Quantum-Si Inc

Overview

Quantum-Si Incorporated (including its subsidiaries, the “Company” or “Quantum-Si”) was incorporated in Delaware on June 10, 2020 as HighCape Capital Acquisition Corp. (“HighCape”). The Company’s legal name became Quantum-Si Incorporated following a business combination on June 10, 2021 between the Company and Q-SI Operations Inc. (formerly Quantum-Si Incorporated) (the “Business Combination”), which was founded in 2013.

We are a life sciences company focused on the development and commercialization of proteomics research tools, with the mission to bring single-molecule proteomics analysis to every lab, everywhere. We have developed a proprietary universal single-molecule detection platform that we are initially applying to proteomics to enable Next-Generation Protein Sequencing TM (“NGPS”). Traditionally, proteomic workflows to sequence proteins have several limitations including low throughput (only one protein at a time), requires the use of hazardous chemicals, is time consuming and labor intensive requiring days or weeks of a scientist’s time to complete. NGPS delivers single amino acid level resolution, using a low cost, low maintenance instrument and includes a suite of automated data analysis tools so that any lab, with modest scientific expertise, can easily implement protein sequencing into their workflows. Our products include instrumentation (Platinum and Platinum Pro), consumable kits for library preparation and sequencing for use with our instruments and a suite of automated data analysis tools. We began a controlled launch of the Platinum instrument and started to take orders in December 2022, and subsequently began shipping Platinum in January 2023. We moved to a full commercial launch of Platinum beginning in the second quarter of 2024. In January of 2025, we announced the launch of Platinum Pro with first shipments expected to occur by the end of the first quarter of 2025.

In November 2024, we presented a technology and product roadmap that we believe positions us to be a leader in proteomics. The roadmap includes continued updates and enhancements to our current platform including instrumentation, consumable kits and software tools, and a next generation platform called Proteus. This new Proteus platform is expected to significantly scale the sequencing output per sample, sample throughput per run and increase workflow automation. In addition, during our presentation in November 2024, we provided data demonstrating the wide range of proteomics applications that are addressable with our proprietary single molecule, kinetic detection technology. We intend to execute on this roadmap through a combination of internal development programs and external partnerships to ultimately bring to market the most comprehensive proteomics platform in our industry.

We believe that our core technology can address the broadest range of applications in the rapidly evolving proteomics tools market. Our current and future platforms aim to address many of the key challenges and bottlenecks with legacy proteomic solutions, such as mass spectrometry (“MS”), which include high instrument costs both in terms of acquisition and ownership, and complexity with data analysis, which together limit broad adoption. We believe our platform, which offers single molecule, amino acid level resolution at a lower instrument cost and with greater automation than legacy proteomic solutions, could allow our products to have wide utility across the study of the proteome. For example, our platform could be used for biomarker discovery and disease detection, pathway analysis, immune response, vaccine development, quality assurance and quality control, among other applications.

According to 2021 SVB Leerink research report, proteomics represents a $75 billion market opportunity spanning from life science research through diagnostics. Within this, proteomics research represented a $20 billion opportunity, while proteomic diagnostics and personalized medicine represented the remaining $55 billion. Within the $20 billion current addressable research market, we are focusing on an initial target market of approximately $8 billion that includes protein identification (approximately $3 billion), protein expression and quantification (approximately $3 billion) and proteoforms and post translational modifications (approximately $1.5 billion).

Our team has decades of cumulative experience in developing, commercializing and scaling tools in the life sciences industry. Our management team has previously employed similar approaches at other companies to launch other disruptive technologies, including market leading next generation DNA sequencing technologies. We believe this experience will allow us to introduce our platform in a structured manner to demonstrate its use, value and practicality, while working directly with our customers, to help ensure a positive experience.

We began a controlled launch of Platinum in December 2022, operated under this controlled commercial launch in 2023 and through the first quarter of 2024, at which point we began a full commercial launch at the beginning of the second quarter of 2024. Revenue for the years ended December 31, 2024 and 2023 was$3.1 million and$1.1 million, respectively, and there was no revenue for the year ended December 31, 2022. We incurred net losses of$101.0 million,$96.0 million and$132.4 million for the years ended December 31, 2024,2023 and 2022, respectively.

Importance of Proteomics

The human proteome is diverse, complex and dynamic, with multiple protein variants derived from each gene due to multiple biological steps required to generate the functional proteome, including transcription, translation and post-translational modifications (“PTMs”). While our genomes contain approximately 20,000 genes, current estimates are that these genes ultimately code for more than 1,000,000 different protein variants called proteoforms. Thus, most of the diversity that exists in our cells comes from proteins, which are organic compounds made up of amino acids. Aside from water, the majority of the molecules in our bodies are comprised of proteins, which play a central role in the body’s biological processes, from the immune system response, signaling pathways to transporting oxygen molecules and providing our cells with structure. Proteins or a group of interacting proteins are responsible for virtually every biological function within a living organism. Unlike the genome, the proteome is in constant flux depending on the state of the cell. However, even with the knowledge of the proteome’s influence, the proteome remains largely unexplored relative to the genome. Over the past decades, genomics has ushered in a greater understanding of human biology and disease through the decoding of the human genome, providing a greater understanding of the genes that lay out the instructions for the function, development and reproduction of organisms. While genomics has allowed the interrogation of genetic variation, protein variants hold information yet to be explored or connected to the network of genomic knowledge to better understand cellular function and disease. The protein’s elaborate structure, complicated composition, and vast number of variants, provide a dynamic look into the functions they provide. For example, proteins function as antibodies that bind to specific particles like viruses to protect the body; they act as enzymes to carry out chemical reactions in cells; they act as messengers like hormones to transmit signals; they exist as structural components; and form the basis for storage to carry additional molecules throughout the body.

Proteomic discovery provides insight into what is immediately happening biologically. This insight may be based on both genetic and environmental factors that influence protein structure and function. Given their dynamic nature, proteins, while complex structures, are an excellent indicator that we believe can be used to track therapeutic response, disease progression and a person’s overall health. In a sense, DNA tells us “what could happen” and proteins tell us “what is happening.”

While our products are limited to RUO applications, we note that proteomics tools have been broadly used across a wide range of applications, including:

•Systems biology: system-wide investigations of disease pathways to identify biomarkers, drug action, toxicity, efficacy and resistance;

•Drug discovery and development: identification of drug candidates, novel drug delivery systems, and aid in drug development;

•Biomarker discovery: identification of protein markers for disease identification and management;

•Personalized medicine: tailoring of disease treatment based real-time proteomic data;

•Industry / agriculture: bioproduction and study of plant-pathogen interaction (e.g. crop engineering for drought resistance); and

•Food science: identification of allergies, understanding an improvement of nutritional values and food quality and safety control.

Limitations of Legacy Proteomic Technologies

There is higher diversity and level of complexity related to proteins than genes. Depending on the combination of genes, specific proteins are built to perform specialized functions in the body. A single gene can encode multiple proteoforms depending on the role the protein will ultimately play in the cell. Protein synthesis happens in two stages. First is transcription, where DNA is converted into messenger RNA. Second is translation, where a cell’s ribosomes read the RNA instructions to assemble the protein. An increase in the complexity of the proteome is facilitated by post translational modifications (“PTMs”) where pieces of the protein are modified to either activate or inactivate the protein as part of a signaling pathway to localize the protein to a certain cellular compartment. Legacy proteomic techniques can be grouped into three general categories: Mass Spectrometry, Affinity-based methods and Sequencing via Edman Degradation.

