What changed in this filing

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Item 1. Business

2026-03-25 compared with 2025-03-11 · 86 added, 71 removed, 332 unchanged (32% of the section changed)

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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.

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

We launched our DTx electroporation platform for discovery in February 2026.

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

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We expect that this acquisition will strengthen our ability to serve ex vivo and in vivo cell and gene therapy developers with an innovative suite of tools and services spanning early R&D through clinical development and commercialization.

We anticipate that successful integration of SeQure into our Company (which is not guaranteed) will allow us to expand our service offerings for our partners and leverage our commercial and field application scientist teams to work with developers earlier in their research processes.

The integration of SeQure into our Company has allowed us to expand our service offerings for our partners and leverage our commercial and field application scientist teams to work with developers earlier in their research processes.

Our Competitive Strengths

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This figure includes both existing active SPL programs currently in clinical development and future SPL programs that are encompassed in our SPL agreements.

From the 18 active clinical programs under our SPL agreements, the total pre-commercial milestone opportunity could exceed $220 million if all of the active programs were to achieve regulatory approvals.

We have already received about $10 million of milestone revenue from active programs.

From the 13 clinical programs active under our SPL agreements as of December 31, 2025, the total pre-commercial milestone opportunity could exceed $130 million if all of the active programs were to achieve regulatory approvals.

We have received over $30 million in milestone revenue to date..

• Leadership team and workforce with deep domain knowledge.

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The foundation of our technology platform is our proprietary and patented Flow Electroporation technology, which we have developed and optimized for more than 25 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 nucleus.

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

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

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

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

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

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By delivering high efficiency, while maintaining high cell viability, at any scale, the ExPERT platform is designed to improve our customers’ ability to achieve the required therapeutic index, enabling accelerated, cost-efficient translation of complex cellular therapies from research to clinical development.

Our ExPERT platform consists of four instruments, the ATx, STx, GTx and VLx, which use a broad range of PAs, 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 clinical development, in support of the intended therapeutic commercialization.

Our ExPERT platform consists of five instruments, the DTx, ATx, STx, GTx and VLx, which use a broad range of PAs, 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 clinical development, in support of the intended therapeutic commercialization.

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

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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, as well as autoimmune and neurogenerative

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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As the cell therapy market continues to evolve, developers face both the challenges of more complex approaches, which 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:

The use of viral vectors, which are commonly used for gene and protein delivery, carries several challenges, however, especially given the increase in complexity of these “next-generation” ex vivo cell therapy approaches, such as:

• Viral payload limitations.

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

Many methods of gene manipulation require delivery of relatively large payloads, including proteins such as Cas9 for CRISPR or DNA and mRNA molecules that encode large therapeutics proteins.

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

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Concerns exist regarding viral vector manufacturing capacity and the cost associated with viral development and manufacturing.

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

Additional bottlenecks arise from demand for viral

approaches, which has led to subsequent demand for cGMP plasmids.

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.

Such characteristics include reducing immunogenicity risk of viral vectors, driving high efficiency of multi-molecule delivery while maintaining high cell viability and potency, reducing the risk of potential genotoxicity of multiplex editing (potential for translocations), delivering a large number of molecules at scale, the ability to deliver to a large number of cell types in a time efficient matter, and manufacturing in a cGMP environment, all at a manageable cost.

The challenges of viral delivery methods and increased complexity of next-generation cell therapies has driven increased adoption of non-viral delivery technologies, such as electroporation.

These advanced delivery technologies must address a number of needs that include reducing immunogenicity risk of viral vectors, driving high efficiency of multi-molecule delivery while maintaining high cell viability and potency, reducing the risk of potential genotoxicity of multiplex editing (potential for translocations), delivering a large number of molecules at scale, the ability to deliver to a large number of cell types in a time efficient matter, and manufacturing in a cGMP environment, all at a manageable cost.

The challenges of viral delivery methods and increased complexity of next-generation cell therapies have driven increased adoption of non-viral delivery technologies, such as electroporation.

We believe our ExPERT technology is well positioned as a non-viral delivery platform in the cell therapy market.

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While difficult to predict given uncertainty around regulatory approvals and clinical risk, the first next-generation ex vivo cell therapy using non-viral approaches was approved in the United States in 2023 using our platform.

enhances our opportunity by potentially providing SPL agreement revenues regardless of which approaches advance in the coming years.

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 cells (“TCR”) and stem cells) and cell sources (autologous and allogeneic) enhances our opportunity by potentially providing SPL agreement revenues regardless of which approaches advance in the coming years.

Additionally, our instruments and platform have been used in over 75 clinical trials to date for drugs being developed to treat a variety of indications, from hematological malignancies to solid tumors to inherited genetic disorders.

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These customers may also purchase associated PAs and consumables as needed.

Our SPL customers also commit to pay precommercial milestone payments for each therapeutic licensed under the agreement and produced using our platform, to be paid as they achieve key precommercial clinical development events (including, for example, Investigational New Drug (“IND”) applications and approvals, 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).

(“BLA”) approvals in specified regions).

In addition, almost all of our SPL agreements also include a commitment to pay us post-approval sales-based payments for commercialized therapeutics.

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We have entered into 33 SPL agreements with commercial cell therapy developers, with 31 of those agreements currently active.

Of our current SPL customers, one is in the commercial stage and 18 are active in clinical development, meaning they have at least an FDA-cleared IND application or foreign equivalent.

Of our SPL customers, one is in the commercial stage and 13 are active in clinical development as of December 31, 2025, meaning they have at least an FDA-cleared IND application or foreign equivalent.

An IND is a request for authorization from the FDA to administer a therapeutic being investigated in humans in a clinical research setting and to ship such products in interstate commerce for use in investigational clinical trials.

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This figure includes both existing active SPL programs currently in clinical development and future SPL programs that are encompassed in our SPL agreements.

From the 18 active clinical programs under our SPL agreements, the total pre-commercial milestone opportunity can exceed $220 million if all of the active programs were to achieve regulatory approvals.

We have already received about $10 million of milestone revenue from active programs.

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, and may never receive FDA or other regulatory approval for all or any product candidates covered by their SPL 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.

From the 13 clinical programs active under our SPL agreements as of December 31, 2025, the total pre-commercial milestone opportunity can exceed $130 million if all of the active programs were to achieve regulatory approvals.

We have received over $30 million in milestone revenue to date.

and may never receive FDA or other regulatory approval for all or any product candidates covered by their SPL 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.

Although Precision BioSciences, Inc.

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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 an instrument incorporating the same underlying technology and protocols.

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

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.

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

Customers can start with the lower to medium scale research instrument (DTx and 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.

VLx provides the capability for large-scall cell engineering and drug discovery applications.

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 customers’ therapeutic products which we enable.

The DTx, ATx and STx are 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 customers’ therapeutic products that we enable.

Our platform allows 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 platform.

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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 four ExPERT instruments:

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

Designed for research and discovery applications

The ExPERT DTx a high throughput transfection platform for research and drug discovery applications.

The DTx streamlines workflows by processing up to 96 samples in a single-three minute run.

The DTx was developed for researchers whether performing gRNA or nuclease screens, antibody discovery, or evaluating novel receptor constructs.

With directly scalable, precision turned electroporation protocols, we believe the DTx supports a clear, efficient path to downstream development and GMP-compliant manufacturing when paired with the ATx, STx and GTx.

We announced the launch of the DTx in February 2026.

Research focused, static electroporation for small to medium scale transfection

Our ExPERT ATx static electroporation instrument is a research focused, high performance electroporation platform for small to medium scale transfection.

The ATx instrument delivers high efficiency and viability at research scale and can utilize our range of PAs capable of transfecting from 75,000 to 700 million cells.

The ATx instrument delivers high efficiency and viability at research scale and can utilize our range of PAs capable of transfecting from 75,000 to 700 million cells, depending on the specific cell type.

Additionally, our ATx instrument is compatible with all of our static PAs, which can also be used on our GTx instrument, allowing for a seamless transition to our clinical cGMP-compatible platform.

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Flow Electroporation for protein production and drug development

Our ExPERT STx instrument, which is generally used in the field of protein production and for other drug discovery applications, also incorporates our proprietary Flow Electroporation Technology for high yield transient expression of proteins, viral vectors, vaccines, virus like particles (“VLPs”) and biologics.

Our STx instrument has high efficiency and can rapidly transfect from 75,000 to 20 billion cells.

Our STx instrument yields high transfection efficiency and can rapidly transfect from 75,000 to 20 billion cells depending on the cell type.

When combined with flexible cell culture strategies, the STx allows for substantial improvement in yields of high-quality, transiently expressed proteins while enabling reduced media costs.

Another key application area for the STx is expression of therapeutic targets for cell-based assays.

Traditionally, drug screening has been performed using stable cell lines because conventional transfection technologies, such as lipofection, may induce changes to membrane composition, which does not offer the consistency and scalability that are critical for sensitive, high throughput screens.

Another key application area for the STx is expression of therapeutic targets and reporter molecules for cell-based assays.

Traditionally, drug screening has been performed using stable cell lines because conventional transfection technologies, such as lipofection, may induce changes to membrane composition and they do not offer the consistency and scalability that are critical for sensitive, high throughput screens.

By enabling high efficiency transfection of multiple plasmids simultaneously into billions of cells, the STx provides drug developers with the ability to express complex, multi-subunit proteins, such as ion channels, in physiologically relevant cells.

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By incorporating the Flow Electroporation technology, larger volumes of up to 20 billion cells can be electroporated within 20 minutes.

With a processing potential that ranges from 75,000 to 20 billion cells on a cGMP, 21 CFR Part 11 compatible system, the GTx represents a platform for clinical electroporation at large scale.

With a processing potential that ranges from 75,000 to 20 billion cells, depending on the cell type, on a cGMP, 21 CFR Part 11 compatible system, the GTx represents a platform for clinical electroporation at large scale.

The GTx integrates several design features that are critical for use in a cGMP setting, such as barcode reading capability to maintain positive identification of patient samples, 21 CFR Part 11 compatible software and networking capability for automated uploading of electronic batch records to either a central server or to a cloud-based data management platform.

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This system is designed for the rapid and large-scale production of recombinant proteins, monoclonal antibodies, viral vectors, vaccines, 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.

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

As of September 2023, the VLx has an established regulatory path supported by our FDA Master File.

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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.

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.

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.

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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 classes of 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).

Our ExPERT system uses two classes of PA designs — a static cuvette used for smaller cell volumes (from 75,000 cells up to 200 million cells, depending on the cell type) 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 5 mL to 1,000 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 the GTx , STx or VLx 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.

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

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

This process is repeated until the entire sample volume is processed.

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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 we have continued to expand the availability of the ExPERT PA portfolio design.

We launched the ExPERT cuvettes in 2020 based on customer feedback, which incorporated design improvements to facilitate handling and ease of use, and we have continued to expand the availability of 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.

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 allows 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.

At the same time, 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 R-50x8 is an 8-well cuvette capable of processing up to 225,000 cells in each well, depending on the cell type.

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

In 2022, we added the R/G-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, depending on the cell type.

The R/G-20K assembly allows 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 sterile addition of our proprietary electroporation buffer to concentrated cell samples before electroporation.

At the same time, for our VLx Platform, we introduced the R/G-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

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 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

Our proprietary electroporation buffer, a balanced salt solution that protects cells during transfection, is formulated for use with all our instrument platforms and PAs.

This consumable is used for all cell types, eliminating the need to change buffers as users switch protocols, cell types or scale up.

Our proprietary electroporation buffer, a balanced salt solution that provides a physiologically appropriate environment for cells during transfection, is formulated for use with all our instrument platforms and PAs.

This consumable is used for all mammalian cell types, eliminating the need to change buffers as users switch protocols, cell types or scale up.

The buffer is made in a cGMP facility, is fully chemically defined and is free of human or animal components, and is tested to meet technical, sterility and endotoxin specifications.

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

Our in-house PA 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, and we store some inventory at an off-site location for purposes of business continuity planning.

We also store a portion of our inventory at an off-site location for purposes of business continuity and risk mitigation.

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

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

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

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

In addition, in-house manufacturing allows research and development teams located in the same facility to more rapidly develop new products and enhancements.

Electroporation Buffer

Our proprietary GMP grade electroporation buffer is designed, developed, and shipped from our headquarters facility.

We outsource to a third-party the production and bottling / bagging of the buffer into its final configuration for sale.

The electroporation buffer is available for sale from MaxCyte and our third-party distributors only.

For both instrument and PA manufacturing, we regularly assess our supply chain to ensure our ability to respond to customer demand for our products.

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There are other companies, both established and early-stage, that have or are developing electroporation and other non-viral delivery technologies that could be applicable to both bioprocessing and cell engineering, and who are or may compete directly with our business.

These companies include Lonza Group AG, Thermo Fisher Scientific Inc., Miltenyi Biotec, Bio-Rad Laboratories, Inc.

and Harvard Biosciences Inc.

(BTX), as well as several other smaller companies, including spinouts from academic labs.

These companies include Lonza Group AG, Thermo Fisher Scientific Inc.

TMO) , Miltenyi Biotec, Bio-Rad Laboratories, Inc.

BIO) and Harvard Biosciences Inc.

HBIO ), as well as several other smaller companies, including spinouts from academic labs.

Some of these companies may have substantially greater financial and other resources than us, including larger research and development staff or more established sales forces.

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Intellectual Property

Our long-standing intellectual property strategy has been to obtain patent protection in relevant jurisdictions over our instruments and related methods, as well as design patents covering 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 19, 2025, we have more than 200 granted U.S.

Our long-standing intellectual property strategy has been to obtain patent protection in relevant jurisdictions over our instruments, processing assemblies and consumables, and related methods, as well as design patent protection covering 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.

We also maintain a layered protection strategy that combines patent rights with proprietary know-how and trade secrets relating to our electroporation workflows, software/control parameters, and formulations.

As of December 31, 2025, we had more than 200 granted U.S.

and foreign patents, including in Australia, Canada, Japan, China, South Korea, and certain countries in Europe, as well as over 100 pending patent applications worldwide.

Our portfolio protects our core technology, the Flow Electroporation process, the processing assemblies and consumables, control and process elements, and application methods of using our non-viral delivery platform.

The protection over our instruments and related methods is estimated to last through at least 2028 and through 2037 for our electroporation applications.

Our design protection covering the ExPERT system has the potential to provide protection through at least 2048.

In addition to our granted patents and filed applications, we maintain protection over a number of trade secrets related to our cell processing technology and other core technology areas, including our electroporation protocols, pulsing patterns, proprietary buffer, and other formulations we have developed.

Our portfolio protects our core technology, including the Flow Electroporation® process, the processing assemblies and consumables used with our systems, control and process elements, and application methods of using our non-viral delivery platform.

Protection over our instruments and related control and process elements is estimated to last through at least 2028, and protection for our electroporation applications is estimated to extend through at least 2037, subject to jurisdiction-specific patent term rules and other factors.

Our design protection covering the ExPERT system has the potential to provide protection through at least 2048, subject to jurisdiction-specific term and maintenance requirements.

In addition, through our SeQure business, we hold and/or license intellectual property related to gene-editing risk assessment assays and associated methods.

This intellectual property is intended to complement our platform strategy by strengthening workflow positioning around guide selection, off-target nomination, and confirmation of gene-editing outcomes, including a combination of owned and licensed patents and applications in relevant jurisdictions.

In addition to our granted patents and filed applications, we maintain protection over a number of trade secrets related to our cell processing technology and other core technology areas, including our electroporation protocols, pulsing patterns, software/control parameters, proprietary buffer, and other formulations we have developed.

Our years of accumulated know-how, together with the technical expertise of our employees, provide us with a competitive advantage.

We use this know-how and technical expertise to optimize, revise and improve our proprietary methods and protocols, such as cell handling and preparation techniques unique to different cells and target molecules, which we confidentially share with our customers.

We maintain the confidentiality of our trade secrets, know-how and proprietary methods and protocols to protect our intellectual property from competitors including through confidentiality provisions in our agreements with our SPL customers and execution of non-disclosure agreements with prospective clients.

One key element of this protection is our FDA Master File and Technical Files described in more detail below, which allow us to submit to the regulatory authorities confidential detailed information about our ExPERT system and PAs.

We maintain the confidentiality of our trade secrets, know-how and proprietary methods and protocols to protect our intellectual property from competitors, including through confidentiality provisions in our agreements with our customers and through the execution of non-disclosure agreements with prospective clients.

One key element of this protection is our FDA Master File and Technical Files described in more detail below, which allow us to submit to regulatory authorities confidential detailed information about our ExPERT system and processing assemblies.

The relevant submission can be referenced by our customers or licensees to support their own regulatory filings without the need for us to disclose the confidential information contained in the FDA Master File and Technical Files.

We also seek to protect our brand through the procurement of trademark rights.

As of February 19, 2025, we owned 22 registered trademarks in the United States, over 155 registered foreign trademarks, 9 pending U.S.

trademark applications, and more than 20 pending foreign trademark applications.

This collection includes trademarks for our company name, logos and stylized versions of our ExPERT product line names.

As of December 31, 2025, we owned 20 registered trademarks in the United States, had 165 foreign trademark filings (registered and pending in the aggregate), and had one pending U.S.

trademark application, as reflected on our active trademark filings list.

This collection includes trademarks for our company name, logos and stylized versions of our ExPERT product line names and related branding, and includes SeQure-related branding.

In order to supplement the protection of our brand, we maintain registration of several internet domain names.

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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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Third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications.

Our customers and collaborators’ ability to commercialize their products successfully will depend in part on the extent to which coverage and adequate reimbursement for these products will be available from third-party payors.

Our customers and collaborators’ ability to commercialize their products successfully will depend in part on the extent to which coverage and adequate

reimbursement for these products will be available from third-party payors.

As such, cost containment reform efforts may result in an adverse effect on our operations.

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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