MAXCYTE INC
For the period ended Dec 31, 2024. Filed Mar 11, 2025.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Mar 11, 2025
MXCT$1.26-3.8%Stored close · as of Nov 6, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-K
Period ended 2023-12-31; filed 2024-03-12.
0001558370-24-003001
Item 1A. Risk FactorsCurrent report: 10-K
Period ended 2024-12-31; filed 2025-03-11.
0001558370-25-002721
Item 1A. Risk FactorsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 275 previous paragraphs and 263 current paragraphs.
151 unchanged; 93 reworded; 3 added; 11 removed; 20 previous and 16 current paragraphs rearranged.
Tables are not compared: 122 previous and 117 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (3)
Current report
New income, sales, use or other tax laws, statutes, rules, regulations, or ordinances could be enacted at any time, which could adversely affect our business operations and financial performance. Further, existing tax laws, statutes, rules, regulations, or ordinances could be interpreted, changed, modified, or applied adversely to us. For example, the Tax Cuts and Jobs Act of 2017 (“TCJA”) enacted many significant changes to the U.S. tax laws. Future guidance from
Current report
the Internal Revenue Service and other tax authorities with respect to the TCJA may affect us, and certain aspects of the TCJA could be repealed or modified in future legislation. For example, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) modified certain provisions of the TCJA. In addition, it is uncertain if and to what extent various states will conform to the TCJA or any newly enacted federal tax legislation. For example, the U.S. government enacted the Inflation Reduction Act in 2022, which, among other things, significantly changes the taxation of certain business entities, including by imposing a 1% excise tax on certain share buybacks, effective for tax years beginning in 2023. If and when applicable, it is possible than the 1% excise tax on share buybacks could result in an additional tax liability over the regular federal corporate tax liability in a given year. Any resulting tax liability could adversely impact our business, financial condition, results of operation, and liquidity. Changes in corporate tax rates, the realization of net deferred tax assets relating to our operations, the taxation of foreign earnings, and the deductibility of expenses under the TCJA or future reform legislation could have a material impact on the value of our deferred tax assets, could result in significant one time charges, and could increase our future U.S. tax expense.
Current report
In addition, recent and upcoming presidential and congressional elections in the United States could also result in significant changes in, and uncertainty with respect to, tax legislation, regulation and government policy directly affecting us and our business. For example, the United States government may enact significant changes to the taxation of business entities including, among other things, a permanent increase in the corporate income tax rate, an increase in the tax rate applicable to the global intangible low-taxed income, and elimination of certain exemptions, and the imposition of minimum taxes or surtaxes on certain types of income. The likelihood of these changes being enacted or implemented is unclear.
Removed paragraphs (11)
Previous report
New product development involves a lengthy and complex process and we may be unable to develop or commercialize products on a timely basis, or at all.
Previous report
Products from our research and development programs will take time and considerable resources to develop, and may include improvements or changes to our current products, and we may not be able to complete development and commercialization of new or enhanced products on a timely basis, or at all. There can be no assurance that our research and development efforts will produce commercially viable products and solutions and before we can commercialize any new products, we will need to expend significant funds in order to, for example:
Previous report
Our product development processes involve a high degree of risk, and these efforts may be delayed or fail for many reasons, including failure of the product to perform as expected and failure to reliably demonstrate the advantages of the product.
Previous report
Even if we are successful in developing new products, it will require us to make significant additional investments in marketing and selling resources to commercialize any such products. As a result, we may be unsuccessful in commercializing new products that wedevelop, which could adversely affect our business, financial condition, results of operations and prospects.
Previous report
Recent changes to our leadership team and the resulting management transition might harm our future operating results.
Previous report
On December 10, 2023, the Board appointed Maher Masoud as our Chief Executive Officer, replacing Doug Doerfler, who had served in that role since 1999.
Previous report
Although we believe this leadership transition is in the best interest of the Company and its stockholders, changes in executive management inherently create uncertainty. Such transition involves the loss of personnel with deep institutional and technical knowledge, could divert management’s attention from business concerns, or could impact our public or market perception, all of which could have a negative impact on our business. The transition also could potentially disrupt our operations and relationships with employees, suppliers, partners, and customers due to added costs, operational inefficiencies, decreased employee productivity and increased turnover. We must successfully integrate our new leadership team within our organization to achieve our operating objectives; as such, the leadership transition may temporarily affect our business performance and results of operations while the new members of our leadership team engage in their new roles within our business. In addition, our competitors may seek to use this transition and the related potential disruptions to gain a competitive advantage over us. Our future operating results depend substantially upon the continued service of our key personnel and in significant part upon our ability to attract and retain qualified management personnel. If we are unable to mitigate these or other similar risks, our business, results of operations and financial condition may be materially and adversely affected.
Previous report
Operating as a public company in the United States has also made it more difficult and more expensive for us to obtain director and officer liability insurance, and we may in the future be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage that we currently have. As a result, it may be more difficult for us to attract and retain qualified people to serve on our board of directors, on our board committees or as executive officers. Wedo not know, however, if we will be able to maintain existing insurance with adequate levels ofcoverage. Any significant uninsured liability may require us to pay substantial amounts, which could negatively affect our business, financial condition and results of operations.
Previous report
Securities traded on AIM may carry a higher risk than securities traded on other markets, which may impact the value of your investment.
Previous report
Our shares of common stock are currently traded on AIM. Investment in equities traded on AIM is sometimes perceived tocarrya higher risk than an investment in equities quoted on markets with more stringent listing requirements, such as the main market of the London Stock Exchange, New York Stock Exchange or Nasdaq. This is because AIM is less heavily regulated and imposes less stringent corporate governance and ongoing reporting requirements than those other markets. In addition, AIM requires only half-yearly, rather than quarterly, financial reporting. You should be aware that the value of our shares of common stock may be influencedby many factors, some of
Previous report
which may be specific to us and some of which may affect AIM companies generally, including the depth and liquidity of the market, our performance, a large or small volume of trading in our shares of common stock, legislative changes and general economic, political or regulatory conditions, and that the prices may be volatile and subject to extensive fluctuations. Therefore, the current market price of our shares of common stock may not reflect the underlying value of our company.
Reworded paragraphs (93)
Previous wording
We are a cell engineering and life sciences company focused on advancing the discovery, development and commercialization of next-generation cell-based medicines. The biopharmaceutical development industry, where the majority of our customers operate, is a highly speculative undertaking and involves a substantial degree of risk. We have incurred significant losses since inception andhave financed our operations principally through private financings and public offerings of our securities. We have historically relied on sales and licensing of our instruments, as well as sales of our portfolio of single-use disposable PAsfor the significant majority of ourrevenue. Wemay be unable to sell or license our instruments to new customers and existing customers may cease or reduce their utilization of our instruments or fail to renew licenses of our instruments. Our net losses were $37.9 million and $23.6 millionfor the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023, we had an accumulated deficit of $175.8 million. Our losses have resulted principally from expenses incurred for research and development for our* *cell engineering platforms and from sales and marketing costs, manufacturing expenses, management and administrative costs as well as other expenses that wehave incurred while building our business infrastructure.
