▸ Medicaid, imprisonment, contractual damages, reputational harm, disgorgement and the curtailment or restructuring of our operations.· · · · ● 1 ▸ The development and launch of new products may slow or stop existing product revenue in anticipation of superior technology that is pending launch.· · · · ● 1 ▸ A 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.· · · ● ● 2 ▸ 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.· · · ● ● 2 ▸ Environmental, social and governance matters may impact our business and reputation.· · · ● ● 2 ▸ If any of these events occur, they could materially adversely affect our business, financial condition, results of operations and prospects.· · · ● ● 2 ▸ If one or more of these risks occurs, it could require us to dedicate significant resources to remedy such occurrence, and if we are unsuccessful in finding a solution, our financial results will suffer.· · · ● ● 2 ▸ Increasingly, 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.· · · ● ● 2 ▸ 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.· · · ● ● 2 ▸ group Risks Related to Our Financial Condition and Capital Requirements· · · ● ● 2 ▸ We 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 transaction.· · · ● ● 2 ▸ We may not gain commercial traction for our current products, and we may not be able to successfully commercially launch other future products.· · · ● ● 2 rw ▸ Epidemics, pandemics or other public health crises could adversely affect our business.· · ● ● ● 3 rw ▸ 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.· · ● ● ● 3 rw ▸ 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.· · ● ● ● 3 rw ▸ We may need to raise additional capital to fund ongoing research and development, operating activities, and commercialization activities.· · ● ● ● 3 ▸ Geopolitical conflicts could potentially affect our sales and disrupt our operations and could have a material adverse impact on our business.· ● ● ● ● 4 rw ▸ Our success depends on broad scientific and market acceptance, which we may fail to achieve.· ● ● ● ● 4 ▸ group Risks Related to Our Business and Industry· ● ● ● ● 4 ▸ To the extent our commercial launch plan is unsuccessful, our financial results will be adversely impacted.· ● ● ● ● 4 rw ▸ Unfavorable 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 operations.· ● ● ● ● 4 rw ▸ 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.· ● ● ● ● 4 rw ▸ We have entered into Technology and Services Exchange Agreements (the “TSEAs”) by and among us and other participant companies controlled by the Rothberg family, consisting of Butterfly Network, Inc., OrphAI Therapeutics, Inc.,· · · ● · 1 ▸ As technologies change in the future for life sciences research tools in general and in proteomics and genomics technologies specifically, we will be expected to upgrade or adapt our products in order to keep up with the latest technology. To· · ● · · 1 ▸ At the federal level, regulations promulgated pursuant to HIPAA as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) establish privacy and security· · ● · · 1 ▸ December 31, 2023, if we assume that each outstanding whole warrant is exercised and one share of HighCape Class A common stock is issued as a result of such exercise, with payment of the exercise price of $11.50 per share, our fully-diluted· · ● · · 1 ▸ Health, Inc.), Liminal Sciences, Inc. and Detect, Inc. The TSEA with Butterfly Network, Inc. was signed in November 2020, and the TSEA with the remaining participant companies was signed in February 2021 and became effective upon the Closing of· · ● · · 1 ▸ If our security measures, or those of our vendors and partners, are compromised due to any cybersecurity attacks or incidents, including as a result of third-party action, employee or customer· · ● · · 1 ▸ In December 2022, we initiated a controlled launch of Platinum® for RUO. Prior to that, in 2021 we initiated our· · ● · · 1 ▸ Notice of certain incidents may be required to be provided to affected individuals, the Secretary of the Department of Health and Human Services, and for extensive breaches, notice may also need to be made to the media. Additionally, state law· · ● · · 1 ▸ October 2023, the FDA issued a proposed rule aimed at regulating LDTs under the current medical device framework and proposing to phase out its existing enforcement discretion policy for this category of diagnostic tests; the public comment· · ● · · 1 ▸ Our Branford, Connecticut facilities primarily house our corporate headquarters as well as research and development activities, and we have a product development and operations facility located in· · ● · · 1 ▸ Our operations could be significantly adversely affected by the effects of a widespread outbreak of epidemics, pandemics or other health crises, including COVID-19. We cannot accurately predict the· · ● · · 1 ▸ Practice requirements that are set forth in the QSR, unless explicitly exempted by regulation.· · ● · · 1 ▸ 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· · ● · · 1 ▸ Regulations (“QSR”), those device products would be subject to mandatory general controls that apply to all classes of medical devices. In addition to establishment registration, device listing and compliance with applicable QSR, general controls· · ● · · 1 ▸ Rothberg family, consisting of Butterfly Network, Inc., OrphAI Therapeutics, Inc., Hyperfine, Inc., 4Bionics LLC, identifeye HEALTH Inc. (f/k/a Tesseract· · ● · · 1 ▸ Rothberg may have interests that differ from yours and may vote in a way with which you disagree, and which may be adverse to your interests. This concentrated control may have the effect of delaying, preventing or deterring a change in control· · ● · · 1 ▸ Valley, Pennsylvania, and internationally.