MaxCyte (United States)

We believe that our current facilities are adequate and suitable to meet our current requirements. We may need to obtain additional facility space to meet future needs as our operations grow over time. We believe we will be able to obtain additional space on acceptable and commercially reasonable terms if and as required.

• Our international operations may raise additional risks, which could have an adverse effect on our operating results.
• If we fail to offer high-quality customer service, our business and reputation could suffer.
• If we cannot maintain and expand current SPL agreements and enter into new agreements that generate marketed licensed products, our business could be adversely affected.
• If the quality or delivery of our products does not meet our customers’ expectations and needs relative to their regulatory obligations, our reputation could suffer and ultimately our sales and financial results could be negatively impacted.
• The failure of our customers to meet their contractual obligations to us could adversely affect our business.
• Our customers have significant discretion in determining when and whether to make announcements, if any, about the status of their clinical developments and timelines for advancing collaborative programs, and the price of our common stock may decline as a result of announcements of unexpected results or developments.
• Our customers may not achieve projected development and regulatory milestones and other anticipated key events in the expected timelines or at all, or may discontinue some or all of their programs, which could have an adverse impact on our business and could cause the price of our common stock to decline.
• Biopharmaceutical drug, biologics and therapeutics development is inherently uncertain, and it is possible that none of the drug, biologic or therapeutic candidates discovered using our platform that are further developed by our customers will receive marketing approval or become viable commercial products on a timely basis or at all.
• In recent periods, we have depended on a limited number of customers for our revenue, the loss of any of which could have an adverse impact on our business.
• Our customers’ products or product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences following any potential marketing approval, which could cause our future results of operations to be materially and adversely affected.
• We have pursued and may in the future pursue collaborations or licensing arrangements, joint ventures, strategic alliances, partnerships or other strategic investment or arrangements, which may fail to produce anticipated benefits and adversely affect our operations.
• We have engaged in and may engage in future acquisitions that could disrupt our business, cause dilution to our stockholders and harm our financial condition and operating results.
• Risks Related to the Supply and Manufacturing of Our Products
• We depend on continued supply of high-quality components and raw materials for our ExPERT instruments and PAs from third-party suppliers, and if shortages of these components or raw materials arise, we may not be able to secure enough components to build new products to meet customer demand or we may be forced to pay higher prices for these components.
• Disruptions in global supplies could affect our ability to manufacture our PAs in commercial quantities successfully..
• Our results of operations will be harmed if we are unable to accurately forecast customer demand for our products and manage our inventory.
• Risks Related to Our Product Sales
• Our future success depends on our ability to develop and successfully introduce new and enhanced products that meet the needs of our customers.
• Many of our customers have limited resources and to the extent they limit development to a smaller number of product candidates or discontinue development of product candidates using our platform, our product sales would be negatively impacted.
• If we are unable to successfully develop new products, adapt to rapid and significant technological change, respond to introductions of new products by competitors, make strategic and operational decisions to prioritize certain markets, technology offerings or partnerships, and develop and capitalize on markets, technologies or partnerships, our business could suffer.
• Our systems are complex in design and may contain defects that are not detected until deployed by our customers, which could harm our reputation, increase our costs and reduce our sales. If our products do not perform as expected or the reliability of the technology on which our products are based is questioned, our operating results, reputation and business will suffer.
• If we are unable to successfully expand our commercial operations, including hiring additional qualified sales representatives, application scientists, engineers, scientific personnel and customer support staff, our business may be adversely affected.
• If we are unable to expand or leverage the number of peer-reviewed articles published using data generated through the use of our products or otherwise increase brand awareness in our target markets, the demand for our products and our business may be adversely affected.
• Risks Related to Our Regulatory Environment and Our Industry
• Changes in tariffs or other government trade policies may materially adversely affect our business and results of operations, including by reducing demand for our products.
• We are subject to governmental export controls that could impair our ability to compete in international markets due to licensing requirements and subject us to liability if we are not in compliance with applicable laws.
• We are subject to stringent and changing U.S. and foreign laws, regulations, rules, contractual obligations, policies, and other obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to adverse business consequences.
• We are subject to U.S. and certain foreign anti-corruption and anti-money laundering laws and regulations. We can face criminal liability and other serious consequences for violations, which can harm our business.