Current wording
We are a cell engineering and life sciences company focused on advancing the discovery, development and commercialization of next-generation cell-based medicines. The biopharmaceutical development industry, where the majority of our customers operate, is a highly speculative undertaking and involves a substantial degree of risk. We have incurred significant losses since inception andhave financed our operations principally through private financings and public offerings of our securities. We have historically relied on sales and licensing of our instruments, as well as sales of our portfolio of single-use disposable PAsfor the significant majority of ourrevenue. Wemay be unable to sell or license our instruments to new customers and existing customers may cease or reduce their utilization of our instruments or fail to renew licenses of our instruments. Our net losses were $41.1 million and $37.9 millionfor the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, we had an accumulated deficit of $216.9 million. Our losses have resulted principally from expenses incurred for research and development for our* *cell engineering platforms and from sales and marketing costs, manufacturing expenses, management and administrative costs as well as other expenses that wehave incurred while building our business infrastructure.
Previous wording
We have devoted a significant portion of our financial resources and efforts to building our organization, developing ourex vivocell engineering platforms, acquiring technology, building out our manufacturing capabilities, organizing and staffing the company, business planning, establishing our intellectual property portfolio, raising capital, securing license and partnership arrangements with customers and providing general and administrative support for these operations.
Current wording
We have devoted a significant portion of our financial resources and efforts to building our organization, developing ourex vivocell engineering platforms, acquiring technology, building out our manufacturing capabilities, organizing and staffing the Company, business planning, establishing our intellectual property portfolio, raising capital, securing license arrangements with customers and providing general and administrative support for these operations.
Previous wording
Tobecome and remain profitable, we must succeed in realizing meaningful precommercial milestone payments from our current SPLs and potentially secure future commercial partnership, licensing or collaboration arrangements for use of our cell engineering platforms and similar arrangements for cell therapy programs in development that havenot yet been partnered. This will require us to be successful in a range of challenging activities, including continuing to develop our technology and products, accessing, developing and advancing manufacturing capacity, advancing our sales and marketing capabilities and commercializing and selling our products. We may never succeed in any or all of these activities and, evenif wedo, we maynever generate alevelof revenue that is sufficient to achieve profitability. Even if we do achieve profitability, we may not be able to sustain profitability or meet outside expectations for our financial results, including profitability. If we are unable to achieve or sustain profitability or to meet outside expectations for our financial results, the value of our shares of common stock could be materially adversely affected.
Current wording
Tobecome and remain profitable, we must succeed in realizing meaningful precommercial milestone payments from our current SPLs and potentially securing future commercial partnership, licensing or collaboration arrangements for use of our cell engineering platforms and similar arrangements for cell therapy programs in development that havenot yet been partnered. This will require us to be successful in a range of challenging activities, including continuing to develop our technology and products, accessing, developing and advancing manufacturing capacity, advancing our sales and marketing capabilities and commercializing and selling our products. We may never succeed in any or all of these activities and, evenif wedo, we maynever generate alevelof revenue that is sufficient to achieve profitability. Even if we do achieve profitability, we may not be able to sustain profitability or meet outside expectations for our financial results, including profitability. If we are unable to achieve or sustain profitability or to meet outside expectations for our financial results, the value of our shares of common stock could be materially adversely affected.
Previous wording
Our ExPERT technology platform and family of instruments was commercially launched in April 2019 with a new instrument launched in late 2022. Sales and licensing of ExPERT technology systems and related instruments together accounted for 45% and 51% of our revenue for the years ended December 31, 2023 and 2022, respectively. We expect that, for at least the foreseeable future, sales and licensing of our ExPERT technology systems will continue to account for a substantial portion of ourrevenue. The sales cycle for our cell engineering instruments is complex and can take up to 12 months or longer to complete.
Current wording
Our ExPERT technology platform and family of instruments was commercially launched in April 2019 with the latest instrument launched in late 2022. Sales and licensing of ExPERT technology systems and related instruments together accounted for 45% of our revenue for the years ended December 31, 2024 and 2023. We expect that, for at least the foreseeable future, sales and licensing of our ExPERT technology systems will continue to account for a substantial portion of ourrevenue. The sales cycle for our cell engineering instruments is complex and can take up to 12 months or longer to complete.
Previous wording
Material, one-time milestone payments earned as SPL partners achieve clinical progress are also a significant portion of our revenue, although such milestone paymentsare not in our control, are unpredictable because of the early-stage nature of cell therapy clinical development, and may contribute materially to the volatility of ourrevenue. As a result of our lengthy and unpredictable sales cycle, we may be prone to quarterly fluctuations in ourrevenue. Quarterly fluctuations may make it difficult for us to predict our future operating results. Consequently, comparisons of our operating results on a period-to-period basis may not be meaningful. Investors should not rely on our past results as an indication of our future performance.
Current wording
Material, one-time milestone payments earned as SPL customers achieve clinical progress are also a significant portion of our revenue, although such milestone paymentsare not in our control, are unpredictable because of the early-stage nature of cell therapy clinical development, and may contribute materially to the volatility of ourrevenue. As a result of our lengthy and unpredictable sales cycle, we may be prone to quarterly fluctuations in ourrevenue. Quarterly fluctuations may make it difficult for us to predict our future operating results. Consequently, comparisons of our operating results on a period-to-period basis may not be meaningful. Investors should not rely on our past results as an indication of our future performance.
Previous wording
including monoclonal antibodies. The success of the VLx, including new engineering modifications to the platform, may depend inparton theavailability, compatibility and capability of appropriate technologies upstream and downstream of electroporation to support potential large-scale applications enabledbythe VLx platform, our ability to develop and launch GMP-compliant processing assemblies, and willingness of customers to adopt the VLx for new applications. We expect that additional investment will be needed to build out process development capabilities, manufacturing capacity, new processing assembly design and the addition of large-scale bioprocessing-specific field resources and those investments may not be successful. Further, we could encounter delays and setbacks in implementing engineering modifications necessary for certain large-scale applications, resulting in delayed acceptanceby future customers and partners of such a large-scale system. In addition, the sales and implementation cycles of customers for such a large-scale platform may require more time than originally assumed as we may encounter delays in acceptance by potential customers for the VLx platform in large-scale applications, which could negatively impact forecasted revenues.
Current wording
One of the components of our growth strategy is to sell ourrecently launched ExPERTVLx platform for large-scale bioprocessing applications, including viral vector production in suspension cell cultures and rapid production of proteins, including monoclonal antibodies. The success of the VLx, including new engineering modifications to the platform, may depend inparton theavailability, compatibility and capability of appropriate technologies upstream and downstream of electroporation to support potential large-scale applications enabledbythe VLx platform, our ability to develop and launch GMP-compliant processing assemblies, and willingness of current and potential customers to adopt the VLx for new applications. We expect that additional investment will be needed to build out process development capabilities, manufacturing capacity, new processing assembly design and the addition of large-scale bioprocessing-specific field resources, and those investments may not be successful. Further, we could encounter delays and setbacks in implementing engineering modifications necessary for certain large-scale applications, resulting in delayed acceptanceby future customers of such a large-scale system. In addition, the sales and implementation cycles of customers for such a large-scale platform may require more time than originally assumed as we may encounter delays in acceptance by potential customers for the VLx platform in large-scale applications, which could negatively impact forecasted revenues.
