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Thank you. I appreciate the guidance. Will be fascinating to see how this all plays out. I may add here to my original position ($2.68).
I am quite sure that once PDUFA action
date fetches positve outcomes, the
offering will immediately take place.
Thank you sir for sharing. Do you and others here believe raising more capital will take place before or after the pending PDUFA target action date coming in May?
TIA
Naturally the offering is already in the works (sigh)
Although not immediate!
In retrospect it was a mistake letting Lonza
do the manufacturing for Gamida.
This was one of the reasons for the FDA delay
in the approval.
Too bad Gamida has had to pay this substantial
amount for the vreach of contract, the positive
point is that the burden is off their shoulders,
and it seems the road to FDA final approval in
coming May is paved smooth.
Is that good or bad, beyond the fact they have to pay $ to get out this deal?
Murocman
Item 8.01 Other Events.
As previously reported in its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2022, Gamida Cell Ltd. (the “Company”) was previously engaged in discussions with Lonza Netherlands B.V. (“Lonza”) to terminate that certain Manufacturing Services Agreement, dated as of June 10, 2019 (the “Manufacturing Agreement”), with Lonza for the manufacture of omidubicel. On December 29, 2022, the Company entered into a settlement agreement (the “Settlement Agreement”) with Lonza pursuant to which the Company agreed to pay an aggregate amount of €8,000,000 to Lonza in a series of installments, with the first installment of €1,500,000 paid prior to December 31, 2022 and the final installment payment to be paid no later than September 30, 2024. In connection with these payments, Lonza and the Company agreed to terminate the Manufacturing Agreement and to a mutual release of any claims arising out of the Manufacturing Agreement.
Article published in Hebrew and Google auto-translated:
Gamida Sel: to improve the chances of success in bone marrow transplantation
Year of establishment: 1998
CEO: Abigail Jenkins
Field of activity: improvement of bone marrow transplants in cancer patients
Market value: 90 million dollars
Gamida Sel has developed a product designed to improve the success of umbilical cord blood transplantation in the treatment of blood cancer. In a clinical trial, the company showed that its product shortens the time needed to absorb the transplanted immune system from 22 days to 12. This is a significant reduction, since this time is expensive for the transplant center and dangerous for the patient who is without an active immune system. The company's trial also showed a decrease in the number of infections experienced by the patients and a shortening of the hospitalization period.
The company estimates that the product will capture additional market shares for those who are candidates for umbilical cord blood transplantation anyway: transplants from a matched adult donor, from a non-matched donor, and also audiences who currently do not receive any treatment because no donor can be found for them (mainly the African-American community).
A market survey conducted by the company showed that the doctors believe that the product can shorten the treatment time compared to a donation from a matched source and save on side effects compared to a donation from a non-matched source. Comparing the company's trial results to real-world data, it appears that compared to a matched donor, Gamida Sel's implant was absorbed faster.
The original date for FDA approval was January 30, but after the documents were submitted, he asked for more information. Investors responded by lowering the stock by 20% from the date of the postponement until today. However, it is generally better to request additional information before the final approval date than after.
Gamida Sel is preparing to market its products by itself, and although it has more intriguing products in the pipeline, it is currently devoting most of its resources to this move. It even had to cut back on personnel when the date scheduled to receive the FDA's answer was postponed. The company's advantage and disadvantage is the small market. She believes that the product can be relevant to about 10,000 patients a year, in 70 medical centers, which can be covered with the help of about 25 sales people. 19 of these centers have already experienced the product as part of clinical trials, or as part of a program for pre-approval treatment in humanitarian cases - a program that is considered a positive sign of approval.
To reach a reasonable market potential, the company will have to price its product expensively. Will the insurance companies accept high pricing? Her card against them is the savings in hospitalization time and complications. In any case, receiving the indemnity may take a long time, and the company will have to prepare itself to finance some of the procedures at the beginning to help the product gain momentum.
Gamida Sel intends to manufacture its product in a factory in Jerusalem. This is a relatively complex production, and the company will have to make sure that it is economical for them.
I would agree with Midas.
First that the Science is good.
Second, I very much doubt a buy-out is in the works.
a. They just raised money to be more than comfortable to get past the postponed PDUFA date. The FDA requested data doesn't seem to have been anything untoward, but will require more time for review.
b. PDUFA coming up in 4.5 months with a relatively simple go-to-market strategy and it seems payers and co-pay system are already on board.
Thus it would make no sense at all to sell-out before at least brining in revenue over the course of at least 1-2 years on the market. Assuming all goes well that is.
Gamida Cell Announces Closing of $25 Million Financing With Highbridge
https://finance.yahoo.com/news/gamida-cell-announces-closing-25-120000727.html
BOSTON, December 12, 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, announced the closing of a senior secured convertible term loan of $25 million with certain funds managed by Highbridge Capital Management, LLC (collectively, "Highbridge"). Pursuant to the loan agreement, Gamida Cell’s wholly-owned subsidiary, as borrower, will draw down $25 million from the facility with a maturity date of December 12, 2024.
The proceeds from the term loan, together with the net proceeds from Gamida Cell’s $20 million public offering of ordinary shares announced on September 27, 2022 and its existing cash and cash equivalents and trading financial assets, are expected to (i) fund commercial readiness and initial launch activities to support launch of omidubicel, if approved; (ii) fund the continued development of its NK product pipeline, including clinical stage asset GDA-201; and (iii) be used for general corporate purposes, including general and administrative expenses and working capital.
"We are pleased to secure additional capital from an existing investor as we continue to prepare for the launch of omidubicel, which is pending FDA review. Omidubicel has the potential to address the unmet need for patients with hematologic malignancies in need of an allogeneic hematopoietic stem cell transplant," said Abbey Jenkins, CEO of Gamida Cell. "As we anticipate our shift from clinical to commercial stage, we are now in a stronger financial position to prepare for launch while continuing development of our promising NK pipeline, including our clinical stage asset GDA-201."
The term loan was made at 97% of the principal amount thereof, constitutes a senior secured obligation of Gamida Cell and its wholly owned subsidiaries and will accrue interest at an annual rate of 7.5% per year The facility, which has a maturity of December 12, 2024, calls for interest only payments for the first four months and principal and interest payments amortized over the remaining term. Installment payments may be payable in cash or in ordinary shares subject to certain conditions. Subject to certain limitations, the term loan may be exchanged into Gamida Cell’s ordinary shares, in certain cases at the option of Highbridge and in others at the option of Gamida Cell, at an initial exchange rate of 0.52356 ordinary shares per $1.00 principal amount of notes (equivalent to an exchange price of $1.91 per ordinary share).
"We have been encouraged by Gamida’s milestone achievements this year, including BLA acceptance with Priority Review," commented Jonathan Segal, Co-Chief Investment Officer of Highbridge Capital Management. "We look forward to continuing to work collaboratively with Gamida Cell’s management team and board."
Gamida Cell may prepay all but not less than all of the term loan for cash, at its option, at 100% of the principal amount, plus a make whole amount comprised of all accrued and unpaid and remaining coupons due through the maturity date and a prepayment premium of 5% on the principal amount to be prepaid.
Does that explain the struggling SP? I am not an avid follower of all news GMDA but if you could share some insight, I would appreciate it.
I am sure NOT or rather i should say
i hope NOT
My exremely humble opinion.
In short i would say GMDAs science is good,
management is by far less.
With this current Enterprise value (EV) of ~$95 Million, does anyone following this company think they could be purchased for a ridiculous amount? TIA for anyones opinion.
Gamida Cell to Present Corporate Highlights at Multiple Upcoming Investor Conferences
https://finance.yahoo.com/news/gamida-cell-present-corporate-highlights-130000624.html
BOSTON, November 23, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, today announced that members of the management team will present at the following upcoming investor conferences:
34th Annual Piper Sandler Healthcare Conference, November 29, 2022 with a fireside chat at 1:00 p.m. ET.
Evercore ISI Healthcare Conference, December 1, 2022 with a fireside chat at 2:15 p.m. ET.
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.
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.
The BLA for omidubicel has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 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 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 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.
Gamida Cell Provides Regulatory Update on Omidubicel
https://finance.yahoo.com/news/gamida-cell-provides-regulatory-omidubicel-215200687.html
Recent company submission in response to FDA request extends PDUFA date by three months
BOSTON, November 21, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematological and solid cancers and other serious diseases, today provided an update on recent interactions with the U.S. Food and Drug Administration (FDA) relating to the company’s Biologics License Application (BLA) for omidubicel, the company’s advanced cell therapy candidate for allogeneic hematopoietic stem cell transplant.
