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Gamida Cell Appoints Abigail L. Jenkins as President and Chief Executive Officer, Bringing Broad Leadership Experience in Commercializing Innovative Therapies
https://finance.yahoo.com/news/gamida-cell-appoints-abigail-l-110000570.html
Julian Adams, Ph.D., to Retire and Remain on the Board as Planned Succession
BOSTON, September 19, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the global leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, today announced that Abigail "Abbey" L. Jenkins, MS, has joined as President & CEO. Ms. Jenkins has also been appointed to Gamida Cell’s Board of Directors. Ms. Jenkins succeeds Julian Adams, Ph.D., who is retiring in accordance with planned succession and will continue to serve on the company’s Board of Directors.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220919005300/en/
"Abbey is an inspiring leader who brings to Gamida Cell an expertise in building and scaling organizations as they mature through commercialization alongside continued advancement of innovations in R&D. In addition, she is skilled in corporate strategy and is highly respected by her colleagues for her commitments to build strong company cultures focused on patient centric missions," said Robert Blum, Chairman of Gamida Cell’s Board of Directors. "On behalf of Gamida Cell’s Board, we welcome Abbey and thank Julian for his longstanding commitment to the company’s science and values during a pivotal time during which the company achieved major milestones including the submission of the BLA for omidubicel and the initiation of the clinical development of GDA-201. We look forward to his continued service and scientific counsel to the Board."
Ms. Jenkins brings over 20 years of leadership experience in the biopharmaceutical industry delivering life-enhancing therapies from research to commercialization for patients in need. She served as the Chief Commercial and Business Officer at Lyndra Therapeutics, where she established and led global commercial, business development, corporate strategy and portfolio management across multiple therapeutic areas. Prior to Lyndra, she served as Senior Vice President and Business Unit Head of Vaccines at Emergent BioSolutions, where she oversaw the company’s largest therapeutic division from discovery through commercialization. Ms. Jenkins also served as Chief Commercial Officer and U.S. Business Head at Aquinox Pharmaceuticals. Additionally, she has held senior commercial and business development positions at Relypsa, Actavis, Pfizer and Medimmune/AZ.
Ms. Jenkins holds a Master of Science in biotechnology and biotech business enterprise from The Johns Hopkins University, a Bachelor of Arts in psychology and biology from Indiana University, and a certificate of achievement in General Management as a Kellogg Executive Scholar. In September, she was recognized by PharmaVoice as one of the top 100 Most Inspiring Leaders, Disrupter category, for change-agents who are defining excellence in leadership in the biopharma industry.
"I am excited to lead Gamida Cell as we work to fulfill our mission of creating cures for blood cancers and serious hematologic diseases. Under Julian’s leadership, the team has built a strong pipeline of next-generation cell therapies that hold the potential to meaningfully change the future of cancer care for patients and healthcare providers," said Ms. Jenkins. "Our next goal will be to successfully deliver the first-ever allogeneic hematopoietic stem cell therapy, omidubicel, to market if approved and which we believe can expand access and eligibility for cancer patients in need of a stem cell transplant as well as reduce the overall burden on healthcare resources."
"It has been a distinct honor and a privilege to discover and develop novel medicines over the course of my 40-year career and to serve this company as its CEO these past five years," said Dr. Adams. "I wish to thank all my Gamida Cell colleagues for their unwavering support as well as their extraordinary efforts to bring our science of NAM-enabled cell therapies closer to benefiting patients with hematologic malignancies. Today, Gamida Cell is in a position of strength, with excellent prospects for the future."
About NAM Technology
Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.
About Omidubicel
Omidubicel is a NAM-enabled cell therapy candidate developed as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment in comparison to standard umbilical cord blood in an international, multi-center, randomized Phase 3 study (NCT0273029) in patients with hematologic malignancies undergoing allogeneic bone marrow transplant. The Phase 3 study also showed reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. One-year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by significant reduction in infectious complications as well as reduced non-relapse mortality and no significant increase in relapse rates nor increases in graft-versus-host-disease (GvHD) rates. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the US and EU.
The BLA for omidubicel has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2023. If approved, omidubicel will be the first allogeneic advanced stem cell therapy donor source for patients with blood cancers in need of a stem cell transplant.
Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority. For more information about omidubicel, please visit https://www.gamida-cell.com.
About Gamida Cell
Gamida Cell is pioneering a diverse immunotherapy pipeline of potentially curative cell therapy candidates 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 therapy candidates 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 omidubicel), regulatory filings submitted to the FDA (including the potential timing of the FDA’s review and approval of the BLA for omidubicel), timing of commercialization efforts, and the potentially life-saving or curative therapeutic and commercial potential of Gamida Cell’s product candidates (including omidubicel).. 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 Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission (SEC) on August 15, 2022, 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/20220919005300/en/
Contacts
For investors:
Courtney Turiano
Stern Investor Relations, Inc.
Courtney.Turiano@sternir.com
1-212-362-1200
For media:
Heather DiVecchia
Director, IR and Corporate Communications
Heather@gamida-cell.com
1-617-892-9083
Gamida Cell Ltd. (NASDAQ:GMDA) Receives $14.17 Consensus Target Price from Brokerages
https://reporter.am/2022/09/15/gamida-cell-ltd-nasdaqgmda-receives-14-17-consensus-target-price-from-brokerages.html
Posted by AM Reporter Staff on Sep 15th, 2022
Gamida Cell logoShares of Gamida Cell Ltd. (NASDAQ:GMDA – Get Rating) have been assigned a consensus recommendation of “Buy” from the six analysts that are currently covering the firm, MarketBeat.com reports. Five equities research analysts have rated the stock with a buy rating. The average 1 year price objective among brokers that have covered the stock in the last year is $14.17.
GMDA has been the topic of a number of recent analyst reports. Piper Sandler increased their price objective on shares of Gamida Cell from $6.00 to $8.00 in a research report on Monday, August 15th. JMP Securities reissued a “buy” rating and issued a $17.00 price objective on shares of Gamida Cell in a research report on Thursday, June 2nd.
Gamida Cell Presents Data Demonstrating the Impact of Transplantation with Omidubicel for Patients with Hematologic Malignancies at 2022 Cord Blood Connect Meeting
https://finance.yahoo.com/news/gamida-cell-presents-data-demonstrating-120000628.html
- Patients treated with omidubicel reported higher health-related quality of life scores during first-year post-transplant as compared to transplantation with umbilical cord blood (UCB)
- If approved, Omidubicel is projected to have meaningful improvement in patient outcomes among racial and ethnic minorities by potentially extending access to allogeneic hematopoietic cell transplant (allo-HCT) and reducing time to transplant
- Data highlights robust and diverse T cell reconstitution, with significantly higher recent thymic emigrant (RTE) T cells at 1 year, no loss of TCR repertoire diversity, providing mechanistic rationale for lower viral and overall infection rates observed in patients transplanted with omidubicel
BOSTON, September 12, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, today announced the presentation of data supporting the potential of omidubicel for the treatment of patients with blood cancers in need of an allogeneic hematopoietic stem cell transplant at the 2022 Cord Blood Connect Meeting, being held in South Beach, Florida. "We continue to be encouraged by the growing body of evidence supporting the improved outcomes and lower infection rates seen in patients treated with omidubicel as well as the superior health-related quality of life scores compared to transplantation with UCB. We also demonstrated the potential role for omidubicel to address the unmet need for patients who are currently eligible for transplant, but cannot find a match," said Julian Adams, chief executive officer of Gamida Cell. "Our omidubicel BLA was accepted by the FDA and granted priority review with a PDUFA date of January 30, 2023, which we believe further underscores the unmet need for patients with blood cancers in need of a stem cell transplant."
Gamida Cell presented a poster titled "Health-Related Quality of Life (HRQL) Following Transplantation with Omidubicel Versus Umbilical Cord Blood (UCB) in Patients with Hematological Malignancies: Results from a Phase III Randomized, Multicenter Study," which included an analysis of 75 patients to evaluate changes in HRQL measures between the two study arms. Outcomes evaluated included Functional Assessment of Cancer Therapy General (FACT-G) domain scores for physical, social/family, functional and emotional well-being, and EQ-5D-3L index scores at days 42, 100, 180 and 365 post-transplant. During the first-year post-transplant, patients receiving omidubicel had numerically superior average FACT-G domain and EQ-5D-3L index scores compared to UCB, with mean differences across time points ranging from 1.4-3.1 for physical well-being, 0-1.3 for social/family well-being, 0.5-1.4 for emotional well-being, 1.6-3.2 for functional well-being, and 0.03-0.09 for the EQ-5D-3L index score. The data suggest meaningfully greater preservation or improvement of important HRQL domains in patients treated with omidubicel compared to UCB. Learn more
Gamida Cell also presented a poster titled "Projected Impact of Omidubicel on Racial and Ethnic Disparities in Allogeneic Hematopoietic Cell Transplant Access and Outcomes for Patients with Hematologic Malignancies in the US," which featured an analysis of projected impact of allogeneic hematopoietic cell transplant (allo-HCT) access and clinical outcomes in a hypothetical population of 10,000 allo-HCT-eligible patients with hematologic malignancies lacking an HLA-matched related donor. Assuming 20% omidubicel use, the proportion of patients receiving allo-HCT increased by 71% in Black, 43% in Asian, 30% in Hispanic, and 5% in white patients. The model suggests that access to omidubicel, upon approval, is projected to decrease time to allo-HCT and improve patient outcomes, with the greatest improvements among the racial and ethnic groups underserved by the current standard of care. Learn more
In a poster titled "Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel Leads to Robust Recovery and Diversity of T cells" patients treated with omidubicel were found to have robust and diverse T cell constitution. In an analysis of the T-cell development of 37 patients, patients transplanted with omidubicel demonstrated higher numbers of Recent Thymic Emigrants (RTEs) in peripheral blood at one year post transplant compared to transplantation with UCB, which suggest faster thymopoiesis and provide mechanistic rational for the lower infection rates and improved outcomes in these patients. Learn more
All three posters were made available beginning Saturday, September 10, 2022, 6:15-7:45 p.m. ET, during the 2022 Cord Blood Connect Meeting.
About Omidubicel
Omidubicel is an advanced cell therapy candidate developed as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment in comparison to standard umbilical cord blood in an international, multi-center, randomized Phase 3 study (NCT0273029) in patients with hematologic malignancies undergoing allogeneic bone marrow transplant. The Phase 3 study also showed reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. One-year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by significant reduction in infectious complications as well as reduced non-relapse mortality and no significant increase in relapse rates nor increases in graft-versus-host-disease (GvHD) rates. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the US and EU.
Omidubicel is an investigational stem cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. For more information about omidubicel, please visit https://www.gamida-cell.com.
About NAM Technology
Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.
About Gamida Cell
Gamida Cell is pioneering a diverse immunotherapy pipeline of potentially curative cell therapy candidates 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 therapy candidates 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 omidubicel), regulatory filings submitted to the FDA (including the potential timing of the FDA’s review of the BLA for omidubicel), commercialization planning efforts, and the potentially life-saving or curative therapeutic and commercial potential of Gamida Cell’s product candidates (including 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 Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission (SEC) on August 15, 2022, 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.
1CIBMTR 2019 – allogeneic transplants in patients 12+ years with hematological malignancies.
2Gamida Cell market research
View source version on businesswire.com: https://www.businesswire.com/news/home/20220912005342/en/
Contacts
For investors:
Courtney Turiano
Stern Investor Relations, Inc.
Courtney.Turiano@sternir.com
1-212-362-1200
For media:
Heather DiVecchia
Director, Investor Relations and Corporate Communications
Heather@gamida-cell.com
1-617-892-9083
Thank you sir!! Definitely plan on adding given the current PPS and fabulous outlook for FDA approval. Best to you.
I envy you for your entry point price!
Good Luck!
Started a position in GMDA today. Been watching and researching this one for 12 months. Bought in @ $2.68
#GamidaCell COO/CCO Michele Korfin joins #PrecisionADVANCE and #EndpointsNews at Cell&Gene Day to discuss curative approaches with innovative cell therapies and their value propositions, patient access, and health equity.
— Gamida Cell (@GamidaCellTx) August 24, 2022
Learn More: https://t.co/074tjcQg9N #omidubicel pic.twitter.com/J0pYt1JrjA
Gamida Cell
@GamidaCellTx
#CellandGeneTherapyInsight highlights how #GamidaCell is strategically preparing for commercial readiness in the cellular cancer immunotherapy space. http://ow.ly/aj1B50Kpobg
#StemCell Therapy
#Omidubicel
#NKCellTherapy
#GDA201
#Hematology
#BloodCancers
#Lymphoma
#LRF
#LLS
https://twitter.com/GamidaCellTx/status/1562047262892646400/photo/1
Gamida Cell (NASDAQ:GMDA – Get Rating) had its price target upped by equities researchers at Piper Sandler from $6.00 to $8.00 in a report issued on Monday, The Fly reports. Piper Sandler’s price objective would indicate a potential upside of 147.68% from the stock’s current price.
Separately, JMP Securities reaffirmed a “buy” rating and set a $17.00 price target on shares of Gamida Cell in a research report on Thursday, June 2nd. Six analysts have rated the stock with a buy rating, According to data from MarketBeat.com, the company has an average rating of “Buy” and a consensus price target of $14.17.
https://www.etfdailynews.com/2022/08/17/gamida-cell-nasdaqgmda-price-target-raised-to-8-00-at-piper-sandler/
JMP Securities Sticks to Their Buy Rating for Gamida Cell (GMDA)
August 15 2022 - 03:05PM
In a report released today, Jason Butler from JMP Securities reiterated a Buy rating on Gamida Cell (GMDA - Research Report), with a price target of $17.00. The company's shares opened today at $3.07.According to TipRanks, Butler is an analyst with an average return of -2.8% and a 43.10% success rate. Butler covers the Healthcare sector, focusing on stocks such as Concert Pharma, Syros Pharmaceuticals, and Aquestive Therapeutics.Currently, the analyst consensus on Gamida Cell is a Strong Buy with an average price target of $14.80, implying a 382.08% upside from current levels. In a report released today, Piper Sandler also maintained a Buy rating on the stock with a $8.
https://www.tipranks.com/news/blurbs/jmp-securities-sticks-to-their-buy-rating-for-gamida-cell-gmda?utm_source=advfn.com&utm_medium=referral
Gamida Cell Ltd. (GMDA) Q2 2022 Earnings Call Transcript
By Motley Fool Transcribing - Aug 15, 2022 at 3:00PM
Gamida Cell Ltd. (GMDA 7.31%)
Q2 2022 Earnings Call
Aug 15, 2022, 8:00 a.m. ET
Operator
Ladies and gentlemen, [Audio gap] and I'll be your operator for today's call. Please be advised that this call is being recorded at Gamida Cell's request. Now, I would like to introduce your host for today's conference, Heather DiVecchia, Gamida Cell's director of investor relations and corporate communications. Please go ahead.
Heather DiVecchia -- Director, Investor Relations and Corporate Communications
Thank you, Olivia, 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 2022. 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.gamidacells.com. Here with me on our call today are Julian Adams, chief executive officer; Ronit Simantov, our chief medical officer and scientific officer; Michele Korfin, our chief operating officer and chief commercial officer; and Shai Lankry, our chief financial officer.
Now, I'd like to turn the call over to Julian.
Julian Adams -- Chief Executive Officer
Thank you, Heather, and thanks to everyone for joining us this morning. This was an extraordinary quarter for GamidaCell as we continue our momentum into the second half of 2022 focused on delivering on multiple milestones and accomplishments for all our stakeholders. All that we've accomplished this quarter continues to lay the groundwork for even larger inflection points. Advancing toward the potential commercialization of our first NAM-enabled cell therapy candidate Omidubicel.
Continuing the development of our lead NAM-enabled cell therapy candidate GDA-201 for patients with lymphoma who need new treatment options. Developing our expanding pipeline of genetically modified NAM-enabled NK cell therapy candidates supported by robust preclinical data, and exploring future opportunities that leverage our proprietary NAM technology across a broad range of innate and adaptive immune cells. Recently we announced our own Omidubicel Biologics License Application or BLA was accepted by the FDA and granted priority review with a PDUFA date of January 30, 2023. We are pleased to have received priority review which validates the importance of Omidubicel cell for patients with blood cancers in need of an allogeneic hematopoietic stem cell transplant.
As a reminder, Omidubicel cell has breakthrough therapy designation as well as Orphan Drug status. With the U.S. review underway, we are continuing with our preparations to support a potential commercial launch. If approved, Omidubicel cell has the potential to achieve 20% to 25% of the addressable market at peak market share by improving outcomes for patients based on our encouraging clinical data and increasing access, especially for patients who are eligible for transplant, but cannot find a match.
This 20 to 25% equates to 2,000 to 2,500 patients treated in the U.S. each year. Michelle will provide additional detail on our launch strategy and plans later in this call. Beyond Omidubicel cell, we also announced the dosing of our first patient in our company-sponsored Phase 1/2 clinical study evaluating a cryopreserved readily available formulation of GDA-201 our lead program our expanding NAM-enabled NK pipeline for the treatment of follicular and diffuse large B-cell lymphomas.
We continue to be encouraged by the results observed in a Phase 1 investigator-sponsored study of the fresh formulation. Ronit will provide additional detail on the Phase 1/2 study supporting GDA-201. Our continued focus on patients and our vision for advancing potentially curative cell therapies has never been more important. Prior to turning the call over to Ronit, I'd like to thank my colleagues at Gamida Cell for their dedication to our mission.
Additionally, Gamida Cell would like to sincerely thank the clinical trials sites and the patients and their families that have been such important partners as we advance our pipeline of NAM-enabled cell therapies. With that, I'll turn the call over to Ronit.
Ronit Simantov -- Chief Medical Officer
Thanks, Julian, and good morning, everyone. Thank you for joining us on our call this morning. As Julian mentioned, we're excited to share that BLA for Omidubicel cell was accepted by the FDA with priority review. Recall that our submission was based on a successful global Phase 3 randomized study comprised of 125 patients aged 12 to 65 with high-risk hematologic malignancy that were in need of allogeneic stem cell transplant, but had no readily available matched donor.
The study demonstrated a median time to neutrophil engraftment of 12 days for patients randomized to Omidubicel cell, compared to 22 days for the comparator group. These results were not only statistically significant, but also highly clinically significant as neutrophil engraftment is a key milestone in recovery in patients undergoing bone marrow transplant. Turning to GDA-201, our lead product candidate in our NK cell therapy pipeline, leveraging our proprietary NAM technology in the expansion of NK cells to enhance their functionality, direct tumor cell killing properties and Antibody-dependent cellular cytotoxicity or ADCC. Despite recent advances in the development of therapies for patients with lymphoma, we continue to hear from lymphoma experts that there is a high unmet need among patients with lymphoma who have active disease after previous treatment.
