Classical Lissencephalies and Subcortical Band Heterotopias

REDWOOD CITY, Calif., June 22, 2023 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a biotechnology company focused on the development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) to address diseases such as chronic spontaneous urticaria, lower to intermediate risk myelodysplastic syndromes (LR-MDS) as well as novel stem cell transplant conditioning regimes, today announced that the first patient has been dosed in a Phase 1 trial evaluating briquilimab as second-line therapy in subjects with lower-risk myelodysplastic syndrome. “The initiation of this trial in LR-MDS represents a significant milestone in our briquilimab development program,” said Ronald Martell, President and Chief Executive Officer of Jasper. “To date, the potential of briquilimab has been clinically assessed across five transplant indications and we are excited to explore its potential as a treatment option for a chronic disease such as LR-MDS. This trial underscores our commitment to improving outcomes and quality of life for patients with rare and chronic diseases driven by mast and stem cells.” Jeffery Lancet, M.D., Chair of the Department of Malignant Hematology at Moffitt Cancer Center, where the Phase 1 trial is being conducted, added, “LR-MDS patients often face limited treatment options that primarily focus on increasing blood cell production and survival rather than restoring normal blood homeostasis. By directly targeting and depleting the diseased stem cells, briquilimab has the potential to restore bone marrow to a healthier and more functional state, with the ultimate goal of improved long-term outcomes and quality of life. We are excited to test briquilimab in the LR-MDS setting.” Edwin J. Tucker, M.D., Chief Medical Officer of Jasper, stated, “There is a significant need for therapies for people living with LR-MDS. While certain treatments could be employed to manage the symptoms, they do not typically target diseased cells or offer a comprehensive therapeutic approach. With its compelling therapeutic potential in targeting c-Kit, briquilimab holds great promise in lower-risk MDS and could provide a profound benefit for patients in dire need of new therapies. We are excited to embark on this clinical journey and contribute to the advancement of treatment options for patients with chronic diseases.” The open-label, single-arm Phase 1 trial will evaluate the safety and tolerability of briquilimab as a second-line therapy in subjects with LR-MDS. The trial will employ a 3+3 dose escalation design to identify the maximum tolerated dose or optimal biologic dose and recommended Phase 2 dose of briquilimab monotherapy as a chronic therapeutic for LR-MDS patients with documented cytopenia such as red blood cell transfusion dependence, thrombocytopenia or neutropenia. The trial will be conducted at Moffitt Cancer Center in Tampa, FL, and is expected to enroll up to 30 patients that will receive briquilimab every 56 days for 4 consecutive cycles. For more information on the Phase 1 trial of briquilimab for the treatment of LR-MDS please visit clinicaltrials.gov and reference identifier: NCT05903274. About Jasper Jasper is a clinical-stage biotechnology company developing briquilimab, a monoclonal antibody targeting c-Kit (CD117) as a therapeutic for chronic mast and stem cell diseases such as chronic spontaneous urticaria and lower to intermediate risk myelodysplastic syndromes (MDS) and as a conditioning agent for stem cell transplants for rare diseases such as sickle cell disease (SCD), Fanconi anemia (FA) and severe combined immunodeficiency (SCID). To date, briquilimab has a demonstrated efficacy and safety profile in over 130 dosed subjects and healthy volunteers, with clinical outcomes as a conditioning agent in SCID, acute myeloid leukemia (AML), MDS, FA, and SCD. In addition, briquilimab is being advanced as a transformational non-genotoxic conditioning agent for gene therapy. For more information, please visit us at www.jaspertherapeutics.com. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding briquilimab’s potential, including with respect to its potential to address diseases such as chronic spontaneous urticaria, lower to intermediate risk myelodysplastic syndromes as well as novel stem cell transplant conditioning regimes, its potential to restore bone marrow, its potential to improve long-term outcomes and quality of life, its therapeutic potential to target c-Kit, its potential profound benefit for patients in dire need of new therapies, its potential to contribute to the advancement of treatment options for patients with chronic diseases and its ability to target and deplete the diseased stem cells, the development of briquilimab, Jasper’s commitment to improving outcomes and quality of life for patients with rare and chronic diseases driven by mast and stem cells and Jasper’s expectations regarding the timing of, recruitment for and dosing in the clinical trial. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of Jasper and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Many actual events and circumstances are beyond the control of Jasper. These forward-looking statements are subject to a number of risks and uncertainties, including general economic, political and business conditions; the risk that the potential product candidates that Jasper develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; the risk that clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; the risk that Jasper will be unable to successfully market or gain market acceptance of its product candidates; the risk that prior trial results may not be replicated; the risk that Jasper’s product candidates may not be beneficial to patients or successfully commercialized; patients’ willingness to try new therapies and the willingness of physicians to prescribe these therapies; the effects of competition on Jasper’s business; the risk that third parties on which Jasper depends for laboratory, clinical development, manufacturing and other critical services will fail to perform satisfactorily; the risk that Jasper’s business, operations, clinical development plans and timelines, and supply chain could be adversely affected by the effects of health epidemics; the risk that Jasper will be unable to obtain and maintain sufficient intellectual property protection for its investigational products or will infringe the intellectual property protection of others; and other risks and uncertainties indicated from time to time in Jasper’s filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent Quarterly Reports on Form 10-Q. If any of these risks materialize or Jasper’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While Jasper may elect to update these forward-looking statements at some point in the future, Jasper specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Jasper’s assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements. Contacts:John Mullaly (investors)LifeSci Advisors617-429-3548jmullaly@lifesciadvisors.com Jeet Mahal (investors)Jasper Therapeutics650-549-1403jmahal@jaspertherapeutics.com Lauren Barbiero (media)Real Chemistry646-564-2156lbarbiero@realchemistry.com

Dr. Brun also appointed as Chairperson of Jasper Research and Development Committee and to Compensation Committee Board member Vishal Kapoor appointed to Jasper Audit and Compensation Committees REDWOOD CITY, Calif., June 20, 2023 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a biotechnology company focused on the development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) to address diseases such as chronic spontaneous urticaria (CSU), lower to intermediate risk myelodysplastic syndromes (LR-MDS) as well as novel stem cell transplant conditioning regimes, today announced the appointment of Scott Brun, M.D., to Jasper’s Board of Directors. Dr. Brun will also join Jasper’s Research and Development Committee as Chairperson and become a member of Jasper’s Compensation Committee. Concurrently, board member Vishal Kapoor has been appointed to join Jasper’s Audit and Compensation Committees. Additionally, Lawrence Klein, Ph.D., has stepped down from Jasper’s Board of Directors as of June 20, 2023, due to requirements of his recent appointment as a Partner of Versant Ventures. “Scott is a distinguished pharma industry executive and physician, with deep experience in drug development, particularly in immunology, with several successful approvals and commercial launches to his credit,” said Ron Martell, CEO of Jasper. “We are delighted to welcome Scott to our Board, and look forward to benefiting from his strategic insights and venture perspective as we continue to develop briquilimab for CSU, LR-MDS and stem cell transplant conditioning.” “I am extremely impressed with the strategic direction the Jasper management team and Board have established for briquilimab, as well as the enormous potential the asset has in a broad range of chronic treatment indications,” said Dr. Brun. “I look forward to working with Ron, his leadership team and my colleagues on the Board to further develop briquilimab in multiple disease states.” Dr. Brun has over two decades of drug development and leadership experience in the pharmaceutical industry. He was most recently a Senior Advisor to Horizon Therapeutics and Vice President of Scientific Affairs and Head of AbbVie Ventures. Previously, Dr. Brun served as Vice President and Head of Pharmaceutical Development at AbbVie. During his tenure, Dr. Brun oversaw a global organization that was responsible for AbbVie’s portfolio of early and late-stage pipeline compounds as well as marketed compounds within immunology, oncology, neurology, , renal, infectious disease, and women’s and men’s health. Dr. Brun contributed to the development and approval of a number of products across therapeutic areas, including Skyrisi, Rinvoq, Viekira, Mavyret, Venclexta, and Orilissa. Prior to joining AbbVie, Dr. Brun spent over 15 years at Abbott Laboratories, where he held positions of increasing leadership in drug development within the R&D organization. Dr. Brun is currently acting as an independent consultant and advisor to the venture capital and biopharmaceutical industry. He is a venture partner at the global life science venture capital firm Abingworth, a member of the boards of directors of Axial Therapeutics, Trishula Therapeutics, Forte Biosciences (Nasdaq: FBRX) and Cabaletta Bio (Nasdaq: CABA) and a consultant to a variety of startup companies and academic incubator programs. Dr. Brun received his B.S. in Biochemistry from the University of Illinois at Urbana-Champaign and earned his M.D. from the Johns Hopkins University School of Medicine. He completed his residency in ophthalmology at the Massachusetts Eye and Ear Infirmary, Harvard Medical School. About Jasper Jasper is a clinical-stage biotechnology company developing briquilimab, a monoclonal antibody targeting c-Kit (CD117) as a therapeutic for chronic mast and stem cell diseases such as chronic spontaneous urticaria and lower to intermediate risk myelodysplastic syndromes (MDS) and as a conditioning agent for stem cell transplants for rare diseases such as sickle cell disease (SCD), Fanconi anemia (FA) and severe combined immunodeficiency (SCID). To date, briquilimab has a demonstrated efficacy and safety profile in over 130 dosed subjects and healthy volunteers, with clinical outcomes as a conditioning agent in SCID, acute myeloid leukemia (AML), MDS, FA, and SCD. In addition, briquilimab is being advanced as a transformational non-genotoxic conditioning agent for gene therapy. For more information, please visit us at www.jaspertherapeutics.com. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding briquilimab’s potential, the development of briquilimab for CSU, LR-MDS and stem cell transplant conditioning and chronic treatment conditions, briquilimab’s further development in multiple disease states and the strategic direction for briquilimab. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of Jasper and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Many actual events and circumstances are beyond the control of Jasper. These forward-looking statements are subject to a number of risks and uncertainties, including general economic, political and business conditions; the risk that the potential product candidates that Jasper develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; the risk that clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; the risk that Jasper will be unable to successfully market or gain market acceptance of its product candidates; the risk that prior study results may not be replicated; the risk that Jasper’s product candidates may not be beneficial to patients or successfully commercialized; patients’ willingness to try new therapies and the willingness of physicians to prescribe these therapies; the effects of competition on Jasper’s business; the risk that third parties on which Jasper depends for laboratory, clinical development, manufacturing and other critical services will fail to perform satisfactorily; the risk that Jasper’s business, operations, clinical development plans and timelines, and supply chain could be adversely affected by the effects of health epidemics; the risk that Jasper will be unable to obtain and maintain sufficient intellectual property protection for its investigational products or will infringe the intellectual property protection of others; and other risks and uncertainties indicated from time to time in Jasper’s filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2022 and any subsequent Quarterly Reports on Form 10-Q . If any of these risks materialize or Jasper’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While Jasper may elect to update these forward-looking statements at some point in the future, Jasper specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Jasper’s assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements. Contacts: John Mullaly (investors)LifeSci Advisors617-429-3548jmullaly@lifesciadvisors.com Jeet Mahal (investors)Jasper Therapeutics650-549-1403jmahal@jaspertherapeutics.com Lauren Barbiero (media)Real Chemistry646-564-2156lbarbiero@realchemistry.com

Thought leaders Dr. Steven Devine and Dr. Usama Gergis to share perspectives on unmet needs and the clinical landscape in stem cell transplant Update on the progress of the commercial launch for Omisirge® to be provided BOSTON--(BUSINESS WIRE)-- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, will host an Investor Day on Thursday, June 29, 2023 beginning at 8 a.m. EDT in New York City, and will also be available via a live webcast. The Investor Day will feature presentations by two thought leaders in stem cell transplant: Steven M. Devine, M.D., Chief Medical Officer at the National Marrow Donor Program® (NMDP)/Be The Match®, who will discuss the unmet needs in stem cell transplant, and Usama Gergis, M.D., M.B.A., Director of Stem Cell Transplant and Immune Cellular Therapy, Department of Medical Oncology, Sidney Kimmel Cancer Center, Thomas Jefferson University in Philadelphia, who will discuss the clinical landscape for patients in need of stem cell transplant. Additionally, the program will feature presentations by the Gamida Cell executive team regarding Omisirge® (omidubicel-onlv), which was approved April 17, 2023 by the U.S. Food and Drug Administration for patients with hematologic malignancies who are planned for allogeneic hematopoietic stem cell transplantation. Please see full Prescribing Information, including the Boxed Warning. The program will take place at the offices of Cooley LLP, entrance at 55 Hudson Yards, New York, NY 10001. For those unable to attend in person, there will be a simultaneous live webcast. This event is intended for institutional investors, sell-side research analysts and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. To reserve a seat, please click here to register. To access the webcast, please register here. A copy of the presentation materials and webcast links may be accessed on the Events and Presentations page under the Investors section of the Gamida Cell website. 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, 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 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. 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 May 15, 2023, 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. View source version on businesswire.com: Contacts Investor and Media Contact: Dan Boyle Orangefiery media@orangefiery.com 1-818-209-1692 Source: Gamida Cell Ltd. 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