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Data further characterize the mechanism for Gamida Cell’s proprietary nicotinamide (NAM) technology’s expansion and enhancement of cellsBOSTON, 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-201GDA-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 ReactionsAllergic 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 ReactionsInfusion 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 DiseaseAcute 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 SyndromeEngraftment 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 FailurePrimary 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 OriginTwo 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 InfectionsTransmission 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 DiseasesOMISIRGE 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

BOSTON--( BUSINESS WIRE )-- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that an oral presentation highlighting Gamida Cell’s investigational natural killer (NK) cell therapy candidate GDA-201 will be shared at the International Society for Cell and Gene Therapy (ISCT) 2023 Annual Meeting. The meeting takes place May 31-June 3 in Paris, France. Additionally, a poster will be presented with data from Gamida Cell’s pre-clinical NK cell therapy candidate GDA-501, an engineered intrinsic NK cell with a CAR modification targeting the HER2 protein. “ The data being presented at ISCT add to the body of evidence demonstrating the power of our nicotinamide (NAM) technology to enhance and expand cells,” said Ronit Simantov, M.D., Chief Medical and Scientific Officer of Gamida Cell. “ The unique, active phenotype of NAM-NK cells and the high levels of potency and cytotoxicity observed support the strong potential of GDA-201 as a cell therapy for cancer.” Additional details about the presentations are as follows: Title: GDA-201: Phenotypic and Functional Characterization of Cryopreserved Nicotinamide-Expanded Allogeneic Natural Killer Cells Demonstrate an Activated and Non-exhausted Phenotype Abstract Number: 36 Presentation Date: June 2, 9:15-10:15 am CET Presenting Author: Yona Geffen, Ph.D.; Vice President of R&D at Gamida Cell Highlights: This study investigated the phenotype and function of GDA-201, NK cells expanded using Gamida Cell’s proprietary NAM technology. NAM-NK demonstrated increased expression of lymphoid homing marker CD62L and decreased levels of lineage exhaustion markers CD57 and CD161 compared with NK cells expanded in the absence of NAM. Batch-to-batch variability of 18 batches of cryopreserved formulation of GDA-201 from 18 donors demonstrated an overall variability of ≤25% in critical parameters including viability, phenotyping and cytotoxicity. Title: GDA-501 HER2 Chimeric Antigen Receptor Natural Killer Cells: Dual Cytotoxicity in Solid Tumors Mediated via HER2 and TRAIL Abstract Number: 1225 Presentation Date: June 1, 6-7:30 pm CET Presenting Author: Julia Rifman, Ph.D.; Senior Project Manager at Gamida Cell Highlights: GDA-501, an expanded, enhanced and engineered NAM HER2-CAR NK cell, showed high levels of TNF-related apoptosis-inducing ligand (TRAIL) expression, suggesting possible meditation of target cell apoptosis. Compared with non-engineered NK cells cultured with NAM, GDA-501 cells displayed increased cytotoxicity against HER2+ tumor cells. When TRAIL was neutralized on GDA-501, a decrease in cytotoxicity was observed. These data suggest that the cytotoxic effect of GDA-501 may be mediated by dual mechanisms: HER2 binding by the HER2-CAR and apoptosis mediated by TRAIL. Note: Gamida Cell announced it would discontinue the development of GDA-501 in March 2023. About GDA-201 GDA-201 is an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. Preclinical studies have shown that GDA-201 may address key limitations of cultured NK cells by increasing cytotoxicity and in vivo retention as well as proliferation in the bone marrow and lymphoid organs. Furthermore, these data suggest GDA-201 may improve antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. A multicenter Phase 1/2 study of GDA-201 for the treatment of non-Hodgkin lymphoma is ongoing (NCT05296525). 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®, 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. Omisirge ® is a registered trademark of Gamida Cell Inc. © 2023 Gamida Cell Inc. All Rights Reserved. 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 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 SEC on May 15, 2023, the accompanying prospectus 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.