Previous wording
Another component of our growth strategy is expanding our SPL model, through which we build collaborative relationships with our customers as we facilitate their effortsto bring critical cell-based medicines to market. Even if we are able to enter into additional future SPL arrangements and similar arrangements for future therapeutic products that havenot yet been partnered, there can be no assurance that any of the therapeutic products that are being or might be developedbyour partners using our technology will continue to advance through clinical development, receive regulatory approvals or be successfully developed into commercially viable products. As a result, we may suffer setbacks in increasing awareness and adoption of our products in addition to the material impact on our financial results as a result of milestones not being realized and leased instruments being returned. Further, setbacks in the clinical trials of our current or future partners, such as serious adverse events, including patient deaths, could significantly impact capital available to customers and our ability to enter into future SPL agreements with new therapeutic product companies.
Current wording
Another component of our growth strategy is expanding our SPL model, through which we build collaborative relationships with our customers as we facilitate their effortsto bring critical cell-based medicines to market. Even if we are able to enter into additional future SPL arrangements and similar arrangements for future therapeutic products that havenot yet been partnered, there can be no assurance that any of the therapeutic products that are being or might be developedbyour customers using our technology will continue to advance through clinical development, receive regulatory approvals or be successfully developed into commercially viable products. As a result, we may suffer setbacks in increasing awareness and adoption of our products in addition to the material impact on our financial results as a result of milestones not being realized and non-renewal of licenses. Further, setbacks in the clinical trials of our current or future customers, such as serious adverse events including patient deaths, could significantly impact capital available to customers and our ability to enter into future SPL agreements with new therapeutic product companies.
Previous wording
Our growth strategy also involves expanding our international operations. In addition to risks associated with international operations in general, we will also need to navigate complex foreign regulatory requirements with which we may not be familiar or have experience. To operate successfully, or for our partners to obtain regulatory approval in other countries, we must comply with numerous and varying regulatory requirements imposed by such countries regarding safety, efficacy, manufacturing, clinical trials, commercial sales, pricing and distribution of our products. Although our partners have historically been able to reference our FDA Master File in the United States and our Master and Technical Files in some other countries in the course of clinical development of their therapeutic products, we cannot ensure that we will obtain or establish a regulatory Master or Technical File in other countries. If we fail to establish a regulatory Master or Technical File in any jurisdiction, this could make customers in such jurisdictions less likely to adopt our instruments, and the geographic market for our products could be limited.
Current wording
Our growth strategy also involves expanding our international operations. In addition to risks associated with international operations in general, we will also need to navigate complex foreign regulatory requirements with which we may not be familiar or have experience. To operate successfully, or for our customers to obtain regulatory approval in other countries, we must comply with numerous and varying regulatory requirements imposed by such countries regarding safety, efficacy, manufacturing, clinical trials, commercial sales, pricing and distribution of our products. Although our SPL customers have historically been able to reference our FDA Master File in the United States and our Master and Technical Files in some other countries in the course of clinical development of their therapeutic products, we cannot ensure that we will obtain or establish a regulatory Master or Technical File in other countries. If we fail to establish a regulatory Master or Technical File in any jurisdiction, this could make customers in such jurisdictions less likely to adopt our instruments, and the geographic market for our products could be limited.
Previous wording
In addition to our financial results, our management regularly reviews a number of operating and financial metrics, including a breakdown of product and leased revenue into instrument sales, PAs, leased revenue (recurring revenue), product placements, cumulative product placements, revenueby customer market (cell therapy and drug discovery), status or number of installed instruments, SPLs, program licenses (research, clinical and SPL), and potential precommercial milestones, to evaluate our business, measure our performance, identify trends affecting our business, formulate financial projections and make strategic decisions. As both our business andthe industry in which we operate evolve, the metricsby which we evaluate our performance may also change. In addition, while the calculation of the metrics we use is based on what we believe to be reasonable estimates, our internal tools are not independently verifiedbya third partyand havea number of limitations and, furthermore, our methodologies for tracking these metrics may change over time.
Current wording
In addition to our financial results, our management regularly reviews a number of operating and financial metrics, including a breakdown of product and license revenue into instrument sales, PAs, license revenue (recurring revenue), product placements, cumulative product placements, status or number of installed instruments, SPLs, program licenses (research, clinical and SPL), and potential precommercial milestones, to evaluate our business, measure our performance, identify trends affecting our business, formulate financial projections, and make strategic decisions. As both our business andthe industry in which we operate evolve, the metricsby which we evaluate our performance may also change. In addition, while the calculation of the metrics we use is based on what we believe to be reasonable estimates, our internal tools are not independently verifiedbya third partyand havea number of limitations and, furthermore, our methodologies for tracking these metrics may change over time.
Previous wording
Our customer base includes biopharmaceutical and biotechnology companies and academic institutions focused on cell-based therapeutics. Our success will depend in part upon our ability to increase our market penetration by expanding sales to existing customers and acquiring new customers and partnerships within our existing markets, and our ability to market new products and applications to existing and new customers. Attracting new customers and introducing new products and applications require substantial time and expense. Forexample, it may be difficult to identify, engage and market to customers who are unfamiliar with our current products. Wecannot guarantee that we will be able to further penetrate our existing markets or that these markets will be able to sustain our current and future product and service offerings. Any failure to increase penetration in our existing markets could adversely affect our ability to improve our operating results.
Current wording
Our customer base includes biopharmaceutical and biotechnology companies and academic institutions focused on cell-based therapeutics. Our success will depend in part upon our ability to increase our market penetration by expanding sales to existing customers and acquiring new customers and entering into SPL agreements within our existing markets, and our ability to market new products and applications to existing and new customers. Attracting new customers and introducing new products and applications require substantial time and expense. Forexample, it may be difficult to identify, engage and market to customers who are unfamiliar with our current products. Wecannot guarantee that we will be able to further penetrate our existing markets or that these markets will be able to sustain our current and future product and service offerings. Any failure to increase penetration in our existing markets could adversely affect our ability to improve our operating results.