As part of its ongoing BLA review, FDA issued an information request and viewed the data in the response as a major amendment, resulting in an extension of the omidubicel Prescription Drug User Fee Act (PDUFA) date from January 30, 2023 to May 1, 2023. The agency also rescheduled Gamida Cell’s late-cycle meeting to the first quarter of 2023.
The data FDA requested were laboratory results for intermediate time points for patients enrolled in the Phase 3 study. These additional data provided by Gamida Cell to FDA are consistent with prior data submissions.
"We appreciate the FDA’s collaboration as they conduct their review of omidubicel," said Abigail "Abbey" Jenkins, Gamida Cell’s President and Chief Executive Officer. "If approved, omidubicel will be the first and only advanced cell therapy for patients with blood cancer in need of an allogeneic stem cell transplant. We are committed to bringing this potentially transformative therapy forward as quickly as possible."
Gamida Cell Ltd. (GMDA)Q3 2022 Earnings Call Transcript
Nov. 14, 2022 11:08 AM ETGamida Cell Ltd. (GMDA)
Gamida Cell Ltd. (NASDAQ:GMDA) Q3 2022 Results
Conference Call November 14, 2022 8:00 AM ET
Company Participants
Heather DiVecchia - Director of IR & Corporate Communications
Abigail Jenkins - President & CEO
Ronit Simantov - CMO & Chief Scientific Officer
Michele Korfin - COO & Chief Commercial Officer
Shai Lankry - CFO
Conference Call Participants
Edward Tenthoff - Piper Sandler
Jonathan Miller - Evercore ISI
Gilbert Blum - Needham
Mark Breidenbach - Oppenheimer
Operator
Ladies and gentlemen, thank you for standing by. Welcome to Gamida Cell's Conference Call for the Third Quarter 2022 Financial Results. My name is Shannon, 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
Thank you, Shannon, and good morning, everyone. Welcome to today's call during which we will provide an update on the company and review our financial results for the third quarter of 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.gamidacell.com. So with me on our call today are Abi Jenkins, President and Chief Executive Officer; Ronit Simantov, Chief Medical Officer and Scientific Officer; Michele Korfin, Chief Operating Officer and Chief Commercial Officer; and Shai Lankry, Chief Financial Officer.
Now, I would like to turn the call over to our recently appointed President and CEO, Abi Jenkins.
Abigail Jenkins
Thank you, Heather, and thanks to everyone for joining us this morning. It is an exhilarating time for Gamida Cell as we mark another quarter of meaningful progress and prepare to shift from clinical to commercial stage with the potential approval of our transformative stem cell therapy candidate, omidubicel. I would like to start off by saying how excited I am to speak with everyone today on my first earnings call as Gamida Cell's President and CEO, a role that I assumed in September. I was drawn to Gamida Cell for three reasons: the mission, the science and the team. I've worked to bring innovative therapies with the promise of addressing diseases of high unmet need for over 25 years. While many of those products made an impact through treatment or disease prevention, none have the potential to be truly curative.
Our mission of developing curative therapies for people with cancer or other serious diseases is incredibly inspiring, and is made possible because of our remarkable science. Our NAM technology, both increases the number of stem cells and immune cells and enhances their functionality, enabling us to create potentially transformative cell therapies that go beyond what is possible with the existing approaches. NAM is the power behind omidubicel, our lead product candidate which has breakthrough status and is currently under priority review with the FDA with a PDUFA date of January 30, 2023.
Omidubicel has the potential to transform the treatment landscape for patients in need of a stem cell transplant. Our Phase III clinical data demonstrate omidubicel significantly reduced the time to neutrophil engraftment from 22 to 12 days versus standard cord blood transplant. Neutrophil engraftment is a key predictor of patient outcomes. Earlier this month, we further showed that in real world data, omidubicel produced the shortest median time for neutrophil engraftment of any hematopoietic stem cell transplant option, including that as a match related donor source. Omidubicel achieved neutrophil engraftment in 10 days as compared with 15 to 20 days for other donor sources. We believe that omidubicel offers a meaningful new transplant option as the data support the neutrophil engraftment occurs rapidly and historical, maintaining an effect for up to 10 years based on clinical studies.
In addition, omidubicel reduces total days hospitalized post-transplant, which improves outcomes while reducing costs to the healthcare system. If approved, omidubicel will be the first FDA approved allogeneic hematopoietic stem cell therapy to address an expanding unmet need for patients with blood cancers in need of a stem cell transplant. NAM is also the power behind our pipeline of allogeneic NK cell therapies, including our clinical stage therapy GDA-201. Ronit will be going into more details in this regard following my remarks.
Speaking of and bringing us to the third reason I was drawn to Gamida Cell, the team. The advancement of our NAM enabled cell therapies is possible as a result of our talented team of experienced leaders like Ronit and Michelle, who have successfully developed and launched multiple life enhancing treatments in hematology and oncology, including cell therapies. We have many experienced and talented team members across Gamida Cell discovering, developing and preparing to deliver our advanced cell therapies to patients in need.
Let's turn now to Q3 results. This was an important quarter marked by continued progress towards larger inflection points. Our BLA for omidubicel was accepted by the FDA and granted priority review. Beyond omidubicel, we progressed our Phase I/II clinical study evaluating a cryopreserved readily available formulation of GDA-201, our lead NAM enabled NK cell therapy for the treatment of follicular and diffuse large B-cell lymphomas. GDA-201 holds tremendous promise and we look forward to its continued progression in the clinic.
Beyond GDA-201, we continue to be excited by our NK pipeline of cell therapy candidates and we believe our NAM technology increases targeting, potency and persistence of a broad range of innate and adaptive cell types, including NK cells. However, we are going to hold on selecting the next IND candidate from the NK pipeline at this time to both prioritize resources to the commercialization of omidubicel and advancement of GDA-201, as well as enable development activities on these candidates to further progress.
Next, we highlighted promising preclinical and clinical results across our pipeline at multiple medical and scientific meetings, including Cord Blood Connect, the Society of Hematologic Oncology and the Society for Immunotherapies of Cancer. Additionally, we strengthened our financial position with a public offering in September 2022 raising $20 million, as well as obtaining a commitment letter for Highbridge Capital for a $25 million senior secured convertible term loan. With this capital raise and with our FDA review of omidubicel progressing on track, we are accelerating into launch mode. Michelle will provide more details on this very important initiative later on the call.
I believe Gamida Cell is a company that is poised for long term success. And I want to thank my predecessor, Julian Adams, for his vision and leadership in bringing the company to where it is today. Julian leaves us an incredible legacy scientific innovation, which enabled us to develop assets like omidubicel and GDA-201. We are grateful to continue to benefit from his guidance on our Board of Directors and wish him well in his retirement.
I would also like to take an opportunity to commend my new colleagues, I am continually inspired by your teamwork and dedication with our important work every day and that you're putting patients first in all we do as we advance on our mission. Additionally, I would like to sincerely thank all of the clinical trial sites and the patients and their families that have been such important partners as we advance our pipeline of NAM enabled cell therapies. We believe we have truly transformative therapy with on -- a truly transformative NAM therapy with omidubicel and we are motivated every day by the meaningful impact it can have on patients' lives.
With that, I will now turn the call over to Ronit, to take us through key data supporting our NAM enabled cell therapies. Ronit?
Ronit Simantov
Thank you, Abi, and good morning, everyone. Thank you for joining us on our call. This morning, I will review our clinical data on omidubicel, provide an update on long term follow-up, quality of life and immune reconstitution data presented over this past quarter and preview our upcoming real world data presentation. I will then discuss our GDA-201 study and the rest of our pipeline.
As we eagerly approach our PDUFA date of January 30, 2023, we continue to add to the body of scientific and clinical evidence demonstrating the potential of omidubicel to address unmet needs in patients undergoing allogeneic stem cell transplant. Most relevant to our regulatory submission is our successful Phase III global randomized study, which met its primary and all secondary endpoints. The study was comprised of 125 patients ages 12 to 65 with high risk hematologic malignancies who are in need of an 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 compared to 22 days for the comparative group transplanted with standard cord blood. These results were not only statistically significant, but also highly clinically significant, as neutrophil engraftment is a key milestone in recovery of patients undergoing stem cell transplant.
This quarter, we presented long term follow-up data from the omidubicel clinical program at the Society of Hematologic Oncology or SOHO meeting, supporting the durable clinical benefit of omidubicel in the years after transplant. These data included follow-up of 105 patients transplanted with omidubicel in our Phase I, II and III studies between 2006 and 2022. The data demonstrated three year overall survival and disease free survival of 63% and 56%, respectively. Moreover, follow-up data of up to 10 years showed durable production of blood cells and immune cells, indicating sustained long term recovery of the bone marrow in patients transplanted with omidubicel.
Patient health related quality of life data from our Phase III study were also presented at the SOHO meeting, and recently published in the Journal Transplantation and Cellular Therapy, the official publication of the American Society for Transplantation and Cellular Therapy. In an analysis of 108 patients who completed validated health related quality of life surveys at screening and through the first year after transplant, measures of physical and functional well-being, as well as other health related quality of life scores were more favorable for omidubicel and with control. These data suggest clinically meaningful and continual improvements in the physical, functional and overall well-being of patients treated with omidubicel.
Prior to SOHO, we presented translational data at the Cord Blood Connect meeting in September, demonstrating recovery of immune cell in patients treated with omidubicel. In an analysis of the T-cell recovery in a subset of 37 patients from the Phase III trial, patients transplanted with omidubicel had more rapid, robust and diverse immune cell reconstitution, including higher numbers of recent thyme mammograms in the blood at one year post transplant compared to patients transplanted with standard cord blood. These immune constitution data may provide mechanistic support for the observation that patients translated with omidubicel have lower rates of bacterial and viral infections after transplant.
While our Phase III data compared omidubicel to standard cord blood, now in collaboration with the Center for International Blood and Marrow Transplant Research or CIBMTR we have explored the effectiveness of omidubicel compared to other allogeneic transplant donor sources used in clinical practice. As recently announced, these data have been accepted as a podium presentation at the Annual Meeting of the American Society of Hematology or ASH meeting. We compared results from 52 patients who received omidubicel in our Phase III clinical trial with results from 807 patients in the CIBMTR database with similar demographic and clinical characteristics who are transplanted with other donor sources, including matched unrelated, mismatched unrelated and haploidentical donors.
Our data show that omidubicel was associated with significantly more rapid neutrophil recovery and importantly, other outcomes, including graft versus host disease, relapsed and overall survival were comparable across donor sources. These real world data are the first to demonstrate the comparative efficacy of omidubicel to donor sources beyond standard cord. The abstract has been posted on the ASH website and the data will be shared at ASH in December. The new data presented this quarter continues to support the clinical benefit and safety of omidubicel and give us confidence as we prepare to bring this potential therapy to patients following FDA approval.
Before turning to Michelle, who will provide an update on our plans to launch omidubicel in the U.S. market upon potential FDA approval, I would like to give you an update on GDA-201, our lead product candidates in our NK cell therapy pipeline. GDA-201 leverages our proprietary NAM technology in the expansion of NK cells to enhance functionality, tumor cell killing properties and Antibody Dependent Cellular Cytotoxicity or ADCC. 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 and two year survival of 78% in heavily pretreated patients with non-Hodgkin lymphoma. Despite the recent advances in the development of therapy for patients with non-Hodgkin lymphoma, we continue to hear from experts that there is a high unmet need among patients who have active disease after treatment.
Our company sponsored Phase I/II clinical study evaluating the prior preserved formulation of GDA-201 is progressing on track and we are continuing to enroll patients in the Phase I dose escalation portion of the study. The study includes patients who have relapsed or refractory lymphoma after at least two prior treatments, which may include CAR-T cell therapy or stem cell transplant. Phase I includes patients with follicular diffuse large B-cell, marginal zone and mantle cell lymphoma histology. The Phase I portion of the study is designed to evaluate the safety of increasing doses of GDA-201 with dosing similar to that in the previous investigator led study. Up to four dose levels will be tested to determine the maximum tolerated dose and recommended Phase II dose, based on dose limiting toxicities.
The Phase II expansion portion of the study is designed to evaluate the safety and efficacy of GDA-201 in two separate patient cohorts of approximately 30 patients each with follicular lymphoma and diffuse large B-cell lymphoma. The Phase I is currently ongoing and we're looking forward to continuing to progress 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. Our novel product candidates leverage CAR and CRISPR mediated technologies 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. This quarter, we announced new preclinical data supporting GDA-501 at the SITC meeting. In a poster presentation, GDA-501, a HER2-CAR NAM-NK cell displayed significantly enhanced in vitro cytotoxicity when cultured with HER2 positive cancer cells. Further, GDA-501 showed increased potency based on biomarkers and elevated level of proinflammatory cytokine compared with control cells. Importantly, increased cytotoxicity and potency were persistent. These preclinical data demonstrated potent antitumor activity of GDA-501 and support its therapeutic potential as a novel cell therapy against HER2 positive cancers.
With that, I will turn the call over to Michelle who will talk more about omidubicel and our advancements in manufacturing and our commercialization plans. Michelle?
Michele Korfin
Thank you, Ronit, and good morning, everyone. I would like to reiterate how excited we are to be in this position as we are poised to bring our first NAM enabled cell therapy, omidubicel, to the U.S. market, which if approved will be the first and only FDA approved allogeneic hematopoietic stem cell therapy for patients with blood cancers in need of a stem cell transplant.
The potential clinical benefit of omidubicel continues to be supported by a growing body of data that has been reported in blood for our Phase III data and in well recognized medical meetings. Based on these data, we have heard consistent positive feedback from transplanters focused on our clinical outcomes, including rapid time to neutrophil engraftment, durability of response and quality of life for their patients. As we approach the January 30, 2023 PDUFA date for omidubicel, we continue to work toward our goal of maximizing a positive patient and transplant center experience when using omidubicel as the donor source of choice.
As Ronit reviewed, the data that will be presented at ASH, in addition to extensive market insight feedback, transplanters can consider omidubicel not just as an alternative to standard cord blood, but as an alternative to all other donor sources. Upon approval, we are ready to deliver omidubicel to transplant centers. We will work closely with transplant centers to make sure they have the necessary procedures and logistics in place to deliver a cell therapy like omidubicel to patients in need. Importantly, we continue to hear positive feedback from payers, recognizing the meaningful impact of omidubicel for patients potentially setting us up for well-defined paths for coverage and reimbursement.
I am proud of all the work we have completed thus far to define the unmet need that omidubicel could address and have a clear launch strategy and a well-defined launch plan. As a result of the successful financing this past quarter, we are now in a position to continue building out a specialized and integrated organization in preparation for a launch following potential FDA approval. This integrated team, including commercial, medical affairs, quality and operations is focused on ensuring that we are ready to provide patients with access at the time of launch and we have now moved to launch execution.
During 2023, we will be primarily focused on ramping up transplant centers throughout the U.S. As we have discussed, this will be a targeted launch as we know 70 transplant centers make up approximately 80% of the transplants. This part of the launch execution for omidubicel will be critical to ensure a positive patient experience and includes important programs such as education and training sessions and process and logistics review. Although omidubicel has a less stringent matching criteria than other sources, there is still a matching requirement. So we need to work with centers to assure appropriate chain of identity and chain of custody. In addition, at time of potential FDA approval, we will have a patient support system in place to facilitate access.
Now I would like to share with you some of our market research that drives our strategy and plans of action. As a result of extensive market insight studies, we have determined two critical differentiators that can position omidubicel as a treatment of choice for transplanters and their patients. The first is driven by clinical studies and transplant experience that leads hundreds of transplanters and market insight studies to indicate that they feel omidubicel delivers better outcomes compared to other donor sources. And second, the benefit of omidubicel increasing access so patients have broader access to transplant.
Let me start with improving outcomes. Improved outcome results in capturing share from current donor sources. We have learned from our extensive insights that omidubicel has the potential to capture share from all donor sources. From a donor source distribution, we know that matched unrelated donor shares approximately 45%, haploidentical approximately 22%, match related donor approximately 22%, mismatched unrelated donor approximately 7% and cord blood about 5%. Insights support share capture across all donor sources.
Starting with matched unrelated donors in the United States, the key unmet need that omidubicel will address is time. It takes on average about two to three months to align an unrelated donor to the patient. That puts the patient at risk for relapse and then not being able to proceed to transplant. Omidubicel has consistently been delivered back to the transplant center in about 30 days. So this is a key aspect that would lead a transplanter to choose omidubicel over an unrelated donor. For haploidentical donors, this is a family member that is a 50% match. The challenges that omidubicel can address involve patient outcomes. Due to the partial match, hepar identical donor results in a delayed time to neutrophil engraftment, on average about 18 days according to published literature, as well as an increased risk of infection and graft versus host disease or GVHD.
Although post-transplant cyclophosphamide is used to mitigate GVHD, that also introduces risk for the patient, especially due to cyclophosphamide's cardiotoxicity. omidubicel's rapid time to neutrophil engraftment of 10 days and encouraging out comes for infection rates and GVHD lead transplanters to indicate they see a benefit from omidubicel over haploidentical, which would allow for greater access.
