What changed in this filing

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Item 1A. Risk Factors

2026-03-25 compared with 2025-03-11 · 99 added, 108 removed, 959 unchanged (18% of the section changed)

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As of December 31, 2025, we had an accumulated deficit of $261.5 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 we have incurred while building our business infrastructure.

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 we have incurred while building our business infrastructure.

We expect that our expenses and operating losses may continue for the foreseeable future as we expand our research and development efforts, expand the capabilities of our cell engineering platforms and operate as a public company in the United States.

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We may never succeed in any or all of these activities and, even if we do, we may never generate a level of 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 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.

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Our revenue has been primarily generated from the sale and licensing of our instruments, as well as sales of single-use disposable PAs, which require a substantial sales cycle and are prone to quarterly fluctuations in revenue, as well as revenues earned based upon customer clinical development progress events which are outside of our control and highly variable from period to period.

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 .

Our ExPERT technology platform and family of instruments was commercially launched in April 2019 with the latest instrument launched in February 2026.

Sales and licensing of ExPERT technology systems and related instruments together accounted for 48% and 45% of our revenue for the years ended December 31, 2025 and 2024, 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 our revenue.

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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.

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.

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Each of these growth strategies will require considerable time and resources, and we may not be successful in executing any or all of these strategies.

One of the components of our growth strategy is to sell our recently launched ExPERT VLx 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 in part on the availability, compatibility and capability of appropriate technologies upstream and downstream of electroporation to support potential large-scale applications enabled by the 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 acceptance by 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.

Another component of our growth strategy is expanding our SPL model, through which we build collaborative relationships with our customers as we facilitate their efforts to bring critical cell-based medicines to market.

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The variables that go into the calculation of our market opportunity are subject to change over time , and there is no guarantee that any particular number or percentage of customers covered by our market opportunity estimates will purchase our products or generate any particular level of revenue for us at all.

Any expansion in our market depends on a number of factors, including the cost and perceived value associated with our products and those of our competitors.

expansion in our market depends on a number of factors, including the cost and perceived value associated with our products and those of our competitors.

Even if the markets in which we compete meet our size estimates and growth forecasts, our business could fail to grow at projected rates, if at all.

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For example, we believe our products have applications in markets for engineered cell therapies in immuno-oncology and inherited disorders.

We seek 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 our technology.

We seek 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 our technology.

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.

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Similarly, our potential decisions to delay, terminate or collaborate with third parties in respect of certain markets may subsequently also prove to 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.

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.

Our business is dependent on adoption of our products by organizations such as biopharmaceutical companies and academic institutions for their research and development activities focused on cell-based therapeutics.

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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.

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.

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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 approval of, 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.

The National Institutes of Health (“NIH”) may also be significantly impacted by election cycles and legislative developments, and has experienced instability impacting biomedical research, including the termination of certain research grants and workforce reductions.

Any future decrease in the amount of, or delay in the approval of, 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.

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.

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.

Our current research and development efforts may not produce significant revenue for several years, if at all.

Developing our products is expensive, and the investment in product development may involve a 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.

For the 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.

revenue, than we anticipate.

For the years ended December 31, 2025 and 2024, our research and development expenses were $20.8 million and $22.2 million, respectively, or approximately 63% and 58% , of our total revenue, respectively.

O ur 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.

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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.

For the years ended December 31, 2025 and 2024, approximately 36% and 33%, respectively 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.

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These and any additional sanctions and export controls, as well as any counter responses by the governments of Russia or other jurisdictions, could adversely affect, directly or indirectly, the levels of government spending or the global supply chain.

Conflicts between Russia and Ukraine, in the Middle East, or elsewhere may directly or indirectly affect our supply chain, which may lead to negative implications on the availability and prices of raw materials, energy prices, and our customers, as well as the global financial markets.

Conflicts between Russia and Ukraine, the recent Israel-U.S.

military actions in Iran and attacks in nearby Middle Eastern countries, or elsewhere may directly or indirectly affect our supply

chain, which may lead to negative implications on the availability and prices of raw materials, energy prices, and our customers, as well as the global financial markets.

