Financial Data and Key Metrics Changes - Revenue for Q4 2025 was $8 million, down 3% from $8.2 million in Q4 2024, but at the high end of the pre-announced range of $7.8 million-$8 million [6] - Full year 2025 revenue was $28.5 million, down 7% from $30.8 million in 2024 [7] - Non-GAAP gross margin for Q4 2025 was 43%, up from 42% a year ago; for the full year, it was 47%, up from 35% in 2024, reflecting a 1,200 basis points improvement [8] - Non-GAAP operating expenses for Q4 2025 were $9.7 million, down 9% year-over-year; for the full year, they were $36.6 million, down 47% from $68.9 million in 2024 [9] Business Line Data and Key Metrics Changes - Sold 7,554 nanochannel array flow cells in Q4 2025, down 6% year-over-year; full year flow cells sold were 30,171, down just 0.4% [6][8] - Consumables and software revenue decreased by 1% to $4.8 million in Q4, driven by a 22% decline in software revenue, offsetting 8% growth in consumables [12] - Consumables and software revenue grew for the full year from $19 million to $20.4 million, representing 7% growth [13] Market Data and Key Metrics Changes - The company has narrowed its geographic focus to the United States, Canada, most of Western Europe, and Israel, while maintaining partnerships for support outside these regions [14] - Routine use customers accounted for about 83% of OGM consumables revenue in 2025, with an average revenue per routine use customer of about $89,000 [15][16] Company Strategy and Development Direction - The company shifted its strategy in September 2024 to focus on profitable growth from high volume users and selective customer acquisition [10] - Four strategic pillars were established: support the installed base, increase utilization of optical genome mapping, build support for reimbursement, and improve profitability through lower costs and higher volumes [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in a strong outlook for 2026, initiating revenue guidance of $30 million-$33 million, representing 5%-16% growth over 2025 [25] - A significant catalyst for growth is the increase in the price determination for the hematologic malignancy CPT code, which is expected to accelerate adoption and utilization [32][33] Other Important Information - The company ended 2025 with $29.6 million in cash equivalents and available-for-sale securities, with an expected cash runway extending into 2027 [9] - The establishment of a second Category I CPT code for OGM in constitutional genetic disorders is a key infrastructure development [20] Q&A Session Summary Question: Expectations for new OGM systems installations in 2026 - Management expects installations to be comparable to the previous year but is not providing specific guidance [28] Question: Sales expectations for nanochannel array flow cells in 2026 - Management anticipates that consumables volume will likely track with revenue growth, despite supply constraints affecting sales [29][30] Question: Required sales of nanochannel or new OGM systems to achieve revenue guidance - Management emphasizes focusing on the productivity of routine users and converting potential customers to validated users as key growth drivers [31][32]

Financial Data and Key Metrics Changes - Revenue for Q4 2025 was $8 million, down 3% from $8.2 million in Q4 2024, but at the high end of the pre-announced range of $7.8 million-$8 million [6] - Full year 2025 revenue was $28.5 million, down 7% from $30.8 million in 2024 [6] - Non-GAAP gross margin for Q4 2025 was 43%, up from 42% a year ago; for the full year, it was 47%, up from 35% in 2024, reflecting a 1,200 basis points improvement [7][8] - Non-GAAP operating expenses for Q4 2025 were $9.7 million, down 9% year-over-year; for the full year, they were $36.6 million, down 47% from $68.9 million in 2024 [9] Business Line Data and Key Metrics Changes - Sold 7,554 nanochannel array flow cells in Q4 2025, down 6% year-over-year; full year sales were 30,171 flow cells, down just 0.4% [6][7] - Consumables and software revenue decreased by 1% to $4.8 million in Q4, driven by a 22% decline in software revenue, offsetting 8% growth in consumables [12] - Consumables and software revenue grew for the full year from $19 million to $20.4 million, representing 7% growth [13] Market Data and Key Metrics Changes - The company focused on routine use customers, who accounted for about 83% of OGM consumables revenue in 2025 [15] - Routine use customers, representing about 30-40% of total customers, operated approximately 175 systems or 45% of the global installed base [14] - The average revenue per routine use customer in 2025 was about $89,000, double the average per customer across the entire global installed base [15] Company Strategy and Development Direction - The company shifted its strategy in September 2024 to focus on profitable growth from high volume users and selective customer acquisition [10] - Four strategic pillars were established: support the installed base, increase utilization of optical genome mapping, build support for reimbursement, and improve profitability and scalability [11] - The company aims to enhance customer workflows and expand the use of its products through software upgrades and automation [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in a strong outlook for 2026, initiating revenue guidance of $30 million-$33 million, representing 5%-16% growth over 2025 [26] - The establishment of a second Category I CPT code for OGM and a 47% increase in payment determination for existing codes were highlighted as significant catalysts for growth [20][32] - Management noted that the community is becoming advocates for OGM, indicating a shift in market dynamics [21] Other Important Information - The company ended 2025 with $29.6 million in cash equivalents and available-for-sale securities, with expectations for a cash runway extending into 2027 [9] - The Bionano Symposium 2026 had over 1,250 registrants from 73 countries, showcasing significant community engagement and interest in OGM [23] Q&A Session Summary Question: Expectations for new OGM systems installations in 2026 - Management expects installations to be comparable to the previous year but did not provide specific guidance [28] Question: Sales expectations for nanochannel array flow cells in 2026 - Management indicated that consumables volume is expected to track with revenue growth, despite supply constraints affecting sales [29][30] Question: Revenue growth drivers for 2026 - Management emphasized the importance of routine users and the impact of increased reimbursement rates as key growth catalysts [31][32]

