our allocation of capital in a responsible way
Gregory Renza
That's helpful. Thank you. Maybe just one last one, as you think about capturing value for omidubicel. Just curious if you could provide us an update on where your thinking is as far as partnerships or, or, or regulatory advancements in those regions. Thanks again,
Julian Adams
I'm glad, for this question, because we have actually studied the ex-US territories and let me turn it over to Michelle to provide some insights.
Michele Korfin
Yeah, no, thank you very much. So omidubicel acts as a very encouraging commercial opportunity in parts of Western Europe and in Asia specifically Japan. You know, although we do see an opportunity for am omidubicel to improve outcomes across all graft sources for Japan in particular, you see about a third of the patients utilizing cord blood as their transplant. So when Japanese physicians saw the head-to-head data versus cord for omidubicel, they were very, very encouraged.
So in both Western Europe and Japan, we see an encouraging opportunity and we continue to partner very closely with Josh Hammerman as our Chief Business Officer and others on our team around what's the appropriate way for patients to get access to omidubicel outside of the us. But I think the, probably the key takeaway is just the opportunity is there. And now how do we move forward in terms of allowing patients to have access jazz and her team have had good dialogue with EMA already. So we understand that the regulatory path forward, we look forward to continuing to advance those plans around allowing patients to eventually access on omidubicel outside of the us following regulatory approvals.
Julian Adams
And, I would add to that Michelle, that since we conducted the phase three as an international study with sites in Europe I think we have a the ability to file in Europe without additional studies for the adult population. Japan is always a little bit trickier because there are unique laws in Japan that would have us required to do a bridging study. But all of those are just technical issues and can be addressed.
Operator
Your next question comes from Nishant Gandhi of Needham & Company. Your line is now open.
Nishant Gandhi
Hi, good morning. Thank you for taking our questions. I have a question related to the GDA 2 0 1 data presented at SETI. The results showed that there's a decrease in CD 16 expression with NA cultivation compared to the standard NK cells. Was this be a potential issue for GDA 2 0 1?
Julian Adams
Yeah, let me begin and then turn it over to Ronit as well. First of all, the decrease in CD 16 is very modest at we still see high levels of CD 16, but to address this and to mitigate this variability in CD 16 expression, we are proposing quite high doses in terms of cells per kilo to overcome the donor to donor variability. Ronit, do you have anything to add?
Ronit Simantov
Yeah, I would say I would reiterate that it was a minimal decrease in addition in the context of an overall active non exhausted phenotype. The cells were quite active and so that, that mitigates any of the somewhat slight decrease in the C16 in terms of killing potential cetera. And again, we extrapolate that that was born out in the Minnesota data, and obviously we will look for the same activities as we see comparable comparably, potent and active NK cells in the cryopreserve formulation.
Operator
[Operator instructions] Next question comes from Mark Breidenbach of Oppenheimer. Your line's now open.
Mark Breidenbach
Hey, good morning guys. And thanks for the update. Just a quick one from me with regard to the Dola filing. Can we reasonably assume that another type B meeting we'll have to be scheduled with the FDA before, before a submission? Or is it kind of a situation where you, you can do the analysis and provide the data you need and then just submit the VLA without, without a separate meeting. Thanks.
Julian Adams
Yeah, I think we have a very good perspective on that. And let me ask, sorry, Jas to talk about our filing approach.
Jas Uppal
Thank you, Julian. So yes, we have requested a type B meeting to discuss the analytical comparability data and thereafter. We are not anticipating an additional type B meeting equivalent to a pre VLA FDA have guided us that we just need to submit an amendment to the IND rather than a type B meeting for that particular outcome.
Operator
No further question. I would like to turn the call back to I'm sorry, Julian Adams.
Julian Adams
I want to thank everyone who joined us on the call today. It is really a pivotal time for Gamida Cell. We have had FDA issues, no doubt. They're very technical in nature and very addressable and we are working hard to attend to that. Over and beyond that, I think the team is extremely dedicated and hardworking anThey're very technical in nature and very addressable and we are working hard to attend to that. Over and beyond that, I think the team is extremely dedicated and hardworking and I can't express enough gratitude to the whole Gamida Cell family for their dedication.
Additionally, and I also want to thank patients and their families who have participated in our clinical studies and have really donated to the benefit of our medical knowledge that I hope will prove extremely beneficial to the medical community going forward. And thank you all for your attention this morning.