Data from the investigator-led study at the University of Minnesota on the fresh formulation of GDA-201 were reported at ash in December of last year and demonstrated an overall response rate of 74% with durable responses of 78% -- until your survival of 78% and heavily pretreated patients with lymphoma. Recently, translational data from this study will present it at the American Association of Cancer Research International Meeting on advances in malignant lymphoma. Tumor biopsies were analyzed with high-resolution multiplex imaging techniques to identify the cells found in the lymphoma tissue at 16 days after treatment with GDA-201. Images showed that CD20 Positive lymphoma cells were no longer detectable.
But the tumor was infiltrated with CD8 and CD4 positive T-cells, which are immune cells that can target tumors. These findings help us to generate and hypothesis about the potential mechanism of action of GDA-201. The data suggests that initial tumor cell killing but GDA-201 triggers an adaptive immune response, recruiting T-cells that can provide further anti-tumor effects. This hypothesis will be explored further with additional research.
As Julian highlighted, we recently announced the dosing of the first patient in our company-sponsored Phase 1/2 clinical study evaluating GDA-201 for the treatment of follicular and diffuse large B-cell lymphomas. The study is designed to include patients who have relapsed or refractory lymphoma after at least two prior treatments, which may include CART-cell therapy or stem cell transplant. The Phase 1 dose escalation portion of the study is designed to evaluate the safety of increasing doses of GDA-201 with dosing similar to those in the previous investigator-led study. Up to four dose levels will be tested to determine the maximum tolerated dose and recommended Phase 2 dose based on the dose-limiting toxicity.
Phase 1 also includes patients with follicular diffuse large B-cell, marginal zone, and mantle cell lymphoma histology. The Phase 2 expansion portion of the study is designed to evaluate the safety and efficacy of GDA-201 in two separate cohorts of approximately 30 patients each with follicular lymphoma and diffuse large B-cell lymphoma. The study is currently open at three sites and a number of sites will be limited during the dose escalation phase. Investigators are enthusiastic about enrolling patients in the study and treating patients with GDA-201.
We're looking forward to patients participating in this trial and to progressing this important therapy candidate through the clinic. In our expanding cell therapy pipeline, we are also developing our genetically modified NAM-enabled NK cell therapies in hematologic malignancies and solid tumors. These novel products candidates, leverage CAR and CRISPR mediated strategies to increase targeting potency and persistence and are supported by robust preclinical data. We are evaluating multiple product candidates, including GDA-301, GDA-401, GDA-501, and GDA-601.
GDA-601 is also being advanced with a research collaboration with the Dana-Farber Cancer Institute, which allows us to leverage the expertise of researchers at Dana-Farber to study the in vitro NK cell killing activity of GDA-601 in multiple myeloma. We believe a broad-based NAM-enabled NK platform is well positioned to explore potential partnership opportunity, and we look forward to the continued development of these cell therapeutics. Throughout the rest of the year, we plan to continue to conduct preclinical proof of concept studies for these genetically modified NK therapeutic targets. By the end of 2022, we plan to select a pipeline candidate for IND-enabling studies.
With that, I will turn the call over to Michele who will talk more about Omidubicel and commercial plans. Michele?
Michele Korfin -- Chief Operating Officer and Chief Commercial Officer
Thank you, Ronit, and good morning, everyone. Based on the exciting milestone of FDA acceptance of our Omidubicel BLA with priority review, we have an incredibly high priority at Gamida Cell to ensure patient access to Omidubicel upon its potential approval. We have diligently worked to define the unmet need that Omidubicel could address and have a clear launch strategy and a well-defined plan. With our outstanding launch leadership team in place, we are now ready to move to launch execution.
Upon potential FDA approval, Omidubicel has the potential to address a great unmet need for patients. Therefore, we are motivated to ensure that we are prepared to bring this important therapy to patients as quickly as possible following approval. Starting with manufacturing. We are preparing for launch readiness at our Gamida Cell manufacturing facility.
This facility was integral for the completion of our BLA and is also now focused on commercial readiness. We are ready to manufacture Omidubicel upon FDA approval. Our facility in Israel is modular, so we will have the ability to add additional cores as demand increases from Omidubicel. We are confident we could support the launch demand requirements from our facility from both a production and a supply chain standpoint.
The team has finalized our end-to-end processes to validate our approach to assure chain of identity and chain of custody for our commercial process to ensure a positive transplant center and patient experience. We have also been successfully manufacturing clinical batches in our Gamida Cell manufacturing facility and have been able to deliver Omidubicel back to the transplant centers within 30 days. Beyond manufacturing, we are also working hard to ensure that upon FDA approval that patients could have broad access to Omidubicel. For the approximately 8,000 patients above the age of 12 with hematologic malignancies who undergo an allogeneic stem cell transplant each year, this procedure may be their best chance for a potential cure.
There are two key opportunities that we focus on that Omidubicel may address for these patients upon FDA approval. First, potentially improving outcomes as compared to other donor sources based on transplant or feedback and also potentially increasing access to therapy. For potentially improving outcomes, we have extensive market research that points to clear and consistent insights. Transplants or see important opportunities for Omidubicel to potentially improve outcomes based on their experiences with other donor sources.
This opportunity is due to the strength of our clinical data, the ability to provide patients with a predefined number of cells, and the ability to provide Omidubicel within approximately one month as compared to unrelated donors that may take on average two to three months to align the donor and the patient. Unfortunately, there are approximately 1,200 additional patients each year who are ages 12 with hematologic malignancies who are deemed eligible for an allogeneic stem cell transplant but cannot find an appropriate donor. In terms of potentially increasing access for these patients, unfortunately, there is racial disparity in the U.S. in regards to access to allogeneic stem cell transplant.
If you are non-Caucasian and do not have access to a family member donor, you have avery low likelihood of finding a match in the public database. For example, published data indicate that a black patient in the U.S. has less than a 20% chance of finding a math from the public database. If a patient cannot find an appropriate donor, they will, unfortunately, succumb to their cancer.
Omidubicel has a less stringent matching criteria for patients and moreover, we demonstrated our ability to match racially and ethnically diverse patients in our Phase 3 study as 40% of the patients in our study were non-Caucasian. As Julian mentioned, we anticipate that if approved, these two opportunities combined may result in Omidubicel capturing approximately 20% to 25% of the addressable market once we reach peak market share. So if approved, this will equate to approximately 2,000 to 2,500 patients treated each year in the U.S. with Omidubicel.
We understand the importance of educating both the transplant centers and payers. With regards to reaching transplant centers in the U.S., we have an optimized and targeted approach as the transplant centers that perform allogeneic stem cell transplants are extremely concentrated. For reference in the U.S., there are approximately 200 transplant centers that perform allogeneic stem cell transplants, 70 of those centers conduct approximately 80% of the transplant. Our medical affairs colleagues have been actively engaged with transplant centers and the feedback on our clinical data supports the positive feedback we have heard in our blinded market in sites.
Turning to payers, our conversations with these groups are progressing. Our payer team has been actively engaged with payers at the national and regional level. We will be proactively reaching out to payers who cover at least 90% of the lives in the U.S. We continue to hear consistent feedback on the overall value proposition of Omidubicel, including the strength of the clinical data and the health economic data we have published to date.
Hospitalization represents the majority of charges associated with transplant, so our reduction in healthcare resource utilization in terms of reduced days in the hospital and reduce days in the ICU are very important components of the Omidubicel value proposition. In addition, we saw a reduction in the number of transfusion and consultant visits. These reductions in healthcare resources are very meaningful to the payer, transplant center, and most importantly, the patients. We are excited to continue to hear positive feedback across all stakeholders and are extremely encouraged and driven by the potential of Omidubicel.
We are equally encouraged with the advancement of our GDA-201 program in lymphoma. The lymphoma is the largest patient population of all the blood cancers with a global incidence of over 600,000 patients. There are approximately40,000 patients with relapsed/refractory lymphoma in the U.S. and EU, which is the patient population that will be studied in the GDA-201 Phase 1/2 clinical trial.
There is an unmet need for effective and safe new therapies with a curative approach for these patients. We look forward to the continued advancement of the GDA-201 trial. I will now turn the call over to Shai to review our financial results.
Shai Lankry -- Chief Financial Officer
Thank you, Michele, and good morning, everyone. Today, I will summarize our financial results for the second quarter of2022. As of June 30, 2022, our total cash position was approximately $55 million, compared to $96 million as of December 31, 2021. Research and development expenses for the quarter were $10.6 million, compared to $13.4 million in the same quarter last year.
The decrease was mainly due to a $2.4 million decrease in clinical activities relating to the conclusion of Omidubicel Phase 3 clinical trial and a decrease of $0.4 million in the GDA clinical program. Commercial expenses for the quarter were $3.2 million, compared to $5 million in the second quarter of 2021. The decrease was primarily due to reducing our near-term commercial readiness expenses as we were assessing strategic approaches for the commercialization of Omidubicel. General and administrative expenses were $4.3 million in the second quarter of 2022, compared to $3.9 million for the same period in '21.
The increase was mainly due to a $0.9 million increase in professional services expenses, offset by a decrease of $0.5 million in headcount and related expenses. Finance expenses net were $0.5 million for the second quarter of 2022, compared to $1.3 million for the same period last year. The decrease was due to a $0.6 million decrease in noncash expenses and an increase of $0.2 million in interest income from cash management. Net loss for the second quarter of 2022 was $18.6 million, compared to a net loss of$23.6 million in the second quarter of '21.
We continue to expect cash used for ongoing operating activity this year to range from $65 million to $70 million, we anticipate that our current total cash position will support our ongoing operating activities into mid-2022, excluding the cost of commercializing Omidubicel. Following the corporate restructuring announced in January of this year, we are now realizing the decrease to our cash burn, and we'll continue to diligently manage our cash position to fund our operations. Additionally, we are continuing to evaluate our cash needs and assessing all financing options that supports our corporate strategy to bring Omidubicel to patients. This cash run rate guidance is based on our current operational plan and excludes any additional funding that may be received or business development activities that may be undertaken.
With that, I will turn the call back over to Julian.
Julian Adams -- Chief Executive Officer
Thank you, Shai. For the rest of 2022, there is no higher priority than to enable the successful commercialization of our first NAM-enabled stem cell therapy, Omidubicel to benefit the thousands of cancer patients here in the U.S. who need a curative approach that our allogeneic stem cell therapy may offer. We are also excited about the potential of GDA-201as an NK cell therapy that may benefit tens of thousands of patients worldwide.
We look forward to the results of this promising new approach for lymphoma patients in our company-sponsored Phase 1/2 open-label multi-centered study. We continue to demonstrate our leadership role in the development of NAM-enabled cell therapies through the expansion of our pipeline with multiple genetically modified NAM-enabled NK cell therapy candidates. We believe that our curative approach may make a difference in the lives of cancer patients worldwide and help redefine how patients are treated in the future. Now let's open the call for questions.
Operator?
Questions & Answers:
Operator
Thank you. [Operator instructions] And our first question coming from the line of Edward Tenthoff from Piper Sandler. Your line is open.
Edward Tenthoff -- Piper Sandler -- Analyst
Great. Thank you very much. And just thinking toward -- and again, congrats on all the progress the BLA acceptance, etc. Just wondering from the communications with the FDA, obviously, manufacturing the clinical data.
What else is the FDA keenly focused on evaluating Omidubicel, and what do we -- what should we be considering as plans for other overseas filings and potential regulatory activity? Thanks, guys.
Julian Adams -- Chief Executive Officer
Thank you, Ed, for your question. And I would say that the -- what you've identified is actually the two pivotal aspects of our FDA review. One is, of course, the clinical data, which the FDA has extremely focused on as well as our manufacturing facility and anticipating a preapproval inspection. Michele, would you comment on additional activities and activities outside the U.S.
as well?
Michele Korfin -- Chief Operating Officer and Chief Commercial Officer
For sure. And Ed, good morning. Thank you for joining the call. As I mentioned in my prepared comments, our Omidubicel-owned facility in Israel has been -- it was integral for the BLA filing.
And we continue to now focus on commercial readiness, but a very important point that I also alluded to as we have been manufacturing clinical batches at that facility. We have validated processes end-to-end to assure chain of identity and chain of custody. That facility has advanced in a very impressive and encouraging way. So we were excited to include that facility in our BLA.
In regards to overseas opportunities, so we have very encouraging opportunities to help advance Omidubicel for patients in many regions throughout the world. We have conducted assessments in Western Europe, in Japan, and also in other regions such as Canada. And most of what we see in terms of the opportunity for Omidubicel in the U.S. is also the case overseas in terms of those ability to improve outcomes and also to increase access for patients who are not currently able to find a donor.
So we have a head-to-head study, a very well-conducted study led by Ronit and her team. So once we are through the U.S. regulatory approval process, we will then look to advance regulatory activities in other regions, knowing that there's an important patient need for Omidubicel throughout the world.
Edward Tenthoff -- Piper Sandler -- Analyst
Great. That's very helpful. Thank you so much.
Julian Adams -- Chief Executive Officer
Thanks, Ed.
Operator
And our next question coming from the line of Jon Miller from Evercore. Your line is open.
Jon Miller -- Evercore ISI -- Analyst
Hi, guys. Thanks so much for taking the question. I was interested because of your cash runway guidance explicitly not including commercialization from Omidubicel. What is your, I guess, your focus on launching that internally versus your willingness to consider a partnership or approach partners? Has there been BD interest in the only platform in the U.S.?
Julian Adams -- Chief Executive Officer
So we believe that we are best able to launch Omidubicel in the U.S. We have built a very strong commercial team under Michele. And since it's a highly targeted and focused market, I think we feel that the footprint is -- matches our capabilities. Michele, would you like to further comment?
Michele Korfin -- Chief Operating Officer and Chief Commercial Officer
Sure. Thank you, Julian. Good morning, Jon. Thank you for joining us.
We did assess potential strategic alternatives. And as Julian indicated, we do believe that launching Omidubicel ourselves in the U.S. is the best option for patients and for Gamida. We conducted a thorough assessment of the unmet needs that Omidubicel could address.
We have a well-thought-out launch strategy and launch plan. And also, we have the experienced leadership team in place to launch a breakthrough cell therapy, such as Omidubicel. I mean this team is the commercial team, it's our medical affairs colleagues that I referenced during my prepared comments. And most importantly, we have the leadership team at our Gamida manufacturing facility to offshore readiness from the manufacturing standpoint.
So let me turn it back to you, Jon, to see if there's any follow-up questions.
Jon Miller -- Evercore ISI -- Analyst
Yes. That makes perfect sense. Thank you so much, guys. I guess maybe switching gears, I would be really curious about the time line for the next-gen NK program once it's chosen, how fast you think you can get from IND-enabling studies into the clinic? And relatedly, do you have updated guidance on GDA-201 now that you've started patient dosing there?
Julian Adams -- Chief Executive Officer
Thanks for your question. Let me turn it over to Ronit to describe our plans.
Ronit Simantov -- Chief Medical Officer
Thank you and thanks, Jon. So in terms of the pipeline candidates, after we select a candidate by the end of this year, we will move those forward to IND-enabling studies. And it does take about a year to do those IND-enabling studies, put the IND together, file it, then waiting for R&D acceptance. But during that time, we'll also be designing and initiating operational activities for the clinical trial.
So that as soon as the IND is accepted, just like we did with GDA-201, we can move forward and initiate a new study. So it will take at least a year to do those things after we select the candidate. In terms of GDA-201, so now that we've dosed our patients, we're safely in the Phase 1 portion. Phase 1 portion, time line can vary depending on what you observed in the Phase 1 portion.
There are -- the ability to expand cohort, see dose-limiting toxicities or observe anything that you'd like to test more patients on. But basically, it will take approximately a year to go through the Phase 1 portion and then move over to the Phase 2 portion expansion, where we will have more sites enrolled, and we'll be able to move more quickly on the Phase 2.
Jon Miller -- Evercore ISI -- Analyst
Thanks so much.
Julian Adams -- Chief Executive Officer
Thank you, Jon.
Operator
Thank you. Our next question coming from the line of Gil Blum from Needham. Your line is open.
Gil Blum -- Needham and Company -- Analyst
Hi. Good morning, everyone, and thanks for taking our questions. Just a few questions on GDA-201 here. So we're going to have a bunch of updates across allogeneic cellular therapeutics in the upcoming ASH meeting.
Do you think these updates can help increase the profile for GDA-201 and just general awareness of NK cells?
Julian Adams -- Chief Executive Officer
Yeah. Thanks for that question, Gil. Absolutely and significantly, NK cells have been reported to be quite well tolerated as compared to CAR T-cells. So I think interest in GDA-201 will absolutely increase as we continue to progress our trial going forward.
Gil Blum -- Needham and Company -- Analyst
Maybe a bit of a mechanistic question for Ronit. It was very interesting to hear the biopsy information that you provided at the meeting. So if there is T-cell infiltration, is there any thinking around maybe using reduced intensity conditioning, less conditioning, equaling more T-cells in the patients?
Ronit Simantov -- Chief Medical Officer
Thanks, Gil. So I agree. I think these are really interesting data. We obviously need to do more to elucidate further exactly the type of T-cells and the clonality of the T-cells found in the biopsies and understand more and a greater number of patients, what's going on.
The use of the flu side conditioning regimen in patients who are undergoing cellular therapy is something that is also quite interesting to us, as you recall, in the fresh formulation study, we gave second doses without lymphodepleting chemotherapy, although we never give the first dose without lymphodepleting chemotherapy. And it is a general consensus that the lymphodepletion is necessary in some way. The exact doses is -- are still not quite well elucidated, we're interested in exploring sort of the cytokine effect of that chemotherapy, which has been attributed to which the efficacy has been attributed in terms of the cytokine environment. So definitely something that we're interested in looking at and as we move forward with our dosing, we are open to exploring those sort of conditioning regimens that may be useful in potentiating responses to GDA-201.
Gil Blum -- Needham and Company -- Analyst
OK. Thank you. And maybe a last one. You mentioned potential partnerships and the discussion on GDA-201.
Are we already thinking of partnering GDA-201 despite it being in the early stage? Or this is more like a strategic collaboration with another agent or what is the thinking around here?
Julian Adams -- Chief Executive Officer
Yes. So we do have an interest in exploring what is the most efficient way to bring GDA-201 to patients potentially in the commercial setting. So we are exploring all of our options and I can't comment right now on any partnering discussions, but we'll do so in the future.
Gil Blum -- Needham and Company -- Analyst
OK. Excellent. Thank you for taking all of our questions this morning.
