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Thu Oct 22 · pre-market2 signals on Oct 21108 insider buys this week · $250.3MCIRO short report next: Oct 31The week ahead

BNGO

Bionano Genomics, Inc.
NASDAQ · TECHNOLOGY · LABORATORY ANALYTICAL INSTRUMENTS
1.25
+0.00 +0.00%
USD · close Oct 21

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How BNGO rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025
Text kept
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New in FY2025

  • Risk Factors in this Annual Report, including “ If our information technology systems or data or those of third parties upon which we rely, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences. ” Governance Our board of directors addresses the Company’s cybersecurity risk management as part of its general oversight function.
  • The Audit Committee is responsible for overseeing the Company’s cybersecurity risk management processes, including oversight of mitigation of risks from cybersecurity threats.
  • Our cybersecurity risk assessment and management processes are implemented and maintained by certain Company management, including our Principal Financial Officer (“PFO”) who serves as our CISO.
  • Our CISO relies on both internal and external cybersecurity resources to manage overall cybersecurity risks.
  • The Company’s PFO is responsible for hiring appropriate personnel, helping to integrate cybersecurity risk considerations into the Company’s overall risk management strategy, and communicating key priorities to relevant personnel.
  • The Company’s PFO is responsible for approving budgets, helping prepare for cybersecurity incidents, approving cybersecurity processes, and reviewing security assessments and other security-related reports.
  • Our cybersecurity incident response plan is designed to escalate certain cybersecurity incidents to members of management depending on the circumstances, including IT security leadership, the PFO, CEO, General Counsel (“GC”) and third-party consultants as needed.
  • IT security leadership, the PFO, CEO and GC work with the Company’s incident response team to help the Company mitigate and remediate cybersecurity incidents of which they are notified.
  • In addition, the Company’s incident response plan includes reporting to the Audit Committee for certain cybersecurity incidents.
  • The Audit Committee receives periodic reports concerning the Company’s significant cybersecurity threats and risk and the processes the Company has implemented to address them.
  • The Audit Committee also receives various reports, summaries or presentations related to cybersecurity threats, risk and mitigation.
  • PR OPERTIES We lease an aggregate of approximately 24,494 square feet of office, laboratory, and manufacturing space in one building at our headquarters in San Diego, California, with the lease originally expiring on December 31, 2025, and later amended to December 31, 2030.
  • In October 2021, through the acquisition of BioDiscovery, we obtained a finance lease for approximately 4,786 square feet of office space in El Segundo, California that expires in February 2041.
  • We believe our properties are sufficient to satisfy our current needs.
  • LEG AL PROCEEDINGS We are not currently a party to any material legal proceedings and we are not aware of any pending or threatened legal proceedings against us that could reasonably be expected to have a material adverse effect on our business, financial condition or results of operations.
  • MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common stock trades on The Nasdaq Capital Market under the symbol “BNGO.” Common Stock Holders As of March 19, 2026, there were approximately 23 holders of record of our common stock.
  • Certain shares of our common stock are held in “street” name and thus the actual number of beneficial owners of such shares is not known or included in the foregoing number.
  • Dividend Policy We have never declared or paid cash dividends on our capital stock.
  • We currently intend to retain any future earnings for use in the operation of our business and do not intend to declare or pay any cash dividends in the foreseeable future.
  • Any future determination to pay dividends on our capital stock would be at the discretion of our board of directors, subject to applicable laws, and would depend on our financial condition, results of operations, capital requirements, general business conditions and other factors that our board of directors considers relevant.
  • Purchases of Equity Securities by the Issuer and Affiliated Purchasers None.
  • Recent Sales of Unregistered Securities None.
  • MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and related notes included elsewhere in this Annual Report.
  • All dollar amounts and share counts presented below have been rounded to the nearest thousand and, thus are approximate.
  • Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report, including information with respect to our plans and strategy for our business and expected financial results, includes forward-looking statements that involve risks and uncertainties.
  • You should review the section titled “Forward-Looking Statements” and the risks described in Part I, Item 1A Risk Factors and elsewhere in this Annual Report.
  • Overview We are a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine.
  • Our mission is to transform the way the world sees the genome through OGM solutions, diagnostic services and software.
  • We believe there are additional potential future market opportunities for OGM to streamline workflows, reduce the number of technologies required to deliver results, lower costs, and improve findings in the broader pathology market across multiple subdisciplines including newborn screening, population genomics, and neurological and cardiological risk assessment which are not included in our estimates above.
  • Additionally, we believe the market for our platform-agnostic software solution, which can be used in next-generation sequencing and microarray data analysis, includes the clinical NGS market which The Business Research Company has estimated at approximately $4.1 billion in 2025 and predicted would grow to approximately $8.2 billion in 2029, representing a compound annual growth rate of 18.8%.
  • Recent Highlights Commercial Adoption of Offerings for OGM Systems In executing on our commercialization strategy, we expanded the utilization of our OGM systems (our Saphyr system and our Stratys system) and: • Grew our installed base to 387 as of December 31, 2025, an increase of approximately 4.3% from a total installed base of 371 as of December 31, 2024.
  • Installed base represents the global number of OGM instruments installed at end-customer locations and therefore having the technology to process OGM. • Sold 30,171 flowcells in the year ended December 31, 2025, a decrease of approximately 0.4% from 30,307 flowcells sold in the same period of 2024.
  • The OGM cartridge is the consumable that packages nanochannel arrays for DNA linearization.
  • In its current form, the OGM cartridge can comprise one, two or three flowcells per cartridge.
  • Macroeconomic and Geopolitical Developments We are subject to additional risks and uncertainties as a result of adverse geopolitical and macroeconomic developments, such as recent and potential future bank failures, the ongoing international conflicts, related sanctions, any effects of global pandemics and uncertain market conditions, including inflation and supply chain disruptions, and international trade policies (including trade protection measures, such as tariffs, sanctions and other trade barriers), changes in monetary and fiscal policy, United States political developments and other sources of instability, which have not had a material impact on our business and financial results to date, but could result in a material impact to our business or financial results in the future.
  • Additionally, we have experienced a slowdown in our Asia Pacific business, including as a result of headwinds in the region, which negatively impacted our manufacturing partners who are reliant on government funding.
  • While our manufacturing partners in the Asia Pacific region have obtained some approvals from the National Medical Products Administration, and are waiting on more, we do not anticipate that the funding headwinds will change in the near term.
  • We closely monitor and comply with various applicable guidelines and legal requirements in the jurisdictions in which we operate.
  • In the past, we have experienced supply chain challenges, attributable to such adverse geopolitical and macroeconomic developments including increased costs to secure certain component parts in our products and to produce our products at our contract manufacturers.
  • During the year ended December 31, 2025, we did not experience material increases in our supply chain costs, but we may experience such increases in future fiscal periods.