•Mass Spectrometry. MS is a method for the mass determination and characterization of proteins and for more than a decade, has been the dominant tool for unbiased protein analysis. MS workflows allow for the interrogation of individual peptides and protein sequences; however, these techniques are generally complex, lengthy, utilize expensive equipment, and require extensive data analysis by specially trained staff. MS instruments can cost $1,000,000 or more per new instrument and given the technical staff required for performing the process and analyzing the resulting data, the use of MS is often constrained to large, centralized core laboratories. In addition, current sensitivity and dynamic range restrictions of MS also make it difficult to use with liquid samples and restrict the ability to analyze at single molecule resolution or the ability to deeply integrate a protein. Taken together, these factors limit the broad scale adoption of MS in the market.

•Affinity-Based Methods. Affinity-based methods are effective when specific protein(s) or epitopes of interest are known. Affinity-based methods usea variety of molecules, such as antibodies or aptamers, which bind to specific regions, rather than individual amino acids, and therefore may not detect the presence of a protein variant. For instance, the average binding site of an affinity reagent is an epitope with a length of 5 to 8 amino acids, whereas the average length of a human protein is approximately 470 amino acids. Changes or modifications to the protein may prevent the affinity reagent from binding, resulting in missed identification or false negative results. In addition, affinity reagents do not recognize differences in protein structure outside of the targeted binding site making them ineffective at differentiating protein variants. These fundamental challenges limit the ability of affinity-based methods to accurately survey the full complexity of the proteome. Furthermore, affinity-based methods when applied to highly multiplexed analysis of proteins, requires the use of expensive DNA sequencing instrumentation and reagents to resolve barcodes necessary to complete the analysis process. This additional step and instrumentation requirement often limits the use of these high-plex methods to large, core laboratories that have the required infrastructure and data analysis capabilities in their laboratories.

•Sequencing via Edman Degradation. Edman degradation is a method for sequencing of single amino acids from a peptide by alternating acidic and alkaline conditions to cleave the N terminal amino acid from a peptide with the resulting cleaved amino acid being detected using chromatography or electrophoresis. Edman degradation requires the use of hazardous chemicals, is labor and time intensive, and is subject to failures due to naturally occurring chemical modifications of amino acids such as acetylation. While Edman Degradation offers single amino acid level resolution, the technical challenges and limitations of the procedure limit its usefulness outside of a select number of research laboratories.

Our Market Opportunity

Proteomics represents a large and growing market opportunity. According to a 2021 SVB Leerink research report, proteomics represented a $75 billion market opportunity spanning from life science research through diagnostics. Within this, the proteomics research market represents a $20 billion addressable market, and we are focused on an initial target market of approximately $8 billion that includes protein identification (approximately $3 billion), protein expression and quantification (approximately $3 billion) and proteoforms and post translational modifications (approximately $1.5 billion).

Proteomics Landscape

Given the complexity of analyzing the proteome, the market today, is highly fragmented with a mix of legacy and new technologies that address specific requirements of proteomic researchers with no single solution addressing the full range of requirements. When evaluating and purchasing new proteomics research instrumentation, customers must make tradeoffs across a range of product attributes and capabilities including the breadth of coverage (proteins) versus depth of resolution (amino acid, PTM), sample throughput versus instrument costs, biased (affinity-based methods) versus unbiased (protein sequencing, mass spectrometry) amongst others. In addition, many of the legacy technologies also involve a complex, manual workflow and specialized staff to perform data analysis. The combination of these factors means that proteomics research tool adoption remains constrained to specialty facilities, often called core laboratories. For researchers outside of these core laboratories, they must send out their proteomics analysis work increasing the cost and extending the time to complete their research studies. Additionally, in many countries outside of the United States or Western Europe, there are few to no core laboratories to send work to, so the availability of advanced proteomics tools is extremely limited.

Today, our protein sequencing platforms, Platinum and Platinum Pro, address these market challenges in two distinct ways. First, our single molecule, amino acid level resolution capability allows researchers to deeply characterize proteins including protein isoforms, variants and PTMs, types of analysis that are either very difficult to perform or not feasible at all using affinity-based methods or MS. This makes Platinum and Platinum Pro a valuable complement to current technologies used in proteomics core laboratories. Second, our instrument has a low capital cost and includes automated data analysis, easing adoption in both core laboratories and smaller research laboratories looking to insource their proteomics work saving time and budget compared to sending samples to core laboratories. For countries with limited or no core laboratory infrastructure, our platform in some cases, represents the only advanced proteomics instrument local researchers can implement.

Looking to the future, we believe that our Proteus instrument and core technology will be able to address a broad range of proteomics analysis methods, thereby limiting the need for a laboratory to own multiple, specialized platforms. Proteus will provide single molecule, amino acid level resolution as we do with Platinum and Platinum Pro, while also offer significantly higher sequencing output per sample, increased sample throughout per run, automation of the sequencing workflow and automated data analysis. We believe that the Proteus platform will enable any lab to perform a broad range of proteomics analysis methods on a single instrument.

Our protein sequencing platforms are currently intended for research use only or “RUO”. In the future, it is possible that our products may be used for clinical purposes. If our products are used for clinical purposes, they may require regulatory authorization.

Our Products

Our products include instruments, consumables and software used together as a platform for protein analysis. Our customers use commercially available products to prepare their proteins which is the starting material for the protein sequencing process as depicted below.

Overview of the Protein Sequencing Process

The protein sequencing process starts with a step called library prep. The first step in library prep is to digest the proteins into smaller fragments called peptides. In the second part of the library prep process, a linker is attached to the end of the peptide. This linker is designed to attach to the bottom of the reaction well in our sequencing consumable. Once the library prep process is complete, the user then sets up the sequencing step. In this step, the prepared library is combined with sequencing reagents and introduced into a chamber in our sequencing consumable. The sequencing consumable contains millions of features, each capable of performing a single molecule sequencing reaction. The sequencing reagents contain amino acid recognizers, enzymes that remove terminal amino acids and other buffers. A single recognizer is capable of uniquely identifying more than one amino acid. Our technology is designed to accurately determine the recognizer by its unique kinetic signature. After removing the terminal amino acid, the recognition process repeats until the full peptide chain is sequenced. While traditional single-molecule platforms rely on a single measurement for the detection of an event, the advantage of our approach is that our technology can obtain tens to hundreds of data points for each amino acid. Cumulatively, we expect the multiple measurements to deliver high amino acid call accuracy. We believe we are the first company to have successfully commercialized a NGPS product.

Common biological questions that researchers use NGPS to answer include the following:

•What protein is present? Amino acid resolution can provide insight into more than just whether a protein is present or absent. The sequence information could also indicate what version of the protein is present and how it has been changed from the normal version.

•How much of the protein is present? Relative quantification provides information about protein abundance relative to other proteins or protein variants present in the sample.

