Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

All eight (100%) treatment-arm patients are relapse-free and have achieved and maintained complete donor chimerism following treatment with TSC-100 or TSC-101 Patient with high-risk, TP53-mutated MDS is relapse-free for over one year following treatment with TSC-101 Patient with AML converted from detectable to undetectable disease following treatment with TSC-101 Data presented at TANDEM meeting suggests complete donor chimerism is an early indicator of treatment success Company to host virtual KOL event today, Monday, February 26, at 8:00 a.m. ET, to discuss the data presented at the 2024 Tandem Meetings WALTHAM, Mass., Feb. 26, 2024 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today announced an oral presentation at the 2024 Tandem Meetings: Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT®) and the Center for International Blood and Marrow Transplant Research (CIBMTR®). The oral presentation, selected for the plenary session as a Best Abstract, highlights updated data from the Phase 1 multi-arm clinical trial evaluating TSC-100 and TSC-101, designed to treat residual disease and prevent relapse following hematopoietic cell transplantation (HCT) in patients with acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or acute lymphocytic leukemia (ALL) (NCT05473910). “We are excited to report updated data from our heme program, with eight patients across our treatment arms and six patients in our control arm. We remain encouraged to see that no relapses have occurred to date in treated patients, four of whom have been on the study for over ten months. One patient with high-risk, TP53-mutated MDS has now reached the one-year mark following treatment with TSC-101, a meaningful milestone as the likelihood of relapse decreases significantly over time, leading to an improved quality of life,” said Debora Barton, M.D., Chief Medical Officer. “We have also enrolled six patients in the control arm, receiving transplant alone. To date, two control-arm patients relapsed following transplant, at days 161 and 180, and one of these patients succumbed to the relapse at day 265. A third patient required clinical intervention at day 133 because of concerns of impending relapse.” “Sustained complete donor chimerism may be the most valuable indicator of treatment success,” added Gavin MacBeath, Ph.D., Chief Executive Officer. “HCT is currently the best treatment option for many patients suffering from AML, MDS, and ALL, as approximately 60% of patients are cured by this treatment. Unfortunately, roughly 40% of patients relapse following HCT, at which point there are limited treatment options and a poor prognosis. Donor chimerism measures any remaining patient-derived hematopoietic cells that could potentially lead to relapse. We are using a high-sensitivity next-generation sequencing assay to track donor chimerism in all patients in our study. We are encouraged to see that all eight patients treated with our cell therapy products achieved and maintained complete donor chimerism at every time-point, with four of these patients past the 10-month mark. This is a very good sign for these patients, and we look forward to sharing follow-up data, as well as data on additional patients, as the study continues to enroll in 2024.” The Phase 1 trial is a multi-arm dose escalation study evaluating TSC-100 and TSC-101, which are designed to treat residual disease and prevent relapse following HCT in patients with AML, ALL or MDS undergoing haploidentical donor allogeneic HCT with reduced intensity conditioning. Primary endpoints include safety and dose-finding, and secondary and exploratory endpoints include relapse rates versus standard-of-care (HCT alone) as well as supportive surrogates of efficacy, including donor chimerism and minimal residual disease (MRD). MRD identifies any residual disease-related DNA present in a patient, and chimerism measures any remaining recipient-derived hematopoietic cells in a patient following HCT (NCT05473910). Key Presentation Highlights Include: TSC-100 treatment arm (N=4: T-ALL, AML, AML, MDS) 4/4 patients treated with TSC-100 achieved complete donor chimerism with no relapse. TSC-101 treatment arm (N=4: TP53-mutated MDS, AML, B-ALL, B-ALL) 4/4 patients treated with TSC-101 achieved complete donor chimerism with no relapse, including a patient with high-risk, TP53-mutated MDS who has reached one year of follow-up.One patient with AML was MRD-positive following HCT and converted to and maintained MRD-negative status following treatment with TSC-101 (most recent measurement at day 180). TSC-100 and TSC-101 persistence noted for prolonged periods: Persistence of TSC-100 and TSC-101 was observed at all time points after dosing, with the longest follow-up of over 9 months.Repeat dosing (dose levels 2 and 3) led to a 3-fold