Operator
Thank you. And our next question coming from the line of Mark Breidenbach from Oppenheimer. Your line is open.
Mark Breidenbach -- Oppenheimer and Company -- Analyst
Hey. Good morning and congrats on the recent progress. Julian, I was wondering if you can give us a sense for how much of additional pre-launch investment you think would be needed to support manual launch, assuming you continue with plans to go at alone on the launch? And is there a contingency plan in place in case the BLA is approved ahead of its PDUFA date?
Julian Adams -- Chief Executive Officer
Thank you for your excellent question and optimism. Shai, maybe you could comment on the launch planning budget.
Shai Lankry -- Chief Financial Officer
Yes. Absolutely. Hi, Mark. Good morning.
So as Michele alluded in her prepared remarks, this is not an extensive, I would say, budget that needed to launch Omidubicel. We are talking about roughly between $30 million to $40 million to prepare the company to launch Omidubicel. And we are evaluating, if any, as you can imagine, any biotech company, we are evaluating all options to bring Omidubicel to patients.
Mark Breidenbach -- Oppenheimer and Company -- Analyst
Ok. That's super helpful -- go ahead.
Shai Lankry -- Chief Financial Officer
Julian, do you want to add your remarks as well?
Julian Adams -- Chief Executive Officer
No. And I think we're quite confident that we can execute, again, under Michele's leadership and Ronit's medical affairs team, I think we can cover this highly focused transplant center engagement, and we feel very confident in our abilities.
Mark Breidenbach -- Oppenheimer and Company -- Analyst
And just a quick one maybe for Ronit. In the company-sponsored trial of 201, can you just tell us what the starting this was? Was the 20 million cells per kilogram sort of like we saw in the University of Minnesota trial? And can you tell us what tumor histology that the first patient presented with? Thank you very much.
Ronit Simantov -- Chief Medical Officer
Thanks, Mark. So we are starting a dose or close to the $20 million dose. It's actually 2.5 times of the seven cells per kilogram, and that was really just on the basis of sort of our manufacturing feasibility and calculations of the escalation to make them nice round. So it's about the same, but it was guided by the first dose level in the fresh.
We're not going to comment yet about details about the patient. But at the right time, we'll certainly share those.
Mark Breidenbach -- Oppenheimer and Company -- Analyst
OK. Thanks so much for taking the questions and congrats on the progress.
Julian Adams -- Chief Executive Officer
Thank you.
Operator
Thank you. [Operator instructions] Our next question coming from the line of Jason Butler from JMP Securities. Your line is open.
Roy Buchanan -- JMP Securities -- Analyst
Hi. It's Roy for Jason. Just a really quick one on the contracts that you've mentioned between the payers and the transplant centers for Omidubicel. Can you just provide some additional details on that process, once it's approved, is Omidubicel just added to a list of options? Or do you need to go through committees? And if so, it sounds like much of that is going to happen before approval, is that the case? Thanks.
Julian Adams -- Chief Executive Officer
Michele, this is for you.
Michele Korfin -- Chief Operating Officer and Chief Commercial Officer
Thank you, Julian. Good morning, Roy. Thank you for joining us. So there's -- let's talk about the commercial payers first, and then I'll talk about Medicare.
So in regards to the patient mixture, we do anticipate the majority of patients will fall under commercial payers, but that's roughly between 50% to 60%and then probably about roughly 25% or so Medicare and roughly 5% Medicaid. So we're focused on both commercial and Medicare. Let's talk about commercial first. So commercial payers have said publicly and also in our discussions with them that upon FDA approval of therapies that are onetime therapies with curative intent, they will cover these therapies.
And we saw that with the CAR-Ts also. So what that means, Roy, to your question is they're not going to have to convene a formulary review committee or a pharmacy and therapeutics committee meeting. They -- commercial payers such that they will cover these onetime therapies with curative intent upon FDA approval. So coverage is well defined.
In terms of reimbursement, so those contracts, as you alluded to between the payers and the transplant centers or individual contracts, they are highly confidential. That's not anything that the manufacturer gets involved with because it's between the transplant centers and the payers. But we have had ongoing dialogue with both the transplant centers and the payer side to understand what the process will look like for reimbursement upon FDA approval. And we're very encouraged that transplant centers and payers are both saying, yes, there are mechanisms in place within our current contract that allow for reimbursement upon FDA approval.
And as I've mentioned, we've been actively engaged in health economic analyses. We've published much of that data already, and we will continue to generate data in case that is needed as part of their ongoing discussions for reimbursement. And then just on the Medicare side, we've already begun to apply for the required codes that would be needed for Medicare. We understand what Medicare that Omidubicel would be mapped at this point in time to the allogeneic stem cell transplant DRG.
And then Medicare also has mechanisms in place to pay for or to reimburse the centers for the actual donor stores. So on both the commercial side and the Medicare side, we are very encouraged by the coverage and then also the reimbursement. So let me stop there, Roy, and turn it back to you to see if there's any other questions.
Roy Buchanan -- JMP Securities -- Analyst
Perfect. No, that is it. Thank you very much.
Michele Korfin -- Chief Operating Officer and Chief Commercial Officer
Thank you.
Operator
Now I'm showing no further questions at this time. I would now like to turn the call back over to Mr. Julian Adams for any closing remarks.
Julian Adams -- Chief Executive Officer
Thank you. Our leadership team will be available after the call if there are any opportunities for follow-up discussions. We'll keep you current on all of our developments, and we thank you again for your interest and support in Gamida Cell. Thank you, everyone, for joining us to support in Gamida Cell.
Thank you, everyone, for joining us on today's call.
Operator
[Operator signoff]
Duration: 0 minutes
Call participants:
Heather DiVecchia -- Director, Investor Relations and Corporate Communications
Julian Adams -- Chief Executive Officer
Ronit Simantov -- Chief Medical Officer
Michele Korfin -- Chief Operating Officer and Chief Commercial Officer
Shai Lankry -- Chief Financial Officer
Edward Tenthoff -- Piper Sandler -- Analyst
Jon Miller -- Evercore ISI -- Analyst
Gil Blum -- Needham and Company -- Analyst
Mark Breidenbach -- Oppenheimer and Company -- Analyst
Roy Buchanan -- JMP Securities -- Analyst
More GMDA analysis
Gamida Cell Reports Second Quarter 2022 Financial Results and Provides Company Update
https://finance.yahoo.com/news/gamida-cell-reports-second-quarter-110000546.html
- Received FDA acceptance of BLA for omidubicel with Priority Review; PDUFA target action date set for January 30, 2023 -
- Dosed first patient in company-sponsored Phase 1/2 study of cryopreserved formulation of GDA-201 for the treatment of follicular and diffuse large B-cell lymphomas -
- Finished second quarter of 2022 with $55.1 million in cash;
sufficient funding for the company’s operations into mid-2023, excluding the cost of commercializing omidubicel -
- Company to host conference call at 8:00 a.m. ET today -
BOSTON, August 15, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, today provided a business update and reported financial results for the quarter ended June 30, 2022. Net loss for the second quarter of 2022 was $18.6 million, compared to a net loss of $23.6 million in the second quarter of 2021. As of June 30, 2022, Gamida Cell had total cash, cash equivalents and investments of $55.1 million.
Recently, Gamida Cell:
Received acceptance for filing from the U.S. Food and Drug Administration (FDA) with priority review for its Biologics License Application (BLA) for omidubicel. The BLA has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2023. If approved, omidubicel will be the first allogeneic advanced stem cell therapy donor source for patients with blood cancers in need of a stem cell transplant.
Dosed the first patient in a company-sponsored Phase 1/2 study evaluating a cryopreserved formulation of GDA-201, a readily available cell therapy candidate for the treatment of follicular and diffuse large B-cell lymphomas.
Continued development of the company’s proprietary NAM-enabled NK cell pipeline, including genetically modified product candidates GDA-301, GDA-401, GDA-501 and GDA-601, which aim to treat solid-tumor and hematological cancers. These cell therapy candidates utilize CAR, membrane bound- and CRISPR-mediated technologies to increase the NK cell targeting, potency and persistence against hematologic malignancies and solid tumors. Promising new pre-clinical data on GDA-301 and GDA-601 were presented at the International Society for Cell & Gene Therapy Meeting. The data demonstrated that both NAM-enabled cell therapy candidates represented a novel potent and cytotoxic approach in fighting cancer.
Advanced strategic evaluation for omidubicel commercialization, including assessing whether to commercialize omidubicel ourselves or to pursue strategic alternatives to commercialize omidubicel, upon receipt of regulatory approval. The company currently has sufficient cash to fund the company’s operations into mid-2023, excluding the cost of commercializing omidubicel.
"2022 is a potentially transformative year for Gamida Cell as we continue to execute against our clinical and regulatory milestones. We were excited that the FDA accepted our BLA submission with priority review, and if approved, omidubicel will be the first allogeneic advanced stem cell therapy donor source for patients with blood cancers in need of a stem cell transplant. We believe that omidubicel has the potential to change the outlook for patients suffering from blood cancers through improved outcomes, quality of life and increased access for patients who are currently eligible for transplant, but cannot find a match," said Julian Adams, Ph.D., chief executive officer of Gamida Cell. "In addition, the development of our NAM-enabled NK cell therapy candidate, GDA-201, creates an opportunity to potentially bring a new treatment option to tens of thousands of patients with relapsed/refractory lymphoma worldwide. We continue to execute our mission of advancing our broad pipeline of NAM-enabled cell therapies with a curative approach for patients with solid tumors and blood cancers and other serious blood diseases."
Second Quarter and Recent Developments
Omidubicel: Advanced Cell Therapy
BLA accepted by FDA with Priority Review: In August 2022, the FDA accepted for filing Gamida Cell’s BLA for omidubicel for the treatment of patients with blood cancers in need of an allogeneic hematopoietic stem cell transplant. The FDA granted Priority Review for the BLA and has set a PDUFA target action date of January 30, 2023. In parallel, Gamida Cell is preparing for the commercialization of omidubicel in the U.S.
GDA-201: NAM-Enabled NK Cell Therapy
Dosed the first patient in Phase 1/2 study of cryopreserved formulation of GDA-201: In August 2022, Gamida Cell completed the dosing of the first patient in a company-sponsored Phase 1/2 study evaluating a cryopreserved formulation of GDA-201 for the treatment of follicular and diffuse B-cell lymphomas.
The Phase 1 portion of the study is designed as a dose escalation phase to evaluate the safety of GDA-201, and will include patients with follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL)/high grade B-cell lymphoma (HGBCL), marginal zone lymphoma or mantle cell lymphoma. The Phase 2 expansion phase is designed to evaluate the safety and efficacy of GDA-201 in 63 patients comprised of two patient cohorts, FL and DLBCL. The study will include patients who have relapsed or refractory lymphoma after at least two prior treatments, which may include CAR-T or stem cell transplant.
NAM-Enabled NK Cell Pipeline Expansion
Progressed NAM-enabled genetically modified NK pipeline: Gamida Cell continues to progress its NAM-enabled genetically modified NK pipeline, which utilizes CAR, membrane bound- and CRISPR-mediated technologies to increase targeting, potency and persistence against hematologic malignancies and solid tumors. The company continues to conduct in vitro and in vivo preclinical proof-of-concept studies for these genetically modified NK therapeutic targets which are already showing encouraging results and plans to select the next NK pipeline product candidate for IND enabling studies by the end of 2022. These therapeutic targets include:
GDA-301: Knockout of CISH (cytokine inducible SH2 containing protein) in NK cells using CRISPR/Cas9 in combination with a membrane-bound IL-15/IL-15Ra;
GDA-401: A development candidate with an undisclosed target;
GDA-501: Anti HER2 CAR-engineered NK cells to target solid tumors expressing HER2, based on a single-chain variable fragment of the widely used humanized monoclonal antibody trastuzumab; and
GDA-601: CRISPR Knockout of CD38 on NK cells combined with anti CD38 CAR. CD38 is an established immunotherapeutic target in multiple myeloma, but its expression on NK cells and its further induction during ex vivo NK cell expansion represents a barrier to the development of an anti CD38 CAR-NK cell therapy. Gamida Cell is advancing this program in collaboration with the Dana-Farber Cancer Institute to study the in vitro cytotoxicity of GDA-601 in fresh tumor tissue samples from multiple myeloma patients.
Corporate Updates
Appointed Ivan M. Borrello, M.D. to Board of Directors: Dr. Borrello is an Associate Professor of Oncology at the Sydney Kimmel Comprehensive Cancer Center at Johns Hopkins and a renowned physician and author who has made major contributions to better the understanding of immunotherapies and the treatment of hematologic malignancies as well as bone marrow transplant. The Company also announced the resignation of Ofer Gonen from its Board of Directors.
Second Quarter 2022 Financial Results
Research and development expenses were $10.6 million in the second quarter of 2022, compared to $13.4 million in the same quarter in 2021. The decrease was attributable mainly to a $2.4 million decrease in clinical activities relating to the conclusion of our Phase 3 clinical trial and a decrease of $0.4 million in the GDA-201 clinical program.
Commercial expenses were $3.2 million in the second quarter of 2022, compared to $5.0 million in the second quarter of 2021. The decrease was attributable mainly to reducing near-term commercial readiness expenses, as we continued to assess strategic approaches for the commercialization of omidubicel.
General and administrative expenses were $4.3 million in the second quarter of 2022, compared to $3.9 million in the same period in 2021. The increase was mainly due to a $0.9 million increase in professional services expenses, offset by a decrease of $0.5 million in headcount related expenses.
Finance expenses, net, were $0.5 million in the second quarter of 2022, compared to $1.3 million in the same period in 2021. The decrease was primarily due to $0.6 million in non-cash expenses and an increase of $0.2 million in interest income from cash management.
Net loss was $18.6 million in the second quarter of 2022, compared to a net loss of $23.6 million in the second quarter of 2021.
2022 Financial Guidance
Gamida Cell expects that its current cash, cash equivalents and investments will support the company’s ongoing operating activities into mid 2023, excluding the cost of commercializing omidubicel. If we decide to market omidubicel ourselves, we will require substantial additional funding. This cash runaway guidance is based on the company’s current operational plans and excludes any additional funding and any business development activities that may be undertaken. Gamida Cell continues to assess all financing options that support its corporate strategy.
Expected Milestones in 2022 and Early 2023
Omidubicel
PDUFA target action date of January 30, 2023.
NK cell pipeline expansion
Conduct preclinical proof of concept studies of the NAM-enabled, genetically modified NK therapeutic targets
Select pipeline candidate for IND-enabling studies
Conference Call Information
Gamida Cell will host a conference call today, August 15, 2022, at 8:00 a.m. ET to discuss these financial results and company updates. To access the conference call, please register here and be advised to do so at least 10 minutes prior to joining the call. A live webcast of the conference call can be accessed in the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.
About Omidubicel
Omidubicel is an advanced cell therapy candidate developed as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment in comparison to standard umbilical cord blood in an international, multi-center, randomized Phase 3 study (NCT0273029) in patients with hematologic malignancies undergoing allogeneic bone marrow transplant. The Phase 3 study also showed reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. One-year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by significant reduction in infectious complications as well as reduced non-relapse mortality and no significant increase in relapse rates nor increases in graft-versus-host-disease (GvHD) rates. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the US and EU.
Omidubicel is an investigational stem cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. For more information about omidubicel, please visit https://www.gamida-cell.com.
About GDA-201
Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy candidate for the potential 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 study data. Preclinical studies have shown that GDA-201 may address key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, these data suggest GDA-201 may improve antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. There are approximately 40,000 patients with relapsed/refractory lymphoma in the US and EU, which is the patient population that will be studied in the currently ongoing GDA-201 Phase 1/2 clinical trial.
For more information about GDA-201, please visit https://www.gamida-cell.com. For more information on the Phase 1/2 clinical trial of GDA-201, please visit www.clinicaltrials.gov.
GDA-201 is an investigational cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority.
About NAM Technology
Our NAM-enabling technology, supported by positive omidubicel Phase 3 results, is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.
About Gamida Cell
Gamida Cell is pioneering a diverse immunotherapy pipeline of potentially curative cell therapy candidates 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 therapy candidates 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, pre-clinical and clinical trials of Gamida Cell’s product candidates (including omidubicel and GDA-201), anticipated regulatory filings (including the timing of review of the BLA for omidubicel by the FDA), commercialization planning efforts, the potentially life-saving or curative therapeutic and commercial potential of Gamida Cell’s product candidates (including GDA-201 and omidubicel), Gamida Cell’s expectations for the clinical development milestones set forth herein, and Gamida Cell’s expectations regarding its projected cash, cash equivalents and investments to be used for operating activities. 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, including the scope, progress and expansion of Gamida Cell’s clinical trials and ramifications for the cost thereof; clinical, scientific, regulatory and technical developments; the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics; and 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 Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission (SEC) on May 12, 2022, 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.
CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share and per share data)
June 30,
December 31,
2022
2021
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
37,890
$
55,892
Marketable securities
17,172
40,034
Prepaid expenses and other current assets
2,294
2,688
Total current assets
57,356
98,614
NON-CURRENT ASSETS:
Restricted deposits
3,591
3,961
Property, plant and equipment, net
37,967
35,180
Operating lease right-of-use assets
6,107
7,236
Severance pay fund
1,579
2,148
Other long-term assets
1,421
1,647
Total non-current assets
50,665
50,172
Total assets
$
108,021
$
148,786
LIABILITIES AND EQUITY
CURRENT LIABILITIES:
Trade payables
$
2,738
$
8,272
Employees and payroll accruals
4,978
4,957
Operating lease liabilities
2,517
2,699
Accrued interest of convertible senior notes
1,652
1,640
Accrued expenses and other current liabilities
10,412
7,865
Total current liabilities
22,297
25,433
NON-CURRENT LIABILITIES:
Convertible senior notes, net
71,801
71,417
Accrued severance pay
1,840
2,396
Long-term operating lease liabilities
4,233
5,603
Total non-current liabilities
77,874
79,416
CONTINGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY:
Share capital -
169
169
Additional paid-in capital
383,915
381,225
Accumulated deficit
(376,234
)
(337,457
)
Total shareholders’ equity
7,850
43,937
Total liabilities and shareholders’ equity
$
108,021
$
148,786
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and per share data)
Three months ended
June 30,
Six months ended
June 30,
2022
2021
2022
2021
Unaudited
Research and development expenses, net
$
10,563
$
13,350
$
21,868
$
24,710
Commercial expenses
3,193
4,988
7,072
9,219
General and administrative expenses
4,290
3,874
8,429
7,387
Total operating loss
18,046
22,212
37,369
41,316
Financial expenses, net
508
1,345
1,408
1,427
Loss
$
18,554
$
23,557
$
38,777
$
42,743
Net loss per share, basic and diluted
0.31
0.40
0.65
0.72
Weighted average number of shares
59,546,273
59,253,315
59,510,918
59,188,504
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands (except share and per share data)
Six months ended
June 30,
2022
2021
Cash flows from operating activities:
Loss
$
(38,777
)
$
(42,743
)
Adjustments to reconcile loss to net cash used in operating activities:
Depreciation of property, plant and equipment
224
206
Financing expense (income), net
(273
)
1,694
Share-based compensation
2,530
2,025
Amortization of issuance costs
385
269
Operating lease right-of-use assets
1,226
1,032
Operating lease liabilities
(1,649
)
(1,187
)
Accrued severance pay, net
14
-
Increase in prepaid expenses and other assets
(19
)
(358
)
Decrease in trade payables
(5,535
)
(884
)
Increase (decrease) in accrued expenses and current liabilities
2,285
(622
)
Net cash used in operating activities
(39,589
)
(40,568
)
Cash flows from investing activities:
Purchase of property, plant and equipment
(1,540
)
(6,118
)
Purchase of marketable securities
(3,708
)
(68,151
)
Proceeds from maturity of marketable securities
26,175
17,824
Proceeds (investments) from restricted deposits
500
(1,000
)
Net cash provided by (used in) investing activities
$
21,427
$
(57,445
)
Cash flows from financing activities:
Proceeds from exercise of options
$
76
$
556
Proceeds from share issuance, net
84
-
Proceeds from issuance of convertible senior notes, net
-
70,777
Net cash provided by financing activities
160
71,333
Decrease in cash and cash equivalents
(18,002
)
(26,680
)
Cash and cash equivalents at beginning of period
55,892
127,170
Cash and cash equivalents at end of period
$
37,890
$
100,490
Significant non-cash transactions:
Purchase of property, plant and equipment on credit
282
1,563
Supplemental disclosures of cash flow information:
Cash paid for interest
$
(2,203
)
$
-
View source version on businesswire.com: https://www.businesswire.com/news/home/20220815005184/en/
Contacts
For investors:
Courtney Turiano
Stern Investor Relations, Inc.
Courtney.Turiano@sternir.com
1-212-362-1200
For media:
Heather DiVecchia
Chief of Staff
Heather@gamida-cell.com
1-617-892-9083
Gamida Cell Q2 2022 Earnings Preview
Aug. 12, 2022 1:13 PM ETGamida Cell Ltd. (GMDA)
By: Deepa Sarvaiya, SA News Editor
Gamida Cell (NASDAQ:GMDA) is scheduled to announce Q2
earnings results on Monday, August 15th, before market open.
The consensus EPS Estimate is -$0.29 (+61.8% Y/Y).
2.9900+0.3500 (+13.2576%)
As of 09:51AM EDT. Market open.
Volume 409,929
Avg. Volume 389,893
Within 21 minutes exceeded average daily volume!
Gamida Cell Ltd. (GMDA): Ready For An Explosive Trading Day
https://investchronicle.com/2022/08/10/gamida-cell-ltd-gmda-ready-for-an-explosive-trading-day/
By Sarah Baker
August 10, 2022
For the readers interested in the stock health of Gamida Cell Ltd. (GMDA). It is currently valued at $2.46. When the transactions were called off in the previous session, Stock hit the highs of $2.55, after setting-off with the price of $2.14. Company’s stock value dipped to $2.01 during the trading on the day. When the trading was stopped its value was $2.17.Recently in News on August 8, 2022, Gamida Cell Announces the Date of Its Second Quarter 2022 Financial Results and Webcast. Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, today announced that the company will host a conference call and live audio webcast on Monday, August 15, 2022, at 8:00 a.m. ET to review its second quarter 2022 financial results and provide an update on the company. You can read further details here
Gamida Cell Ltd. had a pretty Dodgy run when it comes to the market performance. The 1-year high price for the company’s stock is recorded $4.72 on 03/30/22, with the lowest value was $1.48 for the same time period, recorded on 07/26/22.
2.6550+0.1950 (+7.9268%)
As of 01:54PM EDT. Market open.
Volume 1,124,188
Avg. Volume 373,722
Gamida Cell Announces Dosing of First Patient in Company-Sponsored Phase 1/2 Study of NK Cell Therapy Candidate GDA-201
https://finance.yahoo.com/news/gamida-cell-announces-dosing-first-110000995.html%
-The company-sponsored Phase 1/2 study is evaluating a cryopreserved, readily available formulation of GDA-201 for the treatment of follicular and diffuse large B cell lymphomas -
BOSTON, August 10, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, announces dosing of the first patient in a company-sponsored Phase 1/2 study evaluating a cryopreserved, readily available formulation of GDA-201 for the treatment of follicular and diffuse large B cell lymphomas (NCT05296525).
"We are excited to further advance the development of GDA-201, a NAM-enabled natural killer (NK) cell therapy candidate which we believe has the potential to be a new readily available, cryopreserved treatment option for cancer patients with relapsed/refractory lymphoma," said Ronit Simantov, M.D., chief medical and scientific officer of Gamida Cell. "Our NK cells elicited an adaptive immune response in patients in the previous investigator-sponsored study with the fresh formulation of GDA-201, potentially leading to durable remissions. We are truly grateful for the contribution of all the participants and clinical collaborators who will allow us to continue studying GDA-201 in this multi-center open label trial."
The Phase 1 portion of the study is a dose escalation phase, designed to evaluate the safety of GDA-201, and will include patients with follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL)/high grade B-cell lymphoma, marginal zone lymphoma or mantle cell lymphoma. The Phase 2 expansion phase is designed to evaluate the safety and efficacy of GDA-201 in 63 patients comprised of two cohorts of patients with either FL or DLBCL. The study will include patients who have relapsed or refractory lymphoma after at least two prior treatments, which may include CAR-T or stem cell transplant.
"Interest in NK cell therapies has increased in recent years as a potential alternative to current cell therapies, as NK cells have the potential to be effective in hematological and solid tumors while avoiding common safety issues," said Veronika Bachanova, M.D., Ph.D., University of Minnesota. "We are particularly excited about Gamida’s cryopreserved formulation of GDA-201, which has potential as a new treatment option for patients."
GDA-201 leverages Gamida Cell’s proprietary NAM (nicotinamide) technology platform to expand the number and functionality of NK cells to direct tumor cell killing properties and antibody-dependent cellular cytotoxicity (ADCC). In an investigator-sponsored Phase 1/2 study in patients with relapsed or refractory lymphoma, treatment with the fresh formulation of GDA-201 with rituximab demonstrated significant clinical activity. Of the 19 patients with non-Hodgkin lymphoma (NHL), 13 complete responses and one partial response were observed, with an overall response rate of 74% and a complete response rate of 68%. Two-year data on outcomes and cytokine biomarkers associated with survival data demonstrated a median duration of response of 16 months (range 5-36 months) and an overall survival at two years of 78% (95% CI, 51%–91%). In this study, GDA-201 was well-tolerated and no dose-limiting toxicities were observed in 19 patients with NHL and 16 patients with multiple myeloma. The most common Grade 3/4 adverse events were thrombocytopenia, hypertension, neutropenia, febrile neutropenia, and anemia. There were no incidents of cytokine release syndrome, neurotoxic events, graft versus host disease or marrow aplasia.
About NAM Technology
Our NAM-enabled technology, supported by positive Phase 3 data for omidubicel, is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM, we can expand and metabolically modulate multiple cell types — including stem cells and NK cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.
2.4600+0.2900 (+13.36%)
At close: August 9 04:00PM EDT
Volume 1,645,990
Avg. Volume 373,722
Great!
2.3500+0.1800 (+8.29%)
As of 12:03PM EDT. Market open.
Nice Robust Volume too!
These 2 Penny Stocks Are Poised for a Big Rally, Says Oppenheimer
TipRanks
Tue, August 9, 2022 at 5:39 PM
Gamida Cell (GMDA)
The first potentially high-yielding penny stock we’ll look at is Gamida Cell, a clinical-stage biopharma researcher with a focus on cell therapy treatments for severe blood disorders and blood cancers. The company features a proprietary research platform using nicotinamide to expand on various natural cell types, especially natural killer (NK) cells while maintaining their potency. Moving from this platform, the company has developed omidubicel, a new drug under investigation as a treatment for hematological malignancies.
Omidubicel has completed Phase 3 testing in that area – blood cancers – and the company has progressed to the Biologics License Application to the FDA. The next regulatory step is review from the agency, with a PDUFA date of January 30, 2023. According to the company, ‘If approved, omidubicel will be the first allogeneic advanced stem cell therapy donor source for patients with blood cancers in need of a stem cell transplant.’ Gamida also has a Phase 1/2 study ongoing, investigating omidubicel as a treatment for severe aplastic anemia.
Also on the clinical track is Gamida’s second drug candidate, GDA-201. The drug is being evaluated in the treatment of non-Hodgkin Lymphoma. A clinical hold from last fall was removed earlier this year, and Gamida is proceeding with Phase 1/2 clinical trials.
Based on the potential of the company's drug candidates, and its $2.09 share price, Oppenheimer analyst Mark Breidenbach thinks that now is the time to get in on the action.
Breidenbach sees the likely FDA approval of omidubicel as the main catalyst for this stock, writing: “We remain confident in omidubicel’s regulatory approval based on its strong Phase 3 data... Relative to unmanipulated cord blood, omidubicel demonstrated faster neutrophil engraftment and platelet recovery— translating to significant reductions in serious infections and hospitalization time. We believe omidubicel could represent an attractive new option due to its reliable procurement speed (~30 days) and near-universal HLA compatibility... In preparation for the potential launch, Gamida has engaged with >45 high-volume US transplant centers and has begun to proactively educate payers to help ensure coverage shortly after approval."
To this end, Breidenbach puts an Outperform (i.e. Buy) rating on Gamida shares, and his $15 price target suggests potential for a whopping 618% upside in the next 12 months. (To watch Breidenbach’s track record, click here)
Gamida Cell Announces the Date of Its Second Quarter 2022 Financial Results and Webcast
https://finance.yahoo.com/news/gamida-cell-announces-date-second-120000917.html
BOSTON, August 08, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, today announced that the company will host a conference call and live audio webcast on Monday, August 15, 2022, at 8:00 a.m. ET to review its second quarter 2022 financial results and provide an update on the company.
To access the conference call, please register here and be advised to do so at least 10 minutes prior to joining the call. A live webcast of the conference call can be accessed in the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.
Yes, I thought so as well.
I guess we just need to look at it as a chance to accumulate more cheap shares!
Murocman
Gamida stock rises 13% as FDA grants priority review to stem cell therapy omidubicel
Aug. 01, 2022 7:21 AM ETGamida Cell Ltd. (GMDA)
By: Ravikash, SA News Editor
The U.S. Food and Drug Administration (FDA) granted priority review to Gamida Cell's (NASDAQ:GMDA) application seeking approval of stem cell therapy omidubicel to treat patients with blood cancers in need of an allogenic hematopoietic stem cell transplant.
The FDA accepted the company's Biologics License Application (BLA) and is expected to make a decision by Jan. 30, 2023.
Under priority review, the FDA's goal is to take action within six months,
compared to 10 months under standard review.
Gamida said the FDA is not planning to hold an Advisory Committee
meeting as part of the BLA review.
The company noted that the BLA was backed by data from a phase 3 trial.
Upon FDA approval, omidubicel will be manufactured at the Gamida's manufacturing facility in Israel, the company added.
Gamida Cell Announces FDA Acceptance of Biologics License Application for Omidubicel with Priority Review
https://finance.yahoo.com/news/gamida-cell-announces-fda-acceptance-110000411.html
- If approved, omidubicel will be the first allogeneic advanced stem cell therapy donor source for patients with blood cancers in need of a stem cell transplant -
- PDUFA target action date is January 30, 2023 -
- Company to host conference call on BLA acceptance and commercial opportunity today at 8:00 a.m. ET -
BOSTON, August 01, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Biologics License Application (BLA) for omidubicel for the treatment of patients with blood cancers in need of an allogenic hematopoietic stem cell transplant. Omidubicel is a first-in-class, advanced NAM-enabled stem cell therapy candidate with breakthrough and orphan drug designations.
The FDA granted Priority Review for the BLA and has set a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2023. The FDA grants Priority Review to product applications that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. At this time, the FDA has indicated that it is not planning an advisory committee meeting as part of the BLA review.
"The FDA’s acceptance of our BLA with Priority Review signifies a critical milestone in our mission to deliver a new stem cell therapy option for patients in need of a donor for an allogeneic stem cell transplant," said Julian Adams, Ph.D., chief executive officer of Gamida Cell. "We are encouraged by the positive and sustained follow-up results from patients participating in the Phase 3 trial of omidubicel, including a positive overall survival trend one-year out from treatment. These results provide promising rationale that, if approved, omidubicel could become a treatment of choice for patients in need of an allo-HSCT transplant. We look forward to working with the FDA throughout the review process to bring omidubicel to patients as quickly as possible."
Upon FDA approval, omidubicel will be manufactured at the Gamida Cell owned manufacturing facility in Israel. This is a newly constructed, state-of-the-art, modular facility which allows for additional capacity to be added to address growing demand. Batches from this facility were used to support the BLA for omidubicel and the facility is currently manufacturing clinical batches.
The omidubicel BLA is supported by the statistically significant results from Gamida Cell’s pivotal Phase 3 study, the results of which were published in Blood, the official journal of the American Society of Hematology. Results for the study’s primary endpoint, the median time to neutrophil engraftment in patients with hematologic malignancies undergoing allogeneic bone marrow transplant with omidubicel compared to standard umbilical cord blood (UCB), demonstrated a median time to neutrophil engraftment of 12 days for patients randomized to omidubicel compared to 22 days for the comparator group (p < 0.001). The secondary endpoints of this Phase 3 study were all achieved and were statistically significant. These secondary endpoints were platelet engraftment, the rate of infection, and days alive and out of hospital. Omidubicel was generally well tolerated in the Phase 3 study.
The full Blood manuscript is available here: https://ashpublications.org/blood/article/doi/10.1182/blood.2021011719/476235/Omidubicel-Versus-Standard-Myeloablative-Umbilical.
In 2019, approximately 8,000 patients who were 12 years old and up with hematologic malignancies underwent an allogeneic stem cell transplant in the United States.1 Unfortunately, it is estimated that another 1,200 patients were eligible for transplant but could not find a donor source.2 If approved, omidubicel has the potential to improve outcomes for patients based on transplanter feedback and to potentially increase access for patients to get to transplant. If approved, omidubicel has the potential to treat approximately 2,000 – 2,500 patients each year in the U.S.
Conference Call Information
Gamida Cell will host a conference call today, August 1, 2022, at 8:00 a.m. ET to discuss this update. To access the conference call, please register here and please be advised to do so at least 10 minutes prior to joining the call. A live webcast of the conference call can be accessed in the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.
About Omidubicel
Omidubicel is an advanced cell therapy candidate developed as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment in comparison to standard umbilical cord blood in an international, multi-center, randomized Phase 3 study (NCT0273029) in patients with hematologic malignancies undergoing allogeneic bone marrow transplant. The Phase 3 study also showed reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. One-year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by significant reduction in infectious complications as well as reduced non-relapse mortality and no significant increase in relapse rates nor increases in graft-versus-host-disease (GvHD) rates. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the US and EU.
Omidubicel is an investigational stem cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. For more information about omidubicel, please visit https://www.gamida-cell.com.
About NAM Technology
Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.
About Gamida Cell
Gamida Cell is pioneering a diverse immunotherapy pipeline of potentially curative cell therapy candidates 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 therapy candidates 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 omidubicel), regulatory filings submitted to the FDA (including the potential timing of the FDA’s review of the BLA for omidubicel), commercialization planning efforts, and the potentially life-saving or curative therapeutic and commercial potential of Gamida Cell’s product candidates (including 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 Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission (SEC) on May 12, 2022, 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.
1CIBMTR 2019 – allogeneic transplants in patients 12+ years with hematological malignancies.
2Gamida Cell market research
View source version on businesswire.com: https://www.businesswire.com/news/home/20220801005265/en/
Contacts
For investors:
Courtney Turiano
Stern Investor Relations, Inc.
Courtney.Turiano@sternir.com
1-212-362-1200
For media:
Heather DiVecchia
Chief of Staff
Heather@gamida-cell.com
1-617-892-9083
Yeah I read it and it seems like sometimes BLA approval grants the ability to market and other times there is still a PDUFA approval needed. That’s what I was confused about in Gamida’s case.
At any rate, this morning’s PR answered that question.
Good news and I would hope this candidate would be about as close as a sure thing as there is for approval!
Will definitely be accumulating more on any dips.
Murocman
Read this:
https://www.nuventra.com/resources/blog/regulatory-differences-between-an-nda-bla/#:~:text=To%20formally%20request%20approval%20to,to%20traditional%20small%20molecule%20drugs.
What are the Regulatory Differences Between an NDA and BLA?
by Scientific Writing Team
To formally request approval to market a new drug in the United States, Sponsors must submit either a New Drug Application (NDA) or a Biologics License Application (BLA) to the FDA. As their names suggest, BLAs relate to biological products while NDAs generally pertain to traditional small molecule drugs. While they share the same goal of obtaining marketing approval, they also vary slightly in content and scope. In this post, we explore the similarities and differences between the two marketing applications, as well as special considerations based on recent regulatory changes.
What are New Drug Applications (NDA) & Biologics License Applications (BLA)?
An NDA is an application to permit the sale and marketing of a new drug in the United States. A traditional NDA consists of data and information about the drug as gained from both nonclinical and clinical studies, as well as a summary of formulation development and manufacturing processes, and proposed labeling information to be included in the drug’s packaging.
In general, an NDA should contain enough data for the FDA to determine if the drug is safe and effective for its proposed use, if the benefits of taking the drug outweigh the risks, and if the drug product is manufactured in a way that preserves its identity, strength, quality, and purity. Drugs that are approved via an NDA pathway are regulated under Section 505 of the Food, Drug, & Cosmetics (FD&C) Act.
A BLA is a request to introduce, or deliver for introduction, a biological product into interstate commerce. Like an NDA, a BLA should include all information about the biological product that was gained over the development process and should demonstrate the biologic’s safety, purity, and potency. The BLA also contains the proposed labeling information to be included in the drug’s packaging. Per the Biologics and Price Competition and Innovation (BPCI) Act of 2009, as of March 23rd, 2020, all biological products must be approved through the BLA pathway, and therefore will be licensed under Section 351 of the Public Health Service (PHS) Act, in addition to being regulated by the FD&C Act.