· · ● · · 1 ▸ We recently commercialized our first product and have generated limited revenue to date. Even with our Platinum®· · ● · · 1 ▸ We recently commercially launched our first product, Platinum® for RUO. We are following a three-phase launch plan· · ● · · 1 ▸ We rely on certain contract manufacturers to manufacture and supply our instruments, components of our instruments, and certain components of our consumable· · ● · · 1 ▸ We rely on certain contract manufacturers to manufacture and supply our instruments, components of our instruments, and certain components of our consumable offerings. Since our contracts with· · ● · · 1 ▸ A 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· ● ● · · 2 rw ▸ group Although we review our use of open-source software to avoid· ● · · · 1 ▸ Any such litigation or dispute, whether successful or not, could have a material adverse effect on our business, financial condition, results of operations and cash flows.· ● · · · 1 ▸ 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,· ● ● · · 2 ▸ Effective internal controls are necessary for us to provide reliable financial reports and prevent fraud. Material weaknesses could result in material misstatements to our annual or interim· ● ● · · 2 ▸ FTC Act includes ensuring that there is scientific data to substantiate the claims being made, that the advertising is neither false nor misleading, and that any user testimonials or endorsements we or our agents disseminate related to the· ● · · · 1 ▸ Geopolitical conflicts, including the ongoing conflicts in Ukraine and Israel and Gaza, could adversely impact our operations or those of our suppliers, manufacturers or customers. The extent to which these events· ● ● · · 2 rw ▸ If our facilities or our third-party manufacturers’ facilities become unavailable or inoperable, our research and development program and commercialization· ● ● · · 2 ▸ In December 2022, we launched PlatinumTM for RUO. Prior to that, in 2021 we initiated our early access limited release to enable key thought leaders early access to our platform. If we are able to· ● · · · 1 ▸ In January and August 2023, we committed to organizational restructurings designed to decrease our costs and create a more streamlined organization to support our business. In connection with these· ● ● · · 2 rw ▸ In order to successfully generate revenue from our products, we need to supply our customers with products that meet their expectations for quality and functionality in accordance with established specifications on a timely basis. Our instruments· ● · · · 1 ▸ In the event it becomes necessary to utilize other equipment for our semiconductor chip manufacturing, we would experience additional costs, delays and difficulties in manufacturing our· ● ● · · 2 rw ▸ In the future, if we choose to develop and market our products for clinical or diagnostic uses in the United States, we will be required to comply with FDA’s regulations for in vitro diagnostic· ● ● · · 2 rw ▸ Johnston, our Chief Commercial Officer, Michael P. McKenna, Ph.D., our Executive Vice President, Product Development and Operations, and Christian LaPointe, Ph.D., our General Counsel and Corporate Secretary, is critical to our vision, strategic· ● · · · 1 ▸ Office (“EPO”), or other foreign patent offices review the patent claims, such as in an ex-parte reexamination, inter partes review, post-grant review proceeding· ● ● · · 2 ▸ 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· ● ● · · 2 ▸ Our products may contain software licensed by third parties under open-source· ● · · · 1 ▸ group Our products may not compete favorably, and we may not be· ● · · · 1 ▸ Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets, including changes in inflation, interest rates and overall· ● ● · · 2 ▸ Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a utility patent is generally 20 years from its earliest U.S.· ● ● · · 2 rw ▸ Specifically, these decisions stand for the proposition that patent claims that recite laws of nature are not themselves patentable unless those patent claims have sufficient additional features that provide practical assurance that the processes· ● ● · · 2 ▸ Statement focused on certain settlement terms and provisions related to certain tender offers following a business combination, which terms are similar to those contained in the warrant agreement governing our warrants. As a result of the SEC· ● ● · · 2 rw ▸ The 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· ● ● · · 2 ▸ There exists some degree of uncertainty over the breadth of claims that may be allowed or enforced in our patents or in third-party patents. It is possible that third parties will attempt to design around our current or future patents such that· ● ● · · 2 ▸ We are currently undergoing a leadership transition and an internal restructuring, and we depend on our key personnel and other highly qualified personnel, and· ● · · · 1 ▸ We are undertaking internal restructuring activities that could result in disruptions to our business or otherwise materially harm our results of operations or financial· ● · · · 1 ▸ We have in the past experienced material weaknesses in our internal control over financial reporting, and if we experience such material weaknesses in our· ● ● · · 2 ▸ We may identify third-party technology that we may need to license or acquire in order to develop or commercialize our products or technologies. However, we may be unable to secure such licenses or· ● ● · · 2 ▸ We may in the future seek to acquire or invest in businesses, applications or technologies that we believe could complement or expand our existing or future products, enhance our technical· ● ● · · 2 ▸ We may require additional capital to develop and commercialize our products and to develop new products. In addition, our operating plans may· ● · · · 1 ▸ We recently commercially launched our first product, but we may not be able to successfully commercially launch other future products.