Although we do not currently conduct any operations in Russia, Ukraine or the Middle East, further escalation of geopolitical tensions could have a broader impact that expands into other markets where we do business or conduct operations, which could adversely affect our business and sales of our products.

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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

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 party to 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.

Many factors may impact the success of these 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 party to 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.

We engage in conversations with companies regarding potential SPL agreements on an ongoing basis.

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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

future growth is dependent on the ability of our customers to successfully develop and commercialize therapies discovered or produced using our platform.

As a result, our 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.

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.

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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 approved by the 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 customers, creating uncertainty or delays in achieving milestones.

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 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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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.

For the year ended December 31, 2024, two cell therapy companies with which we have entered into SPL agreements accounted for 32% of our total revenue, and our five largest customers accounted for an aggregate of approximately 46% of our total revenue for the year through a combination of instrument license fees, milestones realized and processing assembly revenue.

For the year ended December 31, 2025, one cell therapy company with which we have entered into an SPL agreement accounted for 26% of our total revenue, and our five largest customers accounted for an aggregate of approximately 42% of our total revenue for the year through a combination of instrument license fees, milestones realized and processing assembly revenue.

These agreements cover a large number of programs under contract, and therefore represent a large portion of potential downstream value.

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As a result, if we fail to maintain our relationships with our SPL customers or if any of these customers discontinue their programs or transition to alternative cell engineering technologies, our future results of operations could be materially and adversely affected.

An increasing portion of our revenue is derived from milestone payments from our SPL customers.

We expect that an increasing portion of our revenue will be derived from milestone payments from our SPL customers.

Accordingly, we may be more dependent on the success of a limited number of our customers’ programs than we would be if our revenue was derived more broadly from many customer contracts.

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We have pursued and may in the future pursue opportunities for collaboration, out-license, joint ventures, acquisitions of products, assets or technology, strategic alliances or partnerships that we believe could advance our development.

For example, we recently acquired SeQure Dx.

For example, in 2025 we acquired SeQure.

We may consider pursuing growth through the acquisition of technology, assets or other businesses that may enable us to enhance our technologies and capabilities.

Proposing, negotiating and implementing these opportunities may be a lengthy and complex process.

negotiating and implementing these opportunities may be a lengthy and complex process.

Other companies, including those with substantially greater financial, marketing, technology or other business resources, may compete with us for these opportunities or arrangements.

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As part of our strategy for growth, we have acquired a company, and in the future, we may acquire other companies, assets, or technologies in an effort to complement our existing offerings to enhance our market position .

For example, we recently acquired SeQure Dx.

For example, in 2025, we acquired SeQure.

Should we choose to pursue additional acquisitions in the future, we may not be able to find suitable acquisition candidates and we may not be able to complete such acquisitions on favorable terms, if at all.

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• Our due diligence process may fail to identify significant existing issues with the target company’s product quality, product architecture, financial disclosures, accounting practices, internal controls, legal contingencies, intellectual property and other matters.

Acquisitions, including the SeQure Dx acquisition, may not generate sufficient revenue to offset the associated costs of the transactions or may result in other adverse effects, which could have a material adverse effect on our business, operating results, and financial condition.

In addition, negotiations for acquisitions, collaborations or investments that are not ultimately consummated could result in significant diversion of management time, as well as

substantial out-of-pocket costs, any of which could have a material adverse effect on our business, operating results and financial condition.

Acquisitions may not generate sufficient revenue to offset the associated costs of the transactions or may result in other adverse effects, which could have a material adverse effect on our business, operating results, and financial condition.

In addition, negotiations for acquisitions, collaborations or investments that are not ultimately consummated could result in significant diversion of management time, as well as substantial out-of-pocket costs, any of which could have a material adverse effect on our business, operating results and financial condition.

Risks Related to the Supply and Manufacturing of Our Products

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Additionally, damage to a manufacturing facility or other property of any of our suppliers or their distribution channels due to fire, flood or other natural disaster or casualty event may have a material adverse effect on our business, financial condition and results of operations.