•How has the protein been modified? Single-molecule sensitivity could show how the protein has been post-translationally modified thus providing greater insights to its role in the context of biological processes within the cell.

Our Current Product Offerings Consists of the Platinum and Platinum Pro Instruments, Library Preparation and Barcoding Kits, Sequencing Kit and Platinum Analysis Software

Instruments

Platinum - NGPS Instrument

We believe Platinum was the first to market the NGPS instrument. While traditional instruments like MS can cost up to $1,000,000 or more per new instrument, our Platinum device is currently priced at approximately $85,000. Platinum is designed to provide single molecule, amino acid level resolution with a streamlined workflow, including automated data analysis, making it accessible to researchers in all laboratory types.

Platinum Pro - NGPS Instrument

In January of 2025, we announced the launch of Platinum Pro with first shipments expected to occur by the end of the first quarter of 2025. Platinum Pro will provide the same technology capabilities of Platinum (single molecule, amino acid resolution) and includes an enhanced user interface, cloud or on instrument data analysis and an available Pro Mode, an option for customers who want to build custom analysis methods utilizing the power of our single molecule, kinetic detection technology. Our Platinum Pro device is currently priced at approximately $120,000.

Consumables

We expect to derive recurring revenue from the sale of consumables that are required to run samples on the Platinum and Platinum Pro instruments or future generations of sequencing platforms that we may launch. Current consumable kits consist of library preparation kits and sequencing kits. These kits are designed for use only with our instruments.

Library Preparation

Our library preparation kit is designed to prepare a customer’s protein sample for sequencing. This kit includes the reagents required to digest the protein(s) into peptides and attach a linker that allows the peptide to bind to the bottom of the reaction features on our sequencing consumable.

Barcoding Kit

Our barcoding kit is a type of library preparation kit, that is specifically designed to optimize the workflow and performance of our technology when applied to protein barcoding applications. This kit includes the reagents required to prepare the barcodes for sequencing and the associated protocol provides information about barcode sequence design and performance.

Sequencing Kit

Our sequencing kits contain the reagents and consumables used to perform NGPS on the Platinum or Platinum Pro instrument. In the currently marketed kit, the consumable is a semiconductor chip with two million features.

Platinum Analysis Software

Our Platinum Analysis Software is a cloud-based solution that automates data analysis workflows and provides a user-friendly interface and visualization of the sequencing results. Our software suite includes tools to map peptides and visualize the amino acid coverage, align peptides to proteins, including a protein inference workflow and a variant caller workflow that is specifically designed to aid users in the identification and relative quantification of variants including single amino acid changes or PTMs.

Going forward, with the launch of our Platinum Pro instrument, we plan to offer a combination of cloud-based and on-instrument software and data analysis tools to address situations where customers have limited or no ability to access to the cloud environment.

Our Competitive Strengths

We believe that our competitive strengths include the following:

•Differentiated technology with broad applicability across a range of proteomics analysis methods. At the core, our technology provides single molecule, kinetic detection of individual amino acids. By enabling single molecule detection, we are not reliant on ensemble measurements, which can often vary from sample to sample and even run to run. Amino acid level resolution allows researchers to deeply characterize proteins including protein isoforms, variants and PTM’s, all types of analysis that are either very difficult to perform or not feasible at all using affinity-based methods or MS. Finally, our ability to detect the kinetic signatures of amino acid recognizers can be extended to other detection molecules including engineered proteins, nanobodies or antibodies. Looking to the future, we believe that our core technology will be able to address a broad range of proteomics analysis methods, thereby limiting the need for a laboratory to own multiple, specialized platforms.

•Platinum Analysis Software provides automated, user-friendly data analysis and visualization workflows. Our Platinum Analysis Software is a suite of tools that can map peptides and visualize the amino acid coverage, align peptides to proteins, including a protein inference workflow and a variant caller workflow that is specifically designed to aid users in the identification and relative quantification of variants including single amino acid changes or PTMs. These automated tools allow researchers, regardless of their laboratory infrastructure or staff specialization, to perform NGPS.

•Business model that leverages growing installed base of instruments each utilizing an increasing number of consumables over time. As part of our commercialization efforts, we aim to grow our installed base of instruments globally while in parallel, expanding the range of applications that customers can perform with our technology through continued launch of new instruments, consumable kits and software workflows. From this process and the increase of the installed base over time, we expect to grow a substantial base of recurring revenues from our customers purchasing a greater number of consumables per instrument over time.

•Platform to enable expanded access to proteomics tools. Our instrument has a low capital cost and includes automated data analysis, easing adoption in both core laboratories and smaller research laboratories looking to insource their proteomics work saving time and budget compared to sending samples to core laboratories. For countries with limited core laboratory infrastructure, our platform in some cases represents the only advanced proteomics instrument local researchers can implement.

•Robust patent protection. We have a strong intellectual property strategy in which we have 396 issued patents and 598 pending applications as of December 31, 2024. In addition, we believe many of our pending and issued patents include foundational technology in the proteomics field.

•Experienced Life Science Management team and Board of Directors with significant experience in healthcare. We have a world-class management team and Board of Directors, including our chairman, executive officers, and other senior management, with decades of cumulative experience in the healthcare and life sciences end-markets. We believe this leadership team positions us as a potentially disruptive force in creating a new market of next generation protein sequencing.

Our Strategies

Our strategies include the following:

•First to market using a phased approach to broad commercialization and adoption. We began a controlled launch of the Platinum instrument and started to take orders in December 2022, and subsequently began commercial shipments of Platinum in January 2023, moving to a full commercial launch at the beginning of second quarter 2024. Members of our team have previously utilized a similar phased launch approach to successfully launch and drive long term adoption of other disruptive technologies. We believe this approach allow us to introduce our platform in a structured manner to demonstrate its use and practicality, while working directly with our key potential customers and industry thought leaders to help ensure a positive experience. Our leadership team has decades of cumulative experience working directly in the life sciences industry with many of the companies and research centers that have the potential to become customers.

•Build our commercial infrastructure globally. We are continuing to build our commercial and operational infrastructure to sell and support our platform as we gain traction throughout the world. Presently, we have a direct sales force in the United States, with a combined direct and distributor approach in Europe, and distributor relationships in certain key markets in the rest of the world. Further, in November 2024 we announced a North American distribution agreement with Avantor to distribute the Platinum Pro and related consumables. We formally began accepting orders through Avantor in the first quarter of 2025 and anticipating ramping activity through this relationship throughout 2025.

•Invest in scientific affairs and market development activities to drive evidence generation and increase the awareness of the importance NGPS. We believe that our platform has the capability to enable users to generate a depth of proteomic information that until our launch, was not available. We believe the utility of our platform spans basic research, drug discovery and development, translational research and quality control testing across multiple market segments including academic research, biopharma, contract development and manufacturing organization (“CDMOs”), government and industrial. We plan to invest in scientific affairs and market development activities and partnerships to generate the scientific evidence of the importance and utility of NGPS and to expand the awareness and demand for our products.