Naturally the donor challenges focus on donor age. The average age of diagnosis for an adult leukemia patient is about 60 years of age. Chances are your sibling who could be your match related donor who would also be in their 50s, 60s or 70s. Published clinical data supports the older the donor the worse the patient outcomes are. Omidubicel with our starting material being cord blood, prior to the expansion enhancement of our manufacturing does not have an age concern since our starting material comes from a newborn. A mismatch unrelated donor poses two concerns for transplanter. The partial match leads to suboptimal outcomes and the concern around the two to three months on average to align the patient in the donor. Mismatched unrelated donors have on average about 17 days for neutrophil engraftment. And again, the omidubicel clinical data and 30 day turnaround positions omidubicel to take market share from mismatch unrelated donor sources.
And finally cord blood, based on the statistically significant results from our pivotal Phase III study, transplanters anticipate a strong share capture for omidubicel. Moving to increased access, it is estimated in the United States that there's approximately 1,200 patients 12 years of age and older with hematologic malignancies that are eligible for transplant, but cannot find an appropriate donor. Unfortunately, there's health disparities. If you are non-Caucasian and you do not have access to family members for a donor source, it is incredibly difficult to find a match in the public database.
For example, a patient who is black has less than a 20% chance of finding a donor source in a public database. Because of omidubicel's less stringent matching criteria, we can match a diversity of patients quickly. Our Phase III demographics supported that with 40% of the patients being non-Caucasian. Most oncology clinical trials are probably under 10% of non-Caucasian patients. With the combination of improving outcomes, which means capturing share from other donor sources and increasing access, upon reaching peak market share, omidubicel has the potential to capture 20% to 25% of the addressable patient population which would equate to 2,000 to 2,500 patients per year in the United States.
In turn of launch readiness, the leadership of our commercial, medical affairs and operations teams are working diligently to assure we are now in launch prep execution mode. The teams have had preliminary discussions with many of the top transplant centers to assess their needs for introducing a new cell therapy into their facilities. We have our full payer team in place for launch. Reimbursement mechanisms are also defined on both the commercial and medicare sides, including the recent issuance of the CMS ICD-10 PCS code for omidubicel potentially allowing for payers to cover omidubicel upon FDA approval without formulary review boards, which has created reimbursement challenges for other novel cell therapies in the past.
A very important aspect of a successful cell therapy launch is manufacturing. We have been successfully manufacturing clinical batches at the Gamida Cell owned facility. The head of our manufacturing team, Vladimir Melnikov, brings 25 years of experience with manufacturing aseptic therapies and his expertise with bringing therapies through regulatory approvals from the manufacturing perspective. The team under Vladimir's leadership has not only developed the required processes for commercial manufacturing, but we have also validated those processes. Upon FDA approval of omidubicel, our manufacturing facility is ready.
Knowing that transplant is the only potential curative option for patients with certain hematologic malignancies, January 30, 2023 will be a very important day for patients, transplanters and Gamida Cell. We have the opportunity upon potential FDA approval to provide access to omidubicel and address the unmet needs that we consistently hear from transplanters. We have a clear understanding of the unmet needs, a well thought out launch strategy and we are now executing on our launch plan. We have a great experienced launch leadership team in place that knows the importance of providing a life enhancing therapy like omidubicel to patients realizing the sense of urgency and the important role that omidubicel can play for patients with blood cancers and how omidubicel can change the way patients are treated in the future.
I would now like to turn the call over to Shai to review our financial results.
Shai Lankry
Thank you, Michelle, and good morning, everyone. Today, I will summarize our financial results for the third quarter of 2022. As of September 30, 2022, our total cash position, including the recent $20 million equity financing in the close of September 30, was approximately $61.3 million compared to $96 million as of December 21, 2021.
Research and development expenses for the quarter were $9.9 million compared to $11.7 million in the same quarter last year. The decrease was mainly due to $1.6 million decrease in clinical activities related to the conclusion of our Phase III clinical trial and a decrease of $0.2 million in the GDA-201 clinical program. Commercial expenses for the quarter were $2.8 million compared to $5.8 million in the third quarter of 2021. The decrease was primarily due to a $2.5 million decrease in launch readiness activities and a zero point six million dollars decrease in headcount related expenses.
General and administrative expenses were $4.4 million in the third quarter of 2022 compared to $5 million in the same period in 2021. The decrease was mainly driven by a $0.6 million decrease in professional services expenses and a $0.2 million decrease in headcount related expenses. Finance expenses net were $0.7 million, both in the third quarter of '22 and '21 with no material changes. Net loss for the third quarter of 2022 was $17.8 million compared to a net loss of $23.2 million in the third quarter of last year. We anticipate that our current total cash position will support our ongoing operating activities into mid-2023, excluding the cost of commercializing omidubicel beyond the initial launch, which is now underway.
Our cash runway guidance is based on our current operational strength 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 Abi.
Abigail Jenkins
Thank you, Shai. Before I turn the call over to the operator for questions, I would like to reiterate how excited we are to be in this position, on the verge of a turning point for the company as we rapidly approach our PDUFA date and target action date of January 30, 2023. We believe in the compelling value proposition of omidubicel and the potential to transform patients' lives. We continue to advance our NAM enabled NK cell therapy pipeline led by GDA-201. With all that we've accomplished this quarter and this year overall, we will enter 2023 with strong momentum and poised now more than ever to deliver long term growth for all of our stakeholders.
Now, let's open the call for questions. Shannon?
Question-and-Answer Session
Operator
Thank you. [Operator Instructions] Our first question comes from the line of Edward Tenthoff with Piper Sander. Your line is now open.
Edward Tenthoff
Great. Thank you very much and congrats on all the progress. Looking forward to the upcoming PDUFA date, obviously, and really appreciate all the detail with respect to the large corporations. I'm trying to get a sense for what kind of sales force you need to field in order to cover those top 70 centers? And how many of those centers have been involved in the clinical trials and already have omidubicel experience? I'm trying to get a sense for sort of what kind of cadence to expect from some of those top sellers? Thanks so much.
Abigail Jenkins
Great. Michelle, do you want to take that?
Michele Korfin
Yes, absolutely. Good morning, Ted. Ted, in regards to the first part of your question, so we know there's approximately 70 transplant centers that are responsible for about 80% of the transplants. And we already have relationship with many of those centers, including both their clinical experience with omidubicel through clinical trials and our EAP program. We had previously discussed and our approach has not changed that we see up to 25 commercial account managers to address the footprint of the transplant centers in the United States. And in addition, Ronit and her team will have medical science liaisons also.
In regards to your second part of the question, let me turn to Ronit to discuss the number of centers in the United States that were part of our Phase III study.
Ronit Simantov
Sure. Hi, Ted. So in our clinical trials for omidubicel, which included both the Phase III trial and our previous trials in non-hematologic malignancies, total of about 19 centers in the U.S. who've had some experience with omidubicel over the past several years.
Edward Tenthoff
Great. That's really helpful. And just to kind of get a sense, how -- so I'm trying to get a sense sort of how many transplants that maybe fit within this 20% to 25% or just how many transplants are performed on a monthly or quarterly basis? Just again sort of the cadence of how many transplants get performed at the centers? Thanks.
Abigail Jenkins
So, Ted, I'll talk about the 20% to 25%. So, we talk about that as peak market share where we would estimate the addressable transplant population to be approximately 10,000 to 11,000 patients each year.
Edward Tenthoff
That's helpful. I can work it out from that. Thanks so much.
Abigail Jenkins
Perfect. Thank you, Ted.
Operator
Thank you. Our next question comes from the line of Jonathan Miller with Evercore ISI. Your line is now open.
Jonathan Miller
Hi, guys. Thanks for taking my question. And also I’ll echo -- congrats on the progress and upcoming PDUFA. I look to dig in a little bit into what you mean when you say the runway, cash runway will cover initial launch. What are some of the things you're thinking about there in terms of timeline of launch or maybe there are particular set of goals that you think you can cover? Obviously, Michelle has been doing a lot of work commercial here already. But can you talk about what you still have to do that's covered by your current cash runway and what you would need additional financing to reach after the initial launch phase is over?
Abigail Jenkins
Shai, maybe you start and then Michelle, you can chime in.
Shai Lankry
Hey, Jon. Good morning. Thank you for your question. So as we said, our cash runway is still mid-2023 and this excluding the commercialization of omidubicel, of course, beyond the initial launch activity that's already underway. This cash runway guidance does not take into account and it's a very important point, the Highbridge commitments letter of $25 million, which I can say is a side note, both parties are working very closely to bring this to the finish line soon. Launch activity is already being started and we are bringing and we are focusing to bring omidubicel to patients. We cannot comment today on current and future financing activities, but as you can imagine as anybody at the company, we are always evaluating our cash needs and continue to assess all financing options and tools to support our corporate strategy. We are committed for this product and committed to ensuring there is a solid financial runway for this company. Michelle, do you want to elaborate?
