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Resurrection from the dead?
It's about time!
Showing some life this morning with upwards price action and strong volume….
Yes sir! All that effort and sadly they are about done. Some lucky company will pick up all the IP for pennies
Certainly looks like curtains down for GMDA.
Sad Story!
I listened to the Piper Sandler interview today.
Sounds like no real prospects for a partnership, etc. until the launch ramp improves?
Bottom line nothing imminent and I surmise the KOL event is to drum up some interest and increased uptake of Omisurge to help improve the sales ramp.
That’s my take anyway.
Murocman
Gamida Cell to Host Virtual Thought Leader Fireside Chat on December 4, 2023
https://finance.yahoo.com/news/gamida-cell-host-virtual-thought-011100511.html
BOSTON, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, is hosting a virtual fireside chat with thought leader Gary Schiller, MD, FACP, Professor of Medicine and Director of the Hematological Malignancy & Stem Cell Transplant Program at the David Geffen School of Medicine at University of California – Los Angeles.
Dr. Schiller will discuss his experience working with patients in need of allogeneic stem cell transplant, as well as the patient journey from diagnosis to transplant, the decision-making process for donor source selection, and his experience with Omisirge® (omidubicel-onlv) since its FDA approval.
A live question and answer session will follow the fireside chat.
Details are as follows:
Virtual Thought Leader Fireside Chat
Monday, December 4, 2023, at 4:30 – 5:15 p.m. ET
Click here to register.
A replay of the event may be accessed on the Events and Presentations page under the Investors section of the Gamida Cell website.
This event is intended for institutional investors, sell-side research analysts and business development professionals only.
About Gary Schiller, MD, FACP
Gary Schiller, MD, FACP is the Director of the Hematological Malignancy/Stem Cell Transplant Program at the David Geffen School of Medicine at UCLA, supervising 150-200 transplants per year. He has extensive clinical research experience, having conducted investigator-initiated and multicenter trials, mostly in hematologic malignancies and Blood and Marrow Transplantation. He is past Chair of the Faculty Executive Committee for the School of Medicine at UCLA. He is an author of over 225 publications and 450 abstracts and presented in more than 350 events. He has mentored residents, medical students, and fellows for more than 30 years. He served as a member and Chair of the Committee on Training for the American Society of Hematology, worked with its Trainee Council developing programs for the national meeting of the Society and curriculum for its Trainee Day, and is Chair of the ASH Foundation committee. Dr. Schiller has an outstanding track record in clinical research, teaching, and mentoring. He was co-investigator on Alternative Training grant for Bone Marrow Failure syndromes and developed the Sickle Hemoglobinopathy program at UCLA. He also has extensive experience outside of medicine with nonprofit, charitable institutions. He has served on the Board of Trustees of Wilshire Boulevard Temple, and was Chairman of the Los Angeles Museum of the Holocaust. Dr. Schiller has 30 years of experience in the diagnosis and management of adults with hematologic malignancies and those undergoing allogeneic stem cell transplantation for non-malignant disorders.
Omisirge® (omidubicel-onlv) Indication
Omisirge is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.
Important Safety Information for Omisirge
BOXED WARNING: INFUSION REACTIONS, GRAFT VERSUS HOST DISEASE, ENGRAFTMENT SYNDROME, AND GRAFT FAILURE
Infusion reactions may be fatal. Monitor patients during infusion and discontinue for severe reactions. Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin or bovine material.
Graft-versus-Host Disease may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD.
Engraftment syndrome may be fatal. Treat engraftment syndrome promptly with corticosteroids.
Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery.
Contraindications
OMISIRGE is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine products.
Warnings and Precautions
Hypersensitivity Reactions
Allergic reactions may occur with the infusion of OMISIRGE. Reactions include bronchospasm, wheezing, angioedema, pruritis and hives. Serious hypersensitivity reactions, including anaphylaxis, may be due to DMSO, residual gentamicin, Dextran 40, human serum albumin (HSA) and bovine material in OMISIRGE. OMISIRGE may contain residual antibiotics if the cord blood donor was exposed to antibiotics in utero. Patients with a history of allergic reactions to antibiotics should be monitored for allergic reactions following OMISIRGE administration.
Infusion Reactions
Infusion reactions occurred following OMISIRGE infusion, including hypertension, mucosal inflammation, dysphagia, dyspnea, vomiting, and gastrointestinal toxicity. Premedication with antipyretics, histamine antagonists, and corticosteroids may reduce the incidence and intensity of infusion reactions. In patients transplanted with OMISIRGE in clinical trials, 47% (55/117) patients had an infusion reaction of any severity. Grade 3-4 infusion reactions were reported in 15% (18/117) patients. Infusion reactions may begin within minutes of the start of infusion of OMISIRGE, although symptoms may continue to intensify and not peak for several hours after the completion of the infusion. Monitor patients for signs and symptoms of infusion reactions during and after OMISIRGE administration. When a reaction occurs, pause the infusion and institute supportive care as needed.
Graft-versus-Host Disease
Acute and chronic GvHD, including life-threatening and fatal cases, occurred following treatment with OMISIRGE. In patients transplanted with OMISIRGE Grade II-IV acute GvHD was reported in 58% (68/117). Grade III- IV acute GvHD was reported in 17% (20/117). Chronic GvHD occurred in 35% (41/117) of patients. Acute GvHD manifests as maculopapular rash, gastrointestinal symptoms, and elevated bilirubin. Patients treated with OMISIRGE should receive immunosuppressive drugs to decrease the risk of GvHD, be monitored for signs and symptoms of GvHD, and treated if GvHD develops.
Engraftment Syndrome
Engraftment syndrome may occur because OMISIRGE is derived from umbilical cord blood. Monitor patients for unexplained fever, rash, hypoxemia, weight gain, and pulmonary infiltrates in the peri-engraftment period. Treat with corticosteroids as soon as engraftment syndrome is recognized to ameliorate symptoms. If untreated, engraftment syndrome may progress to multiorgan failure and death.
Graft Failure
Primary graft failure occurred in 3% (4/117) of patients in OMISIRGE clinical trials. Primary graft failure, which may be fatal, is defined as failure to achieve an absolute neutrophil count greater than 500 per microliter blood by Day 42 after transplantation. Immunologic rejection is the primary cause of graft failure. Monitor patients for laboratory evidence of hematopoietic recovery.
Malignancies of Donor Origin
Two patients treated with OMISIRGE developed post-transplant lymphoproliferative disorder (PTLD) in the second-year post-transplant. PTLD manifests as a lymphoma-like disease favoring non-nodal sites. PTLD is usually fatal if not treated. The etiology is thought to be donor lymphoid cells transformed by Epstein-Barr virus (EBV). Serial monitoring of blood for EBV DNA may be warranted in patients with persistent cytopenias. One patient treated with OMISIRGE developed a donor-cell derived myelodysplastic syndrome (MDS) during the fourth-year post-transplant. The natural history is presumed to be the same as that for de novo MDS. Monitor life-long for secondary malignancies. If a secondary malignancy occurs, contact Gamida Cell at (844) 477-7478.
Transmission of Serious Infections
Transmission of infectious disease may occur because OMISIRGE is derived from umbilical cord blood. Disease may be caused by known or unknown infectious agents. Donors are screened for increased risk of infection, clinical evidence of sepsis, and communicable disease risks associated with xenotransplantation. Maternal and infant donor blood is tested for evidence of donor infection. See full Prescribing Information, Warnings and Precautions, Transmission of Serious Infections for list of testing performed. OMISIRGE is tested for sterility, endotoxin, and mycoplasma. There may be an effect on the reliability of the sterility test results if the cord blood donor was exposed to antibiotics in utero. Product manufacturing includes bovine-derived reagents. All animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use. These measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Test results may be found on the container label and/or in accompanying records. If final sterility results are not available at the time of use, Quality Assurance will communicate any positive results from sterility testing to the physician. Report the occurrence of transmitted infection to Gamida Cell at (844) 477-7478.
Transmission of Rare Genetic Diseases
OMISIRGE may transmit rare genetic diseases involving the hematopoietic system because it is derived from umbilical cord blood. Cord blood donors have been screened to exclude donors with sickle cell anemia, and anemias due to abnormalities in hemoglobins C, D, and E. Because of the age of the donor at the time cord blood collection takes place, the ability to exclude rare genetic diseases is severely limited.
ADVERSE REACTIONS
The most common adverse reactions (incidence > 20%) are infections, GvHD, and infusion reaction.
Please see full Prescribing Information, including Boxed Warning.
About Gamida Cell
Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include Omisirge® (omidubicel-onlv), an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, Facebook, Twitter and Instagram.
Cautionary Note Regarding Forward-Looking Statements
This press release may contain forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the potentially life-saving or curative therapeutic and commercial potential of Omisirge® (omidubicel-onlv). 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 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. 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 November 14, 2023, and other filings that Gamida Cell makes with the SEC from time to time (which are available at 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.
Omisirge® is a registered trademark of Gamida Cell Inc. © 2023 Gamida Cell Inc. All Rights Reserved.
Investor Contacts:
Chuck Padala
LifeSci Advisors
chuck@lifesciadvisors.com
1-646-627-8390
Media Contact:
Dan Boyle
Orangefiery
media@orangefiery.com
1-818-209-1692
Source: Gamida Cell, Ltd
I am pretty sure your timing is perfect.
GLTY
I had bought at 70cents, if I had more powder,I would have bought in the 20 cent range without a doubt!
Gamida Cell to Present Corporate Highlights at the Piper Sandler 35th Annual Healthcare Conference
https://finance.yahoo.com/news/gamida-cell-present-corporate-highlights-130000108.html
BOSTON, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that its management team will present corporate highlights at the upcoming Piper Sandler 35th Annual Healthcare Conference in New York, NY.
Presentation Details
Format:
Fireside Chat
Date/Time:
Tuesday, November 28, 2023 at 11:00 –11:25 AM ET
Webcast:
Click here.
The Gamida Cell management team will be available for one-on-one meetings during the conference. Interested investors should contact their Piper Sandler representative.
Gamida Cell (NASDAQ:GMDA) Price Target Cut to $2.00
https://www.defenseworld.net/2023/11/19/gamida-cell-nasdaqgmda-price-target-cut-to-2-00.html
Posted by Defense World Staff on Nov 19th, 2023
Gamida Cell Ltd. logoGamida Cell (NASDAQ:GMDA – Free Report) had its price objective reduced by Piper Sandler from $5.00 to $2.00 in a research report sent to investors on Wednesday, Benzinga reports. They currently have an overweight rating on the stock.
GMDA has been the topic of a number of other reports. JMP Securities restated a market outperform rating and issued a $6.00 price target on shares of Gamida Cell in a research report on Thursday, September 28th. Needham & Company LLC reiterated a buy rating and set a $6.00 target price on shares of Gamida Cell in a research report on Tuesday, August 15th. Finally, HC Wainwright reduced their target price on shares of Gamida Cell from $11.00 to $5.00 and set a buy rating on the stock in a research report on Wednesday. Five equities research analysts have rated the stock with a buy rating, According to MarketBeat.com, the company presently has an average rating of Buy and a consensus price target of $5.40.
FWIW
I wish we had some idea, some info
in regards the the offer, one of them
which GMDA rejected.
Sometimes it pays to compromise.
I am more concerned about the fact that no
partner was hooked on.
Perhaps a miracle will happen, or else a R/S
will occur sooner than later.
Very disappointing.
I “suspect” we will soon see a reverse stock split soon. Probably 1 share for every 10 or 20.
Gamida Cell files for $150M mixed shelf
Nov. 15, 2023 5:31 PM ETGamida Cell Ltd. (GMDA)
By: Vansh Agarwal, SA News Editor
Gamida Cell (NASDAQ:GMDA) on Wednesday filed a prospectus for a
mixed securities shelf offering of up to $150M.
This prospectus is not an offer to sell these securities.
SEC Filing
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
(b) Director Departure
On November 14, 2023, Mr. Jeremy Blank submitted his resignation from the board of directors of Gamida Cell Ltd. (the “Company”), which resignation was effective immediately. Mr. Blank’s resignation was not the result of any disagreement with the Company. The Cooperation Agreement, dated as of August 11, 2023, by and among the Company, Jeremy Blank and Community Master Fund, LP, terminated pursuant to its terms upon Mr. Blank’s resignation.
Q3 2023 Gamida Cell Ltd Earnings Call
Participants
Mike Kuczkowski; Corporate Communications; Gamida Cell Ltd.