•Continued technical innovation to drive product enhancements, new products, and additional applications. Our leadership team has deep expertise in technology development and commercialization in the life sciences and diagnostics markets. Since the launch of our Platinum instrument, we have delivered a steady cadence of new products including sequencing kits, library prep kits, a barcoding kit and software workflows including protein inference and variant caller. In January of 2025, we announced the launch of Platinum Pro with first shipments expected to occur by the end of the first quarter of 2025. We aim to continually innovate and deliver new products, product enhancements, applications, workflows, and other tools to enable our customers to leverage the power of NGPS at scale. See “Product Roadmap” below for further information.

•Lead with accessibility. Our mission is to bring NGPS to every lab, everywhere. Our instrument has a low capital cost and includes automated data analysis, easing adoption in both core laboratories and smaller research laboratories looking to insource their proteomics work saving time and budget compared to sending samples to core laboratories. For countries with limited core laboratory infrastructure, our platform in some cases represents the only advanced proteomics instrument local researchers can implement. As we develop new platforms, we aim to expand the capability of our core technology and further increase the level of workflow automation while continuing to offer our platform at a price point that is advantageous to our customers compared to the capabilities and cost of many legacy proteomics technologies. Our ability to develop our platforms in such a way may allow proteomic analysis to reach new markets and new users, potentially enabling and accelerating innovative discoveries.

•Build an ecosystem that delivers platform consolidation and a streamlined customer experience. Given the complexity of analyzing the proteome, customers often own and must manage many specialized instruments each addressing a subset of their research needs. Many of the associated laboratory workflows are also highly manual and require specialized facilities and staff. We believe that our core technology can address the broadest range of proteomics analysis methods in the market and through partnerships and internal development programs (Proteus), we will be able to simplify the customer experience through platform consolidation and greater workflow automation.

•Maintain a strong intellectual property portfolio for existing and new technologies. We have a broad and deep patent protection strategy, which includes 396 issued patents and 598 pending applications as of December 31, 2024, including certain foundational IP around proteomics. Protection of our intellectual property is a strategic priority for the business; we have taken, and will continue to take, steps to protect our current and future intellectual property and proprietary technology. We believe our broad patent portfolio and continued rigorous patent protection strategy will help to allow us to focus on our key priorities of commercializing our platform, continuing to innovate with new technologies, and preventing fast-followers.

Commercial Strategy

As we continue to commercialize our platforms, we plan to build out our commercial infrastructure to sell and support our products, across a growing number of market segments and geographies. Presently, we have a direct sales force in the United States, with a combined direct and distributor approach in Europe, and distributor relationships in certain key markets in the rest of the world. In November 2024, we announced a North American distribution agreement with Avantor to distribute the Platinum Pro platform and related consumables.

Our leadership team has decades of experience bring new technologies to the market and working directly with many of the companies and research centers that have the potential to become customers. Our commercial strategy includes the following areas of focus.

1. Continue to build our direct sales and support infrastructure in the U.S. and Western Europe. We plan to continue to build our commercial and operational infrastructure to sell and support our platform as we seek to grow adoption in these regions. In addition to our direct investments, we will continue to evaluate opportunities to partner with leading companies to augment our commercial footprint while minimizing the level of direct investment required.

2. Commercial partnerships. In November 2024, we announced a North American distribution agreement with Avantor to distribute the Platinum Pro and related consumables. Avantor is a leading distributor of life sciences products with established relationships in our target market segments. We formally began accepting orders through Avantor in the first quarter of 2025.

3. Geographic partnerships. We exited 2024 with 18 international distribution partners spanning many countries across Europe, Middle East, Africa, Asia Pacific and South America. Each of our international partners brings a depth of local expertise in the fields of genomics and proteomics and have experience bringing new technologies to market. We expect to continue to expand this international network in 2025.

4. Technical and scientific support. We believe that a key to successfully commercializing a new technology like NGPS, is providing high quality technical and scientific support to customers. We use a mix of field based and in house scientific staff to support our customers through all phases of the commercial process from pre-sales, to training and onboarding and through post-sales support. We will continue to invest in this area in both our direct markets and regionally to support our geographic partners as appropriate.

5. Key opinion leaders (“KOL”) and evidence generation. We believe that our platform has the capability to enable users to generate a depth of proteomic information that until our launch, was not available. We work closely with KOLs in the development and commercialization of our products including supporting research studies that lead to the presentation and/or publishing of data using our technology. We plan to continue to invest in research studies and scientific collaborations to generate scientific evidence that supports the importance and utility of NGPS in proteomics research.

6. Technology access program. We believe that our core technology has broad utility across the field of proteomics research. While our internal R&D focus is on the development and commercialization of NGPS, we believe there would be interests from potential customers and strategic partners, to leverage our single molecule, kinetic detection capabilities for other proteomics applications. As part of the launch of Platinum Pro, we are offering Pro Mode, which enables a customer to access our technology for custom application development. To support that work, we initiated a Technology Access Program that allows customers to engage directly with our R&D scientists to explore custom applications of our core technology in support of their on-going research efforts.

Product Roadmap

We believe that our product and technology roadmap and internal development processes position us as a leader in the proteomics market. Since the launch of Platinum in December 2022, we have executed on numerous product launches across instruments, library prep kits, sequencing kits and software tools. This steady cadence of technology advancements ensures our customers have a continuous flow of new capabilities that enable them to pursue their research interests to the fullest. The following is our actual product launches through February 2025, and estimated timing of product launches after February 2025:

At an investor and analyst day on November 20, 2024, we laid out a long-term product and technology roadmap that we believe is capable of delivering a platform (Proteus) and core technology that can address the broadest range of proteomics applications in the market today. The roadmap includes innovations across all areas of our technology.

1. Sequencing Instrumentation and Consumables. In January 2025, we launched Platinum Pro, a new generation of instrumentation that utilizes our current technology architecture, namely a semiconductor chip. Looking to the future, we are developing a new platform called Proteus, which introduces a new instrument and consumable architecture that is being designed to scale the sequencing output per sample from two million features per consumable today, to billions of features per consumable in the future. The first generation of Proteus and associated sequencing consumables, which is estimated to be ready for launch in the second half of 2026, is being designed to have 80 million features per consumable and 160 million features per instrument run when using two consumables.

2. Library Preparation. In December 2024, we launched a version 2 of our library preparation kit which lowered the input quantity of protein required and increased the sample success rate across a broad range of proteins tested. In addition, we also launched a barcoding kit which is designed specifically for the efficient preparation of protein barcodes for NGPS. We expect to continue to innovate in library preparation with key areas of focus being sample input concentration and complex sample preparation amongst other parameters or features.

3. Sequencing Chemistry. Our current sequencing kit recognizes 13 of the 20 known, naturally occurring, amino acids accounting for up to 69% of amino acids in the proteome. We are continuing to evolve our sequencing chemistry with key areas of focus being amino acid coverage, sequence speed and depth, amongst other parameters. We believe that recognition of all 20 amino acids is feasible over time.

4. Software. Our core technology is single molecule, kinetic detection at the amino acid level. Each of our amino acid recognizers exhibits a unique kinetic signature. Utilizing artificial intelligence, we can continuously train our models and improve the accuracy of the database used to interpret these kinetic signatures, resulting in higher data output and accuracy. We expect to continue to evolve this aspect of our software in addition to continuing to evolve our analysis workflows, data visualizers and other software tools that add value to our customers.

