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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.
Gamida Cell to Host Virtual Event Highlighting GDA-201 and NAM-Enabled, Genetically Modified NK Cell Therapy Pipeline
https://finance.yahoo.com/news/gamida-cell-host-virtual-event-110000991.html
BOSTON, September 28, 2021--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced that it will host a virtual event detailing the company’s proprietary NAM-enabled natural killer (NK) cell therapy pipeline on Tuesday, October 26, 2021 at 8:00 a.m. ET.
During the event, the company will highlight updates on the clinical development of GDA-201, its lead cryopreserved, off-the-shelf cell therapy candidate for the treatment of patients with follicular and diffuse large b-cell lymphomas, and Gamida Cell’s new development programs leveraging next-generation, NAM-enabled, genetically modified NK cells in development for solid tumors and hematological cancers. Specifically, Gamida Cell will provide an update on the following genetically modified NK cell therapies:
GDA-301, a CISH knockout and membrane-bound IL-15 NK cell construct that has demonstrated increased potency against leukemia and multiple myeloma cell lines
GDA-501, a CAR-HER2 NK cell construct that has shown increased cytotoxicity against an ovarian tumor cell line
GDA-601, a CD38 knockout + CD38 CAR NK cell construct that has yielded increased cytotoxicity against a multiple myeloma cell line
The event will feature management presentations and participation by the following speakers:
Jeff Miller, M.D., Professor of Medicine, Division of Hematology, Oncology and Transplantation at University of Minnesota
Veronika Bachanova, M.D., Ph.D., Hematologist/Oncologist at University of Minnesota Health
Patient treated with GDA-201
The live event will be available at the following link. A replay of the webcast will be available on the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com, and will be available for at least 14 days following the event.
About GDA-201
Gamida Cell applied the capabilities of its nicotinamide (NAM)-based cell expansion technology to develop GDA-201, an innate NK cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical trial results, as reported at the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition1. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, GDA-201 improves antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. For more information on the clinical study of GDA-201, please visit https://www.gamida-cell.com/our-rd/ and www.clinicaltrials.gov.
GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
Gamida Cell to Present Corporate Highlights at Multiple Investor Conferences in September
https://finance.yahoo.com/news/gamida-cell-present-corporate-highlights-110000107.html
BOSTON, September 02, 2021--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced that company management will present its corporate highlights at the following virtual investor conferences in September:
H.C. Wainwright 23rd Annual Global Investment Conference, September 13-15, 2021. Company presentation will be available to view on-demand beginning on September 13 at 7:00 a.m. ET.
Baird’s 2021 Global Healthcare Conference, September 14, 2021 with a presentation at 11:25 a.m. ET.
In the fourth quarter of 2021, Gamida Cell is targeting a BLA submission for omidubicel, the first potential approval of a cell therapy for blood cancer patients in need of an allogeneic bone marrow transplant. This submission is expected to occur by the end of the year, subject to a pre-BLA meeting with the U.S. Food and Drug Administration (FDA) planned for the fourth quarter. In the third quarter of 2021, the Company is planning an IND submission to support the initiation of a Phase 1/2 clinical study of cryopreserved, off-the-shelf GDA-201 in patients with follicular and diffuse large b-cell lymphomas.
A webcast of both conference presentations will be available on the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com, and will be available for at least 14 days following the event.
About Gamida Cell
Gamida Cell is an advanced cell therapy company committed to cures for patients with blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn or Twitter at @GamidaCellTx.
Hi Spideyboy,
In Ref to:
Trillium Therapeutics Inc. TRIL entered into a definitive agreement with pharma giant Pfizer PFE, whereby it will be acquired by the latter.
....For Pfizer, the acquisition is expected to strengthen its hematology portfolio with the addition of Trillium’s next-generation immuno-therapeutics targeting hematological malignancies.
https://finance.yahoo.com/news/trillium-tril-acquired-pfizer-2-160304451.html
With a quick glance i see that GMDA is by far more
advanced than TRIL. Wouldn't you think that GMDA
would have been a better option for PFE? (and us
naturally)
What Kind Of Investors Own Most Of Gamida Cell Ltd. (NASDAQ:GMDA)?
Simply Wall St
Fri, August 13, 2021, 10:00 AM
https://finance.yahoo.com/news/kind-investors-own-most-gamida-070017051.html
Every investor in Gamida Cell Ltd. (NASDAQ:GMDA) should be aware of the most powerful shareholder groups. Insiders often own a large chunk of younger, smaller, companies while huge companies tend to have institutions as shareholders. We also tend to see lower insider ownership in companies that were previously publicly owned.
Gamida Cell is not a large company by global standards. It has a market capitalization of US$332m, which means it wouldn't have the attention of many institutional investors. Taking a look at our data on the ownership groups (below), it seems that institutional investors have bought into the company. Let's take a closer look to see what the different types of shareholders can tell us about Gamida Cell.
Check out our latest analysis for Gamida Cell
ownership-breakdown
What Does The Institutional Ownership Tell Us About Gamida Cell?
Institutional investors commonly compare their own returns to the returns of a commonly followed index. So they generally do consider buying larger companies that are included in the relevant benchmark index.
As you can see, institutional investors have a fair amount of stake in Gamida Cell. This implies the analysts working for those institutions have looked at the stock and they like it. But just like anyone else, they could be wrong. It is not uncommon to see a big share price drop if two large institutional investors try to sell out of a stock at the same time. So it is worth checking the past earnings trajectory of Gamida Cell, (below). Of course, keep in mind that there are other factors to consider, too.
earnings-and-revenue-growth
It looks like hedge funds own 5.6% of Gamida Cell shares. That catches my attention because hedge funds sometimes try to influence management, or bring about changes that will create near term value for shareholders. The company's largest shareholder is FMR LLC, with ownership of 10.0%. In comparison, the second and third largest shareholders hold about 7.9% and 7.3% of the stock.
We did some more digging and found that 8 of the top shareholders account for roughly 51% of the register, implying that along with larger shareholders, there are a few smaller shareholders, thereby balancing out each others interests somewhat.
While it makes sense to study institutional ownership data for a company, it also makes sense to study analyst sentiments to know which way the wind is blowing. There are a reasonable number of analysts covering the stock, so it might be useful to find out their aggregate view on the future.
Insider Ownership Of Gamida Cell
While the precise definition of an insider can be subjective, almost everyone considers board members to be insiders. Company management run the business, but the CEO will answer to the board, even if he or she is a member of it.
I generally consider insider ownership to be a good thing. However, on some occasions it makes it more difficult for other shareholders to hold the board accountable for decisions.
Our data cannot confirm that board members are holding shares personally. Not all jurisdictions have the same rules around disclosing insider ownership, and it is possible we have missed something, here. So you can click here learn more about the CEO.
General Public Ownership
The general public, with a 22% stake in the company, will not easily be ignored. This size of ownership, while considerable, may not be enough to change company policy if the decision is not in sync with other large shareholders.
Private Company Ownership
We can see that Private Companies own 15%, of the shares on issue. It's hard to draw any conclusions from this fact alone, so its worth looking into who owns those private companies. Sometimes insiders or other related parties have an interest in shares in a public company through a separate private company.
Public Company Ownership
It appears to us that public companies own 10% of Gamida Cell. It's hard to say for sure but this suggests they have entwined business interests. This might be a strategic stake, so it's worth watching this space for changes in ownership.