Company reports on productive interactions with FDA and preparations for launch of omidubicel, if approved, in advance of May 1 PDUFA date Company outlines strategic restructuring, plans to prioritize omidubicel launch and reduce operating expenses to extend cash runway Company to explore strategic options to support a broader launch of omidubicel, including potential US and global partnerships with pharmaceutical companies Company intends to continue GDA-201 Phase 1 study, discontinue development of natural killer (NK) cell preclinical candidates and consolidate its operations in Israel in Kiryat Gat Company to host conference call at 8:00 am ET today BOSTON--(BUSINESS WIRE)-- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today provided a business update and reported financial results for the year ended December 31, 2022. Net loss for 2022 was $79.4 million, compared to a net loss of $89.8 million in 2021. As of December 31, 2022, Gamida Cell had total cash and cash equivalents of $64.7 million. The company highlighted positive data, productive regulatory interactions and progress on commercial readiness activities supporting its lead product candidate, omidubicel, an advanced cell therapy candidate for allogeneic stem cell transplant, as it advances toward its May 1, 2023 target Prescription Drug User Fee Act (PDUFA) action date. The company also announced a strategic restructuring of its operations to prioritize launch of omidubicel to ensure that, if approved, patients who may potentially benefit will have access to therapy. To reduce expenses, the company will discontinue development of its preclinical NK cell therapy candidates while continuing to enroll patients in the GDA-201 Phase 1 clinical trial. “Our mission is to bring potentially curative therapies to patients,” said Abbey Jenkins, President and Chief Executive Officer of Gamida Cell. “We believe we have a clear path to approval and are preparing for the commercial launch of omidubicel, if approved. Given the challenging economic environment, to date, we have not been able to raise adequate funding to support our full pipeline and enable a more robust launch of omidubicel, if approved. As a result, we are taking decisive actions to do three things 1) prioritize resources toward the launch 2) reduce expenses across the board 3) seek potential commercial or strategic partnerships to maximize patient access to omidubicel, a potentially life-saving therapy. Today’s actions are difficult. Especially since our engineered NK cell therapy candidates, which are derived from healthy donors, have demonstrated encouraging pre-clinical data that differentiate them from other NK cell therapy approaches. The science is promising, but these changes are economically necessary to ensure omidubicel reaches as many patients as possible.” Today Gamida Cell announced it would: Implement a strategic restructuring to focus on omidubicel launch, if approved: The company intends to allocate the vast majority of its resources to executing a launch of omidubicel, if approved, although with a more limited investment and slower ramp than previously planned in order to manage its financial resources. The company reported productive interactions with the FDA, including a recently completed Late Cycle Meeting and a previously reported Pre-Licensing Inspection of the company’s Kiryat Gat, Israel, manufacturing facility, with no 483 observations received to date. Recently presented data continue to support the clinical benefits and safety of omidubicel, which, if approved, may be a valuable new donor source for patients in need of allogeneic stem cell transplant. Commercial readiness activities have made progress as the company prepares to onboard approximately 10-15 of the top 70 transplant centers in the United States in 2023. Omidubicel has received positive feedback from leading transplant centers, including ones that did not participate in the company’s clinical trials. The company has met with U.S. payers, including payers that cover more than 90% of commercially covered lives, and reported that payers indicate they anticipate covering a one-time therapy with curative intent. Continue its GDA-201 Phase 1 study: The company will continue to enroll patients in its GDA-201 Phase 1 dose escalation study. Reduce operating expenses in order to extend its cash runway: The company will discontinue the development of its engineered NK cell therapy preclinical pipeline, including GDA-301, GDA-501 and GDA-601, while maintaining the IP to these candidates. It will implement a headcount reduction of 17%, with the majority of impacted headcount tied to the discontinuation of the pre-clinical NK cell therapy candidates. The company will also close its operations in Jerusalem and consolidate Israel operations at its state-of-the-art manufacturing facility in Kiryat Gat. These changes are expected to extend the company’s cash runway through Q3 2023. Explore strategic options: The company intends to seek potential commercial or strategic partnerships to maximize patient access to omidubicel, if approved. Fourth Quarter and Recent Developments Omidubicel: Advanced Cell Therapy New data presented at ASH and TCT: The company presented new data characterizing peripheral blood lymphocytes measured in correlation with time to neutrophil and platelet engraftment in omidubicel-transplanted and standard cord blood-transplanted patients at the 2023 Tandem Meetings, Transplantation & Cellular Therapy (TCT) Meetings of the American Society for Transplantation & Cellular Therapy and the Center for International Blood and Marrow Transplant Research in February. Seven days post-transplant, omidubicel-transplanted patients showed a statistically significant correlation between CD3+/CD4+ T cell counts and time to neutrophil engraftment. Similar correlations were noted between CD3+/CD8+/CD19+ cell counts and time to platelet engraftment. Patients transplanted with standard cord blood showed no such correlations at Day 7 post-transplant, and only began to show correlations starting at 14 days post-transplant. Data support past findings that omidubicel stimulates a faster immune response than standard cord blood, which may be a contributing mechanism resulting in the lower incidence of serious bacterial, fungal and viral infections for omidubicel-transplanted patients. New publication in press: The company reported a publication in press in Transplantation and Cellular Therapy, now available online, reporting on long-term follow-up of patients transplanted with omidubicel across five clinical trials. The analysis showed a three-year overall survival of 62.5% and disease-free survival of 54%. With up to 10 years of follow-up, omidubicel showed durable hematopoiesis. Manufacturing readiness: The company’s state-of-the-art manufacturing facility in Kiryat Gat, Israel, is ready for commercial launch if omidubicel is approved and is currently producing omidubicel for the company’s Extended Access Program (EAP) and its ongoing omidubicel aplastic anemia study. The facility, which has completed its Israeli Ministry of Health and FDA pre-licensure inspections with no 483 observations to date, has the ability to deliver omidubicel back to the transplant center within approximately 30 days from the start of manufacturing. Commercial readiness: The company continues to advance efforts throughout the organization to prepare for the launch of omidubicel, if approved. GDA-201: Intrinsic NK Cell Therapy New data presented at Tandem Meetings: The company presented a poster at the 2023 Tandem Meetings, Transplantation & Cellular Therapy (TCT) Meetings of the American Society for Transplantation & Cellular Therapy and the Center for International Blood and Marrow Transplant Research reporting new preclinical data on the cryopreserved formulation of GDA-201, which showed increased potency and enhanced cytotoxicity. GDA-201 cells were tested for viability, phenotyping, function and potency. Previous characterization of GDA-201 showed high levels of CD56, CD16, CD49a and CD62L expression, low levels of CD57, and low levels of immune checkpoints such as LAG3 and CD200R. The new analyses showed that cryopreserved GDA-201 exhibited high viability (>90%) and high purity up to 12 months post-manufacturing and preserved the ability to proliferate post-thaw. GDA-201 maintained high levels of expression of CD16, which mediates antibody-dependent cellular toxicity, and CD62L, which is a homing and retention marker. GDA-201 also demonstrated high potency, based on the intracellular secretion of TNF-alpha & IFN-gamma and extracellular degranulation marker CD107a. In addition, external investigator Veronika Bachanova, M.D., Ph.D., Professor at the University of Minnesota Medical School, gave an oral presentation highlighting novel observations of “on treatment” tumor biopsies from eight patients treated with GDA-201 in a Phase 1 study. The microscopic spatial analysis demonstrated that while GDA-201 cells were virtually undetectable in tumors after 14 days, T cells were observed in 50-95% of tumor site cellularity. Most biopsies obtained as early as three to seven days post-infusion showed strong indications of widespread tumor death. These observations suggest that GDA-201 infusions trigger profound immune microenvironment changes, supporting the influx of host T cells early post-GDA-201 infusion. These findings further suggest the engagement of the adaptive immune system and effective tumor elimination. Corporate Developments On March 20, the company announced that Shawn Cline Tomasello was elected Chairwoman of the Board of Directors, succeeding Chairman Robert I. Blum, who resigned. Ms. Tomasello joined the Gamida Cell Board of Directors in June 2019. She has extensive experience in leading