We have limited experience manufacturing our PAs and may be unable to manufacture our PAs in high-quality commercial quantities successfully and consistently to meet demand, which could limit our growth.

We have limited experience manufacturing our products and only began to manufacture our PAs in-house in 2022.

To manufacture our PAs in the quantities that we believe will be required to meet the currently anticipated market demand, we will need to increase manufacturing capacity, which will involve significant challenges and may require additional

quality controls.

We may not successfully complete any required increase to existing manufacturing capacity in a timely manner, or at all.

Disruptions in global supplies could affect our ability to manufacture our PAs in commercial quantities successfully.

If there is a disruption to our manufacturing operations or inventory management, we may have limited or no other means of producing our products until we resolve such issues with our manufacturing facilities, develop alternative manufacturing facilities or contract with third-party manufacturers capable of producing our products.

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Conversely, if we underestimate customer demand for our products, we may not be able to deliver products in a timely manner or at all, and this could result in reduced revenue and damage to our reputation and customer relationships.

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.

In addition, if we experience a significant increase in demand, we may not have adequate manufacturing capacity to meet such demand, and additional supplies may not be available when required on terms that 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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These customers necessarily are selective with respect to which product candidates they select for development and advance through clinical trials.

Beginning in 2023 and continuing in 2024, we observed customers, particularly early-stage customers, reprioritize their spending and operations to focus on lead product candidates rather than secondary or tertiary programs.

Beginning in 2023 and continuing in 2024 and 2025, we observed customers, particularly early-stage customers, reprioritize their spending and operations to focus on lead product candidates rather than secondary or tertiary programs.

To the extent that our customers limit development and clinical advancement to a smaller group of product candidates, our opportunities to support them with our platform are reduced.

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We currently sell and license our products primarily in the cell therapy market, which is characterized by significant enhancements and evolving industry and regulatory standards and a high degree of regulatory scrutiny.

As a result, our

customers’ needs are rapidly evolving.

As a result, our customers’ needs are rapidly evolving.

If we do not appropriately innovate and offer our customers comprehensive solutions and otherwise invest in new technologies, our offerings may become less desirable in the markets we serve, and our customers could move to new technologies offered by our competitors or make products themselves.

Without the timely introduction of new instruments, single-use PAs, software, services, enhancements and new product integrations with electroporation, our offerings may become less competitive over time, in which case our competitive position and operating results could suffer.

operating results could suffer.

Accordingly, we focus significant efforts and resources on the development and identification of new products and applications to further drive adoption of our platform.

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In addition, if our efforts to expand do not generate a corresponding increase in revenue or result in a decrease in our operating margin, our financial results will be adversely impacted.

If we are unable to hire,

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 our revenue.

Additionally, our highly specialized application scientists and scientific personnel work closely with researchers, clinicians and current and prospective customers to optimize and implement cell engineering methods, processes and applications to meet their specific needs.

If we are unable to hire, 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 our revenue.

applications to meet their specific needs.

Hiring these highly skilled application scientists and scientific personnel is competitive due to the limited number of people available with the necessary scientific and technical backgrounds and ability to understand our products at a technical level, and training such individuals requires significant time, expense and attention.

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In addition, while we believe our FDA Master Files and equivalent Master and Technical Files have the potential to create certain efficiencies and reduce certain regulatory development risks for our customers, there is no guarantee that referencing our FDA Master File or Master and Technical Files, as applicable, will result in success in customers’ submissions seeking authorization for clinical trials or marketing authorization.

We cannot be certain that the FDA or foreign regulators will not require audits of and information on our ExPERT systems used in clinical development as our customers advance their cellular therapies from preclinical through clinical development toward marketing approval.

We cannot be certain that the FDA or foreign regulators will not require audits of and information on our ExPERT systems used in clinical development as our

customers advance their cellular therapies from preclinical through clinical development toward marketing approval.

Such additional information requests and audits of our facilities could result in delays in the development and potential regulatory approval of our partners’ cellular therapy product candidates, affecting timing of milestone payments and our future ability to enter into new SPL agreements.

Failure to adequately respond to any such regulatory requests could result in the regulator preventing our electroporation system from being utilized for a partners’ cellular therapy.