· ● ● · · 2 rw ▸ A variety of organizations measure the performance of companies on such ESG topics, and the results of these assessments are widely publicized. In addition, investment in funds that specialize in● ● ● · · 3 rw ▸ Absent the license agreements, we may infringe patents subject to those agreements, and if the license agreements are terminated, we may be subject to litigation by the licensor. Litigation could● ● ● · · 3 rw ▸ Alternatively, if a court were to find these provisions of our certificate of incorporation inapplicable or unenforceable with respect to one or more of the specified types of actions or● ● ● · · 3 rw ▸ Although our current protein sequencing products are labeled, promoted, and sold as RUO products that are therefore not regulated as IVD medical devices, the FDA or comparable agencies of other● ● ● · · 3 rw ▸ Although we review our use of open-source software to avoid subjecting our proprietary software to conditions we do not intend, the terms of many open source-software licenses have not been● · ● · · 2 rw ▸ Any legislative or administrative rule making or new federal oversight of LDTs, if and when finalized, may impact the sales of our products and how customers use our products, and may require us to● · ● · · 2 rw ▸ As is common in the life sciences industry, we engage the services of consultants and independent contractors to assist us in the development of our products. Many of these consultants and● ● ● · · 3 rw ▸ As of December 31, 2024, we had federal net operating loss carryforwards (“NOLs”) to offset future taxable income of approximately $388.3 million, of which $65.5 million will begin to expire in 2033 if not utilized. A lack of future taxable● ● ● ● · 4 rw ▸ As previously disclosed in Amendment No. 1 to our Annual Report on Form 10-K/A for the year ended December 31, 2020, we identified a material weakness in our internal control over financial reporting related to● · · · · 1 ▸ As we continue to scale commercially and develop new products, and as our products incorporate increasingly sophisticated technology, it will be increasingly difficult to ensure our products are● ● ● · · 3 rw ▸ California Privacy Rights Act (CPRA), was approved by California voters in the election of November 3, 2020. The CPRA will modify the CCPA significantly, potentially resulting in further uncertainty and requiring us to incur additional costs and● · · · · 1 ▸ Careful consideration should be given to the following risk factors, in addition to the other information set forth in this Annual Report, including the section of this Annual● ● ● · · 3 rw ▸ Changes in either the patent laws or interpretation of the patent laws in the United States or in other jurisdictions could increase the uncertainties and costs surrounding the prosecution of patent● ● ● · · 3 rw ▸ Class B common stock, and as of February 15, 2022, Dr. Rothberg and his affiliates held 80.1% of the voting power of our capital stock and is able to control matters submitted to our stockholders for approval, including the election of● · · · · 1 ▸ Climate change has had significant legislative and regulatory effects on a global basis, and there are expected to be additional changes to the regulations in these areas. These changes could● ● ● · · 3 rw ▸ December 31, 2017 may offset no more than 80 percent of such year’s taxable income and there is no ability for such NOLs to be carried back to a prior taxable year. The CARES Act modifies the TCJA with respect to the TCJA’s limitation on the● · · · · 1 ▸ December 31, 2017, are subject to limitations adopted by the Tax Cuts and Jobs Act, as modified by the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”). Under the TCJA, in general, NOLs generated in taxable years beginning after● · · · · 1 ▸ Delaware or, if such court does not have subject matter jurisdiction thereof, the federal district court of the State of Delaware. Subject to the foregoing, the federal district courts of the United States are the exclusive forum for the● · · · · 1 ▸ Despite our efforts to create security barriers to such threats, it is virtually impossible for us to entirely mitigate these risks. In August 2020, we discovered ransomware on a server along with a ransom note seeking 50 bitcoin or approximately● · · · · 1 ▸ Dr. Rothberg and our remaining leadership team, including the board of directors, the uncertainty inherent in this ongoing leadership transition may be difficult to manage, may cause concerns from third parties with whom we do business, and may● · · · · 1 ▸ Effective internal controls are necessary for us to provide reliable financial reports and prevent fraud. Our management is in the process of developing a remediation plan, which includes, without limitation, the● · · · · 1 ▸ Even if we commercially launch our products, our success depends on broad scientific and market acceptance, which● · · · · 1 ▸ Federal Food, Drug, and Cosmetic Act (“FDCA”).● · · · · 1 ▸ Following the Business Combination, there were 3,833,319 outstanding warrants issued in connection with the initial public offering of HighCape (the “Public Warrants”) to purchase 3,833,319 shares● ● ● · · 3 rw ▸ For a number of years, the FDA has exercised its regulatory enforcement discretion not to regulate LDTs as medical devices if the tests are created and used within a single laboratory. However, in● ● ● · · 3 rw ▸ Founder, which will limit an investor’s ability to influence the outcome of important transactions, including a change in control.● · · · · 1 ▸ HighCape reevaluated the accounting treatment of its Public Warrants and Private Warrants, and determined to classify the warrants as derivative liabilities measured at fair value, with changes in fair value each period reported in earnings.