Abbey Jenkins; President and CEO; Gamida Cell Ltd.
Michele Korfin; COO and Chief Commercial Officer; Gamida Cell Ltd.
Ronit Simantov; Chief Medical Officer and Chief Scientific Officer; Gamida Cell Ltd.
Terry Coelho; CFO; Gamida Cell Ltd.
Gil Blum; Analyst; Needham & Company, LLC
Presentation
Operator
Ladies and gentlemen, thank you for standing by. Welcome to Gamida Cell's conference call for third-quarter 2023 financial results. My name is Chris and I'll be the operator for today's call. Please be advised that this call is being recorded at Gamida Cell's request. I would now like to introduce your host for today's conference, Mike Kuczkowski of Gamida Cell Corporate Communications. Mike, please go ahead.
Mike Kuczkowski
Thank you, Chris, 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 2023. Earlier this morning, we issued a press release summarizing our financial results and providing a business update, which is available on our website at www.gamidacell.com.
Here with me on our call today are Abbey Jenkins, President and Chief Executive Officer; Michele Korfin, Chief Operating Officer and Chief Commercial Officer; Ronit Simantov, Chief Medical Officer and Chief Scientific Officer; and Terry Coelho, our Chief Financial Officer.
Before we begin, I want to remind everyone that during this call, we may make forward-looking statements about our future expectations and plans, including with respect to the potentially life-saving or curative therapeutic potential of Omisirge, omidubicel-onlv; the company's cell therapy candidate, GDA-201; expectations regarding the commercial launch of Omisirge and potential to capture market share and generate revenue; Gamida Cell's plans for commercial or strategic partnerships to support the launch of Omisirge; Gamida Cell's financial runway; Gamida Cell's ability to keep its Israel facilities open, the state of its workforce, and future developments that may adversely impact Gamida Cell's Israel operations.
Our actual results may differ materially from what we project today due to a number of important factors, including those related to 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 our product and product candidate, as well as those considerations described in the risk factors section of our most recent quarterly report on Form 10-Q and other filings that we may make with the SEC from time to time.
These forward-looking statements represent our views only as of today, and we caution you that we may not update them in the future, whether as a result of new information or future events except as required by applicable law.
Now let me turn the call over to our President and Abbey Jenkins.
Abbey Jenkins
Thank you, Mike, and everyone joining us today. I want to begin by providing a brief corporate update. We've made strong progress this quarter, which I'll go into detail on in a moment. But I would be remiss if I didn't start this call by first acknowledging the courage and resilience of our Israeli team members, who have shown incredible dedication and commitment to patients as they continue operations to ensure we reliably deliver Omisirge to patients in need while living and working in a war zone. For patients with hematologic malignancies in need of an allogeneic stem cell transplant, Omisirge may represent their last or best hope for a cure, and we are proud to be able to continue to serve our patients under these challenging circumstances.
Our employees' safety is a key concern, and we are relieved to be able to say everyone remains safe. As you might imagine, the process of getting cells into Israel and delivering Omisirge back to transplant centers in the US could have been impacted when many airlines suspended flight service in Israel. Our team of dedicated employees did not hesitate to put patients first when their own lives were impacted, working diligently to maintain operations and adapting in real time as events unfolded. To see our team members demonstrate such resilience and strength in a challenging environment has been inspiring to witness.
Shifting gears and moving on to our corporate update. Our lean launch has continued to exceed our expectations across the two key metrics we defined for launch, transplant center onboarding and market access for patients. As of this morning, we have onboarded 17 transplant centers, exceeding the top end of our projected goal of 10 to 15 transplant centers for the year. Omisirge has confirmed coverage with US payers covering more than 90% of commercial lives, exceeding our full-year goal of 70%. This includes confirmed coverage with all of the top 20 US commercial payers. Omisirge has also confirmed coverage and reimbursement with Medicare for the Centers for Medicare and Medicaid Services. This means the vast majority of patients now have coverage in place for Omisirge.
The third quarter marks the moment Gamida Cell truly transitioned to a commercial stage company with our first revenue reported. We are so proud to provide Omisirge a potentially life-saving cell therapy for those in need of a transplant donor source. We are reporting revenue from the delivery of two Omisirge unit in the third quarter and are estimating revenue from the delivery of a total of four to six units of Omisirge for the full-year 2023.
The patient volume and Omisirge net ramp are aligned with all our expectations based on a lean launch model, a number of transplant centers onboarded, and consistent with other launches in the cell and gene space. We've received very strong feedback from transplant centers on the onboarding process on Gamida Cell Assist as a tool and resource. And most importantly, on Omisirge ability to fulfill an unmet need. Omisirge is the first and only true pharmaceutical transplant option approved on the basis of a global, randomized Phase 3 trial and transplanters see its value and potential.
As we end 2023 and prepare to enter 2024, we will continue to maintain our lean launch efforts due to resource constraints as we pursue additional funding. The early launch phase of Omisirge has confirmed our market research insights, there is an unmet need in the market that Omisirge can fulfill. Rapid transplant center onboarding has proven that transplant centers are interested in making Omisirge an option for patients with hematologic malignancies. Considering the need to thoughtfully invest based on our cash position, we will be prioritizing virtually all of our resources moving forward to expand patient access to Omisirge. Assuming our ability to extend our cash runway, we expect to have more than 40 transplant centers onboarded by the end of 2024, including at least half of the top 70 transplant centers in the US.
To reiterate, we remain committed to our two-pronged corporate strategy announced earlier this year, which involves, first, launching Omisirge in the US with a focus on expanding patient access by onboarding transplant centers and ensuring market access coverage and reimbursement; and second, pursuing a strategic partnership or transaction to fully -- to support fully resourced commercialization of Omisirge.
In terms of our business development activities, our efforts to identify a strategic partner are ongoing. We have received considerable interest from multiple potential partners during the process, which has been supported by the leading global independent investment bank, Moelis & Company, and has resulted in oral and written proposals. However at present, we have not identified a partnership that will adequately address our strategic needs and plans to continue the business development process in 2024. It will be critical for us to ensure we have sufficient capital to execute this two-pronged strategy.
A key step in the process was achieved at our recent annual general meeting of shareholders held in October. At this meeting, a majority of shareholders voted to approve six proposals relating to the company's business, including an increase in Gamida Cell's authorized share capital. This will provide us with the flexibility to continue to finance our operations and enable a potential transaction should one be available to us.
In summary, our lean launch is proceeding ahead of our expectations, and we expect to maintain our lean launch approach to expand the number of onboarded transplant centers and patients receiving Omisirge into 2024. We are proud to report our first Omisirge deliveries and official transition into being a commercial stage revenue reporting company expecting to deliver a total of four to six units for the full-year 2023. We are seeking the necessary funding to support expanded patient access to Omisirge and enable a strategic partnership to fully resource commercialization of Omisirge.
I will now turn the call over to Michele for a more in-depth update on the Omisirge launch. Michelle, over to you.
Michele Korfin
Thank you, Abbey, and good morning, everyone. As Abbey mentioned, Gamida Cell continues to advance efforts and prioritize resources across the organization to execute Omisirge's lean launch and ensure patients in need have access to the therapy. I will be sharing a few updates on how the launch is progressing, as well as a bit of context regarding the process of delivering Omisirge to a transplant center for use of a donor source for a patient in need of an allogeneic stem cell transplant.
The strong interest in Omisirge from transplant centers, including centers that were not part of the Phase 3 trial, has continued to grow since our last update. As of this morning, we have onboarded 17 transplant centers, exceeding our full-year target range of 10 to 15 centers. Overall, we're pleased with how onboarding is proceeding, having already exceeded our expectations for 2023, and considering the limited resources with which we launched.
In 2024, provided we obtain the necessary resources to support the ongoing commercialization of Omisirge, we anticipate continuing to onboard transplant centers at a robust pace. To support this onboarding, we have expanded our team of account managers since our last call. With our expanded team in place and subject to securing additional financial capital, we anticipate we could onboard more than 40 transplant centers by the end of 2024, including at least half of the top 70 transplant centers in the US. As a reminder, this is a targeted market, with about 70 of the top transplant centers performing 80% of the allogeneic stem cell transplants on an annual basis.
Transplant center onboarding is a key step to enable patients to access Omisirge. Our onboarding team works closely with transplant center personnel on the clinical training and administrative policies and procedures required to begin using Omisirge as a donor source. The Gamida team have the ability to be flexible with the timing of our onboarding approach. How quickly a transplant center is onboarded is determined by the needs of each individual transplant center and can include factors like staff availability to participate in the onboarding and the status of patients currently under evaluation who may be good candidates for Omisirge.
We have been able to onboard centers very quickly who have a patient already identified for Omisirge. Once Omisirge is selected as a donor source by the patient's transplanter and the allogeneic cells are received by Gamida Cell, we are ready to begin manufacturing. We have an experienced team in place and we are ready to reliably deliver Omisirge within 30 days from the start of manufacturing.
In terms of the number of Omisirge deliveries to date, we are tracking as we expected based on the number of transplant centers we anticipated having onboarded at this time and the time it typically takes for a patient to go from being identified as a candidate for transplant to the transplant taking place. Published data have shown that getting to transplant may take four to six months depending on the transplant center's preferred approach and the patient's diagnosis and clinical profile.
The evaluation process for a patient considered for Omisirge is consistent with other donor sources and is therefore very familiar to transplant center personnel. This is why it is so critical for us to focus our resources in the first month of launch on accelerating transplant center onboarding. By exceeding our initial target range of 10 to 15 centers, we are in a position to increase the number of patients receiving Omisirge. As more transplant centers are now onboarded, we are seeing an increasing number of patients enrolled in Gamida Cell Assist. Enrolling a patient in Gamida Cell Assist indicates a transplanter intends to use Omisirge as the patient's donor source.
As a result of our progress, in the third quarter, we reached a milestone of delivering Omisirge as a donor source for two patients. I could share that manufacturing is underway for additional units of Omisirge and we project delivering a total of four to six units of Omisirge for the full-year 2023. Given the pace of transplant center onboarding and the variability and time lines for preparing a patient for transplant, these numbers are in line with our expectations, and we are excited about the possibility that Omisirge will capture up to 20% market share peak, provided we are able to secure the necessary funding to support its fully resourced commercialization.
I also have to note that our Gamida Cell team has gone above and beyond to ensure manufacturing of Omisirge continues at our facility in Kiryat Gat, Israel, making truly heroic efforts to continue operations during the Israel-Hamas war. With the Omisirge launch ongoing and additional patients enrolled in Gamida Cell Assist, one of the foremost concerns for business continuity was ensuring that we could transport Omisirge out of our manufacturing facility and to patients. We were able to adapt and quickly overcome logistical challenges and our facilities remain operational, thanks to the dedication and resilience of our employees.
With that said, we continue to monitor the situation as it evolves, and we'll adjust our plans as needed. We are incredibly proud of the effort of all of our global employees as they have passionately worked with a lean launch team to ensure patients in need have access to Omisirge. Every team member is honored to play a role and bringing Omisirge to patients in need.
Now I'd like to turn the call over to Ronit Simantov, our Chief Medical and Chief Scientific Officer. Ronit?
Ronit Simantov
Thank you, Michele, and good morning, everyone. Today, I'll be sharing early feedback from transplant centers on Omisirge and some recent data on Omisirge and our NK cell therapy candidate, GDA-201.
As Michele stated earlier, we continue to see growing interest in Omisirge from transplant centers. My team and I are engaged in conversations with physicians and staff at transplant centers across the country and the feedback we hear reinforces our confidence in the value of Omisirge. Of note, we know from these discussions that a number of our onboard of transplant centers have identified multiple patients as candidates for Omisirge. The transplant teams we are engaged with be a clear need for an additional donor source option for their patients and are eager to make Omisirge available at their institution.
So far, the patients that have enrolled in Gamida Cell Assist we're seeing some progress Omisirge is the only option and who would otherwise go on transplanted. And some patients where transplanters are considering Omisirge over other options, including haplo.
We recently presented new data at the Society for Immunotherapy of Cancer or SITC Annual Meeting that further advanced our understanding on Omisirge's cellular makeup and potential mechanism of action. The data showed that the application of our NAM technology leads to a unique cellular composition enriched in myeloid populations and dendritic cells, providing a potential mechanism for the rapid engraftment and immune reconstitution observed in patients who were transplanted with Omisirge. This emphasizes how Omisirge is differentiated from other donor source options.