Gamida Cell Ltd (GMDA) CEO Julian Adams on Q2 2021 Results - Earnings Call Transcript
Aug. 11, 2021 1:17 PM ETGamida Cell Ltd. (GMDA)
Gamida Cell Ltd (GMDA) Q2 2021 Earnings Conference Call August 11, 2021 8:00 AM ET
Company Participants
Joshua Hamermesh - Chief Business Officer
Julian Adams - CEO & Director
Ronit Simantov - Chief Medical Officer
Michele Korfin - Chief Operating & Chief Commercial Officer
Shai Lankry - CFO
Conference Call Participants
Jonathan Miller - Evercore ISI
Edward Tenthoff - Piper Sandler & Co.
Douglas Buchanan - JMP Securities
Yinglu Zhang - RBC Capital Markets
Vernon Bernardino - H.C. Wainwright & Co.
Mark Breidenbach - Oppenheimer
Chad Messer - Needham & Company
Operator
Ladies and gentlemen, thank you for standing by. Welcome to Gamida Cell's Conference Call for Second Quarter 2021 Financial Results. My name is Krystal and I'll be the operator for today's call. Please be advised that this call is being recorded at Gamida sales request.
Now I would now like to introduce your host for today's conference, Mr. Josh Hamermesh, Chief Business Officer. Please go ahead.
Joshua Hamermesh
Thank you, Krystal, and good morning, everyone. Welcome to today's call, during which we will provide an update on the company and review our financial results for the second quarter of 2021. Earlier this morning, we issued a press release summarizing our financial results and progress across the company, which is available on our website at www.gamidacell.com.
Here with me on our call today are Julian Adams, Chief Executive Officer; Ronit Simantov Chief Medical Officer; Michele Korfin, Chief Operating Officer and Chief Commercial Officer; and Shai Lankry, Chief Financial Officer. There will also be a Q&A session following our prepared remarks.
During this call, we may make forward-looking statements about our future expectations and plans, including in respect of the timing and initiation and progress of and data reported from the clinical trials of our product candidates, anticipated regulatory filings, including the submission of the BLA for omidubicel to the FDA, commercialization planning efforts, the potentially life-saving or curative therapeutic and commercial potential of omidubicel and our expectations regarding our projected cash to be used for operating activities and cash runway.
Our actual results may differ materially from what we project today due to a number of important factors, including the impact of the COVID-19 pandemic on our operations, the scope progress and expansion of our clinical trials and cost impact thereof, clinical, scientific, regulatory and technical developments and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics and in the endeavor of building a business around such product candidates as well as those considerations described in the Risk Factors section of our most recent annual report on Form 20-F and other filings that we make with the SEC from time to time. These forward-looking statements represent our views only as of today, and we caution you that we may not update them in the future, whether as a result of new information, future events or otherwise.
And now I'd like to turn the call over to Julian.
Julian Adams
Thank you, Josh, and thanks to everyone for joining us this morning. This was a productive quarter for Gamida Cell. We continue to execute on our plan to launch the first allogeneic stem cell therapy, omidubicel for cancer patients in need of a stem cell transplant. In addition, based on promising preliminary studies, we have accelerated our plans to develop a unique NAM enabled natural killer or NK cell GDA-201 for patients with follicular lymphoma and diffuse large B-cell lymphoma. And we are very excited about the expansion of our cell therapy pipeline with 4 new NAM enabled genetically modified NK cell -- cells targeting cancers. Patients are at the forefront of our work, and we are committed to turning our NAM enabled NK product candidates into curative therapies.
I'll start with our most advanced program omidubicel, a potentially life-saving treatment for patients with blood cancers who are in need of a stem cell transplant. This quarter, we announced the results of a Phase III clinical study of omidubicel, which were published in blood, the official Journal of the American Society for Hematology. The published results demonstrate that transplantation with omidubicel needs to fasten neutrophil and platelet recovery compared with the standard of care.
Additionally, the data demonstrates that omidubicel results in fewer bacterial, fungal and viral infections and less time in the hospital. These results add to the compelling body of evidence for the potential of omidubicel as a life-saving therapy that can benefit patients in need of a bone marrow transplant and help reduce the burden on our health care system.
We continue to execute our plan of action to toward becoming a commercial company in 2022, as we prepare for our BLA submission for omidubicel by the end of this year, subject to a pre-BLA meeting with the agency in the fourth quarter. Omidubicel has the potential to be the first FDA approved cell therapy for stem cell transplants. Michele will provide an update on launch readiness later on in the call.
Moving to our NK pipeline. We believe that NK cells hold tremendous potential as a best-in-class next-generation immunotherapy. NK cells antibodies first-line of defense in providing innate immunity. They also have immune privileged properties, which obviate the requirement for HLA matching. Given that any healthy adult donor can provide an apheresis unit, from which we apply our proprietary NAM technology to expand and produce a cryopreserved off-the-shelf allogeneic natural killer cell treatment for cancer patients.
Our NAM enabled NK cells display several important cell surface markers, including high expression of CD16, the Fc-gamma RIII receptor for antibodies, which allows the combination with monoclonal antibodies to target tumors through enhanced antibody-dependent cellular cytotoxicity or ADCC.
Importantly, NAM also increases CD62L were L selected expression, which leads to in vivo homing and retention in lymphoid tissues. Furthermore, NAM increases secretion of inflammatory cytokines for activation of host adaptive immune cells. The combination of these activities results in increased cytotoxicity for more efficient tumor cell killing and durable responses. The combination of NK cells with therapeutic antibodies increased GDA-201's potency of killing an enhanced ADCC, both in vitro and in vivo, supporting clinical treatment with GDA-201 in parallel with selected antibodies for both specific malignancies.
We are advancing the power of NK cells to the next level with our second candidate in clinical development, GDA-201, which has demonstrated remarkable results in preliminary studies as a potential treatment for patients with follicular and diffuse large B-cell lymphomas.
We have completed the GMP batches with our cryopreserved formulation of GDA-201 and are on track to submit an IND in this quarter to support a multicentered Phase I/II study by the end of the year.
Today, we announced that we are expanding the reach of both the NAM technology and the power of NK cells through the growth of our NK pipeline to now include genetically modified variants and proprietary therapies using CRISPR/Cas9 and CAR technologies.
Ronit will give more detail on this exciting new development shortly. And we look forward to providing a more detailed update at an R&D Day later this year. I'm extremely proud of the progress our team has made with this expansion, and I believe that our technology, combined with our expertise in NK biology holds great promise for further -- to further our vision of bringing curative therapies to patients.
I want to conclude my introductory remarks by really thanking our employees for their continued dedication to our mission and hard work.
And with that, I will turn the call over to Ronit.
Ronit Simantov
Thank you, Julian. I'm very excited to provide more detail on our NK pipeline expansion, which we announced this morning. We're confident in the potential to leverage our NAM technology for these newly announced targets based on the encouraging clinical data we've demonstrated with GDA-201 for patients with lymphoma. These new programs will involve genetic modifications intended to direct NK cells against cancer cells, enhancing targeting and persistence and improving cytotoxicity against both hematologic malignancies and solid tumors. This pipeline expansion [indiscernible] research that we've been conducting here at Gamida Cell and in collaboration with key academic researchers and represents important progress in the development of NK therapies for patients.
Our new product candidates include GDA-301, a Knockout of CISH or cytokine inducible SH2 containing protein in NK cells using CRISPR/Cas9 with concomitant insertion of membrane-bound interleukin-15 or IL-15. CISH is a regulator of IL-15 signaling and CISH dilution increases NK sensitivity to IL-15 by lowering the NK activation threshold. NK cells equipped with membrane-bound IL-15 are designed for enhanced persistence and improved antitumor effects.