successful commercial activities at several pharmaceutical companies and providing key strategic guidance on company boards. Dr. Anat Cohen-Dayag and Dr. Naama Halevi Davidov also resigned from the company’s Board of Directors. In December, the company and its wholly owned subsidiary, as borrower, closed on a senior secured convertible term loan of $25 million with certain funds managed by Highbridge Capital Management, LLC. The loan has a maturity date of December 12, 2024. Full Year 2022 Financial Results Research and development expenses, net were $42.7 million in 2022, compared to $50.2 million in 2021. The decrease was primarily due to a $9.6 million decrease in clinical and operational activities relating to the conclusion of our Phase 3 study of omidubicel, offset by an increase of $1.1 million in T&E and other expenses as well as a $1.0 million decrease in Israeli Innovation Authority grants. Commercial expenses in 2022 were $12.9 million, compared to $20.0 million in 2021. The decrease was primarily due to a $8.2 million decrease in commercial launch readiness expenses, offset by an increase of $1.1 million in headcount related expenses. General and administrative expenses were $19.4 million in 2022, compared to $17.0 million in 2021. The increase was mainly driven by an increase of $1.4 million attributed to our corporate headquarters and headcount-related expenses as well as a $1.0 million increase in professional services expenses. Financial expenses, net, were $4.4 million for 2022, compared to $2.6 million for 2021. The increase was primarily due to expenses relating to the closing on a senior secured convertible term loan of $25 million with certain funds managed by Highbridge Capital Management, LLC. Net loss for 2022 was $79.4 million, compared to $89.8 million in 2021. 2023 Financial Guidance Gamida Cell expects its current cash and cash equivalents will support the company’s ongoing operating activities through the third quarter of 2023. This cash runway guidance is based on the company’s current operational plans and excludes any additional funding and any business development activities that may be undertaken. Conference Call Information Gamida Cell will host a conference call today, March 27, 2023, at 8:00 a.m. ET to discuss these financial results and company updates. To access the conference call, please register here and be advised to do so at least 10 minutes prior to joining the call. A live conference call webcast can be accessed in the “Investors & Media” section of Gamida Cell’s website at . A webcast replay will be available approximately two hours after the event for approximately 30 days. About Omidubicel Omidubicel is an advanced cell therapy candidate for allogeneic hematopoietic stem cell (bone marrow) transplant that, if approved, has the potential to expand access and improve outcomes for patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment compared to standard umbilical cord blood in an international, multicenter, randomized Phase 3 study (NCT02730299) in patients with hematologic malignancies undergoing allogeneic bone marrow transplant. The Phase 3 study also showed reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. One-year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by a significant reduction in infectious complications as well as reduced non-relapse mortality and no significant increase in relapse rates nor increases in graft-versus-host-disease (GvHD) rates. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the U.S. and E.U. Omidubicel has a PDUFA target action date of May 1, 2023. Omidubicel is an investigational stem cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. For more information about omidubicel, please visit About GDA-201 GDA-201 is an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. Preclinical studies have shown that GDA-201 may address key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, these data suggest GDA-201 may improve antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. A multicenter Phase 1/2 study of GDA-201 for the treatment of non-Hodgkin lymphoma is ongoing. 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 research and development efforts have produced potentially curative cell therapy candidates for patients with blood cancers. The company applies a proprietary expansion platform leveraging the properties of nicotinamide to cell sources including umbilical cord blood-derived cells and NK cells to create allogeneic cell therapy candidates with the potential to redefine standards of care. These include omidubicel, an advanced cell therapy candidate for allogeneic hematopoietic stem cell transplant that, if approved, has the potential to expand access and improve outcomes for patients with blood cancers, and GDA-201, an intrinsic NK cell therapy candidate being investigated for the treatment of hematological malignancies. For additional information, please visit or follow Gamida Cell on LinkedIn, Twitter, Facebook or Instagram at @GamidaCellTx. Cautionary Note Regarding Forward Looking Statements This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to timing of the FDA’s review of the BLA for omidubicel, and the potentially life-saving or curative therapeutic and commercial potential of Gamida Cell’s product candidates (including omidubicel), and the company’s anticipated cash runway. 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, 2022, and other filings that Gamida Cell makes with the SEC from time to time (which are available at ), 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. CONSOLIDATED BALANCE SHEETS U.S. dollars in thousands (except share and per share data) December 31, 2022 2021 ASSETS CURRENT ASSETS: Cash and cash equivalents $ 64,657 $ 55,892 Marketable securities - 40,034 Prepaid expenses and other current assets 1,889 2,688 Total current assets 66,546 98,614 NON-CURRENT ASSETS: Restricted deposits 3,668 3,961 Property, plant and equipment, net 44,319 35,180 Operating lease right-of-use assets 7,024 7,236 Severance pay fund 1,703 2,148 Other long-term assets 1,513 1,647 Total non-current assets 58,227 50,172 Total assets $ 124,773 $ 148,786 CONSOLIDATED BALANCE SHEETS U.S. dollars in thousands (except share and per share data) December 31, 2022 2021 LIABILITIES AND SHAREHOLDERS’ EQUITY CURRENT LIABILITIES: Trade payables $ 6,384 $ 8,272 Employees and payroll accruals 5,300 4,957 Operating lease liabilities 2,648 2,699 Accrued interest of convertible senior notes 1,652 1,640 Accrued expenses and current liabilities 8,891 7,865 Total current liabilities 24,875 25,433 NON-CURRENT LIABILITIES: Convertible senior notes, net 96,450 71,417 Accrued severance pay 1,914 2,396 Long-term operating lease liabilities 4,867 5,603 Other long-term liabilities 4,690 - Total non-current liabilities 107,921 79,416 CONTINGENT LIABILITIES AND COMMITMENTS SHAREHOLDERS’ EQUITY (DEFICIT): Ordinary shares of NIS 0.01 par value - Authorized: 150,000,000 shares at December 31, 2022 and 2021; Issued: 74,703,030 and 59,970,389 shares at December 31, 2022 and 2021, respectively; Outstanding: 74,583,026 and 59,970,389 shares at December 31, 2022 and 2021, respectively 211 169 Treasury ordinary shares of NIS 0.01 par value; 120,004 and 0 shares at December 31, 2022 and 2021, respectively * - Additional paid-in capital 408,598 381,225 Accumulated deficit (416,832 ) (337,457 ) Total shareholders’ equity (deficit) (8,023 ) 43,937 Total liabilities and shareholders’ equity $ 124,773 $ 148,786 * Represents an amount lower than $1. CONSOLIDATED STATEMENTS OF OPERATIONS U.S. dollars in thousands (except share and per share data) Year ended December 31, 2022 2021 Research and development expenses, net $ 42,692 $ 50,177 Commercial expenses 12,900 20,013 General and administrative expenses 19,401 16,977 Total operating loss 74,993 87,167 Financial expenses, net 4,382 2,626 Loss $ 79,375 $ 89,793 Net loss per share attributable to ordinary shareholders, basic and diluted $ 1.24 $ 1.52 Weighted average number of shares used in computing net loss per share attributable to ordinary shareholders, basic and diluted 63,826,295 59,246,803 CONSOLIDATED STATEMENTS OF CASH FLOWS U.S. dollars in thousands (except share and per share data) Year ended December 31, 2022 2021 Cash flows from operating activities: Loss $ (79,375 ) $ (89,793 ) Adjustments to reconcile loss to net cash used in operating activities: Depreciation of property, plant and equipment 440 431 Financing expense (income), net (375 ) 359 Share-based compensation 5,041 4,233 Amortization of debt discount and issuance costs 783 638 Operating lease right-of-use assets 2,494 2,109 Operating lease liabilities (3,069 ) (2,193 ) Decrease (increase) accrued severance pay, net (37 ) 12 Decrease in prepaid expenses and other assets 224 1,008 Increase (decrease) in trade payables (1,888 ) 1,941 Increase (decrease) in accrued expenses and current liabilities 5,339 (505 ) Net cash used in operating activities (70,423 ) (81,760 ) Cash flows from investing activities: Purchase of property, plant and equipment (6,354 ) (15,054 ) Purchase of marketable securities (5,037 ) (102,179 ) Proceeds from maturity of marketable securities 45,029 61,534 Investment in restricted deposits - (5,222 ) Proceeds from restricted deposits 406 - Net cash provided by (used in) investing activities $ 34,044 $ (60,921 ) Cash flows from financing activities: Proceeds from exercise of options $ 76 $ 626 Proceeds from share issuance, net 22,298 - Proceeds from issuance of convertible senior notes, net 22,770 70,777 Net cash provided by financing activities 45,144 71,403 Increase (decrease) in cash and cash equivalents 8,765 (71,278 ) Cash and cash equivalents at beginning of year 55,892 127,170 Cash and cash equivalents at end of year $ 64,657 $ 55,892