Gamida Cell Reports Third Quarter 2021 Financial Results and Provides Company Update
https://finance.yahoo.com/news/gamida-cell-reports-third-quarter-120000836.html
New data being presented at American Society of Hematology (ASH) Annual Meeting demonstrating GDA-201 overall survival rate of 78% at two years with a median duration of response of 16 months and long-term clinical benefit of omidubicel with long-lasting hematopoietic recovery
Finished third quarter of 2021 with $121 million in cash; reassessing expected spending and prior financial guidance due to the revised timing of the omidubicel BLA submission
Company to host conference call at 8:00 a.m. ET today
BOSTON, November 15, 2021--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, today provided a business update and reported financial results for the quarter ended September 30, 2021. Net loss for the third quarter of 2021 was $19.6 million, compared to a net loss of $14.8 million for the same period in 2020. As of September 30, 2021, Gamida Cell had total cash and cash equivalents of $120.8 million.
During the past quarter, Gamida Cell:
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. As previously disclosed, in a recent pre-BLA meeting, the FDA requested a revised analysis of the manufacturing data generated at Gamida Cell’s wholly owned commercial manufacturing facility to demonstrate the comparability to the omidubicel that was produced at the clinical manufacturing sites for the Phase 3 study. The FDA did not request additional clinical data to initiate the BLA submission once analytical comparability is demonstrated.
Progressed activities with objective to address the FDA’s Clinical Hold on the Investigational New Drug (IND) application for GDA-201, which was imposed based on questions about donor eligibility procedures and sterility assay qualification prior to the initiation of the study in patients with follicular and diffuse large B-cell lymphomas.
Expanded the company’s 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.
"We are committed to advance our programs and bring our important potential therapies to patients as quickly as possible. We are working diligently to respond to the FDA’s information requests for omidubicel and GDA-201, and now expect to submit the BLA for omidubicel to the FDA in the first half of 2022 and we hope to promptly address outstanding issues regarding our IND application relating to GDA-201." said Julian Adams, Ph.D., chief executive officer of Gamida Cell. "Additionally, at our recent NK-focused R&D Day, we provided details on our genetically modified NK cell immunotherapy programs leveraging CAR- and CRISPR-mediated strategies against hematologic malignancies and solid tumors. The company remains focused on our goal of bringing patients with cancer potentially curative cell therapies."
Recent Developments and Planned Presentations at ASH
Omidubicel: Advanced Cell Therapy
BLA Submission: During a recent pre-BLA meeting, the FDA requested that Gamida Cell provide revised analysis of the manufacturing data generated at Gamida Cell’s wholly owned commercial manufacturing facility. Upon completing those requirements, the company anticipates submitting the BLA in the first half of 2022.
New data to be presented at ASH: Gamida Cell will have three omidubicel presentations - two presentations of additional data from the phase III randomized trial of omidubicel, and a poster presentation summarizing long term omidubicel data from multiple studies - at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition (December 11-14, 2021).
Oral presentation of "Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel is Associated with Robust Immune Reconstitution and Lower Rates of Severe Infection Compared to Standard Umbilical Cord Blood Transplantation" on Saturday, December 11, 2021, at 4:30 p.m. ET. Data collected from a subset of 37 patients in the omidubicel Phase III trial shows that, in addition to more rapid short-term hematopoietic recovery, omidubicel-treated patients had more rapid recovery of a wide variety of immune cells including CD4+ T cells, B cells, monocytes, natural killer cells, and dendritic cells. The robust recovery of the broad range of the immune system correlated with and supports clinical data showing fewer severe bacterial, fungal, and viral infections in patients treated with omidubicel.
Poster presentation of "Hospitalization and Healthcare Resource Use of Omidubicel vs. Cord Blood Transplantation for Hematological Malignancies in a Global Randomized Phase III Clinical Trial" on Monday, December 13, 2021, 6:00-8:00 p.m. ET. Resource utilization data during the first 100 days after transplant were analyzed for 108 patients in the phase III trial and shows that omidubicel-treated patients has significantly shorter durations of hospitalization, intensive care unit time, consultant visits, procedures, and transfusions than the control arm. These data provide further evidence of the clinical benefit associated with the more rapid hematopoietic recovery in patients treated with omidubicel and the corresponding reduction in healthcare resource utilization.