Previous wording
Webelieve our products have potential applications across a wide range of markets and wehave targeted certain markets in which we believe our technology has significant advantages, or for which we believe wehavea higher
Current wording
Webelieve our platform has potential applications across a wide range of markets, and wehave targeted certain markets in which we believe wehavea higher probability of success or revenue opportunity or for which the path to commercialize products and realizing or achieving revenue is shorter. Forexample, we believe our products have applications in markets for engineered cell therapies in immuno-oncology and inherited disorders. Weseek to continue
Previous wording
Webelieve our platform has potential applications across a wide range of markets, and wehave targeted certain markets in which we believe wehavea higher probability of success or revenue opportunity or for which the path to commercialize products and realizing or achieving revenue is shorter. Forexample, we believe our products have applications in markets for engineered cell therapies in immuno-oncology and inherited disorders. Weseek to continue to prioritize opportunities and allocate our resources among our programs to maintain a balance between advancing near-term opportunities and exploring additional markets for ourtechnology. However, due to the significant resources required for the development of new markets, we must make decisions regarding which markets to pursue and the amount of resources to allocate to each. Our decisions concerning the allocation of research, development, collaboration, management and financial resources toward particular markets or workflows may not lead to the development of any viable product and may divert resources away from other opportunities that may ultimately be better-suited to our business. Similarly, our potential decisions todelay, terminate or collaborate with third parties in respect of certain markets may subsequently also proveto be suboptimal and could cause us to miss out on valuable opportunities. In particular, if we are unable to develop additional relevant products and applications for markets such as cell therapy or large-scale bioprocessing, it could slow or stop our business growth and negatively impact our business, financial condition, results of operations and prospects.
Current wording
to prioritize opportunities and allocate our resources among our programs to maintain a balance between advancing near-term opportunities and exploring additional markets for ourtechnology. However, due to the significant resources required for the development of new markets, we must make decisions regarding which markets to pursue and the amount of resources to allocate to each. Our decisions concerning the allocation of research, development, collaboration, management and financial resources toward particular markets or workflows may not lead to the development of any viable product and may divert resources away from other opportunities that may ultimately be better-suited to our business. Similarly, our potential decisions todelay, terminate or collaborate with third parties in respect of certain markets may subsequently also proveto be suboptimal and could cause us to miss out on valuable opportunities. In particular, if we are unable to develop additional relevant products and applications for markets such as cell therapy or large-scale bioprocessing, it could slow or stop our business growth and negatively impact our business, financial condition, results of operations and prospects.
Previous wording
In addition, our customers may experience a change of control or otherwise consolidate with other biopharmaceutical companies and academic institutions. If, as a result of such change of control, our customers choose or are forced to modify or terminate cell therapy strategies, adopt other products, or otherwise reduce their use of our products, our ability to execute our growth strategy could be impaired, which may negatively affect our business, financial condition, prospects and results of operations.
Current wording
In addition, our customers may experience a change of control or otherwise consolidate with other biopharmaceutical companies and academic institutions. If, as a result of such events, our customers choose or are forced to modify or terminate cell therapy strategies, adopt other products, or otherwise reduce their use of our products, our ability to execute our growth strategy could be impaired, which may negatively affect our business, financial condition, prospects and results of operations.
Previous wording
We operate in a highly competitive market characterized by rapid technological change, evolving industry standards, changes in customer needs, emerging competition, new product introductions and strong price competition. We currently compete with both established and early-stage life sciences technologies companies that design,
Current wording
We operate in a highly competitive market characterized by rapid technological change, evolving industry standards, changes in customer needs, emerging competition, new product introductions and strong price competition. We currently compete with both established and early-stage life sciences technologies companies that design, manufacture and market electroporation and other non-viral cell engineering technology based on efficacy, price, ease of use, reimbursement and customer support services.
Previous wording
We primarily compete against products marketed by Lonza Group AG, Thermo Fisher Scientific Inc., Miltenyi Biotec, Bio-Rad Laboratories, Inc. and Harvard Bioscience, Inc. (BTX), as well as several other smaller companies, including spinouts from academic labs.
Current wording
We primarily compete against products marketed by Lonza Group AG, Thermo Fisher Scientific Inc.(NYSE: TMO), Miltenyi Biotec, Bio-Rad Laboratories, Inc. (NYSE: BIO) and Harvard Bioscience, Inc. (Nasdaq: HBIO), as well as several other smaller companies, including spinouts from academic labs.
Previous wording
A portion of our revenue is derived from sales to biopharmaceutical companies and academic institutions. Much of their funding is, in turn, provided by public and private financings, including investments from venture capital funds and, for public companies, the capital markets. In the near term, we expect that a portion of our revenue will continue to be derived from sales to biopharmaceutical companies and academic institutions. Accordingly, the spending policies and practices of these customers—which have been impacted by market conditions and other factors—could have a significant effect on the demand for our products. In addition, the demand for our products may depend upon the research and development budgets of these customers, which are impacted by factors beyond our control, such as:
Current wording
A portion of our revenue is derived from sales to biopharmaceutical companies and academic institutions. Much of their funding is, in turn, provided by public and private financings, including investments from venture capital funds and, for public companies, the capital markets. Accordingly, the spending policies and practices of these customers, which have been and may continue to be impacted by market conditions and other factors, could have a significant effect on the demand for our products. In addition, the demand for our products may depend upon the research and development budgets of these customers, which are impacted by factors beyond our control, such as:
Previous wording
In addition, while the majority of our revenues are derived from biopharmaceutical customers, various state, federal and foreign agencies that provide grants and other funding may be subject to stringent budgetary constraints that could result in spending reductions, reduced grant making, reduced allocations or budget cutbacks, which could jeopardize the ability of these customers, or the customers to whom they provide funding, to purchase our products. For example, congressional appropriations to the National Institutes of Health (“NIH”)have generally increased year-over-yearin recent years, but the NIH also experiences occasional year-over-year decreases in appropriations. There is no guarantee that NIH appropriations will not decrease or cease in the future. A decrease in the amount of, or delay in the approvalof, appropriations to NIH or other similar United States or foreign organizations, such as the Medical Research Council in the United Kingdom, could result in fewer grants benefiting life sciences research. These reductions or delays could also result in a decrease in the aggregate amount of grants awarded for life sciences research or the redirection of existing funding to other projects or priorities, any of which in turn could cause our customers and potential customers to reduce or delay purchases or licensing of our products.
Current wording
In addition, while the majority of our revenues are derived from biopharmaceutical customers, various state, federal and foreign agencies that provide grants and other funding may be subject to stringent budgetary constraints that could result in spending reductions, reduced grant making, reduced allocations or budget cutbacks, which could jeopardize the ability of these customers, or the customers to whom they provide funding, to purchase our products. For example, the Trump administration recently announced plans to reduce appropriations to the National Institutes of Health (“NIH”) for biomedical research, which the NIH expects could cut grants for indirect costs related to research, such as buildings, utilities and equipment. There is substantial uncertainty around whether such appropriations will be increased or decreased in the near term, and whether grants will be cut. Any decrease in the amount of, or delay in the approvalof, appropriations to NIH (and associated decreases in grants provided by the NIH) or other similar United States or foreign organizations, such as the Medical Research Council in the United Kingdom, could result in fewer grants benefiting life sciences research. These reductions or delays could also result in a decrease in the aggregate amount of grants awarded for life sciences research or the redirection of existing funding to other projects or priorities, any of which in turn could cause our customers and potential customers to reduce or delay purchases or licensing of our products.
Previous wording
Our operating results may fluctuate substantially due to the potential changes in our customers' resources as described above. Any decrease in our customers’ budgets or expenditures, or in the size, scope or frequency of their capital or operating expenditures, could materially and adversely affect our business, operating results and financial condition.