So that you can have the opportunity to hear from a transplant physician directly about his experiences on Omisirge, I'm pleased to share that we'll be holding a virtual fireside chat with Dr. Gary Schiller, professor of hematology/oncology and Director of hematological malignancies and stem cell transplantation at Ronald Reagan UCLA Medical Center. This event will take place on Monday, December 4 at 4:30 PM Eastern Time via webcast and will also be recorded. Dr. Schiller was an investigator in the Phase 3 study of omidubicel and UCLA Health is one of the 17 onboarded transplant centers where patients can access Omisirge. In addition to sharing his experience with Omisirge, Dr. Schiller will talk about the patient journey from diagnosis to transplant and the decision making around donor source selection.
I'd now like to take some time to share the recent news about our natural killer cell therapy candidate, GDA-201. We recently reported preliminary data from the ongoing multi-center Phase 1 study of cryopreserved GDA-201, designed to evaluate safety and determine maximum tolerated dose. The preliminary data from 10 patients with CD20 positive non-Hodgkin lymphoma in a Phase 1 study showed no dose-limiting toxicities in patients enrolled in the first three cohorts, treated with doses of up to 100 million cells per kilogram of GDA-201. Enrolled patients had relapsed or refractory lymphoma and were heavily pretreated with a median of six prior lines of therapy, including CAR T cell therapy in six patients and prior hematopoietic stem cell transplant in four patients.
We saw marked shrinkage of target lesions in 5 of the 10 patients and efficacy evaluation using Lugano criteria demonstrated two patients with complete response, two with partial response, and one with stable disease. Activity appeared to be dose-dependent with two of the three patients in cohort three responding. These results are consistent with previously reported data from the investigator-initiated study on the fresh formulation of GDA-201, which showed complete responses in patients with non-Hodgkin lymphoma. The fourth and final cohort of the current Phase 1 study is enrolling, and we are on track to report full data in the first quarter of 2024.
We're pleased to continue to work with transplant centers and academic institutions to further the availability of Omisirge and to add to the body of scientific evidence about the mechanism and potential of our innovative NAM technology.
I will now turn the call over to Terry Coelho, our Chief Financial Officer. Terry?
Terry Coelho
Thank you, Ronit, and good morning, everyone. I'm pleased to share that Gamida Cell is reporting revenue for the first time in its history. With the transition to a product revenue generating company, a number of changes have been incorporated into our financial reporting beginning with the third quarter of 2023 and I will point out some of those key changes as we walk through the financial results.
In the third quarter ended September 30, 2023, we are reporting net revenue of $673,000, resulting from the delivery of two units of Omisirge. The gross to net allowances and deductions were particularly low in the third quarter, given the confirmed insurance coverage and transplant status for those patients. Cost of sales, including cost of direct manufacturing and quality in addition to royalty expenses, was $626,000 in the quarter. Over time, we expect the cost of sales and therefore the gross margins to improve measurably as production volumes scale to capacity.
Beginning July 1, 2023, reporting of operating expenses has been modified to reflect the company's transition to commercial stage, with all operating expenses being reported as either research and development expenses or selling, general, and administrative or SG&A expenses. For 2022, and the first two quarters of 2023, previously reported commercial and general and administrative costs were combined into SG&A expenses. Additionally, certain expenses previously reported in research and development are now being reported in SG&A beginning in the third quarter of 2023, with no reclassification of prior periods.
Research and development expenses were $4.2 million in the third quarter of 2023 compared to $9.9 million in the same quarter of 2022. The $5.7 million decrease was primarily due to the aforementioned reporting transition, along with reduced omidubicel clinical spend relating to the Phase 3 clinical trial. Selling, general, and administrative expenses were $13.8 million in the third quarter of 2023, an increase of $6.6 million compared to $7.2 million in the third quarter of 2022.
The aforementioned financial reporting transition, which resulted in the inclusion of medical affairs and certain indirect supply chain and quality assurance expenses in SG&A reporting, contributed $4.4 million to the increase in the quarter. Additionally, excess capacity costs of $2.2 million associated with our manufacturing facility were recorded in SG&A in the third quarter.
Selling and marketing expenses increased by $1.3 million compared to the prior year quarter due to commercial launch activities. To further expand upon the excess capacity costs, these costs reflects the labor and manufacturing overhead costs incurred, but not absorbing cost of goods sold in the period, given that our facility is tasked to produce the anticipated demand over the course of the coming year.
Financial income and expenses net were $16.5 million of income in the third quarter of 2023 compared to $741,000 in expenses in the same period of 2022. The $17.2 million change in financial income was primarily due to $14 million of income related to the valuation of warrants liability and $3.2 million of income related to the valuation of the company's secured convertible senior notes issued in December 2022.
Our net loss in the third quarter was $1.5 million compared to a net loss of $17.8 million in the third quarter of 2022, driven primarily by the $17.2 million change in financial income as just discussed. As of September 30, 2023, Gamida Cell has total cash and cash equivalents of $60.4 million compared to $64.7 million as of December 31, 2022. The decrease of $4.3 million is due primarily to $59.2 million in net cash proceeds from financing activities, comprised of $21.1 million in net proceeds from the issuance of ordinary shares and warrants from the company's underwritten public offering in April 2023 and $39.4 million in net proceeds from the issuance of ordinary shares via the eight PM or at-the-market facility, offset by $1.1 million in principal payments of the company's 2022 convertible senior notes and $62.9 million of net cash used in operating activities.
The company expects its current cash and cash equivalents, including the funds raised subsequent to the close of the third quarter, to support its ongoing operating activities into the second quarter of 2024 based on Gamida Cell's current operational plans and excluding commercialization activities beyond the initial launch of Omisirge, as well as any additional financing activities that may be undertaken. The company raised $25.6 million in net proceeds from its ATM facility in the third quarter at an average price of $1.40 per share.
As of September 30, 2023, the company had reduced its principal balance on the 2022 secured convertible note by $16.7 million, from $25 million as of December 31, 2022, to $8.3 million at the end of the third quarter of 2023. The company also holds a 2021 convertible senior note with an aggregate principal amount of $75 million.
Earlier in the year, we embarked on a strategic restructuring process to prioritize the vast majority of our resources for the launch of Omisirge. And we have now mostly completed that process, including consolidating operations in Israel to a single location. As Abbey mentioned earlier, shareholders at our recent annual general meeting of shareholders voted to approve an increase in Gamida Cell's authorized share capital to 325 million ordinary shares. We believe this increase in authorized shares will provide us with the increased flexibility necessary to finance our operations.
With that, I'll turn the call back over to Abbey for some concluding remarks. Abbey?
Abbey Jenkins
Thank you, Terry. Before I turn the call over to the operator for questions, I want to bring us back around the beginning of the call and summarize the key points from our discussion today. We continue to make strong progress on the commercial launch of Omisirge, having exceeded our goals across both of the key metrics for launch of transplant center onboarding and market access. Additionally, we have reported revenue for two deliveries of Omisirge in the third quarter and project four to six deliveries of Omisirge units for the full-year 2023, which is in line with our initial launch assumptions based on our lean launch model and the transplant process for patients.
With our expanded launch team in place and the securing of additional capital, we anticipate we could onboard a total of more than 40 transplant centers by the end of 2024, including at least half of the top 70 transplant centers in the Us. Operations in Israel continue and our team is adapting processes as necessary to ensure patient access to Omisirge continues during the ongoing Israel-Hamas war.
In terms of business development, we have not identified a partnership that will adequately address our strategic needs and plans to continue the business development process in 2024. We share promising preliminary data from the Phase 1 clinical trial for GDA-201 and are on track to share the full data readout in early 2024.
We are continuing to carefully manage our expenses and prioritizing virtually all of our resources towards the launch of Omisirge. We are thrilled to see increasing demand for Omisirge and are working to ensure that all patients in need have access to our NAM modified cell therapy. We believe our early launch success is a promising sign of Omisirge's long-term potential to increase access and address critical unmet needs in stem cell transplantation.
Now let's open the call for questions. Chris?
Question and Answer Session
Operator
(Operator Instructions) Gil Blum, Needham & Co.
Gil Blum
Hi. Good morning. Thank you for taking our questions. Just given the relatively small number of patients in the queue right now, could you give us some color on the individual patient types or anything that you know at this point?
Abbey Jenkins
Ronit and Michele, do you want to weigh in on this?
Michele Korfin
Sure, thank you.
Ronit Simantov
This is Ronit. I'm happy to weigh in and thanks, Gil, for the question. So yeah, there are patients who are enrolled in Gamida Cell Assist and we know some facts about these patients and what we also know is information that we're hearing directly from transplant physicians when we have conversations with them about potential patients. And the kinds of patients are different, depending on what the transplant center is like. Some are patients who really don't have any other transplant options, there are no other graft sources for them, no unrelated donor registry, no other related donor options and Omisirge is really seen as their only choice. And they would otherwise not receive a transplant, which is quite difficult for them.
There are other patients actually, who we've heard from physicians, who have more than one choice. And what physicians do is they really choose the best potential graft source for their patient of the available choices. And so there are some patients who have other choices, either mismatched or haplo or other potential donor sources for whom Omisirge is actually seen as the best choice. And so that's kind of how things are divided up. These are patients who need allogeneic stem cell transplants and may or may not have any other available donor sources.
Gil Blum
Thank you.
Michele Korfin
Thank you, Roni, and Gil, thank you. I'll just add on just going back to what we spoke about even before launch, we are generally seeing patients that are consistent with what we believe would meet the promise of Omisirge to both increase access and improve outcomes. So on the increasing side, we're seeing patients, as Ronit indicated, where Omisirge is their only donor source option. And that's consistent with the data that we had identified through our market insights that at least 1,700 patients are eligible each year for transplant but unfortunately, were not able to find a donor source before Omisirge approval.
And then on the improving outcome side, as Ronit indicated, we've heard examples where the transplant or has another option, and in one case, the other option was a haploidentical match, but the transplanter is choosing Omisirge for the patient. Although still in an early stage of the launch, we're very encouraged by what we are hearing.
Gil Blum
All right. Thank you for the answers. Maybe a bit about the dynamic with onboarded centers. Are there examples of where it was a bit of a reverse inquiry where the center reached out to you guys?
Michele Korfin
Yes. We have had multiple centers who have reached out to us and some part of the clinical studies, some that were not, that had a patient that was actively being evaluated for transplant and the transplanter felt Omisirge would be the most appropriate option. Certainly, those who were part of the clinical study, we've been in active dialogue with them. But in the case of one particular center who was in the clinical study, they asked if we could expedite the onboarding, which we were able to accommodate to address the patient need.
Gil Blum
Thank you. Very helpful. And maybe a last one. So outreach to physicians, I know you guys have a KOL event in December 4. Are you going to have presence at the upcoming ASH? I didn't see any specific presentation, but a booth for outreach to physicians. Thank you.
Michele Korfin
I'll start and then I'll turn to Ronit. So we will have a presence at ASH. I'll speak about the commercial presence, and then Ronit will talk about the medical, but we'll have our representatives from our launch team at ASH. We will have a commercial booth. So if you're there, please stop by. And we will have the opportunity to attend sessions and understand the dynamics of the scientific developments. But also, just as you alluded to, Gil, you'll have the chance to interact with individuals from the transplant centers that are either onboarded or in the queue to be onboarded. So we're looking forward to San Diego.
I'll turn to Ronit to discuss the medical side.
Ronit Simantov
Thanks, Michele. True, we don't have any academic presentations at ASH this year, but we do have a product theater presentation, as well as our medical folks engaging in small group and individual dialogues with physicians at ASH.
Operator
Does that answer your questions, Gil?
Gil Blum
Thank you. You've gotten all my questions.
Operator
(Operator Instructions) Ladies and gentlemen, we have reached the end of our question-and-answer session and I would like to turn the call back to President and CEO, Abigail Jenkins, for some closing remarks.
Abbey Jenkins
Thank you, Chris. Thank you all for joining us today. To recap, we remain confident in our team's ability to deliver Omisirge to an increasing volume of patients in need of a stem cell transplant in transplant centers across the US. We believe in Omisirge's ability to achieve its market potential and increase patient access to allogeneic stem cell transplant.
Thank you, everyone, for joining us on today's call, and we look forward to providing further updates on future calls. Thank you.
Operator
Thank you very much. Ladies and gentlemen, that concludes today's event and you may now disconnect your lines.