Michele Korfin
Yes, absolutely. And good morning, Jon. I'll start off with a very important point. We feel strongly at Gamida that upon FDA approval, we want to make sure that patients can have access to omidubicel. One of the very, very important parts of that is manufacturing. So the positive news is, our manufacturing facility is ready, we've been manufacturing clinical batches and we have the production and the quality and supply chain individuals in place for time of launch. What we are focused on now as Shai alluded to with the initial launch plan is the initial hiring of personnel predominantly in the United States that will be interfacing with transplant centers. We have our respective commercial medical affairs leadership teams in place, but now the initial part of launch planning is the hiring and also some operating expenses associated with the initial launch.
We do anticipate in 2023 that we'll be ramping up transplant centers, because we do know that transplant centers do need a period of time after FDA approval to develop their processes for cell therapies once they see final prescribing information. So what we also will then do is, continue to ramp up our hiring as transplant centers ramp up. I'll clarify my answer to Ted's question, because I mentioned up to 25 commercial account managers will ramp up the hiring of those commercial account managers over the next few quarters.
Abigail Jenkins
Jon -- let me turn back to you Jon to see if you have any follow-up questions.
Jonathan Miller
Sure. Thanks. That's very helpful. I guess then beyond [OMI] (ph), maybe on GDA-201, do you have any more color on progress there? Are you still expecting to move the Phase II portion next year? And do you have any plans to present Phase I data before that time and maybe in time for folks to get a look at it before any potential financing?
Abigail Jenkins
Ronit, over to you.
Ronit Simantov
Thanks, Jon. So the GDA-201 study is proceeding in the Phase I portion. The dose escalation is ongoing, patients are being enrolled as prescribed by the protocol with the full evaluation of a dose limiting toxicity period of 28 days between each patient. And so, you can imagine that each patient is being evaluated over about a 28 day period, after which time the dose limiting toxicities can be evaluated and then dose escalation can proceed. This will take us as we escalate through four potential dose levels through next year. And we don't have any particular plans to share the outcomes of Phase I portion at this point, but we will continue to examine the results of that portion and see if there is an opportunity to share data before the end of 2023 for the Phase I.
As soon as our dose -- a recommended Phase II dose is identified we will then be able to start our Phase II. We've already started to identify sites for Phase II and begin the operational activities to allow the Phase II to proceed as soon as the dose is identified.
Jonathan Miller
Okay. Thanks very much.
Operator
Thank you. Our next question comes from the line of Jason Butler with JMP Securities. Your line is now open.
Unidentified Participant
Hi, it's Ryan for Jason. Thanks for taking our questions. I guess just to follow-up on the very -- the last question. It sounds like the Phase III start is going to be a 2024 event, is that a likely assumption?
Abigail Jenkins
We haven't pinpointed exactly when the Phase II will start. It really depends on the identification of the recommended Phase II dose. If the dose occurred at a lower dose level than the highest dose and it could occur sooner, but it's driven by our progression through the dose escalation portion. In any case, most of next year will be spent in the Phase I dose escalation portion, after which the Phase II will begin.
Unidentified Participant
Okay, got it. Thank you. And then on omidubicel, how are you guys thinking about potentially partnering to supplement your own commercial efforts? And then what's the uptake then in the expanded access program?
Abigail Jenkins
Thanks, Jason. What I would say on partnering is that, we believe in commercializing omidubicel in the U. S. and we're very focused on getting ready for that potential approval. We believe that there is an opportunity for omidubicel access to expand beyond the U.S. into certain targeted ex-U.S. markets and we're actively engaging in exploratory conversations with potential partners to expand that access internationally.
Unidentified Participant
And then expanded access?
Abigail Jenkins
Ronit?
Ronit Simantov
Happy to take that one. So our expanded access program is open at six sites in the U.S. and it allows us to continue to treat patients until such time as the potential approval takes place. There's a continual interest in enrolling patients in that study amongst the investigators who are involved in the study. And there's a steady stream of patients, including patients from all those sites and we will continue to treat those patients until we have commercialization potentially.
Unidentified Participant
Okay, great. And then on the NK pipeline, I guess if the omidubicel launch advances as you guys expected to, when do you think you'll be in a position to nominate an NK pipeline candidate for an IND? Thanks.
Abigail Jenkins
What I would say is that, there will be a combination of information that we gather through our market landscape assessment and other things, as well as the data that we're generating on that early pipeline. So at this point, we're not prepared to guide to a specific date just that we're intending to move forward and identify an IND candidate at some point in the near future.
Ronit Simantov
And what I will say is that, the research is continuing and we continue to be encouraged by all of the candidates that are currently in the pipeline with some very exciting and interesting research going on in our development organization.
Unidentified Participant
Great. Thank you.
Operator
Thank you. Our next question comes from the line of Gil Blum with Needham and Company. Your line is now open.
Gilbert Blum
Good morning. Just a couple of questions from us. So on your ASH abstract, there is a clear advantage in the neutrophil engraftment over the other modal they sent it over. Platelet engraftment seems more middling. How could this finding influence the potential hospitalization in these patients?
Abigail Jenkins
Ronit?
Ronit Simantov
Thanks, Gil. So yes, platelet engraftment is known to lag behind neutrophil engraftment. In general, platelet engraftment does lag behind. And it usually is not a factor in hospitalization because patients can receive platelet transfusions as outpatients. So generally what happens is that, after neutrophil engraftment takes place, almost universally that platelets have not engrafted yet. And if they reach a certain low level while they're being followed closely as patients, then they get a platelet transfusion as an outpatient. I will say, we have -- we've been able to -- we've noticed that in our clinical trials and have not had any sort of clinical sequelae from a lag in platelet engraftment. It's actually expected in all types of donor transplants, but it will take a little bit longer.
Gilbert Blum
Okay. Thank you for that clarification. And a separate question. So the NAM technology appears to improve metabolism of cells broadening. Have you guys given any thought on application outside of what you're currently pursuing in NK cells and OMI, particularly in a potential partnership?
Abigail Jenkins
Ronit?
Ronit Simantov
There has been interest from a number of different academic and other organizations in using our NAM technology for other types of cells. And those are discussions that we have on a case by case basis and may pursue at some point. We're focused on the work that we're doing now for the NK cells, which we believe are very promising and, obviously, omidubicel, but there is certainly a scientific interest and research interest in looking at other cell types. Some of our own work in the past also indicates that other cell types are amenable to the NAM technology. So stay tuned, yes, this is something of scientific interest and we hope to be able to get to that when the time is right.
Gilbert Blum
All right. Thank you for taking our questions.
Operator
Thank you. [Operator Instructions] Our next question comes from the line of Mark Breidenbach with Oppenheimer. Your line is now open.
Unidentified Participant
Hi. Good morning. This is Jacqueline from Mark from Oppenheimer. Our first question is in the ASH abstract. So it looks like there was a higher rate of acute GvHD for omidubicel versus the other graft sources. But at least most of it looks like it was a group two. Could you please comment on what factors might be driving the discrepancy? Thank you.
Abigail Jenkins
Ronit?
Ronit Simantov
Absolutely. So we did notice that there was more grade two GvHD in the umbilical core in the omidubicel group than in the other transplant groups. And interestingly, we believe that it's probably related to the earlier engraftment because GvHD is a process by which the donor cells recognize the host or the patient cells. And so that doesn't happen until the immune system comes back. The good thing about what we're seeing is that, it's mild GvHD, it’s grade two. When you look at grade three and four, those are the same throughout. So we don't believe that there is a concern here. We actually think it's a reflection of the recovery of the immune system which with omidubicel is not only faster, but it also is actually really durable based on the results of our immune reconstitution data.
Unidentified Participant
Thanks. Another question is on the EU regulatory path. Is there any analytic thinking about an EU regulatory path for omidubicel?
Ronit Simantov
I'm sorry, Jacqueline, I didn't hear your exact question.
Unidentified Participant
Yes, sorry. So is there any appetite thinking about an European regulatory path for omidubicel?
Ronit Simantov
I think you asked if there's any update, that way you asked.
Unidentified Participant
Updated thinking?
Unidentified Participant
Yes. So we're focused -- yes, okay. We're focused -- we're really focused on working with FDA to bring this to the therapy to patients in the U.S.. And we are excited and interested in opportunities internationally based on the data. And the fact is that, we enrolled many patients from Europe in our clinical trials. And so we have international sites and investigators that are interested. So we will strongly work on that, but we don't have any updates at this point about the regulatory interactions with the EMA.
Unidentified Participant
All right. Thank you. Thanks for taking our questions.
Operator
Thank you. I'm currently showing no further questions at this time. I'd like to hand the call back over to Abi Jenkins for closing remarks.