Poster presentation, "Allogeneic Stem Cell Transplantation with Omidubicel: Long-Term Follow-up from a Single Center" on Saturday, December 11, 2021, 5:30-7:30 p.m. ET. Analysis of outcomes of 22 patients with hematologic malignancies treated with omidubicel at Duke University over a 10-year period shows long-term sustained bone marrow function and immune recovery, with a 10-year overall survival of 48%. These data provide further support for the long-term clinical benefit of omidubicel with long-lasting hematopoietic recovery.
GDA-201: NAM-Enabled NK Cell Therapy
IND for Phase 1/2 Study: Gamida Cell is working to address the clinical hold on the IND for a Phase 1/2 study of GDA-201. As a result of the clinical hold, the initiation of our planned Phase 1/2 study of GDA-201 will be delayed beyond the end of 2021, as the company previously projected.
New data presented at SITC: Gamida Cell recently presented promising new preclinical data in two posters characterizing the NAM-enabled mechanisms of action that contribute to the metabolic modulation properties and enhanced tumor cytotoxicity activity of GDA-201 at the Society for Immunotherapy of Cancer’s 36th Annual Meeting (SITC 2021) held from November 10-14, 2021.
New data to be presented at ASH: A poster titled "GDA-201, A Novel Metabolically Enhanced Allogeneic Natural Killer (NK) Cell Product Yields High Remission Rates in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma (NHL): 2-year survival and correlation with cytokine IL7" will be presented at the upcoming ASH Annual Meeting and Exposition on Monday, December 13, 2021, 6:00-8:00 p.m. ET. This analysis provides longer follow-up in the investigator-led study of GDA-201 in patients with non-Hodgkin lymphoma and demonstrated an overall survival rate of 78% at two years, median duration of response of 16 months, and a safety profile that was similar to what had been previously reported.
NAM-Enabled NK Cell Pipeline Expansion
Advanced NAM-enabled genetically modified NK pipeline: During Gamida Cell’s NK-focused virtual R&D Day, the company presented new data and additional details on its genetically modified NK cell immunotherapy programs, which utilize CAR, membrane bound- and CRISPR-mediated strategies to increase targeting, potency and persistence against hematologic malignancies and solid tumors:
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;
GDA-501: anti HER2 CAR-engineered NK cells to target solid tumors expressing HER2, based on a single-chain variable fragment of the widely used humanized monoclonal antibody trastuzumab; and
GDA-601: CRISPR Knockout of CD38 on NK cells combined with anti CD38 CAR. CD38 is an established immunotherapeutic target in multiple myeloma, but its expression on NK cells and its further induction during ex vivo NK cell expansion represents a barrier to the development of an anti CD38 CAR-NK cell therapy. Gamida Cell recently announced a research collaboration with the Dana-Farber Cancer Institute to study the in vitro cytotoxicity of GDA-601 in fresh samples from multiple myeloma patients.
New data presented at PEGS Europe: Data from early-stage studies of GDA-501 demonstrated enhanced potency and cytotoxicity against a HER2-expressing tumor cell line. Data presented on GDA-301 showed cytotoxic activity against a chronic myelogenous leukemia cell line (K562) and a multiple myeloma cell line (RPMI). These data were presented at the 13th Annual Protein and Antibody Engineering Summit (PEGS) in Barcelona, Spain November 2-4, 2021.
Third Quarter 2021 Financial Results
Research and development expenses in the third quarter of 2021 were $12.4 million, compared to $10.5 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 third quarter of 2021 were $6.0 million, compared to $1.9 million for the third quarter of 2020. The increase was mainly attributed to progress with omidubicel commercial readiness activities. Going forward, the company anticipates reducing its near-term commercial readiness expenses in line with the revised omidubicel BLA submission timing.
General and administrative expenses were $4.8 million for the third quarter of 2021, compared to $2.7 million for the same period in 2020. The increase was mainly due to professional services and the hiring of key management positions, to support business growth.
Finance income, net, was $3.5 million for the third quarter of 2021, compared to $0.3 million for the third quarter of 2020. The increase was primarily due to non-cash income, resulting from revaluation of warrants offset by convertible note interest expenses.
Net loss for the third quarter of 2021 was $19.6 million, compared to a net loss of $14.8 million for the same period in 2020.
2021 Financial Guidance
Gamida Cell is re-assessing its planned spending and prior financial guidance as a result of the revised timing of the expected omidubicel BLA submission.