Platinum Pro offers a consumable chip with 2 million features. Proteus 1.0 is anticipated to launch with the capability of accepting two consumable chips, each with 80 million features, creating a total feature range from 80-160 million. The Proteus 2.0 feature set of 10 billion features is estimated based on long-term development initiatives.

Suppliers and Manufacturing

Our products are built using both custom-made and off-the-shelf components supplied by outside manufacturers and vendors located in Asia, Europe, and the United States. These products and product components include our custom-made disposable semiconductor chip, our proprietary mode-locked laser as well as proprietary enzymes, recognizers and buffers used for protein sequencing. The majority of other components for our platform are off-the-shelf.

We purchase some of our components and materials used in manufacturing, including the underlying wafers for our semiconductor chip as well as other critical manufacturing steps, from single source suppliers. We believe that alternatives would be available; however, it will likely take a significant amount of time to identify and validate replacement components, which could negatively affect our ability to supply our products on a timely basis. To mitigate this future risk, we and our third-party contractors attempt to carry a significant inventory of our critical components. However, any transaction disruptions in these suppliers and potential associated ramp up time of a new supplier would result in a supply disruption that could impact our business. In addition, any strategic decision to slow, pause, or stop the manufacturing of any core supply based on assumptions of adequate safety stock that subsequently proves to be an incorrect estimate of supply needs could result in a supply disruption due to the inability to ramp up or ramp down processes.

Our instruments are developed and designed by us but have historically been manufactured by a third-party manufacturing partner. Overall, we believe that our manufacturing strategy is efficient and conserves capital. However, we do not have long-term supply or manufacturing commitments from all our suppliers or manufacturers, and some of our products and components are currently supplied on a purchase order basis. In addition, we will need to increase the supply and manufacturing of our products as we continue to grow. If we are unable to maintain manufacturing at our contract manufacturing partners, it will affect our ability to produce instruments which would harm our research and development efforts and commercial operations. In the event that it becomes necessary to utilize a different contract manufacturer or suppliers for our products, now or in the future, we may experience additional costs, delays and difficulties in doing so, and our business could be harmed.

Certain processes related to our semiconductor chip technology are developed by us but manufactured by a third-party partner. Throughout 2024, we were in a process of transitioning a portion of key activities to a new partner, which has resulted in completed wafers with surface coatings that are usable for commercial purposes, but not fully optimized for long-term production or a fully sustainable process. If we determine finalizing this process is economically appropriate, we believe we can complete final steps by late-2025. However, transitioning these processes could take more time than anticipated and may ultimately prove to be unsuccessful. If we are unable to begin consistently manufacturing our semiconductor chip surface coating process at this new contract manufacturer in a sustainable fashion, it will affect our ability to supply semiconductor chips, affecting the commercial availability of our sequencing kit and our ability to complete development activities that allow us to improve the throughput of our platforms, which could ultimately harm our ability to deliver consumable sequencing kits to our customers, both of which would harm our research and development efforts and commercial operations.

Human Capital Management

Our people are a key reason for our success, and we have structured our organization to maximize productivity and performance. Our future success largely depends upon our continued ability to attract and retain highly-skilled employees.

We believe in attracting, developing, and retaining diverse talent and each individual, regardless of their role, makes a difference and impacts our progress. As of December 31, 2024, we employed 143 full-time employees in the United States andsix full-time employees internationally. In addition, we utilize Professional Employment Organizations (“PEOs”) to provide labor for certain key activities outside the United States. None of our employees are covered by collective bargaining agreements. We understand that our success depends on our highly talented employees, and our human capital management practices focus on attracting and retaining an engaged workforce.

Mission and Core Values. Our mission is to put the groundbreaking power of protein sequencing in the hands of every scientist, every lab, everywhere. We are committed to pioneering a new generation of technology to democratize protein sequencing so that scientists can generate deeper insights faster. Employees are made aware of our values - Embrace Change, Stand Up, Speak Up, Never Settle, and Succeed Together. These values are the basis of our actions and decisions.

Employee Engagement. We have established an annual employee survey process to gather feedback from our employees. The feedback received allows us to grow stronger as a company and allows us to create an environment where employee contributions matter and employees feel valued.

Training and Development. We listen to our employees to understand their training needs. Employees are encouraged to take advantage of our training platform which has a plethora of online learning courses. We conduct monthly seminars to update employees on what is happening throughout our Company.

Compensation and Benefits. Life sciences companies, both large and small, compete for a limited number of qualified applicants to fill specialized positions. To attract qualified applicants and retain employees, we offer a total rewards package consisting of base salary, cash bonus, and equity compensation. Bonus opportunity and equity compensation increase as a percentage of total compensation based on level of responsibility. In addition, we provide a comprehensive benefits package inclusive of medical, dental, and vision healthcare coverage, including company-paid contributions into a Health Savings Account for those employees that enroll in our High Deductible Medical Plan option. Additional employee benefits include, life insurance and disability coverage, 401(k) investment plans, tax advantaged savings account, generous paid time off and leave of absence policies, employee assistance programs, and wellness programs.

Employee Health and Safety. We have training programs for general, chemical and biological safety. We are continuously evaluating the guidance from federal and local authorities and have created strict policies and guidelines that put our employees’ health and safety first.

Competition

We face significant competition in the life sciences technology market. We currently compete with life sciences technology and diagnostic companies that are supplying components, products and services that serve customers engaged in proteomics analysis. These companies include Agilent Technologies, Bio-Rad Laboratories, Danaher, Luminex, Merck KGaA (and its subsidiary MilliporeSigma) and Thermo Fisher Scientific.

We also may compete with a number of emerging growth companies that have developed, or are developing, proteomic products and solutions, such as Nautilus Biotechnology, Olink Proteomics (acquired by Thermo Fisher Scientific), Quanterix, Seer and Standard BioTools. In addition, there are a number of privately-held entities working on similar technologies as ours.

We believe there are currently no commercially available NGPS platforms beyond our Platinum and Platinum Pro systems. The legacy proteomics market today is largely served by companies that offer a variety of analytical instruments, such as MS and associated reagents and consumables. There are also a number of companies that provide proteomic analysis services and have developed or are developing novel proteomic technologies. Additional competing products may emerge from various sources, including life sciences tools, diagnostics, pharmaceutical and biotechnology companies, third-party service providers, academic research institutions, governmental agencies and/or public and private research institutions, among others. Many of the companies with which we compete have substantially greater financial, operational and sales channel resources than we have.

The broader life science instrumentation industry is highly competitive and expected to grow more competitive with the increasing knowledge gained from ongoing research and development. Given the potential market opportunity and scientific importance of proteomic analysis, we expect increased competition and competitor technologies to emerge in the future. We believe the principal competitive factors in our target markets include:

•the scale required to address the complexity and dynamic range of the proteome;

•resolution and sensitivity;

•accuracy and reproducibility of results;

•cost of instruments and consumables;

•efficiency and speed of workflows;

•throughput to meet lab testing volume;

•reputation among customers and key thought leaders;

•innovation in product offerings;

•strength of intellectual property portfolio;

•operational and manufacturing footprint;

•customer support infrastructure; and

•a leadership and commercial team with extensive execution and scientific background.