Current wording
Our operating results may fluctuate substantially due to the potential changes in our customers' resources as described above. Any decrease in our customers’ budgets or expenditures, or in the size, scope or frequency of their
Previous wording
Developing our products isexpensive, and the investment in product development mayinvolvea long payback cycle. Our investment in research and development may not result in the data we hope to develop to support marketing of our products or in marketable products or may result in products that take longer to generate revenue, or generate less revenue, than we anticipate. Forthe years ended December 31, 2023 and 2022, our research and development expenses were $23.8 million and $19.5 million, respectively, or approximately 58% and 44%, respectively, of our total revenue. Our future plans include increased significant investments in research and development of product opportunities for expansion of our products and new application areas for our products. Webelieve that we must continue to dedicate a
Current wording
Developing our products isexpensive, and the investment in product development mayinvolvea long payback cycle. Our investment in research and development may not result in the data we hope to develop to support marketing of our products or in marketable products or may result in products that take longer to generate revenue, or generate less revenue, than we anticipate. Forthe years ended December 31, 2024 and 2023, our research and development expenses were $22.2 million and $23.8 million, respectively, or approximately 58%, of our total revenue. Our future plans include increased significant investments in research and development of product opportunities for expansion of our products and new application areas for our products. Webelieve that we must continue to dedicate a significant amount of resources to our research and development efforts to maintain our competitive position. However, we may not receive significant revenue from these investments for several years, if at all.
Previous wording
International customers have typically accounted for a meaningful portion of our revenue. For the year ended December 31, 2023, approximately 21% of our revenue was derived from international customers, with the most significant markets being the United Kingdom, Switzerland, Canada and China. We expect that our international revenue and operations will continue to expand in the future. Our international operations are subject to a variety of risks that we do not face in the United States, including:
Current wording
International customers have typically accounted for a meaningful portion of our revenue. For the year ended December 31, 2024, approximately 33% of our revenue was derived from international customers, with the most significant markets being the United Kingdom, Switzerland, Canada and China. We expect that our international revenue and operations will continue to expand in the future. Our international operations are subject to a variety of risks that we do not face in the United States, including:
Previous wording
If we cannot maintain and expand current partnerships and enter into new partnerships that generate marketed licensed products, our business could be adversely affected.
Current wording
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.
Previous wording
Wedo nothaveour own pipeline of therapeutic candidates, and instead we focus oureffortson the development of our cell engineering offerings, including our ExPERT platform. Our partners then use our instruments and PAs for cell engineering to develop their own therapeutic candidates without our direct involvement. As a result, our success depends on our ability to expand the number and scope of our partnerships. Many factors may impact the success of these partnerships, including our ability to perform our obligations, our partners’ satisfaction with our products, competitive offerings of other companies, our partners’ ability to successfully develop, secure regulatory approval for and commercialize therapeutic candidates using our products, our partners’ internal priorities (including fluctuations in research and developments budgets), our partners’ resource allocation decisions and competitive opportunities, disagreements with our partners, the costs required of either partyto the partnerships and related financing needs, and operating, legal and other risks in any relevant jurisdiction, as well as severe adverse events in cell therapy trials regardless of association with our partners.
Current wording
customer arrangements, including our ability to perform our obligations, our partners’ satisfaction with our products, competitive offerings of other companies, our partners’ ability to successfully develop, secure regulatory approval for and commercialize therapeutic candidates using our products, our customers’ internal priorities (including fluctuations in research and developments budgets), our customers’ resource allocation decisions and competitive opportunities, our ability to resolve disagreements with our customers, the costs required of either partyto the agreement and related financing needs, and operating, legal and other risks in any relevant jurisdiction, as well as severe adverse events in cell therapy trials regardless of association with our customers.
Previous wording
commercialize their therapeutic candidates. In such circumstances, we may not generate any substantial revenues from such a collaboration in the form of milestone payments, royalties or otherwise. Speculation in the industry about our existing or potential partnerships can be a catalyst for adverse speculation about us which can adversely affect our reputation and our business.
Current wording
Weengage in conversations with companies regarding potential SPL agreements on an ongoing basis. These conversations may not result in commercial agreement. Even if agreement is reached, the resulting relationship may not be successful, including due to factors beyond our control, such as our customers’ inability to successfully develop, obtain regulatory approvals for, or commercialize their therapeutic candidates. In such circumstances, we may not generate any substantial revenues from such a collaboration in the form of milestone payments, royalties or otherwise. Speculation in the industry about our existing or potential SPL customers can be a catalyst for adverse speculation about us which can adversely affect our reputation and our business.
Previous wording
Further, our customers are subject to the extensive risks and uncertainties that apply to product candidates in this area including those associated with preclinical and clinical research and development and related regulatory and Institutional Review Board authorization and oversight, manufacturing challenges and compliance standards, the data requirements and review process for seeking marketing authorization, and the potential for safety and efficacy concerns to emerge at any stage of product development andeven after approval.
Current wording
Further, our customers are subject to the extensive risks and uncertainties that apply to product candidates in this area, including those associated with preclinical and clinical research and development and related regulatory and Institutional Review Board (“IRB”) authorization and oversight, manufacturing challenges and compliance standards, the data requirements and review process for seeking marketing authorization, and the potential for safety and efficacy concerns to emerge at any stage of product development andeven after approval.
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The failure of our partners to meet their contractual obligations to us could adversely affect our business.
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The failure of our customers to meet their contractual obligations to us could adversely affect our business.
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Our reliance on our partners poses a number of additional risks, including the risk that they may not perform their contractual obligations to our standards, in compliance with applicable legal or contractual requirements, in a timely manner or at all; they may not maintain the confidentiality of our proprietary information; and disagreements or disputes could arise that could cause delays in, or termination of, the research, development or commercialization of therapeutic candidates produced using our instruments and PAs.
Current wording
Our reliance on our customers poses a number of additional risks, including the risk that they may not perform their contractual obligations to our standards, in compliance with applicable legal or contractual requirements, in a timely manner or at all; they may not maintain the confidentiality of our proprietary information; and disagreements or disputes could arise that could cause delays in, or termination of, the research, development or commercialization of therapeutic candidates produced using our instruments and PAs.
Previous wording
Some of our partners operate in markets subject to political and social risk, corruption, infrastructure problems and
Current wording
Some of our customers operate in markets subject to political and social risk, corruption, infrastructure problems and natural disasters, and are often subject to country-specific data privacy and data security risk as well as burdensome legal and regulatory requirements. Any of these factors could adversely impact their financial condition and results of
Previous wording
Our partners 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.
Current wording
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.
Previous wording
Our partners have significant discretion in determining when and whether to make announcements about the status of their programs that use ourtechnology, including their preclinical and clinical programs, such as setbacks or terminations, and timelines for advancing therapeutic candidates developed using our platform. Wedo not plan to disclose, and historically, have not disclosed, the development status and progress of individual therapeutic candidates of our partners. Our partners may wish to report such information more or less frequently than we prefer or may not wish to report such information at all. In addition, if partners choose to announce a collaboration with us or their progress, there is no guarantee that we will concurrently recognize any fees or that such announcement will be indicative of future fees to us, as such fees are not due to us until our partner reaches certain specific activities or clinical progress events, for example INDsubmissions orstartof pivotal trials. The price of our common stock may decline as a result of the public announcement of unexpected results or developments in our partnerships, or as a result of our partners withholding such information.