Expected Milestones in 2022
Omidubicel
BLA submission to the FDA in the first half of 2022
GDA-201
Initiation of a company-sponsored Phase 1/2 clinical study in NHL in 2022
NK cell pipeline expansion
Establish preclinical proof of concept studies of the NAM-enabled, genetically modified NK therapeutic targets in 2022
Select pipeline candidate(s) for IND enabling studies by end of 2022
Conference Call Information
Gamida Cell will host a conference call today, November 15, 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 4347485. A recording of the webcast will be available approximately two hours after the event, for approximately 30 days.
Gamida Cell Provides Update on Pre-BLA Meeting With FDA for Omidubicel
https://finance.yahoo.com/news/gamida-cell-provides-pre-bla-120000275.html
[url]- Gamida Cell conducted pre-BLA meeting for omidubicel with FDA
- FDA requested revised analysis of manufacturing data generated at Gamida Cell’s commercial manufacturing facility
- BLA submission expected in the first half of 2022
BOSTON, November 11, 2021--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, completed a Type B Pre-Biologics License Application (BLA) meeting with the U.S. Food and Drug Administration (FDA) for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant. The FDA requested that Gamida Cell provide revised analysis of the manufacturing data generated at Gamida Cell’s wholly-owned commercial manufacturing facility to demonstrate the comparability to the omidubicel that was produced at the clinical manufacturing sites for the Phase 3 study. The FDA did not request additional clinical data to initiate the BLA submission once analytical comparability is demonstrated. The company will continue to work collaboratively with the FDA and anticipates submitting the BLA in the first half of 2022 in lieu of the company’s previous plan to submit the BLA by the end of 2021.
"Despite the delay in timing to bring omidubicel to patients after a potential FDA approval, we are encouraged by the FDA’s reaction to our Phase 3 data as the pivotal trial of omidubicel. We have gained further clarity with the FDA on the requirements for demonstrating comparability for our commercial manufacturing facility," said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell. "With the FDA’s feedback in hand, we believe that we are one step closer for omidubicel to be made available to patients in need."
Omidubicel, an investigational advanced cell therapy for allogeneic bone marrow transplant
Omidubicel is the foundational product based on Gamida Cell’s proprietary NAM-enabled cell expansion technology. It is the first cell therapy for bone marrow transplant to receive Breakthrough Therapy Designation from the FDA. The BLA submission will be 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 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.
Gamida Cell Presents New Data on Nicotinamide-Enabled NK Cell Therapy at Society for Immunotherapy of Cancer's (SITC) 36th Annual Meeting
https://finance.yahoo.com/news/gamida-cell-presents-data-nicotinamide-130000652.html
BOSTON, November 09, 2021--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, today announced data evaluating the mechanism of action of nicotinamide (NAM)-enabled NK cells, demonstrating enhanced homing, cytotoxicity and tumor reduction by GDA-201, the lead candidate in its NAM-enabled NK cell therapy pipeline. The data will be presented at the Society for Immunotherapy of Cancer’s 36th Annual Meeting (SITC 2021) taking place in Washington, DC, and virtually November 10-14, 2021.
The presentations identify network interactions between differentially expressed genes and intracellular metabolites associated with enhanced biological functional activity of GDA-201 NK. The data show that NAM increases cytotoxicity, ADCC, homing and in vivo antitumor activity of NK cells by modulating multiple metabolic pathways, down-regulating immune checkpoint inhibitors, increasing resistance to reactive oxygen species and influencing other cellular processes. An artificial intelligence–assisted analysis identified 1,204 differentially expressed genes, and 100 significantly modified metabolites, due to the effect of NAM. These data further validate the unique benefits of the NAM technology and its potential to improve clinical outcomes.
"NAM gives us a powerful tool for preserving and enhancing desirable qualities of NK cells and a broad range of other cell types. It has been shown to improve persistence and potency against cancer and may offer advantages in overcoming an immunosuppressive tumor microenvironment," said Julian Adams, Ph.D., chief executive officer of Gamida Cell. "These data are helping us to better understand how our proprietary NAM technology platform produces these benefits as we continue to pursue clinical trials of GDA-201 and other NK cell therapies."
Gamida Cell will present two posters at the conference, entitled "Cytotoxicity of nicotinamide (NAM)-enhanced natural killer (NK) cells (GDA-201) is based on metabolic modulation as demonstrated by artificial intelligence–assisted analysis of NK cell transcriptome and metabolome," and "Nicotinamide (NAM) rejuvenates ex vivo expanded natural killer cells and enhances their tumor killing capacity."
About GDA-201
Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled 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 about GDA-201, please visit https://www.gamida-cell.com.