Failure to adequately respond to any such regulatory requests could result in the regulator preventing our electroporation system from being utilized for a partner’s cellular therapy.

This could result in our customers not utilizing our ExPERT system for their other clinical programs and negatively impact our ability to enter into SPL agreements with other cellular therapy developers.

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For example, in recent years, the U.S.

government imposed and proposed, among other actions, new or higher tariffs on specified imported products originating from China in response to what it characterized as unfair trade practices, and China responded by imposing and proposing new or higher tariffs on specified U.S.

There can be no assurance that a broader trade agreement will be successfully negotiated between the United States and China to reduce or eliminate these tariffs.

These tariffs, and the related geopolitical uncertainty between the United States and China, may cause decreased demand for our products or increase cost of components used in our products, which could have a material adverse effect on our business and results of operations.

government imposed and proposed, among other actions, new or higher tariffs on imports originating from China , Canada, Mexico, India, and other countries, and such countries have taken, or have threatened to take, retaliatory actions, including in some cases imposing retaliatory tariffs.

These tariffs, and the related geopolitical uncertainty in U.S.

trade policy may cause decreased demand for our products or increase cost of components used in our products, which could have a material adverse effect on our business and results of operations.

For example, certain of our foreign customers may respond to the imposition of tariffs or threat of tariffs on products we produce by delaying purchase orders or purchasing products from our competitors.

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In addition, tariffs on components that we may import from China or other nations will adversely affect our profitability unless we are able to exclude such components from the tariffs or we raise prices for our products, which may result in our products becoming less attractive relative to products offered by our competitors.

Future actions or escalations by either the United States, China or other nations that affect trade relations may also negatively affect our business, or that of our suppliers or customers, and we cannot provide any assurances as to whether such actions will occur or the form that they may take.

Additionally, the Trump administration has proposed imposing tariffs on a number of countries, including Canada and Mexico, in response to which Canada and Mexico have responded with proposals for retaliatory tariffs.

Future actions or escalations by either the United States or other nations that affect trade relations may also negatively affect our business, or that of our suppliers or customers, and we cannot provide any assurances as to whether such actions will occur or the form that they may take.

We cannot predict what additional changes to trade policy will be made in the future.

As the situation continues to evolve, the Company anticipates that products it may import and products it may export may be adversely affected.

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embargoed or sanctioned countries, governments, persons, and entities.

Obtaining export licenses can be difficult, costly and time-consuming and we may not always be successful in obtaining necessary export licenses, and our failure to obtain required export approval for our products or limitations on our ability to export or sell our products imposed by export control or sanctions laws may harm our revenues and adversely affect our business, financial condition, and results of

Noncompliance with these laws could have negative consequences, including government investigations, penalties, and reputational harm.

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inability to process personal information or to operate in certain jurisdictions;

limited ability to develop or commercialize our

limited ability to develop or commercialize our products;

expenditure of time and resources to defend any claim or inquiry;

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Our customers who use our platform may be subject to broadly applicable healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we research, market, sell, and distribute our products.

Such laws include federal and state anti-kickback laws, false claims laws, transparency laws, and health information privacy and security laws.

Such laws include, but are not limited to, federal and state anti-kickback laws, false claims laws, transparency laws, and health information privacy and security laws.

Violations of such laws may result in substantial criminal, civil, and administrative penalties, including imprisonment, exclusion from participation in federal healthcare programs, such as Medicare and Medicaid, and significant fines, monetary penalties, forfeiture, disgorgement and damages, contractual damages, reputational harm, administrative burdens, diminished profits and future earnings, and the curtailment or restructuring of operations.

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Recently, domestic and international equity and debt markets experienced, and may continue to experience, heightened volatility and turmoil, including, among other things, severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, supply chain shortages, increases in inflation rates, higher interest rates and uncertainty about economic stability.

During 2024, the Federal Reserve lowered interest rates three times, after raising interest rates at a significant pace during 2022 and 2023 in an effort to curb inflation.

During 2025 and 2024, the Federal Reserve lowered interest rates three times each year, after raising interest rates at a significant pace during 2022 and 2023 in an effort to curb inflation.