Current wording
Our customers have significant discretion in determining when and whether to make announcements about the status of their programs that use ourtechnology, including their preclinical and clinical programs, such as setbacks or terminations, and timelines for advancing therapeutic candidates developed using our platform. Wedo not plan to disclose, and historically, have not disclosed, the development status and progress of individual therapeutic candidates of our customers. Our customers may wish to report such information more or less frequently than we prefer or may not wish to report such information at all. In addition, if customers choose to announce a collaboration with us or their progress, there is no guarantee that we will concurrently recognize any fees or that such announcement will be indicative of future fees to us, as such fees are not due to us until our partner reaches certain specific activities or clinical progress events, such as INDsubmissions orstartof pivotal trials. The price of our common stock may decline as a result of the public announcement of unexpected results or developments in our SPL customers, or as a result of our customers withholding such information.
Previous wording
Our partners 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.
Current wording
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.
Previous wording
From time to time, we may make public statements regarding the expected timing of certain milestones and key events, as well as regarding developments and milestones under our partnerships, to the extent that our partners have publicly disclosed such information or permit us to make such disclosures. Certain of our partners have also made public statements regarding their expectations for the development of programs under partnership with us and they and other partners may in the future make additional statements about their goals and expectations for the progress of their programs and/or their partnerships with us. The actual timing of these events and any resultant revenue to us may vary dramatically due to a number of factors such as delays or failures in our or our current and future partners’ therapeutic discovery and development programs and the numerous uncertainties inherent in the development of therapeutics. As a result, there can be no assurance that our partners’ current and future programs will advance or be completed in the time frames we or they expect, or at all.
Current wording
From time to time, we may make public statements regarding the expected timing of certain milestones and key events, as well as regarding developments and milestones under our SPL agreements, to the extent that our customers have publicly disclosed such information or permit us to make such disclosures. Certain of our customers have also made public statements regarding their expectations for the development of programs under SPL agreements with us and they and other customers may in the future make additional statements about their goals and expectations for the progress of their programs and/or their arrangements with us. The actual timing of these events and any resultant revenue to us may vary dramatically due to a number of factors such as delays or failures in our current and future partners’ therapeutic discovery and development programs and the numerous uncertainties inherent in the development of therapeutics. As a result, there can be no assurance that our partners’ current and future programs will advance or be completed in the time frames we or they expect, or at all.
Previous wording
In addition, we have very little visibility into, or advance notice of, any changes in our partners’ development timelines and expectations, which means that we may not be able to swiftly react and adapt to changed expectations related to the achievement and payment of milestones under our agreements. If our partners fail to achieve one or more of these milestones or other key events as we or they expect, our business could be materially adversely affected and the price of our common stock could decline.
Current wording
In addition, we have very little visibility into, or advance notice of, any changes in our partners’ development timelines and expectations, which means that we may not be able to swiftly react and adapt to changed expectations related to the achievement and payment of milestones under our agreements. If our customers fail to achieve one or more of these milestones or other key events as we or they expect, our business could be materially adversely affected and the price of our common stock could decline.
Previous wording
Biopharmaceutical drug, biologics andtherapeutics 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 partners will receive marketing approval or become viable commercial products on a timely basis or at all.
Current wording
Biopharmaceutical drug, biologics andtherapeutics 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.
Previous wording
We offer our cell engineering platform to partners who are engaged in drug, biologics and therapeutics discovery and development. These partners include large pharmaceutical companies, biotechnology companies of all sizes and non-profit and academic institutions. While we receive early payments generated through sales of our ExPERT instruments and PAs and recurring revenue through the annual licenses of the ExPERT instrument to our partners, we estimate that the vast majority of the economic value of the SPL partnerships that we enter into with our partners is in the downstream payments that are payable if certain milestones are met or approved products are sold. As a result, our future growth is dependent on the ability of our partners to successfully develop and commercialize therapies discovered or produced using our platform. Due to our reliance on our partners, the risks relating to product development, regulatory authorization or approval and commercialization apply to us derivatively through the activities of our partners. There can be no assurance that our partners will successfully develop, secure marketing approvals for and commercialize any drug, biologic or therapeutic candidates discovered or produced with our instruments. As a result, we may not realize the intended benefits of our partnerships. We have entered into 26 SPL partnerships resulting in a growing number of clinical milestone payments and the first licensed program to receive regulatory marketing approval occurred in 2023.
Current wording
future growth is dependent on the ability of our customers to successfully develop and commercialize therapies discovered or produced using our platform. Due to our reliance on our partners, the risks relating to product development, regulatory authorization or approval and commercialization apply to us derivatively through the activities of our partners. There can be no assurance that our customers will successfully develop, secure marketing or regulatory approvals for and commercialize any drug, biologic or therapeutic candidates discovered or produced with our instruments. As a result, we may not realize the intended benefits of these SPL agreements. We have 29 SPL agreements resulting in a growing number of clinical milestone payments. The first licensed program to receive regulatory marketing approval occurred in 2023.
Previous wording
Due to the uncertain, time-consuming and costly clinical development and regulatory approval process, our partners may not successfully develop any drug, biologic or therapeutic candidates with our platform, or our partners may choose to discontinue the development of these candidates for a variety of reasons, including due tosafety, risk versus benefit profile, exclusivity, competitive landscape, manufacturing challenges, commercialization potential, production limitations or prioritization of their resources. Forproduct candidates of the type expected to be developed using ourtechnology, there is the potential they could create a safety risk to patients and can also limit product efficacy. It is possible that none of these drug, biologic or therapeutic candidates will ever receive regulatory approval and, evenif approved, such candidates may never be successfully commercialized resulting in clinical progress milestones and commercial sales-based payments not being earned.
Current wording
Due to the uncertain, time-consuming and costly clinical development and regulatory approval process, our customers may not successfully develop any drug, biologic or therapeutic candidates with our platform, or our customers may choose to discontinue the development of these candidates for a variety of reasons, including due tosafety, risk versus benefit profile, exclusivity, competitive landscape, manufacturing challenges, commercialization potential, production limitations or prioritization of their resources. Forproduct candidates of the type expected to be developed using ourtechnology, there is the potential they could create a safety risk to patients and can also limit product efficacy. It is possible that none of these drug, biologic or therapeutic candidates will ever receive regulatory approval and, evenif approved, such candidates may never be successfully commercialized resulting in clinical progress milestones and commercial sales-based payments not being earned.
Previous wording
Regulatory authorities have substantial discretion in the review and approval process and may refuse to accept any application or may decide that our partners’ data are insufficient to support progression to further stages of preclinical or clinical development or for marketing approval and require additional preclinical, clinical or other studies. The number and types of preclinical studies and clinical trials that will be required for regulatory approval also varies depending on the product candidate (including cell therapies, for which development is inherently challenging), the disease or condition that the product candidate is designed to address, and the regulations applicable to any particular product candidate. Application of the legal and regulatory standards for approval, and the type and amount of clinical data and data supporting chemistry, manufacturing and control necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. It is possible that any product candidates our partners may seek to develop in the future will never obtain the appropriate, necessary regulatory approvals.