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 Announces the Date of Its Third Quarter 2021 Financial Results and Webcast
https://finance.yahoo.com/news/gamida-cell-announces-date-third-130000755.html
BOSTON, November 08, 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 Monday, November 15, 2021, at 8:00 a.m. ET to review its third 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 4347485. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.
Novartis to sell its Roche stake in a bilateral transaction to Roche
https://www.novartis.com/news/media-releases/novartis-sell-its-roche-stake-bilateral-transaction-roche
Basel, November 4, 2021 — Novartis has agreed to sell 53.3 million (approximately 33%) Roche bearer shares in a bilateral transaction to Roche for a total consideration of USD 20.7 billion.
Novartis will have $20.7 Billion to go on a shopping spree....
The big question is whether Novartis, which owns 15% of Gamida, will be tempted to spend once more; the pharma giant has reportedly twice turned down an option to buy out the company under an agreement that calls for a $165m up-front payment.
https://www.evaluate.com/vantage/articles/news/snippets/can-gamidas-win-lure-novartis-again
Hmmmmmm!
Gamida Cell Announces Data to Be Presented at 63rd ASH Annual Meeting
Thu, November 4, 2021, 3:00 PM
https://finance.yahoo.com/news/gamida-cell-announces-data-presented-130000316.html
BOSTON, November 04, 2021--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, today announced four presentations at the 63rd American Society of Hematology (ASH) Annual Meeting, which is being held in Atlanta, Georgia or virtually from December 11-14, 2021.
New data on omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant, will be presented during an oral presentation showing that hematopoietic stem cell transplantation with omidubicel is associated with robust immune constitution and lower rates of severe infection compared to standard umbilical cord blood transplantation. Additionally, there will be three poster presentations and one e-publication highlighting additional clinical data from omidubicel and GDA-201, the company’s natural killer (NK) cell immunotherapy in development for the treatment of hematologic and solid tumors with standard of care antibody therapies. Together the data that will be presented at ASH reflect the progress across Gamida Cell’s NAM-enabled pipeline of cell therapies being developed as potentially curative approaches for cancer patients in need of new and better therapeutic options.
Details about the ASH presentations are as follows:
Title: Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel Is Associated with Robust Immune Reconstitution and Lower Rates of Severe Infection Compared to Standard Umbilical Cord Blood Transplantation (Oral)
Abstract Number: 333
Lead Author: Paul Szabolcs, M.D., Division of Blood and Marrow Transplantation and Cellular Therapy, UPMC Children’s Hospital of Pittsburgh, Pittsburg, PA
Time: Saturday, December 11, 2021, 4:00 p.m. – 5:30 p.m. EST (session time) and 4:30 p.m. EST (presentation)
Title: Allogeneic Stem Cell Transplantation with Omidubicel: Long-Term Follow-up from a Single Center (Poster)
Abstract Number: 1827
Lead Author: Chenyu Lin, M.D., Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University Medical Center, Durham, NC
Time: Saturday, December 11, 2021, 5:30 p.m. – 7:30 p.m. EST
Title: GDA-201, a Novel Metabolically Enhanced Allogeneic Natural Killer (NK) Cell Product Yields High Remission Rates in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma (NHL): 2-Year Survival and Correlation with Cytokine IL7 (Poster)
Abstract Number: 3854
Lead Author: Veronika Bachanova, M.D., Ph.D., Division of Hematology, Oncology and Transplantation, University of Minnesota, Minneapolis, MN
Time: Monday, December 13, 2021, 6:00 p.m. – 8:00 p.m. EST
Title: Hospitalization and Healthcare Resource Use of Omidubicel Vs Cord Blood Transplantation for Hematological Malignancies in a Global Randomized Phase III Clinical Trial (Poster)
Abstract Number: 4036
Lead Author: Navneet Majhail, M.D., Taussig Cancer Institute, Department of Hematology and Oncology, Cleveland Clinic, Cleveland, OH
Time: Monday, December 13, 2021, 6:00 p.m. – 8:00 p.m. EST
Title: Transcriptional and Metabolic Profiling of Nicotinamide-Enhanced Natural Killer (NAM-NK) Cells (GDA-201) (e-Publication)
Abstract Number: 4791
Lead Author: Dima Yackoubov, M.Sc., Gamida Cell, Jerusalem, Israel
Gamida Cell Presents Data on its NAM-Enabled NK Cell Therapies at Protein & Antibody Engineering Summit (PEGS) Europe
https://finance.yahoo.com/news/gamida-cell-presents-data-nam-110000432.html
BOSTON, November 04, 2021--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, today announced that Aviad Pato, Ph.D., Head of Immunology Research, presented data on two nicotinamide (NAM)-enabled NK cell therapies, GDA-501 and GDA-301, at the Protein & Antibody Engineering Summit (PEGS) Europe taking place in Barcelona, Spain, and virtually November 2-4, 2021.