Although the Federal Reserve may continue to decrease rates in 2026, future decisions to decrease, hold steady, or increase interest rates and the timing of such decisions are unknown.

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For example, the Tax Cuts and Jobs Act of 2017 (“TCJA”) enacted many significant changes to the U.S.

Future guidance from

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.

The Coronavirus Aid,

Relief, and Economic Security Act (the “CARES Act”) modified certain provisions of the TCJA.

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.

On July 4, 2025, President Trump signed into law the legislation known as the One Big Beautiful Bill Act (“OBBBA”).

The OBBBA made significant changes to the U.S.

federal income tax laws in various areas.

Among other changes, the OBBBA permanently extended certain provisions that were enacted in the TCJA, such as the 100% bonus depreciation, and made certain changes to treatment of R&D costs (as further discussed under “Notes to Consolidated Financial Statements – Recent Accounting Pronouncements – Income Taxes”).

Future guidance from the Internal Revenue Service and other tax authorities with respect to newly enacted federal tax legislation may affect us, and certain aspects of current tax law could be repealed or modified in future legislation.

In addition, it is uncertain if and to what extent various states will conform to the newly enacted federal tax legislation.

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.

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 current or future federal tax 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.

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.

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If a pandemic, epidemic, outbreak of an infectious disease, or other public health emergency occurs in the United States or worldwide, our business may be adversely affected, by, among other things, disruptions to the research and development activities of our customers, disruptions to the development of our collaboration partners’ product candidates, disruptions to our ability to enter into new collaborations with potential SPL customers in a timely manner, disruptions in the operations of our third-party manufacturing organizations upon whom we rely for the production and supply of our products, and other disruptions to our operations.

For example, in response to COVID-19 in 2020, we temporarily closed our headquarters and other offices, and our employees and contractors who were able to perform their duties remotely continue to do so.

We also implemented travel restrictions and other significant changes in how we operate our business.

The operations of our customers were likewise altered.

We may also need to implement travel restrictions and other significant changes in how we operate our business.

The operations of our customers may also be likewise altered.

Potential implications of future public health emergencies may include:

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We and the third parties upon which we rely are subject to a variety of evolving threats, including but not limited to, malicious code (such as viruses), personnel misconduct or error, malware (including as a result of advanced persistent threat intrusions), ransomware attacks, denial-of-service attacks (such as credential stuffing), credential harvesting, social-engineering attacks (including through phishing attacks), ransomware attacks, supply-chain attacks, personnel misconduct or error, insider threats, software bugs, server malfunctions, software or hardware failures, loss of data or other information technology assets, adware, telecommunications failures, earthquakes, fires, floods, and other similar threats.

In particular, severe ransomware attacks, including those perpetrated by organized criminal threat actors, nation-states, and nation-state-supported actors, are becoming increasingly prevalent and can lead to significant interruptions in our operations, loss of sensitive information and income, reputational harm, and diversion of funds.

reputational harm, and diversion of funds.

Extortion payments may alleviate the negative impact of a ransomware attack, but we may be unwilling or unable to make such payments due to, for example, applicable laws or regulations prohibiting such payments.

Remote work has become more common and also poses increased risks to our information technology systems and data, as more of our employees utilize network connections, computers and devices outside our premises or network, including working at

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.

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Security incidents and attendant consequences may cause customers to stop using our products, deter new customers from using our products, and negatively impact our ability to grow and operate our business.

In addition, we could be subject to regulatory actions and/or claims made by individuals and groups in private litigation related to data collection and use practices and other data privacy laws and regulations, including claims for misuse or inappropriate disclosure of data as well as unfair or deceptive practices.

In addition, we could be subject to regulatory actions and/or claims made by individuals and groups in private litigation related to

data collection and use practices and other data privacy laws and regulations, including claims for misuse or inappropriate disclosure of data as well as unfair or deceptive practices.

Our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in our contracts are sufficient to protect us from liabilities, damages, or claims related to our data privacy and security obligations.

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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.