Current wording
Regulatory authorities have substantial discretion in the review and approval process and may refuse to accept any application or may decide that our partners’ data are insufficient to support progression to further stages of preclinical or clinical development or for marketing approval and require additional preclinical, clinical or other studies. The number and types of preclinical studies and clinical trials that will be required for regulatory approval also vary depending on the product candidate (including cell therapies, for which development is inherently challenging), the disease or condition that the product candidate is designed to address, and the regulations applicable to any particular product candidate. Application of the legal and regulatory standards for approval, and the type and amount of clinical data and data supporting chemistry, manufacturing and control necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. It is possible that any product candidates our customers may seek to develop in the future will never obtain the appropriate, necessary regulatory approvals.
Previous wording
In addition, evenif these drug, biologic or therapeutic candidates receive regulatory approval in the United States, our partners maynever obtain approval or commercialize them outside of the United States, which would limit their full market potential and therefore may impact our ability to realize their potential downstream value. Furthermore, approved drugs, biologics or therapeutics may not achieve broad market acceptance among physicians, patients, the medical community and third-party payors, in which case revenue generated from their sales could be limited. Third-party payors may opt to implement efficacy-based payment mechanisms overa multi-year period, which could impact potential product sales in anygiven year. Likewise, our partners haveto make decisions about which clinical stage and preclinical drug, biologic and therapeutic candidates to develop and advance, and our partners may nothavethe resources toinvestin all of the drug, biologic or therapeutic candidates that are produced using our platform, or clinical data and other development considerations may not support the advancement of one or more drug candidates developed using our platform. Decision-making about which drug or therapeutic candidates to prioritize involves inherent uncertainty, and our partners’ development program decision-making and resource prioritization decisions, which are outside of our control, may adversely affect the potential value of those partnerships. Additionally, subject to its contractual obligations to us, if one or more of our partners is involved in a business combination, the partner might deemphasize or terminate the development or commercialization of any drug, biologic or therapeutic candidate that utilizes our platform. If one of our SPL customers terminates its agreement with us, we may find it more difficult to attract new partners.
Current wording
In addition, evenif these drug, biologic or therapeutic candidates receive regulatory approval in the United States, our customers maynever obtain approval or commercialize them outside of the United States, which would limit their full market potential and therefore may impact our ability to realize their potential downstream value. Furthermore, approved drugs, biologics or therapeutics may not achieve broad market acceptance among physicians, patients, the medical community and third-party payors, in which case revenue generated from their sales could be limited. Third-party payors may opt to implement efficacy-based payment mechanisms overa multi-year period, which could impact potential product sales in anygiven year. Likewise, our customers haveto make decisions about which clinical stage and preclinical drug, biologic and therapeutic candidates to develop and advance, and our customers may nothavethe resources toinvestin all of the drug, biologic or therapeutic candidates that are produced using our platform, or clinical data and other development considerations may not support the advancement of one or more drug candidates developed using our platform. Decision-making about which drug or therapeutic candidates to prioritize involves inherent uncertainty, and our partners’ development program decision-making and resource prioritization decisions, which are outside of our control, may adversely affect the potential value of those agreements. Additionally, subject to its contractual obligations to us, if one or more of our customers is involved in a business combination, the partner might deemphasize or terminate the development or commercialization of any drug, biologic or therapeutic candidate that utilizes our platform. If one of our SPL customers terminates its agreement with us, we may find it more difficult to attract new partners.
Previous wording
Our partners, and therefore our potential financial outcomes under our agreements, are also subject to inherent industry-wide FDAand other regulatory risk. The number of new drug applications and biologics license applications approved by the FDA varies significantly over time and if there were to be an extended reduction in the number of new drug applications and biologics license applications approvedbythe FDA, the industry could contract and our business could be materially harmed. Furthermore, regulatory agencies may introduce new submission requirements or implement new regulations for cell and gene therapies which could result in extended timelines for our partners, creating uncertainty or delays in achieving milestones. Such delays in these milestones could materially affect our ability to forecast and receive milestone payments outlined in our license agreements.
Current wording
Our customers, and therefore our potential financial outcomes under our agreements, are also subject to inherent industry-wide FDAand other regulatory risk. The number of new drug applications and biologics license applications approved by the FDA varies significantly over time and if there were to be an extended reduction in the number of new drug applications and biologics license applications approvedbythe FDA, the industry could contract and our business could be materially harmed. Furthermore, regulatory agencies may introduce new submission requirements or implement
Previous wording
Our partners’ failure to effectively advance, market and sell suitable drug, biologic and therapeutic candidates developed using our platform could havea material adverse effect on our business, financial condition, results of operations and prospects, and cause the market price of our common stock to decline. In addition to the inherent uncertainty in development addressed above, our ability to forecast our future revenues may be limited.
Current wording
Our customers’ failure to effectively advance, market and sell suitable drug, biologic and therapeutic candidates developed using our platform could havea material adverse effect on our business, financial condition, results of operations and prospects, and cause the market price of our common stock to decline. In addition to the inherent uncertainty in development addressed above, our ability to forecast our future revenues may be limited.
Previous wording
In recent periods, we have depended on a limited number of partners for our revenue, the loss of any of which could have an adverse impact on our business.
Current wording
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.
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capital or operating expenditures, could materially and adversely affect our business, operating results and financial condition.
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Wedo nothaveour own pipeline of therapeutic candidates, and instead we focus oureffortson the development of our cell engineering offerings, including our ExPERT platform. Our customers then use our instruments and PAs for cell engineering to develop their own therapeutic candidates without our direct involvement. As a result, our success depends on our ability to expand the number and scope of our SPL agreements. Many factors may impact the success of these
Current report — wording carried from elsewhere
We offer our cell engineering platform to customers who are engaged in drug, biologics and therapeutics discovery and development. These customers include large pharmaceutical companies, biotechnology companies of all sizes and non-profit and academic institutions. We receive early payments generated through sales of our ExPERT instruments and PAs and recurring revenue through the annual licenses of the ExPERT instrument to our partners, but we estimate that the vast majority of the economic value of the SPL agreements that we enter into with our customers is in the downstream payments that are payable only if certain milestones are met or approved products are sold. As a result, our
Current report — wording carried from elsewhere
new regulations for cell and gene therapies which could result in extended timelines for our customers, creating uncertainty or delays in achieving milestones. Such delays in these milestones could materially affect our ability to forecast and receive milestone payments outlined in our license agreements.
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substantial out-of-pocket costs, any of which could have a material adverse effect on our business, operating results and financial condition.
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quality controls. Wemay not successfully complete any required increase to existing manufacturing capacity in a timely manner, or at all.