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Gamida Cell Reports Third Quarter 2023 Financial Results and Provides Company Update
https://finance.yahoo.com/news/gamida-cell-reports-third-quarter-120000319.html
Company continues to advance launch, reports initial revenue from Omisirge® (omidubicel-onlv)
Company to host conference call today at 8:30 a.m. ET
BOSTON, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today reported financial results for the quarter ended September 30, 2023, and provided a business update.
“The third quarter marked the first patients receiving Omisirge following FDA approval and the point at which Gamida Cell truly transitioned to a commercial-stage company with our first revenue reported,” said Abbey Jenkins, President and Chief Executive Officer of Gamida Cell. “Our lean launch prioritized two key performance indicators – transplant center onboarding and market access – both of which have surpassed our expectations, ahead of schedule. We anticipate continuing to onboard additional transplant centers, leading to a ramp-up of patients and Omisirge deliveries in the coming months.”
To date, a total of 17 transplant centers have been onboarded, exceeding the company’s 2023 target range of 10 to 15. Transplant center onboarding is a critical step in the process of making Omisirge available to patients, as it is required in order for transplant center teams to select Omisirge as a donor source. The company reported revenue for the delivery of two units of Omisirge in the third quarter of 2023 and projects revenue from a total of four to six units for full year 2023.
The company also provided an update on its market access efforts, reporting confirmed coverage with U.S. payers covering more than 90% of commercial lives, exceeding the full year goal of 70%. This includes confirmed coverage with all 20 of the top U.S. commercial payers. Omisirge also has confirmed coverage and reimbursement with Medicare from the Centers for Medicare and Medicaid Services (CMS).
Looking to 2024, the company will continue to maintain a lean launch effort due to resource constraints. Contingent on additional funding to extend its cash runway, the company anticipates onboarding more than 40 transplant centers by the end of 2024, including at least half of the top 70 transplant centers in the U.S.
Michele Korfin, Chief Operating and Chief Commercial Officer of Gamida Cell, said, “The strong interest for transplant centers to be onboarded and excellent feedback from transplanters as they are evaluating patients for Omisirge are encouraging indicators of its potential. We are excited about the opportunity for Omisirge to capture up to 20% market share at peak, provided we are able to secure the necessary funding to support fully resourced commercialization. We are proud of what our team has accomplished to date with limited resources to deliver Omisirge to patients in need of a donor source for allogenic stem cell transplant.”
Additionally, Jenkins provided an update on the company’s operations in Israel, noting that Gamida Cell’s manufacturing facility in Kiryat Gat has remained operational amid the ongoing Israel-Hamas war. “The dedication, courage and resilience demonstrated by our employees in Israel is an inspiration to us all. Despite the horror of terrorist attacks, they have continued to put patients first and have shown incredible strength and commitment to ensuring we can reliably deliver Omisirge to patients in need.”
Gamida Cell will hold a fireside chat with Gary Schiller, M.D., Professor, Department of Medicine, Hematology/Oncology and Director, Hematological Malignancies/Stem Cell Transplantation Unit at Ronald Reagan UCLA Medical Center, a part of UCLA Health. UCLA Health was a clinical trial site for the Phase 3 study of omidubicel in patients with hematologic malignancies and is one of the 17 transplant centers where patients can currently access Omisirge. Dr. Schiller will discuss his experience working with patients in need of allogeneic stem cell transplant, including the patient journey from diagnosis to transplant, decision making around donor source selection and his experience with Omisirge since approval. The virtual event will take place on Monday, December 4 from 4:30-5:15pm ET.
Third Quarter Highlights and Recent Developments
Corporate Developments
Annual shareholders meeting: Gamida Cell held its Annual General Meeting of Shareholders in New York City on October 19. At the meeting, shareholders approved six proposals relating to the company’s business, including:
The reappointment of Directors Ken Moch and Jeremy Blank
The reappointment of Kost, Forer, Gabbay & Kaiserer as the company’s independent auditors for the fiscal year ending December 31, 2023, until the 2024 Annual General Meeting of Shareholders
Amendments to the company’s compensation policy, and CEO and non-executive directors’ compensation
An increase in Gamida Cell’s authorized share capital to 325,000,000 ordinary shares
Corporate presentation and panel discussion at Cell & Gene Meeting on the Mesa: Abbey Jenkins, President and Chief Executive Officer, presented corporate highlights, including commercial launch updates for Omisirge and an overview of market opportunity at the annual Cell & Gene Meeting on the Mesa held October 10-12 in Carlsbad, CA and livestreamed globally. Jenkins also participated in a panel discussion titled “A record setting year for cell and gene therapies – how do we keep the momentum going?”
Strategic review: Efforts to identify a strategic partner are ongoing. The company reported it has received considerable interest from multiple potential partners during the process, which has been supported by the leading global independent investment bank, Moelis & Company LLC, and has resulted in oral and written proposals. However, according to the company, it has not identified a partnership that will adequately address strategic needs. Gamida Cell intends to continue the business development process in 2024.
Scientific Publications and Medical Meetings
Publication in Transplantation and Cellular Therapy: The company announced the publication of a secondary analysis of the Phase 3 clinical trial for Omisirge titled “Hospitalization and Healthcare Resource Utilization of Omidubicel-onlv Versus Umbilical Cord Blood Transplantation for Hematologic Malignancies: Secondary Analysis from a Pivotal Phase 3 Clinical Trial.” The publication is available online on the Transplantation and Cellular Therapy website.
Data presented at Society for Immunotherapy of Cancer's (SITC) Annual Meeting: Gamida Cell presented data further characterizing the mechanism of the company’s proprietary nicotinamide (NAM) technology on the expansion and enhancement of cells at SITC November 1-5 in San Diego, California. The full press release is available here.
Omidubicel: Researchers used immunophenotyping to evaluate and characterize the cellular populations in the cultured fraction (CF) and non-cultured fraction (NF) of omidubicel compared to standard umbilical cord blood (UCB). The data indicated that omidubicel is characterized by a significantly increased number of myeloid cells compared to UCB. The results provide a potential mechanism for the rapid engraftment and immune reconstitution observed in patients transplanted with omidubicel.
GDA-201: Researchers sought to better understand the impact of Gamida Cell’s NAM technology on natural killer (NK) cell kinetics. The data presented showed increased survival of feeder cells and prolonged support in NK cell expansion, resulting in higher fold expansion in NK cells expanded with NAM. In addition, NK cells expanded with NAM showed significantly higher cytotoxicity and an active phenotype. These data provide further evidence for the unique cell culture kinetics of NAM-NK cells.
Upcoming participation in the American Society of Hematology (ASH) Annual Meeting and Exposition: Members of the Gamida Cell team will attend the upcoming ASH Annual Meeting December 9-12 in San Diego, California. A product theater will be presented on Omisirge.
GDA-201
Preliminary data from Phase 1 study: On October 16, the company announced data in 10 patients with CD20 positive non-Hodgkin lymphoma enrolled in the first three cohorts in an ongoing multicenter Phase 1 study of GDA-201. The study is designed to evaluate safety and determine the maximum tolerated dose. Preliminary results showed marked shrinkage of target lesions in five patients; efficacy evaluation showed two patients with complete response, two with partial response and one with stable disease. No dose-limiting toxicities were reported in the 10 patients treated with doses up to 1x108 cells/kg GDA-201 in combination with rituximab. Activity appears to be dose dependent with two of the three patients in Cohort 3 responding. The fourth and final cohort of the study, at the target dose level of 2x108 cells/kg, is currently enrolling at six sites in the U.S. Full Phase 1 data are expected in the first quarter of 2024. Solely for financial reasons, we do not plan to conduct the Phase 2 portion of the GDA-201 Phase 1/2 study.
Third Quarter 2023 Financial Results
Net Revenue for the third quarter 2023 was $0.7 million, resulting from the delivery of two units of Omisirge. Cost of sales, including costs of direct manufacturing and quality in addition to royalty expenses, was $0.6 million in the quarter. Over time we expect the cost of sales, and therefore the company’s gross margin, to improve measurably if production volumes scale to capacity.
Beginning July 1, 2023, the company’s reporting of operating expenses was modified to reflect the company’s transition to the commercial stage, with all operating costs now being reported as either research and development expenses, or selling, general & administrative (SG&A) expenses. For 2022 and the first two quarters of 2023, previously reported commercial and general & administrative costs were combined into SG&A expenses. Additionally, certain expenses previously reported in research and development are being reported in SG&A beginning in the third quarter of 2023, with no reclassification of prior periods.
Research and development expenses were $4.2 million in the third quarter of 2023, compared to $9.9 million in the same quarter in 2022. The $5.7 million decrease was primarily due to the aforementioned reporting transition, along with reduced omidubicel clinical spend relating to the Phase 3 clinical trial.
SG&A expenses were $13.8 million in the third quarter of 2023, an increase of $6.6 million compared to $7.2 million in the third quarter of 2022. The aforementioned financial reporting transition, which resulted in the inclusion of medical affairs expenses and certain indirect supply chain and quality assurance expenses in SG&A reporting, contributed $4.4 million to the increase in the quarter. Additionally, excess capacity costs of $2.2 million associated with our manufacturing facility were recorded in SG&A in the third quarter. Selling and marketing expenses increased by $1.3 million compared to the prior year quarter, due to commercial launch activities.
Financial income/expenses, net, were $16.5 million of income in the third quarter of 2023, compared to $0.7 million of expenses in the same period of 2022. The $17.2 million change in financial income was primarily due to $14.0 million of income related to the valuation of warrants liability and $3.2 million of income related to the valuation of the Company’s secured convertible senior notes issued in December 2022.
Net loss was $1.5 million in the third quarter of 2023, compared to a net loss of $17.8 million in the third quarter of 2022, driven primarily by the $17.2 million change in financial income referenced in the financial income/expenses, net above.
Cash position: As of September 30, 2023, Gamida Cell had total cash and cash equivalents of $60.4 million compared to $64.7 million as of December 31, 2022. The decrease of $4.3 million is due primarily to $59.2 million in net cash proceeds from financing activities, comprised of $21.1 million in net proceeds from the issuance of ordinary shares and warrants from the company’s underwritten public offering in April 2023, and $39.4 million in net proceeds from the issuance of ordinary shares via the at-the-market (ATM) facility, offset by $1.1 million in principal payments of the Company’s 2022 convertible senior note, and $62.9 million of net cash used in operating activities. The company expects its current cash and cash equivalents, including the $0.5 million in funds raised through its ATM facility subsequent to the close of the third quarter, to support its ongoing operating activities into the second quarter of 2024, based on Gamida Cell’s current operational plans and excluding commercialization activities beyond the initial launch of Omisirge as well as any additional financing activities that may be undertaken.
Debt position: As of September 30, 2023, the company had reduced its principal balance on the December 2022 secured senior convertible note by $16.7 million, from $25.0 million as of December 31, 2022, to $8.3 million at the end of the third quarter of 2023. The company also has outstanding 2021 convertible senior notes with an aggregate principal amount of $75.0 million.
Conference Call Information
Gamida Cell will host a conference call today, November 14, at 8:30 a.m. ET to discuss these financial results and company updates. To access the conference call by phone, please register here or dial 1-877-425-9470 for domestic callers or 1-201-389-0878 for international callers and enter the conference ID 13741024. A live conference call webcast can be accessed here. A webcast replay will be available approximately two hours after the event for approximately 30 days.
About Gamida Cell
Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include Omisirge® (omidubicel-onlv), an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic natural killer (NK) cell therapy candidate being investigated for the treatment of hematologic malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, X, Facebook or Instagram.
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 the potentially life-saving or curative therapeutic and commercial potential of Omisirge® (omidubicel-onlv), the Company’s cell therapy candidate, GDA-201, expectations regarding the commercial launch of Omisirge and potential to capture market share or generate revenue, Gamida Cell’s plans for commercial or strategic partnerships to support the launch of Omisirge, Gamida Cell’s financial runway, Gamida Cell’s ability to keep its Israel facilities open, the state of its workforce, and future developments that may adversely impact Gamida Cell’s Israel operations. 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 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. 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 November 14, 2023, and other filings that Gamida Cell makes with the SEC from time to time (which are available at 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.
OMISIRGE® is a registered trademark of Gamida Cell Inc. © 2023 Gamida Cell Inc. All Rights Reserved.