What is a Biological Product?
Biological products are a subset of drugs defined by Section 351 of the PHS Act as a “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, … applicable to the prevention, treatment, or cure of a disease or condition of human beings.” The definition was later amended by the BPCI Act of 2009 and the Further Consolidated Appropriations Act of 2020 to include proteins (excluding peptides). Because biological products are typically derived from living systems, their large, complex structures are often difficult to characterize. This is a key distinction from traditional drug molecules, which are chemically synthesized and structurally both simpler and smaller in size.
The manufacturing process for biological products is also more complicated, due to genetic variability in the source material. Because of this, it is critical that BLAs contain a thorough description of product development and relevant manufacturing procedures, as well as all steps taken to ensure that the final biological product performs consistently across batches.
Key Differences Between BLAs & NDAs
While BLAs and NDAs serve the same purpose of gaining approval to market a drug in the United States, they differ slightly in terms of their application content and submission requirements. Regarding approval criteria, NDAs must fulfill three conditions:
The drug is safe and effective for the proposed use and that the benefits outweigh the risks
The labeling is appropriate and contains all necessary information about the drug
Manufacturing methods preserve the drug’s identity, strength, quality, and purity
Similarly, contents of a BLA should establish that the biological product is safe and potent; however, because biological products are processed from living material, BLA content must also demonstrate purity specifically in terms of showing that the final product does not contain extraneous material.
Due to the complexities of manufacturing biological products, a pre-license inspection of the facility is generally required before a BLA is approved. Pre-approval inspections sometimes also take place during an NDA review, but are typically conducted based on risk assessment by the Agency.
Once a BLA is approved, the Sponsor is granted a license for the biological product, which permits its introduction into interstate commerce per Section 351 of the PHS Act. This licensing process is not a part of the NDA, as drugs that are approved by NDA are regulated only by the FD&C Act, and not the PHS Act.
Until very recently, certain biological products could be approved under an NDA rather than a BLA. However, according to the Biologics Price Competition and Innovation Act (further discussed below) this is no longer the case, and all biological product approvals now occur through a BLA.
Regulatory Agencies
There are two Centers within the FDA that are responsible for the review and approval of drug marketing applications and general regulatory oversight: the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). While all conventional drug products (i.e., small molecules) are regulated by CDER, biological products can be regulated by either CDER or CBER, depending on the product’s classification as discussed above.
The majority of BLA submissions are assigned to CBER; however, BLAs for certain biological product categories are reviewed by CDER instead. These product categories include monoclonal antibodies for in vivo use, most proteins for therapeutic use (e.g., cytokines, enzymes, and other novel proteins except those assigned to CBER, such as vaccines and blood products), immunomodulators, and growth factors. Regardless of the category, NDAs for all drug products fall under the jurisdiction of CDER.
Key Similarities Between BLA & NDA
Like an NDA, a BLA is submitted to the FDA in order to market a new drug in the US. As they share the same goal of obtaining marketing approval, NDAs and BLAs are similar in that both must contain enough information to demonstrate the efficacy and safety of the drug, as well as demonstrate an ideal risk:benefit ratio, in order to be successful. Additionally, many of the same regulations apply to NDAs and BLAs, including labeling and advertising rules, accelerated approval pathways, pediatric study requirements, and PDUFA fees.
Regardless of whether a Sponsor is submitting an NDA or BLA, the same pre-marketing regulations apply. This includes initial filing of an IND and subsequent maintenance of the IND throughout the drug development program until the marketing application is submitted. The structure and contents of the IND do not differ between drugs and biological products.
Biologics Price Competition and Innovation Act
It is important to note that on March 23, 2020, the Biologics Price Competition and Innovation (BPCI) Act went into effect. Along with introducing an abbreviated approval pathway for highly similar biological products (i.e., biosimilars), this act mandated that moving forward, all biological products must be submitted for marketing approval through a BLA, and not an NDA. For biological products that had been previously approved via NDA (e.g., protein products), the approved marketing application will be “deemed to be a license” (i.e., serve as an approved BLA) for the biological product under Section 351 of the PHS Act.
Conclusions
NDAs and BLAs are the two types of applications that are submitted in order to market a new drug in the United States. While they are both submitted to gain FDA drug approval, they differ in terms of product categories, approval criteria, and certain regulations. Nuventra consultants are widely experienced in the preparation and submission of both BLAs and NDAs for numerous drugs and indications.
I always get BLA’s and NDA’s mixed up.
If the BLA is approved, the therapeutic is approved, subject to any restrictions, limitations or required follow ups with the FDA, correct?
Murocman
Gamida Cell (GMDA) Investor Presentation- Slideshow
Jun. 24, 2022 2:24 PM ETGamida Cell Ltd. (GMDA)
The following slide deck was published by Gamida Cell Ltd. in conjunction with this event.
https://seekingalpha.com/article/4520221-gamida-cell-gmda-investor-presentation-slideshow
Gamida Cell Ltd.'s (NASDAQ:GMDA) Shift From Loss To Profit
By Simply Wall St
PublishedJune 15, 2022
https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-gmda/gamida-cell/news/gamida-cell-ltds-nasdaqgmda-shift-from-loss-to-profit?utm_medium=article&utm_source=robinhood
We feel now is a pretty good time to analyse Gamida Cell Ltd.'s (NASDAQ:GMDA) business as it appears the company may be on the cusp of a considerable accomplishment. Gamida Cell Ltd., a clinical-stage biopharmaceutical company, develops cell therapies to cure blood cancers and serious hematologic diseases. With the latest financial year loss of US$90m and a trailing-twelve-month loss of US$91m, the US$110m market-cap company amplified its loss by moving further away from its breakeven target. As path to profitability is the topic on Gamida Cell's investors mind, we've decided to gauge market sentiment. We've put together a brief outline of industry analyst expectations for the company, its year of breakeven and its implied growth rate.
View our latest analysis for Gamida Cell
Consensus from 6 of the American Biotechs analysts is that Gamida Cell is on the verge of breakeven. They expect the company to post a final loss in 2023, before turning a profit of US$8.4m in 2024. The company is therefore projected to breakeven around 2 years from now. In order to meet this breakeven date, we calculated the rate at which the company must grow year-on-year. It turns out an average annual growth rate of 66% is expected, which is extremely buoyant. Should the business grow at a slower rate, it will become profitable at a later date than expected.
earnings-per-share-growth
NasdaqGM:GMDA Earnings Per Share Growth June 15th 2022
We're not going to go through company-specific developments for Gamida Cell given that this is a high-level summary, however, bear in mind that generally biotechs, depending on the stage of product development, have irregular periods of cash flow. This means that a high growth rate is not unusual, especially if the company is currently in an investment period.
Before we wrap up, there’s one issue worth mentioning. Gamida Cell currently has a debt-to-equity ratio of over 2x. Generally, the rule of thumb is debt shouldn’t exceed 40% of your equity, which in this case, the company has significantly overshot. Note that a higher debt obligation increases the risk in investing in the loss-making company.
Next Steps:
This article is not intended to be a comprehensive analysis on Gamida Cell, so if you are interested in understanding the company at a deeper level, take a look at Gamida Cell's company page on Simply Wall St. We've also compiled a list of relevant factors you should look at:
Valuation: What is Gamida Cell worth today? Has the future growth potential already been factored into the price? The intrinsic value infographic in our free research report helps visualize whether Gamida Cell is currently mispriced by the market.
Management Team: An experienced management team on the helm increases our confidence in the business – take a look at who sits on Gamida Cell’s board and the CEO’s background.
Gamida Cell to Present Corporate Highlights at the JMP Securities Life Sciences Conference
https://finance.yahoo.com/news/gamida-cell-present-corporate-highlights-110000806.html%
BOSTON, June 13, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, announces that company management will present its corporate highlights at the JMP Securities Life Sciences Conference, June 16, 2022 with a presentation at 2:00 p.m. ET in New York, NY.
Management will discuss 2022 catalysts and potential milestones including the U.S. market opportunity for omidubicel upon potential U.S. Food and Drug Administration (FDA) approval, accelerating the development of its first-in-class NAM-enabled natural killer (NK) cell therapy candidate, GDA-201, as a potential new approach for patients with follicular and diffuse large B-cell lymphomas, and expansion of its NAM-enabled cell therapy pipeline with multiple next-generation, genetically engineered NK cells.
A webcast of the 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.
The Company also announces the resignation of Ofer Gonen from its Board of Directors, effective June 9, 2022. Mr. Gonen will be joining MediWound Ltd. as chief executive officer effective June 30, 2022.
https://finance.yahoo.com/news/gamida-cell-appoints-ivan-m-110000306.html
Gamida Cell Appoints Ivan M. Borrello, M.D., Expert in Immuno-Oncology, Cell Therapies, and Bone Marrow Transplant to Board of Directors
https://finance.yahoo.com/news/gamida-cell-appoints-ivan-m-110000306.html
BOSTON, June 10, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, announces the appointment of Ivan M. Borrello, M.D. to its Board of Directors, effective June 9, 2022. Dr. Borrello is an Associate Professor of Oncology at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and a renowned physician and author who has made major contributions to better the understanding of immunotherapies and the treatment of hematologic malignancies as well as bone marrow transplant. He will also be joining Gamida Cell’s Science and Technology Committee.
The Company also announces the resignation of Ofer Gonen from its Board of Directors, effective June 9, 2022. Mr. Gonen will be joining MediWound Ltd. as chief executive officer effective June 30, 2022.
"I am excited to have Ivan join our Board of Directors. As a distinguished physician in hematologic malignancies, cellular therapeutics, and immunotherapies, Ivan has significantly contributed to the progress in the clinical oncology field," said Julian Adams, Ph.D., chief executive officer of Gamida Cell. "His deep knowledge and clinical experience in immune-based therapies, most notably in establishing the first adoptive T-cell clinical trials at Johns Hopkins, will continue to support Gamida Cell as we advance our pipeline of NAM-enabled cell therapy candidates for patients with blood cancers and other serious blood disorders. In addition, on behalf of the entire Board of Directors, I want to thank Ofer for his longstanding service to Gamida Cell. We wish him every success going forward."
"It is a privilege to join Gamida Cell’s Board of Directors, as the company leverages its truly innovative NAM-technology to develop potentially curative cell therapy candidates," said Dr. Borrello. "I believe the Company's novel technology holds tremendous promise, which is supported by remarkable clinical data, coupled with their deep expertise in oncology and the development of cellular therapy candidates. I look forward to supporting Gamida Cell as it continues to advance its growing pipeline of cell therapy candidates for patients with solid tumor and blood cancers and other serious blood diseases."
Dr. Borrello’s clinical research interest is focused on developing immune-based therapies for the treatment of multiple myeloma. His laboratory research has focused on the development of a novel approach of adoptive T-cell therapy utilizing marrow infiltrating lymphocytes (MILs) as a more tumor-specific T-cell approach. He has held multiple appointments at Johns Hopkins University, including Instructor, Immunotherapy and Hematopoiesis, Johns Hopkins Oncology Center from 1999 to 2000, and Assistant Professor, Immunotherapy and Hematopoiesis, Hematologic Malignancies, Johns Hopkins Oncology Center, from 2001 to 2008. Dr. Borrello is also the director of the myeloma program and medical director of the Cell Therapy Lab. Dr. Borrello received his medical degree from the Medical College of Virginia and completed his residency at the University of Chicago and fellowship at Johns Hopkins.
Gamida Cell to Present Corporate Highlights at the Jefferies Healthcare Conference
Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, announces that company management will present its corporate highlights at the Jefferies Healthcare Conference, June 8, 2022 with a presentation at 11:00 a.m. ET in New York, NY.
Management will discuss 2022 catalysts and potential milestones including the U.S. market opportunity for omidubicel upon potential U.S. Food and Drug Administration approval, accelerating the development of its first-in-class NAM-enabled natural killer (NK) cell therapy candidate, GDA-201, as a potential new approach for patients with follicular and diffuse large B-cell lymphomas, and expansion of its NAM-enabled cell therapy pipeline with multiple next-generation, genetically engineered NK cells.
A webcast of the 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.
Omidubicel, if approved, has the potential to improve outcomes for patients based on transplanter feedback and to potentially increase access for patients to get to transplant. Omidubicel, if approved, has the potential to treat approximately 2,000 – 2,500 patients each year in the U.S.
Gamida Cell Completes Rolling Biologics License Application Submission to the FDA for Omidubicel
https://finance.yahoo.com/news/gamida-cell-completes-rolling-biologics-110000831.htmlGMDA
- Omidubicel is a first-in-class, advanced NAM-enabled stem cell therapy candidate being evaluated as the first potential allogeneic advanced cell therapy donor source for patients with blood cancers in need of a transplant –
- Omidubicel has Orphan Drug Designation and Breakthrough Therapy Designation -
BOSTON, June 02, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, today announced completion of the rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for omidubicel for the treatment of patients with blood cancers in need of an allogenic hematopoietic stem cell transplant.
"The BLA submission marks an important milestone for both Gamida and the transplant community, as omidubicel has the potential to be the first approved advanced cell therapy product for allogeneic stem cell transplantation," said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell. "Completion of this BLA submission is a key inflection point in our mission to deliver a new treatment option for patients with blood cancers. We look forward to working closely with the FDA to bring this potentially important therapy to patients."
The FDA has 60 days to determine whether the BLA for omidubicel is acceptable for filing. The omidubicel BLA is supported by the statistically significant results from Gamida Cell’s pivotal Phase 3 study, the results of which were published in Blood, the official journal of the American Society of Hematology. For the study’s primary endpoint, the median time to neutrophil engraftment in patients with hematologic malignancies undergoing allogeneic bone marrow transplant receiving omidubicel compared to standard umbilical cord blood (UCB), 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).
In key secondary endpoints of this Phase 3 study: platelet engraftment was significantly accelerated [55 percent of patients randomized to omidubicel achieving platelet engraftment by day 42, compared to 35 percent for the comparator (p = 0.028)]; the rate of infection was significantly reduced [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 = 0.03)]; and hospitalization in the first 100 days after transplant was significantly reduced [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)]. Omidubicel was generally well tolerated in the Phase 3 study.
The full Blood manuscript is available here: https://ashpublications.org/blood/article/doi/10.1182/blood.2021011719/476235/Omidubicel-Versus-Standard-Myeloablative-Umbilical.
About Omidubicel
Omidubicel is an advanced cell therapy candidate developed as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment in comparison to standard umbilical cord blood in an international, multi-center, randomized Phase 3 study (NCT0273029) in patients with hematologic malignancies undergoing allogeneic bone marrow transplant. The Phase 3 study also showed reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. One-year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by significant reduction in infectious complications as well as reduced non-relapse mortality and no significant increase in relapse rates nor increases in graft-versus-host-disease (GvHD) rates. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the US and EU.
Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority. For more information about omidubicel, please visit https://www.gamida-cell.com.
M arket Opportunity
In 2019, approximately 8,000 patients who were 12 years old and up with hematologic malignancies underwent an allogeneic stem cell transplant.1 Unfortunately, it is estimated that another 1,200 patients were eligible for transplant but could not find a donor source.2 Omidubicel, if approved, has the potential to improve outcomes for patients based on transplanter feedback and to potentially increase access for patients to get to transplant. Omidubicel, if approved, has the potential to treat approximately 2,000 – 2,500 patients each year in the U.S.
About NAM Technology
Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.
Gamida Cell Announces Opening to Enrollment of Company-Sponsored Phase 1/2 Study of NK Cell Therapy Candidate GDA-201
https://finance.yahoo.com/news/gamida-cell-announces-opening-enrollment-110000783.html
BOSTON, June 01, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, today announced the activation of the initial clinical sites to screen and enroll patients in the company-sponsored Phase 1/2 study evaluating a cryopreserved formulation of GDA-201, a readily available cell therapy candidate for the treatment of follicular and diffuse large B cell lymphomas (NCT05296525). On April 26, 2022, Gamida had announced that the U.S. Food and Drug Administration (FDA) cleared its investigational new drug (IND) application and removed the clinical hold for a cryopreserved formulation of GDA-201.
"We are excited to be screening patients for enrollment in our company-sponsored Phase 1/2 clinical study of our novel, cryopreserved formulation of GDA-201, which has the potential to address the significant unmet need that exists for patients with follicular and diffuse large B cell lymphomas having relapsed or refractory disease," said Ronit Simantov, M.D., chief medical and scientific officer of Gamida Cell. "As described in previously announced clinical data, an investigator-sponsored (IS) study evaluating the fresh formulation of GDA-201 demonstrated encouraging results in heavily pretreated patients with lymphoma. With the initiation of enrollment, we look forward to dosing the first patient in our clinical study of the novel cryopreserved formulation of GDA-201."
GDA-201 leverages Gamida Cell’s proprietary NAM technology platform to expand the number and functionality of NK cells to direct tumor cell killing properties and antibody-dependent cellular cytotoxicity (ADCC). In an investigator-sponsored Phase 1/2 study in patients with relapsed or refractory lymphoma, treatment with the fresh formulation of GDA-201 with rituximab demonstrated significant clinical activity. Of the 19 patients with non-Hodgkin lymphoma (NHL), 13 complete responses and one partial response were observed, with an overall response rate of 74% and a complete response rate of 68%. The most common Grade 3/4 adverse events were thrombocytopenia, hypertension, neutropenia, febrile neutropenia, and anemia. At the December 2021 Annual Meeting of American Society of Hematology, two-year follow-up data were reported on outcomes and cytokine biomarkers associated with survival. The data demonstrated a median duration of response of 16 months (range 5-36 months) and an overall survival at two years of 78% (95% CI, 51%–91%). In the IS study, GDA-201 was well-tolerated and no dose-limiting toxicities were observed in 19 patients with NHL and 16 patients with multiple myeloma.
The study of the cryopreserved formulation of GDA-201 is currently open to enrollment at Henry Ford Health (Detroit, MI) and the Masonic Cancer Center at the University of Minnesota; additional sites will be added in the coming months and updated in Clinicaltrials.gov (NCT05296525). The Phase 1 portion of the study is designed to evaluate the safety of GDA-201 in patients with follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL)/high grade B-cell lymphoma (HGBCL), marginal zone lymphoma or mantle cell lymphoma. The Phase 2 expansion phase is designed to evaluate the safety and efficacy of GDA-201 in two patient cohorts, FL and DLBCL/HGBCL. The study will include patients who have relapsed or refractory lymphoma after at least two prior treatments, which may include CAR-T or stem cell transplant.
About NAM Technology
Our NAM-enabling technology, supported by positive Phase 3 data, is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.