Core Insights - Bionano Genomics showcased its advancements in optical genome mapping (OGM) at the 2026 ACMG Annual Meeting, with a significant increase in studies presented, highlighting the growing importance of OGM in genomics research [1][5] Group 1: Event Participation and Presentations - Bionano Genomics participated in the 2026 ACMG Annual Meeting held from March 14-18 in Baltimore, Maryland, presenting twelve studies, which is a two-fold increase from 2025 [1] - The studies included four oral presentations and eight poster presentations, focusing on the application of OGM in detecting structural variants (SVs) in cancer genomics and genetic disorders [1][2] Group 2: Applications and Impact of OGM - The studies demonstrated OGM's capability to identify SVs that may be overlooked by other techniques, particularly in areas such as hematologic malignancies and rare diseases [1][5] - A workshop titled "Ask the OGM Expert" was conducted by Nikhil Sahajpal, PhD, allowing attendees to gain insights on OGM applications [1] - Baylor Genetics announced the commercial release of a service providing OGM data to the research community, further enhancing the accessibility of this technology [1] Group 3: Industry Perspective - Erik Holmlin, CEO of Bionano, emphasized the increasing application of OGM and its potential to aid researchers in exploring complex genomic variations, positioning OGM as a central technique in modern cytogenetics [5]

Core Viewpoint - Bionano Genomics is hosting the Bionano Symposium 2026, a virtual event focused on optical genome mapping (OGM), showcasing advancements and applications in various research fields [1][2][3] Event Overview - The symposium will take place from February 23-26, 2026, featuring over 30 researchers from North America, Europe, and Asia [2] - The event will include scientific presentations, interactive panel discussions, and a virtual poster hall [2][3] Research Applications - The symposium will cover multiple research applications including hematologic malignancies, solid tumors, bioprocessing, constitutional genetic disorders, and gene and cell therapy [2][4] - Each day will focus on specific topics, such as advancements in hematologic malignancies, new frontiers in oncology research, constitutional genetic disorder research, and the landscape of genome analysis with Bionano products [4][9] Technology and Tools - Bionano will showcase its tools including Ionic, Saphyr, and Stratys systems, along with VIA software for genome analysis [5][6] - Key opinion leaders will discuss various applications of these tools, emphasizing their role in enhancing laboratory workflows and genomic analysis [5][6] Company Mission - Bionano Genomics aims to transform genome analysis through OGM solutions, diagnostic services, and software, positioning itself as a leader in the field [6]

