Core Insights - Bionano Genomics and Greenwood Genetic Center published a study in Genome Research using optical genome mapping (OGM) to explore the genetic landscape of neural tube defects (NTDs), which are the most common birth defects of the central nervous system [1][2][3] Group 1: Study Findings - The study analyzed structural variants (SVs) in a cohort of 104 NTD cases, identifying genetic factors in 8% of cases, with an additional 13% showing likely pathogenic variants and 9% from mouse models, totaling 30% of cases with potential genetic insights [2][6] - NTDs affect approximately 300,000 births annually worldwide and are a leading cause of infant mortality and lifelong disability [2] - The research highlights the potential of OGM to uncover previously undetected genetic variants and rare structural variants that could enhance understanding of NTDs [3][6] Group 2: Implications and Future Directions - The findings may improve future patient management and guide therapeutic interventions, offering hope to families affected by NTDs [3][6] - The study identified four candidate genes (RMND5A, HNRNPC, FOXD4, and RBBP4) with strong potential involvement in NTDs, expanding the clinical implications of known genes associated with NTD risk [6]

Core Insights - Bionano Genomics, Inc. is participating in the ACMG Annual Clinical Genetics Meeting 2025, showcasing its optical genome mapping (OGM) technology in various research areas [2][4] - The conference will feature presentations on OGM's applications in hematological malignancies, constitutional genetic disorders, and rare genetic diseases [2][4] - The event highlights the growing impact of OGM in clinical research and its acceptance for routine use in cytogenetics [5][4] Company Overview - Bionano Genomics provides genome analysis solutions aimed at transforming the understanding of the genome through OGM technology [6] - The company offers diagnostic services, software, and OGM solutions applicable across basic, translational, and clinical research [6] - Bionano's mission includes enabling researchers and clinicians to address challenging biological and medical questions [6] Conference Details - The ACMG Annual Meeting will take place from March 18-22, 2025, in Los Angeles, USA, gathering industry professionals and researchers [3] - Key presentations include topics such as the evolution of cytogenomic technology and the integration of OGM with targeted next-generation sequencing (NGS) [4][5] - Notable speakers include Dr. Adam Smith, Dr. Laila El-Khattabi, and Dr. Nikhil Sahajpal, who will present findings from various clinical research cohorts [4][5] Research Focus - OGM is being utilized to improve the diagnosis of structural variations and aneuploidies in constitutional and reproductive disorders [4] - The CHROMAPS project, a multi-institutional collaboration, aims to evaluate structural variations in genetic disorders using OGM [4] - Presentations will also cover OGM's role in advancing precision therapeutics and CAR-T cell-based immunotherapies [5]

Core Points - Bionano Genomics, Inc. will host a conference call and live webcast on March 31, 2025, at 4:30 p.m. Eastern Time to report financial results for Q4 and full year 2024 and to highlight recent corporate progress [1] Group 1: Conference Call & Webcast Details - The conference call is scheduled for March 31, 2025, at 4:30 p.m. ET [2] - Participants can register and access the live webcast through the provided links [2] - A replay of the conference call and webcast will be available on Bionano's investor relations website for at least 30 days [2] Group 2: Company Contact - Erik Holmlin is the CEO of Bionano Genomics, Inc., and can be contacted at +1 (858) 888-7610 or via email [3]

Core Insights - Bionano Genomics, Inc. announced a study demonstrating the utility of optical genome mapping (OGM) for detecting structural variants associated with chromoanagenesis (CAG) in acute myeloid leukemia (AML) [1][4] - The study found that CAG was present in 16% of AML cases, with approximately two-thirds of high-risk cytogenetic profiles showing this variant, indicating OGM's higher sensitivity compared to traditional methods [1][9] - The median survival for AML patients with CAG was significantly lower at 5 months compared to 14 months for those without CAG, highlighting the importance of early detection for treatment planning [9] Study Details - The study analyzed a cohort of 410 AML cases and was led by Dr. Guilin Tang from MD Anderson Cancer Center, marking the first known use of OGM to study CAG [2] - OGM demonstrated high resolution and sensitivity in detecting catastrophic chromosomal events, reinforcing its potential to refine AML risk stratification [9] Company Overview - Bionano Genomics provides genome analysis solutions aimed at transforming the understanding of the genome through OGM, diagnostic services, and software [5] - The company offers OGM solutions for various research applications and has developed a platform-agnostic genome analysis software solution [5]

Core Viewpoint - Bionano Genomics, Inc. will implement a reverse stock split at a ratio of 1-for-60, effective January 24, 2025, with trading on a split-adjusted basis starting January 27, 2025 [1][2]. Group 1: Reverse Stock Split Details - The reverse stock split will combine every 60 shares of common stock into one share, maintaining the par value at $0.0001 per share [3]. - A new CUSIP number, 09075F404, will be assigned to the common stock effective January 27, 2025, while the stock will continue to be listed on the Nasdaq Capital Market under the symbol "BNGO" [3]. - The reverse stock split will proportionately reduce the number of shares issuable upon conversion of outstanding convertible debentures and the exercise of stock options, restricted stock units, and warrants [3]. Group 2: Impact on Shareholders - No fractional shares will be issued; instead, stockholders entitled to a fractional share will receive a cash payment [4]. - The reverse stock split will affect all common stockholders proportionally, not altering their percentage ownership except in cases of fractional shares [4]. - Stockholders holding shares through banks or brokers will have their positions automatically adjusted without needing further action [5]. Group 3: Company Overview - Bionano Genomics provides genome analysis solutions aimed at enhancing research and clinical applications through optical genome mapping (OGM) [7]. - The company offers a range of products including OGM solutions, diagnostic services, and software, with a focus on transforming genomic analysis [7].