increase in circulating TSC-100 and TSC-101 levels compared to single dosing (dose level 1) at the same time points. Six control arm patients (MDS, MDS, MDS, AML, AML, AML) have been enrolled and received standard of care HCT alone: One control-arm patient with high-risk, TP53-mutated MDS evolved with MRD positivity and worsening mixed chimerism, experienced clinical relapse approximately six months post-transplant, and succumbed to relapse approximately nine months post-transplant.One control-arm patient with MDS experienced clinical relapse approximately five months post-transplant.One control-arm patient with MDS developed worsening mixed chimerism requiring early termination of immunosuppression, resulting in complete donor chimerism but with grade 1 skin graft-versus-host disease.One control-arm patient never achieved complete donor chimerism, with more than four months follow-up post-transplant.2/6 control-arm patients achieved complete donor chimerism following HCT. Virtual KOL Event The Company will host a virtual KOL event featuring: Monzr M. Al Malki, M.D., Associate Professor in the Department of Hematology & Hematopoietic Cell Transplantation and Director of the Unrelated Donor Bone Marrow Transplant and Haploidentical Transplant Programs at City of HopeRan Reshef, M.D., M.Sc., Professor of Medicine and Director of the Cellular Immunotherapy Program at Columbia University Irving Medical Center The conference call will be held today, February 26, at 8:00 a.m. ET, to discuss the data presented at the Tandem Meetings. Details for attending the live event can be found here. A replay will be made available on the “Events and Presentations” section of the Company’s investor relations website at ir.tscan.com. About TScan Therapeutics, Inc. TScan is a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer. The Company’s lead TCR-T therapy candidates, TSC-100 and TSC-101, are in development for the treatment of patients with hematologic malignancies to eliminate residual disease and prevent relapse after allogeneic hematopoietic cell transplantation. The Company is also developing multiplexed TCR-T therapy candidates for the treatment of various solid tumors. The Company has developed and continues to expand its ImmunoBank, the Company’s repository of therapeutic TCRs that recognize diverse targets and are associated with multiple HLA types, to provide customized, enhanced, multiplexed TCR-T therapies for patients with a variety of cancers. Forward-Looking Statements This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding the Company’s plans, progress, and timing relating to the Company’s hematologic malignancies program, including the potential implications of initial data from a large prospective clinical trial, presentation of additional data, and potential indicators of treatment success; the potential benefits of any of the Company’s current or future product candidates in treating patients; and the Company’s goals and strategy. TScan intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “plan,” “on track,” or similar expressions or the negative of those terms. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. The express or implied forward-looking statements included in this release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: the beneficial characteristics, safety, efficacy, therapeutic effects and potential advantages of TScan’s TCR-T therapy candidates; TScan’s expectations regarding its preclinical studies being predictive of clinical trial results; the timing of the initiation, progress and expected results of TScan’s preclinical studies, clinical trials and its research and development programs; TScan’s plans relating to developing and commercializing its TCR-T therapy candidates, if approved, including sales strategy; estimates of the size of the addressable market for TScan’s TCR-T therapy candidates; TScan’s manufacturing capabilities and the scalable nature of its manufacturing process; TScan’s estimates regarding expenses, future milestone payments and revenue, capital requirements and needs for additional financing; TScan’s expectations regarding competition; TScan’s anticipated growth strategies; TScan’s ability to attract or retain key personnel; TScan’s ability to establish and maintain development partnerships and collaborations; TScan’s expectations regarding federal, state and foreign regulatory requirements; TScan’s ability to obtain and maintain intellectual property protection for its proprietary platform technology and our product candidates; the sufficiency of TScan’s existing capital resources to fund its future operating expenses and capital expenditure requirements and execute on upcoming anticipated milestones into 2026; and the effect of the COVID-19 pandemic, including mitigation efforts and political, economic, legal and social effects, on any of the foregoing or other aspects of TScan’s business or operations; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of TScan’s most recent Annual Report on Form 10-K and any other filings that TScan has made or may make with the SEC in the future. Any forward-looking statements contained in this release represent TScan’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, TScan explicitly disclaims any obligation to update any forward-looking statements. ContactsHeather SavelleTScan Therapeutics, Inc.VP, Investor Relations857-399-9840hsavelle@tscan.com Joyce AllaireLifeSci Advisors, LLCManaging Director617-435-6602jallaire@lifesciadvisors.com