Abigail Jenkins
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 on today's call.
Operator
This concludes today's conference call. Thank you for your participation. You may now disconnect.
Gamida Cell Reports Third Quarter 2022 Financial Results and Provides Company Update
https://finance.yahoo.com/news/gamida-cell-reports-third-quarter-120000927.html
– Commercial launch preparations underway ahead of January 30, 2023 PDUFA target action date –
– New data presented across multiple medical meetings to support the potential of omidubicel as an advanced cell therapy, including long term follow-up data from the Phase 3 study, a real-world analysis of donor sources, and health-related quality of life scores and the potential for omidubicel to increase access to transplant for patients –
– Appointed Abigail Jenkins as President and CEO as part of planned succession –
– Strengthened financial position with sale of ordinary shares for gross proceeds of $20 million and signed a commitment letter for $25 million senior secured convertible term loan, both in September 2022 –
– Company to host conference call at 8:00 a.m. ET today –
BOSTON, November 14, 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 September 30, 2022. Net loss for the third quarter of 2022 was $17.8 million, compared to a net loss of $23.2 million in the third quarter of 2021. As of September 30, 2022, Gamida Cell had total cash, cash equivalents and investments of $61.3 million.
Recently, Gamida Cell:
Advanced commercial readiness activities to support the potential launch of omidubicel in preparation for the target action date of January 30, 2023 under Prescription Drug User Fee Act (PDUFA).
Presented new data supporting the potential of omidubicel for the treatment of patients with blood cancers in need of allogeneic hematopoietic stem cell transplant at the Tenth Annual Meeting of the Society of Hematologic Oncology (SOHO) and the 2022 Cord Blood Connect Meeting (CBC). Data presented included new three-year follow-up data from the Phase 3 study that demonstrated that patients treated with omidubicel had an overall and disease-free survival rate of 63% and 56% at three years, respectively. Additional data presentations demonstrated that treatment with omidubicel led to higher health-related quality of life scores, and that, if approved, omidubicel is projected to meaningfully improve patient outcomes among racial and ethnic minorities by extending access and reducing time to transplant for patients who may not be able to currently find a donor source.
Appointed Abigail "Abbey" Jenkins as President and CEO as part of a planned succession.
Executed an underwritten public offering in September 2022 that raised $20 million before deducting underwriting discounts, commissions and offering expenses. The company also announced a commitment letter for a $25 million senior secured convertible loan in September 2022 with Highbridge Capital Management, LLC.
Continued pre-clinical 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. At the Society for Immunotherapy of Cancer’s 37th Annual Meeting (SITC), Gamida Cell announced encouraging preclinical data on GDA-501, supporting its continued pre-clinical development. "Gamida Cell is entering a pivotal time of growth as we prepare to transition from being a clinical stage to commercial stage company upon the potential approval of omidubicel. The January 30, 2023 PDUFA date for omidubicel is rapidly approaching and, if approved, omidubicel will offer a transformative new option to patients in need of an allogeneic stem cell transplant," said Abbey Jenkins, president and CEO of Gamida Cell. "The Gamida Cell team has utilized robust market insights to understand the important role that omidubicel can play for transplanters, if approved, in terms of both improving patients outcomes and increasing access for patients who cannot currently find a donor source. We have now accelerated launch preparations across our commercial, operations and medical affairs teams to ensure we can begin making omidubicel available upon potential approval in January. Beyond omidubicel, we are enrolling patients in our company-sponsored Phase 1/2 study of GDA-201 and are continuing to develop our genetically modified NK cell immunotherapy programs that leverage CAR- and CRISPR-mediated technologies. We are excited about the progress across our pipeline as we advance on our mission to deliver potentially curative therapies to patients with cancer and other serious diseases."
Third Quarter and Recent Developments
Omidubicel: Advanced Cell Therapy Candidate
Data presentations at the 64th American Society of Hematology (ASH) Annual Meeting: In November, Gamida Cell announced it will present new real-world analysis data comparing the safety and efficacy of omidubicel to alloHCT donor sources used in clinical practice from the Center for International Blood and Marrow Transplant Research (CIBMTR) database at the December ASH annual meeting. The analysis demonstrated that omidubicel was associated with more rapid neutrophil recovery (median: 10 days) than all other donor sources (median 15-20 days; p-value <0.001) and evaluated other outcomes comparing omidubicel Phase 3 results and those from the CIBMTR database. Overall survival (OS) was comparable across donor sources.
Presented new long-term data from Phase 3 trial at SOHO: In September, at SOHO, Gamida Cell presented new long term follow-up data and health-related quality of life scores of patients treated with omidubicel. In an analysis of 105 patients transplanted with omidubicel between 2006 and 2020 (median follow-up of 22 months), the data demonstrated an overall and disease-free survival rate of 63% (95% CI, 53%-73%) and 56% (95% CI, 47%-67%) at three years, respectively. A second presentation featured an analysis of 108 patients that completed validated health-related quality of life (HRQL) surveys on screening and days 42, 100, 180, and 365 post-transplant. Measures of physical and functional well-being and other HRQL scores were more favorable with omidubicel and suggest clinically meaningful and sustained improvements in physical, functional and overall well-being compared to umbilical cord blood (UCB) transplantation.
Presented data demonstrating the impact of transplantation with omidubicel for patients with hematologic malignancies at CBC: In September, at CBC, Gamida Cell presented data supporting the potential of omidubicel for the treatment of patients with blood cancers in need of an allogeneic hematopoietic stem cell transplant. The data suggest during the first-year post-transplant, patients receiving omidubicel had meaningfully greater preservation or improvement of important HRQL domains compared to UCB recipients. A second poster featured an analysis of the projected impact of allogeneic hematopoietic cell transplant on clinical outcomes and potential access for patients who currently cannot find a donor source, with the greatest improvements among the racial and ethnic groups underserved by the current standard of care. In a third poster, results of a translational sub-study from the Phase 3 trial showed that patients transplanted with omidubicel had more rapid and robust immune reconstitution than controls, including higher numbers of Recent Thymic Emigrants in peripheral blood at one year post transplant compared to transplantation with UCB, which suggest faster thymopoiesis and provide a mechanistic rational for the lower infection rates in these patients.
Continued launch preparations in preparation for January 30, 2023 PDUFA date: The company’s Biologics License Application (BLA) for omidubicel is under review with the U.S. Food and Drug Administration (FDA) with a target action PDUFA date of January 30, 2023. Gamida Cell continues to advance readiness activities throughout the organization to support the potential launch of omidubicel.
GDA-201: NAM-Enabled NK Cell Therapy
Continued advancement of Phase 1/2 study of cryopreserved formulation of GDA-201: Gamida Cell continues to advance its company-sponsored Phase 1/2 study evaluating a cryopreserved formulation of GDA-201 for the treatment of follicular and diffuse B-cell lymphomas.
NAM-Enabled NK Cell Pipeline Development
Presented preclinical data on GDA-501: At the SITC Annual Meeting, Gamida Cell announced new preclinical data on GDA-501, a genetically modified HER2-CAR NAM-NK cell therapy candidate, that provide support for its continued preclinical development. GDA-501 displayed significantly enhanced in vitro cytotoxicity when cultured with HER2+ targeted cancer cells, as well as increased potency based on elevated levels of proinflammatory cytokines and biomarkers compared with control cells. Importantly, increased cytotoxicity and potency were persistent. These preclinical data demonstrate potent antitumor activity.
Continued the development of 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. In order to both prioritize resources to the commercialization of omidubicel and advancement of GDA-201, as well as enable development activities to progress further, the company will hold on selecting an IND candidate and will continue to conduct in vitro and in vivo preclinical proof-of-concept studies for these genetically modified NK therapeutic targets.
Corporate Updates
Appointed Abigail Jenkins as President and CEO: As part of a CEO succession plan, Julian Adams retired as CEO and Abigail "Abbey" Jenkins was appointed as President and CEO. Ms. Jenkins has also been appointed to Gamida Cell’s Board of Directors. Ms. Jenkins brings over 25 years of leadership experience in the biopharmaceutical industry developing life-enhancing therapies from research to commercialization. Julian Adams will remain on the company’s Board of Directors.
Strengthened financial position: In September 2022, Gamida Cell executed an underwritten public offering raising approximately $20 million, before deducting underwriting discounts, commissions and offering expenses. Also, in September 2022, the company announced it entered into a commitment letter with Highbridge Capital Management, LLC for a $25 million senior secured, convertible term loan. These capital commitments will be used to fund the commercial readiness activities to support the potential launch of omidubicel, if approved, and to further the clinical development of its NK product candidates, including GDA-201.