Core Insights - Bionano Genomics published a case study demonstrating the successful application of optical genome mapping (OGM) in preimplantation genetic testing for structural rearrangements (PGT-SR), leading to a viable pregnancy and the birth of a healthy baby after years of recurrent pregnancy loss (RPL) experienced by the couple [1][2][3] Group 1: Case Study Details - The couple's RPL was attributed to complex chromosomal rearrangements (CCRs) in the male partner, which were identified using OGM, revealing previously undetected issues that traditional cytogenetic methods missed [2][7] - The OGM findings informed the selection of the most viable embryo, resulting in a successful pregnancy confirmed by prenatal testing that showed a normal karyotype [2][3] Group 2: Company Overview - Bionano Genomics specializes in genome analysis solutions, aiming to transform genomic understanding through OGM, diagnostic services, and software [4] - The company provides OGM solutions applicable across various research fields and offers a platform-agnostic genome analysis software solution, along with nucleic acid extraction and purification technologies [4] Group 3: Industry Impact - The case study suggests that OGM could significantly aid individuals facing infertility or RPL, which affects millions globally, indicating a potential breakthrough in reproductive health [3]

Core Insights - Bionano Genomics reported preliminary financial results for Q4 and FY 2024, indicating a transitional year with significant changes aimed at cost reduction and advancing optical genome mapping (OGM) technology [1][2][8] Financial Performance - Q4 2024 revenue is expected to be between $7.9 million and $8.1 million, a decrease of approximately 25% compared to Q4 2023, primarily due to the discontinuation of clinical service products [4][5] - Full year 2024 revenue is projected to be between $30.5 million and $30.7 million, reflecting a decrease of about 15% from $36.1 million in 2023 [5] - The installed base of OGM systems increased by 14% to an estimated 371 systems by the end of 2024 [4][5] - The number of nanochannel array flowcells sold in Q4 2024 is expected to be 8,058, representing a 1% increase from Q4 2023 [4][5] - Cash and cash equivalents as of December 31, 2024, were approximately $20.9 million, with $11.4 million subject to restrictions [5] Strategic Initiatives - The company focused on restructuring to reduce operating costs by approximately $100 million since May 2023, while discontinuing non-core products [2][7] - Significant milestones were achieved in 2024, including the full commercial release of the Stratys™ system, which enhances data generation rates and streamlines workflows [10] - The American Medical Association established a category I CPT code for OGM, facilitating reimbursement for users [10] Market Position and Technology Advancements - Bionano's OGM technology is positioned as a replacement for legacy workflows in cytogenetics and molecular pathology, with ongoing advancements in VIA software for data analysis [2][10] - Collaborations with NVIDIA led to the development of Stratys™ Compute, enhancing data analysis capabilities [10] - The OGM community published significant research, further validating the technology's applications in various medical fields [10]

Core Viewpoint - Bionano Genomics' optical genome mapping (OGM) technology has demonstrated the ability to identify a specific variant in acute promyelocytic leukemia (APL) that is often missed by traditional cytogenetic methods, suggesting OGM could enhance therapy selection and patient management in blood cancers [1][2][3]. Group 1: OGM Technology and Findings - OGM successfully detected a PML::RARA fusion variant in APL that was not identified by karyotyping and was non-informative by FISH [2][7]. - APL, a subtype of acute myelogenous leukemia (AML), has a treatment response rate to all-trans retinoic acid (ATRA) and arsenic trioxide (ATO), but conventional cytogenetics fails to identify actionable variants in approximately 13% of APL cases [2][7]. - The identification of the PML::RARA fusion variant by OGM aligns with previous findings that OGM can detect both variants identified by standard cytogenetics and additional pathogenic variants that are often missed [2][7]. Group 2: Company Overview - Bionano Genomics specializes in genome analysis solutions aimed at transforming genomic insights through OGM, diagnostic services, and software [4]. - The company provides OGM solutions applicable across various research domains, along with a platform-agnostic genome analysis software and nucleic acid extraction solutions utilizing proprietary isotachophoresis technology [4]. - Bionano also offers OGM-based diagnostic testing services through its subsidiary, Lineagen, Inc. [4].

Core Viewpoint - Bionano Genomics, Inc. has successfully closed a registered direct offering, raising approximately $10 million, with potential additional proceeds from warrants also amounting to around $10 million if fully exercised [1][3]. Group 1: Offering Details - The offering consisted of 39,682,540 shares of common stock and warrants to purchase an equal number of shares, priced at $0.252 per share [1]. - The warrants have an exercise price of $0.252 per share and will be exercisable upon stockholder approval, expiring five years after such approval [1]. - H.C. Wainwright & Co. served as the exclusive placement agent for this offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for general corporate purposes, including working capital, research and development, repayment of existing debt, and capital expenditures [3]. Group 3: Regulatory Information - The securities were offered under a shelf registration statement filed with the SEC, which became effective on May 8, 2023 [4]. - A final prospectus supplement related to the offering has been filed with the SEC and is available on their website [4]. Group 4: Company Overview - Bionano Genomics provides genome analysis solutions aimed at enhancing research and clinical applications, focusing on optical genome mapping and diagnostic services [6]. - The company also offers a platform-agnostic genome analysis software solution and nucleic acid extraction services using proprietary technology [6].

SAN DIEGO, Jan. 03, 2025 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced that it has entered into a definitive agreement with certain institutional investors for the purchase and sale of an aggregate of 39,682,540 shares of its common stock (or common stock equivalents) and warrants to purchase up to an aggregate of 39,682,540 shares of common stock (the “Warrants”), at a combined offering price of $0.252 per share of common stock (or per common stock equivalent) and accompanying W ...