• Our customers who use our platform may be exposed to broadly applicable U.S. federal and state healthcare laws and regulations, including those relating to kickbacks and false claims, transparency, and health information privacy and security law. Failure to comply with such laws and regulations may result in substantial penalties.
• Risks Related to Our Financial Position and Capital Requirements
• We may need additional funding and may be unable to raise capital when needed, which could force us to delay, reduce, eliminate, or abandon our commercialization efforts or product development programs.
• Our results of operations and liquidity needs could be materially and adversely affected by market fluctuations, an economic downturn, inflation, increases in interest rates, and other macroeconomic conditions.
• Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
• Our ability to use our net operating losses, business tax credits, and similar tax attributes to offset future taxable income or taxes may be subject to certain limitations.
• Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition, or results of operations.
• Risks Related to Our Operations
• A pandemic, epidemic, outbreak of an infectious disease or other public health emergency in the United States or worldwide could adversely affect our business and the businesses of our partners.
• If our information technology systems, or those of third parties upon which we rely, or our data, 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.
• We outsource certain aspects of our cybersecurity risk management program to a third-party Managed Services Provider (“MSP”) to monitor the security and privacy of our information assets, and any failure to provide such services could have a material adverse effect on our business.
• We are highly dependent on our senior management team and key personnel and our business could be harmed if we are unable to attract and retain personnel necessary for our success.
• We expect to grow in the future, and we may experience difficulties in managing our growth. If we are unable to manage the anticipated growth of our business, our future revenue and operating results may be harmed.
• Our officers, employees, independent contractors, consultants and commercial partners may engage in misconduct or activities that are improper under other laws and regulations, or make significant errors, which could create liability for us.
• If we were to be sued for product liability, we could face substantial liabilities that exceed our resources, limit sales of our existing products and limit commercialization of any products that we may develop.
• If our customers fail to safely and appropriately use our products, or if we are unable to train our customers on the safe and appropriate use of our products, our reputation may be negatively impacted and we may be unable to achieve our expected sales, growth or profitability.
• Litigation and other legal proceedings may harm our business.
• We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of our employees’ former employers.
• Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
• Our insurance policies are expensive and protect us only from some business risks, which leaves us exposed to significant uninsured liabilities.
• The majority of our operations are currently conducted at a single location and any disruption at our facility could negatively impact our operations and increase our expenses.
• We may face exposure to foreign currency exchange rate fluctuations.
• Risks Related to Our Intellectual Property
• Our ability to compete and the success of our business could be jeopardized if we are unable to protect our intellectual property adequately.
• Legal proceedings to assert our intellectual property rights could be costly and could impair our operations.
• We may be sued by third parties for alleged infringement of their proprietary rights, which could be costly and time-consuming and which could limit our ability to use certain technologies in the future or to develop future products.
• Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.
• We may be obligated to disclose our proprietary technology to our customers, which may limit our ability to protect our intellectual property.
• General Risk Factors Associated with an Investment in Our Common Stock
• We may not be able to maintain the listing of our common stock on Nasdaq, which could adversely affect our liquidity and the trading volume and market price of our common stock.
• The price of our common stock is likely to be volatile and may fluctuate due to factors beyond our control.
• If securities or industry analysts do not publish research, or publish inaccurate or unfavorable research, about our business, the price of our common stock and our trading volume could decline.
• The requirements of being a public company in the United States may strain our resources, increase our operating costs, divert management’s attention, and affect our ability to attract and retain qualified board members or executive officers.
• Increasing scrutiny and evolving expectations from customers, regulators, investors, and other stakeholders with respect to our environmental, social and governance practices may impose additional costs on us or expose us to new or additional risks.
• Future sales of our common stock in the public market could cause our share price to fall.
• Because we do not expect to pay dividends on our common stock in the foreseeable future, capital appreciation, if any, would be your sole source of gain.
• We are an “emerging growth company” and a “smaller reporting company,” and we cannot be certain if the reduced reporting requirements applicable to “emerging growth companies” and “smaller reporting companies” will make our common stock less attractive to investors.
• If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which could harm our business and the trading price of our common stock.
• Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of our company more difficult, limit attempts by our stockholders to replace or remove our current management and limit the market price of our common stock.
• Our certificate of incorporation designates the Court of Chancery of the State of Delaware and, to the extent enforceable, the federal district courts of the United States of America as the exclusive forums for substantially all disputes between us and our stockholders, which will restrict our stockholders’ ability to choose the judicial forum for disputes with us or our directors, officers or employees.