Core Insights - Bionano Genomics showcased the advancements of optical genome mapping (OGM) at the AMP Annual Meeting, emphasizing its superior ability to detect structural variants compared to traditional methods [1][4] - The conference featured thirteen studies demonstrating OGM's effectiveness in identifying clinically relevant structural variants, highlighting its potential as a high-resolution technique for understanding complex diseases [2][3] Group 1: OGM Utility and Applications - OGM has been integrated into laboratory workflows, enhancing its application in clinical and translational research settings [3] - Key studies presented included applications of OGM in recurrent pregnancy loss, pediatric low-grade gliomas, and various hematological malignancies [3] Group 2: Research Highlights - Notable presentations included the use of OGM for genome-wide structural variant detection in fresh-frozen tissue and its complementarity with next-generation sequencing in multiple myeloma [3] - The studies collectively illustrate OGM's capacity to uncover genetic mechanisms driving diseases, reinforcing its role in modern genomics [2][3] Group 3: Company Commitment - Bionano Genomics is dedicated to innovating and expanding its OGM platform, aiming to make comprehensive structural variant analysis routine and accessible [4]

Core Insights - Bionano Laboratories announced a significant increase of 47% in the clinical lab fee schedule for the CPT code 81195, raising it from $1263.53 to $1853.22, effective January 1, 2026, which pertains to optical genome mapping (OGM) for hematologic malignancies [1][2][4] Summary by Sections Payment Determination - The Centers for Medicare & Medicaid Services (CMS) previously set the payment for CPT code 81195 at $1263.53, effective January 1, 2025, based on a crosswalk to an existing code. A request for reconsideration led to a unanimous vote by the clinical diagnostic laboratory test committee to re-price the code to $1853.22, effective January 1, 2026 [2] Importance of CPT Codes - CPT codes for OGM are essential for reimbursement from third-party payers for Bionano Laboratories' laboratory developed tests (LDTs). Currently, there are two codes: 81195 for hematologic malignancy analysis and 81354 for constitutional genetic disease [3] Impact on OGM Services - The increase in reimbursement for CPT code 81195 is expected to facilitate the offering of OGM-based LDTs for hematologic malignancies, as it provides a more favorable reimbursement environment. The new payment level is deemed appropriate for the additional data collection and reporting required for OGM in blood cancers [4] Company Overview - Bionano Laboratories, a subsidiary of Bionano Genomics, specializes in optical genome mapping (OGM) testing and offers a range of diagnostic services. The company aims to transform genome analysis through advanced technologies and provides OGM solutions for various research applications [5][6]

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on September 11, 2025. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Bionano Genomics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Bionano Genomics, Inc. 9540 Towne Centre Drive, Suite 100 San Diego, California 921 ...

Core Viewpoint - Bionano Genomics, Inc. has announced the release of upgraded software versions VIA 7.2 and Solve 3.8.3, along with enhancements to its Stratys Compute server, aimed at improving genomic data analysis and interpretation speed, particularly for hematological malignancies and constitutional genetic disorders [1][2]. Group 1: Software Upgrades - VIA 7.2 automates variant calling, annotation, and interpretation using AI, enhancing the contextualization of variant calls across various data types [1][4]. - Solve 3.8.3 expands its control database of background structural variants (SVs) by 18%, improving sensitivity, specificity, and resolution for SV detection [4][5]. - The upgrades to the Stratys Compute server double the number of cancer samples that can be analyzed per week and expand functionality to include analysis pipelines previously available only on CPU versions [4][5]. Group 2: Company Mission and Offerings - Bionano aims to transform genome analysis through optical genome mapping (OGM) solutions, diagnostic services, and software, catering to basic, translational, and clinical research [3]. - The company provides an industry-leading, platform-agnostic genome analysis software solution and nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology [3].

Core Insights - Bionano Laboratories announced the establishment of a new Category I CPT code for optical genome mapping (OGM) in cytogenomic genome-wide analysis, effective January 1, 2026, which is crucial for reimbursement from third-party payers [1][2][3] Group 1: CPT Code Significance - The new CPT code is the second issued for OGM, following code 81195 established in 2024 for hematological malignancies, indicating that OGM has met rigorous Category I standards [2] - The approval of this CPT code is expected to enhance the awareness and utility of OGM in both oncology and clinical genetic testing communities [3] Group 2: Bionano Laboratories' Offerings - Bionano Laboratories provides CLIA-certified laboratory developed tests (LDTs) utilizing OGM technology to detect structural and copy number variations related to genetic disorders [1][4] - The OGM-Dx Postnatal and Prenatal Whole Genome SV tests are designed to detect all classes of structural variants traditionally tested by multiple methods, showcasing the advantages of OGM over legacy methods [3] Group 3: Company Overview - Bionano Genomics aims to transform genome analysis through OGM solutions, diagnostic services, and software, catering to applications across basic, translational, and clinical research [5]