● · · · · 1 ▸ If not remediated, these material weaknesses could result in material misstatements to our annual or interim financial statements that might not be prevented or detected on a timely basis, or in delayed filing of● · · · · 1 ▸ If our operations are found to be in violation of any of the healthcare laws or regulations described above or any other healthcare regulations that apply to us, we may be subject to penalties,● ● ● · · 3 rw ▸ If our research and development program or commercialization program were disrupted by a disaster or catastrophe, the launch of new products and the timing of improvements to our products could be● ● ● · · 3 rw ▸ If our security measures, or those of our vendors and partners, are compromised due to any cybersecurity attacks or data security breaches,● ● · · · 2 rw ▸ If third parties, including our competitors, believe that our products or technologies infringe, misappropriate or otherwise violate their intellectual property, such third parties may seek to● ● ● · · 3 rw ▸ 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● ● ● · · 3 rw ▸ If we do not prevail in such disputes, we may lose any or all of our rights under such license agreements, experience significant delays in the development and commercialization of our products and● ● ● · · 3 rw ▸ If we do not successfully develop and deploy our Quantum-Si CloudTM software service, our commercialization● ● · · · 2 rw ▸ 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● ● ● · · 3 rw ▸ If we experience a significant disruption in our information technology systems or breaches of data security, our business could be adversely affected.● ● · · · 2 rw ▸ If we identify any material weaknesses in the future, any such newly identified material weakness could limit our ability to prevent or detect a misstatement of our accounts or disclosures that● ● ● · · 3 rw ▸ If we sought and received regulatory marketing authorization for certain of our protein sequencing products, we would be subject to ongoing FDA obligations and continued regulatory oversight and● ● ● · · 3 rw ▸ In connection with Legacy Quantum-Si’s financial statement close process for the years ended December 31, 2020 and 2019, we identified a material weakness in the design and operating effectiveness of our internal● · · · · 1 ▸ In light of investors’ increased focus on ESG matters, there can be no certainty that we will manage such issues successfully, or that we will successfully meet society’s expectations as to our● ● ● · · 3 rw ▸ In manufacturing our products, we depend upon third parties for the supply of our instruments and various components, many of which require a significant degree of technical expertise to produce. If● ● ● · · 3 rw ▸ In our development and commercialization plans for our products, we may forego other opportunities that may provide greater revenue or be more profitable. If our research and product development● ● ● · · 3 rw ▸ In the United States, various federal and state regulators, including governmental agencies like the Consumer Financial Protection Bureau and the Federal Trade Commission, have adopted, or are● ● ● · · 3 rw ▸ In the event it becomes necessary to utilize a different contract manufacturer for our products or components of our products, we would experience additional costs, delays and difficulties in● ● ● · · 3 rw ▸ In the event it becomes necessary to utilize a different third party for the production of wafers, we would experience additional costs and significant delays, including identifying and entering● ● ● · · 3 rw ▸ In the future, we plan to develop and market our products for clinical or diagnostic uses in the United States, thereby subjecting us to FDA regulation as● · · · · 1 ▸ In the ordinary course of our business, we currently, and in the future will, collect, store, transfer, use or process sensitive data, including personally identifiable information of employees. The● ● ● · · 3 rw ▸ Increasingly, in addition to the importance of their financial performance, companies are being judged by their performance on a variety of environmental, social and governance (“ESG”) matters,● ● ● · · 3 rw ▸ Litigation proceedings may be necessary for us to enforce our patent and other intellectual property rights. In any such proceeding, a court may refuse to stop the other party from using the● ● ● · · 3 rw ▸ Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain other countries are not as● ● ● · · 3 rw ▸ Monitoring unauthorized disclosure is difficult, and we do not know whether the steps we have taken to prevent such disclosure are, or will be, adequate. If we were to enforce a claim that a third● ● ● · · 3 rw ▸ Obtaining and maintaining our patent protection depends on compliance with various required procedures, document submissions, fee payments and other● ● ● · · 3 rw ▸ Officer; Michael P. McKenna, Ph.D., our President and Chief Operating Officer, Matthew Dyer, Ph.D., our Chief Business Officer, and Christian LaPointe, Ph.D., our General Counsel and Corporate Secretary, is critical to our vision, strategic● · · · · 1 ▸ On April 12, 2021, the Acting Director of the Division of Corporation Finance and Acting Chief Accountant of the SEC together issued a statement regarding the accounting and reporting considerations● ● ● · · 3 rw ▸ On February 8, 2022, John Stark, our then-Chief Executive Officer and member of our board of directors, stepped down from all of his positions with us. Jonathan M. Rothberg, Ph.D., the Chairman of● ● · · · 2 rw ▸ Other than the acquisition of Majelac, to date, the growth of our operations has been organic, and we have limited experience in acquiring other businesses or technologies. We may not be able to● ● ● · · 3 rw ▸ Our Guilford, Connecticut, facilities house our corporate, research and development and quality assurance teams. In June 2021, we entered into a lease for a product development and● ● · · · 2 rw ▸ 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● ● ● · · 3 rw ▸ Our ability to achieve and maintain scientific and commercial market acceptance of our products depends and will depend on a number of factors. Our products are and will be subject to market forces● ● ● · · 3 rw ▸ Our advertising for current and future products is subject to federal truth-in-advertising laws enforced by the Federal Trade Commission (“FTC”), as well as comparable state