OGM Technology and Systems - The Saphyr® system can analyze up to 4,000 human genomes per year at 100x coverage, while the Stratys™ system can analyze up to 13,500 human genomes per year at the same coverage[50]. - OGM systems are capable of detecting structural variants (SVs) larger than 500 base pairs with high sensitivity, making them the most sensitive detectors currently available on the market[51]. - The OGM workflow has demonstrated up to a 75% reduction in turnaround time for analysis of acute lymphoblastic leukemia (ALL) subjects compared to traditional methods like karyotyping and FISH[51]. - OGM systems are designed to replace traditional cytogenetic tools that are expensive, slow, and labor-intensive, potentially increasing assay success rates across various applications in genomics[41]. - The proprietary approach of OGM systems allows for comprehensive detection of all classes of SVs and copy number variants (CNVs) at a cost-effective and efficient rate[38]. - The integration of OGM data into the VIA software is expected to enhance analysis and reporting capabilities, facilitating easier adoption of OGM by customers[44]. - The company is actively researching the potential of OGM to replace CMA as the front-line test for children with developmental disorders, pending necessary insurance reimbursement codes[45]. - OGM systems are expected to analyze approximately 1.7 million constitutional genetic disease samples and 8.3 million cancer samples per year[72]. - The OGM reagents are sourced from a limited number of suppliers, which may affect supply continuity if replacements are needed[86]. - The Direct Label and Stain (DLS) kit allows for approximately 16 labels per 100,000 base pairs in the human genome, improving genome mapping accuracy[56]. - The company’s software solutions include algorithms for assembling genome maps and bioinformatics processing, enabling comprehensive analysis of genomic variants[63]. - The Saphyr® system images DNA at approximately 205 gigabase pairs per hour, while the Stratys™ system images nearly 820 gigabase pairs per hour[80]. - Bionano Laboratories has phased out ASD and NDD LDTs in 2024, focusing solely on OGM-based LDTs[82]. Market and Economic Potential - The global genomics products and services market is projected to grow from approximately $42.4 billion in 2023 to about $66.8 billion by 2029, reflecting a compound annual growth rate (CAGR) of 9.4%[69]. - The economic potential for Optical Genome Mapping (OGM) in cytogenetics and molecular pathology is estimated at approximately $10.0 billion annually, with $3.0 billion attributed to cell and gene therapy applications[70]. - Customers have published over 1,300 papers utilizing OGM technology, with more than 75% published since 2021 and 26% in 2024 alone[80]. - The company is focusing on expanding its market presence in China and India, recognizing significant growth opportunities in these regions[76]. Acquisitions and Enhancements - The company acquired BioDiscovery in 2021 and Purigen in 2022 to enhance its capabilities in data analysis and nucleic acid isolation, respectively[36]. - The company acquired the Ionic® Purification system in November 2022, which enhances nucleic acid purification efficiency, yielding higher purity and less fragmentation compared to traditional methods[59]. Compliance and Regulatory Environment - A category 1 CPT code for OGM in hematologic malignancies was issued, effective January 1, 2025, which may enhance reimbursement opportunities[74]. - The company is required to report private payor pricing to CMS, which will be used to revise payment rates under the Medicare Clinical Laboratory Fee Schedule (CLFS) starting in 2025[141]. - In the U.S., molecular pathology tests have multiple reimbursement coding options, including CPT codes, with several PLA codes available for OGM-based tests as of January 1, 2024[114]. - The FDA published a final rule on LDTs on May 6, 2024, which will phase out general enforcement discretion over four years, requiring premarket review and compliance with QSR, registration, and medical device reporting[108]. - The company is subject to HIPAA and maintains a compliance program to address security incidents and ensure timely reporting of breaches[124]. - The company must comply with various state laws regarding health information privacy, which may impose stricter requirements than federal laws[125]. - The FDA's enforcement actions for non-compliance can include sanctions such as fines, recalls, and civil or criminal prosecution[105]. - The company is subject to international regulations governing laboratory licensure and marketing approval for tests marketed outside the U.S.[138]. - The company’s San Diego lab is CLIA accredited and CAP certified, providing OGM-based LDTs for various applications[91]. - The company received CAP accreditation for its San Diego facility in 2023, enhancing its compliance with quality standards[119]. Financial Overview - Approximately 90% of the diagnostic service revenue for Bionano Laboratories is paid by private third-party payors[129]. - As of December 31, 2024, Bionano Laboratories had approximately $9.2 million in cash and cash equivalents, $0.3 million in short-term investments, and $11.4 million in restricted cash and cash equivalents[515]. - The company does not expect anticipated changes in interest rates to have a material effect on its interest rate risk in future reporting periods[516]. - The fair value of acquisition-related contingent consideration and convertible High Trail Notes has been adjusted due to increased risk-free interest rates, but this did not materially impact the financial statements[517]. - The company is exposed to market risks related to interest rates, foreign currency exchange rates, and inflation in its operations both domestically and internationally[514]. - The company has minimal foreign currency exposure, primarily in British Pound, Chinese Renminbi, Euro, and Canadian dollar, and does not expect significant changes in foreign currency denomination in the next 12 months[519]. - A hypothetical 10% change in foreign exchange rates is not expected to have a material impact on the company's financial condition or results of operations[519]. - Inflationary pressures from geopolitical events and supply chain challenges have increased logistical costs and raw material prices, but the company does not believe inflation has materially affected its financial condition[520]. - The cost of revenue as of December 31, 2024, was not significantly impacted by cost increases due to inflation[520]. - The company does not expect anticipated changes in inflation to materially affect its business or financial condition in future reporting periods[521]. - The company may face challenges in offsetting significant inflationary pressures through price increases, which could harm its financial condition[521]. Workforce and Diversity - The company had a total of 100 employees as of December 31, 2024, with 74 located in the U.S. and 26 employed outside the U.S.[143]. - The company values diversity, equity, and inclusion across its workforce and is focused on initiatives that support a culture centered on belonging[145]. Sales and Marketing Strategy - The company’s sales strategy includes a direct sales force in North America and Europe, supported by field application specialists for customer education and technical support[78]. - The sales cycle for the company's systems can take nine to 12 months due to extensive evaluations and tender processes required by potential customers[81]. Risks and Challenges - The company is subject to various state and federal laws that prohibit fraud and abuse involving healthcare programs, which are enforced aggressively by multiple agencies[130]. - The Anti-Kickback Statute prohibits offering or receiving remuneration in exchange for referrals related to federal healthcare programs, with severe penalties for violations[131].