GAMIDA CELL LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share and per share data)
September 30,
December 31,
2023
2022
(Unaudited)
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
60,431
$
64,657
Short-term restricted deposit
2,723
-
Inventory
2,324
-
Accounts Receivable
676
-
Prepaid expenses and other current assets
2,355
1,889
Total current assets
68,509
66,546
NON-CURRENT ASSETS:
Restricted deposits
377
3,668
Property, plant and equipment, net
42,667
44,319
Operating lease right-of-use assets
3,706
7,024
Severance pay fund
1,288
1,703
Other long-term assets
1,201
1,513
Total non-current assets
49,239
58,227
Total assets
$
117,748
$
124,773
LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT)
CURRENT LIABILITIES:
Trade payables
$
1,664
$
6,384
Employees and payroll accruals
6,058
5,300
Operating lease liabilities
1,497
2,648
Accrued interest of convertible senior notes
710
1,652
Accrued expenses and other current liabilities
10,725
8,891
Total current liabilities
20,654
24,875
NON-CURRENT LIABILITIES:
Convertible senior notes, net
81,419
96,450
Warrants liability
11,610
-
Accrued severance pay
1,381
1,914
Long-term operating lease liabilities
2,302
4,867
Other long-term liabilities
-
4,690
Total non-current liabilities
96,712
107,921
CONTINGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY (DEFICIT):
Ordinary shares of NIS 0.01 par value
357
211
Treasury ordinary shares of NIS 0.01 par value
*
*
Additional paid-in capital
471,012
408,598
Accumulated deficit
(470,987
)
(416,832
)
Total shareholders’ equity (deficit)
382
(8,023
)
Total liabilities and shareholders’ equity (deficit)
$
117,748
$
124,773
* Represents an amount lower than $1
GAMIDA CELL LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and per share data)
(Unaudited)
Three months ended
September 30,
Nine months ended
September 30,
2023
2022
2023
2022
Net Revenue
$
673
-
$
673
-
Cost of Sales
626
-
626
-
Research and development expenses, net
$
4,248
$
9,864
$
21,776
$
31,732
Selling, general and administrative
13,837
7,197
34,691
22,698
Total operating expenses
18,085
17,061
56,467
54,430
Total operating loss
18,038
17,061
56,420
54,430
Financial (income) expenses, net
(16,519
)
741
(2,265
)
2,149
Net Loss
$
1,519
$
17,802
$
54,155
$
56,579
Net loss per share attributable to ordinary shareholders, basic and diluted
0.01
0.29
0.53
0.95
GAMIDA CELL LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands (except share and per share data)
(Unaudited)
Nine months ended September 30,
2023
2022
Cash flows from operating activities:
Net Income (Loss)
$
(54,155
)
$
(56,579
)
Adjustments to reconcile loss to net cash used in operating activities:
Depreciation of property, plant and equipment
1,024
391
Financing expense (income), net
61
(2,461
)
Share-based compensation
4,297
3,829
Change in Fair Value of Warrants liability
(9,143
)
-
Change in Fair Value of convertible senior note
1,039
-
Warrants Issuance Costs
1,733
-
Amortization of loan issuance costs
625
582
Change in assets and liabilities:
Inventory
(92
)
-
Operating lease right-of-use assets
2,020
1,922
Operating lease liabilities
(2,417
)
(2,395
)
Increase in Accounts Receivable
(676
)
-
Increase (decrease) in accrued severance pay, net
(118
)
23
Increase (decrease) in prepaid expenses and other assets
(239
)
1,719
Decrease in trade payables
(4,720
)
(6,355
)
Increase (decrease) in accrued expenses and other liabilities
(2,096
)
5,079
Net cash used in operating activities
(62,857
)
(54,245
)
Cash flows from investing activities:
Purchase of property, plant and equipment
(833
)
(2,865
)
Purchase of marketable securities
-
(4,557
)
Proceeds from maturity of marketable securities
-
37,972
Proceeds from restricted deposits
294
500
Net cash provided by (used in) investing activities
$
(539
)
$
31,050
Cash flows from financing activities:
Proceeds from exercise of warrants liability
$
45
-
Proceeds from exercise of options
-
76
Principal payments of convertible senior note
(1,142
)
-
Proceeds from share issuance and warrants liability, net
60,267
22,298
Net cash provided by financing activities
59,170
22,374
Decrease in cash and cash equivalents
(4,226
)
(821
)
Cash and cash equivalents at beginning of period
64,657
55,892
Cash and cash equivalents at end of period
$
60,431
$
55,071
Gamida Cell Presents New Data on Allogeneic Stem Cell Therapy Omidubicel and Natural Killer (NK) Cell Therapy Candidate GDA-201 at Society for Immunotherapy of Cancer (SITC) Annual Meeting
https://finance.yahoo.com/news/gamida-cell-presents-data-allogeneic-120000624.html
Data further characterize the mechanism for Gamida Cell’s proprietary nicotinamide (NAM) technology’s expansion and enhancement of cells
BOSTON, Nov. 04, 2023 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today shared new data on the impact of the company’s proprietary nicotinamide (NAM) technology on its allogeneic stem cell therapy omidubicel and investigational natural killer (NK) cell therapy candidate GDA-201 at the Society for Immunotherapy of Cancer’s (SITC) Annual Meeting in San Diego, CA.
Both omidubicel and GDA-201 are powered by Gamida Cell’s proprietary NAM technology, which enhances and expands cells to create potentially curative cell therapies for patients with cancer. Omidubicel was approved under the brand name Omisirge™ (omidubicel-onlv) by the U.S. FDA in April 2023 for allogeneic stem cell transplant; GDA-201 is in Phase 1 study for the treatment of non-Hodgkin lymphoma (NCT05296525). Data on the first three cohorts of the Phase 1 study of GDA-201 were recently reported.
“The data presented at SITC further our understanding of the effect of NAM in enhancing and expanding cells,” said Ronit Simantov, MD, Chief Medical and Scientific Officer of Gamida Cell. “Our data characterize the unique cellular composition of omidubicel, which is enriched in myeloid populations and dendritic cells, providing a potential mechanism for rapid engraftment and immune reconstitution, and is associated with lower infection rates observed in patients transplanted with omidubicel. Similarly, our data on GDA-201 demonstrate the unique, active phenotype of our NK cells expanded in the presence of NAM.”
Additional details are as follows:
Title: Significant myeloid and dendritic cellular enrichment of omidubicel graft suggests fast homeostatic proliferation of lymphoid populations
Abstract number: 336
Presenting author: Dima Yackoubov
Time: Saturday, November 4, 2023, 9:00 a.m. – 8:30 p.m. PDT
Location: Exhibit Halls A and B1
Highlights: In this study, immunophenotyping was used to evaluate and characterize the cellular populations in the cultured fraction (CF) and non-cultured fraction (NF) of omidubicel (manufactured with Gamida Cell’s proprietary NAM technology) compared to standard umbilical cord blood (UCB). Manufacturing significantly increased the total nucleated cells (1.2-1.6-fold) and myeloid cells (2.2-3.6-fold) in the omidubicel CF compared to UCB. In addition, high resolution analysis of the CF showed a 25-62-fold increase in myeloid populations and dendritic cells and an absence of mature lymphoid cell populations. The NF was found to contain 50-70% fewer total with a comparable percentage of T cells, B cells, NK cells and NK-T cells to UCB. The results of this phenotypic characterization of omidubicel provide a potential mechanism for the rapid engraftment and immune reconstitution observed in transplanted patients.
Title: GDA-201, nicotinamide (NAM) expanded NK cells derived from peripheral apheresis, show unique culture kinetics and increased expansion
Abstract number: 401
Presenting author: Avner Yeffet, Ph.D.
Time: Friday, November 3, 2023, 9:00 a.m. – 7:00 p.m. PDT
Location: Exhibit Halls A and B1
Highlights: This study evaluated the impact of Gamida Cell’s NAM technology on NK cell kinetics. During the first days of expansion, NAM increased the survival of the feeder cells (45% on day 2-3 vs 13% on day 2-3) and prolonged their support in NK cell expansion, resulting in higher fold expansion persisting up to 21 days. In addition, NK cells expanded using NAM showed significantly higher cytotoxicity against leukemia cells (from a killing cytotoxicity function of 62.54% without NAM to 81.84% with NAM), and preservation of the NK cells in a partially mature state with low expression of CD57. These data provide further evidence for the unique cell culture kinetics of NAM-NK cells, GDA-201, which is currently being evaluated in a Phase 1 clinical trial in patients with non-Hodgkin lymphoma.
About GDA-201
GDA-201 is an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. A multicenter Phase 1 study of GDA-201 for the treatment of non-Hodgkin lymphoma is ongoing (NCT05296525). Results are expected in Q1 2024.
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.
Omisirge™ (omidubicel-onlv) Indication
Omisirge is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.
Important Safety Information for Omisirge
BOXED WARNING: INFUSION REACTIONS, GRAFT VERSUS HOST DISEASE, ENGRAFTMENT SYNDROME, AND GRAFT FAILURE
Infusion reactions may be fatal. Monitor patients during infusion and discontinue for severe reactions. Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin or bovine material.
Graft-versus-Host Disease may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD.
Engraftment syndrome may be fatal. Treat engraftment syndrome promptly with corticosteroids.
Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery.
Contraindications
OMISIRGE is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine products.
Warnings and Precautions
Hypersensitivity Reactions
Allergic reactions may occur with the infusion of OMISIRGE. Reactions include bronchospasm, wheezing, angioedema, pruritis and hives. Serious hypersensitivity reactions, including anaphylaxis, may be due to DMSO, residual gentamicin, Dextran 40, human serum albumin (HSA) and bovine material in OMISIRGE. OMISIRGE may contain residual antibiotics if the cord blood donor was exposed to antibiotics in utero. Patients with a history of allergic reactions to antibiotics should be monitored for allergic reactions following OMISIRGE administration.
Infusion Reactions
Infusion reactions occurred following OMISIRGE infusion, including hypertension, mucosal inflammation, dysphagia, dyspnea, vomiting, and gastrointestinal toxicity. Premedication with antipyretics, histamine antagonists, and corticosteroids may reduce the incidence and intensity of infusion reactions. In patients transplanted with OMISIRGE in clinical trials, 47% (55/117) patients had an infusion reaction of any severity. Grade 3-4 infusion reactions were reported in 15% (18/117) patients. Infusion reactions may begin within minutes of the start of infusion of OMISIRGE, although symptoms may continue to intensify and not peak for several hours after the completion of the infusion. Monitor patients for signs and symptoms of infusion reactions during and after OMISIRGE administration. When a reaction occurs, pause the infusion and institute supportive care as needed.
Graft-versus-Host Disease
Acute and chronic GvHD, including life-threatening and fatal cases, occurred following treatment with OMISIRGE. In patients transplanted with OMISIRGE Grade II-IV acute GvHD was reported in 58% (68/117). Grade III- IV acute GvHD was reported in 17% (20/117). Chronic GvHD occurred in 35% (41/117) of patients. Acute GvHD manifests as maculopapular rash, gastrointestinal symptoms, and elevated bilirubin. Patients treated with OMISIRGE should receive immunosuppressive drugs to decrease the risk of GvHD, be monitored for signs and symptoms of GvHD, and treated if GvHD develops.
Engraftment Syndrome
Engraftment syndrome may occur because OMISIRGE is derived from umbilical cord blood. Monitor patients for unexplained fever, rash, hypoxemia, weight gain, and pulmonary infiltrates in the peri-engraftment period. Treat with corticosteroids as soon as engraftment syndrome is recognized to ameliorate symptoms. If untreated, engraftment syndrome may progress to multiorgan failure and death.
Graft Failure
Primary graft failure occurred in 3% (4/117) of patients in OMISIRGE clinical trials. Primary graft failure, which may be fatal, is defined as failure to achieve an absolute neutrophil count greater than 500 per microliter blood by Day 42 after transplantation. Immunologic rejection is the primary cause of graft failure. Monitor patients for laboratory evidence of hematopoietic recovery.
Malignancies of Donor Origin
Two patients treated with OMISIRGE developed post-transplant lymphoproliferative disorder (PTLD) in the second-year post-transplant. PTLD manifests as a lymphoma-like disease favoring non-nodal sites. PTLD is usually fatal if not treated. The etiology is thought to be donor lymphoid cells transformed by Epstein-Barr virus (EBV). Serial monitoring of blood for EBV DNA may be warranted in patients with persistent cytopenias. One patient treated with OMISIRGE developed a donor-cell derived myelodysplastic syndrome (MDS) during the fourth-year post-transplant. The natural history is presumed to be the same as that for de novo MDS. Monitor life-long for secondary malignancies. If a secondary malignancy occurs, contact Gamida Cell at (844) 477-7478.
Transmission of Serious Infections
Transmission of infectious disease may occur because OMISIRGE is derived from umbilical cord blood. Disease may be caused by known or unknown infectious agents. Donors are screened for increased risk of infection, clinical evidence of sepsis, and communicable disease risks associated with xenotransplantation. Maternal and infant donor blood is tested for evidence of donor infection. See full Prescribing Information, Warnings and Precautions, Transmission of Serious Infections for list of testing performed. OMISIRGE is tested for sterility, endotoxin, and mycoplasma. There may be an effect on the reliability of the sterility test results if the cord blood donor was exposed to antibiotics in utero. Product manufacturing includes bovine-derived reagents. All animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use. These measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Test results may be found on the container label and/or in accompanying records. If final sterility results are not available at the time of use, Quality Assurance will communicate any positive results from sterility testing to the physician. Report the occurrence of transmitted infection to Gamida Cell at (844) 477-7478.
Transmission of Rare Genetic Diseases
OMISIRGE may transmit rare genetic diseases involving the hematopoietic system because it is derived from umbilical cord blood. Cord blood donors have been screened to exclude donors with sickle cell anemia, and anemias due to abnormalities in hemoglobins C, D, and E. Because of the age of the donor at the time cord blood collection takes place, the ability to exclude rare genetic diseases is severely limited.
ADVERSE REACTIONS
The most common adverse reactions (incidence > 20%) are infections, GvHD, and infusion reaction.
Please see full , including Boxed Warning.
About Gamida Cell
Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include Omisirge™ (omidubicel-onlv), an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, X, Facebook or Instagram.
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 the potentially life-saving or curative therapeutic and commercial potential of Omisirge™ (omidubicel-onlv), and the Company’s cell therapy candidate, GDA-201. 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 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. 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 14, 2023, and other filings that Gamida Cell makes with the SEC from time to time (which are available at 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.
OMISIRGE™ is a trademark of Gamida Cell Inc. © 2023 Gamida Cell Inc. All Rights Reserved
Media Contact:
Dan Boyle
Orangefiery
media@orangefiery.com
1-818-209-1692
Investor Contact:
Chuck Padala
LifeSci Advisors
Chuck@lifesciadvisors.com
1-646-627-8390
0.7799+0.0853 (+12.2805%)
As of 03:34PM EDT. Market open.
Volume 1,122,268
Avg. Volume 1,047,475
Finally some signs of life!
Gamida Cell to Report Third Quarter 2023 Financial Results
https://finance.yahoo.com/news/gamida-cell-report-third-quarter-120000632.html
BOSTON, Nov. 01, 2023 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that the company will release its financial results for the third quarter ended September 30, 2023 and provide an update on the company on Tuesday, November 14, 2023.
Following the release, management will host a conference call and live webcast at 8:30 am Eastern Time to discuss the financial results, provide business updates and answer questions..
Gamida Cell Reports Preliminary Data from Phase 1 Study of Natural Killer (NK) Cell Therapy Candidate GDA-201
https://finance.yahoo.com/news/gamida-cell-reports-preliminary-data-203900267.html
Gamida Cell Reports Preliminary Data From Phase 1 Study Of Natural Killer Cell Therapy Candidate Gda-201
Data show promising early evidence of anti-tumor activity in patients with relapsed/refractory B cell non-Hodgkin lymphoma
Full data readout of Phase 1 study expected in Q1 2024
BOSTON, October 16, 2023--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced new early data in 10 patients with CD20 positive non-Hodgkin lymphoma enrolled in the first three cohorts in an ongoing multicenter Phase 1 study of natural killer (NK) cell therapy candidate GDA-201. The study is designed to evaluate safety and determine the maximum tolerated dose.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231016887701/en/
(Graphic: Gamida Cell Ltd.)
Enrolled patients were heavily pretreated with a median of six prior lines of therapy, including CAR-T cell therapy (six patients) and hematopoietic stem cell transplant (four patients). Preliminary results showed marked shrinkage of target lesions in five patients; efficacy evaluation showed two patients with complete response, two with partial response, and one with stable disease. No dose-limiting toxicities were reported in the 10 patients treated with doses up to 1x108 cells/kg GDA-201 in combination with rituximab.
Activity appears to be dose dependent with two of the three patients in Cohort 3 responding. The fourth and final cohort of the study, at the target dose level of 2x108 cells/kg, is currently enrolling.
"We have demonstrated that our nicotinamide (NAM)-modified NK cells have enhanced metabolic fitness, resistance to oxidative stress and potent cytotoxicity, meaning that GDA-201 has the potential for powerful anti-tumor activity," said Ronit Simantov, MD, Chief Medical and Scientific Officer of Gamida Cell. "We are encouraged by the safety and activity observed thus far in our Phase 1 study of cryopreserved GDA-201, which is consistent with results from the Phase 1 study of a fresh formulation of GDA-201 conducted at the University of Minnesota. We look forward to continuing to follow these patients and completing enrollment in our next cohort, and anticipate sharing the full Phase I data in early 2024."
The 10 enrolled patients were diagnosed with diffuse large / high grade B cell lymphoma (6), marginal zone lymphoma (2), follicular lymphoma (1) and mantle cell lymphoma (1). Successive cohorts of patients received dose levels of 2.5x107 cells/kg, 5x107 cells/kg and 1x108 cells/kg of GDA-201 with rituximab after fludarabine/cyclophosphamide lymphodepletion. Two patients treated had cytokine release syndrome (grade 1 and grade 2, respectively). The most common grade 3-4 adverse event was transient neutropenia. There were no reported cases of immune effector cell associated neurotoxicity syndrome or graft versus host disease. There was one death from progressive disease.
The NK cells which comprise GDA-201 are powered by Gamida Cell’s proprietary NAM technology, which enhances and expands cells to enhance functionality and phenotype, increase metabolic fitness and reduce oxidative stress. These functional qualities were studied in detail in a recent study published in July 2023 in Science Translational Medicine, which showed that NK cells cultured with NAM had increased energy levels, enhanced ability to arrive at and invade tumors, and an ability to efficiently eradicate malignant cells in the harsh conditions of the tumor microenvironment.
Additionally, the publication includes clinical data from 19 non-Hodgkin lymphoma patients who received the fresh formulation of GDA-201 in a Phase 1 study conducted at the University of Minnesota. GDA-201 exhibited a promising efficacy profile, with an overall response rate of 74% and a complete response rate of 68%. While GDA-201 cells were detected up to 14 days in patients’ blood, the median duration of response was 16 months (range: 5-36 months), suggesting that GDA-201 treatment may prime an endogenous anti-tumor immune response.
About GDA-201
GDA-201 is an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. A multicenter Phase 1 study of GDA-201 for the treatment of non-Hodgkin lymphoma is ongoing (NCT05296525). Results are expected in Q1 2024.
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 a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include Omisirge™ (omidubicel-onlv), an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, X, Facebook or Instagram.
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 the Company’s cell therapy candidate, GDA-201. 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 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. 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 14, 2023, and other filings that Gamida Cell makes with the SEC from time to time (which are available at 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.
OMISIRGE™ is a trademark of Gamida Cell Inc. © 2023 Gamida Cell Inc. All Rights Reserved.
View source version on businesswire.com: https://www.businesswire.com/news/home/20231016887701/en/
Contacts
Media Contact:
Dan Boyle
Orangefiery
media@orangefiery.com
1-818-209-1692
Investor Contact:
Chuck Padala
LifeSci Advisors
Chuck@lifesciadvisors.com
1-646-627-8390
Excellent timing!
Gamida Cell Issues Update on Israel Operations
https://finance.yahoo.com/news/gamida-cell-issues-israel-operations-180000086.html
BOSTON, October 09, 2023--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today issued an update on its operations in Israel.
"We remain profoundly saddened by the attacks in Israel this weekend and express our deepest condolences to the people of Israel as they mourn the loss of loved ones and defend themselves," said Abbey Jenkins, President and Chief Executive Officer of Gamida Cell. "We have been in touch with our employees in Israel and all are reported safe. We are committed to serving our customers and patients and our manufacturing facility is operational. We thank all our partners and investors who have reached out to express their support. We are continuing to monitor the situation closely and will provide updates as needed."
Gamida Cell issued a statement on Oct. 7 condemning the attacks on Israel and declaring its solidarity with its employees in Israel and the State of Israel, which can be found here.
Thank you murocman, i am
still very much alive and kicking!
https://www.facebook.com/photo/?fbid=10159394603229265&set=pob.716974264
(That is me, albeit many many years ago)
$GMDA We are a proud sponsor of the
@BeTheMatch
Minneapolis Gala.
@BeTheMatch
works every day to save lives through transplant and it was an honor to participate in this evening of inspiration and hope.
#BeTheMatch #Gala #CellTherapy
(Great improvement in PR activities and communications!)
Gamida Cell to Present Corporate Highlights at 2023 Cell & Gene Meeting on the Mesa
https://finance.yahoo.com/news/gamida-cell-present-corporate-highlights-120000260.html
Abbey Jenkins, President and Chief Executive Officer, to also participate in the panel "A record setting year for cell and gene therapies – how do we keep the momentum going?"
BOSTON, October 02, 2023--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that Abbey Jenkins, President and Chief Executive Officer, will present its corporate highlights at the annual Cell & Gene Meeting on the Mesa to be held October 10-12 in Carlsbad, California, and livestreamed globally. Ms. Jenkins will also participate in a panel titled "A record setting year for cell and gene therapies – how do we keep the momentum going?" at the event.
During Gamida Cell’s corporate presentation, Ms. Jenkins will share commercial launch updates for Omisirge™ (omidubicel-onlv), the company's allogeneic stem cell therapy, and an overview of the market opportunity.
Organized by the Alliance for Regenerative Medicine, the Cell & Gene Meeting on the Mesa is an annual three-day conference featuring more than 100 presentations by 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.
Virtual attendance is available and includes a livestream of Gamida Cell’s presentation and the ability to view all conference sessions on-demand. Please visit https://meetingonthemesa.com for more information.
The following are details regarding Gamida Cell’s presentation at the conference:
Date: Wednesday, October 11
Time: 4:45 – 5:00 p.m. PT
Location: Aseptic Technologies Ballroom, Park Hyatt Aviara Resort, 7100 Aviara Resort Dr., Carlsbad, CA 92011
The following are details regarding Ms. Jenkins’ panel participation at the conference:
Panel: A record setting year for cell and gene therapies – how do we keep the momentum going?
Date: Wednesday, October 11
Time: 3:15 – 4:15 p.m. PT
Location: Aseptic Technologies Ballroom, Park Hyatt Aviara Resort, 7100 Aviara Resort Dr., Carlsbad, CA 92011
Complimentary attendance at this event is available for credentialed investors and members of the media only. Investors should contact Savannah Bryant at sbryant@alliancerm.org and interested media should contact Stephen Majors at smajors@alliancerm.org.
Omisirge Indication
Omisirge is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.
Important Safety Information for Omisirge
BOXED WARNING: INFUSION REACTIONS, GRAFT VERSUS HOST DISEASE, ENGRAFTMENT SYNDROME, AND GRAFT FAILURE
Infusion reactions may be fatal. Monitor patients during infusion and discontinue for severe reactions. Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin or bovine material.
Graft-versus-Host Disease may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD.
Engraftment syndrome may be fatal. Treat engraftment syndrome promptly with corticosteroids.
Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery.
Contraindications
OMISIRGE is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine products.
Warnings and Precautions
Hypersensitivity Reactions
Allergic reactions may occur with the infusion of OMISIRGE. Reactions include bronchospasm, wheezing, angioedema, pruritis and hives. Serious hypersensitivity reactions, including anaphylaxis, may be due to DMSO, residual gentamicin, Dextran 40, human serum albumin (HSA) and bovine material in OMISIRGE. OMISIRGE may contain residual antibiotics if the cord blood donor was exposed to antibiotics in utero. Patients with a history of allergic reactions to antibiotics should be monitored for allergic reactions following OMISIRGE administration.