The presentation included data from early-stage studies of GDA-501, Gamida Cell’s investigational cell therapy comprised of CAR-engineered NK cells designed to enhance homing and activation against cancers with HER2 overexpression such as breast, ovarian, lung, bladder, and gastric cancers. Data were also presented on GDA-301, which combines a CRISPR/Cas9 knockout of the CISH (cytokine inducible SH2 containing protein) gene in NK cells with a membrane-bound IL-15/IL-15Ra CAR, which is designed to improve tumor killing by promoting activation and inhibiting negative feedback signals and has potential application in a range of solid tumors and hematologic malignancies.
Data presented by Gamida Cell demonstrated that the engineered GDA-501 NK enhances potency and cytotoxicity against a HER2-expressing tumor cell line. Data also showed that GDA-301 has cytotoxic activity against a chronic myelogenous leukemia cell line (K562) and a multiple myeloma cell line (RPMI).
"The field of NK cell immunotherapy is advancing beyond what has previously been understood from T cell gene editing," said Yona Geffen, Ph.D., Vice President, Research and Development at Gamida Cell. "We are pleased to share this important update on two key potential therapies in Gamida Cell’s robust NK pipeline that show their potential as clinical immunotherapy agents."
The full presentation shared at PEGS Europe is available at www.gamida-cell.com.
Gamida Cell: Recapping A Tough Year
Nov. 02, 2021 12:17 PM ETGamida Cell Ltd. (GMDA)2 Comments
Summary
Today, we revisit an intriguing Israeli-based biotech concern called Gamida Cell for the first time since March.
The shares have seen declines in 2021, like most small biotechs this year, even as the company continues to march to its first FDA approval.
2021 had been a rough year so far for small developmental concern Gamida Cell (NASDAQ:GMDA), as it has been for most of the small biotech space. A record number of IPOs in the sector has taken some demand away from the stocks of existing firms. An inconsistent FDA that has hit myriad small cap firms at the last minute with complete response letters after sitting on marketing applications for many months including recently on Omeros (NASDAQ:OMER) and Eyenovia (NASDAQ:EYEN), hasn't been helpful for sentiment on the sector either. Obviously, company-specific news always determines the course for shares as well.
GMDA stock chart
A lot has happened since we last highlighted this name this Spring, so it's time to revisit this interesting concern. A full analysis follows below.
Company Overview:
Gamida Cell is focused on developing treatments for blood cancers and serious blood disorders. The company is based in Israel and currently is in clinical stage, something it hopes to change in 2022 as it marches toward hopefully its first FDA approval. The stock currently trades around $4.50 a share and sports an approximate market capitalization of $240 million.
GMDA pipeline platform
Source: August Company Presentation
The company has a proprietary developmental platform 'NAM Platform Technology' 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 furthest along of these efforts is a candidate called Omidubicel.
GMDA Omidubicel progress
Source: August Company Presentation
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. It is first such bone marrow product to have received both Orphan Drug Designation in the U.S. and EU as well as Breakthrough Therapy status in the U.S.
Source: August Company Presentation
In May of last year, the company announced topline results from a Phase 3 clinical study in 125 patients. Data demonstrated that omidubicel showed that the median time to neutrophil engraftment was significantly shorter for patients who were randomized to omidubicel than those in the comparator group.
Source: August Company Presentation
Five months later, Gamida reported that the study had met all three of its secondary endpoints related to platelet engraftment, infections, and hospitalizations. Further results were published recently (see section below).
Source: August Company Presentation
Recent Events:
The company's primary focus since we last looked into it has been advancing its primary asset which has a planned BLA (Biologic License Application) submission to the FDA in the fourth quarter of this year. These activities include making sure that both its company owned facility in Israel and another run by its contract manufacturing organization Lonza to produce omidubicel meet all requirements before submission of the BLA.
Source: August Company Presentation
This also means the company further conducting both market and health economic and outcomes research (HEOR) to support planned market entry and market access activities. They are also in the process of setting up Gamida Cell Assist. An effort to ensure all supply chain and logistics programs to facilitate positive patient and transplant center experiences are in place at the time of the launch of omidubicel. The company also recently published the latest results of the international, multi-center, randomized Phase 3 clinical study of omidubicel in the official journal of the American Society of Hematology named appropriately 'Blood'.
