Quantum-Si (QSI) risk factors, FY2025 10-K

Risks Related to Our Financial Condition and Capital Requirements

1. 01We are an early-stage life sciences technology company with a history of net losses and negative cash flow, which we expect to continue, and we may not be able to generate meaningful revenues or achieve and sustain profitability or positive cash flow in the future58% rewritten
2. 02We 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
3. 03Our 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
4. 04The cumulative effects of the factors discussed above could result in large fluctuations and unpredictability in our quarterly and annual operating results. As a result, comparing our operating results on a period-to-period basis may not be meaningful
5. 05We may need to raise additional capital to fund ongoing research and development, operating activities, and commercialization activities
6. 06We may require additional capital to develop and commercialize our products and to develop new products. In addition, our operating plans may change as a result of many factors that may currently be unknown to us, and we may need to seek additional funds sooner than planned

Risks Related to Our Business and Industry

1. 07We may not gain commercial traction for our current products, and we may not be able to successfully commercially launch other future products48% rewritten
2. 08The development and launch of new products may slow or stop existing product revenue in anticipation of superior technology that is pending launchNew
3. 09without the customer-focused applications and capabilities, it could materially impact any potential of long-term financial success and our market credibilityNew
4. 10Our success depends on broad scientific and market acceptance, which we may fail to achieve
5. 11If we are unable to establish superior sales and marketing capabilities, we may not be successful in commercializing our products
6. 12The 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
7. 13Epidemics, pandemics or other public health crises could adversely affect our business
8. 14Increasingly, companies are being judged by their performance on a variety of environmental, social and governance (“ESG”) matters, which are considered to contribute to the long-term sustainability of companies’ performance
9. 15We use artificial intelligence, machine learning and automated decision-making technologies (“AI”) to assist in the performance, efficiency, and speed of various functions at the Company, including, but not limited to, general and administrative activities and research and developmentNew
10. 16Unfavorable global economic conditions, retaliatory economic policies, or other geopolitical conditions associated with intra-country economics and policies could adversely affect our business, financial condition or results of operations59% rewritten
11. 17Geopolitical conflicts could potentially affect our sales and disrupt our operations and could have a material adverse impact on our business
12. 18If we do not sustain or successfully manage our anticipated growth, our business and prospects will be harmed
13. 19Recently 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 goals71% rewritten
14. 20We expect to be dependent upon revenue generated from the sales of our initial products from the time they are commercialized through the foreseeable future
15. 21If 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 actions39% rewritten
16. 22or for economic or other reasons choose to end business with us, our ability to commercialize and supply our instruments and consumable offerings would be adversely affectedNew
17. 23Our 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 could be adversely affected
18. 24A portion of our revenue is generated through a number of key channel partners, and the loss of any such channel partner could adversely impact our business and our results of operations could suffer
19. 25If we do not successfully develop and maintain our Platinum Analysis Software service, our commercialization efforts and therefore business and results of operations could suffer
20. 26Commercializing 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
21. 27We 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
22. 28We rely on third-party foundries to produce silicon 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
23. 29Our 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
24. 30The life sciences technology market is highly competitive. If we fail to compete effectively, our business and results of operations will suffer60% rewritten
25. 31We 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
26. 32We 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
27. 33Our ability to use net operating losses to offset future taxable income may be subject to certain limitations
28. 34If 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
29. 35If 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
30. 36We could become subject to various litigation claims and legal proceedings

Risks Related to Government Regulation

1. 37purposes or as medical devices. If we elect to label and market our products for use as, or in the performance of, clinical diagnostics in the United States, thereby subjecting them to FDA regulation as medical devices, we would be required to obtain pre-market authorization from the FDA, unless an exception appliesNew
2. 38Our reagents may be used by clinical laboratories to create Laboratory-Developed Tests (“LDTs”), which could, in the future, become subject to some form of FDA or other regulatory requirements, which could materially and adversely affect our business and results of operations
3. 39Further, the FDA may disagree that such products are Class 1 medical devices and require us to obtain pre-market clearance or approval before we can continue to sell our reagent products to certain customers
4. 40These laws and regulations, among other things, constrain our business, marketing and other promotional activities by limiting the kinds of financial arrangements we may have with hospitals, physicians or other developers or potential purchasers of our products96% rewritten
5. 41Medicaid, imprisonment, contractual damages, reputational harm, disgorgement and the curtailment or restructuring of our operationsNew
6. 42We could be adversely affected by alleged violations of the Federal Trade Commission Act or other truth-in-advertising and consumer protection laws
7. 43Medical product manufacturers’ use of social media platforms could present new risks

Risks Related to Our Intellectual Property

1. 44substantial cost, and may divert our efforts and attention from other aspects of our business. Any of the foregoing events could have a material adverse effect on our business, financial condition, results of operations and cash flowsNew
2. 45The 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
3. 46We may not be able to protect our intellectual property rights throughout the world
4. 47Issued patents covering our products could be found invalid or unenforceable if challenged
5. 48If 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
6. 49We may be subject to claims challenging the inventorship of our patents and other intellectual property
7. 50We 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
8. 51Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time
9. 52We 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 litigation36% rewritten
10. 53Third parties, including our competitors, could be infringing, misappropriating or otherwise violating our solely owned and/or in-licensed intellectual property rights. Monitoring unauthorized use of intellectual property is difficult and costlyNew
11. 54Obtaining 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
12. 55We 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
13. 56If we cannot license rights to use technologies on reasonable terms, we may not be able to commercialize new products in the future
14. 57Certain 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
15. 58Our 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
16. 59Intellectual property rights do not necessarily address all potential threats

Risks Related to Our Securities and to Being a Public Company

1. 60Our 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 could result in dilution to our stockholders if exercised
2. 61Our warrants are accounted for as liabilities and changes in the value of our warrants could have a material effect on our financial results
3. 62The exercise price for our outstanding warrants is $11.50 per share of our Class A common stock. There can be no assurance that the warrants will be in the money prior to their expiration, and as such, the warrants may expire worthless
4. 63A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of a company’s annual or interim financial statements will not be prevented or detected and corrected on a timely basis
5. 64Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud
6. 65Because 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 companies51% rewritten
7. 66We could fail to maintain the listing of our Class A common stock on the Nasdaq Stock Market LLC, which could seriously harm the liquidity of our shares and our ability to raise capital or complete a strategic transaction74% rewritten
8. 67The dual class structure of our common stock has the effect of concentrating voting power with our Founder, who is also on our Board of Directors, which will limit an investor’s ability to influence the outcome of important transactions, including a change in control
9. 68We cannot predict the impact our dual class structure may have on the stock price of our Class A common stock
10. 69Delaware law and provisions in our certificate of incorporation and bylaws could make a takeover proposal more difficult53% rewritten
11. 70other 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 employeesNew