Revenue Expectations - Preliminary Q4 2024 revenue is expected to be between $7.9 million and $8.1 million, representing an estimated decrease of approximately 25% compared to Q4 2023 revenue of $10.7 million[4]. - Full year 2024 revenue is expected to be in the range of $30.5 million to $30.7 million, an estimated decrease of approximately 15% compared to $36.1 million in 2023[6]. Sales and Installed Base - Installed base of optical genome mapping (OGM) systems reached an estimated 371 as of year-end 2024, a 14% increase from 326 systems at the end of 2023[4]. - Preliminary number of nanochannel array flowcells sold in Q4 2024 is expected to be 8,058, representing an estimated increase of 1% over the 7,980 flowcells sold in Q4 2023[4]. Cost Management - The company has reduced annualized operating costs by approximately $100 million since initiating cost reduction efforts in May 2023[3]. Regulatory and Product Developments - The American Medical Association established a category I CPT code for OGM, which is expected to enhance reimbursement opportunities for OGM users[10]. - The company completed the full commercial release of the high throughput OGM instrument, Stratys™, which is expected to enable a four-fold increase in raw data generation rate compared to the previous Saphyr system[8]. Financial Position - Cash, cash equivalents, and available-for-sale securities as of December 31, 2024, were approximately $20.9 million, with $11.4 million subject to restrictions[7]. - The company raised net proceeds of $3.6 million from ATM sales during Q4 2024 and an additional $1.9 million in 2025 through ATM sales[7]. - The company modified the terms of its senior secured convertible debentures, deferring a $1 million amortization payment due in December 2024[7].

SAN DIEGO, March 31, 2025 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (NASDAQ:BNGO) today reported financial results for the fourth quarter and full year ended December 31, 2024 and revenue outlook for 2025. "2024 has been an important year for Bionano. Despite a challenging external environment with shrinking capital budgets, financial uncertainty for our customers and difficult equity capital markets, we have continued serving our mission of transforming the way the world sees the genome and we believe we ...

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]