We believe that there are currently no other commercially available products that provide the same level of analysis at the same scale and sensitivity that our platform provides. We have continued to enhance our position through our ongoing product development, commercial strategy, deployment of new and updated products as well as ongoing collaborations and partnerships with key thought leaders.

Intellectual Property

Protection of our intellectual property is a strategic priority for our business. We rely on a combination of patents, trademark, copyright, trade secret and other intellectual property rights protection and contractual restrictions to protect our proprietary technologies.

Patented Technologies

The patents owned and in-licensed by us provide comprehensive coverage of our peptide sequencing and nucleic acid sequencing processes and are directed to aspects including instrument and laser light source architecture, pixel design, waveguide architecture, lifetime discrimination methods, machine learning, and surface chemistry. We have developed a portfolio of issued patents and pending patent applications directed to commercial products and technologies for potential development. We believe that our intellectual property is a core strength of our business, and our strategy includes the continued development of our patent portfolio.

Patent Portfolio

As of December 31, 2024, we own 396 issued patents and 598 pending patent applications. Of our 396 issued patents, 98 were issued U.S. utility patents. These issued patents have expected expiration dates ranging between 2034 and 2043.

As of December 31, 2024, of our 598 pending patent applications, 128 were pending U.S. utility patent applications, 9 of which were allowed. In addition, we own 298 issued patents in foreign jurisdictions, including Australia, Brazil, China, Europe, Hong Kong, India, Japan, Korea, Mexico, and Taiwan, and 470 pending patent applications in foreign jurisdictions, including Australia, Canada, China, Europe, Hong Kong, India, Israel, Japan, Korea, Malaysia, Mexico, Singapore, Taiwan, and Thailand, 13 of which were allowed.

Going forward, we will continue to evaluate the potential for filing patents for new intellectual property, as well as strategic adjustments of our existing portfolio to maximize our market position, as well as effective deployment of capital to maintain our existing portfolio.

Trademark Portfolio

We also protect important marks through trademark registrations. As of December 31, 2024, we owned 68 trademark registrations and 94 trademark applications, of which 16 are U.S. trademark applications. Twelve of the U.S. trademark applications have been allowed.

Other Intellectual Property

In addition to patents, we also rely on trade secrets, technical know-how and continuing innovation to develop and maintain our competitive position. We seek to protect our proprietary information and other intellectual property by taking appropriate measures including, for example, generally requiring our employees, consultants, contractors, suppliers, outside scientific collaborators and other advisors to execute non-disclosure and assignment of invention agreements on commencement of their employment or engagement. Agreements with our employees also forbid them from using or incorporating the proprietary rights of third parties during their engagement with us.

We also generally require confidentiality or material transfer agreements from third parties that receive our confidential data or materials.

Licensed Intellectual Property

We have entered into exclusive and non-exclusive licenses in the ordinary course of business relating to our technologies or other intellectual property rights or assets.

Government Regulation

Life Sciences Research Use Only Technologies

Our protein sequencing products are currently intended for RUO applications, although the systems may provide data to customers and other third parties that are themselves engaged in the research and development of potential diagnostic and therapeutic products and services for which they may later pursue clearance, authorization or approval from regulatory authorities, such as the U.S. Food and Drug Administration (“FDA”). All our products are labeled “For Research Use Only,” and will be sold to academic and research life sciences institutions that conduct basic and translational research, and biopharmaceutical and biotechnology companies for non-diagnostic and non-clinical purposes.

Under a long-standing FDA regulation, products that are intended for RUO and are labeled as RUO are not regulated by the FDA as in vitro diagnostic (“IVD”) devices and are not subject to the regulatory requirements discussed below for medical devices. RUO products may therefore be used or distributed for research use without obtaining FDA clearance or approval. Such products must bear the statement: “For Research Use Only. Not for Use in Diagnostic Procedures.” RUO products also cannot make any claims related to safety, effectiveness or diagnostic utility, and they cannot be intended for human clinical diagnostic use.

Accordingly, a product labeled RUO but intended or promoted for clinical diagnostic use may be viewed by the FDA as adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and subject to FDA enforcement action. The FDA will consider the totality of the circumstances surrounding distribution and use of an RUO product, including how the product is marketed and to whom, when determining its intended use. If the FDA disagrees with a company’s RUO status for its product, the company may be subject to FDA enforcement activities, including, without limitation, requiring the company to seek clearance, authorization or approval for the product.

FDA and FTC Regulation of Medical Devices in the United States

In the United States, medical devices are subject to extensive regulation by the FDA under the FDCA and its implementing regulations, and other federal and state statutes and regulations. The laws and regulations govern, among other things, medical device design and development, non-clinical and clinical testing, pre-market clearance, authorization or approval, establishment registration and product listing, product manufacturing, product packaging and labeling, product storage, advertising and promotion, product distribution, recalls and field actions, servicing and post-market clinical surveillance. A number of U.S. states also impose licensing and compliance regimes on companies that manufacture or distribute prescription devices into or within the state.

The Federal Trade Commission (“FTC”) also oversees the advertising and promotion of our current and future products pursuant to its broad authority to police deceptive advertising for goods or services within the United States. Under the Federal Trade Commission Act, the FTC is empowered, among other things, to (a) prevent unfair methods of competition and unfair or deceptive acts or practices in or affecting commerce; (b) seek monetary redress and other relief for conduct injurious to consumers; and (c) gather and compile information and conduct investigations relating to the organization, business, practices, and management of entities engaged in commerce. In the context of performance claims for products, compliance with the FTC Act includes ensuring that there is scientific data to substantiate the claims being made, that the advertising is neither false nor misleading, and that any user testimonials or endorsements disseminated related to the goods or services comply with disclosure and other regulatory requirements. In addition, with respect to products that are marketed asin vitro diagnostic or clinical products, FDA’s regulations applicable to medical device products prohibit them from being promoted for uses not within the scope of a given product’s intended use(s), among other promotional and labeling rules applicable to products subject to the FDCA.

The FDCA and FDA’s implementing regulations define a medical device as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component part or accessory, which is (i) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (ii) intended to affect the structure or any function of the body of man or other animals and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. IVDs are a type of medical device and include reagents and instruments used in the diagnosis or detection of diseases, conditions or infections, including, without limitation, the presence of certain chemicals, genetic information or other biomarkers. Predictive, prognostic, and screening tests can also be IVDs.

Medical devices, including IVD products, must undergo pre-market review by, and receive clearance or approval from, the FDA prior to commercialization, unless the device is of a type exempted from such review by statute, regulation, or an FDA exercise of enforcement discretion. The FDA classifies medical devices into three classes based on risk with Class I being the lowest risk and Class III being the highest risk. The FDA generally must clear or approve the commercial sale of most new medical devices that fall within product categories designated as Class II and III. Commercial sales of most Class II and III medical devices within the United States must be preceded either by pre-market notification and FDA clearance pursuant to Section 510(k) of the FDCA (Class II) or by the granting of a pre-market approval (“PMA”) (Class III), after a pre-market application is submitted. Both 510(k) notifications and PMA applications must be submitted to FDA with significant user fees, although reduced fees for small businesses are available. Class I devices are generally exempt from pre-market review and notification, as are some moderate-risk Class II devices. Manufacturers of all classes of devices must comply with FDA’s QSR, establishment registration, medical device listing, labeling requirements, and medical device reporting (“MDR”) regulations, which are collectively referred to as medical device general controls. Class II devices may also be subject to special controls such as performance standards, post-market surveillance, FDA guidelines, or particularized labeling. Some Class I and Class II devices may be exempted by regulation from the requirement of compliance with substantially all of the QSR.