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are acceptable to us, or at all, or suppliers may not be able to allocate sufficient capacity in order to meet our increased requirements, all of which could negatively affect our business, financial condition and results of operations. If we are unable to meet customer demand, we could lose our existing customers or lose our ability to acquire new customers, which could also negatively impact our business, financial condition and results of operations.
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We currently sell and license our products primarily in the cell therapy market, which is characterizedby significant enhancements and evolving industry and regulatory standards and a high degree of regulatory scrutiny. As a result, our
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develop and retain talented sales personnel or if new sales personnel are unable to achieve desired productivity levels in a reasonable period of time, we may not be able to realize the expected benefits of this investment or increase ourrevenue.
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operations. Noncompliance with these laws could have negative consequences, including government investigations, penalties, and reputational harm.
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products; expenditure of time and resources to defend any claim or inquiry; adverse publicity; or revision or restructuring of our business model or operations.
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home, while in transit and in public locations. Future or past business transactions (such as acquisitions or integrations) could also expose us to additional cybersecurity risks and vulnerabilities, as our systems could be negatively affected by vulnerabilities present in acquired or integrated entities’ systems and technologies. Furthermore, we may discover security issues that were not found during due diligence of such acquired or integrated entities, and it may be difficult to integrate companies into our information technology environment and security program.
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Competition for skilled personnel in our market is intense and may limit our ability to hire and retain highly qualified personnel on acceptable terms, or at all. Toinduce valuable employees to remain at ourcompany, in addition to
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if at all, thereby causing great harm to our business. Additionally, the determination that a patent application or patent claim meets all of the requirements for patentability is a subjective determination based on the application of law in any given jurisdiction. The ultimate determinationbythe United States Patent and Trademark Office (the “USPTO”), or by a court or other trier of fact in the United States, or corresponding foreign national patent offices or courts, on whether a claim meets all requirements of patentability cannot be assured. Accordingly, we cannot predict the breadth of claims that may be allowed or enforced in our patents or patent applications, in our licensed patents or patent applications or in third-party patents. Moreover, given that patents havea limited term, our patent protection will expire over time.
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Certain customer agreements contain provisions permitting the customer to become apartyto, or a beneficiary of, a technology escrow agreement under which we place proprietary know-how and source code for our products in escrow with a third party. Under these escrow agreements, the know-how and source code to the applicable product may be
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for complying with new or revised accounting standards until those standards would otherwise apply to private companies. As a result, our financial statements may not be comparable to the financial statements of issuers who are required to comply with the effective dates for new or revised accounting standards that are applicable to public companies, which may make our common stock less attractive to investors. In addition, if we cease to be an emerging growth company, we will no longer be able to use the extended transition period for complying with new or revised accounting standards.
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One of the components of our growth strategy is to sell ourrecently launched ExPERTVLx platform for large-scale bioprocessing applications, including viral vector production in suspension cell cultures and rapid production of proteins,
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manufacture and market electroporation and other non-viral cell engineering technology based on efficacy, price, ease of use, reimbursement and customer support services.
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significant amount of resources to our research and development efforts to maintain our competitive position. However, we may not receive significant revenue from these investments for several years, if at all.
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Weengage in conversations with companies regarding potential partnerships on an ongoing basis. These conversations may not result in commercial agreement. Even if agreement is reached, the resulting relationship may not be successful, including due to factors beyond our control, such as our partners’ inability to successfully develop or
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natural disasters, and are often subject to country-specific data privacy and data security risk as well as burdensome legal
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and regulatory requirements. Any of these factors could adversely impact their financial condition and results of
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Werely on a limited number of suppliers for certainkey components utilized in the assembly of our ExPERT instruments and manufacture of our PAsand buffer, and in some cases, such as certain instrument components (e.g., CPU chips or PAelectrodes), we rely on a single supplier for a particular component, subassembly or consumable. Approximately 56% of our inventory purchased during the year ended December 31, 2023 was purchased from one
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If we are unable to manufacture PAs consistently and in sufficient quantities to meet anticipated customer demand, our business, financial condition, results of operations and prospects could be harmed. If we choose to scale the commercial production of our PA and increase our manufacturing capacity, we may encounter quality issues that could
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Our offerings include products such as instruments, single-use disposables and the provision of support services to our customers with the goal of supporting the advancement of our customers’ cell-therapies and/or drug or biologic discovery activities. Weaim to provide our customers with a single, integrated platform to discover, develop and
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Our success depends on our ability to provide reliable, high-quality products that enable high performance cell engineering through flexible, efficient and cost-effective solutions. Our systems are complex in design and involve a highly complex and precise manufacturing process. As a result of the technological complexity of our systems, changes
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Our FDA Master File, and equivalent Master and Technical Files in foreign jurisdictions, are an important part of our strategic offering which allows our partners to expedite their cellular therapies or other biologics into and
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Outside the United States, an increasing number of laws, regulations, and industry standards apply to data privacy and security. For example, the EU General Data Protection Regulation (the “EU GDPR”), the UK GDPR (the “UK GDPR”), and China’s Personal Information Protection Law (“PIPL”) impose strict requirements for processing personal information. Under the EU GDPR and UK GDPR, government regulators may impose temporary or definitive bans on data processing and other corrective actions; fines of up to €20 million (£17.5 million under the UK GDPR) or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher; or private litigation related to the processing of personal information brought by classes of data subjects or consumer protection organizations
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to: government enforcement actions (e.g., investigations, fines, penalties, audits, inspections, and similar); litigation (including class-related claims);additional reporting requirements and/or oversight; temporary or permanent bans on all or some processing of personal information; orders to destroy or not use personal information; and imprisonment of company officials.
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Additionally, in the United States and some foreign jurisdictions there have been, and continue to be, several legislative and regulatory changes and proposed reforms of the healthcare system in aneffortto contain costs, improve qualityand expand access to care, including the proposed modification to some of the aforementioned laws. In the United States, there have been and continue to be a number of healthcare-related legislative initiatives that have
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infrastructure in our supply chain or our third-party partners’ supply chains have not been compromised or that they do not contain exploitable defects or bugs that could result in a breach of or disruption to our information technology systems (including our products) or the third-party information technology systems that support us and our services.
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detect or protect against all cybersecurity threats or incidents. Moreover, our failure to adequately monitor our MSP could result in the failure of all or a portion of our information assets and materially or adversely impact our operations. In addition to the services currently provided, we may utilize the MSP for additional aspects of our cybersecurity risk management in the future.
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In addition, job candidates and existing employees often consider the value of the equity awards they receive in connection with their employment. If the perceived benefits of our stock awards decline, either because we are a public company or for other reasons, it may harm our ability to recruit and retain highly skilled employees. Many of our
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We became a public company in the United States in July 2021. As a U.S. public company, we incur significant legal, accounting, and other expenses, including costs associated with public company reporting requirements.
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into common stock in connection with a financing, acquisition, litigation settlement, employee arrangements or otherwise. Any such future issuance could result in substantial dilution to our existing stockholders and could cause our stock price to decline.
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Wewill remain an emerging growth company until the earliest of: (i) December 31, 2026, which is the last day of the fiscal year following the fifth anniversary of our initial public offering in the United States; (ii) the last day of the