consumer protection● ● ● · · 3 rw ▸ Our anticipated growth will place significant strains on our management, operational and manufacturing systems and processes, sales and marketing team, financial systems and internal controls and● ● ● · · 3 rw ▸ Our business will depend significantly on research and development spending by academic institutions and other research institutions, and any reduction in● ● ● · · 3 rw ▸ Our certificate of incorporation provides that, unless we consent to the selection of an alternative forum, any (i) derivative action or proceeding brought on behalf of us; (ii) action asserting a● ● ● · · 3 rw ▸ Our commercial success depends in part on our ability and the ability of future collaborators to develop, manufacture, market and sell our products and use our products and technologies without● ● ● · · 3 rw ▸ Our continued growth and ability to successfully transition from a company primarily focused on research and development to commercialization depends, in part, on attracting, retaining and● ● ● · · 3 rw ▸ Our current license agreements impose, and future agreements may impose, various diligence, commercialization, milestone payment, royalty, insurance and other obligations on us and require us to● ● ● · · 3 rw ▸ Our facilities in Branford, San Diego and those of our third-party manufacturers are vulnerable to natural disasters, public health crises and catastrophic events. If any disaster, public health● ● ● · · 3 rw ▸ Our future success depends upon our ability to recruit, train, retain and motivate key personnel, including our senior management team, as well as our research and development team and manufacturing● ● · · · 2 rw ▸ Our operations have consumed substantial amounts of cash since inception. We expect to spend substantial additional amounts to continue the commercialization of our products and to develop new● ● ● · · 3 rw ▸ Our organizational documents are governed by Delaware law. Certain provisions of Delaware law and of our certificate of incorporation and bylaws could discourage, delay, defer or prevent a merger,● ● ● · · 3 rw ▸ Our owned and licensed patents and patent applications may be subject to validity, enforceability and priority disputes. The issuance of a patent is not conclusive as to our inventorship, scope,● ● ● · · 3 rw ▸ Our patent portfolio may be negatively impacted by current uncertainties in the state of the law, new court rulings or changes in guidance or procedures issued by the USPTO or other similar patent offices around the world. From time to● ● ● ● · 4 rw ▸ Our products contain third-party open-source software components and failure to comply with the terms of the underlying open-source software licenses could● ● ● · · 3 rw ▸ Our products may contain software licensed by third parties under open-source software licenses. Use and distribution of open-source software may entail greater risks than use of third-party● · ● · · 2 rw ▸ Our products may not compete favorably, and we may not be successful in the face of increasing competition from products and technologies introduced by our existing or future competitors, companies● · ● · · 2 rw ▸ Our products provide an end-to-end solution with many different components that work together. As such, a quality defect in a single component can● · · · · 1 ▸ Our products utilize novel and complex technology and may develop or contain undetected defects or errors. Material performance problems, defects, or errors may arise, and as we commercialize our● ● ● · · 3 rw ▸ 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● ● ● · · 3 rw ▸ Our research and product development activities currently require the controlled use of potentially harmful biological and hazardous materials and chemicals. We cannot eliminate the risk of● ● ● · · 3 rw ▸ Our success depends in large part on our and our licensors’ ability to obtain and maintain protection of the intellectual property we may own solely or jointly with, or license from, third parties,● ● ● · · 3 rw ▸ Our success may depend in part on the ability of our licensors and any future licensors to obtain, maintain and enforce patent protection for our licensed intellectual property. Without protection● ● ● · · 3 rw ▸ Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to be paid to the USPTO and various governmental patent agencies● ● ● · · 3 rw ▸ Proceedings to enforce our or our licensors’ patent rights in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business, could● ● ● · · 3 rw ▸ Regardless of whether we are defending against or asserting an intellectual property-related claim in an intellectual property-related proceeding that may be necessary in the future, and regardless● ● ● · · 3 rw ▸ Report titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our Consolidated Financial Statements and related Notes, and in other documents that we file with the SEC, in evaluating our company and our● ● ● · · 3 rw ▸ Senate and House lawmakers formally introduced long-awaited legislation to reform the FDA’s authorities over medical devices that are also in vitro diagnostic products. The bill, called the VALID Act, would● · · · · 1 ▸ Shipment of consumables that effectively expire early or shipment of defective instruments or consumables to customers may result in recalls and warranty replacements, which would increase our costs, and depending upon current inventory levels and● · · · · 1 ▸ So long as more than 50% of the voting power for the election of our directors is held by an individual, a group or another company, we will qualify as a “controlled company” within the meaning of● ● ● · · 3 rw ▸ Such natural disasters have caused, and in the future may cause, damage to and/or disrupt our operations, which may result in a material adverse effect on our business and results of operations. Our suppliers, vendors and business partners also● · · · · 1 ▸ The COVID-19 pandemic and efforts to reduce its spread have adversely impacted, and are