Infusion Reactions
Infusion reactions occurred following OMISIRGE infusion, including hypertension, mucosal inflammation, dysphagia, dyspnea, vomiting, and gastrointestinal toxicity. Premedication with antipyretics, histamine antagonists, and corticosteroids may reduce the incidence and intensity of infusion reactions. In patients transplanted with OMISIRGE in clinical trials, 47% (55/117) patients had an infusion reaction of any severity. Grade 3-4 infusion reactions were reported in 15% (18/117) patients. Infusion reactions may begin within minutes of the start of infusion of OMISIRGE, although symptoms may continue to intensify and not peak for several hours after the completion of the infusion. Monitor patients for signs and symptoms of infusion reactions during and after OMISIRGE administration. When a reaction occurs, pause the infusion and institute supportive care as needed.
Graft-versus-Host Disease
Acute and chronic GvHD, including life-threatening and fatal cases, occurred following treatment with OMISIRGE. In patients transplanted with OMISIRGE Grade II-IV acute GvHD was reported in 58% (68/117). Grade III-IV acute GvHD was reported in 17% (20/117). Chronic GvHD occurred in 35% (41/117) of patients. Acute GvHD manifests as maculopapular rash, gastrointestinal symptoms, and elevated bilirubin. Patients treated with OMISIRGE should receive immunosuppressive drugs to decrease the risk of GvHD, be monitored for signs and symptoms of GvHD, and treated if GvHD develops.
Engraftment Syndrome
Engraftment syndrome may occur because OMISIRGE is derived from umbilical cord blood. Monitor patients for unexplained fever, rash, hypoxemia, weight gain, and pulmonary infiltrates in the peri-engraftment period. Treat with corticosteroids as soon as engraftment syndrome is recognized to ameliorate symptoms. If untreated, engraftment syndrome may progress to multiorgan failure and death.
Graft Failure
Primary graft failure occurred in 3% (4/117) of patients in OMISIRGE clinical trials. Primary graft failure, which may be fatal, is defined as failure to achieve an absolute neutrophil count greater than 500 per microliter blood by Day 42 after transplantation. Immunologic rejection is the primary cause of graft failure. Monitor patients for laboratory evidence of hematopoietic recovery.
Malignancies of Donor Origin
Two patients treated with OMISIRGE developed post-transplant lymphoproliferative disorder (PTLD) in the second-year post-transplant. PTLD manifests as a lymphoma-like disease favoring non-nodal sites. PTLD is usually fatal if not treated. The etiology is thought to be donor lymphoid cells transformed by Epstein-Barr virus (EBV). Serial monitoring of blood for EBV DNA may be warranted in patients with persistent cytopenias. One patient treated with OMISIRGE developed a donor-cell derived myelodysplastic syndrome (MDS) during the fourth-year post-transplant. The natural history is presumed to be the same as that for de novo MDS. Monitor life-long for secondary malignancies. If a secondary malignancy occurs, contact Gamida Cell at (844) 477-7478.
Transmission of Serious Infections
Transmission of infectious disease may occur because OMISIRGE is derived from umbilical cord blood. Disease may be caused by known or unknown infectious agents. Donors are screened for increased risk of infection, clinical evidence of sepsis, and communicable disease risks associated with xenotransplantation. Maternal and infant donor blood is tested for evidence of donor infection. See full Prescribing Information, Warnings and Precautions, Transmission of Serious Infections for list of testing performed. OMISIRGE is tested for sterility, endotoxin, and mycoplasma. There may be an effect on the reliability of the sterility test results if the cord blood donor was exposed to antibiotics in utero. Product manufacturing includes bovine-derived reagents. All animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use. These measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Test results may be found on the container label and/or in accompanying records. If final sterility results are not available at the time of use, Quality Assurance will communicate any positive results from sterility testing to the physician. Report the occurrence of transmitted infection to Gamida Cell at (844) 477-7478.
Transmission of Rare Genetic Diseases
OMISIRGE may transmit rare genetic diseases involving the hematopoietic system because it is derived from umbilical cord blood. Cord blood donors have been screened to exclude donors with sickle cell anemia, and anemias due to abnormalities in hemoglobins C, D, and E. Because of the age of the donor at the time cord blood collection takes place, the ability to exclude rare genetic diseases is severely limited.
ADVERSE REACTIONS
The most common adverse reactions (incidence > 20%) are infections, GvHD, and infusion reaction.
Please see full Prescribing Information, including Boxed Warning.
About Gamida Cell
Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include Omisirge™ (omidubicel-onlv), an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, X, Facebook or Instagram.
Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material
On September 29, 2023, Gamida Cell Ltd. (the “Company”) mailed to its shareholders of record as of the close of business on September 11, 2023 the following materials relating to the Company’s 2023 annual general meeting of shareholders (the “Annual Meeting”):
September 29, 2023
Important Shareholder Meeting
Dear Fellow Shareholders,
As you probably already know, Gamida Cell’s annual general meeting of shareholders is scheduled to be held on Thursday, October 19, 2023, at 10:00am ET. We encourage you to read the proxy statement, vote your shares and attend the meeting as described therein. We’ve included another form of proxy with this letter which will make it easier for you to vote your shares at this very important annual general meeting.
Included among the six ballot items, under Proposal 6 we are seeking approval of an increase in the number of our ordinary shares authorized for issuance in our share reserve, which we believe will provide us with certain flexibility to continue financing the business prudently in order to achieve our two-pronged corporate strategy. Your Board of Directors recommends that you vote in favor of all six of the proposed resolutions and believes we have the right combination of skills and experience to capitalize on the significant opportunity that Omisirge’s recent FDA marketing approval presents.
We would like this opportunity to update you on the progress of our two-pronged approach, which was announced at the end of March 2023 relating to (i) the targeted launch of Omisirge (omidubicel-onlv) in the United States, and (ii) pursuing a strategic partnership or transaction with a bio-pharmaceutical company to expand transplant center onboarding and accelerate patient access to Omisirge.
Targeted Launch of Omisirge
This week we announced that the first patient has received a stem cell transplant with Omisirge. This is a significant milestone for Gamida Cell, marking the advancement of our mission of delivering potentially curative therapies to patients with cancer. We believe this patient is just the first of many who have new hope for a cure, thanks to the availability of Omisirge as a new stem cell transplant donor source.
As we also shared this week, we are pleased with the progress we are making with the launch of Omisirge to date, especially in light of our need to launch with a limited investment and field footprint in order to appropriately manage our cash. Gamida Cell has already exceeded its 2023 launch goals, with 15 transplant centers onboarded across the United States and confirmed coverage with payers that cover 90% of commercial lives. We are actively engaged with more than 90% of the top 70 transplant centers, which perform approximately 80% of transplants. Transplanters are identifying patients for whom they intend to use Omisirge as their donor source, with an increasing number of patients being enrolled in Gamida Cell Assist, which indicates the transplanter’s intention to use Omisirge as the donor source.
We have conducted multiple market research studies that confirm the unmet need in the market and associated market share potential of Omisirge with a fully resourced launch. These studies showed that Omisirge has the potential to capture approximately 20% market share at peak, which we estimate could drive over $600 million in net sales within 5 years.
Pursuing a Strategic Partnership or Transaction
We continue to actively engage with potential strategic partners to identify the best strategic and commercial fit to support the early launch of Omisirge and its long-term potential to address critical unmet needs in stem cell transplantation. To ensure that we maintain early launch momentum while pursuing strategic alternatives, we were pleased to share at our second quarter earnings call that we have strengthened our balance sheet significantly, extending our cash runway into Q2 of 2024.
In the spirit of creating value, we continue to be laser focused on successfully executing both prongs of our corporate strategy, and believe it is critical to maintain financial strength and liquidity in order to effectively position the company in a potential transaction. While we are sensitive to shareholder dilution, raising capital through the issuance of shares may be necessary from time to time. As we strive to successfully complete a strategic transaction, we must continue to invest in the launch of Omisirge and our ongoing operations.
We continue to work on your behalf to create shareholder value and appreciate your support.
Sincerely,
Shawn Tomasello
Thank you rwwine!
I am pretty sure sp will increase, although some bumps
will still occur down the road.
It seems to me that $GMDA management are adopting the
AVIS slogan=We (now) try harder!
Enjoy your weekend!
Very nice to see Midas!! Thank you for sharing the last few updates. Renewing hope for us small investors. Happy Friday to you sir.
“The road ahead certainly looks more promising!”
I wholeheartedly agree sir. I guess my question is, will they continue to go alone or will they secure a partner to support the marketing and sales expansion of their FDA approved treatment?
Finally some positive news!! Thank you for sharing Midas….
Gamida Cell to Present at Society for Immunotherapy of Cancer's (SITC) 38th Annual Meeting
https://finance.yahoo.com/news/gamida-cell-present-society-immunotherapy-120000968.html
BOSTON, September 28, 2023--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that it will be presenting at the Society for Immunotherapy of Cancer’s 38th Annual Meeting (SITC 2023) taking place in San Diego, CA and virtually November 1-5, 2023.
Details about the poster presentations are as follows:
Title: GDA-201, nicotinamide (NAM) expanded NK cells derived from peripheral apheresis, show unique culture kinetics and increased expansion
Abstract number: 401
Presenter: Avner Yeffet, Ph.D.
Time: Friday, November 3, 2023, 9:00 a.m. – 7:00 p.m. PDT
Location: Exhibit Halls A and B1
Title: Significant myeloid and dendritic cellular enrichment of omidubicel graft suggests fast homeostatic proliferation of lymphoid populations
Abstract number: 336
Presenter: Dima Yackoubov
Time: Saturday, November 4, 2023, 9:00 a.m. – 8:30 p.m. PDT
Location: Exhibit Halls A and B1
About GDA-201
GDA-201 is an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. A multicenter Phase 1 study of GDA-201 for the treatment of non-Hodgkin lymphoma is ongoing (NCT05296525). Results are expected in Q1 2024.
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.
Omisirge™ (omidubicel-onlv) Indication
Omisirge is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.
Important Safety Information for Omisirge
BOXED WARNING: INFUSION REACTIONS, GRAFT VERSUS HOST DISEASE, ENGRAFTMENT SYNDROME, AND GRAFT FAILURE
Infusion reactions may be fatal. Monitor patients during infusion and discontinue for severe reactions. Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin or bovine material.
Graft-versus-Host Disease may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD.
Engraftment syndrome may be fatal. Treat engraftment syndrome promptly with corticosteroids.
Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery.
Contraindications
OMISIRGE is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine products.
Warnings and Precautions
Hypersensitivity Reactions
Allergic reactions may occur with the infusion of OMISIRGE. Reactions include bronchospasm, wheezing, angioedema, pruritis and hives. Serious hypersensitivity reactions, including anaphylaxis, may be due to DMSO, residual gentamicin, Dextran 40, human serum albumin (HSA) and bovine material in OMISIRGE. OMISIRGE may contain residual antibiotics if the cord blood donor was exposed to antibiotics in utero. Patients with a history of allergic reactions to antibiotics should be monitored for allergic reactions following OMISIRGE administration.
Infusion Reactions
Infusion reactions occurred following OMISIRGE infusion, including hypertension, mucosal inflammation, dysphagia, dyspnea, vomiting, and gastrointestinal toxicity. Premedication with antipyretics, histamine antagonists, and corticosteroids may reduce the incidence and intensity of infusion reactions. In patients transplanted with OMISIRGE in clinical trials, 47% (55/117) patients had an infusion reaction of any severity. Grade 3-4 infusion reactions were reported in 15% (18/117) patients. Infusion reactions may begin within minutes of the start of infusion of OMISIRGE, although symptoms may continue to intensify and not peak for several hours after the completion of the infusion. Monitor patients for signs and symptoms of infusion reactions during and after OMISIRGE administration. When a reaction occurs, pause the infusion and institute supportive care as needed.
Graft-versus-Host Disease
Acute and chronic GvHD, including life-threatening and fatal cases, occurred following treatment with OMISIRGE. In patients transplanted with OMISIRGE Grade II-IV acute GvHD was reported in 58% (68/117). Grade III-IV acute GvHD was reported in 17% (20/117). Chronic GvHD occurred in 35% (41/117) of patients. Acute GvHD manifests as maculopapular rash, gastrointestinal symptoms, and elevated bilirubin. Patients treated with OMISIRGE should receive immunosuppressive drugs to decrease the risk of GvHD, be monitored for signs and symptoms of GvHD, and treated if GvHD develops.
Engraftment Syndrome
Engraftment syndrome may occur because OMISIRGE is derived from umbilical cord blood. Monitor patients for unexplained fever, rash, hypoxemia, weight gain, and pulmonary infiltrates in the peri-engraftment period. Treat with corticosteroids as soon as engraftment syndrome is recognized to ameliorate symptoms. If untreated, engraftment syndrome may progress to multiorgan failure and death.