Third Quarter 2022 Financial Results
Research and development expenses were $9.9 million in the third quarter of 2022, compared to $11.7 million in the same quarter in 2021. The decrease was attributable mainly to a $1.6 million decrease in clinical activities relating to the conclusion of the Phase 3 clinical trial and a decrease of $0.2 million in GDA-201 clinical program.
Commercial expenses were $2.8 million in the third quarter of 2022, compared to $5.8 million in the third quarter of 2021. The decrease was attributable mainly to an $2.5 million decrease in launch readiness activities, and $0.6 million decrease in headcount related expenses.
General and administrative expenses were $4.4 million in the third quarter of 2022, compared to $5.0 million in the same period in 2021. The decrease was mainly due to a $0.3 million decrease in professional services expenses and $0.3 million decrease in headcount related expenses.
Finance expenses, net, were $0.7 million in the third quarters of 2022 and 2021, with no material changes.
Net loss was $17.8 million in the third quarter of 2022, compared to a net loss of $23.2 million in the third quarter of 2021.
2022 Financial Guidance
Gamida Cell expects that its current total cash position, together with recent financing, will support the company’s ongoing operating activities into mid-2023, excluding the cost of commercializing omidubicel beyond the initial launch. 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 2023
Omidubicel
PDUFA target action date of January 30, 2023.
Conference Call Information
Gamida Cell will host a conference call today, November 14, 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 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 Q3 2022 Earnings Preview
Nov. 13, 2022 9:54 AM ETGamida Cell Ltd. (GMDA)
By: Gaurav Batavia, SA News Editor
Gamida Cell (NASDAQ:GMDA) is scheduled to announce Q3 earnings results on Sunday, November 13th, before market open.
The consensus EPS Estimate is -$0.31 (+6.1% Y/Y) and the consensus Revenue Estimate is $0M
As much as i am pleased with today's action,
both in volume and in price, i am not too
much impressed.
Only approval will really make me happy!
I am still quite confident approval will occur.
Getting some buying on volume here. Might be the start of a reversal run up towards (hopefully) approval.
Murocman
Gamida Cell to Present Corporate Highlights at the Jefferies London Healthcare Conference
https://finance.yahoo.com/news/gamida-cell-present-corporate-highlights-130000206.html
BOSTON, November 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 announced that Abbey Jenkins, President and Chief Executive Officer, will present its corporate highlights at the Jefferies London Healthcare Conference, November 17, 2022 with a presentation at 9:10 a.m. GMT.
Ms. Jenkins 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. Additional topics include, 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.
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.
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 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 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.
GDA-501, NAM enabled NK Cell Therapy, Demonstrates Promising Antitumor Activity Against HER2+ Cancers
https://finance.yahoo.com/news/gda-501-nam-enabled-nk-130000641.html
Preclinical data presented at Society of Immunotherapy of Cancer’s 37th Annual Meeting shows proprietary NAM technology expands NK cells, enhances functionality, increases antitumor activity, and improves homing to targeted cancer cells
Data demonstrates that genetically modified NK cell GDA-501 enhances potency, persistence and cytotoxicity against cancer cells expressing HER2
More than 100,000 patients in US have cancers that express HER2
BOSTON, November 07, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the global leader in the development of NAM-enabled cell therapies for patients with solid and hematological cancers and other serious diseases, today announced encouraging preclinical data on GDA-501, a genetically modified NAM (nicotinamide) Natural Killer (NK) pre-clinical cell therapy candidate from Gamida Cell’s expanding pipeline of cell therapy candidates. The data will be presented at the Society for Immunotherapy of Cancer’s 37th Annual Meeting taking place in Boston, MA from November 10-12, 2022.
NK cells have generated significant interest as potential new treatment options for patients with cancers. In pre-clinical and clinical studies, Gamida Cell’s proprietary NAM technology has demonstrated successful expansion of NK cells, enhanced functionality, increased cytotoxic activity as well as creating a protective effect against oxidative stress and improved homing to targeted blood and solid tumor cancers.
"Our proprietary NAM technology enhances desirable cancer fighting qualities across a broad range of innate and adaptive cell types, including NK cells. As shown in our SITC poster, by optimizing downstream signaling we were able to directly enhance NK cell activity resulting in potent cytotoxicity against HER2-expressing cells. These results suggest that GDA-501 represents a unique allogeneic cell therapy candidate potentially targeting HER2+ solid tumors," said Yona Geffen, Ph.D., Vice President, Research and Development at Gamida Cell. "These data further validate our NAM technology and our pipeline of genetically modified NK cell therapy candidates that offer the potential to improve clinical outcomes for patients with cancers, including cancers that express HER2."
The success of immune cell therapies has been limited in solid tumors due to multiple barriers, including immunosuppressive tumor microenvironment, inefficient trafficking, and heterogeneity of tumor antigens. In a poster presentation titled, "Engineered NAM-NK cells with HER2-CAR expression demonstrate increased cytotoxicity against HER2-expressing solid tumors", GDA-501, a genetically modified HER2-CAR NAM-NK cell, displayed significantly enhanced and persistent in vitro cytotoxicity and potency when cultured with HER2+ targeted cancer cells. Cryopreserved GDA-501 significantly inhibited tumor growth of a HER2+ solid tumor model in vivo. These preclinical data demonstrate potent antitumor activity and suggest that GDA-501 represents a unique potential treatment option using an allogeneic NAM-enabled cell therapy candidate for this poor prognostic group of patients with cancers that express HER2.
The GDA-501 poster (abstract #273) will be presented in Hall C on Thursday, November 10, 2022, from 9:00 AM EST to 9:00 PM EST. The poster presentation is publicly available at www.sitcancer.org.
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 GDA-501
Gamida Cell expanded the use of its NAM-enabled technology to create GDA-501, an allogeneic innate NK cell therapy candidate for the potential treatment of HER2+ solid tumors. Human epidermal growth factor receptor 2 (HER2) is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast, gastric, lung and colorectal cancers.1 GDA-501 is genetically modified with a chimeric antigen receptor (CAR) to target HER2 by optimizing downstream signaling which directly enhances GDA-501 cytotoxicity. In vitro data demonstrated potent cytotoxicity against HER2-expressing cells. As a result, HER2-CAR may be used to target multiple HER2+ solid tumors. For more information about GDA-501, 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 under review with the FDA as a potential 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 non-clinical and clinical trials of Gamida Cell’s product candidates (including GDA-501), and the potentially life-saving or curative therapeutic and commercial potential of Gamida Cell’s product candidates (including GDA-501). 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.
1.Iqbal N, et al. Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications. Mol Biol Int. 2014;852748.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221107005437/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
Gamida Cell Announces the Date of Its Third Quarter 2022 Financial Results and Webcast
https://finance.yahoo.com/news/gamida-cell-announces-date-third-130000848.html
BOSTON, November 07, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, today announced that the company will host a conference call and live audio webcast on Monday, November 14, 2022, at 8:00 AM EST to review its third 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.
Gamida Cell Announces Omidubicel Data To Be Presented as an Oral Presentation at 64th ASH Annual Meeting
https://finance.yahoo.com/news/gamida-cell-announces-omidubicel-data-130700331.html
November 03 2022 - 09:07AM
Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematological and solid cancers and other serious diseases, today announced an oral presentation of a real-world analysis comparing the effectiveness of omidubicel to other allo-HCT donor sources from the Center for International Blood and Marrow Transplant Research (CIBMTR) database. These data are being presented at the 64th American Society of Hematology (ASH) Annual Meeting, which is being held in New Orleans from December 10-13, 2022.
“Data from our phase 3 study compared the safety and efficacy of omidubicel to standard cord blood. We are delighted to have the opportunity, in a podium presentation at ASH, to share the work we have done with CIBMTR, exploring their expansive real-world database and performing the first comparative efficacy analyses between omidubicel and other donor sources for patients undergoing allogeneic stem cell transplant,” said Ronit Simantov, M.D., Chief Medical and Scientific Officer of Gamida Cell. “These data reinforce the clinical relevance of the rapid time to neutrophil engraftment observed in patients transplanted with omidubicel, and support the potential use of omidubicel in patients with hematologic malignancies requiring transplant. We are diligently preparing to bring this important therapy to patients upon potential FDA approval.”
Details about the ASH presentation are as follows:
Title: Clinical Outcomes Following Allogeneic Hematopoietic Cell Transplantation with Omidubicel or Other Donor Sources in Patients with Hematologic Malignancies: Comparison of Clinical Trial Results to Center for International Blood and Marrow Transplant Research Database Controls
Session Title: 732. Allogeneic Transplantation: Disease Response and Comparative Treatment Studies: Clinical Outcome: Real World Studies Based on Database Analyses
Lead Author: Smitha Sivaraman, PhD.