and 817 more.

Gone since FY2024

  • Item 1A Risk Factors and elsewhere in this Annual Report.
  • Moreover, we operate in a very competitive and rapidly changing environment.
  • New risks and uncertainties may emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this Annual Report.
  • The results, events and circumstances reflected in the forward-looking statements may not be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.
  • In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject.
  • These statements are based on information available to us as of the date of this Annual Report.
  • And while we believe that information provides a reasonable basis for these statements, that information may be limited or incomplete.
  • Our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all relevant information.
  • These statements are inherently uncertain, and investors are cautioned not to unduly rely on these statements.
  • The forward-looking statements made in this Annual Report relate only to events as of the date on which the statements are made.
  • We undertake no obligation to update any forward-looking statements made in this Annual Report to reflect events or circumstances after the date of this Annual Report or to reflect new information or the occurrence of unanticipated events, except as required by law.
  • We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements.
  • Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments.
  • RISK FACTOR SUMMARY Below is a summary of the principal factors that make an investment in our securities speculative or risky.
  • This summary does not address all of the risks that we face.
  • Additional discussion of the risks and uncertainties summarized in this risk factor summary, and other risks and uncertainties that we face, are set forth below under the heading “Risk Factors” and should be carefully considered, together with other information in this Annual Report and our other filings with the SEC before making investment decisions regarding our securities. • We have incurred recurring net losses since we were formed and expect to incur losses in the future.
  • We cannot be certain that we will ever achieve or sustain profitability; • Our recurring losses, negative cash flows and significant accumulated deficit have raised substantial doubt regarding our ability to continue as a going concern.
  • We will need to raise additional capital, which may not be available on acceptable terms, if at all, to fund our existing operations.
  • If we are unable to raise sufficient additional capital in the very near term, we will be required to further curtail our operations, liquidate or otherwise dispose of assets, wind-down or cease operations entirely.
  • In these circumstances, investors may not receive full value, or any value, for their investment; • Our corporate cost saving initiatives and the associated headcount reductions we announced in May 2023, October 2023, March 2024, and September 2024 could disrupt our business, and may not achieve our intended objectives; • We are an early commercial-stage company and have a limited commercial history, which may make it difficult to evaluate our current business and predict our future performance; • Our quarterly and annual operating results and cash flows have fluctuated in the past and might continue to fluctuate, which makes our future operating results difficult to predict and could cause the market price of our securities to decline substantially; • Our future capital needs are uncertain and we will require additional funding in the future to advance the commercialization of our OGM systems, Ionic ® Purification system, VIA™ software, and our other products, technologies and services, as well as continue our research and development efforts.
  • If we fail to obtain sufficient additional funding, we will be forced to delay, reduce or eliminate significant portions of our commercialization and development efforts which could negatively impact our revenue opportunities; • The terms of the Debentures (as defined in the Notes to Consolidated Financial Statements) and the Debenture Purchase Agreement (as defined in the Notes to Consolidated Financial Statements) restrict our current and future operations.
  • Upon an event of default under the Debentures, we may not be able to make any accelerated payments under the Debentures or our other permitted indebtedness; • Unfavorable geopolitical and macroeconomic developments could adversely affect our business, financial condition or results of operations; • Acquisitions, joint ventures and other strategic transactions could disrupt or otherwise harm our business and may cause dilution to our stockholders; • If our products or technologies fail to achieve and sustain sufficient market acceptance, our revenue will be adversely affected; • In the near term, sales of our OGM systems, Ionic ® Purification system, VIA software, consumables and genome analysis services will depend on levels of research and development spending by clinical research laboratories, academic and governmental research institutions and biopharmaceutical companies, a reduction in which could limit demand for our technologies and products and adversely affect our business and operating results; • If we do not successfully manage the development and launch of new products and technologies, our financial results could be adversely affected; • Our future success is dependent upon our ability to further penetrate our existing customer base, attract new customers and retain the customers of our acquired businesses; • The size of the markets for our products and technologies may be smaller than we estimate, and new markets may not develop as quickly as we expect, or at all, limiting our ability to successfully sell our products and technologies; • We are currently limited to “research use only,” (“RUO”), with respect to many of the materials and components used in our consumable products including our assays; • We are subject to stringent and evolving U.S. and foreign laws, regulations, and rules, contractual obligations, industry standards, policies and other obligations related to data privacy and security.
  • Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation (including class claims) and mass arbitration demands; fines and penalties; disruption of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse business consequences; • If the U.S.
  • Food and Drug Administration, or FDA, ends enforcement discretion for Laboratory Developed Tests or determines that our RUO products are medical devices or if we seek to market our RUO products for clinical diagnostic or health screening use, we or our collaborators or customers will be required to obtain regulatory clearance(s) or approval(s), and we may be required to cease or limit sales of our then marketed products, which could materially and adversely affect our business, financial condition and results of operations.
  • Any such regulatory process would be expensive, time-consuming and uncertain both in timing and in outcome; • If we are unable to protect our intellectual property, it may reduce our ability to maintain any technological or competitive advantage over our competitors and potential competitors, and our business may be harmed; • We have rights in some intellectual property that has been discovered through government funded programs and thus is subject to federal regulations such as “march-in” rights, certain reporting requirements, and a preference for U.S. industry.
  • Compliance with such regulations may limit our exclusive rights, subject us to expenditure of resources with respect to reporting requirements, and limit our ability to contract with non-U.S. manufacturers; • We depend on technology that is licensed to us by third parties.
  • Any loss of our rights to these technologies could prevent us from selling our products; • If we are unable to maintain our listing on the Nasdaq Capital Market or if we are unable to transfer our listing to another stock market, our ability to publicly or privately sell equity securities and the liquidity of our common stock could be adversely affected; • The price of our securities has been and may in the future be volatile or may decline regardless of our operating performance, and you could lose all or part of your investment; • We may not be successful in identifying and implementing any potential strategic alternatives in a timely manner, or at all, and any strategic transactions that we may consummate in the future could have negative consequences; and • If a strategic transaction is not consummated and we are unable to raise sufficient capital to fund our operations, our Board may decide to pursue a dissolution and liquidation.
  • In such an event, the amount of cash available for distribution to our stockholders will depend significantly on the timing of such liquidation as well as the amount of cash that may need to be reserved for commitments and contingent liabilities.
  • BUSINESS Overview We are a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine.
  • Our mission is to transform the way the world sees the genome through optical genome mapping (“OGM”) solutions, diagnostic services and software.
  • We market and sell OGM systems, including the Saphyr ® system and the Stratys™ system, which deliver OGM data to enable ultra-sensitive and ultra-specific detection of all classes of structural variation (“SV”).
  • These systems are used to identify structural changes in chromosomes, the study of which is known as cytogenetics, and to accelerate the search for answers in genetic disease and cancer applications as well as in applications for cell and gene therapy.
  • The systems are comprised of an instrument, chip consumables, reagents and software containing a suite of data analysis and visualization tools.
  • OGM has been shown to outperform the current gold standard cytogenetic methods including karyotyping, fluorescence in-situ hybridization (“FISH”), Southern blot and chromosomal microarray (“CMA”), for the detection of SVs.
  • OGM has also been shown to identify structural changes in chromosomes that cannot be identified using current commercially available gene sequencing solutions.
  • We market and sell the Ionic ® Purification system, which is able to deliver high quality DNA in a more natural, native form and with fewer contaminants when compared to other isolation and purification solutions.
  • The Ionic ® Purification system is used to extract, purify, and concentrate DNA or RNA from a variety of sample types, and is comprised of an instrument, consumables, and reagents.
  • We market and sell the VIA™ software which delivers genomic data interpretation solutions tailored for research use in cytogenomics and molecular pathology labs in genetic disease and cancer research markets, with an emphasis on SV.
  • This industry leading, platform agnostic software solution is designed to provide analysis, visualization, interpretation and reporting of SVs, single-nucleotide variants and absence of heterozygosity across the genome in one consolidated view.
  • Our software currently enables analysis of OGM, next-generation sequencing (“NGS”) and microarray data.

and 1529 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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