expected to continue to materially and adversely impact our business● ● · · · 2 rw ▸ The COVID-19 pandemic has also had an adverse effect on our ability to attract, recruit, interview and hire at the pace we would typically expect to support our rapidly expanding operations. To the● ● · · · 2 rw ▸ The COVID-19 pandemic has had, and is expected to continue to have, an adverse impact on our operations, particularly as a result of preventive and precautionary measures that we, other businesses,● ● · · · 2 rw ▸ The cost of protecting against, investigating, mitigating and responding to potential breaches of information technology systems and cybersecurity incidents and complying with applicable breach● ● ● · · 3 rw ▸ The 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● ● ● · · 3 rw ▸ 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● ● ● · · 3 rw ▸ The laws of some foreign countries do not offer intellectual property rights to the same extent as the laws of the United States, and we and our licensors may encounter difficulties in obtaining,● ● ● · · 3 rw ▸ The licensing or acquisition of third-party intellectual property rights is a competitive area, and several more established companies may pursue strategies to license or acquire third-party intellectual property rights that we may consider● · · · · 1 ▸ The life sciences technology market is highly competitive. If we fail to compete effectively, our business and● · · · · 1 ▸ The market for proteomics and genomics technologies and products is evolving, making it difficult to predict with any accuracy the size of the markets for our current and future products. Our● ● ● · · 3 rw ▸ The registered or unregistered trademarks or trade names that we own may be challenged, infringed, circumvented, declared generic, lapsed or determined to be infringing on or dilutive of other● ● ● · · 3 rw ▸ The severity and frequency of weather-related natural disasters has been amplified, and is expected to continue to be amplified, by global climate change. Such natural disasters have caused, and in● ● ● · · 3 rw ▸ The success of life sciences products is due, in large part, to acceptance by the scientific community and their adoption of certain products in the applicable field of research. The life sciences● ● ● · · 3 rw ▸ The success of our products depends, in part, on our ability to design and deploy our Platinum Analysis Software service in a manner that enables the integration with potential customers’ systems● ● ● · · 3 rw ▸ The technology and personnel-sharing arrangements under the TSEAs may prevent us from fully utilizing our personnel if such personnel are also being used by the other participant companies and may● ● ● · · 3 rw ▸ There are currently outstanding an aggregate of 3,968,319 warrants to acquire shares of our Class A common stock, which comprise 135,000 Private Warrants held by HighCape’s initial stockholders at● ● ● · · 3 rw ▸ There are numerous U.S. federal and state, as well as foreign, laws pertaining to healthcare fraud and abuse, including anti-kickback, false claims and physician transparency laws. Our business● ● ● · · 3 rw ▸ There can be no assurance that future products for which we may seek pre-market clearance or approval will be approved or cleared by FDA or a comparable foreign regulatory authority on a timely● · ● · · 2 rw ▸ These anti-takeover provisions as well as certain provisions of Delaware law could make it more difficult for a third party to acquire us, even if the third party’s offer may be considered● ● ● · · 3 rw ▸ These 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,● ● ● · · 3 rw ▸ Third parties, including our competitors, could be infringing, misappropriating or otherwise violating our solely owned and/or in-licensed intellectual property rights. Monitoring unauthorized use● ● ● · · 3 rw ▸ This variability and unpredictability could also result in us failing to meet the expectations of industry or financial analysts or investors for any period. If we are unable to realize our● ● ● · · 3 rw ▸ To the extent our intellectual property offers inadequate protection, or is found to be invalid or unenforceable, we would be exposed to a greater risk of direct competition. If our intellectual● ● ● · · 3 rw ▸ Trade Commission, have adopted, or are considering adopting, laws and regulations concerning personal information and data security. Certain state laws may be more stringent or broader in scope, or offer greater individual rights, with respect to● · · · · 1 ▸ U.S. Congress, and decisions by the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that may have a material adverse effect on our ability to obtain new patents and to defend and enforce● ● ● · · 3 rw ▸ United States allow for various post-grant opposition proceedings that have not been extensively tested, and their outcome is therefore uncertain. Furthermore, if third parties bring these proceedings against our patents, regardless of the merit of● · · · · 1 ▸ United States at several stages over the lifetime of the patents and/or applications. The USPTO and various non-U.S. governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar● · · · · 1 ▸ United States may differ from that required to obtain FDA marketing authorization and we may not be able to obtain foreign regulatory approvals on a timely basis or at all. In Europe, we would need to comply with the new Medical Device● · · · · 1 ▸ Various courts, including the U.S. Supreme Court, have rendered decisions that impact the scope of patentability of certain inventions or discoveries relating to life sciences technology.