Time: Saturday, December 10, 2022, 2:00 p.m. – 3:30 p.m. EST (session time) and 2:30 p.m. EST (presentation time)
Location: Ernest N. Morial Convention Center, 391 – 392
A prospective cohort analysis study to compare the effectiveness of omidubicel versus other allo-HCT donor sources (MUD, MMUD and haploidentical) used in clinical practice is being presented. The study compared data from the omidubicel (n=52) and control arms (n=56) of the phase 3 study with a cohort of similar patients derived from the CIBMTR database (n = 807) who had undergone transplant with matched unrelated donors, mismatched unrelated donors, or haploidentical donors. The analysis showed that omidubicel was associated with more rapid neutrophil recovery (median: 10 days) compared to all other donor sources (median 15-20 days; p<0.001). While platelet recovery took longer in the omidubicel cohort, rates of severe acute and chronic graft versus host disease (GVHD) were comparable. Importantly, analyses of non-relapse mortality, disease-free survival, and overall survival showed similar results among all donor sources. While the phase 3 study compared omidubicel to standard cord blood, these real-world data reinforce the clinical utility of omidubicel as a graft source in patients in need of an allogeneic stem cell transplant.
Gamida Cell to Present Corporate Highlights at 2022 Cell & Gene Meeting on the Mesa
https://finance.yahoo.com/news/gamida-cell-present-corporate-highlights-110000248.html
BOSTON, October 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 that Michele Korfin, Chief Operating Officer and Chief Commercial Officer, will present its corporate highlights at the annual Cell & Gene Meeting on the Mesa to be held October 11-13, 2022 in Carlsbad, California and livestreamed globally.
Ms. Korfin 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. Additional topics include, 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.
Organized by the Alliance for Regenerative Medicine, the Cell & Gene Meeting on the Mesa is a three-day conference featuring more than 90 dedicated company presentations by leading public and private companies, highlighting technical and clinical achievements over the past 12 months in the areas of cell therapy, gene therapy, gene editing, tissue engineering and broader regenerative medicine technologies, as well as over 100 panelists and featured speakers.
Virtual attendance is available which includes a live webcast of Gamida Cell’s presentation and the ability to view all conference sessions on-demand. Please visit https://meetingonthemesa.com for full information including registration.
Complimentary attendance at this event is available for credentialed investors and members of the media only. Investors should contact Laura Stringham at lstringham@alliancerm.org and interested media should contact Stephen Majors at smajors@alliancerm.org.
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 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.
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 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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221010005190/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
Company officials buying stock
in the offering with their OWN
personal money is a positive
very bullish sign.
https://ih.advfn.com/stock-market/NASDAQ/gamida-cell-GMDA/stock-news/89219951/statement-of-changes-in-beneficial-ownership-4
Company officials buying stock
in the offering with their OWN
personal money is a positive
very bullish sign.
https://ih.advfn.com/stock-market/NASDAQ/gamida-cell-GMDA/stock-news/89219951/statement-of-changes-in-beneficial-ownership-4
Clinical Trial Saves Leukemia Patient
After being diagnosed with high-risk leukemia, Jesus Torres needed a bone marrow transplant if he was to have any chance of a cure. Like many Hispanics, he faced challenges finding a matching donor in the international donor pool. Fortunately, his hematologist Patrick Hagen, MD, was able to enroll Jesus in a clinical trial studying a new treatment using umbilical cord blood as his donor source. Just three months after his transplant, Jesus had no signs of leukemia and is living a normal life now.
Gamida Cell gains on long-term data for blood cancer therapy
Sep. 29, 2022 11:08 AM ETGamida Cell Ltd. (GMDA)
By: Dulan Lokuwithana, SA News Editor
Israel-based biotech Gamida Cell Ltd. (NASDAQ:GMDA) announced Thursday that its stem cell therapy candidate omidubicel led to clinical benefit at three years in a group of patients with blood cancer who typically have a poor prognosis.
The analysis included long-term follow-up data from 105 patients who underwent omidubicel transplants between 2006-2020.
The company said that the study presented at the Annual Meeting of the Society of Hematologic Oncology indicated 63% overall survival and 56% disease-free survival at three years, in addition to long-term blood cell formation and immunity.
Another 108-patient study demonstrated that omidubicel could lead to a higher health-related quality of life than umbilical cord blood transplantation.
In August, GMDA announced that the FDA granted priority review for omidubicel as a treatment for patients with blood cancers who need an allogenic hematopoietic stem cell transplant. The regulator is expected to make a decision by Jan. 30.
Long-Term Data from Omidubicel Phase 3 Trial Demonstrates Overall Survival and Sustainable Durable Outcomes for Patients with Blood Cancers at the Society of Hematologic Oncology Meeting
https://finance.yahoo.com/news/long-term-data-omidubicel-phase-110000158.html
At three years, new data showed overall survival and disease-free survival of 63% and 56% respectively
At ten years, follow-up data demonstrated sustained long-term bone marrow recovery
Omidubicel patients reported clinically meaningful health-related quality of life scores compared to umbilical cord blood
BOSTON, September 29, 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 new long term follow-up data and health-related quality of life scores of patients treated with omidubicel at the Tenth Annual Meeting of the Society of Hematologic Oncology (SOHO), being held in Houston, Texas.
"These data reinforce our commitment to advance transformational cell therapy research and underscore the potential of our NAM technology platform. Our lead stem cell therapy candidate, omidubicel, addresses the unmet need for patients with hematologic malignancies, demonstrated by the robust and growing body of encouraging clinical evidence, including the long-term follow up data and quality of life improvement," said Ronit Simantov, M.D., Chief Medical Officer of Gamida Cell. "As we approach the PDUFA date of January 30, 2023, and upon potential FDA approval, we are prepared to execute our plan that ensures access to those patients who can benefit from omidubicel as quickly as possible."
The long-term, durable clinical benefit of omidubicel was observed at three years across a patient population that typically has a poor prognosis. A study titled, "Multicenter Long-Term Follow Up of Allogeneic Hematopoietic Stem Cell Transplantation with Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials," highlighted long-term follow-up of 105 patients transplanted with omidubicel between 2006-2020 (median follow-up of 22 months). The data demonstrated an overall survival and disease-free survival of 63% (95% CI, 53%-73%) and 56% (95% CI, 47%-67%) at three years, respectively, as well as durable long-term hematopoiesis and immune competence. Learn More
Overall well-being health-related quality of life scores for patients treated with omidubicel demonstrated clinical benefit compared to standard of care. A study titled, "Health-Related Quality of Life Following Allogeneic Hematopoietic Stem Cell Transplantation with Omidubicel Versus Standard Umbilical Cord Blood" featured an analysis of 108 patients that completed validated health-related quality of life (HRQL) surveys on screening and days 42, 100, 180, and 365 post-transplant. Measures of physical and functional well-being and other HRQL scores were more favorable with omidubicel. These data suggest clinically meaningful and sustained improvements in physical, functional, and overall well-being compared to umbilical cord blood transplantation. Learn More
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 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 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/20220929005316/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
Gamida Cell Announces Pricing of Approximately $20 Million Public Offering of Ordinary Shares
https://finance.yahoo.com/news/gamida-cell-announces-pricing-approximately-040800033.html
Wed, September 28, 2022 at 7:08 AM
BOSTON, September 28, 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 the pricing of a follow-on public offering of 12,905,000 of its ordinary shares at a public offering price of $1.55 per share for aggregate gross proceeds of $20 million, before deducting underwriting discounts and commissions and estimated offering expenses. In addition, Gamida Cell has granted the underwriters a 30-day option to purchase up to an additional 1,935,750 ordinary shares at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on or about September 30, 2022, subject to satisfaction of customary closing conditions.
Gamida Cell intends to use the net proceeds from this offering, together with its existing cash and cash equivalents and trading financial assets: for (i) commercial readiness activities to support potential launch of omidubicel, if approved; (ii) the continued clinical development of its NK product candidates, including GDA-201; and (iii) general corporate purposes, including general and administrative expenses and working capital.
Piper Sandler & Co. and JMP Securities, a Citizens Company, are acting as joint book-running managers for this offering.
Gamida Cell shares slide after stock offering
Sep. 27, 2022 4:18 PM ETGamida Cell Ltd. (GMDA)
By: Shweta Agarwal, SA News Editor
Gamida Cell (NASDAQ:GMDA) has launched a follow-on public offering of its shares on Tuesday that is to grant underwriters an overallotment option to purchase an additional 15% of the offering.
The Israel-based development stage biopharma firm said it intends to use the net proceeds to fund omidubicel's commercial launch, for the the continued clinical development of its NK product candidates, including GDA-201 and for general corporate purposes.
GMDA stock is down 14% in after-hours trading.
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.
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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%)
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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.
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