Moreover, as electronic and digital medical devices have become increasingly connected to the Internet, hospital networks, and other medical devices to provide features that improve health care and patient accessibility, FDA and other regulatory authorities have recognized that those same features also increase the risk of cybersecurity threats. These types of medical devices may be vulnerable to cybersecurity incidents that could potentially impact the safety and effectiveness of the device, and device manufacturers are responsible for identifying cybersecurity risks and hazards associated with our products. In recent years, the FDA has increased its scrutiny of this issue as part of the review and marketing authorization process for new medical devices; the agency also monitors reports of cybersecurity incidents as part of its post-marketing device surveillance activities. In addition, as part of the Consolidated Appropriations Act for 2023, signed into law on December 29, 2022 (P.L. 117-328), Congress created new pre-market requirements for developers of “cyber devices,”

defined as medical devices that include software, connect to the Internet, and contain any technological features that could be vulnerable to cybersecurity threats.

Ongoing Post-Market Regulatory Requirements and FDA Enforcement

If our products were deemed to be “medical devices” by the FDA, then our company would be subject to general controls which include:

•establishment registration and device listing;

•the QSR, which requires manufacturers, including third-party manufacturers, to follow design, testing, control, storage, supplier/contractor selection, complaint handling, documentation and other quality assurance procedures;

•labeling regulations, which govern the mandatory elements of the device labels and packaging (including Unique Device Identifier markings for certain categories of products);

•the FDA’s prohibitions against the promotion of products for uncleared, unapproved or “off-label” uses and other requirements related to promotional activities;

•the MDR regulations, which require that manufacturers report to the FDA if a device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur;

•voluntary and mandatory device recalls addressing problems when a device is defective and/or could be a risk to health;

•correction and removal reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; and

•post-market surveillance regulations, which apply to certain Class II or III devices when necessary to protect the public health or to provide additional safety and effectiveness data for the device.

Additionally, certain Class II and Class III devices are subject to special controls. To ensure compliance with regulatory requirements, medical device manufacturers are subject to market surveillance and periodic, pre-scheduled and unannounced inspections by the FDA and certain state authorities. Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may lead to any of the following sanctions:

•Warning Letters or Untitled Letters that require corrective action;

•fines and civil penalties;

•unanticipated expenditures;

•delays in approving/clearing or refusal to approve/clear any of our future products;

•FDA refusal to issue certificates to foreign governments needed to export our products for sale in other countries;

•suspension or withdrawal of FDA approval or clearance (as may be applicable);

•product recall or seizure;

•partial suspension or total shutdown of production;

•operating restrictions;

•injunctions or consent decrees; and

•civil or criminal prosecution.

A company, any contract manufacturers, and some suppliers of components or device accessories would also be required to manufacture medical device products in compliance with current Good Manufacturing Practice requirements set forth in the QSR, unless explicitly exempted by regulation, should we develop and seek regulatory authorization for one or more diagnostic intended uses for our products. The QSR requires a quality system for the design, manufacture, packaging, labeling, storage, installation and servicing of marketed devices, and includes extensive requirements with respect to quality management and organization, device design, buildings, equipment, purchase and handling of components or services, production and process controls, packaging and labeling controls, device evaluation, distribution, installation, complaint handling, servicing, and record keeping. The FDA recently issued a final rule that amends its implementing regulations in order to harmonize the QSR with ISO 13485:2016; the rule changes will become effective on February 2, 2026. Although the harmonization process is not expected to have a significant impact on the quality system compliance operations of device manufacturers because most requirements described in the QSR correspond to requirements set forth in ISO 13485:2016, device manufacturers will likely need to revise certain quality system procedures to ensure compliance with the harmonized regulations. Any failure to make such revisions or adapt to the harmonized regulations, once they become effective, may result in observations of non-compliance during facility inspections by the FDA or comparable regulatory authorities.

The FDA evaluates compliance with the QSR, as well as other applicable device regulatory requirements, through periodic pre-scheduled or unannounced inspections that may include registered manufacturing facilities. Following such inspections, FDA may issue reports known as Forms FDA 483 or Notices of Inspectional Observations, which list instances where the FDA inspector believes the manufacturer has failed to comply with applicable regulations and/or procedures. If the observations are sufficiently serious or the manufacturer fails to respond appropriately, the FDA may issue Warning Letters, which are notices of intended enforcement actions against the manufacturer. For less serious violations that may not rise to the level of regulatory significance, FDA may issue Untitled Letters. The FDA may take more significant administrative or legal action if a manufacturer continues to be in substantial noncompliance with applicable regulations.

For example, if the FDA believes a medical device developer or any of its contract manufacturers or regulated suppliers are not in compliance with these requirements and patients are being subjected to serious risks, the agency can shut down manufacturing operations, require recalls of medical device products, refuse to approve new marketing applications for future products, initiate legal proceedings to detain or seize products, enjoin future violations, or assess civil and criminal penalties against a manufacturer or its officers or other employees.

U.S. Fraud and Abuse Laws and Other Compliance Requirements

FCPA and Other Anti-Bribery and Anti-Corruption Laws. The U.S. Foreign Corrupt Practices Act (“FCPA”) prohibits U.S. corporations and their representatives from offering, promising, authorizing or making payments to any foreign government official, government staff member, political party or political candidate in an attempt to obtain or retain business abroad. The scope of the FCPA would include interactions with certain healthcare professionals or organizations in many countries. Our present and future business has been and will continue to be subject to various other U.S. and foreign laws, rules and/or regulations.

U.S. and European Data Security and Data Privacy Laws

All U.S. states have enacted legislation protecting the privacy and security of “personal information” such as identifiable financial or health information, social security numbers, credit card information and other personally identifiable information. These laws overlap and apply simultaneously with federal privacy and security requirements and regulated entities must comply with all of them. The California Consumer Privacy Act (“CCPA”) went into effect January 1, 2020, and is one of the most restrictive state privacy laws, protecting a wide variety of personal information and granting significant rights to California residents with respect to their personal information. Regulations under CCPA have been modified several times and continue to be modified. Additionally, a new privacy law, the California Privacy Rights Act, (“CPRA”) was approved by California voters in the election of November 3, 2020 and went into effect in January of 2023. The CPRA modified the CCPA significantly, and may result in further uncertainty, additional costs and expenses stemming from efforts to comply with this law, and increases the potential for harm and liability for failure to comply. Among other things, the CPRA established a new regulatory authority, the California Privacy Protection Agency, which is enacting new regulations and has expanded enforcement authority. Other states in the U.S. have implemented or are considering privacy laws similar to CCPA. Colorado, Connecticut, Delaware, Florida, Indiana, Iowa, Montana, New Jersey, Oregon, Tennessee, Texas, Utah, and Virginia have enacted similar data protection laws to California and other U.S. states have proposals under consideration, increasing the regulatory compliance risk. In dealing with health information for the development of our technology or for commercial purposes, we will be indirectly affected by HIPAA and state-imposed health information privacy and cybersecurity laws because these laws regulate the ability of our potential customers and research collaborators to share health information with us. Additionally, we must identify and comply with all applicable state laws for the protection of personal information with respect to personal information that we collect.