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 candidate 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. There are approximately 40,000 patients with relapsed/refractory lymphoma in the US and EU, which is the patient population that will be studied in the GDA-201 Phase 1/2 clinical trial.
For more information about GDA-201, please visit https://www.gamida-cell.com. For more information on the Phase 1/2 clinical trial of GDA-201, please visit www.clinicaltrials.gov.
GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
Gamida Cell to Present Corporate Highlights at the H.C. Wainwright Global Life Sciences Conference
May 17 2022 - 04:30PM
Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, today announced that company management will present at the upcoming H.C. Wainwright Global Life Sciences Conference. A pre-recorded presentation will become available to registered conference attendees on May 24, 2022 at 7:00 a.m. ET. Management will discuss 2022 catalysts and potential milestones including the U.S. launch opportunity for omidubicel upon potential U.S. Food and Drug Administration approval, accelerating the development of its first-in-class NAM-enabled natural killer (NK) cell therapy candidate, GDA-201, as a potential new approach for patients with follicular and diffuse large B-cell lymphomas, and expansion of its NAM-enabled cell therapy pipeline with multiple next-generation, genetically engineered NK cells.
A webcast of the presentation will be available on the “Investors & Media” section of Gamida Cell’s website at www.gamida-cell.com, and will be available for at least 14 days following the event.
Gamida Cell Ltd. (GMDA) Management on Q1 2022 Results - Earnings Call Transcript
May 10, 2022 11:26 AM ETGamida Cell Ltd. (GMDA)
Gamida Cell Ltd. (NASDAQ:GMDA) Q1 2022 Results Conference Call May 10, 2022 8:00 AM ET
Company Participants
Heather DiVecchia - Chief of Staff
Michele Korfin - Chief Operating Officer and Chief Commercial Officer
Ronit Simantov - Chief Medical Officer and Chief Scientific Officer
Shai Lankry - Chief Financial Officer
Conference Call Participants
Eric Musonza - Evercore
Edward Tenthoff - Piper Sandler
Gilbert Blum - Needham and Company
Matthew Cross - Alliance Global Partners
Operator
Ladies and gentlemen, thank you for standing by. Welcome to Gamida Cell’s Conference Call for the First Quarter 2022 Financial Results. My name is Carmen and I will be your Operator for today’s call. Please be advised that this call is being recorded at Gamida Cell’s request.
Now, I would like to introduce your host for today’s conference, Heather DiVecchia, Gamida Cell’s Chief of Staff. Please go ahead.
Heather DiVecchia
Thank you, Carmen and good morning, everyone. Welcome to today’s call during which we will provide an update on the Company and review our financial results for the first quarter of 2022. Earlier this morning, we issued a press release summarizing our financial results and progress across the Company, which is available on our website at website at www.gamidacell.com.
Please note that unfortunately, our Chief Executive Officer, Julian Adams is unable to join us this morning due to contracting COVID-19. Company operations are unaffected and Julian has advised us that his symptoms are improving, and he expects to recover shortly.
With that here with me on our call today are Michele Korfin, our Chief Operating Officer and Chief Commercial Officer; Ronit Simantov, our Chief Medical Officer and Chief Scientific Officer; and Shai Lankry, Chief Financial Officer.
During this call, we may make Forward-Looking Statements about our future expectations and plans, including in respect to 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 Gamida Cell’s product candidate, including GDA-201 and 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 impacts of 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 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 10-K 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, fewer future events or otherwise.
Now I would like to turn the call over to Michelle.
Michele Korfin
Thank you, Heather, and thank you to everyone for joining us this morning. Gamida Cell had a productive quarter as we made important progress across all areas of our Company. We continue to build momentum as we head into several inflection points expected this year, most near-term being the full BLA submission for Omidubicel, which we are on track to complete in the second quarter of this year.
Additionally, our GDA-201 program advanced marked by the recent clearance by FDA of our IND and removal of the clinical hold for the cryopreserved formulation. We are excited to have reached this milestone and are now moving forward with our plans to initiate a company sponsored Phase I/II study in patients with follicular and diffuse large B-cell lymphomas, which Ronit will provide additional detail on.
Beyond GDA-201, which is our lead program in our expanding NAM enabled NK cell pipeline. We are also looking forward to announcing a new product candidate from our genetically engineered NAM enabled NK cell constructs later this year. We recently announced preclinical data at the ISCT conference supporting the development of GDA-301 and GDA-601.
It is an exciting time in Gamida Cell’s development and we are focused on advancing our pipeline of potentially curative cell therapies. Our continued commitment is demonstrated by the new and recent data on Omidubicel that we presented this quarter, focused on Omidubicel’s, encouraging clinical data and our health economic efforts, which we will comment on later on in the call.
With all we have accomplished only this past quarter, but also in the last few months, we are poised to be a leader in the development of NAM-enabled cell therapies with two promising and important clinical programs and a robust pipeline of genetically modified NK cell product candidates in preclinical development.
The progress we achieved this quarter continues to add to the important foundation that we have established. This strong foundation is due to our dedicated employees and their continued focus on patients and our vision of advancing therapies to help to address unmet needs.
With this, I will now turn the call over to Ronit.
Ronit Simantov
Thanks, Michelle. And good morning everyone. Thank you for joining us on the call this morning. Let me start with our lead program Omidubicel, which has breakthrough therapy designation as well as orphan drug status and to potential to be the first FDA-approved cell therapy for stem cell transplant.
Earlier this year, we were excited to initiate the rolling BLA submission for Omidubicel starting with our non-clinical module, followed by the submission of our clinical module. I’m pleased that we are currently on track to complete the full BLA submission in the second quarter of this year, moving us closer to bringing this important potential therapy to patients. Our BLA for Omidubicel is supported by strong Phase III results, which met all primary and secondary endpoints.
This past quarter, we announced the presentation of new data at the Transplantation & Cellular Therapy or TCT meeting. As we have continued to add to the body of evidence demonstrating the potential of Omidubicel to address unmet needs in patients undergoing allogeneic stem cell transplantation. Patients often have serious infections after transplant due to the slow recovery of their immune system, following treatment.
In a presentation that received a TCT best abstract award, Dr. Paul Szabolcs presented data from our Phase III randomized trial of Omidubicel, showing rapid recovery of abroad repertoire of immune cells, which was associated with reduced infection rates in Omidubicel treated patients.
In another oral presentation at TCT, Dr. [indiscernible] presented the final results of our Phase III study, including patient follow-up of over one year after transplant. The results showed that the early engrossment and lower infection rates previously observed in patients treated with Omidubicel were accompanied by longer-term clinical benefits, including a reduction in transplant related mortality and a trend towards an increase in overall survival, with no increase in relapsed or graft versus host disease, compared to transplantation with standard umbilical cord blood.
In addition, among our six posters at TCT, we presented 10-year follow-up data of patients treated in the Omidubicel clinical development program, demonstrating long-term sustainable hematopoiesis and immune confidence, with one case of secondary graft failure and one case of severe chronic GVHD among the 22 patients in the cohort.
We also presented an analysis of resource utilization in the Phase III study, demonstrating that faster hematopoietic recovery and lower rates of infections in patients transplant with Omidubicel were associated with significantly shorter length of hospital stay, reduced admissions to intensive care unit settings and lower healthcare resource utilization, compared to control.
Another poster outlined a quantitative analysis of well-established measures of patient health related quality of life, in a randomized Phase III study. The analysis demonstrated that Omidubicel was associated with meaningfully greater preservation or improvement of quality of life.
Tying together clinical data in the Phase III study to important outcomes from a patient focused perspective. Overall, we have continued to develop a robust set of clinical scientific translational and quality of life data demonstrating the potential clinical benefit of transplantation with Omidubicel.
Now turning to our NK pipeline, I will start with an update on GDA-201, we are proceeding with our plans to initiate a study of GDA-201 in patients with non-Hodgkin lymphoma. Although there have been recent advances for patients with lymphoma, we recognize that there is still an unmet need for patients with relapse and refractory disease.
Given the responses observed in the investigator led study at the University of Minnesota using the fresh formulation of GDA-201. We have developed the cryopreserved formulation, which allows us to perform a multicenter study.
We are very pleased to receive FDA clearance of our IMD for GDA-201, removing the clinical hold and allowing us to move forward with the study. We are proceeding with the operational activities at several sites, and we anticipate conducting formal site initiation visits and opening sites for enrollment this quarter.
Turning to our research and development activities, we are continuing to advance the preclinical data for our gene edited NK cell pipeline aimed at hematologic malignancies and solid tumors. We recently presented two posters at the International Society for Cell Gene Therapy or IFCP meeting in San Francisco. One poster presented new preclinical data on GDA-301, our CISH knockout membrane bound IL-15 expressing NK cell. Our poster showed cytotoxicity in potency of GDA-301 in multiple tumor cell line.
The second poster detailed preclinical data demonstrating cytotoxicity of GDA-601, our CD-38 knockout anti CD-38 CAR expressing NAM NK cells against multiple myeloma cell lines. We look forward to presenting more data at scientific meetings this year.
We plan to continue to conduct preclinical proof of concept studies for these genetically modified NK therapeutic candidates and by the end of 2022, we plan to select a pipeline candidate for IND enabling studies.
With that, I will turn the call over to Michele to now talk more about Omidubicel and commercial preparation. Michele.
Michele Korfin
Thank you, Ronit. I will now comment on our advancements with our CMC module and our launch readiness for Omidubicel. Earlier this year, we initiated our rolling BLA submission for Omidubicel, and we are nearing completion of the rolling BLA, which is on track for completion in the second quarter of this year.
In the first quarter of this year, we reached an important milestone with the FDA’s acknowledgement of the analytical comparability from our planned Gamida Cell owned commercial facility in Israel, as compared to the manufacturing facility used for the Phase III study. This allowed us to move forward with completion of the remaining production modules in our facility in Israel to support the BLA.
Our cross functional team in Israel, including operations quality R&D and regulatory are progressing well on the CMC module in preparation for completing that module and the BLA submission in the second quarter. We are not only preparing for the BLA submission from an operations perspective, but also preparing for launch readiness.
Our facility in Israel is modular and upon FDA approval of Omidubicel, we will have the ability to add additional cores as demand grows from Omidubicel. We are confident we could support the launch demand requirements from our facility, not only from a production, but also a supply chain standpoint.
The team is diligently working to ensure our manufacturing reliability, chain of identity and chain of custody for our commercial process to ensure a positive transplant center and positive patient experience.
Transitioning to launch readiness, the Gamida team recognizes the unmet need that Omidubicel may address for patients upon FDA approval. We are focused on our launch readiness to ensure upon FDA approval that patients could have access to Omidubicel. For patients with hematologic malignancies that are deemed eligible for an allergenic stem cell transplant, the procedure may be their best chance for a potential cure.
There are two key opportunities that Omidubicel may address for patients upon FDA approval. The first being potentially improving outcomes as compared to other donor sources based on transplant or feedback and the second potentially increasing access
In the United States are approximately 8,000 patients above the age of 12 with hematologic malignancies who undergo an allogeneic stem cell transplant each year. For potentially improving outcomes, we have conducted extensive market research over the last two years, and the insights are consistent and clear.
Transplanters see important opportunities for Omidubicel to potentially improve outcomes based on their experience with other donor sources. This is due to the strength of our clinical data, the ability to provide patients with pre-defined number of cells and the ability to provide Omidubicel within approximately one month of patient identification.
The majority of the patients in the United States are still receiving their graft from an unrelated donor and that could take on average, at least two to three months to align the patient and the donor. This timing for unrelated donors unfortunately puts the patient at risk for relapse.
Unfortunately, there are approximately 1,200 patients each year who are ages 12 and up with hematologic malignancies, who are deemed eligible for allogeneic stem cell transplant but cannot find an appropriate donor.
In terms of potentially increasing access for patients, unfortunately, there is racial disparity in the U.S. in regards to access to allogeneic stem cell transplants. If you are non-Caucasian and do not have access to a family member donor, you have a very low likelihood of finding a match in the public database. For example, patients who are African American may have less than a 20% chance of finding a match.
Omidubicel has a less stringent matching criteria, and we demonstrated our ability to match racially and ethnically diverse patients in our Phase III study, approximately 40% of the patients in our study were non-Caucasian.
And a study recently highlighted in a Poster Presentation at TCT, we leveraged available registry data and population modeling to project the potential impact of Omidubicel on racial and ethnic disparities.
In the model population increases in Omidubicel use in eligible patients were associated with potentially higher proportions of patients undergoing transplant and overall potentially improved outcomes with improvements being greater among racial minorities.
Taken together we anticipate that these two opportunities combined pending FDA approval, both improving outcomes based on transplant or feedback and increasing access may result in Omidubicel capturing approximately 20% to 25% of the addressable market once we reach peak market share. So upon FDA approval, this would equate to approximately 2,000 to 2,500 patients treated each year in the U.S. alone with Omidubicel.
In regards to reaching transplant centers in the U.S., the transplant centers that perform allogeneic stem cell transplants are extremely concentrated. For reference in the U.S., there are approximately 200 transplant centers that perform allogeneic stem cell transplants, 70 of those centers conduct approximately 80% of the transplants, allowing for an optimized approach to commercialization by initially targeting those centers.
Another important aspect of our launch is engaging with payers to ensure that they understand the potential value of Omidubicel upon FDA approval. Payer conversations are underway with national and key regional payers and we continue to hear consistent encouraging feedback on the overall value proposition of Omidubicel, including the strength of the clinical data and the health economic data we have published to-date.
We are also encouraged by their feedback on both the coverage and reimbursement approach they anticipate taking with Omidubicel upon FDA approval. We are excited to continue to hear positive feedback across all stakeholders and are extremely encouraged and driven by the potential of Omidubicel. We look forward to continuing to provide updates on our commercial preparations.
I will now 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 first quarter of 2022. As of March 31, 2022, our total cash position was approximately $70 million compared to $96 million as of December 31, 2021.
Research and development expenses for the quarter were $11.3 million, compared to $11.4 million in the first quarter of last year. The decrease was primarily due to a $1.1 million decrease in Omidubicel cell and GDA-201 clinical studies activities, offset by an increase of $1 million in boarding our scientific capabilities in talent.
Commercial expenses for the quarter were $3.9 million, compared to $4.2 million in the first quarter of 2021. The decrease was mainly due to reducing our near-term commercial readiness expenses, as we are assessing alternatives for the commercialization of Omidubicel, including potential U.S. or global partnership.
General and administrative expenses were $4.1 million in the first quarter of 2022, compared to $3.5 million for the same period in 2021. The increase was mainly due to a $0.5 million increase in headcount and related expenses.
Finance expenses net were $0.9 million for the first quarter of 2022, compared to $0.1 million for the same period last year. The increase was primarily due to a $0.6 million increase in interest expenses from our convertible node.
Net loss for the first quarter of 2022 was $20.2 million, compared to a net loss of $19.2 million in the first quarter of 2021. We expect cash used for ongoing operating activities for the entirety of this year to range from $65 million to $70 million.
We anticipate our current total cash position will support our ongoing operating activities into mid 2023. This cash run way guidance is based on our current operational plans 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 Michele.
Michele Korfin
Thank you, Shai. As we look ahead to the rest of the year, we are uniquely poised to deliver on our mission of developing potentially curative cell therapies for patients with blood cancers and other serious diseases.
We look forward to our full BLA submission for Omidubicel expected in the second quarter of this year and the initiation of our Phase I/II multicenter Gamida Cell sponsored study for the cryopreserve formulation of GDA-201 in patients with follicular and diffuse large B cell lymphomas this year.
We are excited for the opportunity to continue to leverage our unique NAM-enabled platform across a broad range of cell therapy candidates, and we look forward to providing updates throughout the year.
Now we will open the call for questions, Carmen.
Question-And-Answer Session
Operator
Thank you. [Operator Instructions] Your first question comes from John Miller with Evercore. Please go ahead.
Eric Musonza
Hi, this is Eric Musonza calling in for Jonathan Miller. Just had two quick questions on GDA-20,1 with trial sites opening in second quarter, when can we expect the first patient in and what sort of dynamics do you see around enrollment like do you expect COVID or summer travel to impact that? And then I have one follow-up.
Heather DiVecchia
Excellent. Thank you, Eric. Thanks for joining the call. I will turn to Ronit to address both of those. Thank you.
Ronit Simantov
Thanks Eric. So, in terms of opening sites, so sites will open this quarter and patients will need to be recruited and screened appropriately before the first patient is treated. So it usually takes several weeks for that to happen until a patient is actually treated with GDA-201.
But you know there is a lot of interest among the investigators for this study. There is an unmet need. These are patients who are relapsed or refractory, and clearly need additional therapies and are engaged in enrolling in a clinical trial. And so with the high need for these patients and the fact that they are ill with very serious cancer. We believe that enrollment will be robust for these patients.
I will make one more point about this portion of the study. It is a Phase I portion of the study. And so as this is a Phase I where toxicities are being evaluated patient-by-patient, we will be evaluating toxicity in each patient before proceeding with enrollment to the next patient. So we can carefully gauge patient enrollment as we move forward in the next few months and evaluate dose limiting toxicities. Once we evaluate that, then we can enroll patients more concurrently.
Eric Musonza
Got it. Very helpful. And just one more question. Do you expect any differences in enrollment timeline between follicular and the DLBCL cohorts?
Ronit Simantov
At this point, we don’t anticipate a difference between those two cohorts, but that is something that we can gauge as we move along. We certainly have the ability to analyze them separately, if need be, if there is a discrepancy we can manage that within the confines of the clinical trial design. But at this point, we don’t anticipate that there will be a difference because our investigators have expressed that patients with both histologies are in need of new therapies.
Eric Musonza
Great. Thank you.
Heather DiVecchia
Thank you Eric.
Operator
Your next question comes from Ted Tenthoff with Piper Sandler. Please go ahead.
Edward Tenthoff
Great, thank you and good morning everyone. I’m curious, what is sort of going on or what the latest is with respect to commercial prep for Omidubicel. I know, you are considering potential strategic alternatives, but also really just trying to get a sense for as you are finishing up the BLA, what might be the most likely scenario for marketing.
Michele Korfin
Excellent. Good, good morning, Ted. And thank you for joining us. I will go ahead and, and take that question. So in regards to commercial preparation, we have accomplished some critical milestones to-date.
So first off was really honing the commercial insights to understand first off the overall opportunity, but second of all, what could Omidubicel potential be for that opportunity. So, we have over the last couple of years, and most recently we have reiterated or relooked at some of these market insights.
We recognize the two key opportunities from Omidubicel. One is the ability to improve outcomes as compared to other donor sources, and this is based on transplant or feedback. And then the second is increasing access.