Jan. 30, 2024 -- MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and innovative bioprocessing applications, and Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced the signing of a strategic platform license (SPL). Under the terms of the agreement, Wugen gains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. In return, MaxCyte will receive annual license fees and program-related revenue. Wugen is developing the next generation of off-the-shelf memory natural killer (NK) and CAR-T cell therapies for cancer. The company’s investigational cell therapies originate from healthy donors and are further engineered to enhance their function of eliminating cancer cells. Wugen’s lead program is evaluating WU-CART-007, a CD7 targeted CAR-T cell therapy, in a global Phase 1/2 clinical trial for the treatment of relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL) in adolescent and adult patients. WU-CART-007 has received Orphan Drug, Fast Track, and Rare Pediatric Disease Designations from the U.S. Food and Drug Administration for the treatment of R/R T-ALL/LBL. Additional information is available on clinicaltrials.gov, identifier NCT# 04984356. “As WU-CART-007 is transferred onto the ExPERT platform and continues to progress in the clinic, we are able to support efficient and seamless expansion to large-scale manufacturing,” said Maher Masoud, President and CEO of MaxCyte. “By working with MaxCyte, Wugen can maximize the number of doses in each manufacturing run for later stage clinical development and potential commercial phase.” “Our partnership with MaxCyte is an exciting step in advancing our groundbreaking therapies for difficult-to-treat cancers,” said Kumar Srinivasan, PhD, MBA, President and CEO of Wugen. “This collaboration brings us even closer to delivering life-saving treatments to patients with limited options. With MaxCyte's expertise, we're in a position to expedite progress through crucial development stages and make a significant impact on patients’ lives.” MaxCyte’s ExPERT™ instrument portfolio represents the next generation of clinically validated electroporation technology for complex and scalable cell engineering. Offering high transfection efficiency, seamless scalability, and enhanced functionality, the ExPERT™ platform is crucial for enabling the next wave of biological and cellular therapeutics. Wugen is MaxCyte’s 26th clinical/commercial partnership overall, each of which generates pre-commercial milestone revenue, the vast majority of which includes sales-based payments. At MaxCyte, we pursue cell engineering excellence to maximize the potential of cells to improve patients’ lives. We have spent more than 20 years honing our expertise by building best-in-class platforms, perfecting the art of the transfection workflow, and venturing beyond today’s processes to innovate tomorrow’s solutions. Our ExPERT™ platform, which is based on our Flow Electroporation® technology, has been designed to support the rapidly expanding cell therapy market and can be utilized across the continuum of the high-growth cell therapy sector, from discovery and development through commercialization of next-generation, cell-based medicines. The ExPERT family of products includes: four instruments, the ATx™, STx™, GTx™ and VLx ™; a portfolio of proprietary related processing assemblies or disposables; and software protocols, all supported by a robust worldwide intellectual property portfolio. By providing our partners with the right technology platform, as well as scientific, technical and regulatory support, we aim to guide them on their journey to transform human health. Learn more at maxcyte.com and follow us on X (formerly Twitter) and LinkedIn. Wugen, Inc. is a clinical-stage biotechnology company developing the next generation of off-the-shelf memory natural killer (NK) and CAR-T cell therapies for cancer. Wugen is leveraging its proprietary Moneta™ platform and deep genomic engineering expertise to pioneer a new class of memory NK cell therapies to treat hematological and solid tumor malignancies. For more information, please visit https://wugen.com/ The content above comes from the network. if any infringement, please contact us to modify.

