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academic, acquired, Addendum, allocate, allocation, amortizable, amortized, amounted, amounting, antidilution, application, area, arm, ARTSA, assembly, authority, automated, backlog, billed, Branford, broad, brought, building, buyer, cancel, CarbonTM, charge, classification, cloud, combined, Committee, comparable, complexity, conflict, Consultant, core, define, delay, differentiated, direct, Director, Division, Employee, enacted, equitable, established, evaluated, evidence, evolving, execute, expensed, facility, faster, final, finance, fourth, free, fulfillment, functionality, funding, globe, goodwill, Governance, governed, handling, headcount, impaired, impairment, implementing, improved, industry, institution, introduced, leading, located, Majelac, member, milestone, military, modification, monthly, Munson, negotiated, Nominating, nondeductible, nondiscretionary, omitted, originally, ownership, participant, Pennsylvania, PlatinumTM, preceded, preclude, preexisting, preliminary, Prepaid, prevent, program, purpose, ranging, rapidly, raw, recovered, reimbursement, rendered, renew, resolution, Restated, ROU, Russia, satisfy, secured, seek, sheet, spectrometry, speed, sponsor, Street, supported, terminate, termination, terminology, today, Traditionally, turnaround, twelve, unbiased, unlock, unresolved, vendor, weight
Financial report summary
?Competition
Bio-Rad Laboratories Inc. - Ordinary Shares • Thermo Fisher Scientific • Danaher • Agilent • Standard BioTools • Quanterix • Seer Inc - Ordinary Shares • Nautilus Biotechnology • Olink Holding AB • SomaLogicRisks
- We are an early-stage life sciences technology company with a history of net losses, which we expect to continue, and we may not be able to generate meaningful revenues or achieve and sustain profitability in the future.
- We have a limited operating history, which may make it difficult to evaluate the prospects for our future viability and predict our future performance. As such, you cannot rely upon our historical operating performance to make an investment or voting decision regarding us.
- Our operating results may fluctuate significantly in the future, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we or other third parties may provide.
- We may need to raise additional capital to fund ongoing research and development, operating activities, and commercialization activities.
- We recently commercially launched our first product, but we may not be able to successfully commercially launch other future products.
- Our success depends on broad scientific and market acceptance, which we may fail to achieve.
- If we are unable to establish sales and marketing capabilities, we may not be successful in commercializing our products.
- The size of the markets for our products may be smaller than estimated, and new market opportunities may not develop as quickly as we expect, or at all, limiting our ability to successfully sell our products.
- Epidemics, pandemics or other public health crises, including COVID-19, could adversely affect our business.
- Environmental, social and governance matters may impact our business and reputation.
- Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.
- Geopolitical conflicts could potentially affect our sales and disrupt our operations and could have a material adverse impact on our business.
- If we do not sustain or successfully manage our anticipated growth, our business and prospects will be harmed.
- Recently and in the past, we have undergone leadership transitions and an internal restructuring, and we depend on our key personnel and other highly qualified personnel, and if we are unable to recruit, train and retain our personnel in the future, we may not achieve our goals.
- We expect to be dependent upon revenue generated from the sales of our initial products from the time they are commercialized through the foreseeable future.
- Our business will depend significantly on research and development spending by academic institutions and other research institutions, and any reduction in spending could limit demand for our products and adversely affect our business, results of operations, financial condition and prospects.
- If we use biological and hazardous materials in a manner that causes injury or violates laws or regulations, we could be liable for damages or subject to enforcement actions.
- We rely on certain contract manufacturers to manufacture and supply our instruments, components of our instruments, and certain components of our consumable offerings. If these manufacturers should fail or not perform satisfactorily, our ability to commercialize and supply our instruments and consumable offerings would be adversely affected.
- Our internal manufacturing equipment is specialized with limited vendor options and long lead times. If these pieces of equipment were to stop working and be unable to be repaired in a timely manner or at all, our ability to manufacturer our semiconductor chips would be adversely affected.
- If we do not successfully develop and maintain our Platinum Analysis Software service, our commercialization efforts and therefore business and results of operations could suffer.
- Commercializing our products outside of the United States could expose us to business, regulatory, political, operational, financial, and economic risks associated with doing business outside of the United States.
- We have limited experience producing and supplying our products, and we may be unable to consistently manufacture or source our instruments and consumables to the necessary specifications or in quantities necessary to meet demand on a timely basis and at acceptable performance and cost levels.
- We rely on third-party foundries to produce wafers, which when packaged and tested internally, lead to our supply of semiconductor chips. If these third-party foundries should fail or not perform satisfactorily, our ability to supply semiconductor chips would be negatively and adversely affected.
- Our products could have defects or errors, which may give rise to claims against us and adversely affect our business, financial condition, results of operations and cash flows.
- The life sciences technology market is highly competitive. If we fail to compete effectively, our business and results of operations will suffer.
- We are party to Technology and Services Exchange Agreements by and among us and certain affiliated companies, pursuant to which the parties agreed to share personnel and certain non-core technologies. The sharing arrangements under the agreements may prevent us from fully utilizing our personnel and/or the technologies shared under the agreements. Furthermore, if these agreements were to terminate, or if we were to lose access to these technologies and services, our business could be adversely affected.
- We may acquire other companies or technologies which could divert our management’s attention, result in additional dilution to our stockholders and otherwise disrupt our operations and harm our operating results.