Graft Failure
Primary graft failure occurred in 3% (4/117) of patients in OMISIRGE clinical trials. Primary graft failure, which may be fatal, is defined as failure to achieve an absolute neutrophil count greater than 500 per microliter blood by Day 42 after transplantation. Immunologic rejection is the primary cause of graft failure. Monitor patients for laboratory evidence of hematopoietic recovery.
Malignancies of Donor Origin
Two patients treated with OMISIRGE developed post-transplant lymphoproliferative disorder (PTLD) in the second-year post-transplant. PTLD manifests as a lymphoma-like disease favoring non-nodal sites. PTLD is usually fatal if not treated. The etiology is thought to be donor lymphoid cells transformed by Epstein-Barr virus (EBV). Serial monitoring of blood for EBV DNA may be warranted in patients with persistent cytopenias. One patient treated with OMISIRGE developed a donor-cell derived myelodysplastic syndrome (MDS) during the fourth-year post-transplant. The natural history is presumed to be the same as that for de novo MDS. Monitor life-long for secondary malignancies. If a secondary malignancy occurs, contact Gamida Cell at (844) 477-7478.
Transmission of Serious Infections
Transmission of infectious disease may occur because OMISIRGE is derived from umbilical cord blood. Disease may be caused by known or unknown infectious agents. Donors are screened for increased risk of infection, clinical evidence of sepsis, and communicable disease risks associated with xenotransplantation. Maternal and infant donor blood is tested for evidence of donor infection. See full Prescribing Information, Warnings and Precautions, Transmission of Serious Infections for list of testing performed. OMISIRGE is tested for sterility, endotoxin, and mycoplasma. There may be an effect on the reliability of the sterility test results if the cord blood donor was exposed to antibiotics in utero. Product manufacturing includes bovine-derived reagents. All animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use. These measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Test results may be found on the container label and/or in accompanying records. If final sterility results are not available at the time of use, Quality Assurance will communicate any positive results from sterility testing to the physician. Report the occurrence of transmitted infection to Gamida Cell at (844) 477-7478.
Transmission of Rare Genetic Diseases
OMISIRGE may transmit rare genetic diseases involving the hematopoietic system because it is derived from umbilical cord blood. Cord blood donors have been screened to exclude donors with sickle cell anemia, and anemias due to abnormalities in hemoglobins C, D, and E. Because of the age of the donor at the time cord blood collection takes place, the ability to exclude rare genetic diseases is severely limited.
ADVERSE REACTIONS
The most common adverse reactions (incidence > 20%) are infections, GvHD, and infusion reaction.
Please see full Prescribing Information, including Boxed Warning.
About Gamida Cell
Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include Omisirge™ (omidubicel-onlv), an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, X, Facebook or Instagram.
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 the potentially life-saving or curative therapeutic and commercial potential of Omisirge™ (omidubicel-onlv), and the Company’s cell therapy candidate, GDA-201. 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 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. 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 14, 2023, and other filings that Gamida Cell makes with the SEC from time to time (which are available at 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.
OMISIRGE™ is a trademark of Gamida Cell Inc.
© 2023 Gamida Cell Inc. All Rights Reserved
View source version on businesswire.com: https://www.businesswire.com/news/home/20230927063152/en/
Contacts
Media Contact:
Dan Boyle
Orangefiery
media@orangefiery.com
1-818-209-1692
Investor Contact:
Chuck Padala
LifeSci Advisors
Chuck@lifesciadvisors.com
1-646-627-8390
PR Newswire
First Patient Receives Gamida Cell's Omisirge™ (omidubicel-onlv)
https://finance.yahoo.com/news/first-patient-receives-gamida-cells-203000857.html
Omisirge is the only allogeneic stem cell therapy approved by the U.S. Food and Drug Administration (FDA) on the basis of a global randomized Phase 3 trial
Rapid onboarding of transplant centers and significant payer coverage demonstrate strong launch progress
BOSTON, September 27, 2023--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that the first patient has received a stem cell transplant with Omisirge (omidubicel-onlv).
"This is a significant milestone for Gamida Cell, advancing our mission of delivering potentially curative therapies to patients with cancer," said Abbey Jenkins, President and Chief Executive Officer of Gamida Cell. "This patient will be the first of many who have new hope for a cure thanks to the availability of Omisirge as a new stem cell transplant donor source. This is why we do the work that we do – to make a difference for people with cancer."
Omisirge was approved by the U.S. FDA in April 2023 for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.
Gamida Cell has already exceeded its 2023 launch goals, with 15 transplant centers onboarded across the United States and confirmed coverage with payers that cover 90% of commercial lives. Gamida Cell is actively engaged with more than 90% of the top 70 transplant centers, which conduct approximately 80% of transplants. An increasing number of patients are being enrolled in Gamida Cell Assist®, which signals a transplanter’s intent to use Omisirge as the donor source.
"The launch of Omisirge is progressing very well in terms of payer coverage, transplant center onboarding and transplanter interest in using Omisirge as a donor source," said Michele Korfin, Chief Operating and Chief Commercial Officer of Gamida Cell. "We recognize the importance of making sure eligible patients can access Omisirge. To appropriately manage our cash, we launched with a limited investment and field footprint. The positive launch progress and strong interest from transplant centers now warrant expanding that investment and the team from four to eight account managers by the start of 2024. We are encouraged by transplanter feedback that Omisirge may both increase the number of patients able to access an appropriate donor source and address some limitations of other donor sources."
Approximately 8,000 stem cell transplants are performed in the U.S. each year in patients with hematologic malignancies1 and another 1,700 patients are estimated to be eligible for transplant but unable to find a donor.2 The ability to find a donor is historically more challenging for racially and ethnically diverse populations than for patients who are white.3 Gamida Cell market analyses indicate that Omisirge has the ability to capture approximately 20% of allogeneic stem cell transplant market share by ~2028.
Omisirge Indication
Omisirge is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.
Important Safety Information for Omisirge
BOXED WARNING: INFUSION REACTIONS, GRAFT VERSUS HOST DISEASE, ENGRAFTMENT SYNDROME, AND GRAFT FAILURE
Infusion reactions may be fatal. Monitor patients during infusion and discontinue for severe reactions. Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin or bovine material.
Graft-versus-Host Disease may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD.
Engraftment syndrome may be fatal. Treat engraftment syndrome promptly with corticosteroids.
Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery.
Contraindications
OMISIRGE is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine products.
Warnings and Precautions
Hypersensitivity Reactions
Allergic reactions may occur with the infusion of OMISIRGE. Reactions include bronchospasm, wheezing, angioedema, pruritis and hives. Serious hypersensitivity reactions, including anaphylaxis, may be due to DMSO, residual gentamicin, Dextran 40, human serum albumin (HSA) and bovine material in OMISIRGE. OMISIRGE may contain residual antibiotics if the cord blood donor was exposed to antibiotics in utero. Patients with a history of allergic reactions to antibiotics should be monitored for allergic reactions following OMISIRGE administration.
Infusion Reactions
Infusion reactions occurred following OMISIRGE infusion, including hypertension, mucosal inflammation, dysphagia, dyspnea, vomiting, and gastrointestinal toxicity. Premedication with antipyretics, histamine antagonists, and corticosteroids may reduce the incidence and intensity of infusion reactions. In patients transplanted with OMISIRGE in clinical trials, 47% (55/117) patients had an infusion reaction of any severity. Grade 3-4 infusion reactions were reported in 15% (18/117) patients. Infusion reactions may begin within minutes of the start of infusion of OMISIRGE, although symptoms may continue to intensify and not peak for several hours after the completion of the infusion. Monitor patients for signs and symptoms of infusion reactions during and after OMISIRGE administration. When a reaction occurs, pause the infusion and institute supportive care as needed.
Graft-versus-Host Disease
Acute and chronic GvHD, including life-threatening and fatal cases, occurred following treatment with OMISIRGE. In patients transplanted with OMISIRGE Grade II-IV acute GvHD was reported in 58% (68/117). Grade III- IV acute GvHD was reported in 17% (20/117). Chronic GvHD occurred in 35% (41/117) of patients. Acute GvHD manifests as maculopapular rash, gastrointestinal symptoms, and elevated bilirubin. Patients treated with OMISIRGE should receive immunosuppressive drugs to decrease the risk of GvHD, be monitored for signs and symptoms of GvHD, and treated if GvHD develops.
Engraftment Syndrome
Engraftment syndrome may occur because OMISIRGE is derived from umbilical cord blood. Monitor patients for unexplained fever, rash, hypoxemia, weight gain, and pulmonary infiltrates in the peri-engraftment period. Treat with corticosteroids as soon as engraftment syndrome is recognized to ameliorate symptoms. If untreated, engraftment syndrome may progress to multiorgan failure and death.
Graft Failure
Primary graft failure occurred in 3% (4/117) of patients in OMISIRGE clinical trials. Primary graft failure, which may be fatal, is defined as failure to achieve an absolute neutrophil count greater than 500 per microliter blood by Day 42 after transplantation. Immunologic rejection is the primary cause of graft failure. Monitor patients for laboratory evidence of hematopoietic recovery.
Malignancies of Donor Origin
Two patients treated with OMISIRGE developed post-transplant lymphoproliferative disorder (PTLD) in the second-year post-transplant. PTLD manifests as a lymphoma-like disease favoring non-nodal sites. PTLD is usually fatal if not treated. The etiology is thought to be donor lymphoid cells transformed by Epstein-Barr virus (EBV). Serial monitoring of blood for EBV DNA may be warranted in patients with persistent cytopenias. One patient treated with OMISIRGE developed a donor-cell derived myelodysplastic syndrome (MDS) during the fourth-year post-transplant. The natural history is presumed to be the same as that for de novo MDS. Monitor life-long for secondary malignancies. If a secondary malignancy occurs, contact Gamida Cell at (844) 477-7478.
Transmission of Serious Infections
Transmission of infectious disease may occur because OMISIRGE is derived from umbilical cord blood. Disease may be caused by known or unknown infectious agents. Donors are screened for increased risk of infection, clinical evidence of sepsis, and communicable disease risks associated with xenotransplantation. Maternal and infant donor blood is tested for evidence of donor infection. See full Prescribing Information, Warnings and Precautions, Transmission of Serious Infections for list of testing performed. OMISIRGE is tested for sterility, endotoxin, and mycoplasma. There may be an effect on the reliability of the sterility test results if the cord blood donor was exposed to antibiotics in utero. Product manufacturing includes bovine-derived reagents. All animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use. These measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Test results may be found on the container label and/or in accompanying records. If final sterility results are not available at the time of use, Quality Assurance will communicate any positive results from sterility testing to the physician. Report the occurrence of transmitted infection to Gamida Cell at (844) 477-7478.
Transmission of Rare Genetic Diseases
OMISIRGE may transmit rare genetic diseases involving the hematopoietic system because it is derived from umbilical cord blood. Cord blood donors have been screened to exclude donors with sickle cell anemia, and anemias due to abnormalities in hemoglobins C, D, and E. Because of the age of the donor at the time cord blood collection takes place, the ability to exclude rare genetic diseases is severely limited.
ADVERSE REACTIONS
The most common adverse reactions (incidence > 20%) are infections, GvHD, and infusion reaction.
Please see full Prescribing Information, including Boxed Warning.
About Gamida Cell
Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include Omisirge™ (omidubicel-onlv), an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, X, Facebook or Instagram.
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 the potentially life-saving or curative therapeutic and commercial potential of Omisirge™ (omidubicel-onlv). 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 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. 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 14, 2023, and other filings that Gamida Cell makes with the SEC from time to time (which are available at 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.
Omisirge is a trademark of Gamida Cell Inc.
____________________
1Data are of transplants performed from January 1–December 31, 2020. These data were reported to the Center for International Blood and Marrow Transplant Research® (CIBMTR) as of February 4, 2021.
2Gamida Cell market research.
3Be The Match® website (accessed 5/30/23); IT-Ideation Department, February 2021 (ethnic background %).
View source version on businesswire.com: https://www.businesswire.com/news/home/20230927409567/en/
Contacts
Media Contact:
Dan Boyle
Orangefiery
media@orangefiery.com
1-818-209-1692
Investor Contact:
Chuck Padala
LifeSci Advisors
Chuck@lifesciadvisors.com
1-646-627-8390
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