Over 2,100 registrants with attendees from 92 countries Average daily attendance of 574 32 oral presentations delivered across four consecutive days 69 scientific posters featuring optical genome mapping (OGM) on view in the online exhibit hall Content covered wide a range of research applications for OGM including hematologic malignancies, cell and gene therapy, and constitutional genetic diseases On-demand presentations from Symposium available for remainder of 2024 SAN DIEGO, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (BNGO) today announced the conclusion of Bionano’s 2024 Symposium, the quintessential event for the optical genome mapping (OGM) community, which was held January 22-25, 2024, and featured a record 32 oral presentations and 69 scientific posters from genomic scientists at leading institutions, including Brigham and Women’s Hospital, The University of Texas MD Anderson Cancer Center, Institute Curie, Memorial Sloan Kettering Cancer Center and Johns Hopkins University School of Medicine. Symposium had over 2,100 registrants from 92 countries and averaged 574 attendees per day. During this four-day online event, presenters reported on their use of OGM for applications in cancer, genetic disease, and cell and gene therapy. Symposium 2024’s Defining Themes Presentations delivered by researchers from across the globe highlighted the following themes: OGM has moved beyond concordance studies as data sets expand, research reveals new, actionable biomarkers, and user groups form to drive standardization and implementation of the workflow. Insights that OGM is providing in hematological malignancy research are relevant in the context of applications to potential therapeutic development and maybe even one day patient management. OGM is helping to unravel persistent, complex mysteries in genetic disease that impact people, even in more common disorders like Down syndrome and Marfan syndrome. OGM has the potential to meet the key requirements of the cell and gene therapy community. OGM can serve as an alternative to, and an important bridge between, cytogenetics and molecular pathology by elevating something that is digital and molecular and complementing next-generation sequencing (NGS) which is an essential component of molecular pathology today. “We were impressed by the engagement at our 2024 Symposium and are excited by the accomplishments of the global researchers who presented their OGM data during sessions and in scientific posters,” commented Alka Chaubey, PhD, FACMG, chief medical officer at Bionano. “OGM’s ability to identify pathogenic variants missed by many legacy techniques was highlighted in multiple presentations, including a presentation from day three, covering a research study that used OGM to successfully detect a repeat expansion missed by conventional cytogenetic methods over 15 years of analysis. Presenters also showcased OGM’s expansion into new application areas, where it has potential to outperform classical techniques, complement sequencing-based methods, and broaden researchers’ understanding of genomic landscapes.” Research shared over the four-day virtual event expanded on key findings in several applications of OGM: Day 1: New Standards in Hematologic Malignancies OGM can provide researchers with a simple, easy to implement workflow: Tiffany Clouston from Saint John Regional Hospital highlighted increasing demand for cytogenetics combined with limited staffing and training resources as a driver for her lab’s adoption of OGM, with sample preparation kits that are easy to use, and a sample-to-answer workflow that delivers whole genome structural variant (SV) analysis at high resolution, improving turnaround time. OGM can perform comparably to classical cytogenetics and can enable detection of additional pathogenic variants: Dr. Guilin Tang from the University of Texas MD Anderson Cancer Center described results from a study on 28 T-lymphoblastic leukemia (T-ALL) samples that showed that OGM detected SVs in 100% of samples, even those with normal karyotype, and revealed additional, clinically relevant information in 56% of samples. International consortia have formed all over the world and they are establishing guidelines for standardized implementation of OGM and reporting of OGM data: Agnes Daudignon from Lille Hospital and Dr. Adam Smith from University of Toronto described two different consortia, a French group of OGM users called FrOGG, and the International Consortium for Hematologic Malignancies, which have formed to help members validate, implement and standardize OGM, fueling its expansion into new labs. Day 2: New Frontiers in Oncology OGM has the potential to impact therapy selection and cancer risk assessment and to expand the understanding of heme malignancy applications compared to sequencing and classical cytogenetic methods: Dr. Isabelle Raymond-Bouchard from Maisonneuve-Rosemont Hospital presented results from a study that used OGM to analyze 50 multiple myeloma (MM) samples, showing that OGM was highly concordant with classical cytogenetic methods and identified variants that led to a 30% increase in prognostic information, which may result in improved therapy selection. Dr. Scott