To induce valuable employees to remain at our company, in addition to

salary and cash incentives, we have issued, and will in the future issue, equity awards that vest over time.

To induce valuable employees to remain at our company, in addition to salary and cash incentives, we have issued, and will in the future issue, equity awards that vest over time.

The value to employees of equity awards that vest over time may be significantly affected by movements in our stock price that are beyond our control and may at any time be insufficient to counteract more lucrative offers from other companies.

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If we fail to attract new personnel or fail to retain and motivate our current personnel, it will negatively affect our business, financial condition and results of operations.

We have increased the size of our organization and expect to further increase it in the future, and we may experience difficulties in managing our growth.

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.

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• improving our operational, financial and management controls, reporting systems and procedures.

We have experienced significant growth in recent years and anticipate further growth in our business operations both inside and outside the United States.

We anticipate further growth in our business operations both inside and outside the United States.

This future growth could strain our organizational, administrative and operational infrastructure, including quality control, operational, finance, customer service and sales organization management.

We expect to continue to increase our headcount and to hire more specialized personnel in the future as we grow our business.

We will need to continue to hire, train and manage additional qualified scientists, engineers, technical personnel, sales and marketing staff, and improve and maintain our products to properly manage our growth.

We expect to increase our headcount and to hire more specialized personnel in the future as we grow our business.

We will need to hire, train and manage additional qualified scientists, engineers, technical personnel, sales and marketing staff, and improve and maintain our products to properly manage our growth.

Rapid expansion in personnel could mean that less experienced people develop, market and sell our products, which could result in inefficiencies and unanticipated costs, reduced quality and disruptions to our operations.

If our new hires perform poorly, if we are unsuccessful in hiring, training, managing and integrating these new employees or if we are not successful in retaining our employees, our business may be harmed.

We may not be able to maintain the quality or

expected turnaround times of our products or satisfy customer demand as it grows.

We may not be able

to maintain the quality or expected turnaround times of our products or satisfy customer demand as it grows.

Our ability to manage our growth properly will require us to continue to improve our operational, financial and management controls as well as our reporting systems and procedures.

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General Risk Factors Associated with an Investment in Our Common Stock

Our common stock is traded on two separate stock markets and investors seeking to take advantage of price differences between such markets may create unexpected volatility in our share price;

in addition, investors may not be able to easily move shares for trading between such markets.

Our shares of common stock are traded on both AIM, a market operated by the London Stock Exchange plc (the “London Stock Exchange”), and the Nasdaq Global Select Market.

Price levels for our common stock may fluctuate significantly on either market, independent of our common stock price on the other market.

Investors could seek to sell or buy our common stock to take advantage of any price differences between the two markets through a practice referred to as arbitrage.

Any arbitrage activity could create unexpected volatility in both our common stock prices on either market and the volumes of shares of our common stock available for trading on either market.

In addition, holders of common stock on either market will not be immediately able to transfer such common stock for trading on the other market without effecting necessary procedures with our transfer agent.

This could result in time delays and additional costs for our stockholders.

Further, if we are unable to continue to meet the regulatory requirements for admission to AIM or listing on the Nasdaq Global Select Market, we may lose our admission to AIM or listing on the Nasdaq Global Select Market, which could impair the liquidity of shares of our common stock.

Investors whose source of funds for the purchase of shares of our common stock is denominated in a currency other than U.S.

Dollars may also be adversely affected by fluctuations in the exchange rate between such currency and the U.S.

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.

Our common stock is listed on The Nasdaq Global Select Market, which imposes continued listing requirements with respect to listed securities, including a minimum bid price requirement.

On March 16, 2026, we received notice from the Listing Qualifications staff of The Nasdaq Stock Market LLC (“Nasdaq”) that, because the closing bid price for our common stock had fallen below $1.00 per share for 30 consecutive trading days, we no longer complied with the minimum bid price requirement for continued listing on the Nasdaq Global Select Market under Nasdaq Listing Rule 5450(a)(1).

The Notice has no immediate effect on the listing of the Company’s common stock on the Nasdaq Global Select Market, and the Company’s common stock will continue to trade on the Nasdaq Global Select Market.

Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided an initial compliance period of 180 calendar days, or until September 14, 2026, to regain compliance with the minimum bid price requirement.

To regain compliance, the closing bid price of the Company’s common stock must meet or exceed $1.00 per share for a minimum of ten consecutive trading days prior to September 14, 2026.

If the Company does not regain compliance by September 14, 2026, the Company may be eligible for an additional 180 calendar day compliance period if it applies to transfer the listing of its common stock from the Nasdaq Global Select Market to the Nasdaq Capital Market.

To qualify, the Company would be required to meet the continued listing requirement for the market value of its publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the minimum bid price requirement, and provide written notice of its intention to cure the minimum bid price deficiency during the second compliance period.

As part of its review process, Nasdaq will make a determination as to whether it believes the Company will be able to cure this deficiency.

If Nasdaq staff determines that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible for such additional compliance period, Nasdaq will provide notice that the Company’s common stock will be subject to delisting.

Upon receipt of such notice, the Company would have the right to appeal any determination to delist its common stock, and the common stock would remain listed on the Nasdaq Global Select Market until completion of the appeal process.

We may not be able to maintain compliance with the minimum bid price requirement or other applicable Nasdaq listing rules.

If Nasdaq delists our common stock, it is unlikely that we will be able to list our common stock on another national securities exchange and, as a result, we expect our securities would be quoted on an over-the-counter market.

If this were to occur, we and our stockholders could face significant adverse consequences, including limited availability of market quotations and analyst coverage for our common stock, and reduced liquidity for trading of our securities, all of which would likely reduce the market price of our common stock.

In addition, our common stock could be considered a “penny stock,” which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in reduced trading activity in the secondary trading market for our common stock.

Delisting could result in additional adverse consequences including reduced ability to issue additional securities or obtain additional financing on terms acceptable to us, or at all, as well as the potential loss of confidence of our customers, suppliers and employees, any of which could harm our business and future prospects.

The price of our common stock is likely to be volatile and may fluctuate due to factors beyond our control.

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The expenses incurred by public companies generally for reporting and corporate governance purposes have been increasing.

We expect these rules and regulations to increase our legal and financial compliance costs and to make some activities more time-consuming and costly and divert management’s time and attention from revenue-generating activities to compliance activities.

It could also make it more difficult or costly for us to obtain certain types of insurance, including director and officer liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage.

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Accordingly, investors cannot rely on dividend income from our common stock and any returns on an investment in our common stock will likely depend entirely upon any future appreciation in the price of our common stock.

Provisions in our governing documents will require disclosure of information about stockholders that would not otherwise be required to be disclosed under applicable U.S.

state or federal laws.

In accordance with the AIM Rules for Companies published by the London Stock Exchange (the “AIM Rules”), we are required to disclose information regarding the legal and beneficial owners, whether directly or indirectly, of three percent or more of our outstanding common stock.

In order to allow us to comply with the AIM Rules, our certificate of incorporation contains a provision requiring any legal or beneficial owner of three percent or more of the voting power attributable to our outstanding common stock to notify us of his, her or its holdings, as well as of any change in his, her or its legal or beneficial ownership above three percent of our outstanding common stock, which increases or decreases his, her or its holding through any single percentage.

Comparatively, none of the U.S.

state or federal laws, or the rules of the SEC or the Nasdaq Global Select Market require stockholders to report this beneficial ownership information to us or us to disclose this information to the public or a regulatory body.

We are required to make this information public in the United Kingdom under the AIM Rules, thereby revealing certain stockholders’ holdings in our Company.

In addition, we do not control the identity of our stockholders and the market price of our shares of common stock could possibly be impacted by the disclosure of the identity of certain stockholders that legally or beneficially own three percent or more of our outstanding common stock.

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.

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies,” including the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, or Section 404, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

Pursuant to Section 107 of the JOBS Act, as an emerging growth company, we have elected to use the extended transition period

for complying with new or revised accounting standards until those standards would otherwise apply to private companies.

periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

Pursuant to Section 107 of the JOBS Act, as an emerging growth company, we have elected to use the extended transition period 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.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors