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Item 1. Business

2023-03-15 compared with 2022-03-22 · 151 added, 165 removed, 236 unchanged (57% of the section changed)

We are a leading commercial cell engineering company focused on providing enabling platform technologies to advance innovative cell-based research and development as well as next-generation cell therapeutic discovery, development and commercialization.

Over the past twenty years, we have developed and commercialized our proprietary Flow Electroporation platform, which facilitates complex engineering of a wide variety of cells.

We are a leading commercial cell engineering company focused on providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics and to support innovative cell-based research and development.

Over more than two decades, we have developed and commercialized our proprietary Flow Electroporation ® platform, which facilitates complex engineering of a wide variety of cells.

Electroporation is a method of transfection, or the process of deliberately introducing molecules into cells, that involves applying an electric field in order to temporarily increase the permeability of the cell membrane.

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Cell therapy has emerged as one of the fastest growing and most promising treatment modalities to address a host of human diseases.

Over the past few years, the success of multiple U.S.

Food and Drug Administration, or FDA, approved cell therapies providing long-lasting amelioration of symptoms or presence of disease has catalyzed tremendous investment—leading to exponential growth in cell-based therapies being evaluated for therapeutic applications.

The Alliance for Regenerative Medicine, or ARM, an international advocacy organization, estimated in August 2021 that the regenerative medicine sector, which consists of gene, cell, and tissue-based therapeutic developers raised an aggregate of $14.1 billion in the first half of 2021, which represents the strongest first half on record and is on pace to exceed the $19.9 billion raised in 2020.

As of August 2021, ARM estimates that there were more than 2,600 ongoing clinical trials focused on regenerative and advanced medicine, which includes gene therapy, cell-based immuno-oncology, cell therapy and tissue engineering, including 1,320 industry-sponsored trials by 1,200 companies and 965 unique therapies in development, and forecasts that this number will grow to 3,100 by 2026 with 355 programs expected to be in Phase 3 development.

Our ExPERT platform, which is based on our proprietary Flow Electroporation technology, has been designed to address this rapidly expanding cell therapy market and can be utilized across the continuum of the high-growth cell therapy sector, from discovery and development through commercialization of next-generation, cell-based medicines.

The ExPERT family of products includes three instruments, which we call the ATx, STx and GTx, respectively, as well as a portfolio of proprietary related disposables and consumables (as well as the VLx instrument for very large-scale cell engineering made available for sale in December 2021).

These include processing assemblies, or PAs, designed for use with our instruments, as well as accessories supporting PAs such as electroporation buffer solution and software protocols.

The recent success of multiple U.S.

Food and Drug Administration (the “ FDA”) approved cell therapies providing long-lasting amelioration of symptoms or presence of disease has catalyzed tremendous investment—leading to exponential growth in cell-based therapies being evaluated for therapeutic applications.

The Alliance for Regenerative Medicine (“ARM”), an international advocacy organization, estimates that the regenerative medicine sector, which consists of gene, cell, and tissue-based therapeutic developers raised an aggregate of $12.6 billion in 2022 and that, as of January 2023, there were more than 2,220 active clinical trials focused on regenerative and advanced medicine, which includes gene therapy, cell-based immuno-oncology, cell therapy and tissue engineering.

Our ExPERT platform, which is based on our Flow Electroporation technology, has been designed to address this rapidly expanding cell therapy market and can be utilized across the continuum of the high-growth cell therapy sector, from discovery and development through commercialization of next-generation, cell-based medicines.

The ExPERT family of products includes four instruments, which we call the ATx™, STx™, GTx™ and VLx™, as well as a portfolio of proprietary related disposables and consumables.

We launched the ExPERT VLx™ instrument for very large-scale cell engineering in September 2022.

Our disposables and consumables include PAs designed for use with our instruments, as well as accessories supporting PAs such as electroporation buffer solution and software protocols.

We have garnered meaningful expertise in cell engineering via our internal research and development efforts as well as our customer-focused commercial approach, which includes a growing application scientist team.

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From leading commercial cell therapy drug developers and top biopharmaceutical companies to top academic and government research institutions, including the U.S.

National Institutes of Health, or NIH, our customers have extensively validated our technology.

National Institutes of Health (“NIH”), our customers have extensively validated our technology.

We believe the features and performance of our platform have led to sustained customer engagement.

Our existing customer base ranges from large biopharmaceutical companies, including all of the top 10, and

20 of the top 25, pharmaceutical companies based on 2021 global revenue, to hundreds of biotechnology companies and academic centers focused on translational research.

Our existing customer base ranges from large biopharmaceutical companies, including all of the top 10, and 20 of the top 25, pharmaceutical companies based on 2021 global revenue, to hundreds of biotechnology companies and academic centers focused on translational research.

Our Competitive Strengths

We believe our industry leadership position and continued growth will be driven by the following competitive strengths:

• Our proprietary technology platform unlocks the significant potential of advanced cell-based therapeutics .

We have built our ExPERT platform to advance the growing demands for non-viral delivery and next-generation cell and gene engineering approaches.

Our platform technology enables delivery of almost any molecule into almost any cell type.

We believe our platform leads the industry in performance (measured by consistency, efficiency, viability, flexibility and scale).

Our platform is further supported by a robust intellectual property portfolio.

• Proprietary technology platform that unlocks the significant potential of cell-based therapeutics .

We built our ExPERT platform to advance the growing demands for non-viral delivery and next-generation cell and gene engineering approaches.

Our ExPERT platform enables delivery of almost any molecule into almost any cell type.

We believe our ExPERT platform leads the industry in performance, as measured by consistency, efficiency, viability, flexibility and scale.

Our ExPERT platform is further supported by a robust intellectual property portfolio.

• Comprehensive, high-performance transfection platform .

We believe our ExPERT platform offers a unique value proposition given the flexibility to scale up from research to cGMP manufacturing on a single platform— enabling the engineering of cells ranging from tens of thousands of cells to tens of billions of cells in a single transfection run in 30 minutes or less.

We believe our ExPERT platform offers a unique value proposition given the flexibility to scale up from research to current good manufacturing practices (“cGMP”) manufacturing on a single platform— enabling the engineering of cells ranging from tens of thousands of cells to more than tens of billions of cells in a single transfection run taking 30 minutes or less.

Our long-term internal engineering expertise is supplemented by our customer focused approach—with a growing application scientist team working with our customers across increasingly diverse applications.

• Positioned as a leader in the large and growing next-generation cell therapy market with the ability to capitalize on rising demand for non-viral approaches.

We believe we are well positioned to capture increased market share within the large and growing next-generation cell therapy market.

• Recognition as a leader in the large and growing next-generation cell therapy market with the ability to capitalize on rising demand for non-viral approaches.

We believe we are well positioned to increase our market share within the large and growing next-generation cell therapy market.

Since the FDA approved the first engineered CAR-T cell therapies to treat blood-based cancers in 2017, the number of cell therapy candidates being evaluated pre-clinically and clinically has grown exponentially.

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• Innovative partnership business model focused on value creation and shared success .

Our SPLs allow us to participate in the value creation of our customers’ programs via pre-commercial milestones and in nearly all cases commercial sales-based payments.

We intend to continue to build a portfolio of strategic partnerships with cell therapy developers, which provide us with a growing, diversified source of potential downstream revenue.

Our SPL partnerships allow us to participate in the value creation of our customers’ programs via precommercial milestones and in nearly all cases commercial sales-based payments.

We intend to continue to build a portfolio of strategic partnerships with cell therapy developers, which provide us with a growing, diversified source of annual licenses and potential downstream revenue.

In addition to the high performance and flexibility of the ExPERT platform, we believe our partnership model further reduces clinical risk and development timelines for our cell therapy partners.

By entering into an SPL with us, for example, our partners gain access to our FDA Master File to support their IND-enabling studies and potentially shorten clinical development.

By entering into SPL partnerships with us, for example, our partners gain access to our FDA Master File to support their IND-enabling studies and potentially shorten clinical development.

Our FDA Master File, which is a submission to the FDA with confidential detailed information about our products, methods, processes and data, was originally established in 2002 and has been continuously updated as platform improvements are implemented to support different applications and cell types.

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annual instrument license fees from cell therapy customers;

potential pre-commercial milestones under SPLs;

and potential commercial sales-based payments under SPLs.

We generate high recurring revenue from our ExPERT instrumentation licenses, as well as disposables and consumables (or buffer) sales, which provides visibility into future near-term revenue.

Over the last three years, annual renewals of instrument licenses were greater than 80% on average—and for our SPLs were near 100%.

In addition to recurring revenue, we have the potential to receive meaningful pre-commercial and commercial payments under SPLs if our customers are successful in advancing programs through the clinic and into the commercial stage.

In aggregate, we have the potential to receive over $1.25 billion in pre-commercial milestone payments under our current SPLs, if all of the programs were to receive regulatory approvals.

• Founder-led leadership team and workforce with deep domain knowledge.

potential precommercial milestones under SPL partnerships;

and potential commercial sales-based payments under SPL partnerships.

We generate recurring revenue from our ExPERT instrumentation licenses, as well as disposables and consumables (or buffer) sales, which provides high visibility into future near-term revenue.

In addition to recurring revenue, we have the potential to receive meaningful precommercial and commercial payments under SPL partnerships as our customers achieve success in advancing programs through the clinic and into the commercial stage.

In aggregate, given our SPLs entered into to-date, we have the potential to receive over $1.55 billion in precommercial milestone payments, if all of the programs were to be granted regulatory approvals.

• Leadership team and workforce with deep domain knowledge.

Our management team combines strong and broad subject matter expertise with a demonstrated history of commercial and operational execution.

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The foundation of our technology is our proprietary and patented Flow Electroporation platform, which we have developed and optimized for more than 20 years.

Electroporation, or electro-permeabilization, leverages the fundamental properties of cell membranes, the ability to create reversible permeability in the presence of an electric charge, as a universal method to introduce foreign molecules, or transfect, eukaryotic cells, which are cells with a cell membrane and neucleus.

Electroporation can be applied to almost any eukaryotic cell type to deliver a broad range of molecules, including DNA, mRNA, siRNA and proteins.

Electroporation can be applied to almost any eukaryotic cell type to deliver a broad range of molecules, including DNA, human messenger RNA (“mRNA”), siRNA and proteins.

Our proprietary Flow Electroporation platform is fully scalable and can support small-scale research and development through large-scale cell engineering for development of commercial therapeutics.

Our technology platform is marketed under the ExPERT brand.

Our technology platform is marketed under the ExPERT brand, the elements of which are depicted in the graphic above.

The value of our ExPERT brand starts with Efficiency—with high delivery Efficiency , users can achieve Potency , with high Potency, users improve their chances of therapeutic Efficacy , and if this can be repeated, Reproducibly from patient to patient, users have a successful Therapy .

By delivering high efficiency at any scale, the ExPERT platform is designed to improve our customer’s ability to achieve the required therapeutic index, enabling accelerated, cost-efficient translation of complex cellular therapies from research to the clinic.

Our ExPERT platform consists of three instruments, the ATx, STx and GTx, which use a broad range of PAs, or disposables, of different volumes to enable scalable electroporation from tens of thousands to billions of cells to

facilitate the translation of complex cellular therapies from concept to the clinic, in support of the intended therapeutic commercialization.

Our ExPERT platform consists of four instruments, the ATx, STx, GTx and VLx, which use a broad range of PAs, or disposables, of different volumes to enable scalable electroporation from tens of thousands to billions of cells to facilitate the translation of complex cellular therapies from concept to the clinic, in support of the intended therapeutic

commercialization.

Our family of instruments and disposables have been designed to support scale-up for cell therapy development, as shown in the picture below.

Concept DoE Optimization Verification

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Disposables (referred to as processing assemblies) facilitate scale up on same GMP platform

Our ExPERT family of instruments and disposables support scale-up for cell therapy

Overview of our ExPERT Platform

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(i) the ability to use our technology to deliver almost any molecule into almost any cell type, including hard-to-transfect human primary cells, while maintaining high cell viability and function;

(ii) the capacity to introduce larger and more diverse and multiple payloads compared to other intracellular delivery technologies, such as viral vectors;

and (iii) the flexibility to scale up from research to current good manufacturing practices, or cGMP, manufacturing on a single platform—enabling the engineering of cells ranging from tens of thousands of cells to tens of billions of cells in a single transfection run in 30 minutes or less.

(ii) the capacity to introduce larger and more diverse molecules, as well as multiple payloads, which exceeds the capabilities of other intracellular delivery technologies, such as viral vectors;

and (iii) the flexibility to scale up from research to cGMP, manufacturing on a single platform—enabling the engineering of cells ranging from tens of thousands of cells to tens of billions of cells in a single transfection run in 30 minutes or less.

We believe our ExPERT intracellular delivery platform provides value across numerous applications in the life sciences market, including research, discovery, development, and manufacturing of next-generation, cell-based

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Our ExPERT technology platform is being used in the clinic to support the development of next-generation cell therapy approaches to treat human disease.

Following the successful clinical development leading to FDA approvals of CAR-T cell therapies in blood-based cancers, developers have focused on improving efficacy, lowering the cost of manufacturing and/or expanding engineered cell therapies into new indications, such as solid tumors.

To address these goals, the ex vivo cell therapy industry has trended towards developing more complex therapies that require sophisticated engineering and gene manipulation as well as the use of different starting cell types.

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Our Industry Background

As the cell therapy market continues to evolve, more complex approaches are being deployed to improve efficacy, reduce time to patient and expand the application of cell therapy to additional indications.

As the cell therapy market continues to evolve, more complex approaches are being deployed to improve efficacy, reduce time to treat patients and expand the application of cell therapy to additional indications.

The use of viral vectors carries several challenges, however, especially given the increase in complexity of these “next-generation” ex vivo cell therapy approaches, such as:

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Many methods of gene manipulation require insertion of relatively large molecules, including proteins such as CAS9 RNP for CRISPR or plasmids.

Viral vectors, particularly AAV, have fundamental payload capacity limitations, curtailing their utility for complex engineering systems.

Additionally, the industry has continued to shift to using complexed molecules including combination of proteins and mRNA which cannot be delivered by viral means.

Viral vectors, particularly Adeno-Associated Virus (“AAV”), have fundamental payload capacity limitations, curtailing their utility for complex engineering systems.

Additionally, the industry has continued to shift to using complex molecules including combination of proteins and mRNA which cannot be delivered by viral means.

• Concerns around toxicity.

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Additional bottlenecks arise from demand for viral approaches, which has led to subsequent demand for cGMP plasmids.

The ongoing COVID-19 pandemic has further exacerbated demand, particularly for adenovirus, and suspension cells, which are difficult to engineer at high volume.

Concurrently, regulatory scrutiny and product characterization requirements are increasing as more gene and cell therapy products reach the clinic, as noted by the FDA’s revised guidelines for viral vector analytics in early 2020.

Furthermore, vein-to-vein manufacturing times remain high and efficiencies are needed to deliver cell therapeutic medicines to patients faster.

Novel intracellular delivery approaches are needed to support the increased complexity of the burgeoning cell therapy pipeline.

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While difficult to predict given uncertainty around regulatory approvals and clinical risk, according to Evaluate Pharma, a provider of commercial intelligence and predictive analytics to the pharmaceutical industry, the first next-generation ex vivo cell therapies using non-viral approaches could be approved in the United States as early as 2023.

Our platform’s ability to engineer a diversity of cell types (including CAR-T, chimeric antigen receptor Natural Killer cells, or CAR-NK/NK, T cell receptor, or TCR, and stem cells) and cell sources (autologous and allogeneic) enhances our opportunity by potentially providing for SPL revenues regardless of which approaches advance in the coming years.

Additionally, our instruments and platform are well validated, having been used in over 40 clinical trials to date and having been involved in the development of drugs to treat a variety of indications spanning from hematological malignancies to solid tumors to inherited genetic disorders.

Our platform’s ability to engineer a diversity of cell types (including CAR-T, chimeric antigen receptor Natural Killer cells (“CAR-NK/NK”), T cell receptor (“TCR”) and stem cells) and cell sources (autologous and allogeneic) enhances our opportunity by potentially providing SPL partnership revenues regardless of which approaches advance in the coming years.

Additionally, our instruments and platform have been used in over 40 clinical trials to date for drugs being developed to treat a variety of indications, from hematological malignancies to solid tumors to inherited genetic disorders.

We believe that the increasing number of publications highlighting the performance of our platform compared to other electroporation, transfection and transduction approaches will continue to drive acceptance of our products in the cellular engineering market segments.

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Research Licenses

Research licenses are agreements we have entered into with customers (which could be academic institutions or commercial entities), which provide access to the use of our instruments for pre-clinical research-only purposes, without the rights or ability to produce material for use in the clinic.

Research licenses are agreements we have entered into with customers (which could be academic institutions or commercial entities), which provide access to the use of our instruments for preclinical research-only purposes, without the rights or ability to produce material for use in the clinic.

Research licenses provide the customer with the ability to use the platform for research in exchange for a non-refundable, annual lease payment of typically $150,000 per instrument per year, or in certain circumstances under a sale of an instrument to a cell therapy user.

We have entered into many research licenses to-date, either as (i) stand-alone research license agreements, (ii) research and clinical license agreements that do not have associated commercial rights or (iii) under an SPL, which allows a customer to use the instrument for clinical development and potential commercial sale of a therapeutic product.

Research licenses under a stand-alone research license agreement (as well as instruments purchased for research use) could represent opportunities for future SPLs.

We have entered into many research licenses to-date, either as (i) stand-alone research license agreements, (ii) research and clinical license agreements that do not have associated commercial rights or (iii) under an SPL partnership, which allows a customer to use the instrument for clinical development and potential commercial sale of a therapeutic product.

Research licenses under a stand-alone research license agreement (as well as instruments purchased for research use) could represent opportunities for future SPL partnerships.

Clinical Licenses

Clinical licenses are agreements with academic institutions or commercial entities that provide access to the use of our instruments in the clinical evaluation and development of a therapeutic product intended for human use.

In a clinical license, we retain title to the instrument and provide the customer with the ability to use the platform for production of clinical material for human clinical use, as well as access to our application scientist team, all in exchange for an annual lease payment that typically approximates $250,000 per instrument per year for commercial customers.

Academic clinical licenses can represent opportunities for future SPLs to the extent that commercial entities seek and obtain rights to such programs from the academic institution.

Clinical licenses are agreements with academic institutions or commercial entities that provide access to the use of our instruments for the clinical evaluation and development of a therapeutic product intended for human use.

In a clinical license, we retain title to the instrument and provide the customer with the ability to reference our FDA Master File (and international equivalents), use the platform for production of clinical material for human clinical use, as well as access to our application scientist team, all in exchange for an annual lease payment that typically approximates $250,000 per instrument per year for commercial customers.

Academic clinical licenses can represent opportunities for future SPL partnerships to the extent that commercial entities seek and obtain rights to such programs from the academic institution.

Strategic Platform Licenses (SPLs)

Given our value proposition in non-viral delivery, we have established strategic relationships in the form of SPLs with a growing number of leading cell therapy developers as they work to bring next-generation cell therapies into and through the clinic and advance those candidates to potential commercialization.

Under these SPLs and other license agreements with our customers, we retain title to the licensed instrument and associated intellectual property, and in exchange for an annual license fee per instrument, we provide our customers with non-exclusive access, for a defined field of use to our:

Given our value proposition in non-viral delivery, we have established strategic relationships in the form of SPL partnerships with a growing number of leading cell therapy developers as they work to bring next-generation cell therapies into and through the clinic and advance those candidates to potential commercialization.

Under these SPL partnerships and other license agreements with our customers, we retain title to the licensed instrument and associated intellectual property, and in exchange for an annual license fee per instrument, we provide our customers with non-exclusive access, for a defined field of use to our:

• cGMP-compatible platform, which enables early-optimization and scale-up from pre-clinical research into clinical development using our intellectual property portfolio;

• FDA Master File and Technical Files, which may accelerate and streamline development and reduce regulatory risk in the creation and development of our partners’ therapeutic drug candidates;

• Experienced commercial team of sales personnel and application scientists who work directly with our customers to solve cell engineering problems;

• experienced team of sales personnel and application scientists who work directly with our customers to solve cell engineering problems;

• continuous know-how and cell engineering process improvements.

In return, these SPLs provide us with the ability to secure downstream program-related pre-commercial milestones and, in most cases, commercial sales-based payments.

In addition, from our SPL customers, we receive both annual research and clinical license fees as well as payments from sales of our proprietary disposables as recurring revenue streams.

Given growth in the cell therapy pipeline and increased investment in the space, we estimate that the number of potential SPLs for us will continue to grow significantly, based on our estimates of growth in the cell therapy pipeline, growth in the number of therapeutic delivery entrants into the market and ongoing shift to non-viral delivery.

Our customer relationships may evolve to an SPL after the customer’s drug candidate optimization and verification process nears completion and the clinical process development stage begins.

Specifically, if a customer wishes to use our products in the clinical phase of process development, they will need to enter into an SPL, as a customer must obtain clinical rights to perform clinical process development, including for engineering runs.

Customer discussion for an SPL can take place any time during our engagement.

Our SPL customers typically pay an annual license fee per instrument per year for a research license (for pre-clinical use) or per instrument per year for a clinical license (for clinical or commercial use) or in certain circumstances purchase an instrument for research use.

In return, these SPL partnerships provide us with the ability to receive downstream program-related precommercial milestone payments and, in most cases, commercial sales-based payments.

In addition, from our SPL partnership customers, we receive both annual research and clinical license fees as well as payments from sales of our proprietary disposables as recurring revenue streams.

Given growth in the cell therapy pipeline and increased investment in the space, we estimate that the number of potential SPL partnerships for us will continue to grow significantly, based on our estimates of growth in the cell therapy pipeline, growth in the number of therapeutic delivery entrants into the market and ongoing shift in the industry to non-viral delivery.

Our customer relationships may evolve to an SPL partnership after the customer’s drug candidate optimization and verification process nears completion and the clinical process development stage begins.

Specifically, if a customer wishes to use our products in the clinical phase of process development, they will need to enter into an SPL partnership, as a customer must obtain clinical rights to perform clinical process development, including for engineering runs.

Customer discussion for an SPL partnership can take place any time during our engagement.

Our SPL customers typically pay an annual license fee per instrument per year for a research license (for preclinical use) or per instrument per year for a clinical license (for clinical or commercial use) or in certain circumstances may purchase an instrument for research use.

Partners also purchase associated single-use disposables and consumables as needed.

Our SPL partners also commit to pay pre-commercial milestone payments for each therapeutic licensed under the agreement and produced using our platform, as they achieve key pre-commercial clinical development events (including for example, IND filing, dosing of an agreed number of patients in a Phase 1 clinical trial, initiating a pivotal clinical trial, and BLA approvals in specified regions).

Almost all of our SPLs also include a commitment to pay us post-approval sales-based payments for commercialized therapeutics.

We view our ability to sign SPLs as a key measure of our success in partnering with leading therapeutic developers in the clinic and supports the high performance of our platform.

The following graphic is an example of typical single-product revenues from a representative SPL:

Our SPLs and research and clinical licenses may be terminated at the option of our customers at any time.

Our SPL partners also commit to pay precommercial milestone payments for each therapeutic licensed under the agreement and produced using our platform, as they achieve key precommercial clinical development events (including, for example, IND filing, dosing of an agreed number of patients in a Phase 1 clinical trial, initiating a pivotal clinical trial, and Biologics License applications (“BLA”) approvals in specified regions).

Almost all of our SPL partnerships also include a commitment to pay us post-approval sales-based payments for commercialized therapeutics.

We view our ability to sign SPL partnerships as a key measure of our success in partnering with leading therapeutic developers in the clinic, which then supports the performance of our platform.

The following graphic is an example of typical single-product revenues from a representative SPL partnership:

Our SPL partnerships and research and clinical licenses may be terminated at the option of our customers at any time.

Annual instrument lease fees are non-refundable and customers may not use our instruments or process assemblies after terminating their agreement with us.

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Upon contract termination, our customers would be responsible for any further clinical studies or data development that regulators may require to allow a change in their cell engineering methodology.

To date, none of our SPL licensees has ever terminated their contract with us.

We have entered into 16 SPLs with commercial cell therapy developers since January 1, 2017, all of which remain active as of the date of this report.

Of the over 95 potential program allowed under our current SPLs, more than 15% are in the clinic, meaning they have at least an FDA-cleared investigational new drug application, or IND.

An IND is a request for authorization from the FDA to administer an investigational new drug to humans.

We have entered into 19 SPL partnerships with commercial cell therapy developers and, to date, none of our SPL partnership licensees has ever terminated their contract with us.

Of the over 125 potential programs allowed under our current SPL partnerships, 16 are active in the clinic, meaning they have at least an FDA-cleared investigational new drug application (“IND”).

An IND is a request for authorization from the FDA to administer a therapeutic being investigated in humans in a clinical research setting.

An IND must become effective before human clinical trials may begin.

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Clinical trials then involve the administration of the investigational product to human subjects under the supervision of qualified investigators and are conducted under protocols detailing, among other things, the objectives of the study, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated.

Our 16 SPLs have the potential to generate over $1.25 billion in pre-commercial milestone payments if all of the licensed programs were to achieve regulatory approvals.

In addition, under the SPLs, we typically have the potential to receive significant, sales-based commercial payments for approved products.

However, clinical development involves a lengthy and expensive process with uncertain outcomes, including the results of pre-clinical research, as well as product

safety and efficacy, and therefore our customers may not begin or complete clinical development, or may never receive FDA or other regulatory approval for, all product candidates covered by their SPL agreements with us, in which case we will not receive the full potential pre-commercial milestone payments or the sales-based commercial payments or royalties contemplated by our agreements.

Our 19 SPL partnerships have the potential to generate over $1.55 billion in precommercial milestone payments if all of the licensed programs were to achieve regulatory approvals.

In addition, under the SPL partnerships, we typically have the potential to receive significant, sales-based commercial payments for approved products.

However, clinical development involves a lengthy and expensive process with uncertain outcomes, including the results of pre-clinical research, as well as clinical trials demonstrating product safety and efficacy, and therefore our customers may not begin or complete clinical development, or may never receive FDA or other regulatory approval for all or any product candidates covered by their SPL partnership agreements with us, in which case we will not receive the full potential precommercial milestone payments or the sales-based commercial payments or royalties contemplated by our SPL agreements.

ExPERT Instruments

The ExPERT instrument family was designed to provide a single unifying technology that can be used from concept to clinic, with both the research and clinical versions of the instrument incorporating the same underlying technology and protocols.

Our customers have a choice of three different instrument versions that are standardized on the same technology to deliver the same high performance—the ATx, STx and GTx (as well as the VLx instrument for very large-scale cell engineering which became available for sale in December 2021).

Customers can start with the lower to medium scale research instrument (ATx) and then scale to the clinical version (GTx), without the need for re-optimization and re-validation.

The STx provides the same scale as the GTx, but is used for drug discovery applications, not for human therapeutic use, and is not covered by our FDA Master File or our Technical Files.

Our customers have a choice of three different instrument versions that are standardized on the same technology to deliver equivalent high performance—the ATx, STx and GTx, as well as a portfolio of proprietary related disposables and consumables.

In September 2022, we introduced a fourth instrument, the ExPERT VLx, for large-scale cell engineering.

Customers can start with the lower to medium scale research instrument (ATx) and then scale up to the clinical version (GTx) without the need for re-optimization or re-validation.

The STx provides the same scale as the GTx but is used for drug discovery applications, such as preclinical monoclonal antibody production, and not for human therapeutic use.

The STx is not covered by our FDA Master File or our Technical Files.

We believe these systems will also be supportive of the commercial marketing of our partners’ therapeutic products which we enable.

By allowing our customers to perform their research and process optimization on a research platform and seamlessly scale to a clinically validated, cGMP environment and 21 CFR Part 11 compatible clinical platforms, significant time and cost savings can be realized.

All of our instruments have been designed to provide customers with the key features required for a scalable high-performance transfection solution.

Each of our ExPERT instruments are benchtop with the same small footprint and have integrated touch screens with an intuitive Graphical User Interface, or GUI, designed for simple training and operation.

All our instruments have been designed to provide customers with the key features required for a scalable high-performance transfection solution.

Each of our ExPERT instruments are benchtop with the same small footprint and have integrated touch screens with an intuitive Graphical User Interface (“GUI”), designed for simple training and operation.

To support use in the cGMP suite for clinical manufacturing, our GTx ExPERT software is network capable to enable upload of electronic batch records to a local shared drive and has a software intermediary to facilitate integration and automated data transfer to cloud-based data management solutions.

We have integrated hardware and software design solutions, manufactured under cGMP, that are tailored for use in cGMP manufacturing of clinical products for advanced cellular therapies.

The following chart summarizes the features of the three ExPERT instruments:

The following chart summarizes the features of the four ExPERT instruments:

Research focused, static electroporation for small to medium scale transfection

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The ATx is designed and used by our customers for early design of experiment and process optimization at small scale to minimize cell acquisition and reagent costs.

Once optimized for the biological function with smaller numbers of cells, the process can be replicated and scaled before being transferred to the clinical platform (GTx) for eventual manufacturing in the cGMP suite or to the STx platform for drug discovery.

Flow Electroporation for protein production and drug development

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Designed for very large volume cell-engineering

The VLx Large-Scale Transfection System is a cGMP compliant instrument specifically designed for very large volume cell-engineering.

The ExPERT VLx Large-Scale Transfection System is a cGMP compliant instrument specifically designed for very large volume cell-engineering.

Using proprietary Flow Electroporation Technology, the VLx supports the ability to transfect up to 200 billion cells in less than 30 minutes—10 times the capacity of the STx and GTx.

This system is designed for the rapid and large-scale production of recombinant proteins, monoclonal antibodies, viral vectors, vaccines, virus-like particles, or VLPs, and allogeneic cell therapies.

We introduced the VLx under the ExPERT umbrella in December 2021 to provide our customers with an easier to use system that incorporates the benefits of the ExPERT platform.

We plan to expand the functionality of the VLx into new applications, such as large-scale bioprocessing.

We expect that additional investment will be needed to build out process development capabilities, manufacturing capacity, for new processing assembly design and the addition of large-scale bioprocessing-specific field resources.

This system is designed for the rapid and large-scale production of recombinant proteins, monoclonal antibodies, viral vectors, vaccines, virus-like particles (“VLPs”), and allogeneic cell therapies.

We launched the VLx under the ExPERT brand in September 2022 to provide customers with an easy to use, large-scale system that incorporates the benefits of the ExPERT platform for large-scale bioprocessing.

Disposables—Processing Assemblies (PAs)

Our range of disposable PAs is an important differentiator for us.

We are not aware of any other company with the breadth and diversity of volume ranges and designs to enable high efficiency electroporation in flow, single-well and multi-well formats, for use in both the research and clinical settings.

We view the PA design as one of the key contributors to the high efficiency and viability of the ExPERT platform.

We have designed a range of PAs that are specially designed to process and electroporate the user’s chosen quantity of cells.

We are not aware of any other company with the breadth and diversity of supported processing volumes that enable high efficiency electroporation flow, in single-well and multi-well formats, for use in both the research and clinical settings.

We view our PA designs as one of the key contributors to the capacities, high efficiency and viability delivered by the ExPERT platform.

We have developed a broad range of PAs that are specially designed to process and electroporate the user’s chosen quantity of cells.

Each PA contains two electrodes, between which a medical-grade gasket is sandwiched that has a unique well design consistent with the processing volume required and to allow maximum retrieval of cells.

We have designed a unique range of PAs capable of electroporating cell volumes from small to large scale, in single and multi-well formats, for both research and clinical use.

Cells are placed into the sample bag in large scale PAs or into the well or wells in

small scale PAs and the PA is then connected to the instrument for processing.

Our PAs are capable of electroporating cell volumes from small to large scale, in single and multi-well formats, for both research and clinical use.

Cells are placed into the sample bag in large scale PAs, or into the well or wells in small scale PAs, and the

PA is then connected to the instrument for processing.

The instrument touch screen allows the operator to select the desired cell protocol that encodes the electroporation parameters, select the type of PA to be used and enter any sample specific information.

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Larger volumes of cells are accommodated by larger capacity PAs and a set of simple software commands through the intuitive GUI.

Our ExPERT system uses two PA designs — a static cuvette used for smaller cell volume requirements (from 75,000 cells up to 200 million cells) and a cartridge that is used for both static and Flow Electroporation for larger cell volumes (700 million up to tens of billions of cells).

The Flow Electroporation PA (CL-2) allows for processing of cellular volumes ranging from 10 mL to 100 mL and up to tens of billions of cells.

The CL-2 consists of bags and associated tubing, made from medical grade materials, that are connected to the electroporation cartridge.

Users will transfer their cells and loading molecules to the sample bag, and the pump on either the GTx or STx instrument pumps a fixed volume of cells into the cartridge chamber where they are electroporated.

Our ExPERT system uses two PA designs — a static cuvette used for smaller cell volumes (from 75,000 cells up to 200 million cells) and a cartridge design that is used for both static and Flow Electroporation for larger cell volumes (700 million up to tens of billions of cells).

The Flow Electroporation PA (Flow PA) allows for processing of cellular volumes ranging from 10 mL to 100 mL and up to tens of billions of cells.

The Flow PA consists of bags and associated tubing, made from medical grade materials, that are connected to the electroporation cartridge.

Users transfer their cells and loading molecules to the sample bag, and the pump on either the GTx or STx instrument pumps a fixed volume of cells into the cartridge chamber where they are electroporated.

Once the electroporation is complete, the cells are pumped to the collection bag and the chamber is filled with the next volume of cells for electroporation.

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The maximum volume of 100 mL of cells can be processed in approximately 15–20 minutes.

Our two ExPERT PA designs are shown in the pictures below:

We have conducted extensive end-user research over the last several years to continue to improve the design of the PAs and the range of products available.

As a result, we launched the ExPERT cuvette in 2020 based on customer feedback, which incorporated a new design to improve handling and ease of use.

In 2021, we expanded the availability of the ExPERT PA design, continuing to roll it out across the entire range of cuvettes.

Conversion of the portfolio will be completed in 2022.

We also expanded our portfolio of multi-well cuvettes, which reduce manual handling and improve productivity in the lab, with the launch of our R-50x8.

Examples of our two ExPERT PA designs are shown in the pictures below:

We have conducted extensive end-user research to continue improving the design of the PAs and the range of products available.

We launched the ExPERT cuvette in 2020 based on customer feedback, which incorporated a new design to improve handling and ease of use and have continued to expand the availability the ExPERT PA portfolio design.

We have also expanded our portfolio of multi-well cuvettes, which reduce manual handling and improve productivity in the lab, with the launch of our R-50x8.

The R-50x8 is an 8-well cuvette capable of processing up to 225,000 cells in each well.

By enabling eight samples to be processed in the same cuvette, a more efficient process can be achieved by users.

We expect to convert our entire portfolio of PAs to the ExPERT design by the end of 2023.

We plan to continue to support customers using legacy processing assemblies until they transition to our ExPERT products.

In 2022, we added the R-20K Flow Electroporation Processing Assembly for our STx and GTx platforms, which can process between 5 mL and 20 mL sample volumes, which can accommodate between 200 million and up to 4 billion cells.

The R-20K assembly will allow clients to develop therapies at small or mid-scale volumes with improved cell recovery in a closed process adaptable format to assist in de-risking their manufacturing process at the electroporation step.

To further support our customers’ sterile closed process workflows, we also introduced ‘Closed Process Electroporation Buffer’ products in two volume sizes, 500 mL and 1 Liter, which allow for the addition of our proprietary electroporation buffer to concentrated cell samples before electroporation.

For our VLx Platform we introduced the R-1L Flow Electroporation Processing Assembly, which can process in 30 minutes or less between 100 mL and 1 Liter sample volume accommodating up to 200 billion cells in a single run.

The R-1L assembly allows for

large volume sample processing that can be adapted to a closed and sterile workflow for continuous end-product production.

The following matrix shows our full line of currently available PAs and their respective specifications and features, including the ExPERT instruments with which they can be used:

We are committed to continuing to strategically invest in improvements in the PA design and range of products to ensure that customers have solutions that address all of their volume and use requirements, in both research and clinical settings, including current development of advancements for PA(s) that support the VLx.

We are committed to strategically investing in improvements in the PA design and range of products to ensure that customers have solutions that address all of their volume and use requirements, in both research and clinical settings, including current development of advancements for PA that support the VLx.

Supporting Products

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We follow a direct sales model in North America, the United Kingdom, and Europe, while also selling through third-party distributors in Asia and some regions of Europe.

As of December 31, 2021, we have over 20 field sales and application scientists located in the United States, the United Kingdom, and several regions in Europe and Asia.

As of December 31, 2022, we had over 25 field sales and application scientists located in the United States, the United Kingdom, and several regions in Europe and Asia.

Since the commercial launch of our first Flow Electroporation instrument, the installed base of our instruments has grown to more than 600 instruments globally.

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As our primary point of contact in the marketplace, our field teams focus on delivering a consistent marketing message and high level of customer support, while also working to help us better understand the evolving market and customer needs.

We intend to expand our sales, support, and marketing efforts in regions such as the Asia-Pacific region.

We currently use distributors

in countries in these regions, such as in China and Japan, and continuously assess the need for direct sales and local support personnel to supplement our distributors’ resources.

expand our sales, support, and marketing efforts in regions such as the Asia-Pacific region.

We currently use distributors in countries in these regions, such as in China and Japan, supplemented by dedicated MaxCyte team members, and continuously assess the need for direct sales and local support personnel to supplement our distributors’ resources.

As we expand into a new geography, we generally rely initially on third-party distributors until we are able to recruit a direct sales force, field application scientists and business development resources in the country or region.

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Investment in research and development is at the core of our business strategy.

Members of our research and development team specialize in many functional areas including molecular biology, cellular biology, physics, gene editing, cell culture, protein manufacturing, mechanical engineering, cell handling processes, electroporation algorithm development and customer technical support.

Members of our research and development team specialize in many functional areas including molecular biology, cellular biology, physics, gene editing, cell culture, protein manufacturing, process development, mechanical engineering, cell handling processes, electroporation algorithm development and customer technical support.

Our research and development teams are aligned into two teams, applications and instrumentation.

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The research and development functional teams work together as a core team, following a stage-gate process to develop, qualify and launch new products to market.

Other research and development activities include customer technical support such as lab cell processing techniques, instrumentation training and application support.

Other research and development activities include customer technical support such as cell processing techniques, instrumentation training and application support.

Most of our research and development operations are conducted in our Maryland facility.

We have made substantial investments in product and technology development since our inception.

Research and development expenses totaled $15.4 million, $17.7 million and $17.6 million in the years ended December 31, 2021, 2020 and 2019, respectively.

Although our CARMA pre-clinical and clinical development was concluded in the first half of 2021, we expect our research and development expenses outside of CARMA to increase significantly for the foreseeable future as we develop data supporting the use of our products in various applications and continue to enhance our existing products as well as develop new products for our current and new markets.

Research and development expenses totaled $19.5 million and $15.4 million in the years ended December 31, 2022 and 2021, respectively.

We expect our research and development expenses to increase significantly for the foreseeable future as we develop data supporting the use of our products in various applications and continue to enhance our existing products as well as develop new products for our current and new markets.

Manufacturing and Supply

We design our single use PA disposables and conduct final functional testing in our Maryland facility.

In addition, we design, develop and manufacture the ExPERT instruments in-house.

We design, develop and manufacture our single use PA disposables and conduct final functional testing in our Maryland facility, and for risk mitigation, we utilize a third-party manufacturer for a portion of the PA disposables supply.

In addition, we design, develop and manufacture our ExPERT instruments in-house.

Our in-house manufacturing and design function is certified as ISO 9001 compliant and our manufacturing facility and controlled-access shipping, receiving and storage spaces are located at our current headquarters in Maryland.

We intend to relocate our manufacturing to a significantly larger space in a new facility during 2022.

We relocated our operations, including inventory and manufacturing, to a significantly larger space in a new facility during 2022.

Our range of ExPERT instruments are manufactured, tested and shipped from our Maryland facility under cGMP.

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Presently, our Maryland manufacturing

facility can support the production of ExPERT instruments in excess of current demand, and we will continue to obtain the space and staffing necessary to meet customer demand for the foreseeable future.

facility can support the production of ExPERT instruments in excess of anticipated demand, and we plan to continue obtaining the space and staffing necessary to meet customer demand for the foreseeable future.

Processing Assemblies

Our family of ExPERT instruments incorporate a broad range of proprietary single use PAs that are specially designed to meet the needs of our customers for cell volume, single- or multi-well configuration, and static or flow processing.

These PAs are only available from us and are designed for use only with our instruments and, our range of PAs are designed, developed, tested and shipped from our Maryland facility.

We currently outsource manufacturing of components and final clean-room disposables assembly to third parties.

We plan to move the cleanroom assembly activities in-house in order to enhance operational control over quality, expand capacity, enable automation implementation and improve other areas of operations.

In addition, in-house manufacturing is expected to allow research and development to more rapidly develop new products and enhancements when manufacturing and research and development are in the same facility.

We are currently constructing a new facility for occupancy in mid-2022 that will include new cleanroom space for assembly of processing assemblies.

Staffing and manufacturing process development for in-house PA manufacturing began in early 2022.

We will seek to establish commercial scale PA production capacity by the end of 2022 and full initial capacity during 2023.

Our PAs are only available from us and are designed for use only with our instruments.

The PAs are designed, developed, tested and shipped from our Maryland facility.

We outsource supply and manufacturing of key PA components.

Final clean-room disposables assembly is performed at our headquarters facility and at a third party.

In-house cleanroom PA assembly activities were initiated in 2022 in order to enhance operational control over quality, expand capacity, enable automation implementation, provide for multiple manufacturing sites and improve other areas of operations.

In addition, in-house manufacturing allows research and development to more rapidly develop new products and enhancements as a result of housing research and development in the same facility.

For both instrument and PA manufacturing, we regularly assess our supply chain to ensure availability of components, our ability to respond to customer demand for our products and to qualify multiple suppliers.

We have relationships with several custom parts manufacturers and electronics suppliers that can provide components for our instruments, including components currently provided by a single source.

We have relationships with multiple custom parts manufacturers and electronics suppliers that can provide components for our instruments, including components currently provided by a single source.

Approximately 34% of our inventory held at December 31, 2022 was purchased from one supplier.

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If a single source supplier has a part or process that is time-consuming to transfer to another supplier, our approach is to hold enough inventory of that part to allow adequate time for technical transfer and qualification wherever possible.

Our ongoing strategy is to maintain adequate levels of inventories at all times and to qualify at least two suppliers for critical quality components, and we plan to continue the diversification of our supply chain as we scale.

Our ongoing strategy is to maintain adequate levels of inventories at all times and to qualify at least two suppliers for critical components, and we plan to continue the diversification of our supply chain as we scale.

This inventory strategy was designed to minimize supply chain risk and as a result we are currently able to ship on demand and to date have never had a backorder for a product.

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Our intellectual property strategy has been, and still is, to obtain patent protection in relevant jurisdictions over our instruments, methods utilizing our instruments, as well as design patents over the ExPERT system.

As part of this

strategy, we have focused on obtaining protection for our non-viral delivery platform to the extent possible, particularly in the United States and other key jurisdictions of commercial value.

As of February 11, 2022, we have more than 130 granted U.S.

As part of this strategy, we have focused on obtaining protection for our non-viral delivery platform to the extent possible, particularly in the United States and other key jurisdictions of commercial value.

As of March 8, 2023, we have more than 150 granted U.S.

and foreign patents, including in foreign jurisdictions such as Australia, Canada, Japan, China, South Korea and certain countries in Europe, as well as over 95 pending patent applications worldwide.

The main focus of our patent coverage is to protect our Flow Electroporation, processing chambers/disposables, control and process elements, and methods/applications of using our non-viral delivery platform.

The main focus of our patent coverage is to protect our Flow Electroporation process, as well as the processing assemblies/disposables, control and

process elements, and methods/applications of using our non-viral delivery platform.

Our patent portfolio provides protection over our instruments and related methods through at least 2028 and over our electroporation applications and methods through 2034.

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trademark applications, and more than 31 pending foreign trademark applications.

Our registered trademarks and pending trademark applications include trademarks for MaxCyte, CARMA, a stylized version of ExPERT and our logo.

Our registered trademarks and pending trademark applications include trademarks for our company name, a stylized version of ExPERT, and our logo.

In order to supplement protection of our brand, we have also registered several internet domain names.

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The FDA and similar governmental authorities regulate, among other things, the research, development, testing, manufacturing, clearance, approval, labeling, storage, recordkeeping, advertising, promotion, marketing, distribution, post-market monitoring and reporting, as well as import and export of technologies including biological drug products.

Our biopharmaceutical and life sciences customers are subject to extensive regulations by the FDA and equivalent regulatory authorities in other countries, regarding the conduct of pre-clinical studies and clinical trials, in the manufacture of product candidates and products for use in humans (i.e., “Good Manufacturing Practice” laws and regulations) and the marketing authorization and commercialization of biological drug products.

Our biopharmaceutical and life sciences customers are subject to extensive regulations by the FDA and equivalent regulatory authorities in other countries, regarding the conduct of preclinical studies and clinical trials, in the manufacture of product candidates and products for use in humans (i.e., “Good Manufacturing Practice” laws and regulations) and the marketing authorization and commercialization of biological drug products.

The activities of sponsors, applicants and manufacturers are subject to regulation of those jurisdictions where the research or manufacturing occur, and also jurisdictions for which applications are planned or have been made and the product is intended to be marketed.

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We have established a quality management system (under ISO 9001:2015 standards) which is designed to respond to customer expectations and needs and support customer adherence to applicable regulatory requirements.

technologies we offer for potential use by customers in a cGMP environment are produced under this ISO 9001:2015 quality management system.

The technologies we offer for potential use by customers in a cGMP environment are produced under this ISO 9001:2015 quality management system.

Master Files and Technical Files to Support Customer Regulatory Submissions

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We have also discussed the potential to submit a Master File with the Therapeutic Goods Administration in Australia.

In this way, the regulatory body may review information on our platform in the context of its utilization by our partners in regulated products, for example, as described in our customers’ Investigational New Drug (IND) applications.

We continuously update the Master and Technical Files in order to support the regulatory activities of our customers.

The FDA and regulators in other countries allow Master and Technical Files, but they do not approve them.

Rather, they review them in the context of evaluating the submissions by our customers wherein our files are referenced.

Rather, they review them in the context of evaluating the submissions by our customers that reference our files.

Healthcare Laws and Reform

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The Foreign Corrupt Practices Act

The Foreign Corrupt Practices Act, or FCPA, prohibits any U.S.

The Foreign Corrupt Practices Act (“FCPA”), prohibits any U.S.

individual or business from paying, offering, or authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business.

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Data Privacy and Security Laws and Regulations

In the ordinary course of business, we may process personal data (including, without limitation, clinical trial data and other data concerning health).

Accordingly, we may be subject to numerous data privacy and security obligations, including federal, state, local and foreign laws, regulations, guidance, and industry standards related to data privacy, security, and protection.

In the ordinary course of business, we collect, receive, store, process, generate, use, transfer, disclose, make accessible, protect, secure, dispose of, transmit, and share (collectively, process) personal information, such as clinical

trial data and other health data.

Accordingly, we may be subject to numerous data privacy and security obligations, including federal, state, local, and foreign laws, regulations, guidance, industry standards, external and internal privacy and security policies, contractual requirements and other obligations related to data privacy and security.

These frameworks are evolving and may impose potentially conflicting obligations.

Such obligations may include, without limitation, the Federal Trade Commission Act, the Telephone Consumer Protection Act of 1991, the Controlling the Assault of Non-Solicited Pornography And Marketing Act of 2003, the California Consumer Privacy Act of 2018 (“CCPA”), the European Union’s General Data Protection Regulation 2016/679 (“EU GDPR”), the EU GDPR as it forms part of United Kingdom (“UK”) law by virtue of section 3 of the European Union (Withdrawal) Act 2018 (“UK GDPR”), the ePrivacy Directive, and the Payment Card Industry Data Security Standard (“PCI DSS”).

In addition, several states within the United States have enacted or proposed data privacy laws.

For example, Virginia passed the Consumer Data Protection Act, and Colorado passed the Colorado Privacy Act.

The EU GDPR and CCPA are examples of the increasingly stringent and evolving regulatory frameworks related to personal data processing may increase our compliance obligations and exposure for any noncompliance.

European data privacy and security laws (including the EU GDPR and UK GDPR) impose significant and complex compliance obligations on entities that are subject to those laws.

For example, in the European Economic Area, or EEA, the processing of personal data is principally governed by the provisions of the EU GDPR.

The EU GDPR applies to any processing operations carried out in the context of an establishment in the EEA as well as any processing operations relating to the offering of goods or services to individuals in the EEA and/or the monitoring of their behavior in the EEA and to companies established outside the EEA that process personal data in connection with the offering of goods or services to data subjects in the EEA or the monitoring of the behavior of data subjects in the EEA.

The GDPR enhances data protection obligations for controllers of personal data (such as clinical trial sponsors).

These obligations may include limiting personal data processing to only what is necessary for specified, explicit, and legitimate purposes;

requiring a legal basis for personal data processing;

limiting the collection and retention of personal data;

increasing rights for data subjects;

formalizing a heightened and codified standard of data subject consents;

requiring the implementation and maintenance of technical and organizational safeguards for personal data;

mandating notice of certain personal data breaches to the relevant supervisory authority(ies) and affected individuals;

and mandating the appointment of representatives in the UK and/or the EU in certain circumstances.

In the United Kingdom, the UK Data Protection Act 2018 complements the UK GDPR in this regard.

This fact may lead to greater divergence on the law that applies to the processing of such categories of personal data across the EEA and/or United Kingdom.

Additionally, the CCPA imposes obligations on covered businesses to provide specific disclosures related to a business’s collecting, using, and disclosing personal data and to respond to certain requests from California residents related to their personal data (for example, requests to know of the business’s personal data processing activities, to delete the individual’s personal data, and to opt out of certain personal data disclosures).

Also, the CCPA provides for civil penalties and a private right of action for data breaches which may include an award of statutory damages.

In addition, it is anticipated that the California Privacy Rights Act of 2020 (“CPRA”), effective January 1, 2023, will expand the CCPA.

The CPRA will, among other things, give California residents the ability to limit use of certain sensitive personal data, establish restrictions on personal data retention, expand the types of data breaches that are subject to the CCPA’s private right of action, and establish a new California Privacy Protection Agency to implement and enforce the new law.

federal and state consumer protection laws may require us to publish statements that accurately and fairly describe how we handle personal data and choices individuals may have about the way we handle their personal data.

Such obligations may include, without limitation, the Federal Trade Commission Act , the California Consumer Privacy Act of 2018, as amended by the California Privacy Rights Act of 2020 (“CPRA”) (collectively, “CCPA”), the European Union’s General Data Protection Regulation 2016/679 (“EU GDPR”), the EU GDPR as it forms part of United Kingdom law by virtue of section 3 of the European Union (Withdrawal) Act 2018 (“UK GDPR”), the ePrivacy Directive, and wiretapping laws.

Further, the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), imposes specific requirements relating to the privacy, security, and transmission of individually identifiable health information.

In addition, several states within the United States, such as Virginia, Colorado, Connecticut, and Utah, have enacted comprehensive data privacy laws, and similar laws are being considered at the federal, state, and local levels.

The EU GDPR, UK GDPR, and CCPA are examples of the increasingly stringent and evolving regulatory frameworks related to personal information processing that may increase our compliance obligations and exposure for any noncompliance.

European data privacy and security laws (including the EU GDPR and UK GDPR) impose significant and complex compliance obligations on companies that are subject to those laws, notably with respect to the processing of health-related data from European Economic Area (“EEA”) or United Kingdom-based individuals.

Additionally, the CCPA applies to personal information of consumers, business representative, and employees who are California residents, imposes specific requirements on covered businesses, provides for administrative fines of up to $7,500 per violation and allows private litigants affected by certain data breaches to recover significant statutory damages.

In addition, the CPRA expanded the CCPA’s requirements.

Furthermore, U.S.

federal and state consumer protection laws may require us to publish statements that accurately and fairly describe how we handle personal information and choices individuals may have about the way we handle their personal information.

See the section titled “Risk Factors – Risks Related to Our Regulatory Environment and Our Industry” for additional information about the laws and regulations to which we are or may become subject and about the risks to our business associated with such laws and regulations.

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We consider our employee relations to be good.

Our Corporate Information

Corporate Information

We were incorporated under the laws of the State of Delaware in July 1998 under the name Theramed, Inc.

On December 31, 2001, we changed our name to MaxCyte, Inc.

Our principal executive offices are located at 22 Firstfield Road, Suite 110, Gaithersburg, Maryland 20878, and our telephone number is (301) 944-1700.

and changed our name to MaxCyte, Inc.

Our principal executive offices are located at 9713 Key West Avenue, Suite 400, Rockville, Maryland 20850, and our telephone number is (301) 944-1700.

Available Information

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Our website and information included in or linked to our website are not part of this Annual Report.

Our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act are available free of charge through our website as soon as reasonably practicable after they are electronically filed with or furnished to the Securities and Exchange Commission, or SEC.

The SEC maintains an internet site that contains reports, proxy and information statements and other information that we file electronically with the SEC.

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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 1. Business