Ryall from Brigham and Women’s Hospital also highlighted OGM’s impact on MM research, with findings that showed the workflow’s ability to detect clinically relevant SVs and to expand the understanding of the structural landscape of myeloma. OGM can identify clinically relevant SVs missed by traditional methods: A study presented by Dr. Miriam Bornhorst from Lurie Children’s Hospital of Chicago showed that OGM was able to detect 20% more pathogenic variants in 100 pediatric brain tumor samples than classical cytogenetic methods. OGM can characterize and stratifyHomologous Recombination Deficiency (HRD) in breast tumor samples: In a research study on Triple-Negative Breast Cancer (TNBC) presented by Dr. Marc-Henri Stern from Institute Curie, OGM was able to clearly differentiate between homologous recombination proficient (HRP) and deficient (HRD) breast cancer cells, which could potentially help patients get access to life saving PARP inhibitors. High performance and utility make OGM a potential key assay for cancer research: Presenters shared data that underscored OGM’s high sensitivity, specificity, and fast turnaround time when compared to classical techniques including karyotyping (KT) and fluorescence in situ hybridization (FISH), which have been the standard for cytogenetic analysis of cancer samples for decades. Day 3: Advances in Constitutional Applications OGM detected significant SVs missed by NGS, long read sequencing (LRS) and classical cytogenetic methods: Presentations delivered by Dr. Nikhil Sahajpal from Greenwood Genetic Center, Dr. Laila El Khattabi from AP-HP Sorbonne, and Dr. Maria Clara Bonaglia from Scientific Institute E. Medea included findings from OGM that were missed by multiple other methods and that proved important in research connected to unraveling longstanding mysteries in genetic disease. OGM can be highly concordant with traditional methods and accomplish, in a single assay, what took multiple assays in 60% of samples or more: In pre- and postnatal constitutional genetic disorder studies presented by Dr. Roger Stevenson from Greenwood Genetic Center, OGM was shown to be a complete replacement for multiple techniques used in classical cytogenetics. Combination of OGM and NGS can improve upon and potentially replace traditional workflows: Across the presentations in day 3, the combination of OGM and NGS was shown to be highly complementary and that it may enable comprehensive genomic variation analysis in constitutional genetic diseases. Day 4: OGM in Cell and Gene Therapy OGM is the only genome-wide tool used by the National Institute of Standards and Technology (NIST) genome editing consortium: In the search for potentially deleterious effects of gene editing, OGM is the only genome-wide tool that meets the NIST genome editing consortium requirements for cost, accuracy, performance and speed. All other technologies that are part of the NIST consortium are targeted assays. OGM can offer high resolution and sensitivity compared to classical cytogenetic methods: OGM was reported to reliably detect on-target effects of CRISPR/Cas9 gene editing at variant allele frequency (VAF) as low as 1%, potentially providing an advantage over other techniques in quality control of pluripotent stem cells and evaluation of the integrity of laboratory cell lines. OGM can outperform classical cytogenetic methods to screen cell lines more easily for genomic instability and off-target events: Owen Pearce from eGenesis shared data that highlighted how OGM can offer improvements in quality control compared to methods like KT, which will be crucial to cell and gene therapy applications with increasing pressure from the FDA. “Symposium 2024 underscored OGM’s utility and demonstrated that the workflow has expanded beyond concordance studies. The event presentations provided data that showed OGM’s expansion into new applications, and its ability to uncover new actionable biomarkers. We were pleased to see researchers share findings that showed that OGM has the potential to impact genome research in a meaningful way,” commented Erik Holmlin, PhD, president and chief executive officer at Bionano. “I would encourage anyone who was unable to attend live to login, view these presentations and see how bright the future of cytogenetics is with OGM.” Poster winners: Award Title Author Institution Grand prize winner Comprehensive Analysis of B-Cell Precursor Acute Lymphoblastic Leukemia: Insights from Optical Genome Mapping and Next-Generation Sequencing Danielle Brandes University Hospital Düsseldorf Oncology Complex Karyotypes and Novel Findings Revealed by Optical Genome Mapping in Hematologic Malignancies Dr. Shivaprasad H. Sathyanarayana Dartmouth Health Constitutional Applications Optical Genome Mapping Help in Analyzing the Products of Conception Cases in High Maternal Cell Contamination: A Preliminary Study Kolhe Laboratory Augusta University Research and Discovery A Search for Genetic Determinants in Neural Tube Defects Using Optical Genome Mapping Dr. Nikhil Sahajpal Greenwood Genetic Center On-demand presentations are available here with free registration. About Bionano Bionano is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine. The