- We may seek to enter into strategic collaborations and licensing arrangements with third parties, but we may not be successful in establishing or maintaining such arrangements.
- Our ability to use net operating losses to offset future taxable income may be subject to certain limitations.
- If our facilities or our third-party manufacturers’ facilities become unavailable or inoperable, our research and development program and commercialization launch plan could be adversely impacted and manufacturing of our instruments and consumables could be interrupted.
- If we experience a significant disruption in our information technology systems, including our Platinum Analysis Software services, or cybersecurity incidents, our business could be adversely affected.
- We could become subject to various litigation claims and legal proceedings.
- If we elect to label and promote any of our products as clinical diagnostics or medical devices, we would be required to obtain prior marketing authorization from the FDA, which would take significant time and expense and could fail to result in FDA marketing authorization of the device for the intended use or uses we believe are commercially attractive.
- Our RUO products could become subject to government regulation as medical devices by the FDA and other regulatory agencies even if we do not elect to seek regulatory authorization to market our products for diagnostic purposes, which would adversely impact our ability to market and sell our products and harm our business.
- Our reagents may be used by clinical laboratories to create LDTs, which could, in the future, become subject to some form of FDA regulatory requirements, which could materially and adversely affect our business and results of operations.
- We may be subject to certain federal, state and foreign fraud and abuse laws, health information privacy and security laws and physician payment transparency laws, which, if violated, could subject us to substantial penalties. Additionally, any challenge to or investigation into our practices under these laws could cause adverse publicity and be costly to respond to, and thus could harm our business.
- We are currently subject to, and may in the future become subject to, both U.S. federal and state laws and regulations as well as international laws imposing obligations on how we collect, store and process personal information. Our actual or perceived failure to comply with such obligations could harm our business. Ensuring compliance with such laws could also impair our efforts to maintain and expand our business and future customer base, and thereby decrease our revenue.
- We could be adversely affected by alleged violations of the Federal Trade Commission Act or other truth-in-advertising and consumer protection laws.
- Medical product manufacturers’ use of social media platforms presents new risks.
- If we are unable to obtain and maintain and enforce sufficient intellectual property protection for our products and technology, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our products may be impaired.
- The U.S. law relating to the patentability of certain inventions in the life sciences technology industry is uncertain and rapidly changing, which may adversely impact our existing patents or our ability to obtain patents in the future.
- We may not be able to protect our intellectual property rights throughout the world.
- Issued patents covering our products could be found invalid or unenforceable if challenged.
- If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected, and our business could be harmed.
- We may be subject to claims challenging the inventorship of our patents and other intellectual property.
- We may not be able to protect and enforce our trademarks and trade names, or build name recognition in our markets of interest thereby harming our competitive position.
- Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time.
- We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed to us alleged trade secrets of their other clients or former employers, which could subject us to costly litigation.
- We may become involved in lawsuits to defend against third-party claims of infringement, misappropriation or other violations of intellectual property or to protect or enforce our intellectual property, any of which could be expensive, time consuming and unsuccessful, and may prevent or delay our development and commercialization efforts.
- Obtaining and maintaining our patent protection depends on compliance with various required procedures, document submissions, fee payments and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- We currently rely on licenses from third parties, and in the future may rely on additional licenses from other third parties, and if we lose any of these licenses, then we may be subjected to future litigation.
- If we cannot license rights to use technologies on reasonable terms, we may not be able to commercialize new products in the future.
- Certain of our in-licensed patents are, and our future owned and in-licensed patents may be, subject to a reservation of rights by one or more third parties, including government march-in rights, that may limit our ability to exclude third parties from commercializing products similar or identical to ours.
- Our products contain third-party open-source software components and failure to comply with the terms of the underlying open-source software licenses could restrict our ability to sell our products and provide third parties access to our proprietary software.
- Intellectual property rights do not necessarily address all potential threats.
- Our outstanding warrants became exercisable for our Class A common stock in September 2021, which increased the number of shares eligible for future resale in the public market and resulted in dilution to our stockholders.
- Our warrants are accounted for as liabilities and changes in the value of our warrants could have a material effect on our financial results.
- There can be no assurance that the warrants will be in the money prior to their expiration, and they may expire worthless.
- We have in the past experienced material weaknesses in our internal control over financial reporting, and if we experience such material weaknesses in our internal control over financial reporting in the future or otherwise fail to maintain an effective system of internal controls in the future, we may not be able to report our financial condition, results of operations or cash flows accurately or in a timely manner, which may adversely affect investor confidence in us and, as a result, materially and adversely affect our business and the value of our Class A common stock.
- Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
- Because we are a “controlled company” within the meaning of the Nasdaq rules, our stockholders may not have certain corporate governance protections that are available to stockholders of companies that are not controlled companies.
- The dual class structure of our common stock has the effect of concentrating voting power with our Chairman of the Board and Founder, which will limit an investor’s ability to influence the outcome of important transactions, including a change in control.
- We cannot predict the impact our dual class structure may have on the stock price of our Class A common stock.
- Delaware law and provisions in our certificate of incorporation and bylaws could make a takeover proposal more difficult.
- Our certificate of incorporation designates the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings and the federal district courts as the sole and exclusive forum for other types of actions and proceedings, in each case, that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain what such stockholders believe to be a favorable judicial forum for disputes with us or our directors, officers or other employees.