Source: August Company Presentation
On the NAM-Enabled NK Cell Pipeline front, the company is in the late stage planning stage for a Phase 1/2 clinical trial of allogeneic, cryopreserved GDA-201 in patients with follicular and diffuse large B-cell lymphoma. This trial should initiate before year end. It also plans to file another Investigational New Drug or IND application with the FDA in the near future for GDA-201.
Source: August Company Presentation
GDA-201 is described as the following on the company's website:
An innate natural killer (NK) cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. When combined with targeted antibodies, GDA-201 has shown enhanced antibody-dependent cellular toxicity, or ADCC."
The candidate is currently being evaluated in a Phase 1 clinical study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.
Source: August Company Presentation
The company expanded its NAM-enabled NK cell pipeline targeting solid-tumor and hematological cancers as it recently advanced four new development programs that involve modifications intended to direct NK cells against specific tumor markers to improve their cancer killing capabilities into early stage development.
Source: August Company Presentation
Analyst Commentary & Balance Sheet:
Analyst commentary has gotten more positive since the back end of October. Over that time, four analyst firms including JMP Securities have reissued Buy ratings on the stock. Price targets proffered have ranged from $14 to $27 a share. Earlier this week Alliance Global Partners initiated the shares as a new Buy with a $11 price target. The analyst at Alliance sees
An auspicious entry point into the stock" after share weakness in 2021, arguing that investors may be able to take advantage of "a perfect storm of high and low expectations colliding in one company." 2022 catalysts include Gamida Cell being "on the verge" of a potential approval for omidubicel in the hematologic malignancy HSCT setting while also being in the early days of clinical testing with its pipeline of four "and counting" natural killer, or NK, cell therapy assets."
The company ended the first half of 2021 with right around $150 million in cash and marketable securities on its balance sheet after posting a net loss of $21.3 million for the second quarter. In February of this year, the company sold $75 million of 5.875% exchangeable senior notes due in 2026 to certain funds managed by Highbridge Capital Management.
Verdict:
Source: August Company Presentation
Despite the poor performance of stock since we last looked in on Gamida in March of this year, the company has continued to advance its pipeline. 2022 could be an 'inflection year' for Gamida if FDA approval is granted. This seems likely on results, but the FDA has been anything but consistent recently in its decisions.
The company also has some earlier stage 'shots on goal' in its pipeline. I do expect Gamida to raise additional capital at some point on the near term horizon. Quite possibly, shortly after it files its BLA for omidubicel. This is a speculative name, but it seems to continue to have a favorable risk/reward profile. I plan to maintain my small 'watch item' position in GMDA and hope for a brighter 2022.
Bret Jensen is the Founder of and authors articles for the Biotech Forum, Busted IPO Forum, and Insiders Forum
This article was written by
Bret Jensen
Disclosure: I/we have a beneficial long position in the shares of GMDA either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Gamida Cell to Present NAM-Enabled, Genetically Modified NK Cell Therapy Pipeline and Update on GDA-201 at Today’s Virtual R&D Day
https://finance.yahoo.com/news/gamida-cell-present-nam-enabled-110000091.html
Company recently filed an IND application for GDA-201; FDA placed the application on Clinical Hold pending modifications to donor eligibility procedures and sterility assay qualification
Today’s presentations to highlight expanded NAM-enabled NK cell therapy platform including a new collaboration with the Dana-Farber Cancer Institute for GDA-601 targeting multiple myeloma
BOSTON, October 26, 2021--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, will be hosting a virtual R&D Day event detailing the company’s proprietary NAM-enabled natural killer (NK) cell therapy pipeline today, Tuesday, October 26, at 8:00 a.m. ET. During the event, the company will highlight Gamida Cell’s new programs leveraging next-generation, NAM-enabled, genetically modified NK cells in development for solid tumors and hematological cancers, as well as provide an update 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, including an update on the status of its Phase 1/2 Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA).
Update Regarding IND Application for GDA-201:
The company recently submitted an IND application to FDA for a Phase 1/2 trial with a cryopreserved formulation of GDA-201 in patients with diffuse large B cell lymphoma and follicular lymphoma and was notified that the IND application has been placed on Clinical Hold prior to the initiation of patient dosing. The FDA has requested modifications in donor eligibility procedures and sterility assay qualification. Gamida Cell is in active communication with the FDA with the objective to promptly address these requests to potentially enable the requirements for IND acceptance and study initiation. The initiation of the planned Phase 1/2 trial of GDA-201 may be delayed beyond the end of 2021, pending the outcome of FDA interactions.