In terms of improving outcomes, some of the key insights that transplantor share with us is that the strength of the clinical data from our Phase III study, both the efficacy and the safety that Ronit has presented also the ability of having pre-defined number of cells.
And then finally the turnaround time in the United States, the majority of patients currently are still getting their donor source from an unrelated donor. And on average, we are hearing that takes at least two to three months to align the donor in the patient.
And as you know, with acute leukemia as an aggressive lymphomas that puts the patient at risk for relapse. So with Omidubicel being approximately one month from time of patient identification in the Phase III study to return of Omidubicel that is a positive feature.
And then switching to the increasing access or improving access, unfortunately in the United States, we do see many patients who are deemed eligible for transplant that cannot find the donor. The latest data that we have assessed is approximately 1,200 patients each year and that may end up growing. And unfortunately, it is also a 1situation of racial disparity. If you are non-Caucasian in the U.S. and don’t have access to a family member, it is incredibly difficult to find a match.
So to summarize, based on the encouragement of those market insights, in regards to the opportunity for Omidubicel, we have hired our commercial leadership team and we also have the operations and supply chain leadership team in place. So this way that that core group of leaders could continue to assess not only the opportunity, but most importantly the launch readiness.
And that is moving in parallel to our assessment of potential strategic alternatives. We feel very, very strongly that upon FDA approval, we do need to make sure patients have access to Omidubicel so we have got our leadership team in place as we are also in parallel looking at potential strategic alternatives.
Edward Tenthoff
Okay and would those alternatives include both the United States and overseas because this feels to me like a market that is appropriately sized for a biotech company to launch, especially since you guys have so much familiarity with the product, with the treatment group. So I just want to get a little more color on that. Thanks.
Michele Korfin
Yes. Thank you Ted. So we are assessing strategic opportunities globally, so including the U.S., but also ex-U.S., we have conducted initial commercial assessments in Europe and in Asia specifically in Japan and are very encouraged by the commercial opportunity from a Omidubicel in those areas. So, we are, as we discuss strategic alternatives for potential launch of Omidubicel looking globally.
Edward Tenthoff
Great. Thank you very much.
Heather DiVecchia
Thank you Ted.
Operator
Your next question comes from Gil Blum with Needham and Company. Please go ahead.
Gilbert Blum
Good morning everyone and thanks for taking my question. Maybe a broader one, considering recent the result in donated NK cells in the space, I’m just curious how encouraged you are seeing that a company sponsored study could lead to some very interesting early results and how do you think that translates for GDA-201? Thank you.
Heather DiVecchia
Excellent. good morning Gil and thank you for joining us and for the question. Let me turn to Ronit to address Gil’s question.
Ronit Simantov
Sure. Thanks Gil. So, there have been some encouraging results that we have seen from other product, NK cells type product recently and overall, those are actually really encouraging because it sets the stage for NK cells. And in particular, some of the results we have seen are related to high doses delivered of NK cells with results seen with greater response seen at the higher doses.
And that actually sets us up quite well because we are able to deliver with GDA-201 high doses of NK cells, high numbers of NK cells that are extremely functional and retain their killing capacity, because the NAM technology that we have used to expand and maintain the stemness of stem cells actually expand and maintains the NK-ness or the queuing potential of NK cells. So, we actually think it sets us up quite nicely for our Phase I/II study.
Our study is designed to evaluate the safety of the cryopreserved formulation at first and then move right into a formal efficacy evaluation. The entire study is un-blinded - open label study, and we will be able to see as we go what the potential for activity is with this formulation. So, we are excited to start enrolling patients and seeing results.
Gilbert Blum
Thank you. Thank you Ronit that was very helpful. Maybe also on a quick financial question. So, on the SG&A spend, there was a line that mentioned that, there are some cost savings due to consideration of strategic options for commercialization. Just help me to understand, does that mean that the company is cutting back on commercial preparedness launch, or just help me to understand that? Thank you.
Michele Korfin
Thank you, Gill. So, I will start with sort of the strategic aspect and I will turn to Shai for any additions on the financial side. So, we were fortunate last year to hire some incredibly strong commercial leaders. Linda Stamler to lead marketing and account management, [indiscernible] to lead market access. Those two individuals and their teams were able to conduct a lot of the critical market insights and beginning of launch preparation last year.
So then that allowed us to use this past quarter more to evaluate the insights and less OpEx associated with having to gather additional insights and also less hiring. We were able to hire our core group of commercial and operation leaders last year. So, that is sort of the high-level strategic aspects of it. And let me turn to Shai, if there is anything to add from the financial side.
Shai Lankry
Hi Gil, good morning. Thank you for the question. The way we see it, Gamida Cell as a company, continue to diligently manage our cash position. And as such, we announced back in January, this year, that we are assessing some strategic alternative for launching Omidubicel as our vision is to bring Omidubicel to patient.
Yes, we did prioritized, the key activities on not only on the commercial side, but across all the business to make sure, we are not jeopardizing our launch activities. And as I mentioned, and Michele mentioned before making sure each patient will have access to Omidubicel upon the approval.
Gilbert Blum
Alright. Thank you both for taking our questions this morning.
A - Heather DiVecchia
Thank you Gil.
Operator
Your next question comes from Jason Butler with JMP Securities. Please go ahead.
Unidentified Analyst
Hi. So its [Ronan] (Ph) for Jason. Thanks for taking our questions. I want to follow-up on the partnering questions. I guess, can you give a little more detail maybe on the level of interest that you are seeing. Do you think you can have a partnership in pot in place before, a potential approval maybe around year end? And can you remind us what structure you prefer for the U.S. Maybe a co-promote? Thanks.
Michele Korfin
Thank you. Good morning. And thank you for joining us. I will go ahead and take both of the questions. So we won’t comment on specifics in regards to our assessment at this point in time. But I do want to reiterate something very important that that Shai had said earlier.
And that is the fact that although we are assessing strategic alternatives for launch, we also do have the leadership team in place on both the commercial, the medical affairs, the quality and the operations side to assure that patients have access to Omidubicel upon FDA approval.
So when you asked about sort of the latter part of the question in terms of timing, we do have the strategy in place, the plans in place to assure access to patients for Omidubicel upon FDA approval.
At this point in time, as we indicated earlier this year, we are assessing strategic alternatives, but also continuing to do our work internally around assessing the opportunity and assessing what would be needed for launch planning.
Unidentified Analyst
Okay, great. That is helpful. Thank you. Then for the four NK candidates beyond GDA-201, are you going to take only one into the IND enabling studies or potentially multiple candidates, and then what happens to the other candidates if you know that don’t go into IND enabling studies this year, do they go on hold? Are you going to continue to refine them pre clinically? Thanks.
Heather DiVecchia
Excellent. Thank you very much. I will turn to Ronit for to address that question.
Ronit Simantov
Thanks Jason. One at a time. So we will take the lead candidate by the end of this year and, do the appropriate IND enabling studies and continue to develop, based on data of course, the additional candidates and as move those forward as we are able.
Unidentified Analyst
Great. Thank you very much.
Heather DiVecchia
Thank you.
Operator
Your next question comes from Mark Breidenbach with Oppenheimer. Please go ahead.
Unidentified Analyst
Hi, this is [Jacqueline] (Ph) for Mark, and thanks for taking our questions. So can you please remind us what dose levels will be tested in the dose escalation from the GDA-201. And if there are any differences in lympho depletion conditions to cytokine support or rituximab dosing?
Heather DiVecchia
Thank you for joining us Jacqueline. I will turn to Ronit to address both the dosing question and the question around the lympho depletion and rituximab in the protocol.
Ronit Simantov
Absolutely. So the design of the study, the design of the administration or the treatment design is based on the Minnesota study using the fresh formulation. And so we will be testing doses that are similar to the ones used in the Minnesota study and the administration of lympho depleting chemotherapy, rituximab, and IL2 are also very similar if not identical to what was done in the Minnesota study. So I don’t think we have come out yet with the exact dose levels. But they are guided completely by the previous data in Minnesota.
Unidentified Analyst
And when do you expect to commence manufacturing runs for GDA-201 for the Phase I trial?
Heather DiVecchia
Yes, actually a last one Ronit, if you could also take that please.
Ronit Simantov
Of course, I’m happy to take that. So, manufacturing we are building - because, in the Phase I trial, the GDA-201 is produced ahead of time and not matched for patients, but basically readily available. We are building our inventory already and expect to have the product available for patients as soon as the first dosing is required.
Unidentified Analyst
Great. thanks for detailed questions.
Ronit Simantov
Thank you Jacqueline.
Heather DiVecchia
Thank you.
Operator
Your last question comes from Matthew Cross with Alliance Global Partners. Please go ahead.
Matthew Cross
Hi all good morning. Best wishes to Julian for a speedy recovery. I had two quick questions related to the Phase I/II for GDA-201, and kind of following up on your comments that are neat about the scheduling for lymphodepleting chemotherapy and antibody use. I guess considering this internal study will be using the cryopreserve formulation, not the fresh, just wanted to understand any the kind of special considerations here. I guess for the study compared to the prior one, it sounded like the schedule will be more or less the same or based off of the prior study. But given that you are not baking in time for name expansion with the cryopreserved, just wanted to understand whether that scheduling would still look similar and maybe to kind of recap any modifications that would have to be made to this study that were needed to remedy the FDA’s concerns around donor eligibility requirements. And anything that may play into which sites are able to participate in this study, given the combination of those donor eligibility requirement changes and the cryopreservation use here versus what was done previously? Thanks.
Heather DiVecchia
Excellent. Thank you Matt, thank you for joining us and thank you for the well wishes, we will pass them along, thank you. And I will turn to Ronit to answer Matt’s questions in regards to the Phase I/II.
Ronit Simantov
Sure. I’m happy to answer that, and I will take the donor eligibility piece first. So, the donor eligibility procedures and the assay qualifications, we needed to make sure that those are compliance with FDA requirements.
And so we replaced our donor testing laboratory with a Cleo certified lab in the U.S. and we have now made sure that all appropriate tests are licensed and cleared and that eligibility requirement has been met.
So there has been no change in the design of the study based on the quote - the hold itself was not require any changes in the design of the study, the protocol, the sites, or anything that had to do with the clinical trial itself. It really was confined to the eligibility of the product. So that was that piece.
Now in terms of cryopreserve formulation, so that it is great that you that you picked up on that. So in the fresh formulation study, patients had to have a donor available that donor had to be recruited and if reasons had to be done and then the product had to be produced over time.
So because we have a readily available product, now it will be at the site when the patient is enrolled and so that may save some time in terms of getting the patients up and treated because they will have product there, they don’t have to wait for the donor to get already get the donation and do all that.
And then procedurally, there will be a following process, the product will be there, it will be frozen, and it will be thought at the bedside to provide the patient with the product when they need it.
Matthew Cross
Perfect. Okay super helpful. And I just had one quick follow-up, which was around the sizing. It looked like per what you have drawn up on clinicaltrials.gov that there is kind of a target enrollment of about a hundred patients. So I guess I know you are not commenting at this point on the actual dose levels that, that you may step through, but just wanted to confirm whether that total sizing was based around kind of an expectation internally around the number of Phase I cohorts that you may look at, if it will be ultimately still driven by, the standard kind of safety evaluations as you step through doses, or maybe just kind of an expectation for the Phase II population for that portion of the study. Just wanted to get a little bit of an understanding around the assumptions for that sizing. Thanks.
Ronit Simantov
Yes. Absolutely. So, that number, which is put in clinicaltrials.gov and which is incorporated into the protocol itself incorporates, there is some flexibility there because you don’t know for sure how many patients you are going to end up enrolling in Phase I.
It is a standard 3x3 design where, if there is a dose limiting toxicity observed in the dose level numbers are expanded to include more patients. And so this is the maximum size based on the possible expansion of cohorts in the Phase I portion.
And then it also includes the Phase II portion where we are going to be evaluating separately, the patients with lymphoma, from the patients with the aggressive lymphomas and each of those sort of Phase II portions has its own, steps and analysis surrounding it. But they are relatively small cohorts to allow us to evaluate rather quickly efficacy results and then make decisions based on those early efficacy results that we see.
Matthew Cross
Understood. Okay. Thanks again for the clarity. I appreciate it.
Heather DiVecchia
Thank you Matt.
Ronit Simantov
Thanks so much Matthew.
Operator
Thank you. And this concludes our Q&A session. I will turn the call back to Michele Korfin for her final remarks.
Michele Korfin
Thank you, Carmen. Thank you very much for joining us for the call today. And we look forward to keeping you all updated on our future milestones. Have a nice day. Thank you, Carmen. That will conclude our call.
Operator
Thank you, ladies and gentlemen for participating. And you may now disconnect.
Gamida Cell GAAP EPS of -$0.34 in-line
May 10, 2022 7:13 AM ETGamida Cell Ltd. (GMDA)
By: Niloofer Shaikh, SA News Editor
Gamida Cell press release (NASDAQ:GMDA): Q1 GAAP EPS of -$0.34 in-line.
The company expects that its current cash and cash equivalents of $70M will support the company’s ongoing operating activities into mid 2023.
This cash runaway guidance is based on the company’s current operational plans and excludes any additional funding and any business development activities that may be undertaken.
Gamida Cell Reports First Quarter 2022 Financial Results and Provides Company Update
https://finance.yahoo.com/news/gamida-cell-reports-first-quarter-110000541.html
- On track for full BLA submission of omidubicel in the second quarter of 2022 -
- Planning to open sites for enrollment in second quarter of 2022 for Phase 1/2 study of GDA-201 in patients with follicular and diffuse large B-cell lymphomas -
- Presented new preclinical data supporting potential of NAM-enabled, genetically modified NK pipeline cell therapy candidates GDA-301 and GDA-601 -
- Finished first quarter of 2022 with approximately $70 million in cash; sufficient cash to fund the company’s operations into mid-2023 -
- Company to host conference call at 8:00 a.m. ET today -
BOSTON, May 10, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, today provided a business update and reported financial results for the quarter ended March 31, 2022. Net loss for the first quarter of 2022 was $20.2 million, compared to a net loss of $19.2 million in the first quarter of 2021. As of March 31, 2022, Gamida Cell had total cash and cash equivalents of $69.7 million.
During the past quarter, Gamida Cell:
Progressed omidubicel, a potentially life-saving cell therapy candidate for patients with blood cancers in need of stem cell transplant, towards full Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) in the second quarter of this year.
Planning to open sites for enrollment in second quarter of 2022 for Phase 1/2 study of lead natural killer (NK) cell therapy candidate, GDA-201, for patients with follicular and diffuse large B-cell lymphomas. The FDA recently cleared the company’s Investigational New Drug (IND) application and removed the clinical hold on the program, allowing Gamida Cell to move forward with the planned Phase 1/2 study with the cryopreserved formulation.
Continued development of the company’s NAM-enabled NK cell pipeline, including genetically modified product candidates GDA-301, GDA-401, GDA-501 and GDA-601, which focus on solid-tumor and hematological cancers. These product candidates utilize CAR, membrane bound- and CRISPR-mediated technologies to increase the NK cell targeting, potency and persistence against hematologic malignancies and solid tumors.
"We have made significant strides advancing our pipeline and demonstrating the potential benefit of our NAM-enabled cell therapy candidates for patients with blood cancers and other serious blood," said Julian Adams, Ph.D., chief executive officer of Gamida Cell. "And this starts with the recent milestone of the clearance of our IND for the cryopreserved formulation of GDA-201 by removal of the clinical hold. We are proceeding with operational activities in second quarter at multiple sites for our planned Phase 1/2 study, and are on track to advance this novel cell therapy candidate to the clinic this year. We were also pleased to present important data on omidubicel, supporting its potential long term clinical benefit, as we approach the full BLA submission for omidubicel during the second quarter of this year."
First Quarter and Recent Developments
Omidubicel: Advanced Cell Therapy
BLA submission: Following the receipt of positive Type B meeting correspondence from the FDA confirming that analytical comparability has been established between product made at Gamida Cell’s wholly-owned commercial manufacturing facility and the product that was manufactured for the Phase 3 study, Gamida Cell initiated a rolling BLA submission for omidubicel in February 2022. The company is on-track to complete the BLA submission in the second quarter of 2022. In parallel with the BLA submission, Gamida Cell is assessing alternatives for the commercialization of omidubicel, including potential U.S. or global partnerships.
New data presented at the 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings (TCT): In April 2022, Gamida Cell announced two oral and six poster presentations that focused on omidubicel’s positive Phase 3 clinical data, Gamida Cell’s health economic efforts, and transcriptional and metabolic profiling for our lead NK candidate, GDA-201. These presentations continued to add to the totality of evidence supporting omidubicel as a potential allogeneic hematopoietic stem cell transplant and our developments with our NK candidates. Highlights from these presentations included:
A presentation which received TCT’s Best Abstract Award entitled "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." This presentation detailed that Allo-HSCT with omidubicel demonstrated rapid hematopoietic recovery, reduced rates of infections and no increase in acute or chronic GvHD rates compared with standard UCB, with no unexpected adverse events attributable to ex vivo expansion.
An oral presentation titled "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." The data showed that the advantages of early engraftment and lower infections with omidubicel translated into long term clinical benefits in the first-year post-transplant, as demonstrated by reduction in non-relapse mortality, and no increase in relapse or GvHD rate compared to Umbilical Cord Blood Transplantation (UCBT). Additionally, there was a continued trend toward improved OS in favor of the omidubicel arm over time (73% vs 60%).
A health economic study titled "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." The study, which assessed the projected impact of omidubicel on racial and ethnic health disparities in a projection model, showed that, if approved, 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.
GDA-201: NAM-Enabled NK Cell Therapy
IND cleared and clinical hold removed for Phase 1/2 Study with cryopreserved formulation of GDA-201: Gamida Cell recently announced that FDA cleared its IND application and removed the clinical hold for a cryopreserved formulation of GDA-201. The company is now proceeding with operational activities at several clinical trial sites, and is on track to initiate a company-sponsored Phase 1/2 clinical study in patients with follicular and diffuse large B-cell lymphomas in 2022.
NAM-Enabled NK Cell Pipeline Expansion
Progressed NAM-enabled genetically modified NK pipeline: Gamida Cell continues to progress its NAM-enabled genetically modified NK pipeline, which utilizes CAR, membrane bound- and CRISPR-mediated technologies to increase targeting, potency and persistence against hematologic malignancies and solid tumors. The company plans to conduct preclinical proof of concept studies for these genetically modified NK therapeutic targets and to select a product candidate for IND enabling studies by the end of 2022. These therapeutic targets include:
GDA-301: Knockout of CISH (cytokine inducible SH2 containing protein) in NK cells using CRISPR/Cas9 in combination with a membrane-bound IL-15/IL-15Ra;
GDA-401: A development candidate with an undisclosed target.