In the European Union, increasingly stringent data protection and privacy rules that have and will continue to have substantial impact on the use of personal and patient data across the healthcare industry became stronger in May 2018. The General Data Protection Regulation (“GDPR”) applies across the European Union and includes, among other things, a requirement for prompt notice of data breaches to data subjects and supervisory authorities in certain circumstances and significant fines for non-compliance. The GDPR fine framework can be up to 20 million euros, or up to 4% of the company’s total global turnover of the preceding fiscal year, whichever is higher. The GDPR sets out a number of requirements that must be complied with when handling the personal data of such European Union based data subjects including: providing expanded disclosures about how their personal data will be used; higher standards for organizations to demonstrate that they have obtained valid consent or have another legal basis in place to justify their data processing activities; the obligation to appoint data protection officers in certain circumstances; new rights for individuals to be “forgotten” and rights to data portability, as well as enhanced current rights (e.g., access requests); the principal of accountability and demonstrating compliance through policies, procedures, training and audit; and the new mandatory data breach regime. In particular, medical or health data, genetic data and biometric data where the latter is used to uniquely identify an individual are all classified as “special category” data under the GDPR and are afforded greater protection and require additional compliance obligations. Noncompliance could result in the imposition of fines, penalties, or orders to stop noncompliant activities. We are subject to GDPR as we undertake and expand operations in the EU, offer products or services to individuals in the EU, or monitor the behavior of individuals within the EU.

We could also be subject to evolving European Union laws on data export, for transfers of data outside the EU to us, group companies or third parties. The GDPR only permits exports of data outside the EU to jurisdictions that ensure an adequate level of data protection. The United States has not been deemed to offer an adequate level of protection, so in order for us to transfer personal data from the EU to the United States, we must identify a legal basis for data transfer (e.g., the European Union Commission approved Standard Contractual Clauses or certification under the recently-adopted EU-U.S. Data Privacy Framework). On July 16, 2020, the Court of Justice of the European Union or the CJEU, issued a landmark opinion in the case Maximilian Schrems vs. Facebook(Case C-311/18), called Schrems II. This decision (a) calls into question commonly relied upon data transfer mechanisms as between the EU member states and the U.S. (such as the Standard Contractual Clauses) and (b) invalidates the EU-U.S. Privacy Shield on which many companies had relied as an acceptable mechanism for transferring such data from the EU to the U.S. The CJEU is the highest court in Europe and the Schrems IIdecision heightens the burden on data importers to assess U.S. national security laws on their business and future actions of EU data protection authorities are difficult to predict. Consequently, there is some risk of data transfers from the EU being halted. While the recently-adopted EU-U.S. Data Privacy Framework is intended to address the issues and concerns raised by the CJEU in Schrems II and provide an approved method for cross-border data transfer from the EU to the U.S., it will likely be subject to future legal challenges and we have not yet certified to participate in the EU-U.S. Data Privacy Framework. If we have to rely on third parties to carry out services for us, including the processing of personal data on our behalf, we are required under the GDPR to enter into contractual arrangements to help ensure that these third parties only process such data according to our instructions and have sufficient security measures in place. Any security breach or non-compliance with our contractual terms or breach of applicable law by such third parties could result in enforcement actions, litigation, fines and penalties or adverse publicity and could cause customers to lose trust in us, which would have an adverse impact on our reputation and business.

Further, the United Kingdom’s decision to leave the European Union, often referred to as Brexit, has created uncertainty with regard to data protection regulation in the United Kingdom. In particular, while the Data Protection Act of 2018 that “implements” and complements the GDPR achieved Royal Assent on May 23, 2018 and is now effective in the United Kingdom, it is still unclear whether transfer of data from the European Economic Area to the United Kingdom will remain lawful under GDPR.

Other Governmental Regulation

We are subject to laws and regulations related to the protection of the environment, the health and safety of employees and the handling, transportation and disposal of medical specimens, infectious and hazardous waste and radioactive materials. For example, the U.S. Occupational Safety and Health Administration (“OSHA”) has established extensive requirements relating specifically to workplace safety for employers in the United States. This includes requirements to develop and implement multi-faceted programs to protect workers from exposure to blood-borne pathogens, including preventing or minimizing any exposure through needle stick injuries. For purposes of transportation, some biological materials and laboratory supplies are classified as hazardous materials and are subject to regulation by one or more of the following agencies: the U.S. Department of Transportation, the U.S. Public Health Service, the United States Postal Service and the International Air Transport Association. We generally use third-party vendors to dispose of regulated medical waste, hazardous waste and radioactive materials that we may use during our research.

International Laws and Regulations for IVD Products

Whether or not we obtain FDA marketing authorization for a clinical diagnostic product in the future, we must still obtain the requisite approvals from regulatory authorities in non-U.S. countries prior to the marketing of any product for clinical diagnostic use in those countries. The regulations in other jurisdictions vary from those in the United States and may be easier or more difficult to satisfy and are subject to change. For example, the European Commission published Regulation (EU) 2024/1860 in July 2024. This new regulation amended Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostics (IVD Regulation). Under Regulation (EU) 2024/1860, the transitional periods for certain IVDs have been extended, the implementation of the EUDAMED database will be rolled out in phases, and manufacturers are required to provide notification to the competent authority and healthcare institutions before the interruption or discontinuation of supply of certain medical devices and IVDs.

Outside of the European Union, regulatory authorization needs to be sought on a country-by-country basis in order for us to market any clinical diagnostic products. Some countries have adopted medical device regulatory regimes, such as the Medical Device Administrative Control System (“MDACS”) published by the Hong Kong Department of Health, the Health Sciences Authority of Singapore regulation of medical devices under the Health Products Act and Health Products (Medical Devices) Regulations, and Health Canada’s risk-based classification system for devices, among others, that incorporate IVD products like the FDA’s current system. Each country may have its own processes and requirements for IVD licensing, approval/clearance, and regulation, therefore requiring us to seek any regulatory approvals on a country- by-country basis.

Corporate Information

Quantum-Si Incorporated was originally incorporated under the laws of the State of Delaware on June 24, 2013. Our principal executive offices are located at 29 Business Park Drive, Branford, Connecticut 06405, and our telephone number is (866) 688-7374.

Information Available on the Internet

Our internet address is https://www.quantum-si.com, to which we regularly post copies of our press releases as well as additional information about us. Our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and all amendments to those reports, will be available to you free of charge through the Investor Relations section of our website as soon as reasonably practicable after such materials have been electronically filed with, or furnished to the SEC. The SEC maintains an internet site (http://www.sec.gov) that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. We include our web site address in this Annual Report on Form 10-K only as an inactive textual reference. The information contained in our website does not constitute a part of this report or our other filings with the SEC.