Company’s mission is to transform the way the world sees the genome through OGM solutions, diagnostic services and software. The Company offers OGM solutions for applications across basic, translational and clinical research. Through its Lineagen, Inc. d/b/a Bionano Laboratories business, the Company also provides diagnostic testing for patients with clinical presentations consistent with autism spectrum disorder and other neurodevelopmental disabilities. The Company also offers an industry-leading, platform-agnostic software solution, which integrates next-generation sequencing and microarray data designed to provide analysis, visualization, interpretation and reporting of copy number variants, single-nucleotide variants and absence of heterozygosity across the genome in one consolidated view. The Company additionally offers nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. For more information, visit , or . Bionano’s OGM products are for research use only and not for use in diagnostic procedures. Forward-Looking Statements of Bionano This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “can,” “could,” “may,” “potential,” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, OGM’s utility for research in areas including cancer, genetic disease, and cell and gene therapy; the ability and utility of OGM to reveal new, actionable biomarkers; the ability and utility of OGM to identify SVs in hematological malignancy research that are relevant in the context of applications to potential therapeutic development and maybe even one day patient management; the ability and utility of OGM to help unravel persistent, complex mysteries in genetic disease disorders like Down syndrome and Marfan syndrome; the ability and utility of OGM to meet the key requirements of the cell and gene therapy community; the ability and utility of OGM to serve as an important bridge between cytogenetics and molecular pathology by elevating something that is digital and molecular and complementing NGS; the ability and utility of OGM to uncover new actionable biomarkers; the ability and utility of OGM to identify SVs highly concordant with classical cytogenetic methods; the ability and utility of OGM to identify SVs that were missed by classical cytogenetic methods; the ability and utility of OGM to provide results similar to results similar to the presentations given and the posters made available during our 2024 Symposium; the growth and adoption of OGM; and the ability of OGM to replace or complement traditional cytogenetic analysis tools and methods. Each of these forward-looking statements involves risks and uncertainties. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks and uncertainties associated with: the impact of geopolitical and macroeconomic developments, such as recent and future bank failures, global pandemics, inflation, supply chain disruptions, the ongoing conflicts between Ukraine and –Russia and Israel and Hamas, on our business and the global economy; the failure of OGM to be useful for research in areas including cancer, genetic disease, and cell and gene therapy; the failure of OGM to reveal new, actionable biomarkers; the failure of OGM to identify SVs in hematological malignancy research that are relevant in the context of applications to potential therapeutic development and maybe even one day patient management; the failure of OGM to help unravel persistent, complex mysteries in genetic disease disorders like Down syndrome and Marfan syndrome; the failure of OGM to meet the key requirements of the cell and gene therapy community; the failure of OGM to serve as an important bridge between cytogenetics and molecular pathology by elevating something that is digital and molecular and complementing NGS; the failure of OGM to uncover new actionable biomarkers; the failure of OGM to identify SVs highly concordant with classical cytogenetic methods; the failure of OGM to identify SVs that were missed by classical cytogenetic methods; the failure of OGM to provide results similar to results similar to the presentations given and the posters made available during our 2024 Symposium; future study results contradicting the results reported in the presentations given and the posters made available at our 2024 Symposium; general market conditions; changes in the competitive landscape and the introduction of competitive technologies or improvements to existing technologies; changes in our strategic and commercial plans; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts and our ability to continue as a “going concern”; the ability of medical and research institutions to obtain funding to support adoption or continued use of our technologies; and the risks and uncertainties associated with our business and financial condition in general, including the risks and uncertainties described in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2022 and in other filings subsequently made by us with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise. CONTACTS Company Contact: Erik Holmlin, CEO Bionano Genomics, Inc. +1 (858) 888-7610 eholmlin@bionanogenomics.com Investor Relations: David Holmes Gilmartin Group +1 (858) 888-7625 IR@bionano.com