● ● ● · · 3 rw ▸ We also face competition from researchers developing their own products. The area in which we compete involves rapid innovation and some of our customers have in the past, and more may in the● ● ● · · 3 rw ▸ We also may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment or at all. In return for the use of● ● ● · · 3 rw ▸ We also seek to preserve the integrity and confidentiality of our confidential proprietary information by maintaining physical security of our premises and physical and electronic security of our information technology systems, but it is● ● ● ● · 4 rw ▸ We and our manufacturing partners procure certain components of our instruments and consumables from third-party manufacturers, which includes the commonly-available raw materials needed for● ● ● · · 3 rw ▸ We are an early-stage life sciences technology company and have incurred significant losses since Quantum-Si was formed in 2013, and expect to continue to incur losses in the future. We incurred net● ● ● · · 3 rw ▸ 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● ● ● · · 3 rw ▸ 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● ● ● · · 3 rw ▸ 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● ● ● · · 3 rw ▸ We are subject to the periodic reporting requirements of the Exchange Act. We design our disclosure controls and procedures to reasonably assure that information we are required to disclose in● ● ● · · 3 rw ▸ We are, and may in the future become, a party to license agreements that grant us rights to use certain intellectual property, including patents and patent applications, typically in certain● ● ● · · 3 rw ▸ We cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all. Moreover, the terms of any future financing may adversely affect the● ● ● · · 3 rw ▸ We cannot predict whether our dual class structure will result in a lower or more volatile market price of our Class A common stock or in adverse publicity or other adverse consequences. For● ● ● · · 3 rw ▸ We continue to evaluate our compliance obligations, but do not currently have in place formal policies and procedures related to the storage, collection and processing of information, and have not● ● ● · · 3 rw ▸ We currently rely on third-party foundries for the production of wafers, and we may not be able to obtain adequate supplies in a timely manner or on commercially reasonable terms. If any of these● ● ● · · 3 rw ▸ We do not maintain fixed term employment contracts with any of our employees. As a result, our employees could leave the company with little or no prior notice and may be free to work for a● ● ● · · 3 rw ▸ We expect that substantially all of our revenue in the near term will be generated from sales of RUO protein sequencing products to academic institutions and other research institutions. Much of● ● ● · · 3 rw ▸ We face significant competition in the life sciences technology market. We currently compete with life sciences technology and the diagnostic companies that are supplying components, products and● ● ● · · 3 rw ▸ 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● ● ● · · 3 rw ▸ We have and will continue to spend significant amounts of effort developing our software, and potential enhanced versions over time, to meet our potential customers’ evolving needs. There is no● ● ● · · 3 rw ▸ We have entered into Technology and Services Exchange Agreements (the “TSEAs”) by and among us and other participant companies controlled by the● ● ● · · 3 rw ▸ We have identified material weaknesses in our internal control over financial reporting. If our remediation measures are ineffective, or if we experience additional material● · · · · 1 ▸ We have identified two material weaknesses in our internal control over financial reporting.● · · · · 1 ▸ We have limited experience as a company in sales and marketing and our ability to achieve revenue growth depends on us being able to attract customers for our products. Although members of our● ● ● · · 3 rw ▸ We have limited experience producing and supplying our products, and we may be unable to consistently manufacture or source our instruments and consumables to● ● ● · · 3 rw ▸ We have not commercialized any of our products and have not generated any revenue to date. Our operations to date have been limited to developing our● · · · · 1 ▸ We have not yet commercially launched any products. We plan to follow a three phase launch plan for commercialization, which includes an early access● · · · · 1 ▸ We have not yet commercially launched our products, and we may not be able to successfully commercially launch our● · · · · 1 ▸ We may be subject to certain federal, state and foreign fraud and abuse laws, health information privacy and security laws and physician payment transparency● ● ● · · 3 rw ▸ We may become involved in lawsuits to defend against third-party claims of infringement, misappropriation or other violations of intellectual property or to● ● ● · · 3 rw ▸ We may become subject to claims that we, a consultant or an independent contractor inadvertently or otherwise used or disclosed trade secrets or other information proprietary to their former employers or their former or current clients. We may● · · · · 1 ▸ We may choose to challenge, including in connection with any allegation of patent infringement by a third party, the patentability, validity, ownership or enforceability of any third-party patent● ● ● · · 3 rw ▸ We may in the future register with the FDA as a specification developer and list ancillary products such as customized reagents with the FDA as Class I general purpose laboratory● ● ● · · 3 rw ▸ We may in the future register with the FDA as a specification developer and list some of our ancillary products with the FDA as Class I general purpose laboratory equipment, subjecting us to ongoing● ● ● · · 3 rw ▸ We may need to raise additional capital to fund commercialization plans for our products, including manufacturing, sales and marketing activities, expand our● ● · · · 2 rw ▸ We may not be aware of all third-party intellectual property rights potentially relating to our products. Publications of discoveries in the scientific literature often lag behind the actual● ● ● · · 3 rw ▸ We may seek to enlist certain third parties to assist with sales, distribution and customer service and support