In preclinical studies, we've demonstrated elevation of pro-inflammatory cytokines and enhanced potency and cytotoxic activity in the cell. We believe that the CISH target coupled with membrane-bound IL-15 has potential across multiple tumor types.
Additionally, today, we announced the development of GDA-401, which is genetically engineered towards an undisclosed target designed to enhance NK cell survival in a solid tumor microenvironment. As with GDA-301, we believe that GDA-401 has potential application across a broad range of solid tumors.
The third development candidate in our NK pipeline is GDA-501, a chimeric antigen receptor or CAR engineered NK cell, designed to target HER2-positive solid tumors. This candidate has the potential to enhance homing to and activity against tumors over expressing HER2, such as breast cancer, ovarian, lung, bladder and gastric cancers. The NK CAR is based on a single chain variable fragment of the widely used humanized monoclonal antibody trastuzumab. GDA-501 CAR was selected out of several constructs that are primarily focused on optimizing the intracellular signaling domain. These were further validated in preclinical studies, showing increase in cytotoxicity and enhanced potency.
The fourth development candidate in our NK pipeline is GDA-601, which is designed to target multiple myeloma. There is strong biological rationale for the augmentation of allogeneic NK cells with a CAR to enhance myeloma targeting. And CD38 is an established immunotherapeutic target in multiple myeloma. However, CD38 expression on NK cells, which is increased during NK expansion represents a barrier to the development of CD38 CAR NK cell therapy. To overcome anticipated targeting our refractory side of NK cells by anti CD38, we applied CRISPR/Cas9 genome editing to disrupt CD38 protein expression in NK. We combine this with ACD 38 targeting CAR designed to enhance killing of CD38 positive myeloma cells, and we have demonstrated this in preclinical studies.
We believe that NK cells are a very promising new approach to the treatment of cancers, and we are proud to be at the forefront of the research to advance this powerful technology.
I'll now turn the call over to Michele Korfin, our Chief Operating Officer and Chief Commercial Officer, who will talk more about our launch readiness for omidubicel. Michel?
Michele Korfin
Thank you, Ronit, and good morning, everyone. Today, I will review our progress on our commercial manufacturing and launch readiness activities. As we continue to advance our breakthrough therapy, omidubicel for patients in need of an allogeneic stem cell transplant. As Julian mentioned, we are working towards BLA submission for omidubicel in the fourth quarter of this year, and our launch planning and manufacturing activities are underway to support a potential U.S. launch in 2022.
This quarter, we continued to make important progress preparing both our facilities for commercial manufacturing readiness. CMC qualification activities progressed at both the Gamida Cell owned manufacturing facility in Israel and at Lonza. We have made significant advancements in analytical method validation, analytical comparability and clinical manufacturing. We are on track to finalize the CMC qualification requirements for the BLA submission.
In addition, we are very excited about hiring Vladimir and Melnikov as our Senior Vice President, Global Manufacturing and Operations. Vladimir's broad and deep experience provide key expertise as we advance our commercial manufacturing readiness. We believe that there is a significant opportunity with omidubicel. In the U.S. alone, there are over 40,000 patients per year with hematologic malignancies who consider a bone marrow transplant. Unfortunately, only approximately 10,000 patients are able to make it to transplant for a variety of reasons. We have done extensive research and collaboration with the Center for International Blood and Marrow Transplant Research or CIBMTR and independent market research firms to fully assess the unmet need. This market research has enabled us to develop a well-informed launch strategy to reach these patients in transplanters.
Based on our commercial insights, the opportunity for omidubicel can be summarized in 2 key categories. First is increasing access for patients, especially those who are eligible for transplant and cannot find a match. And also improving outcomes-based on the unmet clinical needs with current donor sources that can be addressed by omidubicel. One specific area of advantage for omidubicel is that it has less stringent matching criteria for patients as compared to graft sources from match related or unrelated donors. This is particularly important for patients of non-Caucasian descent who tend to have a more challenging time finding a suitable match donor.
In fact, in the omidubicel Phase III trial, over 40% of the patients enrolled were non-Caucasian, illustrating the important need for a suitable graft source in this patient population. If approved, we believe omidubicel will provide a timely and attractive option for a suitable graft source to patients in need of a bone marrow transplant who would otherwise undergo a search for a matched donor that could take several months, causing high levels of anxiety and also uncertainty for patients who are at great risk or high-risk for relapse.
Upon FDA approval, we believe omidubicel will be an important therapy option for patients in the U.S. in need of an allogeneic stem cell transplant and we are focused on developing a strong launch strategy. Specifically, we have hired a very experienced commercial leadership team in the U.S. and continue to augment the capabilities of our team.
Additionally, we continue to have active dialogue with physicians and payers and feedback on the value proposition of omidubicel has been highly encouraging. Specifically, payers are encouraged by the potential for faster time to neutrophil engraftment, decreased infections, decrease in hospitalizations and less graft-versus-host disease as compared to published literature for other graft sources.
In preparation for the potential approval of omidubicel in the U.S., the development of Gamida Cell assist continues to progress, which will be an important source of support to patients, caregivers and transplant teams throughout each patient's journey with omidubicel. This is a program like no other for patients undergoing a transplant.
We have hired the Gamida Cell Assist leadership team that will be focused on supporting the patients journey with omidubicel. The Gamida cell Assist team will include an experienced case management team that will be focused on ensuring patient access and providing support to patients, their caregivers and the transplant team at the hospital throughout each step of the process.
Gamida Cell Assist will have a number of key roles. One of the most important roles is compliance with the FDA's chain of identity requirements. Gamida Cell Assist will start our chain of identity, which is a unique patient identifier that will follow the patient through the entire process. In addition, we will be able to provide the hospitals and patients with assistance to support access to omidubicel, such as benefit verifications or travel and logic needs. Gamida Cell is committed to supporting a positive journey for patients in their transplant centers so they could focus on what matters most, the patient experience and successful clinical outcomes.
In summary, we are excited by the potential of omidubicel to be the first FDA-approved cell therapy for bone marrow transplant, and we are encouraged by the clinical data and feedback from physicians, payers and patients. We are progressing our launch preparations and remain on track for product launch in 2022, with a focus on assuring a positive patient and transplant center experience.
I will now call -- turn the call over to Shai to review our financial results. Shai?
Shai Lankry
Thank you, Michele, and good morning, everyone. Today, I will summarize our financial results for the second quarter of 2021. As of June 30, 2021, our total cash position will $150.2 million compared to $127.2 million as of December 31st of last year. Research and development expenses for the quarter were $13.5 million compared to $9.3 million for the same period in 2020. The increase was mainly due to omidubicel commercial manufacturing readiness activities as well as the advancements of GDA-201 and our emerging NK pipeline, including broadening our scientific capabilities and talent.
Commercial expenses in the quarter were $5.2 million compared to $1 million for the same period last year. The increase was mainly attributed to progress with omidubicel commercial readiness activities, which includes, among other things the hiring of an experienced commercial leadership team.
Share and administrative expenses were $3.8 million for the second quarter of 2021 compared to $2.5 million for the same period in 2020. The increase was mainly due to higher in key management position to support the business growth.
Finance income net was $1.2 million for the quarter compared to finance expense net of $2.2 million in the same period last year. The increase was primarily due to noncash income resulting from revaluation of warrants, offset by interest expenses from the $75 million convertible note financing we did earlier this year.
Net loss for the quarter was $21.3 million compared to a net loss of $15.1 million for the same period last year. We continue to expect cash use for ongoing operating activities this year to range from $110 million to $120 million. We anticipate that our current total cash position will support our ongoing operating activities into the second half of 2022. This cash runway guidance based on our current operational plan and exclude any additional funding that may be received, or business development activities that may be undertaken.