GDA-501: Anti HER2 CAR-engineered NK cells to target solid tumors expressing HER2, based on a single-chain variable fragment of the widely used humanized monoclonal antibody trastuzumab; and
GDA-601: CRISPR Knockout of CD38 on NK cells combined with anti CD38 CAR. CD38 is an established immunotherapeutic target in multiple myeloma, but its expression on NK cells and its further induction during ex vivo NK cell expansion represents a barrier to the development of an anti CD38 CAR-NK cell therapy. Gamida Cell is advancing this program in collaboration with the Dana-Farber Cancer Institute to study the in vitro cytotoxicity of GDA-601 in fresh samples from multiple myeloma patients.
Presented preclinical data from product candidates at the International Society for Cell & Gene Therapy (ISCT) 2022: Gamida Cell recently presented new preclinical data for GDA-301 and GDA-601 that continued to demonstrate the potential of these product candidates:
A poster titled "GDA-301: Engineered NAM-NK Cells via CISH Knockout and Membrane-Bound IL-15 Expression Increases Cytotoxicity Against Malignancies," detailed that GDA-301 produces enhanced potency and persistence with combined genetic manipulation of CISH gene editing and the engineered expression of membrane-bound IL-15 for targeting hematologic malignancies and solid tumors.
In a poster titled "GDA-601: NAM-NK Cells With CD38 Knockout Expresses Enhanced CD38 Chimeric Antigen Receptor and Targets Multiple Myeloma Cells With Increased Cytotoxicity," it was shown that GDA-601 displays superior antitumoral responses against multiple myeloma cells and represents a promising adoptive cell therapeutic strategy.
First Quarter 2022 Financial Results
Research and development expenses were $11.3 million in the first quarter of 2022, compared to $11.4 million in the same quarter in 2021. The decrease was primarily due to a $1.1 million decrease in omidubicel and GDA 201 clinical study activities, offset by an increase of $1.0 million in broadening the company’s scientific capabilities and talent.
Commercial expenses were $3.9 million in the first quarter of 2022, compared to $4.2 million in the first quarter of 2021. The decrease was attributable mainly to reducing the company’s near-term commercial readiness expenses, as it is assessing alternatives for the commercialization of omidubicel, including potential U.S. or global partnerships.
General and administrative expenses were $4.1 million in the first quarter of 2022, compared to $3.5 million in the same period in 2021. The increase was mainly due to a $0.5 million increase in headcount and related expenses.
Finance expenses, net, were $0.9 million in the first quarter of 2022, compared to $0.1 million in the same period in 2021. The increase was primarily due to a $0.6 million increase in interest expenses from convertible notes.
Net loss was $20.2 million in the first quarter of 2022, compared to a net loss of $19.2 million in the first quarter of 2021.
2022 Financial Guidance
Gamida Cell expects that its current cash and cash equivalents will support the company’s ongoing operating activities into mid 2023. This cash runaway guidance is based on the company’s current operational plans and excludes any additional funding and any business development activities that may be undertaken.
Expected Milestones in 2022
Omidubicel
Completion of full BLA submission to the FDA in the second quarter of 2022
GDA-201
Initiation of a company-sponsored Phase 1/2 clinical study with the cryopreserved formulation in follicular and diffuse large B-cell lymphomas
NK cell pipeline expansion
Conduct preclinical proof of concept studies of the NAM-enabled, genetically modified NK therapeutic targets
Select pipeline candidate for IND-enabling studies
Conference Call Information
Gamida Cell will host a conference call today, May 10, 2022, at 8:00 a.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 3344029. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.
About Omidubicel
Omidubicel is an advanced cell therapy candidate under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel is the first stem cell transplant donor source 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 stem cell transplant. The Phase 3 study also achieved its secondary endpoints of reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. Gamida Cell initiated a rolling BLA submission for omidubicel in the first quarter of 2022 with full BLA submission on track for the second quarter of 2022. In 2019, approximately 8,000 patients who were 12 years old and up with hematologic malignancies underwent an allogeneic stem cell transplant. Unfortunately it is estimated that another 1,200 patients were eligible for transplant but could not find a donor source. Omidubicel has the opportunity, upon FDA approval to improve outcomes for patients based on transplanter feedback and increase access for patients to get to transplant. Omidubicel has the potential to treat approximately 2000 – 2500 patients each year in the U.S. 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 candidate 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. There are approximately 40,000 patients with relapsed/refractory lymphoma in the E.U.5 and U.S. which is the patient population that will be studied in the GDA-201 Phase 1/2 clinical trial.
For more information about GDA-201, please visit https://www.gamida-cell.com. For more information on the Phase 1/2 clinical trial of GDA-201, please visit www.clinicaltrials.gov.
GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
About NAM Technology
Our NAM-enabling technology, supported by positive Phase 3 data, is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (Nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.
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 Gamida Cell’s product candidates (including GDA-201 and 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 10-K, filed with the Securities and Exchange Commission (SEC) on March 24, 2022, 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.
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
U.S. dollars in thousands (except share and per share data)
March 31,
December 31,
2022
2021
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
42,057
$
55,892
Marketable securities
27,661
40,034
Prepaid expenses and other current assets
2,994
2,688
Total current assets
72,712
98,614
NON-CURRENT ASSETS:
Restricted deposits
3,893
3,961
Property, plant and equipment, net
37,533
35,180
Operating lease right-of-use assets
6,722
7,236
Severance pay fund
2,046
2,148
Other long-term assets
1,632
1,647
Total non-current assets
51,826
50,172
Total assets
$
124,538
$
148,786
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
U.S. dollars in thousands (except share and per share data)
March 31,
December 31,
2022
2021
LIABILITIES AND SHARHOLDERS' EQUITY
CURRENT LIABILITIES:
Trade payables
$
4,346
$
8,272
Employees and payroll accruals
4,119
4,957
Operating lease liabilities
2,596
2,699
Accrued interest of convertible senior notes
551
1,640
Accrued expenses and other current liabilities
8,866
7,865
Total current liabilities
20,478
25,433
NON-CURRENT LIABILITIES:
Convertible senior notes, net
71,607
71,417
Accrued severance pay
2,327
2,396
Long-term operating lease liabilities
5,142
5,603
Total non-current liabilities
79,076
79,416
CONTINGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS' EQUITY:
Share capital -
169
169
*
-
Additional paid-in capital
382,495
381,225
Accumulated deficit
(357,680)
(337,457)
Total shareholders' equity
24,984
43,937
Total liabilities and shareholders' equity
$
124,538
$
148,786
* Represents an amount lower than $1.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
U.S. dollars in thousands (except share and per share data)
Three months ended
March 31,
2022
2021
Research and development expenses, net
$
11,305
$
11,360
Commercial expenses
3,879
4,231
General and administrative expenses
4,139
3,513
Total operating loss
19,323
19,104
Financial expenses, net
900
82
Loss
20,223
19,186
Net loss per share attributable to ordinary shareholders, basic and diluted
$
0.34
$
0.32
Weighted average number of shares used in computing net loss per share
attributable to ordinary shareholders, basic and diluted
59,474,366
59,122,973
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
U.S. dollars in thousands (except share and per share data)
Three months ended
March 31,
2022
2021
Cash flows from operating activities:
Loss
$
(20,223)
$
(19,186)
Adjustments to reconcile loss to net cash used in operating activities:
Depreciation of property, plant and equipment
112
98
Financing expense (income), net
(1,172)
220
Share-based compensation
1,194
913
Amortization of issuance costs
191
323
Operating lease right-of-use assets
562
516
Operating lease liabilities
(613)
(929)
Accrued severance pay, net
33
-
Increase in prepaid expenses and other assets
(889)
(515)
Increase (decrease) in trade payables
(3,927)
907
Decrease in accrued expenses and current liabilities
(996)
(3,192)
Net cash used in operating activities
(25,728)
(20,845)
Cash flows from investing activities:
Purchase of property, plant and equipment
(723)
(2,806)
Purchase of marketable securities
(2,086)
-
Proceeds from maturity of marketable securities
14,126
-
Proceeds from restricted deposits
500
-
Net cash provided by (used in) investing activities
$
11,817
$
(2,806)
Cash flows from financing activities:
Proceeds from exercise of options
76
502
Proceeds from issuance of convertible senior notes, net
-
70,777
Net cash provided by financing activities
76
71,279
Increase (decrease) in cash and cash equivalents
(13,835)
47,628
Cash and cash equivalents at beginning of period
55,892
127,170
Cash and cash equivalents at end of period
$ 42,057
$ 174,798
View source version on businesswire.com: https://www.businesswire.com/news/home/20220510005438/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
Gamida Cell Presents New Data from NAM-Enabled Genetically Modified Natural Killer (NK) Pipeline at International Society for Cell & Gene Therapy 2022
https://finance.yahoo.com/news/gamida-cell-presents-data-nam-110000072.html
Poster selected for inclusion in conference’s Elevator Pitch Session: GDA-301 produces enhanced potency and persistence with combined genetic manipulation of CISH gene editing and the engineered expression of membrane-bound IL-15 for targeting hematologic malignancies and solid tumors
GDA-601 generates promising immunotherapeutic potential to target multiple myeloma cells
Company plans to select a genetically modified NK cell therapy candidate for IND enabling study by the end of 2022
BOSTON, May 05, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with solid and hematological cancers and other serious diseases, today will share preclinical data at the International Society for Cell & Gene Therapy (ISCT) 2022, being held in San Francisco, CA, May 4-7, 2022 on GDA-301 and GDA-601, two product candidates in the Company’s NAM-enabled genetically modified natural killer (NK) pipeline.
"The preclinical data generated from our expanding pipeline of NAM-enabled cell therapies is already showing signs of meaningful potential as a future approach to fighting cancer," said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell. "With evidence of enhanced cytotoxicity demonstrated across hematologic cancers and solid tumors with these diverse, genetically modified NK cell immunotherapy programs, we look forward to continuing our progress toward opening new frontiers in cancer immunotherapy."
GDA-301 is an investigational genetically modified NAM-NK cell therapy candidate aimed at targeting hematologic malignancies and solid tumors. The poster (#501), titled "GDA-301: Engineered NAM-NK Cells via CISH Knockout and Membrane-Bound IL-15 Expression Increases Cytotoxicity Against Malignancies," demonstrated that after six hours of co-culture with a chronic myelogenous leukemia (K562) or multiple myeloma (RPMI) cell line, GDA-301, a combined genetic manipulation of CISH gene editing and the engineered expression of mb IL-15, showed increased cytotoxicity compared with control NAM-NK cells. Additional in vitro assays showed elevation of degranulation marker CD107a, and intracellular proinflammatory cytokines interferon-? and tumor necrosis factor-a, suggesting increased potency of GDA-301 compared with control. The potency and cytotoxicity data suggest that GDA-301 represents a novel potential immunotherapeutic targeting hematologic malignancies as well as solid tumors.
The poster on GDA-301 was selected for presentation at the conference’s Elevator Pitch Session 2 on Thursday, May 5, 2022 at 6:00 p.m. EST/3:00 p.m. PST – 7:00 p.m. EST/4:00 p.m. PST.
GDA-301 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
GDA-601 is an investigational genetically engineered NAM-NK cell therapy candidate designed to target multiple myeloma (MM) cells. The poster (#517), titled "GDA-601: NAM-NK Cells With CD38 Knockout Expresses Enhanced CD38 Chimeric Antigen Receptor and Targets Multiple Myeloma Cells With Increased Cytotoxicity," showed that in vitro killing assays performed six hours after co-culture of GDA-601 with a MM (RPMI) cell line showed increased cytotoxicity compared with control NAM-NK cells. Fratricide attributable to CD38 antigen was effectively eliminated with GDA-601. There was a significant enhancement of potency against CD38-positive MM cells demonstrated by elevation of the degranulation marker CD107a and intracellular proinflammatory cytokines interferon-? and tumor necrosis factor-a in vitro. These results suggest that GDA-601 displays superior antitumoral responses against MM cells and represent a promising adoptive cell therapeutic strategy against MM.
Both posters will be presented on Thursday, May 5, 2022 at Poster Session 2, at 5:45 p.m. EST/2:45 p.m. PST – 7:15 p.m. EST/4:15 p.m. PST.
GDA-601 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
For more information, please visit isctglobal.org.
About NAM Technology
Our NAM-enabling technology, supported by positive Phase 3 data, is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (Nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.
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 candidate 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 and the potentially life-saving or curative therapeutic and commercial potential of omidubicel. 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 10-K, filed with the Securities and Exchange Commission (SEC) on March 24, 2022, 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/20220505005255/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
PR Newswire
Gamida Cell Announces the Date of Its First Quarter 2022 Financial Results and Webcast
https://finance.yahoo.com/news/gamida-cell-announces-date-first-120000108.html
BOSTON, May 03, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced that the company will host a conference call and live audio webcast on Tuesday, May 10, 2022, at 8:00 a.m. ET to review its first quarter 2022 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 3344029. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.
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 candidate 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.
Gamida Cell stock falls a day after soaring on FDA lifting clinical hold on GDA-201
Apr. 27, 2022 12:07 PM ETGamida Cell Ltd. (GMDA)
By: Anuron Mitra, SA News Editor
Shares of Gamida Cell (NASDAQ:GMDA) have fallen 8% to $2.48 in morning trade on Wednesday, a day after gaining as much as 16%.
GMDA on April 26 said the U.S. Food and Drug Administration (FDA) had cleared its new drug application and lifted the clinical hold for a cryopreserved formulation of GDA-201, the company's cell therapy candidate for the treatment of patients with follicular and diffuse large B cell lymphomas.
GMDA stock had soared 32% in Tuesday premarket trading on the announcement, and had risen as much as 16% to $3.27 in the opening 10 minutes of trade. However, it then gave up all the gains through the day and ended 4.6% lower as investors priced in the news.
Separately, on Wednesday, GMDA presented updated one-year post-transplant follow up data from a phase 3 study of its cell therapy omidubicel, which is under development as a potential stem cell transplant for patients with blood cancers.
The data showed sustained clinical benefits in the first-year post-transplant with omidubicel, as demonstrated by significant reduction in infectious complications.
The data also showed a reduction in non-relapse mortality and no significant increase in relapse rates with omidubicel vs. standard umbilical cord blood transplantation (UCBT).
The company said there was a continued trend toward improved overall survival in favor of the omidubicel arm (73%), compared to UCBT (60%) over time.
Gamida Cell (GMDA) concluded that HSCT with omidubicel results in rapid hematopoietic recovery, reduced rates of infections and no increase in GvHD rates compared to standard UCB.
GMDA presented the data at the 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings that was held from April 23-26.
In February, the company began a rolling submission of its biologics license application with the U.S. Food and Drug Administration for omidubicel.
Today's premarket activity indicates shorts
are playing their 'tricks'. Pedro was spot on!
Yesterday trade started at +35% ended -6%
May today be the exact opposite!
Gamida Cell Presents Updated One-Year Post-Transplant Follow Up Data from Phase 3 Study of Omidubicel at 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings
https://finance.yahoo.com/news/gamida-cell-presents-updated-one-110000904.html
Omidubicel is a first-in-class, advanced NAM-enabled stem cell therapy candidate with breakthrough and orphan drug designations being evaluated as the first potential allogeneic advanced cell therapy donor source for patients with blood cancers in need of a transplant
Updated data from oral presentation demonstrates overall survival trend due to early engraftment and lower infections with omidubicel
Concludes that HSCT with omidubicel results in rapid hematopoietic recovery, reduced rates of infections and no increase in GvHD rates compared with standard UCB
BOSTON, April 27, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with solid and hematological cancers and other serious diseases, today announced updated one-year post-transplant data presented on omidubicel at the 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings (TCT), being held in Salt Lake City, UT, April 23-26, 2022.
In an oral presentation titled "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," Mitchell Horwitz, M.D., Professor of Medicine, Duke Cancer Institute, shared one-year post-transplant follow up data from the omidubicel Phase 3 trial. The data showed sustained clinical benefits in the first-year post-transplant with omidubicel, as demonstrated by significant reduction in infectious complications. Results also showed reduction in non-relapse mortality and no significant increase in relapse rates with omidubicel, compared to UCBT (23% vs. 18%). It was concluded that HSCT with omidubicel results in rapid hematopoietic recovery, reduced rates of infections and no increase in GvHD rates compared with standard UCB. 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.
"In allo-HSCT, early engraftment and lower infections are the key predictors of long-term success for patients," said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell, "We are encouraged by the continuous positive and sustained results from patients involved in the Phase 3 trial of omidubicel, now one-year out from treatment. These results provide promising rationale that omidubicel could become a compelling treatment option for patients in need of an allo-HSCT transplant."
Gamida Cell initiated a rolling Biologics License Application (BLA) submission for omidubicel in the first quarter of 2022 and is on-track to complete submission of all modules of the BLA in the second quarter of 2022.
In total, Gamida Cell is presenting two oral and six poster presentations at TCT 2022, including an oral presentation that was selected as a TCT Best Abstract. All poster presentations are publicly available at www.ASTCT.org.
About Omidubicel
Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell transplant for patients with hematologic malignancies (blood cancers), for which it has been granted Breakthrough Status and orphan drug designation by the FDA. Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). For more information on clinical trials of omidubicel, please visit the Gamida Cell website.
Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
About NAM Technology
Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we are able to enhance, expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. This allows us to administer a therapeutic dose of cells that may help cancer patients live longer better lives.
About Gamida Cell
Gamida Cell is pioneering a proprietary NAM-enabled immunotherapy pipeline of diverse potentially curative cell therapies for patients with solid tumor and blood cancers and other serious blood diseases. We apply a proprietary 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 transplant, and a line of modified and unmodified NAM-enabled NK cells targeted at solid tumor and hematological malignancies. For additional information on Gamida Cell, 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 and the potentially life-saving or curative therapeutic and commercial potential of omidubicel. 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 10-K, filed with the Securities and Exchange Commission (SEC) on March 24, 2022, 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/20220427005019/en/
Contacts
For investors:
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Stern Investor Relations, Inc.
courtney.turiano@sternir.com
1-212-362-1200
For media:
Rhiannon Jeselonis
Ten Bridge Communications
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1-978-417-1946
Alliance Global Partners Thinks Gamida Cell’s Stock is Going to Recover
April 26 2022 - 08:46AM
In a report released yesterday, Matthew Cross from Alliance Global Partners maintained a Buy rating on Gamida Cell (GMDA – Research Report), with a price target of $11.00.
BIOS ended even worse:
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Bios take a blow, GMDA included in spite
of its (relative) good news today.
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