globally or in certain regions of the world. There is no guarantee, if we do seek to● ● ● · · 3 rw ▸ We may seek to enter into strategic collaborations and licensing agreements with third parties to develop products, such as the creation and identification of content and development of new● · ● · · 2 rw ▸ We or our licensors may be subject to claims that former employees, collaborators or other third parties have an interest in our owned or in-licensed patents, trade secrets or other intellectual● ● ● · · 3 rw ▸ We rely heavily on trade secrets and confidentiality agreements to protect our unpatented know-how, technology and other proprietary information, and to maintain our competitive position. However,● ● ● · · 3 rw ▸ We rely on a small number of contract manufacturers to manufacture and supply our instruments. If these manufacturers should fail or not perform● ● · · · 2 rw ▸ We rely on a small number of contract manufacturers to manufacture and supply our instruments. Since our contracts with these manufacturers do not commit them to carry inventory or make available● ● · · · 2 rw ▸ We rely on patent protection as well as trademark, copyright, trade secret and other intellectual property right protection and contractual restrictions to protect our proprietary products and● ● ● · · 3 rw ▸ We rely, and will continue to rely on, information technology systems to keep financial and employment records, facilitate our research and development initiatives, manage our manufacturing operations, maintain quality control, fulfill customer● ● ● ● · 4 rw ▸ We, as well as certain of our directors and officers, may become subject to claims or lawsuits during the ordinary course of business. If any such claim or lawsuit was brought, regardless of the● ● ● · · 3 rw ▸ While extensions may be available, the life of a patent, and the protection it affords, is limited. In the United States, a patent’s term may, in certain cases, be lengthened by patent term adjustment, which compensates a patentee for● · · · · 1 ▸ While we have initiated the early access limited release phase of our commercialization plan, which we expect to continue in 2022, we do not expect to● · · · · 1 ▸ Any failure to maintain effective internal controls and procedures over financial reporting could severely inhibit our ability to accurately report our financial condition, results of operations or cash flows.● · · ● ● 3 ▸ Intellectual property rights do not necessarily address all potential threats.● · · ● ● 3 ▸ 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● ● ● · ● 4 rw ▸ Our potential customer base for future clinical diagnostic applications of our protein sequencing technologies may be active on social media. We intend to engage through those platforms to elevate our national marketing presence, both for our● ● ● · ● 4 rw ▸ Our protein sequencing products are currently labeled, promoted, and sold primarily to academic and research institutions and research companies as RUO products. They are not currently designed, or intended to be used, for clinical diagnostic● ● ● · ● 4 rw ▸ group Risks Related to Government Regulation● · · ● ● 3 ▸ group Risks Related to Our Securities and to Being a Public Company● · · ● ● 3 ▸ There can be no assurance that the warrants will be in the money prior to their expiration, and they may expire worthless.● · · ● ● 3 ▸ 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.● · · ● ● 3 rw ▸ 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.● ● ● ● ● 5 rw ▸ Delaware law and provisions in our certificate of incorporation and bylaws could make a takeover proposal more difficult.● ● ● ● ● 5 ▸ If we are unable to establish superior sales and marketing capabilities, we may not be successful in commercializing our products.● ● ● ● ● 5 rw ▸ 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.● ● ● ● ● 5 rw ▸ If we cannot license rights to use technologies on reasonable terms, we may not be able to commercialize new products in the future.● ● ● ● ● 5 ▸ If we do not sustain or successfully manage our anticipated growth, our business and prospects will be harmed.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 rw ▸ Issued patents covering our products could be found invalid or unenforceable if challenged.● ● ● ● ● 5 ▸ Medical product manufacturers’ use of social media platforms could present new risks.● ● ● ● ● 5 rw ▸ Our ability to use net operating losses to offset future taxable income may be subject to certain limitations.● ● ● ● ● 5 rw ▸ Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.● ● ● ● ● 5 ▸ 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 could result in dilution to our stockholders if exercised.● ● ● ● ● 5 rw ▸ 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.● ● ● ● ● 5 rw ▸ Our warrants are accounted for as liabilities and changes in the value of our warrants could have a material effect on our financial results.● ● ● ● ● 5 ▸ Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time.● ● ● ● ● 5 ▸ group Risks Related to Our Intellectual Property● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 rw ▸ 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.● ● ● ● ● 5 rw ▸ We cannot predict the impact our dual class structure may have on the stock price of our Class A common stock.● ● ● ● ● 5 ▸ We could be adversely affected by alleged violations of the Federal Trade Commission Act or other truth-in-advertising and consumer protection laws.● ● ● ● ● 5 rw ▸ We could become subject to various litigation claims and legal proceedings.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 rw ▸ We may be subject to claims challenging the inventorship of our patents and other intellectual property.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 rw ▸ 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.● ● ● ● ● 5 rw ▸ We may not be able to protect our intellectual property rights throughout the world.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 rw 