With that, I will turn the call back over to Julian.
Julian Adams
Thanks, Shai. Our vision has always been define curious for patients, hematologic malignancies and blood disorders. And we are excited that the many opportunities ahead. Our accomplishments in 2021 will build extraordinary momentum and create a foundation for success in 2022. With omidubicel, we expect to submit the BLA in the fourth quarter of this year, and we are committed to being launched ready at the time of approval. The GDA-201 on its heels with compelling data, we are planning to initiate a Gamida Cell sponsored clinical study in lymphoma before the end of the year. We plan to share data on the mechanism of action of our NAM platform, translational data and more mature clinical data at major medical meetings and in peer-reviewed publications this year.
Lastly, we're excited about our NK pipeline expansion announced today and look forward to updating you as we have more progress to report later this year.
Now we will open the call for your questions. Krystal, operator.
Question-and-Answer Session
Operator
[Operator Instructions]. Your first question comes from the line of Ted Tenthoff from Piper Sandler.
Julian Adams
Krystal, let's maybe just go to the next caller. We'll give Ted another Chance.
Operator
Your next question comes from the line of Jonathan Miller from Evercore ISI.
Jonathan Miller
Congrats on all the new programs that you just announced. Couple of things across the pipeline. Can you talk to us about spending ramp for OMI commercial launch? How big a team you anticipate needing? And what the time line of that ramp is going to be as we anticipate both the BLA and the subsequent approval? Secondly, on OMI, you've mentioned this enormous potential market question in the states, but what volume do you anticipate current manufacturing being able to fill maybe come from the other side, the supply side of that curve. Then talking about the pipeline, maybe a little bit I'm curious about the timing of clinical initiation of these pipeline programs. Are any of these anticipated to have an IND before the contemplated current cash runway is up? And what is the time line for getting more clarity on the specifics of those programs, especially the target of the 401 asset?
Julian Adams
Michele, let me ask you to respond to the commercial expansion and the capacity question.
Michele Korfin
Absolutely. So in regards to your question about omidubicel field team and timing. So when you look at the benchmarks in the cell therapy space, specifically, if you look at the core T companies that are also focused on the transplant centers in the U.S., their range for personnel is approximately 25 to 30 commercial account managers and approximately 10 to 15 medical science liaisons that would fall under Ronit's team. We do know that in the U.S., 70 transplant centers make up approximately 80% or account for 80% of the transplant. So we actually do feel we could be on the lower end of those ranges and have a very thorough, but efficient footprint in the field. So we're looking on the lower end of those ranges that I've mentioned. So the commercial cap managers closer to the 25 and the medical science liaisons closer to the 10, the lower end of that range.
In terms of ramp-up, so on the commercial side, we have hired Linda Stamler, who was our Vice President for both marketing and account management. So we have the leader of both the marketing and account management team in place already, and Linda is now in the process of mapping up the timing -- hiring the account manager side. And Ronit and her team have made excellent progress in bringing in strong leaders on the medical affairs side also. So the leadership team and also some of the field hiring is already in place. So that's the question on the commercial footprint. In regards to manufacturing, the team at our commercial manufacturing facility in Israel, has really made outstanding progress, not only with getting ready for the qualification requirements for BLA, but also getting ready for commercialization. When the facility was designed in Israel, was designed as a modular facility.
So as we're seeing this encouraging data come in for our forecast going forward upon potential FDA approval, we have the ability to add additional modules at our facility in Israel in Kiryat Gat. So we feel very confident that we not only already have the facility in place for launch readiness for commercial needs, but also, we know what the long-term looks like for adding additional cores or additional modules.
So let me stop there, John, and see if you have any questions on what I just said, and then I could turn to Ronit for the NK question.
Jonathan Miller
No, that was a fabulous response. I guess while we're talking about -- what we're talking to you about the commercial launches and what the opportunities are. Do you have any updated color on the EU market? How the opportunity is different there? And any update on BD for ex U.S.?
Michele Korfin
Yes. So let me talk about the EU market, and I also mentioned other markets. So we have undertaken commercial assessments in both Europe and other parts of the world, including Asia. We're encouraged by the opportunities. There's certainly the great need for other potential graft sources, other cell therapies for allogeneic stem cell transplant patients in Europe and also in certain areas throughout the world, including Asia. So we're certainly very focused on launching omidubicel in the U.S., we feel very confident in our strategy and our execution plans to do it, and we're currently assessing what a potential path to launch could be in Europe and in Asia. The clinical study was designed as a head-to-head comparator. So we do recognize the applicability of that study in certain parts of the world, specifically in Europe.
Jonathan Miller
I'm just saying with regard to the further pipeline in our NK 301, 401. Ronit, do you want to comment on timing? And I'll just cover the general cash position as well.
Ronit Simantov
Yes, absolutely. So we are in the midst of preclinical studies for each of the programs that I've outlined, including in vitro and in vivo studies. And as we build the evidence and prepare the information, we will advance those through IND. We're not providing specific detail about the IND timing right now. But what I can say is that we will have an opportunity later this year in an R&D Day to give more color and detail about all of the aspects of that program. So we look forward to sharing more detail later.
Jonathan Miller
It's clear that we've been able to repurpose a lot of our knowledge, including cryopreservation and cell expansion. But couple that with the technologies for CRISPR/Cas9 and CAR technologies to be able to enhance our pipeline so quickly. Obviously, we will need to raise additional capital to prosecute all these programs. But currently, I see this as an embarrassment of ridges in our pipeline.
Julian Adams
So I certainly look forward to seeing what you have to share with us in the R&D Day.
Operator
Your next question comes from the line of Ted Tenthoff from Piper Sandler.
Edward Tenthoff
Congrats on all the progress. I'm just wondering, listening to your prepared remarks and also some of the question answer. I'm wondering if you're at all contemplating NK cells are my favor too, but are you contemplating evaluating other cell types that could be processed from umbilical court? And from donors?
Julian Adams
Yes. Ted, thank you for your question. In fact, the NAM technology has broad applicability, we've been able to expand dendritic cells, we've been able to expand gamma delta T-cells, this is really just a question of bandwidth in prioritization and we've had some very, very good luck with the NK cell program. And obviously, a lot of attention in the field is being paid to the NK field. That said, it doesn't preclude us from expanding other cell types with therapeutic potential.
Edward Tenthoff
Great. That's really exciting. Looking forward to the BLA and also 201 getting into the clinic?
Julian Adams
Thanks, Ted.
Operator
Your next question comes from the line of Jason Butler from JMP Securities.
Douglas Buchanan
Thanks for taking the questions and congrats on the progress. First one, just wondering if you could give us an update on the expanded access program for omidubicel. And will we see any data from the EAP before the pre-BLA meeting or the BLA submission this year? And then second question on the NK programs. You mentioned Julian leveraging your experience with the cryopreservation of 201. Can you just maybe speak to your plans for manufacturing for the new programs? Will they be cryopreserved products from the start in the clinical development? Or how will you integrate those into your manufacturing facilities?
Julian Adams
So let me turn the first question to Ronit to talk about the EAP, and then I'll answer your NK question.
Ronit Simantov
Absolutely. So our expanded access program is currently running, and we're using it in -- as a method for serving as our clinical bridging cohorts for both the Lonza, Netherlands and Kiryat Gat facilities for our commercial manufacturing programs, and we've been able to do that as the expanded access study has been open and enrolled patients in order to do that. We have some results from those from that study. And we will be happy to share those in collaboration with our academic collaborators. When we all feel that those data mature and ready for publication or presentation. So we are also very excited about other data that we will be sharing further data on our Phase III study and other potential data that have been submitted and hope to make those available by the end of the year in medical meetings as well.
Douglas Buchanan
Okay.
Julian Adams
And Jason, let me respond about the NK program. We intend to only use cryopreserved off-the-shelf products going forward. So our pipeline is so designed that we can both manufacture the cells from apheresis units and then genetically manipulate them and cryopreserve them, and that will be our playbook going forward.
Operator
Your next question comes from the line of Gregory Renza from RBC Capital Markets.
Yinglu Zhang
This is Yinglu on for Greg. First, maybe a follow-up on the EAP. I was wondering how should we think about the time line for manufacturing and data collection for clinical comparability for the site in Israel? And how does that align with your expectation for a pre-BLA meeting and submission in the fourth quarter? And then another one on the NK program now that you have multiple in the pipeline. How do you think about selection and execution across the 5 programs?
Julian Adams
So Ronit, would you comment again on the EAP?
Ronit Simantov
Absolutely. So we have 6 sites for the EAP open in the U.S. with investigators who have worked with us before and are incredibly enthusiastic about enrolling patients. And so as we advance our manufacturing, we have been able to slot in patients for the program and treat them. And we will continue to do that as we advance forward towards submitting the BLA using the facility in Kiryat Gat to treat patients in the coming months.
Julian Adams
And with regards to the NK, the selection process will be all data-driven. We have created a number of very, very interesting targets. We're looking at cell lines, but will eventually augment these to mouse models using PDX models as well as other sophisticated models to make the best selections of product -- for product development. And this will also be informed by our commercial colleagues, who will go careful market assessments and unmet need assessments for the various programs that we are developing.
Yinglu Zhang
Great. Thank you. And congrats on the progress.
Operator
Your next question comes from the line of Vernon Bernardino from H. C. Wainwright.
Vernon Bernardino
Very excited for your progress with the omidubicel and look forward to its filing later this year and further progress on the new programs. I was wondering if you could provide some insight regarding the market research you conducted. Specifically, I was wondering if the market research included a component regarding what effect the pandemic has had on transplantation procedures, particularly the ability to conduct these procedures during surges of COVID cases. But also whether the market researches has prompted any changes in your strategy and targeting that the groups that you identified as a various opportunities?
Julian Adams
Michele, let me invite you to answer on the market research activities.
Michele Korfin
So we conducted a number of different types of market research. And what we're very encouraged by is that the consistency of the research. So this latest round of market research that we conducted. It was over 100 transplanters in the U.S., and it was with the actual clinical data from the Phase III study. Prior research before the study had been completed or all the data set was in was with what we would refer to as a targeted product profile. Now we were getting physician transplant or feedback on the actual clinical data. They were very encouraged by a number of factors, the primary endpoint, the secondary endpoints and the exploratory endpoints.
Payers also that we spoke to, we're encouraged by the clinical data and also recognize the importance of reduction in health care resource utilization, specifically around reduction in time and hospital reduction for interventions due to less infections. So the takeaway from the research continues to be very encouraging. So it has not changed our strategy. What it has done is actually help to better inform our strategy and give us more encouragement and confidence in the opportunity.
Now, Vernon, you -- the question around COVID has been very, very challenging for patients. And we certainly hope that we see this pandemic begin to get to a more stable place for patients. What we can say that comes out in the research is it was very difficult to align donors with patients during the pandemic. Unrelated donors was very difficult because you had to align the donor with the patient. And we know even in traditional times, that could take 2 to 3 months and we were being told during COVID is sometimes it was just not possible to align that the donor with the patient. One of the benefits of omidubicel with our starting material being cord blood that is bank, that the cord blood banks. During our Phase III study, we were still able to access that the cord blood that was required for manufacturing have our proprietary NAM technology expand the cells appropriately and return them to the center. So that was something that came out during the market research as a benefit from omidubicel given that we don’t have to bring a donor into hospital setting as you see with other graft sources.
Vernon Bernardino
That's perfect.
Michele Korfin
So Vernon, let me stop there and see if you have any questions.
Vernon Bernardino
No, that's perfect. That's exactly the insight I was looking for.
Operator
Your next question comes from the line of Mark Breidenbach from Oppenheimer.
Mark Breidenbach
Just a few for me, all kind of the geared towards the NK programs. First, now that the Phase I/II protocol for GDA-201 has been finalized. Can you give us a little color on the study side and the specifics doses that will be tested in Phase I. How many sites you plan to activate that sort of thing. And then I was hoping Ronit could describe the interest signaling domains of the HER2 and CD38 CAR constructs that are being used in some of the new products? Are they both the same? And maybe you can point to any key differences between these and competing CAR NK constructs? And finally, with respect to the use of membrane-bound IL-15, I'm just wondering if you see any IT barriers to this type of -- to putting this type of construct in GDA-301, given that other NK developers are also pursuing similar approaches.
Julian Adams
So Ronit, would you comment on the GDA-201 Phase I/II?
Ronit Simantov
Sure. So in terms of the GDA-201 Phase I/II, we'll be conducting it as a Phase I first at a limited number of sites in the United States, appropriate to a Phase I. We are using doses based on our experience using the product that we tested with the University of Minnesota. So we have experience there in terms of the number of cells, and we'll be using similar dosing based on that experience. After we complete the Phase I, which will be used to evaluate safety as Phase Is are. We'll be transferring the study over to a larger number of sites. To conduct the Phase II. And we've not announced yet the number of patients that will be tested in the Phase II nor the number of sites, but I can share that the operational activities are underway. There's enthusiasm and excitement by potential investigators and all the executional activities in terms of getting the sites and the investigators lined up for the study are happening right now in preparation for initiating the study later this year.
Julian Adams
And once we file the IND and are cleared to open the study, we'll provide more details on the study design, number of patients and some of your other follow-up questions.
Ronit Simantov
Absolutely.
Julian Adams
With regard to the pipeline, we're staying silent on the details of the intracellular signaling today. But at an R&D Day later this year, we planned to go into a lot more detail and rest assured that we've filed all the appropriate intellectual property submissions. And I'm quite confident that we'll have present to operate with the -- the designated genetic manipulations that are underway, both for the CAR and for the Knockout pathways. Mark, are you there?
Mark Breidenbach
Yes. So here, and I assume that, that covers the member-bound IL-15 as well?
Julian Adams
Yes.
Mark Breidenbach
All right. Thank you.
Julian Adams
We've looked at a number of different constructs and really are doing head-to-head comparisons and really just picking the best of the best in the lab.
Operator
[Operator Instructions]. Your next question comes from the line of Chad Messer from Needham & Company.
Chad Messer
Between NDAs and INDs and pipeline expansions, it sounds like you guys certainly are busy over there. We've covered a lot of ground, but maybe just on the pipeline. I was wondering if I could get your thoughts on the HER2 target? You've got a lot of really cutting age technologies or thrown at NAM, which is exciting to see. This is an extremely well-balanced target may be one of the most in oncology with antibodies and small molecules and then in development, any number of other ways are going at it. Just wondering what particular advantages you think you bring in HER targeting specifically in solid tumor target too by the way very exciting to see that. And where you might think the unmet need is, where you think you would develop this? I mean, presumably in some noncellular failures to targeted therapies. But if there's a particular place you see the need?
Julian Adams
It's an excellent question. Obviously, we think that the HER2 CAR has the potential to be as effective, if not much more effective than combining it with Herceptin, the monoclonal antibody. And that's part of our engineering strategy is to make the CARs effective to be able to be used in solid tumors. As you know, solid tumors have a very immunosuppressive microenvironment. And so there are a lot of barriers. And so far, really no one has reported data in solid tumors with any great efficacy, but it's still early days. And what was mentioned in the prepared remarks is that there are a number of HER2-positive cancers. But in particular, I think a lot about gastric cancer and some of the lesser-known cancers that are not as well served by Herceptin or Perjeta. So we're thinking a lot about the various tumor models that we will develop and the clinical program could be a basket trial allowing that offer to patients that are refractory, obviously, to enter the trial.
Operator
There are no further question at this time. Mr. Julian, please continue.
Julian Adams
Well, it just remains for me to thank everyone for joining us on today's call. And we look forward to updating you in the future. Bye for now.
Operator
Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
Gamida Cell Ltd. 2021 Q2 - Results - Earnings Call Presentation
August 2021
Aug. 11, 2021 12:00 PM ETGamida Cell Ltd. (GMDA)
The following slide deck was published by Gamida Cell Ltd. in conjunction with their 2021 Q2 earnings call.
https://static.seekingalpha.com/uploads/sa_presentations/535/73535/original.pdf
Gamida Cell Reports Second Quarter 2021 Financial Results and Provides Company Update
https://finance.yahoo.com/news/gamida-cell-reports-second-quarter-110000781.html
BLA submission for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant, expected in fourth quarter of 2021
Commercial readiness activities underway to support potential launch in 2022
Phase 1/2 clinical trial of GDA-201 in patients with follicular and diffuse large B-cell lymphomas expected to start by the end of the year
Four new development programs announced leveraging next-generation, NAM-enabled, genetically-modified NK cells in solid tumor and hematological cancers
Company to host conference call at 8:00 a.m. ET today
BOSTON, August 11, 2021--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, today reported financial results for the quarter ended June 30, 2021. Net loss for the second quarter of 2021 was $21.3 million, compared to a net loss of $15.1 million for the same period in 2020. As of June 30, 2021, Gamida Cell had total cash and cash equivalents of $150.2 million.
During the quarter, the company continued to execute on plans to submit a Biologic License Application (BLA) for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant. This submission is expected to occur by the end of the year, subject to a pre-BLA meeting with the U.S. Food and Drug Administration (FDA) planned for the fourth quarter. In addition, Gamida prepared to begin a Phase 1/2 trial of GDA-201 in non-Hodgkin lymphoma (NHL), expected to occur by the end of 2021. Also, the company expanded its NAM-enabled natural killer (NK) cell pipeline targeting solid-tumor and hematological cancers, including genetically modified variants of proprietary NK therapies using both CRISPR/Cas9 and CAR methodologies.
"Our progress this quarter represents a major step forward for Gamida Cell and our mission to bring cancer patients potentially curative cell therapies," said Julian Adams, Ph.D., chief executive officer of Gamida Cell. "We are delivering against key process development, quality and manufacturing milestones in preparation for a BLA submission for omidubicel while also advancing our go-to-market strategy for our planned commercial launch. In parallel, we bolstered our NAM-enabled NK pipeline both by readying to advance GDA-201 into the clinic based on its encouraging clinical data in patients with hematological cancers and by expanding our NK cell pipeline to address solid and liquid tumors."
Q2 and Recent Developments
Omidubicel: Advanced Cell Therapy
Continued advancement toward planned BLA submission for omidubicel to the FDA in the fourth quarter of this year. The company’s activities included CMC qualification requirements at both the Gamida–owned facility in Israel and at Lonza, a contract manufacturing organization that will be supplying commercial material upon FDA approval. Advancements were made in analytical methods validation, analytical comparability and clinical manufacturing for Expanded Access Program patients, which are also planned to be used for clinical comparability.
Advanced launch planning activities by expanding Gamida’s commercial, operational and medical affairs teams. Conducted further market research and health economic and outcomes research (HEOR) to support planned market entry and market access activities. Readied Gamida Cell Assist, supply chain and logistics programs to facilitate positive patient and transplant center experiences at time of launch.
Announced that results of the international, multi-center, randomized Phase 3 clinical study of omidubicel were published in Blood, the official journal of the American Society of Hematology. This pivotal trial compared the safety and efficacy of omidubicel to standard umbilical cord blood transplant in patients with high-risk hematologic malignancies undergoing a bone marrow transplant. The results demonstrate that transplantation with omidubicel leads to faster neutrophil and platelet recovery, and results in fewer bacterial, viral and fungal infections and less time in the hospital, compared to a standard umbilical cord blood graft.
GDA-201: NAM-Enabled NK Immunotherapy
Prepared for filing of an Investigational New Drug (IND) application with the FDA.
Finalized clinical study protocol and statistical plan for a planned Phase 1/2 clinical trial of allogeneic, cryopreserved GDA-201 in patients with follicular and diffuse large B-cell lymphoma.
Conducted study start-up activities, including contract research organization (CRO) and clinical site selections.
NAM-Enabled NK Cell Pipeline Expansion
Advanced four new development programs that involve modifications intended to direct NK cells against specific tumor markers to improve their cancer killing capabilities against both hematological and solid tumors. Newly designated product candidates include:
GDA-301: Knockout of CISH (cytokine inducible SH2 containing protein) in NK cells using CRISPR/Cas9 in combination with a membrane-bound IL-15/IL-15Ra. Designed to improve tumor killing by promoting activation and inhibiting negative feedback signals. Potential applications exist across a range of solid tumors and lymphoma.
GDA-401: Undisclosed target genetically engineered to enhance NK cell survival in the solid tumor microenvironment for potential application across a broad range of solid tumors.
GDA-501: CAR-engineered NK cells to target HER2+ solid tumors with the potential to enhance homing and activation against cancers with HER2 overexpression, including breast, ovarian, lung, bladder, gastric and others.
GDA-601: Knockout of CD38 on NK cells to avoid fratricide by CD38 targeted antibodies in combination treatment of multiple myeloma, combined with a CD38 CAR designed to enhance killing of cancerous cells.
Advanced additional NAM-enabled research programs targeting immunosuppressive pathways using both CRISPR/Cas9 and CAR, with potential to treat solid tumor and blood cancers.
Corporate
Hired Vladimir Melnikov as Senior Vice President, Global Operations and Manufacturing. Vladimir has over 25 years of experience in the biopharmaceutical industry. He previously served as general manager at Omrix Biopharmaceuticals and biologic technical operations lead at Ethicon Biosurgery, both part of a Johnson & Johnson Company. In those roles he supervised three Israeli biotech manufacturing sites and technology transfer to external partners. Vladimir will have responsibility for the company’s Israeli manufacturing site and manufacturing partnership with Lonza.
Hired Josh Patterson as General Counsel, effective August 30, 2021. Josh has over 20 years of experience as in-house legal counsel for biopharmaceutical companies. Josh will be joining Gamida Cell from Akcea Therapeutics, a wholly owned subsidiary of Ionis Pharmaceuticals, where he is currently General Counsel. Josh will be responsible for building, leading and managing the legal function for Gamida Cell.
Second Quarter 2021 Financial Results
Research and development expenses in the second quarter of 2021 were $13.5 million, compared to $9.3 million for the same period in 2020. The increase was mainly due to omidubicel commercial manufacturing readiness activities, and the advancement of the GDA-201 program, including broadening scientific capabilities and talent.
Commercial expenses in the second quarter of 2021 were $5.2 million, compared to $1.0 million for the second quarter of 2020. The increase was mainly attributed to progress with omidubicel commercial readiness activities.
General and administrative expenses were $3.8 million for the second quarter of 2021, compared to $2.5 million for the same period in 2020. The increase was mainly due to the hiring of key management positions to support business growth.
Finance income, net, was $1.2 million for the second quarter of 2021, compared to $2.2 million for the second quarter of 2020. The increase was primarily due to non-cash income, resulting from revaluation of warrants offset by interest expenses that resulted from the $75 million convertible note financing in February 2021.
Net loss for the second quarter of 2021 was $21.3 million, compared to a net loss of $15.1 million for the same period in 2020.
2021 Financial Guidance
Gamida Cell reiterates its prior financial guidance and expects cash used for ongoing operating activities in 2021 to range from $110 million to $120 million. The company believes that its current cash and cash equivalents will support the ongoing operating activities into the second half of 2022. This cash runway guidance is based on the company’s current operational plans and excludes any additional funding and any business development activities that may be undertaken.
Expected 2021 Developments and Milestones
Gamida Cell plans to achieve the following key milestones during the second half of 2021:
Omidubicel
Pre-BLA meeting with FDA in the fourth quarter of 2021
BLA submission to the FDA in the fourth quarter of 2021
Commercial readiness activities ongoing for potential launch following approval
GDA-201
IND submission to FDA in third quarter 2021
Initiation of a company-sponsored Phase 1/2 clinical study in NHL before year-end 2021
NK cell pipeline expansion
Advance pipeline of NAM-enabled, genetically-modified NK cells in solid tumor and blood cancers
Conference Call Information
Gamida Cell will host a conference call today, August 11, 2021, at 8:00 a.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 5258448. A recording of the webcast will be available approximately two hours after the event, for approximately 30 days.
Gamida Cell Announces the Date of Its Second Quarter 2021 Financial Results and Webcast
Wed, August 4, 2021, 3:00 PM
https://finance.yahoo.com/news/gamida-cell-announces-date-second-120000733.html
BOSTON, August 04, 2021--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced that the company will host a conference call and live audio webcast on Wednesday, August 11, 2021, at 8:00 a.m. ET to review its second quarter 2021 financial results and provide an update on the company.
Management will discuss the company’s progress during the quarter, including advances in the development of omidubicel, which has the potential to be the first approved cell therapy for blood cancer patients in need of an allogeneic bone marrow transplant, following the planned BLA submission in the fourth quarter of 2021. Gamida Cell will also provide an update on its pipeline of NAM-enabled natural killer (NK) cell therapies, including GDA-201 and genetically-modified NK cell constructs. The Company is planning an IND submission to support the initiation of a Phase 1/2 clinical study of cryopreserved, off-the-shelf GDA-201 in patients with follicular and diffuse large b-cell lymphomas.
The webcast will be available on the "Investors & Media" section of the Gamida Cell website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 9949715. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.
Form 6-K Gamida Cell Ltd.
Gamida Cell Ltd.
On August 2, 2021, Nurit Benjamini submitted her resignation from the Board of Directors of Gamida Cell Ltd. (the “Company”), which resignation will be effective August 18, 2021. Ms. Benjamini’s resignation was not the result of any disagreement with the Company. Effective upon Ms. Benjamini’s resignation on August 18, 2021, Stephen Wills, CFO of Palatin Technologies, Inc, will chair the Audit Committee and Ofer Gonen, CEO of Clal Biotechnology Industries, will join the Audit Committee.
Gamida Cell to Present at the BTIG Virtual Biotechnology Conference
https://finance.yahoo.com/news/gamida-cell-present-btig-virtual-120000826.html
Tue, August 3, 2021, 3:00 PM
BOSTON, August 03, 2021--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced that the company will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on Tuesday, August 10, 2021 at 3:00 p.m. ET.
The live webcast will be available on BTIG’s conference website at the time of the event, after which it will be available through BTIG’s research access.
In the fourth quarter of 2021, Gamida Cell is targeting a BLA submission for omidubicel, the first potential approval of a cell therapy for blood cancer patients in need of an allogeneic bone marrow transplant. In the second half of 2021, the Company is planning an IND submission to support the initiation of a Phase 1/2 clinical study of cryopreserved, off-the-shelf GDA-201 in patients with follicular and diffuse large b-cell lymphomas.
Hi Itstime,
I know of at least 3 companies whom
the FDA was supposed to come visit
their premises for inspection as
PDUFA.
The 3 companies are: SLGL, PLX and
MDWD.
Due to Covid restrictions no inspection
took place in all 3, no further date given.
In my opinion GMDA will face a similar
situation and suffer the same decrease
in sp as all 3, although GMDA has not yet
submitted BLA.
Hi Midas,
What are your thoughts on why sp is slipping?
Gamida Cell Ltd.
On June 25, 2021, Gamida Cell Ltd. (the “Company”) announced that Dr. Tracey Lodie, the Company’s Chief Scientific Officer, has tendered her resignation, effective on July 9, 2021, to pursue another opportunity at a private cell therapy company outside the area of oncology. Dr. Lodie will remain engaged with Gamida Cell by serving as a scientific advisor and consultant to the Company to see both omidubicel and GDA-201 through key regulatory and development milestones.
Gamida Cell Announces Publication in Blood, the Journal of the American Society of Hematology, of the First Pivotal Trial to ...
June 23 2021 - 07:00AM
Omidubicel is a first-in-class, NAM-enabled, advanced cell therapy being evaluated as a potential life-saving treatment for patients with blood cancers in need of an allogeneic hematopoietic stem cell (bone marrow) transplant
The Phase 3 clinical trial achieved both primary and secondary endpoints
Gamida Cell remains on track to submit a Biologics License Application for omidubicel in the fourth quarter of this year
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced that the results of a Phase 3 clinical study of omidubicel have been published in Blood, the official journal of the American Society of Hematology. Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell transplant solution for patients with hematologic malignancies.
The results demonstrate that transplantation with omidubicel leads to faster neutrophil and platelet recovery compared to a standard umbilical cord blood graft, and results in fewer early bacterial and viral infections and less time in the hospital.
“We are pleased that the data from this well-conducted international Phase 3 trial have been published in Blood, the highly respected, peer-reviewed journal of the American Society of Hematology,” said Ronit Simantov, M.D., chief medical officer of Gamida Cell. “The robust results of this clinical trial have demonstrated that omidubicel could provide an important new option for patients with hematologic malignancies in need of a bone marrow transplant.”
Data from this study were previously presented at the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy and Center for International Blood & Marrow Transplant Research, and most recently during the Presidential Symposium at the 47th Annual Meeting of the European Society for Blood and Marrow Transplantation. The pivotal study was an international, multi-center, randomized Phase 3 trial designed to compare the safety and efficacy of omidubicel to standard umbilical cord blood transplant in patients with high-risk hematologic malignancies undergoing a bone marrow transplant.
“Previous studies have shown that engraftment with omidubicel is durable, with some patients in the Phase 1/2 study now a decade past their transplant. The Phase 3 data reinforce omidubicel’s potential to be a new standard of care for patients who are in need of stem cell transplantation but do not have access to an appropriate matched donor,” said Mitchell Horwitz, M.D., lead author of the paper and a professor of medicine at the Duke Cancer Institute.
The full Blood manuscript is available here: https://ashpublications.org/blood/article/doi/10.1182/blood.2021011719/476235/Omidubicel-Versus-Standard-Myeloablative-Umbilical.
Details of Phase 3 Efficacy and Safety Results Shared in Blood
The intent-to-treat analysis included 125 patients aged 13–65 years with a median age of 41. Forty-four percent of the patients treated on study were non-Caucasian, a population known to be underrepresented in adult bone marrow donor registries. Patient demographics and baseline characteristics were well-balanced across the two study groups. Patients with acute lymphoblastic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, myelodysplastic syndrome or lymphoma were enrolled at more than 30 clinical centers in the United States, Europe, Asia, and Latin America.
Gamida Cell previously reported in May 2020 that the study achieved its primary endpoint, showing that omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment, a measure of how quickly the stem cells a patient receives in a transplant are established and begin to make healthy new cells and a key milestone in a patient’s recovery from a bone marrow transplant. The median time to neutrophil engraftment was 12 days for patients randomized to omidubicel compared to 22 days for the comparator group (p<0.001).
All three secondary endpoints, details of which were first reported in December 2020, demonstrated a statistically significant improvement among patients who were randomized to omidubicel compared to patients randomized to standard cord blood graft. Platelet engraftment was significantly accelerated with omidubicel, with 55 percent of patients randomized to omidubicel achieving platelet engraftment at day 42, compared to 35 percent for the comparator (p = 0.028). Hospitalization in the first 100 days after transplant was also reduced in patients randomized to omidubicel, with a median number of days alive and out of hospital for patients randomized to omidubicel of 61 days, compared to 48 days for the comparator (p=0.005). The rate of infection was significantly reduced for patients randomized to omidubicel, with the cumulative incidence of first grade 2 or grade 3 bacterial or invasive fungal infection for patients randomized to omidubicel of 37 percent, compared to 57 percent for the comparator (p=0.027). Additional data reported in the manuscript included a comparison of infection density, or the number of infections during the first year following transplantation, which showed that the risk for grade 2 and grade 3 infections was significantly lower among recipients of omidubicel compared to control (risk ratio 0.5, p<0.001).
Data from the study relating to exploratory endpoints also support the clinical benefit demonstrated by the study’s primary and secondary endpoints. There was no statistically significant difference between the two patient groups in incidence of grade 3/4 acute GvHD (14 percent for omidubicel, 21 percent for the comparator) or all grades chronic GvHD at one year (35 percent for omidubicel, 29 percent for the comparator). Non-relapse mortality was shown to be 11 percent for patients randomized to omidubicel and 24 percent for patients randomized to the comparator (p=0.09).
These clinical data results form the basis of a Biologics License Application (BLA) that Gamida Cell plans to submit to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2021.
Man, this thing looked so promising, but has become a complete dog. Must be a lot of shorting going on? Should have dumped when it was at 12 bucks..lol
Anyone know what's going on here?
Gamida Cell to Present Corporate Highlights at Multiple Investor Conferences in June
https://finance.yahoo.com/news/gamida-cell-present-corporate-highlights-120000902.html
Wed, June 9, 2021, 3:00 PM
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced that company management will present its corporate highlights at the following investor conferences in June:
JMP Securities Life Sciences Conference, June 16-17, 2021. In a fireside chat at 12:30 p.m. ET on June 16, 2021, management will discuss a corporate overview for 2021 with a special focus on multiple growth opportunities driven by advances in the development of omidubicel, a potentially life-saving NAM-enabled cell therapy with positive Phase 3 clinical data, and based on encouraging preliminary clinical results, NAM-enabled natural killer (NK) cell immunotherapies including GDA-201.
A.G.P. Summer Healthcare Symposium, June 17, 2021. The company will present its 2021 corporate highlights to investors in one-on-one meetings on June 17, 2021.
In the fourth quarter of 2021, Gamida Cell is targeting a BLA submission for omidubicel, the first potential approval of a cell therapy for blood cancer patients in need of an allogeneic bone marrow transplant. In the second half of 2021, the Company is planning an IND submission to support the initiation of a Phase 1/2 clinical study of cryopreserved, off-the-shelf GDA-201 in patients with follicular and diffuse large b-cell lymphomas.
A live webcast of the JMP Securities fireside chat will be available on the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com, and will be available for at least 14 days following the event.
Gamida Cell Announces Appointment of Senior Vice President, Global Operations and Manufacturing and Provides Commercial Manufacturing Update
https://finance.yahoo.com/news/gamida-cell-announces-appointment-senior-110000946.html
Mon, June 7, 2021, 2:00 PM
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced the appointment of Vladimir Melnikov as senior vice president, global operations and manufacturing. Mr. Melnikov brings over 25 years of experience in the biopharmaceutical industry, particularly in biologics manufacturing, operations, engineering and technology transfer. He will be based in the company’s wholly owned commercial manufacturing facility in Israel.
Prior to joining Gamida Cell, Mr. Melnikov served as general manager at Omrix Biopharmaceuticals and biologic technical operations lead at Ethicon Biosurgery, both part of a Johnson & Johnson Company. In those roles he supervised three Israeli biotech manufacturing sites and technology transfer to external partners. In positions of increasing responsibility at Omrix, he played a pivotal role in new product development and launch, process scale-up, development of new facilities and equipment and obtaining regulatory approvals. Mr. Melnikov has proven success in production, supply chain, engineering and leading multifunctional teams. Mr. Melnikov will have responsibility for the Gamida Cell global operations and manufacturing, which will include the company’s Israeli manufacturing site and oversight of the company’s contract manufacturing partnership with Lonza. The scope will focus on both omidubicel and readiness for Gamida Cell’s natural killer cell platform, including GDA-201. Mr. Melnikov holds a M.Sc. in life sciences from Hebrew University of Jerusalem, an MBA in biopharma from the College of Management, and he completed the Course of Directors and Senior Executives at Tel Aviv University.
"With Vladimir on board, we feel even more confident that we are making positive steps toward bringing omidubicel, our proprietary advanced cell therapy, to patients in need of an allogeneic hematopoietic stem cell transplant," said Julian Adams, Ph.D., chief executive officer of Gamida Cell. "In December 2020, the U.S. Food and Drug Administration provided clear feedback on what will be required for our commercial manufacturing facilities to be ready to submit a Biologics License Application for omidubicel, and we remain on track to submit our BLA in the fourth quarter of this year."
In addition to the appointment of Mr. Melnikov, Gamida Cell has made important progress in its strategy to have two commercial manufacturing facilities ready and available at the time of omidubicel’s potential approval. One of these manufacturing plants is wholly owned by Gamida Cell and located in Israel. The other site is a commercial manufacturing facility for which the company has a contractual relationship with Lonza. Construction of Gamida Cell’s Israel facility has been completed, and the initial production team has been hired, trained and qualified. In Q1 2021, the company successfully completed the required engineering runs and aseptic simulations for process qualification. Methods validations are underway, with planned completion in Q2 2021. Gamida Cell anticipates finalizing analytical comparability runs and process performance qualification by Q3 2021.
The company’s additional commercial facility, in partnership with Lonza, is currently manufacturing clinical batches for Gamida Cell’s expanded access program and is also progressing on the requirements.
"We are encouraged by the progress we are making to fulfill the FDA CMC requirements for our omidubicel BLA submission and are also diligently working on launch readiness," said Michele Korfin, chief operating officer and chief commercial officer of Gamida Cell. "The key focus of our omidubicel launch is to assure a positive patient and transplant center experience, including the best possible product. Manufacturing is a critical part of this, and we are also progressing well on our timeline to assure readiness for commercial manufacturing."
About Omidubicel
Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). In both Phase 1/2 and Phase 3 clinical studies (NCT01816230, NCT02730299), omidubicel demonstrated rapid and durable time to engraftment and was generally well tolerated.1,2 Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn®, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.
Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
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5 Nahum Heftsadie Street
Givaat Shaul
Jerusalem 91340
Israel
97222 659 666
http://www.gamida-cell.com
https://investors.gamida-cell.com/static-files/19b66eb5-8912-4828-a311-64227b63ec0f
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