"While we work to resolve outstanding issues with our IND, we are pleased to be able to share updates regarding our NAM-enabled NK cell programs," said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell. "We believe that the issues raised by FDA are addressable and can hopefully be resolved in an expeditious manner. In the meantime, we are pleased to elaborate on the power of NAM combined with the genomic tools that we have harnessed to enable us to create potentially transformative immuno-oncological therapies that may move beyond what is currently possible with existing approaches. These advances in our NK cell pipeline will help to further our mission to bring cancer patients potentially curative cell therapies."
Update Regarding NK Cell Therapy Programs:
During today’s virtual event, Gamida Cell management and partners will provide an overview of the company’s NK cell programs, including:
Objective to improve treatment of both hematological cancers and solid tumors in which genetic modifications to allogeneic NK cells may overcome immunosuppressive microenvironments.
Review of Gamida Cell’s proprietary NAM expansion process, which enhances the potency, function and persistence of NK cells while improving homing to and retention in lymphoid tissues.
Descriptions of Gamida Cell’s genetically modified NK cell immunotherapy programs (GDA-301, GDA-401, GDA-501 and GDA-601), which utilize CAR- and CRISPR-mediated strategies to increase targeting, potency and persistence against hematologic malignancies and solid-tumors.
Discuss a research collaboration with the Dana-Farber Cancer Institute studying the in vitro natural killer (NK) cell killing activity of GDA-601, Gamida Cell’s nicotinamide (NAM)-enabled genetically modified NK cell therapy in multiple myeloma. GDA-601 is a CD38 CRISPR knockout combined with a CD38 CAR NK cell construct that has demonstrated promising preclinical results, including reduced fratricide and increased cytotoxicity against a multiple myeloma cell line.
Phase 1 data on the safety and efficacy of GDA-201, a NAM-enabled, unmodified allogeneic NK cell therapy that has produced positive clinical results in the treatment of diffuse large B cell lymphoma and follicular lymphoma, both of which have significant unmet need.
"This is an exciting time for Gamida Cell as we have expanded R&D activities to augment our NK cell pipeline," said Ronit Simantov, M.D., Chief Medical Officer of Gamida Cell. "During today’s event, we will share our plans to advance the clinical development of GDA-201 based on highly encouraging clinical data in patients with lymphoma that have arisen from a physician sponsored study. We also plan to illustrate how our proprietary NAM expansion process, combined with our advanced genetic modifications, differentiate our NK cell programs as may meaningfully help patients with solid tumors and hematologic malignancies."
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)-enabled 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 about GDA-201, please visit https://www.gamida-cell.com.
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 at Society for Immunotherapy of Cancer's (SITC) 36th Annual Meeting
https://finance.yahoo.com/news/gamida-cell-present-society-immunotherapy-120000145.html
BOSTON, October 19, 2021--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, today announced that data evaluating the company’s NAM-enabled NK cell platform will be presented at the Society for Immunotherapy of Cancer’s 36th Annual Meeting (SITC 2021) taking place in Washington, DC, and virtually November 10-14, 2021.
Details about the SITC poster presentations are as follows:
Title: Cytotoxicity of nicotinamide enhanced natural killer cells GDA-201 is based on metabolic modulation as demonstrated by AI assisted analysis of NK cell transcriptome and metabolome
Abstract number: 217
Time: Friday, November 12, 2021, 7:00 a.m. – 8:30 p.m. EST
Location: Hall E
Title: Nicotinamide rejuvenates ex-vivo expanded NK cells and enhances their tumor killing capacity
Abstract Number: 162
Time: Saturday, November 13, 2021, 7:00 a.m. – 8:30 p.m. EST
Location: Hall E
About GDA-201
Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled 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 about GDA-201, please visit https://www.gamida-cell.com.
GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
Followers
|
19
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
963
|
Created
|
05/09/19
|
Type
|
Free
|
Moderators |
5 Nahum Heftsadie Street
Givaat Shaul
Jerusalem 91340
Israel
97222 659 666
http://www.gamida-cell.com
https://investors.gamida-cell.com/static-files/19b66eb5-8912-4828-a311-64227b63ec0f
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |